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#Study Description
Brief Summary
The aim of the study is to investigate how phosphorylation of STAT3, p38 mitogen-activated protein kinase (MAPK), extracellular signal-regulated kinase (ERK) and protein kinase B (AKT) reacts to remote ischemic conditioning (rIC) in healthy humans, which could point to mechanisms by which rIC may protect against ischemia-reperfusion injury (IRI), and if rIC affects immune reactivity.
Detailed Description
In rIC brief episodes of non-lethal ischemia and reperfusion in one vascular bed, tissue or organ, has shown to have protective effects against IRI in various organs. The protective effect of rIC seems convincing, but to date it is not clear which mechanisms give rIC its effects, and why effects are absent in some situations. Effects of rIC on the immune system are also not clear, but important if rIC is used in transplantation and autoimmunity settings, and also in regards to infection risk. Patients studied have often been given medical treatment and/or have comorbidities affecting the results.
This project will measure how intracellular phosphorylation of STAT3, p38 MAPK, ERK and AKT, inflammatory cell patterns and cytokine production react to rIC in healthy humans, and potentially give a better understanding of the mechanisms that mediate the protective effects of rIC. The intracellular mediators studied are involved in the initiation of cytokine production and regulate apoptosis and activation of the inflammatory cells. An altered balance between leucocytes and their mediators could be of importance for rIC effects, particularly in transplantation and autoimmunity, and this will be elucidated in our study.
As a secondary end point the investigators will measure the effect of rIC on pulse variability and blood pressure using a non-invasive device, since evidence regarding these aspects is sparse, although documented positive effects of rIC have primarily been on the heart and vascular system.
#Intervention
- DEVICE : Single Cuff Tourniquet 8000
- If randomized to ischemic conditioning the cuff will be inflated as stated before. If randomized to non-ischemic conditioning the cuff will not be inflated.
- Other Names :
- 20-54-711, 20-54-712
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy and well
Exclusion Criteria:
* Smoker.
* Taking regular medication.
* Any acute, chronic or systemic disease
* No hard physical exercise 72 hours prior to study participation.
* No alcohol or caffein-containing drinks 24 hours prior to study participation.
* Fasted for at least 6 hours prior to study participation.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03541239
|
{
"brief_title": "Immune Modulation by Ischemic Pre-conditioning in Healthy Individuals: Intracellular Signalling in Regulatory Cells",
"conditions": [
"Ischemia Reperfusion Injury",
"Ischaemia Reperfusion Injury"
],
"interventions": [
"Device: Single Cuff Tourniquet 8000"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT03541239",
"official_title": "Immune Modulation by Ischemic Pre-conditioning in Healthy Individuals: Intracellular Signalling in Regulatory Cells",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-07-19",
"study_completion_date(actual)": "2016-07-19",
"study_start_date(actual)": "2016-03-31"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-22",
"last_updated_that_met_qc_criteria": "2018-05-29",
"last_verified": "2016-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-05-30",
"first_submitted": "2016-06-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Efficacy and safety of Traditional Chinese Medicine (Wendan decoction) combined with conventional neurologic intensive care in patients with acute moderated to severe brain injury in early stage - A randomized controlled study.
Detailed Description
This study adopted a prospective, randomized controlled design. All eligible patients included in the study agreed to participated and signed the informed consent from and the study procedures were approved by the ethical committee of Taichung Tzu Chi general hospital (REC103-26). Patients were recruited from the neurosurgery department of Taichung Tzu Chi general hospital between June 2014 and July 2015. A total of 60 patients were enrolled in this study and randomized into intervention group and control group. All patients of both groups were enrolled within 14 days after episode and a follow-up interview until 6 months from the onset. The intervention group mean regular neuro-intensive care combined TCM and the intervention group mean only neuro-intensive care. But there are 7 patients in intervention group and 12 patients in control group quit out this study
#Intervention
- DRUG : Wendan decoction combination in acute brain injury
- In the intervention group, traditional Chinese medicine was given between 14 days of onset and TCM was used 1 month at least in intervention group.
|
#Eligibility Criteria:
Inclusion Criteria:
* traumatic brain injury or spontaneously intracerebral hemorrhage within 14 days of onset;
* an initial score of 3 <= age <= 12 points of GCS score;
* adults between 18 <= age <= 80 old;
* and signed informed consent form.
Exclusion Criteria:
* after 14 days of onset;
* a history of previous TBI or stroke;
* intracranial aneurysm or arteriovenous malformation ruptured;
* combination other major organ injury (heart, lung, intra-abdomen organ, pelvic fracture, major vessels);
* other severe disease such as heart or kidney failure;
* previous diagnosed cancer; and pregnant women.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03851809
|
{
"brief_title": "Safety and Efficacy of Wendan Decoction in Acute Moderated to Severe Brain Injury",
"conditions": [
"Acute Brain Injury"
],
"interventions": [
"Drug: Wendan decoction combination in acute brain injury"
],
"location_countries": null,
"nct_id": "NCT03851809",
"official_title": "A Randomized Controlled Trial of Wendan Decoction as a Palliative Treatment for Acute Brain Injury",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07-31",
"study_completion_date(actual)": "2016-01-31",
"study_start_date(actual)": "2014-06-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-22",
"last_updated_that_met_qc_criteria": "2019-02-21",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-22",
"first_submitted": "2019-02-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Robotic-assisted laparoscopic prostatectomy (RALP) is the gold standard surgical technique in prostate surgery. Many Robotic-laparoscopic surgical techniques also require the intraoperative deep Trendelenburg position and intravenous fluid restriction during surgery. However, the possible side effects of the deep Trendelenburg's position and the fluid restriction on the cardiovascular and renal systems during surgery are unknown. Although the Trendelenburg position is a life-saving maneuver in hypovolemic patients, it also carries undesirable risks. Long console time may contribute to the development of acute kidney injury (AKI) by prolonging the Trendelenburg time and the fluid-restricted time. In this study, investigators aimed to demonstrate the effect of console time on the development of AKI. Investigators also aimed to determine the hemodynamic risk factors that cause the development of AKI in patients monitored with the pressure Recording Analytical Method (PRAM).
Detailed Description
Although open surgery has been used for a long time in the treatment of prostate diseases, robotic-assisted laparoscopic prostatectomy (RALP) has become more common in the last 20 years. The excellence in results has made the use of the robot the gold standard in prostate surgery. However, the presence of two critical factors during RALP surgery still bothers clinicians. The first of these is severe fluid restriction and the other is the deep Trendelenburg position and pneumoperitoneum. The prolongation of the robotic console time also causes the prolongation of fluid restriction and Trendelenburg time. This combination may cause significant pathophysiological changes in both the renal and cardiac systems and may lead to postoperative acute renal injury (AKI). AKI is a serious clinical complication with increasing incidence and is associated with adverse short-term and long-term outcomes worldwide, resulting in a large healthcare burden. Intraoperative advanced monitoring techniques can contribute to the prevention of renal damage that may occur by providing early recognition of these pathophysiological changes occurring in the renal and cardiac systems.
The aim of our study was to determine the effect of console duration on the incidence of AKI after RALP which was managed using intraoperative advanced monitoring techniques (pressure recording analytical method-PRAM). In addition, this study aimed to evaluate the ability of changes in hemodynamic parameters to predict the development of AKI in RALP patients who underwent restrictive fluid therapy.
#Intervention
- OTHER : Restrictive fluid therapy
- 0,5 ml/hour fluid administration during prostatic anastomosis.
After general anesthesia induction, the patients were placed in the deep Trendelenburg position (at least 25°-45° upside down).
- Other Names :
- Trendelenburg position.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with American Society Of Anesthesiology physical status 1 <= age <= 3
* Underwent Robotic-assisted laparoscopic prostatectomy
* Underwent restrictive fluid therapy during the console period
Exclusion Criteria:
* Under 18 years
* Arrhythmia (atrial fibrillation, frequent premature beat)
* History of myocardial infarction in the last 3 months
* Heart failure
* Severe pre-existing lung disease
* Severe valvular heart disease
* Chronic renal disease on dialysis,
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 100 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06000098
|
{
"brief_title": "Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy",
"conditions": [
"Acute Kidney Injury",
"Hemodynamic Instability"
],
"interventions": [
"Other: Restrictive fluid therapy"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06000098",
"official_title": "Effect of Console Time on the Development of Acute Kidney Injury in Robotic-assisted Laparoscopic Prostatectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-15",
"study_completion_date(actual)": "2023-10-16",
"study_start_date(actual)": "2023-09-25"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-02",
"last_updated_that_met_qc_criteria": "2023-08-11",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-21",
"first_submitted": "2023-08-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study done in healthy, non-malnourished young and elderly subjects, is to measure the bioavailability of protein intake and the variation of metabolic markers following consumption of pea protein ' NUTRALYS ® S85 plus' or a reference protein brought in water either alone or at the end of a standardized meal.
#Intervention
- DIETARY_SUPPLEMENT : Pea protein (NUTRALYS ® S85 plus) in water
- After selection and randomization, the subjects will consume per os Pea protein (NUTRALYS® S85 plus) in water containing 0,41 g of tested protein/kg of body weight.
- DIETARY_SUPPLEMENT : Pea protein (NUTRALYS ® S85 plus) within meal
- After selection and randomization, the subjects will consume per os Pea protein (NUTRALYS® S85 plus) within a meal containing 0,41 g of tested protein/kg of body weight.
- DIETARY_SUPPLEMENT : Whey protein in water
- After selection and randomization, the subjects will consume per os whey protein in water containing 0,41 g of tested protein/kg of body weight.
- DIETARY_SUPPLEMENT : Whey protein within meal
- After selection and randomization, the subjects will consume per os whey protein within a meal containing 0,41 g of tested protein/kg of body weight.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult male volunteers, aged over 65 or under 30
* Body mass index (weight in kg/ height² in m²) between 22 and 28 kg/m²,
* Subjects considered to be healthy by the principal investigator doctor according to the interview, medical and clinical examination,
* Biological assessment considered compatible with participation in the study,
* Persons able to sign the informed consent,
* Persons affiliated to social security scheme.
Exclusion Criteria:
* Pathologies or treatments not compatible with the study
* Food allergy or a contraindication to the consumption of the products tested
* Subject in a situation which, in the opinion of the investigator, could interfere with their optimal participation in the study or constitute a particular risk for the subject,
* Subject with a particular diet (vegetarians, vegans, nutritional supplements, etc.),
* Subject weighing < 55 kg,
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06381869
|
{
"brief_title": "Bioavailability of Pea Protein in Young and Old Volunteers",
"conditions": [
"Healthy Male Volunteers"
],
"interventions": [
"Dietary Supplement: Whey protein within meal",
"Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) in water",
"Dietary Supplement: Whey protein in water",
"Dietary Supplement: Pea protein (NUTRALYS ® S85 plus) within meal"
],
"location_countries": [
"France"
],
"nct_id": "NCT06381869",
"official_title": "Study of Comparative Bioavailability, Randomized, in Open Cross Over the Kinetics of Subsequent Plasma Amino Acid Concentrations the Consumption of Pea Protein 'NUTRALYS ® S85 Plus'.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-06-13",
"study_completion_date(actual)": "2019-06-13",
"study_start_date(actual)": "2019-01-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-24",
"last_updated_that_met_qc_criteria": "2024-04-19",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-04-24",
"first_submitted": "2024-04-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objectives of this clinical study include:
* Assess the rate of dislocation and fracture of THA using the new (the 4th generation) ceramic implants.
* Evaluate the survival rate of THA using the new alumina-zirconia (the 4th generation) composite ceramic bearing.
* Investigate the performance of the 4th generation ceramic implants mostly in patients younger than 50 years.
* Compare the preoperative and postoperative scores of Harris Hip Score, UCLA Activity Score and WOMAC.
Detailed Description
This study will evaluate incidence of dislocation and short-term clinical outcome on patients who undergo large diameter 4th generation ceramic bearing total hip Arthroplasty ('THA') in comparison to historical data on 3rd generation CoC THA (28mm) patients. Specifically the study intends to address the following research topics:
1. The incidence of dislocation after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing.
2. The incidence of ceramic fracture after THA with use of the 4th generation Ceramic Bearing in comparison to 3rd generation Ceramic Bearing
3. The survival rate, wear rate, and incidence of osteolysis of THA with use of the 4th generation Ceramic Bearing
4. Range of motion improvement from preoperative to postoperative to support Korean sitting style after THA with use of the 4th generation Ceramic Bearing.
5. Clinical outcomes, activity level and QoL of patients with use of the 4th generation Ceramic Bearing.
6. The performance of THA with use of the new ceramic bearing mostly in patients younger than 50 years.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients suitable for primary Total Hip Replacement
* Patients with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of:
1. Osteoarthritis
2. Avascular necrosis
3. Legg Perthes
4. Rheumatoid Arthritis
5. Diastrophic variant
6. Fracture of the pelvis
7. Fused hip
8. Slipped capital epiphysis
9. Subcapital fractures
10. Traumatic arthritis
* Patients aged over 20
* Patients must be able to understand instructions and be willing to return for follow-up
Exclusion Criteria:
* Absolute contraindications include: infection, sepsis, and osteomyelitis
* Relative contraindications include:
1. uncooperative patient or patient with neurologic disorders who are incapable of following directions,
2. osteoporosis,
3. metabolic disorders which may impair bone formation,
4. osteomalacia,
5. distant foci of infections which may spread to the implant site,
6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and
7. vascular insufficiency, muscular atrophy, or neuromuscular disease.
8. pregnancy
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01103882
|
{
"brief_title": "Short-Term Clinical Outcome of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing",
"conditions": [
"Arthropathy of Hip"
],
"interventions": null,
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01103882",
"official_title": "Short-Term Clinical Outcome Including Dislocation Rate and Ceramic Fracture of Total Hip Arthroplasty Using Larger Diameter of 4th Generation Ceramic Bearing",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-08",
"study_completion_date(actual)": "2017-12",
"study_start_date(actual)": "2010-05"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-06-26",
"last_updated_that_met_qc_criteria": "2010-04-13",
"last_verified": "2018-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-04-15",
"first_submitted": "2010-04-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to prove the safety and efficacy of the SIELLO pacemaker leads.
Detailed Description
The assessment of the safety of SIELLO pacemaker leads is based on the collection of complications which are related to the leads. The assessment of efficacy of the SIELLO pacemaker leads is based on the collection of standard electrical lead data during the implant and follow-up procedures. Subsequent to the implantation of the SIELLO leads,five follow-up visits have been scheduled: at pre-discharge and after 1, 3, 6 and 12 months.
#Intervention
- DEVICE : Pacemaker therapy
- Implantation of the SIELLO pacemaker leads
|
#Eligibility Criteria:
Inclusion Criteria:
* Meet the indications for pacemaker therapy
* Understand the nature of the procedure
* Give informed consent
* Able to complete all testing required by the clinical protocol
* Available for follow-up visits on a regular basis at the investigational site
Exclusion Criteria:
* Meet none of the pacemaker indications
* Meet one or more of the contraindications
* Have a life expectancy of less than six months
* Cardiac surgery in the next six months -Enrolled in another cardiac clinical investigation- Have other medical devices that may interact with the implanted pacemaker
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00943046
|
{
"brief_title": "Master Study for the Investigation of Safety and Efficacy of the SIELLO Pacemaker Leads",
"conditions": [
"Cardiac Pacemaker Syndrome"
],
"interventions": [
"Device: Pacemaker therapy"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT00943046",
"official_title": "Master Study of the SIELLO Pacemaker Leads",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-11",
"study_completion_date(actual)": "2010-12",
"study_start_date(actual)": "2009-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-26",
"last_updated_that_met_qc_criteria": "2009-07-20",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-07-21",
"first_submitted": "2009-07-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the anti-tumor activity of Everolimus among children with recurrent or progressive ependymoma. Recurrent or progressive ependymoma is incurable and has very limited treatment options. The rationale for this study is based upon both pre-clinical and clinical considerations: Immunohistochemistry studies have demonstrated that 20 out of 23 (87%) pediatric ependymomas are immunoreactive for phosphorylated S6, a biomarker that often predicts response to mTOR pathway-targeted therapy. Furthermore, children with with multiply recurrent ependymomas have had objective and durable responses to the mTOR inhibitor, Sirolimus (Rapamune, Pfizer). As a result of this pre-clinical and clinical data, this study will further investigate the activity of an mTOR pathway inhibitor, Everolimus, against children with recurrent or progressive ependymomas. In this study, Everolimus will be administered at a dose and schedule that have previously been demonstrated as safe and effective in children. Children may take Everolimus for up to 2 years on this study, until tumor progression or unacceptable toxicity.
Detailed Description
Ependymoma is the third most common central nervous system neoplasm in children, accounting for approximately 10% of childhood brain tumors. Although the prognosis for children with newly-diagnosed completely resected ependymomas is often good, children with incompletely resected tumors often suffer repeated episodes of tumor progression and die as a result of their tumor. The prognosis for children with recurrent or progressive ependymomas is especially dismal and the majority of children with recurrent or progressive ependymomas will eventually succumb to their tumor within 8.7 to 24 months. At the time of tumor recurrence, therapeutic options are limited. A recent report by Merchant and co-workers described several long-term survivors after tumor recurrence when treated with a second course of radiation therapy.
Unfortunately, although chemotherapy occasionally demonstrates anti-tumor activity against recurrent ependymoma, but responses are rarely durable.12 Indeed, a recent review by Bouffet and co-workers concluded that the frequency of durable responses of recurrent ependymomas to chemotherapy was disappointing and encouraged a re-evaluation of the current chemotherapeutic approach to intracranial ependymoma and that studies are needed to identify new biological targets to inform future clinical trials.
Everolimus is a novel derivative of rapamycin. It has been in clinical development since 1996 as an immunosuppressant in solid organ transplantation. Everolimus is approved in Europe and other global markets (trade name: Certican®) for cardiac and renal transplantation, and in the United States (trade name: Zortress®) for the prevention of organ rejection of kidney transplantation. Everolimus was developed in oncology as Afinitor® and was approved for advanced renal cell carcinoma (RCC) in 2009. In 2010, Afinitor® received United States (US) approval for patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS). Everolimus is also available as Votubia® in the European Union (EU) for patients with SEGA associated with TS. Afinitor® was approved for 'progressive pancreatic neuroendocrine tumor (PNET) in patients with unresectable, locally advanced, or metastatic disease' in 2011 in various countries, including the US and Europe. In 2012, Afinitor® received approval for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2- negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. Furthermore in 2012, Afinitor® received approval for the treatment of adult patients with TSC who have renal angiomyolipoma not requiring immediate surgery.
At the cellular and molecular level, Everolimus acts as a signal transduction inhibitor. It selectively inhibits mTOR (mammalian target of rapamycin), a key protein kinase which regulates cell growth, proliferation and survival. The mTOR kinase is mainly activated via the phosphatidylinositol 3-kinase (PI3-Kinase) pathway through AKT/PKB and the tuberous sclerosis complex (TSC1/2). Mutations in these components or in PTEN, a negative regulator of PI3-kinase, may result in their dysregulation. Abnormal functioning of various components of the signaling pathways contributes to the pathophysiology of numerous human cancers. Various preclinical models have confirmed the role of this pathway in tumor development.
The main known functions of mTOR include the following:
* mTOR functions as a sensor of mitogens, growth factors and energy and nutrient levels;
* Facilitating cell-cycle progression from G1-S phase in appropriate growth conditions;
* The PI3K/mTOR pathway itself is frequently dysregulated in many human cancers, and oncogenic transformation may sensitize tumor cells to mTOR inhibitors;
* PI3-kinase mutations have been reported in the primary tumor in 10-20% of human colorectal cancers;16,17
* The loss of PTEN protein, either through gene deletion or functional silencing (promoter hypermethylation), is reported in approximately 60% of primary human colorectal cancers;
* The mTOR pathway is involved in the production of pro-angiogenic factors (i.e., VEGF) and inhibition of endothelial cell growth and proliferation;
* Through inactivating eukaryotic initiation factor 4E binding proteins and activating the 40S ribosomal S6 kinases (i.e., p70S6K1), mTOR regulates protein translation, including the HIF-1 proteins. Inhibition of mTOR is expected to lead to decreased expression of HIF-1.
Everolimus inhibits the proliferation of a range of human tumor cell lines in vitro including lines originating from lung, breast, prostate, colon, melanoma and glioblastoma. IC50s range from sub/low nM to µM. Everolimus also inhibits the proliferation of human umbilical vein endothelial cells (HUVECS) in vitro, with particular potency against VEGF-induced proliferation suggesting that Everolimus may also act as an anti-angiogenic agent. The anti-angiogenic activity of Everolimus was confirmed in vivo. Everolimus selectively inhibited VEGF-dependent angiogenic response at well tolerated doses. Mice with primary and metastatic tumors treated with Everolimus showed a significant reduction in blood vessel density when compared to controls.
The potential of Everolimus as an anti-cancer agent was shown in rodent models. Everolimus is orally bioavailable, residing longer in tumor tissue than in plasma in a subcutaneous mouse xenograft model, and demonstrating high tumor penetration in a rat pancreatic tumor model. The pharmacokinetic profile of Everolimus indicates sufficient tumor penetration, above that needed to inhibit the proliferation of endothelial cells and tumor cell lines deemed sensitive to Everolimus in vitro.
Everolimus administered orally daily was a potent inhibitor of tumor growth, at well tolerated doses, in 11 different mouse xenograft models (including pancreatic, colon, epidermoid, lung and melanoma) and two syngeneic models (rat pancreatic, mouse orthotopic melanoma). These models included tumor lines considered sensitive and 'relatively resistant' in vitro. In general, Everolimus was better tolerated in mouse xenograft models than standard cytotoxic agents (i.e., doxorubicin and 5-fluorouracil), while possessing similar anti-tumor activity. Additionally, activity in a VEGF-impregnated subcutaneous implant model of angiogenesis and reduced vascularity (vessel density) of Everolimus-treated tumors (murine melanoma) provided evidence of in vivo effects of angiogenesis.
It is not clear which molecular determinants predict responsiveness of tumor cells to Everolimus. Molecular analysis has revealed that relative sensitivity to Everolimus in vitro correlates with the degree of phosphorylation (activation) of the AKT/PKB protein kinase and the S6 ribosomal protein; in some cases (i.e., glioblastoma) there is also a correlation with PTEN status.
In vivo studies investigating the anti-tumor activity of Everolimus in experimental animal tumor models showed that Everolimus monotherapy typically reduced tumor cell growth rates rather than produced regressions. These effects occurred within the dose range of 2.5 mg to 10 mg/kg, orally once a day.
In preclinical models, the administration of Everolimus is associated with reduction of protein phosphorylation in target proteins downstream of mTOR, notably phosphorylated S6 and phosphorylated 4EBP1, and occasionally with an increase in phosphorylated AKT, a protein upstream of mTOR signaling pathway.
All significant adverse events observed in toxicology studies with Everolimus in mice, rats, monkeys and mini-pigs were consistent with its anticipated pharmacological action as an anti-proliferative and immunosuppressant and at least in part reversible after a 2 or 4-week recovery period with the exception of the changes in male reproductive organs, most notably testes.
Rationale: The purpose of this study is to evaluate the anti-tumor activity of Everolimus among children with recurrent or progressive ependymoma. The rationale for this study is based upon both pre-clinical and clinical considerations. Recurrent or progressive ependymoma is incurable and has very limited treatment options. In 2011, the investigators group published a case report describing a young child with a multiply recurrent ependymoma after 4 chemotherapy regimens and several courses of radiation therapy and who had an objective and long lasting response to sirolimus (Rapamune, Pfizer). This patient, who had been treated with various regimens over a span of 20 months without response, subsequently had a near complete response to sirolimus of 18 months duration. Subsequently a second child with a recurrent ependymoma was treated with sirolimus and oral etoposide and had a near-complete response of 18 months duration. Furthermore, immunohistochemistry studies have revealed that 20 out of 23 (87%) pediatric ependymomas were immunoreactive for phosphorylated S6, a biomarker that often predicts response to mTOR pathway-targeted therapy.
Existing data regarding the anti-tumor activity of mTOR inhibitors among children has demonstrated that mTOR inhibitors are well tolerated and have activity against pediatric brain tumors. For example, Franz et al. reported five children with tuberous sclerosis complex and progressive subependymal giant cell astrocytomas who were treated with sirolimus to achieve target trough concentrations between 5 - 15 ng/mL. All tumors demonstrated objective responses to sirolimus. One patient who interrupted sirolimus therapy experienced tumor progression that responded to resumption of sirolimus therapy. A subsequent phase III study of everolimus compared responses of 78 patients treated with everolimus versus 39 patients treated with placebo. 27 of 78 (35%) patients in the everolimus group had at least 50% reduction in the volume of subependymal giant cell astrocytomas versus none in the placebo group (p\<0.0001). Adverse events were mostly grade 1 or 2 and no patients discontinued treatment because of adverse events.
Biomarkers of mTOR pathway activation and sensitivity to mTOR inhibitors, including phosphorylated S6235/236, phosphorylated S6240/244, phosphorylated 4EBP1, phosphorylated PRAS40 (pT246), phosphorylated P70S6K, and PTEN expression, will be performed. Although these biomarkers have, to varying degrees, been correlated with mTOR pathway activation and sensitivity to mTOR inhibitors, these studies are considered to be exploratory in the context of this clinical trial.
#Intervention
- DRUG : Everolimus
- The recommended dose of Everolimus is 4.5 mg/m2/dose, once daily for up to 2 years, until disease progression or unacceptable toxicity occurs.
- Other Names :
- RAD001, AFINITOR
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis and Age: Ependymoma (WHO grade II) or Anaplastic Ependymoma (WHO grade III) that has relapsed or become refractory to standard therapy. Patients must have had histologic verification of their malignancy at original diagnosis or time of recurrence. Age must be >= 2 years and <= 21 years at study entry.
* Tumor tissue must be available (from either time of initial diagnosis or relapse) and submitted for central pathology review and correlative biological studies.
* Performance status: Lansky >= 50% for patients <= 10 years or Karnofsky >= 50% for patients > 10 years.
* Adequate bone marrow, liver and renal function.
* Fasting serum cholesterol <= 300 mg/dL OR <= 7.75 mmol/L AND fasting triglycerides <= 2.5 x the upper limit of normal. 6. Patients must have measurable residual disease, defined as tumor that is measurable in two diameters on MRI. Diffuse leptomeningeal disease is not considered measurable.
* Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy prior to participating in this trial. No prior myelosuppressive chemotherapy for 28 days prior to study enrollment. Must not have received craniospinal radiation therapy within 24 weeks prior to study entry and no involved field radiation therapy for 12 weeks prior to study enrollment. If patients received prior monoclonal antibody treatment, at least three half-lives must be elapsed by the time of treatment initiation. No investigational drugs for 4 weeks prior to study enrollment.
* MRI of the brain and the complete spine: All patients must have an MRI of the brain and spine that has measurable tumor (not only diffuse leptomeningeal tumor) within two weeks prior to study enrollment.
Exclusion Criteria:
* Prior treatment with Everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus).
* Concommitant use of medications known to have inhibition or induction of CYP3A enzymes. Systemic corticosteroids (e.g., dexamethasone is a CYP3A inducer) are not allowed. Inhaled corticosteroids are allowed.
* Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral Everolimus.
* Uncontrolled diabetes mellitus as defined by HbA1c > 8% despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout the trial and adjusted as necessary.
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02155920
|
{
"brief_title": "Everolimus for Children With Recurrent or Progressive Ependymoma",
"conditions": [
"Recurrent Childhood Ependymoma"
],
"interventions": [
"Drug: Everolimus"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02155920",
"official_title": "Phase II Study of Everolimus (RAD001, Afinitor®) for Children With Recurrent or Progressive Ependymoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-07-14",
"study_completion_date(actual)": "2023-07-14",
"study_start_date(actual)": "2015-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-05-08",
"last_updated_that_met_qc_criteria": "2014-06-02",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-06-04",
"first_submitted": "2014-05-29",
"first_submitted_that_met_qc_criteria": "2024-04-15"
}
}
}
|
#Study Description
Brief Summary
This study began enrollment in 2003 with final report completed in October of 2015. This submission is being provided to acquire an NCT number.
This study was successfully executed according to protocol with full enrollment and completion of 89.7% of subjects. Subjects were enrolled into a two arm study 1) Combined therapy (scaling and root planing plus Crest products) vs. 2) delayed treatment. Subjects were followed for 6 months and a wide and extensive battery of biological samples were collected to determine the effects of treatment on the local and systemic inflammatory response.
Detailed Description
The design for this study was a single-blinded, delayed treatment, controlled, randomized, clinical trial. A total of 106 subjects, 2 sets of 53 patients each in one of 2 arms, were enrolled. For both groups at 6 weeks, 3 months, and 6 months periodontal measures, gingival crevicular fluid, and plaque were taken using standardized techniques. Blood for serum was collected at each time point, plus at an additional 2 week visit. GCF samples were collected and analyzed for PGE2 and IL-1 to provide a mediator assessment of periodontal status.These GCF data and the clinical changes were used to assure that the therapy provided had resulted in a local therapeutic benefit. These data were primarily useful as it relates to changes in systemic levels of mediators.
Subjects were recruited from the surrounding communities by means of flyer advertisements, as well as media advertisements in weekly newspapers and on the radio. Recruitment focused on subjects between the ages of 18 and 64 years with periodontal disease.
The investigators excluded persons who have less than 20 teeth; who had any serious systemic disease including: auto-immune type disorders (i.e. systemic lupus erythematous), immunosuppression (chronic systemic c steroid use, cancer chemotherapy or HIV infection), chronic liver disease including hepatitis, or diabetes mellitus; extremely obese (BMI \<40), are pregnant, or who abuse alcohol or drugs. Subjects were selected from periodontal screening examinations as having 4 or more sites with pocket depths of 5 or more mm and two or more sites with attachment loss of 3 mm or more and who required scaling and root planing.
The Phase II set of 106 patients had periodontal therapy consisting of one of two treatments:
Treatment 1: A 6-week observation period (treatment delay), then full-mouth scaling and root planing plus specific oral hygiene regimen (OHR) (Group 1);
Treatment 2: A 6-week observation period (treatment delay), then a further 6-month observation period (delayed treatment), followed by scaling and root planing plus specific oral hygiene regimen (OHR) at 6 months (Group 2).
#Intervention
- PROCEDURE : Scaling and Root Planing (S&RP)
- dental Scaling and Root Planing and oral hygiene regimen
- Other Names :
- Scaling & Root Planing (S&RP)
|
#Eligibility Criteria:
Inclusion Criteria:
* subjects with four or more periodontal pockets of five millimeters or greater and two or more sites with an clinical attachment loss of three millimeters or greater.
Exclusion Criteria:
* subjects with less than 20 teeth
* subjects with serious systemic diseases (lupus, systemic erythematous), immunosuppression (chronic systemic steroid use, cancer, chemotherapy, or HIV infection), chronic liver disease including hepatitis or diabetes mellitus.
* Body Mass Index of of 40 or greater
* pregnant
* abuse alcohol or drugs
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03375372
|
{
"brief_title": "Effects of Periodontal Therapy on Markers of Acute Phase Response, Oxidative Stress",
"conditions": [
"Periodontitis"
],
"interventions": [
"Procedure: Scaling and Root Planing (S&RP)"
],
"location_countries": null,
"nct_id": "NCT03375372",
"official_title": "Effects of Periodontal Therapy on Markers of Acute Phase Response (APR), Oxidative Stress: Phase II {Formerly UNC Biomedical IRB Study # DENT-2019}",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2004-08-01",
"study_completion_date(actual)": "2005-06-04",
"study_start_date(actual)": "2003-04-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-12-18",
"last_updated_that_met_qc_criteria": "2017-12-11",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-12-18",
"first_submitted": "2017-12-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Permanent prostate implants are a type of radiation therapy in which a high dose of radiation is delivered to cancerous tissue by many small radioactive 'seeds'. Studies of early-stage prostate cancer patients treated in this way and followed for 10 - 12 years indicate a cure rate of about 80%. This result is similar to surgery and other forms of radiotherapy, but comes with fewer side effects and greater convenience for the patient. Further studies show that the radiation dose delivered is the most important factor in achieving a cure. At present this dose is estimated by a computer, using a computed tomography (CT) scan of the patient and a simple calculation method. The dose estimate is not as accurate as it could be, however, because the precise extent of the prostate is hard to determine from the CT scan, and the calculation method does not make use of information about patient body tissues. The researchers propose to eliminate these inaccuracies by using magnetic resonance imaging (MRI) to identify the prostate gland and by developing an improved dose calculation algorithm that includes information about patient tissues. This new approach will allow physicians to assess implant quality with greater certainty, improve their implant technique, and ultimately increase the cure rate to as much as 95%.
Detailed Description
This study addresses three major sources of post-implant dosimetry inaccuracy for permanent prostate implants: post-operative edema, prostate contour delineation, and dose calculation method. It is hypothesized that a pragmatic edema model can minimize the first uncertainty, co-registered CT + MR images the second, and an improved dose calculation algorithm the third.
Detailed objectives are to:
* measure and model the effects of edema on dosimetry;
* evaluate CT + MR image registration methods;
* compare dosimetry for CT alone vs. CT + MRI using the contemporary TG-43 dose calculation method;
* set up a Monte Carlo code that makes full use of the information in CT + MR images to perform implant dose calculations;
* compare prostate dosimetry for the Monte Carlo vs. the simpler TG-43 method;
* develop an analytical post-implant dose calculation algorithm for routine clinical use (Monte Carlo is too slow on a single-CPU brachytherapy planning computer); and finally
* assess the performance of the new algorithm.
Of the estimated 250,000 new cases of prostate cancer in North America in 2004, most are early stage disease as a consequence of PSA testing. Permanent prostate implant therapy is a major option for this group, as long-term clinical studies indicate a cure rate equal to surgery and external beam radiotherapy, but with fewer complications. By dealing with dosimetric inaccuracies, a proven treatment can reach its full potential.
#Intervention
- PROCEDURE : Permanent prostate implant
|
#Eligibility Criteria:
Inclusion Criteria:
* Candidate for permanent prostate implant
Exclusion Criteria:
* Not ambulatory
Sex :
MALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00127816
|
{
"brief_title": "Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy",
"conditions": [
"Prostate Cancer"
],
"interventions": null,
"location_countries": [
"Canada"
],
"nct_id": "NCT00127816",
"official_title": "Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-04",
"study_completion_date(actual)": "2013-04",
"study_start_date(actual)": "2005-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-16",
"last_updated_that_met_qc_criteria": "2005-08-05",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-08-09",
"first_submitted": "2005-08-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess the safety and tolerability of TAK-994 following single and multiple oral doses in healthy non-Japanese and Japanese adult participants and healthy elderly participants.
Detailed Description
The drug being tested in this study is called TAK-994. TAK-994 is being tested to find a safe and well-tolerated dose in healthy participants (non-Japanese and Japanese) and healthy elderly participants. The study will enroll up to approximately 160 healthy participants. The study consists of 6 parts and up to 20 cohorts as mentioned below.
* TAK-994: Part A: Single-rising dose (SRD) design to assess the safety, tolerability, and PK of TAK-994 and effect of food on the PK of the TAK-994
* TAK-994: Part B: MRD design to assess the safety, tolerability, PK and PD of TAK-994
* TAK-994: Part C: MRD design to assess the safety, tolerability, PK and PD of TAK-994 and also central nervous system penetration relative to plasma concentrations of TAK-994
* TAK-994: Part D: MRD design to assess the safety, tolerability, PK and PD of TAK-994 for HE participants
* TAK-994: Part E: SRD and MRD design to assess the safety, tolerability, PK and PD of TAK-994 for Japanese origin participants
* TAK-994: Part F (Optional Cohort): Nonrandomized design to assess orexin (OX) levels in the cerebrospinal fluid (CSF) of untreated healthy adult participants.
Participants in each cohort will be randomized to receive treatment with TAK-994 or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). Participants in optional Part F will receive no study drug.
This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 10 months. Participants will be followed up for 7 days after the last dose of study drug for a follow-up assessment.
#Intervention
- DRUG : TAK-994
- TAK-994 tablets.
- DRUG : TAK-994 Placebo
- TAK-994 placebo-matching tablets.
|
#Eligibility Criteria:
Inclusion Criteria:
* Be normotensive, with no history of hypertension or use of antihypertensive medication. Blood pressure (BP) must be less than (<) 140 millimeter of mercury (mmHg) (systolic) and <90 mmHg (diastolic).
Healthy Adult and Elderly Participants (Parts A through D and Part F)
* Must have a body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2) at the screening visit (non-Japanese only).
Healthy Adult Participants (Parts A, B, C, and F)
* Must be aged 18 <= age <= 55, inclusive, at the screening visit.
* Must have a body weight >=50 kilogram (kg) at the screening visit.
HE Participants (Part D)
* Must be aged >=65 years, inclusive, at the time of informed consent.
* Must have a body weight >=40 kg at the screening visit.
Healthy Japanese Adult Participants (Part E)
* Must be aged 18 <= age <= 55, inclusive, at the screening visit.
* Must have a BMI >=18.0 and <=26.0 kg/m^2 at the screening visit.
* Must have been born in Japan to a Japanese mother and father and have maternal and paternal Japanese grandparents.
* Must have not been away from Japan for more than 10 years at the screening visit.
* In the opinion of the investigator, must have a lifestyle that has not changed significantly since relocation from Japan.
Exclusion Criteria:
* Has a known hypersensitivity to any component of the formulation of TAK-994 or related compounds.
* Has a risk of suicide according to endorsement of Item 4 or 5 of the screening/baseline visit Columbia Suicide Severity Rating Scale (C-SSRS) or has made a suicide attempt in the previous 6 months.
* Has a lifetime history of major psychiatric disorder, such as bipolar disorder or schizophrenia. Participant who have history of major depressive disorder (MDD) may be included, but participants who have current active MDD or who have had active MDD in the past 6 months are excluded.
* Has a clinically significant history of head injury or head trauma.
* Has a history of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation.
* Screening electrocardiogram (ECG) reveals a QT interval with the Fridericia's correction method (QTcF) greater than (>) 450 millisecond (ms) (men) or >470 ms (women).
* Has a resting heart rate outside of the range of 45 to 100 beats per minute, confirmed on repeat testing within a maximum of 30 minutes).
Healthy Non-Japanese Adult Participants (Part C and Part F)
* Has undergone CSF collection within 30 days before check-in (Day -2 [Part C] or Day -1 [Part F]).
* Has a known hypersensitivity to anesthesia or its derivatives used during CSF collection or to any medication used to prepare the area of lumbar puncture.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03933488
|
{
"brief_title": "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Healthy Participants",
"conditions": [
"Healthy Participants"
],
"interventions": [
"Drug: TAK-994 Placebo",
"Drug: TAK-994"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03933488",
"official_title": "A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-29",
"study_completion_date(actual)": "2020-03-29",
"study_start_date(actual)": "2019-05-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-06-24",
"last_updated_that_met_qc_criteria": "2019-04-29",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-01",
"first_submitted": "2019-04-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Collagen Supplement is a natural ingredient that contains native collagen derived from chicken sternum. Collagen Supplement is efficacious and safe on healthy subjects as compared to placebo.
Detailed Description
This study will include 100 healthy volunteers in which will be evaluated if the collagen supplement is able to obtain differences versus placebo in pain and function. It will be a randomized, double-blind, placebo-controlled study with proportion 1:1 between treatments
#Intervention
- DIETARY_SUPPLEMENT : Native type II collagen
- 1 capsule/day
- DIETARY_SUPPLEMENT : Placebo
- 1 capsule/day
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and non-pregnant females 30 <= age <= 65 years with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2. (see Section 4.0)
* Unilateral or bilateral knee discomfort for greater than 3 months.
* VAS score during knee movement between 30 <= age <= 50 mm after 7-day withdrawal of excluded medications.
* Reach joint discomfort of 5/10 on a 11-point Likert scale ( score 0 to 10) within 10 minutes of going up and down stairs.
* Clinical laboratory results that are within normal range or considered not clinically significant by the Principal Investigator.
* Be willing to participate in all scheduled visits, tests, and other trial procedures according to the clinical protocol. To do so and be able of using the fitness tracker, a phone or tablet compatible with the Fitbit app is required. (Apple iOS 12.2 or higher, Android OS 7.0 or higher.)
* Be willing to refrain from taking ibuprofen, aspirin or other Non-steroidal anti-inflammatory drugs (NSAIDs), or any other pain reliever (OTC (Over the Counter) or prescription) during the entire study other than acetaminophen (paracetamol) as rescue medication.
* Provide a signed and dated informed consent indicating that the subject has been informed of all pertinent aspects and possible risks associated with participation in the study.
* Be willing to refrain from taking dietary supplements during the entire study that have any underlying joint benefit (collagen, glucosamine, chondroitin, MSM, Hyaluronic Acid, Turmeric, Natural Eggshell Membrane, Omega-3 fatty acids, PEA, Boswellia,...)
Exclusion Criteria:
* History of hypersensitivity to the rescue medication or any of the products used in the study.
* Requirement of drugs to control joint discomfort.
* Regular drug intake to control any kind of pain.
* History of hypersensitivity to eggs, chicken, or fowl.
* History of Knee OA (OsteoArthritis), inflammatory arthropathy, RA (Rheumatoid Arthritis), OA (VAS score greater than 50), or Systemic Lupus Erythematosus.
* Hyperuricemia (>440 μmol/L), history of gout, or both.
* Exercising (intentionally) for more than 10 hours a week
* High intensity exercise for more than 5 hours a week
* Anticipation of surgery within the next 6 months.
* Recent injury in the target knee (past 4 months).
* History of congestive heart failure.
* Anticipated problems with product consumption.
* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies within the last 5 years.
* High alcohol intake (>2 standard drinks per day) or use of recreational drugs (e.g., cocaine, methamphetamine, marijuana, etc.).
* Females who are pregnant or lactating or planning to become pregnant.
* History of any mental illness that might impair the ability of subjects to provide a written informed consent.
* Use of oral corticosteroid, indomethacin, SYSADOAs (symptomatic slow action drug osteoarthritis) within 3 months of Visit 1; topical treatment with corticosteroids within 1 week of visit 1, and consumption of Omega 3 fatty acids or any other joint health dietary supplements within 2 weeks preceding the treatment period.
* Consumed, ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription), or any natural health product, (excluding vitamins) within 7 days of first visit.
* Consumed acetaminophen (paracetamol) within 48 hours of randomization visit.
* Participation in any clinical trials within 30 days prior to first visit.
* Individuals following an energy restricted diet for weight loss
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05282992
|
{
"brief_title": "NAtive Collagen Type II In Healthy VoluntEers With Joint Discomfort",
"conditions": [
"Joint Pain"
],
"interventions": [
"Dietary Supplement: Native type II collagen",
"Dietary Supplement: Placebo"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT05282992",
"official_title": "A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Tolerability of a Food Supplement in Healthy Volunteers With Joint Discomfort",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-14",
"study_completion_date(actual)": "2024-03-18",
"study_start_date(actual)": "2022-03-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-29",
"last_updated_that_met_qc_criteria": "2022-03-07",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-16",
"first_submitted": "2022-02-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug or radiation regiments used to treat cancer. This study examines the investigational drug SCV-07 and it's possible application in treating Oral Mucositis. Studies have shown that SCV-07 can possibly increase a broad immune system response, thus lowering the painful side effects experienced when treated for head and neck cancer.
The purpose of this study is to assess the safety and tolerability of SCV-07 and it's ability to delay the onset of Oral Mucositis for patients receiving chemoradiation for head and neck cancer.
#Intervention
- DRUG : Placebo
- Placebo
- DRUG : SCV-07
- 0.02 mg/kg
- DRUG : SCV-07
- 0.10 mg/kg
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject must have a body weight less than 150 kg at screening
* Have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation therapy as first line treatment(postoperative patients are eligible, if surgery is < 6 weeks prior to initiation of radiotherapy.
* Plan to receive a continuous course of conventional external beam irradiation
* Plan to receive a standard cisplatin chemotherapy regimen
Exclusion Criteria:
* Pregnant or breastfeeding
* Have head and neck tumors of the lips, sinuses, salivary glands or unknown primary tumor
* Prior radiation to the head and neck
* Have a plan to receive cetuximab (Erbitux) in conjunction with chemotherapy
* Had curative surgery more than 6 weeks prior to the initiation of radiotherapy
* Have current oral mucositis
* Presence of active infectious disease excluding oral candidiasis
* Chronic immunosuppression
* Seropositive for HIV or hepatitis B surface antigen or C antibody
* Used an investigational agent within 30 days of randomization
* Have a known sensitivity to any investigational agent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00756951
|
{
"brief_title": "Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer",
"conditions": [
"Oral Mucositis",
"Head and Neck Cancer"
],
"interventions": [
"Drug: Placebo",
"Drug: SCV-07"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00756951",
"official_title": "A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Safety and Efficacy of SC-07 for the Delay to Onset of Severe Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": null,
"study_start_date(actual)": "2008-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-11-23",
"last_updated_that_met_qc_criteria": "2008-09-18",
"last_verified": "2008-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-22",
"first_submitted": "2008-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is to observe the efficacy and safety of glucocorticosteroid treatment in the patients with chronic recurrent drug-induced liver injury (DILI).
Detailed Description
Drug-induced liver injury (DILI) refers to liver diseases caused by drugs and toxic substances. DILI is a clinical event that can be associated with severe outcomes such as acute liver failure. Up to now, approximately 1000 drugs, herbal products, vitamins and illicit compounds are associated with liver injury. Recently, the incidence of DILI is rising. In our hospital, hospitalized patients with DILI was increased from 1.39% in 2002 to 2.31% in 2006, and further up to 3.17% in 2011, which indicated 2.3-folds increase over last ten years.15% to 20% patients with acute DILI are prone to chronic liver disease. For patients with chronic recurrent DILI, routine liver protective treatment was difficult to rescue abnormal liver functions. Moreover, increasing health care costs seriously affect the patient's quality of life. Glucocorticosteroids can inhibit the non-specific inflammation and permeability of the capillary bile duct, limit the activation of T lymphocytes, and selectively inhibit B lymphocytes to produce antibodies, thus preventing or delaying the immune-induced liver injury. Glucocorticoid treatment of severe DILI has accepted some recognition, but the effect of repeated episodes of chronic DILI, due to a lack of randomized controlled studies, is still unclear. Therefore, we shall design two groups on the basis of the ratio of 1:1, namely, glucocorticoid treatment group and standard treatment alone group. Participants in glucocorticoid treatment group will receive methylprednisolone,48mg/d for the 1st week, 32mg/d for the 2nd week, 24mg/d for the next two weeks, followed by 16mg/d for 32 weeks and reduction in doses of methylprednisolone by 4 mg per 4 weeks until drug withdrawal. Participants in glucocorticoid treatment group also receive standard treatment including reduced glutathione, glycyrrhizin, ademetionine, alprostadil,or ursodeoxycholic acid (UDCA) in the first 12 weeks. Participants in standard treatment group will only receive treatment by routine liver protection drugs including reduced glutathione, glycyrrhizin, ademetionine, alprostadil, or ursodeoxycholic acid (UDCA) in the first 12 weeks.The efficacy and safety of glucocorticoid treatment in the patients with chronic recurrent DILI will be observed during the treatment and follow-up period.
#Intervention
- DRUG : Methylprednisolone
- Participants will receive methylprednisolone,48mg/d for the 1st week,32mg/d for the 2nd week,24mg/d for the next two weeks, followed by 16mg/d for 32 weeks and reduction in doses of methylprednisolone by 4 mg per 4 weeks until drug withdrawal.Participants will also receive standard treatment including reduced glutathione, glycyrrhizin, ademetionine, alprostadil, or ursodeoxycholic acid (UDCA) in the first 12 weeks.The total treatment duration will be 48 weeks. Follow-up duration is 24 weeks.
- Other Names :
- MEDROL,NDC0009-0056-02
- DRUG : Standard Treatment
- Participants will only receive standard treatment,namely,routine liver protection drugs including reduced glutathione, glycyrrhizin, ademetionine, alprostadil,or ursodeoxycholic acid (UDCA) from week 0 through week 12 study visit. Participants will then be followed until week 72.
- Other Names :
- Routine liver protection drugs
|
#Eligibility Criteria:
Inclusion Criteria:
* Meet with ACG clinic guidelines for diagnostic criteria of chronic DILI;
* Meet any of the following conditions:
* serum AST or ALT >= 10 fold ULN;
* serum AST or ALT >= 5 fold ULN and TBIL >= 2 fold ULN;
* liver histology indicates bridging necrosis or multiacinar necrosis or moderate or more inflammation or inflammation G3 or more;
* Women of childbearing age had a negative urine pregnancy test, and the subjects are willing to have no family planning during the study and to take effective measures;
* Voluntary participation, understanding and signing of informed consent, comply with the requirements of the research;
Exclusion Criteria:
* Patients with serious pre-existent comorbid conditions (vertebral compression fractures,psychosis,active peptic ulcer, brittle diabetes,uncontrolled hypertension;
* Patients with intolerances to prednisone;
* Patients with severe infection receiving antibiotics, anti-fungal,anti-viral therapy;
* Viral hepatitis,alcoholic or non-alcoholic liver disease,Wilson's disease or other inherited metabolic liver diseases.
* Pregnancy or desire of pregnancy;
* Breast-feeding;
* Liver cancer or other malignant tumor;
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT02651350
|
{
"brief_title": "Efficacy and Safety of Glucocorticosteroid Treatment in the Patients With Chronic Recurrent DILI",
"conditions": [
"Drug-induced Liver Injury,Chronic"
],
"interventions": [
"Drug: Methylprednisolone",
"Drug: Standard Treatment"
],
"location_countries": [
"China"
],
"nct_id": "NCT02651350",
"official_title": "A Randomized Controlled Clinical Trial on the Efficacy and Safety of Glucocorticosteroid in the Patients With Chronic Recurrent Drug-induced Liver Injury",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-07",
"study_completion_date(actual)": "2019-07",
"study_start_date(actual)": "2015-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-08-11",
"last_updated_that_met_qc_criteria": "2016-01-07",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-01-11",
"first_submitted": "2015-12-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Cases which undergone ICSI before with failure of fertilization will do another ICSI cycle with removal of the polar body just before the ICSI procedure and sperm injection at the site of polar body removal. This study group will be evaluated with another group with the classic ICSI procedure
Detailed Description
Patients with previous fertilization failure will be divided into 2 groups:
Group 1 (control): Will undergo classic ICSI procedure in half the MII oocyte of the same case.
Group 2 (study group): The other half of the MII oocyte of the same case will undergo:
1. Polar body removal.
2. ICSI procedure with injection of the spermatozoon in the same zona opening (done by laser for polar body removal).
Results: Will be collected with evaluation of number of 2PN zygotes, Day 1, Day 2, Day 3, Day 5 embryos in all the cases.
#Intervention
- PROCEDURE : polar body removal using zona drilling by laser then suction by injecting pipette
- zona drilling with laser followed by polar body removal then ICSI procedure
- PROCEDURE : Classic ICSI
- Classic ICSI case was done be injecting sperm inside Oocyte while polar body is already existed at 6 or 12 O'clock position.
|
#Eligibility Criteria:
Inclusion Criteria:
* previous fertilization failure
* previous fertilization arrest
Exclusion Criteria:
* NO MII oocyte
* Refusal of the procedure by the couple
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02913781
|
{
"brief_title": "Polar Body Removal Before ICSI for Oocyte Activation in Previous Fertilization Failure Cases",
"conditions": [
"Fertilization"
],
"interventions": [
"Procedure: Classic ICSI",
"Procedure: polar body removal using zona drilling by laser then suction by injecting pipette"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT02913781",
"official_title": "Polar Body Removal Before ICSI as a Method of Oocyte Activation in Previous Fertilization Failure Cases",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12",
"study_completion_date(actual)": "2018-01",
"study_start_date(actual)": "2016-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-09-11",
"last_updated_that_met_qc_criteria": "2016-09-22",
"last_verified": "2018-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-26",
"first_submitted": "2016-09-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The overall objective of this two-group randomized controlled trial is to gather preliminary evidence on the efficacy and safety of early postoperative exercise for improving disability, pain, and general physical health in patients after anterior cervical discectomy and fusion (ACDF) surgery. Our central hypothesis is that an early home exercise program (HEP) performed within the first six weeks after surgery will decrease disability and pain and improve general health, through increases in physical activity and self-efficacy and reductions in fear of movement. The results of our randomized trial will advance research on postoperative management for patients with cervical spine surgery and provide evidence in line with a value-based healthcare approach for optimizing outcomes.
#Intervention
- BEHAVIORAL : Early Home Exercise Program
- The early home exercise program is a 6-week program of home exercises with weekly phone calls to monitor progression and compliance.
- OTHER : Usual Care
- Usual care involves standard postoperative management under the direction of the treating surgeon.
|
#Eligibility Criteria:
Inclusion Criteria:
* Surgical treatment of a cervical degenerative condition (cervical stenosis, spondylosis, degenerative spondylolisthesis, disc herniation) using anterior cervical discectomy and fusion procedure;
* English speaking due to feasibility of employing study personnel to deliver and assess the study intervention; and
* Age older than 21 years (younger individuals do not typically have a cervical degenerative condition)
Exclusion Criteria:
* Patients having surgery secondary to trauma, fracture, tumor, infection, or spinal deformity;
* Patients undergoing cervical corpectomy;
* Diagnosis or presence of severe psychiatric disorder such as schizophrenia or other psychotic disorder, including but not limited to Brief Psychotic disorder and Delusional disorder;
* Documented history of alcohol and/or drug abuse;
* Patients having surgery under a workman's compensation claim; and
* Unable to provide a stable telephone or physical address
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02720172
|
{
"brief_title": "Early Postoperative Home Exercise Program After Cervical Spine Surgery",
"conditions": [
"Spinal Fusion",
"Cervical Spine Degenerative Disease"
],
"interventions": [
"Other: Usual Care",
"Behavioral: Early Home Exercise Program"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02720172",
"official_title": "A Randomized Trial of an Early Postoperative Home Exercise Program Versus Usual Care After Anterior Cervical Discectomy and Fusion Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-07",
"study_completion_date(actual)": "2018-07",
"study_start_date(actual)": "2016-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-12",
"last_updated_that_met_qc_criteria": "2016-03-21",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-03-25",
"first_submitted": "2016-03-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a single arm, multi-center, expanded access study of Iodine I 131 Tositumomab (BEXXAR) therapeutic regimen for patients with relapsed or refractory low-grade or transformed low-grade non-Hodgkin's B-cell lymphoma. The primary objective is to make Iodine I 131 Tositumomab more broadly available to patients. Secondary endpoints will be to obtain additional safety and efficacy information for this treatment regimen. Post study drug administration follow-ups will continue for up to ten years. These will include blood-work and adverse event assessments for 13 weeks post dosing, patient response evaluations at Week 13, Months 6, 12, 18, 24, and Long-Term Follow-ups every 6 months until the elapse of 5 years from the dosimetric dose and then annually thereafter through year 10. Thyroid function will be monitored annually during Long-term follow-up.
#Intervention
- BIOLOGICAL : Iodine I 131 Tositumomab Therapeutic Regimen
- Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) which has been trace-labeled with 5 mCi of Iodine-131 (dosimetric dose). Whole body counts using a gamma camera will be obtained 3 times between Days 0 and 7 following the dosimetric dose to determine a patient-specific mCi dose of Iodine-131 calculated to deliver the desired total body dose of radiation (either 65 cGy or 75 cGy). The therapeutic dose is administered 7-14 days after the dosimetric dose. Patients will receive unlabeled Tositumomab (450 mg) followed by Tositumomab (35 mg) labeled with the patient-specific dose of Iodine-131 (median dose in previous studies was approximately 85 mCi). Patients who are obese will be dosed based upon 137% of their calculated lean body mass. Patients will be treated with thyroid blocking medication at least 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose.
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed diagnosis of low- grade NHL or transformed low-grade NHL (tumor must be CD 20 positive).
* Prior treatment with at least one chemotherapy regimen and have relapsed or progressed, or failed to achieve an objective response on last chemotherapy regimen.
* Karnofsky performance status of at least 60% and anticipated survival of at least 3 months.
* Absolute granulocyte of >= 1,500/mm3.
* Platelet count of >= 100,000/mm3, and not require sustained support of hematopoietic cytokines, or transfusion of blood products.
* Adequate renal function (i.e., <1.5x Upper Limit of Normal), and hepatic transaminases (AST <5 times ULN).
* Signed IRB/IEC-approved informed consent.
Exclusion Criteria:
* Patients with a mean of >25% of the intratrabecular marrow space involved with lymphoma.
* Patients who received cytotoxic chemotherapy, radiation therapy, immunotherapy, or cytokine treatment within 4 weeks prior to study entry (6 weeks for nitrosurea compounds) or who exhibit persistent clinical evidence of toxicity.
* Patients who have undergone stem cell or bone marrow transplant, active obstructive hydronephrosis, active infection, New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.
* Known HIV infection.
* Pregnant or nursing patients.
* Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer, in-situ cervical cancer, or cancer for which the patient has been disease-free for 5 years.
* Patients with progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with more than 3500 cGy.
* Patients who received prior radioimmunotherapy, known brain or leptomeningeal metastases, HAMA positivity.
* Patients who are receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00268203
|
{
"brief_title": "Expanded Access Study Of BEXXAR® For Low Grade And Transformed Low-Grade Non-Hodgkin's Lymphoma",
"conditions": [
"Lymphoma, Non-Hodgkin"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00268203",
"official_title": "Expanded Access Study of Iodine I 131 Tositumomab for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2000-03",
"study_completion_date(actual)": "2013-02",
"study_start_date(actual)": "1998-09"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": [
"PHASE2"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-09",
"last_updated_that_met_qc_criteria": "2005-12-21",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-12-22",
"first_submitted": "2005-12-20",
"first_submitted_that_met_qc_criteria": "2013-10-10"
}
}
}
|
#Study Description
Brief Summary
In a randomized study the investigators aim to characterize the effect of antidepressive medicine on quality of life, body composition, adrenal activity and glucose metabolism in PCOS.
PCOS is a common endocrine disorder characterized by adrenal and ovarian hyperandrogenaemia, anovulation and insulin resistance. The pathogenesis of PCOS may be described by a vicious cycle involving insulin resistance which stimulates ovarian and adrenal hyper androgenaemia and leads to abdominal obesity, causing increased risk for diabetes and cardiovascular disease. Adrenal hyperactivity is associated with depression. Antidepressive medicine may normalize pituitary-adrenal activity and in animal studies antidepressive medicine improved adrenal hyperactivity and normalized insulin sensitivity.
Detailed Description
Clinical study Effects of antidepressive treatment on quality of life, insulin sensitivity and cortisone metabolism in PCOS.
Hypothesis Participants with PCOS have increased hypothalamic-pituitary-adrenal activity compared to healthy women. Antidepressive treatment improves quality of life, cortisone and glucose turnover.
Design A randomized controlled study in 40 PCOS patients who are treated with cipralex or placebo for 12 weeks. Before and after the treatment period the patients have a physical examination, a whole body dexa scan and fasting blood samples. Hypothalamic-pituitary-adrenal is measured by 24 hour samples of cortisone metabolites, 60 minutes ACTH test with basal and stimulated measurement of cortisone and 17-hydroxyprogesterone. Glucose metabolism is examined by oral glucose tolerance test. Biopsies of muscle and fat are also performed.
#Intervention
- DRUG : Escitalopram 20 mg
- Antidepressant
- DRUG : Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* BMI > 25 and <5
* Age 18 <= age <= 45 years
* Two of the following 1: an/oligomenorhea, 2: Hirsutism or hyper androgenaemia, 3: PCO in trans vaginal ultrasound
* Other diagnoses excluded
Exclusion Criteria:
* Post menopausal
* Diabetes
* Eating disorder
* Psychiatric disorder
* Usage of oral anticonceptives or metformin
* Pregnancy or planned pregnancy in the treatment period
* Non-caucasian
* Epilepsy
* Allergy to the medicine
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05840692
|
{
"brief_title": "The Effect of Escitalopram in PCOS",
"conditions": [
"Polycystic Ovary Syndrome"
],
"interventions": [
"Drug: Placebo",
"Drug: Escitalopram 20 mg"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT05840692",
"official_title": "The Effect of Anti Depressive Medicine on Adrenal Activity, Glucose Metabolism, Physical and Mental Health in Polycystic Ovary Syndrome. -A Randomised, Double Blinded, Placebo Controlled Study.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-10",
"study_completion_date(actual)": "2017-10",
"study_start_date(actual)": "2013-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-03",
"last_updated_that_met_qc_criteria": "2023-04-24",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-05-03",
"first_submitted": "2013-05-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will evaluate how much vitamin D is present in a mushroom supplement. This supplement contains an extract from mushrooms that have been exposed to sunlight. The mushroom supplement will be compared to non-commercially available vitamin D supplements produced in a Goo Manufacturing Practices (GMP)-licensed facility.
Detailed Description
Mushrooms have the capability to produce vitamin D in a similar way to human skin. When exposed to ultraviolet light, mushrooms will convert a precursor to vitamin D. This reaction produces large amounts of vitamin D. This study is comparing a natural source of vitamin D to a synthetic source of vitamin D and will help determine if mushrooms are a novel source for this essential nutrient.
#Intervention
- DIETARY_SUPPLEMENT : Mushroom Vitamin D2
- 2000 IU vitamin D2 in a mushroom extract, once/day for 12 weeks
- Other Names :
- Ergocalciferol
- DIETARY_SUPPLEMENT : Cholecalciferol
- 2000 IU crystalline cholecalciferol once/day for 12 weeks
- DIETARY_SUPPLEMENT : Vitamin D2 - Ergocalciferol
- 2000 IU vitamin D2, ergocalciferol once/day for 12 weeks
- Other Names :
- Ercocalciferol
- DIETARY_SUPPLEMENT : Mushroom Extract
- Same quantity of mushroom extract in a capsule
|
#Eligibility Criteria:
Inclusion Criteria:
* All healthy adults, male and female, age 18 <= age <= 64 years
Exclusion Criteria:
* Currently taking, or having taken less than one month prior to start of study, a prescription of 50,000 IU of vitamin D2 or 2000 IU vitamin D2 or vitamin D3
* Allergy to mushrooms
* History of elevated calcium (>10.4 mg%)
* Patients with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
* Supplementation with over the counter formulations of vitamin D2 or vitamin D3
* Subjects with a history of an adverse reaction to orally administered vitamin D.
* Subjects who are taking oral Dilantin or glucocorticoids.
* Exposure to a tanning bed or tanning on a beach for more than eight hours with no sunscreen within 2 weeks prior to start of study.
* History of intestinal malabsorption (i.e. cystic fibrosis, fat malabsorption syndrome, Crohn's Disease, gastric bypass surgery).
* Subjects with any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01815437
|
{
"brief_title": "Evaluating Vitamin D Content in Mushrooms",
"conditions": [
"Vitamin D Deficiency"
],
"interventions": [
"Dietary Supplement: Cholecalciferol",
"Dietary Supplement: Vitamin D2 - Ergocalciferol",
"Dietary Supplement: Mushroom Vitamin D2",
"Dietary Supplement: Mushroom Extract"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01815437",
"official_title": "Evaluation of Vitamin D in a Mushroom Supplement",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-06",
"study_completion_date(actual)": "2013-06",
"study_start_date(actual)": "2012-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-03-27",
"last_updated_that_met_qc_criteria": "2013-03-19",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-03-21",
"first_submitted": "2012-02-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to determine the proportion of study drug dacomitinib or PF-00299804, that is taken up from the digestive tract into the body when given as an oral tablet compared with that taken up by an intravenous dose.
#Intervention
- DRUG : dacomitinib oral
- Dacomitinib 45 mg oral tablet
- DRUG : dacomitinib intravenous
- Dacomitinib 20 mg solution will be given as 1 hour intravenous infusion
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female (of non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
Exclusion Criteria:
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Treatment with an investigational drug within 3 months or 5 half-lives preceding the first dose of study medication, whichever is longer.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Any known allergies or sensitivity to drug excipients.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01796327
|
{
"brief_title": "A Study To Assess Absorption Of Study Drug Dacomitinib (PF-00299804), Given As An Oral Tablet Compared To An Intravenous Infusion In Healthy Volunteers",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Drug: dacomitinib intravenous",
"Drug: dacomitinib oral"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT01796327",
"official_title": "A Phase 1, Single Dose, Fixed Sequence Study To Estimate The Absolute Bioavailability Of Dacomitinib (PF-00299804) By Comparing Oral To Intravenous Administration In Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-06",
"study_completion_date(actual)": "2013-06",
"study_start_date(actual)": "2013-04"
},
"study_design": {
"allocation": null,
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-10-08",
"last_updated_that_met_qc_criteria": "2013-02-20",
"last_verified": "2015-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-02-21",
"first_submitted": "2013-02-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Excessive and poorly controlled anger is one of the most common problems experienced by war Veterans. The consequences can be severe, including increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning. Availability of effective treatments is critical to reducing the adverse effects of anger in Veterans. The investigators propose to conduct a controlled study to determine whether a cognitive behavior treatment that has been adapted for treating anger problems in Veterans of Iraq and Afghanistan results in improved outcomes compared to a supportive therapy. Results will be examined for improvement in anger, functioning, and quality of life at end of 12 weekly sessions, and at 3 and 6 months following treatment.
Detailed Description
Poorly controlled anger is a common problem with often devastating effects in Veterans who have served in a warzone. Adverse consequences include increased risk for divorce, domestic violence, job loss and instability, and other serious impairments in family, social, and occupational functioning. Recent evidence indicates that anger and aggression are likely to be problems for a significant proportion of Veterans of Iraq (Operation Iraqi Freedom, OIF; Operation New Dawn, OND) and Afghanistan (Operation Enduring Freedom, OEF). A survey of reintegration problems among 754 OEF/OIF combat Veterans receiving VA Medical care showed that anger was the most commonly reported problem, with 57% reporting increased problems in controlling anger. Despite encouraging evidence for efficacy of cognitive behavioral interventions in treating anger in civilian samples, much less is known about the efficacy of such treatments for anger problems in military personnel following exposure to war zone trauma. Promising preliminary findings for individually based cognitive behavioral treatment have been reported, and there is evidence that a group anger management treatment delivered by teleconferencing is as effective as the same treatment delivered in person, but to date there is not a single adequately powered randomized trial designed to test the efficacy of an anger treatment compared to an active control condition in Veterans. Building on findings from the investigators' randomized pilot study, the objective of the current proposal is to conduct a randomized clinical trial with sufficient statistical power to test the effectiveness of a manualized cognitive behavioral intervention (CBI) that has been adapted from an existing treatment (Anger Control Therapy; Novaco, 1994, 2001) for the treatment of anger problems in OEF/OIF/OND Veterans, compared to a manualized supportive therapy intervention (SI) control condition. Ninety OEF/OIF/OND Veterans reporting significant problems with anger will be randomized to receive 12 individual sessions of one of the two study conditions. Outcomes including measures of anger and aggression; interpersonal, social and occupational functioning; and quality of life will be assessed during and at the end of treatment and at 3 and 6 month follow-ups. Exploratory analyses will examine 1) whether a diagnosis of PTSD impacts treatment effectiveness and 2) potential mediators of treatment outcome with CBI.
#Intervention
- BEHAVIORAL : Cognitive Behavioral Intervention
- Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
- Other Names :
- CBI
- BEHAVIORAL : Supportive Intervention
- Includes individual therapy sessions using supportive and problem-solving strategies.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or Female current or former member of the military (active duty, National Guard or Reserve) Deployed to Iraq or Afghanistan
* Experience trauma during deployment
* Clinically significant anger
* At least 2 additional symptoms of PTSD hyperarousal
* If on medication, no changes within prior 4 weeks
Exclusion Criteria:
* Current severe substance use disorder or prior severe substance use disorder not in remission for at least 3 months
* Current psychotic symptoms
* current Mania or Bipolar Disorder
* Current suicidal or homicidal ideation requiring hospitalization
* Any severe cognitive impairment or history of Organic Mental Disorder
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02157779
|
{
"brief_title": "Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans",
"conditions": [
"Anger Problems"
],
"interventions": [
"Behavioral: Cognitive Behavioral Intervention",
"Behavioral: Supportive Intervention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02157779",
"official_title": "Treatment of Trauma-Related Anger in OEF/OIF/OND Veterans",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-02-28",
"study_completion_date(actual)": "2019-02-28",
"study_start_date(actual)": "2015-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-18",
"last_updated_that_met_qc_criteria": "2014-06-03",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-06-06",
"first_submitted": "2014-05-06",
"first_submitted_that_met_qc_criteria": "2020-02-26"
}
}
}
|
#Study Description
Brief Summary
Pulmonary vascular dysfunction (DVP) is associated with a pejorative prognosis during ARDS. There is no specific therapeutic intervention to thwart it. Extracorporeal CO2 purification (ECCO2-R) is a technique that has been very rapidly diffused and adopted in intensive care since commercialization of the devices but, the formal clinical evaluation is insufficient. It could significantly improve the prognosis of patients with both DVP and refractory hypercapnia.
Detailed Description
This is a prospective, non-comparative, open-label, multicenter regional study, without random drawing or blindfolding.
The primary objective of the study is the correction by ECCO2-R of hypercapnia in patients with DVP in moderate to severe ARDS under protective ventilation.
The primary endpoint is the percentage of patients with hypercapnia correction (defined as a 20% decrease in PaCO2 at H2 of ECCO2-R initiation).
The secondary objectives are:
* Demonstrate that ECCO2-R allows in hypercapnic ARDS and DVP patients to correct hypercapnia with H6 and H24, improve DVP and hemodynamics, reduce alveolar dead space, improvement of respiratory mechanics
* Assess the tolerance of the evaluated technique.
The Secondary endpoints are:
- Relative change of capnia to H6 and H24 in relation to H0; proportion of patients with a decrease of at least 20% of PaCO2 to H6 and H24; changes in echocardiographic indices; hemodynamic parameters; alveolar deadspace and respiratory mechanics to H2, H6 and H24, compared to H0; Complications, Mortality at reanimation discharge (or on D28 if this date occurs before discharge of reanimation).
The intervention is based on the use of ECCO2-R (PrismaLung®, Prismaflex ® Baxter) in eligible patients. ECCO2-R will be initiated as soon as possible after inclusion, for a duration of at least 24 H (possibly prolonged up to 72 H at the decision of reanimator), by jugular or femoral vein-venous.
The size of the catheters, the machine settings, in particular the blood flow and sweep will be standardized according to the state of the art and the recommendations of the manufacturer
The ECO2R venous technique uses devices consisting of a monitor, an exchanger and a pump.
1. The PrismaLung® Kit (Baxter): Single-use EC-marked extracorporeal circuit intended for use for at least 24 hours (maximum 72 hours).
The PrismaLung® kit is intended for use with the Prismaflex® monitor with software version 8.10 or later and its support in conjunction with Prismaflex® single use treatment sets.
2. The Prismaflex HP-X Set (Baxter): blood line set for extracorporeal blood circulation, EC marked or the HF 1400® set (Baxter) (for extra-corporeal CO2 purification combined with purification).
3. The Prismaflex® monitor (Baxter), EC marked, is used routinely in intensive care (continuous extra-renal purification, therapeutic plasma exchange, haemoperfusion, hemopurification).
So that each center has a dedicated monitor for research, this device will be provided by the Baxter laboratory. The monitor will be equipped with a holder for the Prismalung kit marked CE.
#Intervention
- DEVICE : Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)
- A low-flow CO2 removal device (Prismalung®, Baxter) will be used with a conventional renal replacement therapy (RRT) platform (Prismaflex®, Baxter). In patients already treated with continuous RRT because of renal failure or metabolic acidosis, the HF 1400® (Baxter) set will be used to combine RRT and decarboxylation. Gas flow through the gas exchanger will be set up to 10 L/min, with an oxygen concentration from 0.21 to 1 and a blood flow of 200-400 mL/min. Patients will be ventilated with a target tidal volume of 6 ml/kg (predicted body weight) and a target plateau pressure below 30 cmH2O.
|
#Eligibility Criteria:
Inclusion Criteria:
* Moderate to severe ARDS according to the Berlin definition;
* Pulmonary vascular dysfunction at echocardiography (pulmonary arterial hypertension, right ventricular dilatation or dyskinesia of the interventricular septum);
* Refractory hypercapnia, defined by a PaCO2 >=48 mmHg in spite of the reduction of the instrumental dead space and the increase of the respiratory rate.
* Free and informed written consent for persons in a position to consent; consent of the support person/parent/relative in case of incapacity to consent; inclusion in emergency situations (Article L1122 <= age <= 1-2 of the CSP)
Exclusion Criteria:
* Age <18 years;
* Known pregnancy or breastfeeding;
* Contra-indication to curative anticoagulation, thrombocytopenia <50 G / L, heparin-induced thrombocytopenia, known hypersensitivity to heparin or to compounds;
* Femoral or jugular venous access impossible;
* Refractory hypoxemia with indication at ECMO;
* No affiliation to social security or beneficiary
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03303807
|
{
"brief_title": "Correction by ECCO2-R of Hypercapnia in Patients With DVP in Moderate to Severe ARDS Under Protective Ventilation.",
"conditions": [
"Acute Respiratory Distress Syndrome",
"Hypercapnia"
],
"interventions": [
"Device: Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)"
],
"location_countries": [
"France"
],
"nct_id": "NCT03303807",
"official_title": "Study of Carbon Dioxide Removal to Alleviate Right Ventricule Dysfunction During Acute Respiratory Distress Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-02-25",
"study_completion_date(actual)": "2019-03-21",
"study_start_date(actual)": "2018-01-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-05",
"last_updated_that_met_qc_criteria": "2017-10-02",
"last_verified": "2018-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-06",
"first_submitted": "2017-09-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the current study was to study the effect of diode laser in the treatment of chemotherapy induced mucositis in young patients suffering from leukemia
#Intervention
- DEVICE : Simpler diode laser
- Non-contacting irradiation for 30 seconds on three intraoral sites repeated four times
- DRUG : Conventional symptomatic treatment
- Conventional treatment using oracure, BBC spray, miconaz three times daily
|
#Eligibility Criteria:
Inclusion Criteria:
* children diagnosed with mucositis and receiving chemotherapy
Exclusion Criteria:
* diabetes
* trismus
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT05181943
|
{
"brief_title": "Effectiveness of Photo-biomodulation in the Treatment of Chemotherapy Induced Mucositis",
"conditions": [
"Mucositis"
],
"interventions": [
"Drug: Conventional symptomatic treatment",
"Device: Simpler diode laser"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05181943",
"official_title": "EFFECTIVNESS OF PHOTO BIO-MODULATION IN THE TREATMENT OF CHEMOTHERAPY INDUCED ORAL MUCOSITIS IN CHILDREN WITH ACUTE LEUKEMIA Randomized Controlled Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-11-01",
"study_completion_date(actual)": "2021-12-01",
"study_start_date(actual)": "2020-10-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-01-10",
"last_updated_that_met_qc_criteria": "2021-12-20",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-01-10",
"first_submitted": "2021-12-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A randomized, controlled, three-arm trial to investigate the effects of warm water footbaths with and without the addition of ginger or mustard powder on psychosocial parameters in patients with an oncological disease and in healthy controls.
Detailed Description
A randomized, controlled trial with cross-over design in which the subjects (23 patients with an oncological disease, 13 healthy controls) receive warm water footbaths with added ginger (experimental) or mustard powder (experimental) or without additives (active comparator). The wash-out period between two consecutive footbath interventions is at least one day. Outcome measures are assessed right before (t1), right after (t2) and 10 minutes following the footbath (t3). The main focus is on the change in subjective perception of warmth distribution between t1 and t3. Moreover, the objective skin temperature distribution and psychosocial scores are assessed. The primary outcome measure is analyzed with a linear mixed effects model (after checking for carry-over effects). Secondary outcome measures are described descriptively.
#Intervention
- OTHER : Ginger powder footbaths
- 20-minute footbath with 12 liters of 40°C warm water and an additive of 80g dried ginger powder (reaching up to mid-calf level)
- OTHER : Mustard powder footbaths
- 20-minute footbath with 12 liters of 40° C warm water and an additive of 80g dried mustard powder (reaching up to mid-calf level)
- OTHER : Warm water only footbaths
- 20-minute footbath with 12 liters of 40° C warm water without any additive (reaching up to mid-calf level)
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Age between 18 and 65 years
* Oncological disorder with at least one chemotherapy or radiation in the treatment history
* Current inpatient treatment in the oncology ward of the Filderklinik (Filderstadt, Germany) with a minimum stay of 4 days
Exclusion Criteria:
* Infectious disease (with more than 38 °C core body temperature)
* Skin lesion on the lower legs or feet
* Hypersensitivity to mustard or ginger products
* Cardiac arrhythmia
* Pregnancy
* Insufficient knowledge of the German language
* Bedriddenness
* Poor general condition (according to the assessment of the attending physicians)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04271670
|
{
"brief_title": "Effect of Warm Water Footbaths With Added Ginger or Mustard Powder on Psychosocial Parameters in Patients With an Oncological Disease",
"conditions": [
"Oncologic Disorders"
],
"interventions": [
"Other: Mustard powder footbaths",
"Other: Ginger powder footbaths",
"Other: Warm water only footbaths"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT04271670",
"official_title": "Effect of Warm Water Footbaths With Added Ginger or Mustard Powder on Psychosocial Parameters in Patients With an Oncological Disease: a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-09-18",
"study_completion_date(actual)": "2017-09-18",
"study_start_date(actual)": "2016-01-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-02-17",
"last_updated_that_met_qc_criteria": "2020-02-13",
"last_verified": "2020-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-02-17",
"first_submitted": "2020-02-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation.
Detailed Description
Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (15:15) for non-pharmacological treatment and pharmacological treatment group. Participants of each group will receive twice a week for total 8 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific intervention and dosage of pharmacological and non-pharmacological treatment.
#Intervention
- OTHER : KM non-pharmacological treatment group
- This is a pragmatic setting, and specific intervention is not determined prior to the study. Non-pharmacological treatment including Korean medicine, such as acupuncture, electroacupuncture and chuna, etc, will be chosen by professional physician according to the medical condition of each subject.
- OTHER : Pharmacological treatment group
- This is a pragmatic setting, and specific intervention is not determined prior to the study. The pharmacological treatment will be chosen by professional physician according to the medical condition of each subject.
|
#Eligibility Criteria:
Inclusion Criteria:
* Numeric rating scale (NRS) score of radiating pain 5 or more for recent 3 serial days.
* Onset time of radiating pain occurred within 12 weeks.
* Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI)
* 19 <= age <= 70 years
* participants who agreed and signed informed consent form
Exclusion Criteria:
* Spine metastasis of cancer, acute fracture of spine, or spine dislocation
* Progressive neurologic deficits or severe neurologic deficits
* Soft tissue diseases that can induce low back pain(ie. cancer, fibromyalgia, rheumatoid arthritis, gout,etc)
* Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
* Concurrent use of steroids, immunosuppressants, orpsychotropic medications or any other medication that can interrupt the study result
* Hemorrhagic disease, severe diabetes or taking anticoagulant drug
* Participants who took NSAIDs or pharmacopuncture within 1 week
* Pregnant or lactating women
* Participants who had undergone lumbar surgery within 3 months
* Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial
* Participants who can not write informed consent
* Participants who is difficult to participate in the trial according to investigator's decision
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04833270
|
{
"brief_title": "Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study",
"conditions": [
"Lumbar Disc Prolapse With Radiculopathy"
],
"interventions": [
"Other: Pharmacological treatment group",
"Other: KM non-pharmacological treatment group"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT04833270",
"official_title": "Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-28",
"study_completion_date(actual)": "2022-06-28",
"study_start_date(actual)": "2021-07-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-09-27",
"last_updated_that_met_qc_criteria": "2021-04-04",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-06",
"first_submitted": "2021-04-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if using intensity modulated radiation therapy for brain metastases is safe and will improve local control more than standard whole brain radiation therapy.
Detailed Description
Traditionally, whole brain radiation therapy (WBRT) has been the primary therapy for patients with brain metastases. Despite this therapy, patients still have poor survival of four to six months. Untreated patients have a median survival of one month. Up to one half of these patients die of causes related to the presence of brain metastases. In a Phase I/II RTOG trial, the efficacy and safety of delivering accelerated fractionation was investigated in patients with good prognostic factors. No toxicity was observed with escalating dose of irradiation up 70.40Gy in 1.6Gy twice daily treatments. However, in a randomized trial, the use of hyperfractionation did not appear to improve survival when compared to 30Gy whole brain irradiation delivered in 10 fractions.
Current therapeutic approach also includes stereotactic radiosurgery (SRS). Several retrospective studies have demonstrated improved local tumor control of 80% with addition of SRS to WBRT. These local control rates were comparable to surgery. In a recently published randomized trial by RTOG 95-08 (TJU accrued 42 patients to this trial), Andrews et al. demonstrated improved survival in patients with solitary brain lesion treated with SRS. Median survival was 6.5 months in patients treated with WBRT and SRS compared to 4.9 months in patients treated with WBRT alone. Also, these patients were more likely to have stable or improved performance status.
#Intervention
- RADIATION : Intensity-Modulated Radiotherapy (IMRT)
- The duration of radiation therapy will be total of 3 weeks. During the first week, all patients will be treated initially with whole brain radiation therapy (WBRT) at 2.5Gy per fraction daily 5 days a week to a dose of 12.5Gy. This will be delivered through parallel-opposed fields to cover the entire cranial contents.
For the remaining 2 weeks, patients will be treated using intensity-modulated radiation therapy (IMRT) technology such that a higher dose can be delivered to the tumor. IMRT is capable of generating complex 3-D dose distribution to conform closely to the target volume by modulating the radiation beam. This process is based on the 'inverse method' of treatment planning to optimize radiation dose to tumor target coverage and normal tissue sparing.
- Other Names :
- Radiation Therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed malignancy
* 2 <= age <= 5 parenchymal brain metastases on magnetic resonance imaging (MRI) with a maximum size of 4 cm
* Partial resection allowed. Complete resection allowed only in patients with more than 3 lesions.
* Karnofsky Performance Status (KPS) equal to or greater than 60
* Neurologic function equal to or greater than 2
Exclusion Criteria:
* Recurrent brain tumors
* Major medical or psychiatric illnesses
* Metastases in brainstem, midbrain, pons, or medulla
* Patients with leukemia or lymphoma
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00328575
|
{
"brief_title": "Using Intensity Modulated Radiation Therapy (IMRT) for Brain Metastases",
"conditions": [
"Neoplasm Metastasis"
],
"interventions": [
"Radiation: Intensity-Modulated Radiotherapy (IMRT)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00328575",
"official_title": "Phase I Dose Escalation Trial in Patients With Brain Metastases Using IMRT",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-07",
"study_completion_date(actual)": "2011-06",
"study_start_date(actual)": "2005-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-21",
"last_updated_that_met_qc_criteria": "2006-05-19",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-05-22",
"first_submitted": "2006-05-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective, observational exploratory study of the performance of the Quantra System in adult patients that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure.
Detailed Description
Patients 18 years or older that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure will be enrolled in this prospective, observational exploratory study. From each enrolled subject, blood samples will be collected at multiple time points for analysis on the Quantra QPlus or QStat Cartridge in parallel with other assessments performed as standard of care.
#Intervention
- DIAGNOSTIC_TEST : Quantra System
- Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject is > 18 years.
* Subject is scheduled to undergo either VA or VV ECMO procedure or has been placed on VA or VV ECMO within 24 hours.
* Subject or subject's legally authorized representative (LAR) is willing to provide informed consent, either prospectively or by deferred consent.
Exclusion Criteria:
* Subject is younger than 18 years.
* Subject is pregnant.
* Subject is incarcerated at the time of the study.
* Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent.
* Subject is affected by a condition that, in the opinion of the treatment team, may pose additional risks.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05426564
|
{
"brief_title": "Exploratory Assessment of the Quantra® System in Adult ECMO Patients",
"conditions": [
"Blood Loss",
"Thrombosis",
"Extracorporeal Circulation; Complications"
],
"interventions": [
"Diagnostic Test: Quantra System"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05426564",
"official_title": "Exploratory Assessment of the Quantra® System With the QPlus® and QStat® Cartridges in Adult ECMO Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-05-17",
"study_completion_date(actual)": "2023-06-01",
"study_start_date(actual)": "2022-09-27"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-06-15",
"last_updated_that_met_qc_criteria": "2022-06-21",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-06-22",
"first_submitted": "2022-06-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Knowledge gap: Does the choice of anaesthetic affect outcome for cancer surgery?
Aim: To retrospectively examine possible associations (Cox Multiple Regression) between survival from breast-, colorectal-, or skin cancer and the choice of hypnotic used during surgery, ahead of a prospective randomised controlled trial.
Hypotheses: One- and five-year survival will be significantly higher after radical breast-, colorectal-, or skin cancer surgery in patients given the intravenously administered hypnotic propofol than in patients given the inhalational hypnotic sevoflurane.
Method: To merge two registers, of which one holds demographic- anaesthetic-, and surgical data from 6 303 patients operated on at the three mentioned anatomical locations at the Central Hospital in Vasteras, Sweden during a twelve year period (1998-2009). Of these minimum 4 500 operations would be due to cancer. This register is unique, in that it contains both types of anaesthesia. The other register holds survival data (date and cause of death), stored at the Regional Oncologic Center in Uppsala.
The choice of anaesthetic will be validated by controlling each patient's anaesthetic paper file, concomitantly with extraction of details from anaesthesia and surgery, such as the functional classification of each patient (according to American Association of Anesthesiologists), co-morbidity, duration of anaesthesia and surgery, amount of blood loss and possible transfusion.
Current knowledge: Different anaesthetics have opposite effects on the immune system and on the DNA. There is a well-established association between the state of the immune system and cancer growth, which in turn will influence survival. There is also an association between DNA damage and cancer development. Inhalational anaesthetics, e.g. sevoflurane, act pro-inflammatory, and they are also proven to be genotoxic. Propofol is anti-inflammatory and anti-oxidative, and it is not genotoxic.
Objective: Strengthen the hypotheses, and get statistics for a proper power calculation in advance of a multi-centre, prospective, randomised, controlled trial.
Impact: General anaesthesia is an indispensable part of radical cancer surgery. Undesired effects from anaesthesia on survival has strong relevance for the over all cancer treatment.
Detailed Description
Purpose and aims By means of record-linkage, information from two registers will be merged to retrospectively examine possible associations between survival from breast-, colorectal-, or skin cancer with the choice of hypnotic used during surgical removal of the cancer.
We hypothesize that: the one- and five-year survival rate after radical breast-, colorectal- or skin cancer surgery in general anesthesia is significantly higher in patients given the intravenously administered hypnotic propofol compared with the survival in patients exposed to the inhalational hypnotic sevoflurane.
The hypothesis is based on: 1) The knowledge about the opposite effects on the immune system from the two different anesthetics and from their different genotoxic potentials 2) The well-established associations between the state of the immune system and cancer growth, and DNA damage and cancer development, with potential influences on survival.
Survey of the field Rationale and current state of knowledge A) Immuno-modulation Converging evidence from animal studies and studies of human cell-lines indicate that different anesthetics have opposite effects on the immune system. Commonly used inhalational hypnotics are in this context pro-inflammatory, whereas the intravenously administered hypnotic agent propofol is anti-inflammatory and also anti-oxidative. A few clinical studies have indicated similar effects in patients, and a recent review has suggested that 'tailoring an anesthetic plan to patient's needs will become increasingly critical, and immunology should help in this pursuit'.
More specifically, previous studies have investigated the immunological effects of different anesthetics on monocytes, macrophages, natural killer cells, t-cytotoxic cells, and t-helper cells. By affecting t-helper cells anesthetics indirectly affects the production of anti-inflammatory mediators, such as interleukin-4 and -10. Anesthetics also affect the production of pro-inflammatory cytokines, such as tumor necrosis factor alpha, and interleukin-1 and -6. Moreover, the effects could be indirect by blocking or non-blocking of the surgical stress response via the hypothalamic-pituitary-adrenal axis and the sympathetic nervous system. Thus, stress hormones, such as catecholamines and cortisol, mediates inhibitory effects on immune functions. In a highly complex way, the neuroendocrine system together with both pro-inflammatory- and anti-inflammatory cytokines augments their immuno-suppressive effects. Taken together, results from previous research support that inhalational hypnotics are immuno-suppressive in mice as well as in humans.
Earlier findings also indicate other adverse effects of inhalational hypnotics that could be related to immunological processes. For example, inhalational hypnotics seem to increase the occurrence of cancer metastases. These adverse effects have not been found for propofol. In contrast, propofol seem to inhibit tumor growth and reduce the tendency to induce metastases.
The research field of immuno-modulation from anesthetics was recently reviewed by Kurosawa and Kato. They concluded, that 'clinical anesthesiologists should select anesthetics and choose anesthetic methods with careful consideration of the clinical situation and the immune status of critically ill patients, in regard to long-term mortality, morbidity, and the optimal prognosis'. A key note is, that 'many in vitro investigations have elucidated the dose-dependent and time-dependent immunosuppressive effect of volatile (read inhalational) anesthetics on various immune cells'. It was stressed in another review by Meiler, 'that the perioperative process could be responsible for later adverse events', and the necessity to 'understand the underlying biology and immunology should be particularly helpful in this pursuit'. Thus, the choice of hypnotic may affect survival after cancer surgery. More specifically, the combined effects of surgical stress and the burden of cancer and perhaps other aggravating circumstances, such as high age and malnutrition, may play a salient role in postoperative morbidity and mortality.
B) Genotoxicity Genotoxic agents may negatively affect patient's survival after cancer surgery, as the connection between DNA damage and cancer development is well-known. The potential genotoxicity from inhalational anesthetic agents in patients and in exposed staff in operating rooms has been studied both in vitro and in vivo. A dose-response relationship for inhalational agent exposure and DNA damage has been suggested. The techniques used, the rate of sister chromatid exchange in lymphocytes and the alkaline comet assay, as indicators of genotoxicity are well validated, and they are frequently used in other contexts. Inhalational agents seem to be consistently genotoxic, whereas the less studied propofol seems not to be so.
Project description: Retrospective, follow-up cohort study.
Patients We have in an administrative system demographic-, anesthetic-, and surgical data logged by computer available for all patients exposed to anesthesia and surgery, dated from January 1, 1998 to December 31, 2009. Data includes the choice of hypnotic. All approx. 4500 patients operated on for breast-, colorectal-, or skin cancer (malignant melanoma) have been extracted from this register. Remaining demographic-, anesthetic-, and surgical data of interest will be extracted from patient's individual paper files. A data base will be constructed in the Statistical Program for Social Sciences, SPSS (Chicago, IL, USA). Accessible outcome data are stored at the Regional Oncologic Center in Uppsala.
Bias, especially potential major confounders, control of
1. The risk of selection bias is an inherent major disadvantage with a retrospective study. Here the risk is considered low due to the non-selective use of the hypnotics. Misclassification errors will be corrected on an individual level and important confounders identified at group level, c.f. down.
2. The distribution of different demographic characteristics between the two groups will be controlled for by the thorough survey of every individual patient file. Data on type and stage of the cancer, as well as different prognostic markers will also be included. Any unequal distribution of such confounders will be identified. Data on alcohol consumption will not be available.
3. Opioids also affect the immune system, and they will therefore theoretically constitute to be major confounders. This holds true for morphine, which we never use intra-operatively. Synthetic opioids, such as fentanyl, alfentanil, and remifentanil, all used by us intra-operatively, have been proven not to suppress the immune response like morphine does. On the contrary, the synthetic opioids may have positive effects in this context. We use synthetic opioids for every surgical patient at our hospital, as most other hospitals do worldwide. We have no reason to suspect an uneven administration of postoperative morphine to the two study groups, but this has also to be controlled for during data extraction.
4. Nitrous oxide, impairs the immune defense, and it also impairs DNA production by inhibition of the vitamin B12 component of methionine synthetase. Nitrous oxide will be a potential confounder for a fraction of our study population. It remains to be seen during a thorough survey of our data, if the use of nitrous oxide was evenly distributed between our two study groups?
5. Red blood cell transfusion may affect survival after cancer surgery. An immuno-suppressive effect from the allogenic material is one suggested cause. We will identify those patients having peri-operative red blood cell transfusions, control the distribution between the groups, and include them in a subgroup analysis.
6. A preceding or subsequent anesthetic given in proximity to the index procedure constitutes an important confounder and must therefore be identified. An executive decision was made defining this time span of ± 1 year from the index operation. Patients, who were anesthetized once or more than so besides the index operation within this time frame, and patients who were anesthetized from the end of the time frame to inclusion in the study will constitute separate subgroups. Accordingly, they will be analyzed separately. We assume that 10-20% of patients had another general anesthetic within the defined time interval. This assumption is based on a small pilot investigation of 100 patients in the cohort.
7. Different adjuvant cancer therapies with potent toxicity and serious side-effects will also be registered and controlled for from a confounding point of view.
Linking and matching of databases The administrative database, created as described above, will be record-linked to the regional quality registers at the Regional Oncologic Center (ROC) in Uppsala. The registers have been found to be \>97% completeness compared to the Swedish Cancer Register (SCR), to which reporting is mandatory and regulated by law. The SCR holds diagnoses only and contains no clinical information. The ROC includes a quality register for breast cancer, which was started in 1992. A register for colon cancer was started in 1995, another for melanoma was started in 1996, and one for rectal cancer was created in 1997. These registers contain information on mode of detection, histopathology, stage at diagnosis, other prognostic markers and complementary treatment given. Hence, complete oncologic- and outcome data will be available for all types of cancer included in the study within the defined period of time. Data on type and stage of the cancer, as well as different prognostic markers recorded in the oncologic registers will be extracted, as well as data on recurrences of disease, vital status and date and cause of death. The unique personal identification number will be replaced by unidentified serial numbers, to ensure anonymity for each person after data securing.
Analysis The main endpoint will be a comparison of overall survival using time to event analysis. Cumulative 1- and 5-year overall survival will be assessed using the Kaplan Meier method and the estimates will be compared between patients given sevoflurane or propofol. In a next step, Cox Proportional hazard models will be calculated to assess the risk of death adjusted for potential effect modifiers and confounders. There will also be stratifications for different types of tumors, cardio-pulmonary status, ASA-class etc. Hazard ratios (HR) with 95 % confidence intervals (CI) will be presented for all models. Subgroup analyses will be undertaken for patients having more than one anesthetic within the defined time frame; a) given the same hypnotic as during the index procedure, b) given the other hypnotic at the different occasion(s); and c) for patients having one or more anesthetics outside the defined time frame.
Statistics A clinically relevant absolute difference in five-year-survival would be 5%, e.g. a difference between 85% and 80%, the latter being an average one-year-survival for the period of interest for breast cancer, which constitutes the largest group in the study. With more than 3000 patients anesthetized with sevoflurane, and more than 1000 patients anesthetized with propofol, we will have a 95% power to detect the difference with a P-value of \<0.05, i.e. there will be a good margin for an unanticipated loss of data or ditto exclusions.
Ethics The project was accepted by the Regional Ethics Committee Jan 21, 2009 (2008/350). The retrospective approach will not create ethical considerations.
Significance Undesired effects from anesthesia on survival have strong relevance for the overall cancer treatment. Any suspicions of such a dramatic side-effect as potentially fatal immuno-modulation or genotoxicity must be investigated.
If the hypotheses are confirmed the results from the present study will be used for a large-scale randomized controlled trial (RCT) at multiple centers to compare the two agents, and this in turn might result in a change in practice should the results be positive. If the hypothesis is ruled out, the choice between inhalation and intravenous anesthesia will not be influenced by oncological considerations, which is important to know, although it also have to be confirmed in a RCT.
|
#Eligibility Criteria:
Inclusion Criteria:
* Exposed to general anesthesia for surgical removal of cancer in breast, colo-rectally, or in skin
Exclusion Criteria:
* Paper file unable to find or missing data in anesthetic file or in outcome registry
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01418326
|
{
"brief_title": "Cancer Mortality Affected by the Choice of Anesthetic Drugs?",
"conditions": [
"Breast Cancer",
"Colo-rectal Cancer",
"Skin Cancer"
],
"interventions": null,
"location_countries": [
"Sweden"
],
"nct_id": "NCT01418326",
"official_title": "Cancer Mortality Affected by the Choice of Anesthetic Drugs?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-09",
"study_completion_date(actual)": "2011-10",
"study_start_date(actual)": "2010-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-05-29",
"last_updated_that_met_qc_criteria": "2011-08-16",
"last_verified": "2015-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-08-17",
"first_submitted": "2011-05-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The next influenza pandemic is expected to spread rapidly in resource-poor settings. Influenza viruses spread from human-to-human via large respiratory droplets. Transmission via large-particle respiratory droplets is believed to be mediated by close contact between infected and susceptible persons or contact with droplet-contaminated fomites. Close contact between infected and susceptible persons may consist of skin-to-skin contact (e.g., via hands) or inhalation of respiratory droplets (e.g., due to talking, coughing, or sneezing by the infected person). Airborne transmission, which is expected to result in transmission over long distances (\>1 meter) and which would be mediated by ventilation, is believed to be uncommon. Therefore, the greatest risk of transmission from personal contact comes from those people who are closest to an index case, such as contacts living in the same household. There are, to date, no published estimates of the secondary attack ratio of influenza among household contacts of index case-patients in low-income countries. Moreover, the investigators do not have data on the risk factors for secondary transmission of influenza from index case-patients to their household contacts. There is some data for the benefits of promoting handwashing with soap on the risk of all-cause acute respiratory illness among children \< 15 years old in a resource-poor setting in Pakistan. But, the investigators do not have evidence that promoting handwashing with soap will acutely reduce the risk of secondary transmission. Therefore, the investigators propose to conduct a study in rural Bangladesh to assess the following:
* The secondary attack ratio of influenza among household contacts of an index case-patient with influenza
* The risk factors for secondary transmission of influenza from an index case-patient to household contacts
* The impact of promoting handwashing with soap on the risk of secondary transmission of influenza from an index case-patient to household contacts
* The impact of handwashing promotion on handwashing behavior six months after intervention
* The impact of handwashing promotion on the prevalence of respiratory infections, diarrhea and influenza
Detailed Description
BISTIS builds on hospital-based surveillance for Influenza virus infection, which is ongoing in hospitals around Bangladesh, as part of the Hospital-based Influenza Surveillance (HBIS) and Surveillance for the Epidemiology of Influenza in Bangladesh (SEIB) projects. We intend to recruit patients identified at the Jahurul Islam Medical College Hospital in Kishoregonj, Bangladesh, where both HBIS and SEIB are in place. In this hospital 80% of all the patients who present with influenza-like illness (ILI) to the outpatient departments of Medicine and Pediatrics are from three upazillas of Kishorgonj district: Bajitpur, Kuliar char and Kotiadi. The distances of these three upazillas are within 30 minutes travel time from Jahurul Islam Medical College Hospital (one way) and hence these upazillas will serve as the primary catchment areas for BISTIS. The table below illustrates the number of ILI cases identified through HBIS and SEIB study at Jahurul Islam Medical College Hospital in 2008 and also the number and proportion among them who were tested PCR positive for influenza virus.
n.b., most influenza-positive specimens were collected between May and September in 2007 and 2008
We will also enroll patients who present to two local upazilla health complexes (UHCs), one in Bajitpur and one in Kuliar Char. These local health complexes see numerous patients a day from the rural areas surrounding the clinic. Patients who present to these clinics are more likely to have symptom onset within 24 hours of presentation then those patients who seek care at JIMCH, since patients may only want to go to the hospital if their illness has been severe and prolonged over several days. Some studies on the impact of handwashing promotion have found that the intervention is effective if delivered within 36 hours of the index case-patient's symptom onset; therefore, the UHC sites are appropriate for enrollment of patients for BISTIS in addition to enrollment at JIMCH.
Lastly, we will recruit patients from pharmacies within the catchment areas mentioned above. By collaborating with local pharmacists, we intend on further increasing our enrollment numbers. Patients who present to local pharmacists are likely to have symptom onset within 24 hours of their visit to the pharmacist and are also more likely to be the primary case within their bari.
Specific Aim 1: To measure the secondary attack ratio (SAR) of influenza viruses among household contacts of index cases with influenza, in a rural setting in Bangladesh
Methods for Specific Aim 1
Specimen collection and processing A trained study physician will procure a nasal swab and an oropharyngeal swab from consenting index case-patients meeting the inclusion criteria above using a standardized method. At the Jahurul Islam Medical College Hospital, the nasal and oropharyngeal swabs will both be placed into a single tube containing viral transport media (VTM). An aliquot of the VTM will then be tested for Influenza A and B by the trained physician or nurse using a rapid antigen detection test (QuickVue® Influenza A + B). If the QuickVue® result is positive for Influenza A or Influenza B, the remaining VTM will be kept at 4°C. All VTM will be transported to the ICDDR,B virology laboratory in Dhaka on a weekly basis. At the ICDDR,B virology laboratory, RT-PCR testing for Influenza A (H1N1), Influenza A ( H3N2), and Influenza B will be carried out. If Influenza A H1N1 and A H3N2 are both negative, RT-PCR testing for Influenza A H5N1 will be performed. If the QuickVue® result is negative for both Influenza A and Influenza B, the patient will be informed of the result and thanked for participating in the study. The VTM will be discarded using appropriate infection control procedures, unless the patient is also participating in the ongoing HBIS or SEIB (in which case the remaining specimen will be processed like other surveillance specimens).
Enumeration of bari contacts and questionnaire administration Illness tracking among bari contacts Illness tracking will be carried out on each day for 10 days until after resolution of the index case-patient's illness. Resolution will be defined as the lack of fever, cough, and sore throat for at least 24 hours preceding the FRA's daily illness tracking visit. Thus, if the index case-patient's illness resolves on day 4 after enrollment, illness tracking will continue until day 14 after enrollment. The FRA will visit the patient's home and record information regarding the presence or absence of ILI and SARI symptoms in each household contact using an individual illness tracking form (appendix 9a8a and 9b8b - illness tracking form, ages ≥ 5 and \< 5). For the purposes of screening household contacts for influenza, we will alter the age-specific case definition for children, based on data from urban Bangladesh, which demonstrates that fever and rhinorrhea are the most predictive factors for influenza in children \< 5 years old (WA Brooks, ICDDR,B, personal communication).
If a household contact meets the age-specific case definition and does NOT have any danger signs, the FRA will obtain written informed consent for specimen collection (appendix 2- specimen collection from household contact for adult \> 18 years old, (appendix 3 - specimen collection from household contact for child \< 18 years old). The FRA will alert the medical officer, who will visit the home with the FRA no later than the following day in order to collect nasal and oropharyngeal swabs from the ill household contact. She will immediately place both swabs into VTM, which will then be placed into a cool box, containing ice and a thermometer to ensure temperatures \< 40 C.
All specimens collected in the field will be placed in a cool box and transported to the ICDDR,B laboratory within 72 hours. At the ICDDR,B virology laboratory, all specimens for household contacts will be tested using RT-PCR for Influenza A (H1N1), A (H3N2), and Influenza B (and A (H5N1) if appropriate).
Illness tracking among household contacts will continue in each household until the 10th full day following the resolution of the index case-patient's symptoms, irrespective of whether any household contact develops illness or not.
Specific Aim 2: To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus
Methods for Specific Aim 2
To address this specific aim, we will conduct a randomized controlled trial. Households of index case-patients with influenza-like illness who are recruited at Jahurul Islam Medical College Hospital the UHCs or the local pharmacies will be randomized to the intervention group or the routine practices group.
The two groups will be defined as:
* Intervention Households: intensive promotion of handwashing with soap, and provision of facilitating tools, to the index-case-patient and all available household contacts
* Routine practices Households: continuation of the household's usual handwashing and respiratory hygiene practices group.
For promotion of handwashing with soap to intervention households, Field Intervention Specialists (FIS) will be trained to carry out a structured intervention that will follow constructs of Social Cognitive Theory (SCT). SCT addresses the reciprocal interaction between individuals, their environment, and health behaviors. Given that intervention will occur at the bari level, group-mediated constructs such as observational learning and reinforcements are highly relevant. FISs will visit the intervention households on a daily basis for 10 days after the resolution of the index case-patient's illness in order to encourage handwashing with soap at the recommended times. Routine practices households will also be exposed to the intervention, but only upon completion of the study. As noted above, under Specific Aim 1, an FRA will visit the home of the index case-patient daily for 10 days after the resolution of the index case-patient's symptoms in order to record age-specific case defining symptoms.
Specific aim 3: To identify risk factors, other than handwashing with soap, for intrahousehold transmission of influenza in a rural setting in Bangladesh.
Methods for Specific Aim 3
To address Specific Aim 3, we will conduct a nested cohort study to assess risk factors for intrahousehold transmission of influenza viruses. Here, the cohort under investigation is the routine practices group, as defined under Specific Aim 2. All data required to address this Specific Aim 3 will have been collected as part of the data collection described above under Specific Aim 1.
A case will be defined as: RT-PCR confirmed Influenza virus infection (A or B) in a household contact of an RT-PCR confirmed Influenza virus infection (A or B) index case-patient during 10 days of follow-up after resolution of the index case-patient's symptoms.
Specific aim 4: To assess whether exposure to the BISTIS intervention results in sustained improvements in handwashing behavior.
Methods for Specific Aim 4
To address Specific Aim 4, we will visit each bari that was enrolled in the intervention study 4 - 7 months after illness tracking is complete. The FRA will measure handwashing behavior at the bari. We will complete a structured observation of the bari's common handwashing behaviors. One or two months after the initial follow-up visit, the FRA will return to the bari and once again collect the same information on the handwashing behavior but will also provide soap to the bari. The FRA will collect the soap two days later. Data from the soap will be used to calculate the number of soap use events in the bari. In total an FRA will visit the household a total of three times, two visits for data collection and one visit to collect the soap.
Specific aim 5: To assess if exposure to the BISTIS intervention results in a reduced risk of respiratory infections, diarrhea, and influenza.
Methods for Specific Aim 5
The measurements of the health outcomes will be done in two different ways. At the first visit, after the handwashing behavior information is collected, the FRA will record whether each member of the bari has had symptoms of fever, cough, sore throat, difficulty breathing, respiratory illness or diarrhea in the previous 48 hours. At the third visit, in April 2010, the FRA will record mobile phone numbers of two or three bari members. The FRA will identify a key informant, who will be able to provide information regarding fever in any bari member. The FRA will phone the bari once each week during the influenza season and speak with the key informant once per week to assess whether any bari member has had fever during the previous 24 hours. If any member is reported to have a fever, we will dispatch an MO or lab/medical technician to the bari to obtain nasopharyngeal swab from that member for flu testing by PCR. A case will be defined as: RT-PCR confirmed Influenza virus infection (A or B).
#Intervention
- BEHAVIORAL : Soap
- Promotion of handwashing with soap
|
#Eligibility Criteria:
Inclusion Criteria:
* Persons >= 5 years: Influenza-like illness (ILI), defined as history of fever and either cough or sore throat with fever onset within the previous 24 hours
* Persons < 5 years: any child with acute fever with onset within the previous 24 hours
* Return to home within 24 hours of presentation to Upazilla Health Complex, Jahurul Islam Medical College Hospital or the local pharmacies; i.e., the index case cannot be admitted for treatment. If admitted, the patient would not be eligible.
* No fever in any bari resident during the 7 days preceding the patient's presentation to hospital (see definition below)
* At least two persons (in addition to the index case-patient) who intend to reside in the bari during the subsequent 20 days
* Residence within 30 minutes travel time (one-way) from the Upazilla Health Complex or Jahurul Islam Medical College Hospital or the local pharmacy.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00880659
|
{
"brief_title": "Bangladesh Secondary Transmission Handwashing Protocol",
"conditions": [
"Human Influenza"
],
"interventions": [
"Behavioral: Soap"
],
"location_countries": [
"Bangladesh"
],
"nct_id": "NCT00880659",
"official_title": "Prevention of Secondary Transmission of Human Influenza by Promoting Handwashing With Soap: The Bangladesh Interruption of Secondary Transmission of Influenza Study (BISTIS)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-10",
"study_completion_date(actual)": "2010-12",
"study_start_date(actual)": "2009-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-12-30",
"last_updated_that_met_qc_criteria": "2009-04-13",
"last_verified": "2010-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-04-14",
"first_submitted": "2009-04-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study was to determine the effect of gel nail application on pulse oximetry measurements in healthy subjects. This study was planned as a prospective, self-controlled clinical research to determine the effect of gel nail application on SpO2 and pulse values in healthy people. The population of the study will consist of women who had gel nail application in a private beauty centre between July 2023 and October 2023. The minimum required sample size was calculated as 162 in G\*Power (3.1.9.2) programme (α=0.05 (two-way), 1-β=0.95). The data will be collected with the data collection form prepared in line with the literature. Firstly, the personal information of the participants will be recorded in the data collection form. The middle finger of the left hand of each participant will be the treatment group and the little finger will be the control group. After the gel nail is applied to the middle finger of the left hand, SpO2 and pulse values will be measured simultaneously with a pulse oximeter from the left hand middle finger and little finger of the participant and recorded on the data form. The data obtained from the study will be analysed using SPSS (Statistical Package for Social Sciences) for Windows 26.0 software.
Detailed Description
The aim of this study was to determine the effect of gel nail application on pulse oximetry measurements in healthy subjects. This study was planned as a prospective, self-controlled clinical research to determine the effect of gel nail application on SpO2 and pulse values in healthy people. The population of the study will consist of women who had gel nail application in a private beauty centre between July 2023 and October 2023. The minimum required sample size was calculated as 162 in G\*Power (3.1.9.2) programme (α=0.05 (two-way), 1-β=0.95). The data will be collected with the data collection form prepared in line with the literature.On this form, the age of the individual, the color of the gel nail, smoking status, and the SpO2 and pulse values measured by pulse oximetry from the little and middle finger will be recorded. SpO2 and pulse rates will be measured with a calibrated Jumper pulse oximeter. Since the gel nail and non-gel nail will be measured at the same time, two of the same brand pulse oximeter devices will be provided.Volunteers who meet the inclusion criteria of the research will be informed about the research and will be included in the research on a voluntary basis and their written consent will be obtained. Firstly, the personal information of the participants will be recorded in the data collection form. The middle finger of the left hand of each participant will be the treatment group and the little finger will be the control group. After the gel nail is applied to the middle finger of the left hand, SpO2 and pulse values will be measured simultaneously with a pulse oximeter from the left hand middle finger and little finger of the participant and recorded on the data form. The data obtained from the study will be analysed using SPSS (Statistical Package for Social Sciences) for Windows 26.0 software. Mean and standard deviation will be used in the evaluation of the data. Statistical significance will be accepted as p\<0.05 (95% confidence interval).
#Intervention
- OTHER : Gel nail application
- The middle finger of the left hand of each participant will be the experimental group and the little finger will be the control group. After the gel nail is applied to the middle finger of the left hand, SpO2 and pulse values will be measured by pulse oximetry from the left hand middle finger and little finger of the participant
- Other Names :
- Control group: Non-applied nail
|
#Eligibility Criteria:
Inclusion Criteria:
* No communication problems,
* With full left-hand fingernails,
* No structural problems such as clubbing,
* Body temperature >= 36- <37.5 ºc,
* SpO2 value >= 95%,
* Capillary refill <= 2 seconds,
* Who volunteered to participate in the research,
* No psychiatric or physical illness that prevents communication,
* Without circulatory problems such as Reynauld syndrome and peripheral arterial disease,
* Without anaemia,
* No respiratory diseases such as chronic obstructive pulmonary disease and asthma
* Becoming a woman
Exclusion Criteria:
* Communication problems,
* Incomplete left fingernails,
* Structural problems like sticky fingers,
* Body temperature >= 36- < 37.5 ºc,
* SpO2 value <95%,
* Capillary refill >2 seconds,
* Not volunteering to participate in the research,
* Psychiatric or physical illness that prevents communication,
* With circulatory problems such as Reynauld syndrome and peripheral arterial disease,
* Anaemia
* Respiratory diseases such as chronic obstructive pulmonary disease and asthma
* Not being of the female gender
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06101628
|
{
"brief_title": "Effect of Gel Nail Application on Pulse Oximetry Measurements in Healthy Individuals",
"conditions": [
"Healthy Individuals",
"Gel Nail",
"Oxygen Saturation",
"Nursing",
"Perioperative Care"
],
"interventions": [
"Other: Gel nail application"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06101628",
"official_title": "Effect of Gel Nail Application on Pulse Oximetry Measurements in Healthy Individuals",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-03-30",
"study_completion_date(actual)": "2024-05-30",
"study_start_date(actual)": "2023-07-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-12",
"last_updated_that_met_qc_criteria": "2023-10-17",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-26",
"first_submitted": "2023-10-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study evaluates the performance of a blood test for detecting biomarkers in metastatic breast cancer patients at one clinic against standard testing.
Detailed Description
The primary objective of this pilot study is to detect the expression of FGFR1 and AR on circulating tumor cells (CTCs) isolated from the peripheral blood of metastatic breast cancer (MBC) patients using the OncoCEE™ platform. No procedures will be associated with this study, as these mutations will be evaluated from the leftover blood that has already been sent for standard of care ER and HER2 using the same platform. Results from this testing will be correlated with results obtained from standard testing to calculate the rate of concordance between tests.
|
#Eligibility Criteria:
Inclusion Criteria:
* Current patient at participating clinic
* Metastatic breast cancer diagnosis
* 18 years or older
Exclusion Criteria:
None
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02436772
|
{
"brief_title": "Utilization of the OncoCEE™ Platform to Evaluate Selected Biomarker Alterations in CTCs Isolated From Patients With MBC",
"conditions": [
"Metastatic Breast Cancer"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT02436772",
"official_title": "Utilization of the OncoCEE™ Platform to Evaluate Selected Biomarker Alterations in CTCs Isolated From Patients With MBC",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07-07",
"study_completion_date(actual)": "2017-07-07",
"study_start_date(actual)": "2015-05-13"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-09-02",
"last_updated_that_met_qc_criteria": "2015-05-04",
"last_verified": "2020-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-05-07",
"first_submitted": "2015-05-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This clinical trial is designed to evaluate the efficacy, dose-response and safety of WIN-901X in Asthma patients.
Detailed Description
Double blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients
#Intervention
- DRUG : WIN-901X dose level 1
- 100mg Bid, PO, 12weeks
- DRUG : WIN-901X dose level 2
- 200mg Bid, PO, 12weeks
- DRUG : WIN-901X dose level 3
- 300mg Bid, PO, 12weeks
- DRUG : Placebo
- Bid, PO, 12weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Greater than or equal to 20 and less than 80 years
* Have physician diagnosed asthma with irreversible airway obstruction at least 6 months prior to the screening
* FEV1 between 60% and 85% before inhaling fast-acting bronchodilator at screening
* No history of smoking at least one year prior to the screening
* Having voluntarily signed an informed consent
Exclusion Criteria:
* Have visited emergency room due to the worsening asthma symptoms, within 4 weeks before the screening
* Have been hospitalized due to an acute worsening of asthma within 3 months before the screening
* Have a history of laryngitis, pyrexia, sinusitis, otitis media, respiratory tract infection, and infectious rhinitis within 4 weeks prior to the screening
* Have malignant tumor
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01820481
|
{
"brief_title": "Safety and Efficacy of WIN-901X in Asthma",
"conditions": [
"Asthma"
],
"interventions": [
"Drug: WIN-901X dose level 1",
"Drug: WIN-901X dose level 3",
"Drug: Placebo",
"Drug: WIN-901X dose level 2"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01820481",
"official_title": "Double Blinded, Randomized, Placebo Controlled, Multi-center, Phase 2 : Exploratory Clinical Study to Evaluate the Efficacy, Dose-response and Safety of WIN-901X in Asthma Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-11",
"study_completion_date(actual)": "2013-11",
"study_start_date(actual)": "2012-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-12-09",
"last_updated_that_met_qc_criteria": "2013-03-25",
"last_verified": "2013-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-03-28",
"first_submitted": "2013-03-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compare the effectiveness of a brief family intervention in reducing alcohol use and alcohol-related problems among families of underage drinkers (13-17 years old) who are treated in a hospital emergency department for an alcohol-related event.
Detailed Description
The long-term objectives of this research program are to develop effective interventions in health care settings for reducing problem drinking and associated problems among adolescents and to further enhance intervention approaches by identifying effective elements of treatment. The major purpose of this study is to compare a brief integrated individual and family intervention designed to reduce alcohol use and related problems to an enhanced standard care condition (standard care plus family assessment).
The targeted population is underage drinkers (13-17 years old) who have been treated in an Emergency Department following an alcohol-related event. It is important to intervene with this population because alcohol-involved adolescents may be at higher risk for having continuing alcohol problems (Fillmore, 1988; Zucker, in press). The intervention is conceptualized as using a 'teachable moment' (i.e., shortly after a salient event) to increase family interest in reducing harmful drinking. The experimental intervention integrates an individual Motivational Interview (MI) for the adolescent, based on our research group's prior work with this intervention, with a brief family intervention, the Family Check-Up (Dishion \& Kavanagh, 2003).
The experimental condition will be compared to standard care plus family assessment. This design allows us to test the added benefit of the brief family intervention compared to the benefits often derived from assessment without added treatment. Follow-up interviews will be conducted at 3, 6, and 12 months after the baseline intervention to assess outcome. The specific aims of this proposal are to test the effectiveness of the experimental intervention in reducing alcohol-related problems, alcohol consumption, and other behavior problems compared to the enhanced standard care condition. Second, we will examine whether depressed mood and behavior problems at baseline moderate the effects of the treatment conditions. We will also test whether individual factors (motivation to change behavior) and environmental factors (parent/family influence and peer influence) mediate the relation between the treatment condition and outcomes.
#Intervention
- BEHAVIORAL : MI/Family Check-up
- The experimental intervention integrates an individual Motivational Interview (MI) for the adolescent with a brief family intervention, the Family Check-Up. Follow-up interviews will be conducted at 3, 6, and 12 months after the baseline intervention.
- BEHAVIORAL : MI only
- An individual motivational interview (IMI only) will be conducted at 3, 6, and 12 months after the baseline intervention to assess outcome.
|
#Eligibility Criteria:
Inclusion Criteria:
* Child aged 13 <= age <= 17 years
* Receiving treatment at the approved medical Emergency Department
* Child living in a home with at least one parent or legal guardian
Exclusion Criteria:
* Children who are suicidal, in police custody, not alert/oriented, non-English speaking, in severe pain, or who have sustained severe trauma
* Children with a history of prior substance abuse treatment
Sex :
ALL
Ages :
- Minimum Age : 13 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00247221
|
{
"brief_title": "Brief Intervention for Families of Teens Treated in the Emergency Department for an Alcohol-Related Event",
"conditions": [
"Alcohol Abuse"
],
"interventions": [
"Behavioral: MI/Family Check-up",
"Behavioral: MI only"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00247221",
"official_title": "Family Motivational Interviews for ETOH+ Teens in the ER",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-07",
"study_completion_date(actual)": "2008-07",
"study_start_date(actual)": "2002-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-07-31",
"last_updated_that_met_qc_criteria": "2005-10-28",
"last_verified": "2012-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-11-01",
"first_submitted": "2005-10-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a 16-week intervention to determine the efficacy of an isoflavone-rich soy based meal supplement to improve bone health and prevent weight and fat gain in 18-19 year old college females. The primary hypothesis is that participants who receive soy will have favorable changes in blood markers of bone and less weight and fat gain. The soy is provided by Physicians Pharmaceuticals, Inc. (Revival Doctor-formulated soy protein).
Detailed Description
The proposed study will be a 16-week randomized, double-blind, placebo-controlled trial designed to test whether a daily isoflavone-rich, soy-based meal replacement Revival Soy shake promotes favorables changes in bone biomarkers and attenuates weight gain in female college students. First-year college females were selected because of the potential for significant weight gain during their freshman year. The study will have a parallel design with two groups: the soy treatment group (SOY; n = 60) and a casein-based control (CON; n = 60). Exclusion criteria include significant weight loss or gain in the past 3 months, vegetarians and heavy soy food consumers, National Collegiate Athletic Association Division I athletes, women with eating disorders, present illnesses, chronic disease, and those taking medications or herbal supplements known to affect body weight, body fat or bone. Participants will be stratified based on BMI (18.0-24.9; 25-29.9; ≥30.0) and randomized to either SOY or CON groups.
Female college freshmen enrolled at the University of Georgia will be recruited in the fall of 2005. The soy-based meal replacements will contain 20 g soy protein and 161.2 mg isoflavones, 220-240 kcal, 31-36 g total carbohydrates, 0-2 g dietary fiber, 500 mg calcium, and 2.0-2.5 g total fat per serving. The control shake will have 20 g casein substituted for soy protein, and will be otherwise identical to the soy shakes. The shakes will be available in two flavors: chocolate and vanilla.
#Intervention
- DIETARY_SUPPLEMENT : Soy Protein Dietary Supplement
- The soy-based meal replacements will contain 20 g soy protein and 161.2 mg isoflavones, 220-240 kcal, 31-36 g total carbohydrates, 0-2 g dietary fiber, 500 mg calcium, and 2.0-2.5 g total fat per serving.
- DIETARY_SUPPLEMENT : Placebo
- The control shake will have 20 g casein substituted for soy protein, and will be otherwise identical to the soy shakes. The shakes will be available in two flavors: chocolate and vanilla.
|
#Eligibility Criteria:
Inclusion Criteria:
* 18 <= age <= 19 year old University of Georgia college females of all races/ethnicities.
Exclusion Criteria:
* significant weight loss or gain, currently dieting to lose weight, are planning to lose weight, diet or begin an exercise program, under the age of 18, pregnant or intending to become pregnant, vegetarians, heavy soy food consumers, Division I athletes, women with menstrual irregularities, eating disorders, present or chronic illness, and those taking medications known to affect bone, body weight or body fat.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00244478
|
{
"brief_title": "Soy, Bone and Health in College Females",
"conditions": [
"Osteoporosis",
"Obesity"
],
"interventions": [
"Dietary Supplement: Placebo",
"Dietary Supplement: Soy Protein Dietary Supplement"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00244478",
"official_title": "Influence of Soy on Bone Turnover and Body Composition in College Females",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-03",
"study_completion_date(actual)": "2006-03",
"study_start_date(actual)": "2005-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-09-25",
"last_updated_that_met_qc_criteria": "2005-10-25",
"last_verified": "2015-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-10-26",
"first_submitted": "2005-10-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Objectives: This study will determine the clinical efficacy of bleaching agent 37% carbamide peroxide compared to 35% hydrogen peroxide on the change of color scores in anterior superior teeth, in-office bleaching technique after 7, 14 and 37 days; and the Risk to the tooth sensitivity before, during and 24 hours after the procedure.
Materials and Methods: Fifty patients will be selected for this single-blind, parallel, randomized-controlled clinical trial. The whitening treatment with 37% carbamide peroxide or 35% hydrogen peroxide (control) will be carried out in a single application of 45 minutes for two sessions with a 7-day interval. The sensitivity level will be assessed before, during and 24 hours after the procedure using verbal and analogic visual analogue (VAS) scales. Color alteration will be assessed by a bleach guide scale 7 days after each session and 30 days after the last session. Relative risk to sensitivity will be calculated and adjusted by session; while comparison of overall risk will performed by McNemar's test. Data on the sensitivity level for both scales will be subjected to the Mann-Whitney tests (α = 0.05). The color change will be measured with a spectrophotometer using the CIE L \* a \* b \* and the L\*, a \* and b \* parameter delta data, and ΔE and Δ00, will be individually subjected to two-way repeated measures ANOVA test to compare the two bleaching techniques at each evaluation time (α = 0.05).
Detailed Description
Methods \& Materials: This clinical trial was approved by the Scientific Review Committee and by the Committee for the Protection of Human Subjects of the local university (CAAE 50511415.1.0000.5546).
Trial design: This study will be a randomized-controlled, single-blind clinical trial with a parallel design. The patients included will be submitted to two in-office bleaching sessions with a 7-day interval receiving 35% hydrogen peroxide (control) or 37% carbamide peroxide in a single application of 45 minutes; while the same treatments will be allocated for each session. The study will be conducted at the clinic of the School of Dentistry of the local university from May 2016 to December 2016.
Participants: Patients included in this clinical trial will be at least 18 years old with good oral health. Patients with any of the six upper anterior teeth with caries, restoration, severe discoloration (e.g., stains caused by tetracycline), enamel hypoplasia, gingival recession, dentin exposure, pulpitis, or endodontics will be excluded. Participants submitted to previous bleaching procedures, presenting prior tooth sensitivity, pregnant or breastfeeding will be also excluded. Only patients presenting all six upper anterior teeth with shade mismatching with 2.5 M2 (Vita Bleach guide 3D-Master scale, Vita-Zahnfabrik, Bad Sackingen, Germany) or darker will be included.
Sample Size Calculation:
The sample calculation will be based on the primary continuous outcome for superiority control. Power of the test will be set at 80%, considering a type I error of 0.05; for a minimum detectable difference between treatments 25%, based on a prior study using similar bleaching agent, while a coefficient of variation of 30% of control treatment will be expected. The calculation resulted in fifty patients, through the formula used n = f(α/2, β) × \[p1 × (100 - p1) + p2 × (100 - p2)\] / (p2 - p1)2. The calculation resulted in fifty patients.
Randomization:
A randomized list will be computer-generated by a person not involved in intervention or evaluation. The participants were defined as blocks in the randomization process, where the sequence of treatment (treatment or control) will be randomly set for each block by using computer-generated tables (www.sealedenvelope.com). The sequence will be inserted into sealed envelopes numbered from 1 to 50 that were opened by the operator only at the moment of the intervention. The patients were numbered according to the sequence of enrollment. Neither the participant nor the operator knew the group allocation determining blinding to the protocol.
Baseline evaluation:
Prior to bleaching procedure, the teeth will be cleaned using rubber cups associated to pumice and water. The shades of canine upper teeth will be assessed on a baseline with a spectrophotometer Vita EasyShade (Vita-Zahnfabrik, Bad Säckinge, Germany) using the CIE L \* a \* b \*. 3 measurements on each tooth will be conducted, with the end result the average of 3 values (L \*, a \* and b \*).
Intervention:
Control treatment: A light-cured resin dam will be applied (Top Dam, FGM, Joinville, SC, Brazil) on the gingival tissue corresponding to the teeth to be bleached. A 35% hydrogen peroxide based bleaching agent (Whiteness HP Maxx, FGM, Joinville, SC, Brazil) will be mixed and applied on the vestibular surface of teeth, in the ratio of 1 drop every 3 to the thickener and peroxide, remaining for 45 minutes. After this time, the bleaching agent will be removed. A second session will be as carried out after 1 week following the same procedures.
Experimental Treatment: A 37% carbamide peroxide based bleaching agent (Power bleaching, BM4, Palhoça, SC, Brazil) will be applied on the vestibular surface of teeth with a relative isolation only using cotton roller, remaining for 45 minutes. After this time, the bleaching agent will be removed. A second session will be as carried out after 1 week following the same procedures.
Evaluations:
The tooth sensitivity reported by patients will be assessed using a visual analog scale (VAS) and verbal rating scale (VRS). The VAS consisted of a scale 10 cm in length ranging from 0 (absence of pain) to 10 (unsupportable pain). The patient set his or her level of sensitivity by pointing on the scale corresponding to this level, while the distance from this point to the 0 border will be recorded. For VRS, the patient reported his or her level of sensitivity based on scores: 0 = none, 1 = light, 2 = moderate, 3 = considerable and 4 = severe. The tooth sensitivity will be assessed during the bleaching, immediately after bleaching agent removal and and up to 24 hours after each session. One week after each session and 30 days after the last session the tooth color will be evaluated again using the CIE L \* a \* b \* as previously described.
Statistical Analysis:
For color analysis, the parameter delta data L \*, a \* and b \*, and ΔE and Δ00, will be individually subjected to two-way repeated measures ANOVA test to compare the two bleaching techniques at each evaluation time. Based on presence of any tooth sensitivity (scores different from 0 for VRS), the absolute risk, odds ratio and relative risk will be calculated regarding the treatments for each moment of evaluation/session of bleaching, as well as its confidence intervals (95%). For each moment, differences on presence/absence ratios will be analyzed by Fisher's exact test. For the overall risk related to each treatment, the odds ratio will be adjusted to independent variable 'session of bleaching' using the Mantel-Haenszel statistic. The homogeneity of odds ratios will be analyzed by the Breslow-Day and Tarone's tests. Following, the odds ratio estimated will be converted to relative risk and the overall presence/absence ratios will be analyzed by the McNemar's test, considering the study design (parallel).
For VRS, the data from scores observed in each time of evaluation/session of bleaching will be submitted to the Mann-Whitney rank sum test. Despite the measurement of tooth sensitivity using VAS giving a continuous outcome, data assessed with this scale did not show a normal distribution (Shapiro-Wilk's test). Thus, data from VAS will be also analyzed by the Mann-Whitney rank sum test, while one test per time of evaluation will be carried out. All statistical analyses will be performed considering a 95% significance level (α = 0.05).
#Intervention
- DRUG : 37% Carbamide Peroxide
- * no Gingival dam protection (as manufacturer´s instruction)
* 37% Carbamide Peroxide application (2 sessions of 45 minutes)
* Tooth sensitivity (Verbal and visual scale) and color evaluation
- DRUG : 35% hydrogen Peroxide
- * Gingival dam protection (as manufacturer´s instruction)
* 35% Hydrogen Peroxide application (2 sessions of 45 minutes)
* Tooth sensitivity (Verbal and visual scale) and color evaluation
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients included in this clinical trial will be at least 18 years with good oral health. Only patients presenting canine upper teeth with shade mismatching with 2.5 M2 (Vita Bleach guide 3D-Master scale, Vita-Zahnfabrik, Bad Sackingen, Germany) or darker will be included.
Exclusion Criteria:
* Patients with any of the six upper anterior teeth with caries, restoration, severe discoloration (e.g., stains caused by tetracycline), enamel hypoplasia, gingival recession, dentin exposure, pulpitis, or endodontics will be excluded. Participants submitted to previous bleaching procedures, presenting prior tooth sensitivity, pregnant or breastfeeding will be also excluded.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02935114
|
{
"brief_title": "IN-OFFICE TOOTH BLEACHING WITH 37% CARBAMIDE PEROXIDE",
"conditions": [
"Tooth Sensitivity"
],
"interventions": [
"Drug: 35% hydrogen Peroxide",
"Drug: 37% Carbamide Peroxide"
],
"location_countries": null,
"nct_id": "NCT02935114",
"official_title": "EVALUATION OF CLINICAL EFFICACY AND SENSIBILITY OF BLEACHING AGENT 37% CARBAMIDE PEROXIDE IN-OFFICE TOOTH BLEACHING: CLINICAL TRIAL RANDOMIZED CONTROLLED",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06",
"study_completion_date(actual)": "2016-11",
"study_start_date(actual)": "2016-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-11-15",
"last_updated_that_met_qc_criteria": "2016-10-12",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-10-17",
"first_submitted": "2016-10-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A multi-center, prospective, single-visit study designed to acquire physiologic pulse oximeter waveform data during standard polysomnography (PSG) studies performed at multiple different Sleep Lab Centers.
Detailed Description
The polysomnograms are clinically indicated studies in patients suspected of having sleep-disordered breathing, including, but not limited to: obstructive sleep apnea, complex sleep apnea and/or central sleep apnea. Subjects who have been prescribed with needing a polysomnography (PSG) will be enrolled into the study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects will be referred to the Sleep Lab Center for evaluation of possible sleep-disordered breathing.
* Polysomnography (PSG) is obtained as part of normal, standard clinical practice.
* Subject is able to and willingly signs the informed consent form.
Exclusion Criteria:
* Subject and/or parent/legal guardian is, in the opinion of the investigator, mentally and/or physically unable to provide informed consent/child assent and/or to complete all requirements of the protocol.
* Subject is currently participating in or has participated in an investigational drug study within seven (7) days of enrollment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00775346
|
{
"brief_title": "A Multi-Center Study to Assess the Performance of Saturation Patterns.",
"conditions": [
"Sleep-Disordered Breathing",
"Obstructive Sleep Apnea",
"Sleep Apnea",
"Central Sleep Apnea"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00775346",
"official_title": "A Multi-Center Study to Assess the Performance of the Saturation Pattern Detection (SPD) Software Algorithm.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-10",
"study_completion_date(actual)": "2008-10",
"study_start_date(actual)": "2008-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-08-07",
"last_updated_that_met_qc_criteria": "2008-10-17",
"last_verified": "2014-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-10-20",
"first_submitted": "2008-10-16",
"first_submitted_that_met_qc_criteria": "2010-05-20"
}
}
}
|
#Study Description
Brief Summary
The objective of the study is to evaluate the safety and efficacy of the home-use device Silk'n toothbrush (ToothWave) for the improvement in dental health through the reduction of plaque, gingivitis, and calculus.
Detailed Description
This is a single blind, prospective study aimed to evaluate the safety and efficacy of the Silk'n toothbrush in reduction of gingivitis, dental plaque and calculus.
The study includes a total of 168 treatment sessions, twice a day, and 5 clinic visits over a period of 12 weeks.
One treatment group (Silk'n toothbrush - ToothWave) and 1 control group (an ADA approved power toothbrush (PTB)) will participate in the study.
For each patient, assessment data will be collected at baseline, 4 weeks, and at 6 weeks. Calculus condition will be measured after 12 weeks in addition to the other timepoints. The average data sets will be calculated for each group.
Treatment is defined as a timed 2 minutes of teeth brushing in a regular manner, twice a day (morning and evening). Brushing will be undertaken using the Silk'n toothbrush and standard fluoride toothpaste. The control group will use a regular PTB and standard fluoride toothpaste.
#Intervention
- DEVICE : RF-utilizing powered toothbrush
- RF-utilizing Powered toothbrush
- Other Names :
- RF toothbrush
- DEVICE : Control placebo with no RF
- Placebo control, toothbrush with no RF
|
#Eligibility Criteria:
Inclusion Criteria
* Adult subjects aged 18 <= age <= 70, that are in good health.
* Subject must have:
2.1. Baseline gingivitis (MGI) score of at least 1.80. 2.2. Baseline gingival bleeding (GBI) of >=1 on at least 20 sites. 2.3. Dental Plaque mean score greater than 0.6 according to the RMNPI (Rustogi Modified Navy Plaque Index).
2.4. Total Calculus deposits greater than 9 according to the Volpe-Manhold Index.
* Have a minimum of 20 'scorable' teeth (excluding 3rd molars).
* The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
* The subjects should be willing to comply with the study procedure and schedule, including the follow up visits.
Exclusion Criteria
* Current or history of oral cavity cancer or oropharyngeal cancer.
* Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
* Pregnant or nursing by subject report.
* Any active condition in the oral cavity at the discretion of the investigator.
* Any surgery in the oral cavity within 3 months prior to treatment, or before complete healing.
* Subjects that do not brush regularly.
* Any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04092075
|
{
"brief_title": "Safety and Efficacy of the ToothWave -12 Weeks Calculus Study",
"conditions": [
"Gingivitis",
"Plaque",
"Calculus, Dental"
],
"interventions": [
"Device: RF-utilizing powered toothbrush",
"Device: Control placebo with no RF"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04092075",
"official_title": "Safety and Efficacy of the Silk'n Toothbrush (ToothWave), Home Use Device for Reduction of Calculus, Gingivitis and Dental Plaque.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-04-30",
"study_completion_date(actual)": "2020-04-30",
"study_start_date(actual)": "2019-08-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-07-29",
"last_updated_that_met_qc_criteria": "2019-09-15",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-17",
"first_submitted": "2019-09-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Type 2 diabetes mellitus (T2DM) is a progressive metabolic disorder in which a substantial number of patients cannot attain treatment target despite antidiabetic drugs. The renin-angiotensin system (RAS) has recently been implicated in the development of insulin resistance and impaired glucose metabolism. This study investigates the effect of adding RAS inhibitors to standard antidiabetic therapy in patients with T2DM. The primary outcome measure is the change in serum glycosylated hemoglobin A1c after 24 weeks of treatment. Secondary outcomes measures include changes in plasma lipid profile and blood pressure after treatment.
#Intervention
- DRUG : Valsartan 80 mg and metformin
- Valsartan 80 mg once daily in addition to metformin monotherapy
- DRUG : Metformin
- Metformin monotherapy
|
#Eligibility Criteria:
Inclusion Criteria:
* adults > 21 years
* clinically diagnosed type 2 diabetes mellitus
* recipients of metformin monotherapy
* compliance with prescriptions and dietary intervention
Exclusion Criteria:
* recipients of any second-line antidiabetic drug in addition to metformin
* recipients of any antihypertensive medication before study enrollment
* hemoglobin disorders
* chronic kidney disease
* thyroid dysfunction
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04707508
|
{
"brief_title": "Effect of Adding Renin-Angiotensin System Inhibitors to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Ellitus",
"conditions": [
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: Valsartan 80 mg and metformin",
"Drug: Metformin"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT04707508",
"official_title": "Investigating the Effect of Renin-Angiotensin System Inhibitors in Addition to Standard Antidiabetic Therapy on Glycemic Control in Patients With Type 2 Diabetes Mellitus: A Prospective Open-label Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-01-23",
"study_completion_date(actual)": "2019-11-29",
"study_start_date(actual)": "2017-12-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-01-13",
"last_updated_that_met_qc_criteria": "2021-01-11",
"last_verified": "2021-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-01-13",
"first_submitted": "2021-01-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research is to study and improve the methods used to detect childhood breathing problems during sleep that can affect daytime behavior at home and school. Early diagnosis of these sleep disorders may allow doctors to treat children at a time when the consequences can still be reversed.
Detailed Description
BACKGROUND:
Sleep-disordered breathing (SDB) affects at least 1 to 3 percent of children. Associated morbidity can include inattentive and hyperactive behavior, disruptive behavior disorders, cognitive deficits, and excessive daytime sleepiness. Sleep specialists recommend that children undergo polysomnography to confirm SDB, especially before undergoing treatment, which often involves an adenotonsillectomy. Unfortunately, such testing is rarely performed either before or after surgery. Available data suggest that a clinical diagnosis of SDB does not predict polysomnographic results reliably. However, the extent to which polysomnographic results predict morbidity, and especially treatable morbidity, is not well known. The main goal of the proposed research, therefore, is to study and improve methods for identification of childhood SDB that carries reversible morbidity.
DESIGN NARRATIVE:
Researchers will examine the utility of polysomnography in a group of children scheduled to undergo adenotonsillectomy for clinical indications, and a group of matched control subjects. Initial evaluations, before surgery in the first group, will be compared to results of identical evaluations 6 months later in this controlled nonrandomized trial. Outcomes will be provided by well-validated assessments of behavior, psychiatric status, cognition, and sleepiness. Explanatory variables will include standard clinical and polysomnographic information, and data from two newer techniques. The first, nasal pressure monitoring, shows increased sensitivity for events that characterize SDB, but few results and no outcome data have been reported from use of this method in children. The second is an innovative signal processing algorithm developed by the investigators to show that cortical electroencephalogram (EEG) activity changes in synchrony with non-apneic respiratory cycles in children with SDB. Preliminary data suggest that the magnitude of respiratory cycle-related EEG changes (RCREC) varies with SDB severity, diminishes after SDB treatment, and improves prediction of neurobehavioral outcomes. The specific aims of the proposed research are to show that 1) nasal pressure monitoring, in comparison to standard measures of airflow, improves prediction of neurobehavioral response to adenotonsillectomy; 2) RCREC, in comparison to standard visually-scored EEG-based arousals, do likewise; 3) polysomnographic SDB measures, including nasal pressure monitoring and RCREC, add useful information to that derived from office-based assessments; and 4) polysomnography after adenotonsillectomy can identify clinically relevant residual SDB in some children.
#Intervention
- PROCEDURE : Observational follow-up study of adenotonsillectomy
- Studies of sleep, behavior, cognition, and daytime sleepiness
- Other Names :
- Adenotonsillectomy vs. non-surgical subjects
|
#Eligibility Criteria:
Inclusion Criteria:
* Assent of child (if over the age of 9 or younger but able to understand the nature of the study)
* At least one parent or guardian must sign an informed consent
* Child must be either a healthy volunteer or scheduled for an adenotonsillectomy for any reason
* Children scheduled for adenotonsillectomies must be referred to the program by a treating otolaryngologist who practices at the University of Michigan or St. Joseph Mercy Hospital in Ann Arbor, Michigan
Exclusion Criteria:
* Mental or physical limitations that would prevent proper interpretation of neurobehavioral tests
* Medical history that could confound interpretation of EEG or behavioral data, including epilepsy, psychiatric diagnoses (other than disruptive behavior disorders), head trauma with loss of consciousness for more than 30 seconds, or chronic medication use (e.g., benzodiazepines, other hypnotics, or antihistamines)
* Current treatment by a physician or past surgical treatment for SDB
* A known medical condition that carries independent high risk of SDB (e.g., Pierre Robin syndrome, Down syndrome, or neuromuscular disorders) or excessive daytime sleepiness (e.g., narcolepsy)
* Inability to schedule polysomnography, a Multiple Sleep Latency Test, and neurobehavioral testing before the surgical date
* Determination by any of the patient's physicians that sleep testing is required before surgery can be scheduled (to avoid the possibility that study enrollment itself could affect ability to complete the study)
* Prior enrollment of a sibling in the study
* Expectation that the child will no longer have convenient access to University of Michigan facilities within 6 months or expectation of further surgery within that period
Additional exclusion criteria for healthy volunteers include:
* Any history of adenoidectomy or tonsillectomy
* Plans for either procedure in the future
* History of habitual snoring
* History of large (uninfected) tonsils
* History of recurrent throat infection that might be grounds for adenotonsillectomy (three episodes in each of 3 years, five episodes in each of 2 years, or seven episodes in one year)
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00233194
|
{
"brief_title": "Identification of Sleep-Disordered Breathing in Children",
"conditions": [
"Sleep",
"Sleep Apnea Syndromes",
"Sleep Disordered Breathing"
],
"interventions": [
"Procedure: Observational follow-up study of adenotonsillectomy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00233194",
"official_title": "Identification of Sleep-Disordered Breathing in Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-11",
"study_completion_date(actual)": "2011-07",
"study_start_date(actual)": "2005-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-12-06",
"last_updated_that_met_qc_criteria": "2005-10-03",
"last_verified": "2016-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-10-05",
"first_submitted": "2005-10-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Post-thoracotomy pain is one of the most severe forms of post-operative pain. Among the most common techniques for the management of post-thoracotomy pain, there are the intercostal nerve block, and a recently described block, the erector spinae plane block (ESP).To date, there are no studies that compare the efficacy of ESP block with other pain relief methods in acute post-thoracotomy pain. The objective of this randomized study is to compare the analgesic efficacy of these two techniques in the control of acute post-thoracotomy chest pain, block of erector spinae vs intrapleural intercostal block.
Detailed Description
Post-thoracotomy pain is one of the most severe forms of post-operative pain that can be attributed to muscle incision, rib retraction or resection, and damage to the intercostal nerves. Inadequate control of this post-operative pain can contribute to a deterioration of the respiratory function, with limitation of the ventilation, appearance of atelectasis, ineffective cough, and increased risk of infectious complications. Moreover, recent evidence shows that persistent pain after surgery, in addition to being responsible for chronic post-surgical pain syndrome, is associated with a delay in post-operative recovery and a return to normal daily life activities. The most common techniques for the management of post-thoracotomy pain are in addition to systemic intravenous analgesia, thoracic epidural, paravertebral nerve block and intercostal nerve block. Although the thoracic epidural has been considered for years the gold standard for the control of post-operative pain following thoracotomy, it is not risk-free, requires an expert operator, and can be contraindicated in some categories of patients. The intercostal nerve block, performed through the injection of the local anesthetic in multiple intercostal spaces before performing thoracotomy, may be one of the alternatives to a thoracic epidural in terms of safety and efficacy and is technically easy and quick to perform. This block is found to be particularly effective in reducing post-operative pain when associated with a mini-thoracotomy, helping to improve the outcome of patients undergoing major lung resection. A technique of more recent description (2016) is the erector spinae plane block (ESP) . This interfascial block is performed in the posterior thoracic region homolaterally at the site of the intervention at the level of the T5 transverse process (fifth thoracic vertebra), the ultrasound marker of the block. The ESP block is easy and safe to perform thanks to the ultrasound-guided method and the absence of vascular-nerve structures at risk of damage in the vicinity of the injection site and allows analgesia of the posterior and anterolateral thoracic wall and of the axillary region. In fact, cadaveric studies have shown an anesthetic distribution both in the cranial caudal sense (T2-T8) along the fascia between erector spinae and large rhomboid, and in the anteroposterior direction, with the blockage of the spinal thoracic nerve roots. ESP block was described in the treatment of chronic chest pain in the first place, but was subsequently used as rescue therapy in acute post-thoracotomy pain; it has also been tested in upper abdominal surgery, performed bilaterally. Use in four cases of acute post video thoracoscopy pain management has also been described. Recently, some randomized controlled trials have been carried out that showed: greater analgesic efficacy of ESP compared to intravenous multimodal analgesia standard for the treatment of post-operative pain, with less recourse to rescue doses of morphine following laparoscopic cholecystectomy, mastectomy and cardiac surgery. To date, there are no studies that compare its efficacy with other pain relief methods in acute post-thoracotomy pain. The objective of our study is to compare the analgesic efficacy of these two techniques in the control of acute post-thoracotomy chest pain, blockade of erector spinae vs intrapleural intercostal blockade.
#Intervention
- PROCEDURE : erector spinae plane block with ropivacaine
- The block is performed immediately before surgery. by an ultrasound guide, with the probe positioned longitudinally, the spinous process of T5 is identified. A peripheral block needle is inserted in the cephalo-caudal direction (caliber 21G and length 10 cm) and 3 ml of physiological solution are injected to confirm the injection site: fascial plane between the erector spinae muscle and the large rhomboid, near the tip of the transverse process of T5. Once the correct position of the needle tip has been confirmed, ropivacaine 0.75% 20 ml is injected.
- PROCEDURE : Intercostal nerve block with ropivacaine
- The intercostal nerve block will be performed by the surgeon at the time of thoracotomy from the 4th to the 8th intercostal space, by injecting 20 ml of 0.75% ropivacaine (4 ml for each space). The injection is performed at about 2-3 cm from the spine.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing thoracotomy lung resection surgery between 45 and 80 years
Exclusion Criteria:
* Patients allergic to the drugs used in the study
* Patients with diabetic neuropathy
* Patients with severe hepatic or renal insufficiency
* emergent surgery
* Age <45 years or> 80 years
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04013815
|
{
"brief_title": "Erector Spinae Plane Block for Post-thoracotomy Pain",
"conditions": [
"Pain, Postoperative"
],
"interventions": [
"Procedure: Intercostal nerve block with ropivacaine",
"Procedure: erector spinae plane block with ropivacaine"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT04013815",
"official_title": "Erector Spinae Plane Block Versus Intrapleural Intercostal Plane Block for Post-thoracotomy Pain: a Randomized Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-30",
"study_completion_date(actual)": "2019-11-30",
"study_start_date(actual)": "2019-08-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-24",
"last_updated_that_met_qc_criteria": "2019-07-09",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-10",
"first_submitted": "2019-07-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this research study is to find out what effects (good and bad) TC or TAC has on early stage HER2- breast cancer.
Detailed Description
Both TAC (docetaxel, doxorubicin, and cyclophosphamide) and TC (docetaxel and cyclophosphamide) are established adjuvant chemotherapy regimens for early stage breast cancer. TAC, however, due to the inclusion of the anthracycline doxorubicin, carries a high risk of hematologic and cardiotoxic adverse effects. Substantial evidence supports the concept that early stage HER2-negative breast cancers will benefit similarly from anthracycline-based adjuvant and non-anthracycline-based chemotherapy.
Further, approximately 0 to 9% of HER2-negative breast cancers have alterations in the TOP2A gene, which may predict for benefit from anthracycline-based chemotherapy.
We hypothesize that 6 cycles of TC versus 6 cycles of TAC will have similar efficacy in the treatment of early stage HER2-negative breast cancer and that TC will have less toxicity. If this hypothesis were upheld and the anthracycline doxorubicin could be eliminated from the regimen while obtaining similar efficacy in this population of patients, it would not only be an important advance in the understanding of the biology of cancer, but it would also be of significant clinical benefit to women with breast cancer.
#Intervention
- DRUG : Docetaxel
- Docetaxel 75 mg/m2 IV over 1 hour on Day 1 followed by cyclophosphamide
- Other Names :
- Taxotere
- DRUG : Doxorubicin
- • Doxorubicin 50 mg/m2 IV push over 5-15 minutes via sidearm through a running IV line on Day 1, followed by cyclophosphamide 500 mg/m2 IV over 15-30 minutes on Day 1, followed by docetaxel 75 mg/m2 IV over 1 hour on Day 1. Administer pegfilgrastim 6 mg SC on Day 2 (or filgrastim 5 mcg/kg SC per standard of care).
- Other Names :
- Adriamycin
- DRUG : Cyclophosphamide
- 600 mg/m2 IV over 15-30 minutes on Day 1.
- Other Names :
- Cytoxan
|
#Eligibility Criteria:
Inclusion Criteria:
A woman will be eligible for inclusion in this study if she meets all of the following criteria:
* Age >18 to <70 years.
* Has known ER and PR status
* Has HER2 nonamplified disease, confirmed by FISH
* Has known menopausal status (see Section 7.3 for criteria)
* Has operable, histologically confirmed, Stage I, IIA, IIB, or IIIA, IIIB, or IIIC invasive carcinoma of the breast. Bilateral synchronous breast cancer is allowable provided that 1 primary meets the inclusion criteria.
* Meets 1 of the 3 following criteria:
* T1 <= age <= 3N1 <= age <= 3M0 if ER positive or negative
* T2 <= age <= 3N0M0 if ER positive or negative
* T1N0M0 if ER and PR negative
* Has complete surgical resection of the primary breast tumor: either lumpectomy or mastectomy with sentinel lymph node biopsy or axillary dissection, with clear margins for both invasive and ductal carcinoma in situ (DCIS)
* Has had no prior chemotherapy unless >5 years ago
* Has an ECOG Performance Status (PS) 0 <= age <= 1
* Has laboratory values of: See protocol for specific details
* Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase (ALP) within the ranges shown below. In determining eligibility the more abnormal of the 2 values (AST or ALT) should be used. See protocol for specific details
* Has normal cardiac function as evidenced by a LVEF >50%, but WNL by institutional standard by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be used if MUGA is not available, but the same modality must be used consistently throughout the study to evaluate LVEF. Ejection fraction as determined by ECHO must be WNL by institutional standard.
* Has no evidence of metastatic disease outside of breast by physical examination and chest x-ray. Other scans if done as needed by the patient (eg, bone scan; abdominal, chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic disease
* Has had baseline bilateral mammography
* It has been <84 days since the date of definitive surgery (eg, mastectomy or, in the case of a breast-sparing procedure, axillary dissection) with adequate wound healing, as determined by the Treating Physician
* Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential [not surgically sterilized and between menarche and 1 year postmenopause])
* If fertile, patient has agreed to use an acceptable method of birth control (barrier contraceptive only) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter
* Has adequate tumor specimen available for FISH analysis of TOP2A status (See Appendix VI).
* Has signed a Patient Informed Consent Form
* Has signed a Patient Authorization Form
Exclusion Criteria:
A woman will be excluded from this study if she meets any of the following criteria:
* Has any evidence of metastatic disease following surgical resection of the primary tumor including: positive surgical margins, staging work-up, or physical examination suspicious for malignant disease
* Has T4 disease (ie, patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes)
* Has Stage IV breast cancer (M1 disease on TNM staging system)
* Has a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
* Has had neoadjuvant chemotherapy for this breast cancer
* Has ever had a myocardial infarction (MI) or has a history of heart failure, uncontrolled angina, severe uncontrolled arrhythmias, pericardial disease, or electrocardiographic evidence of acute ischemic changes
* Is receiving concurrent immunotherapy, hormonal therapy (eg, tamoxifen, hormone replacement therapy), or radiation therapy. Must discontinue prior to registering on the study.
* Is receiving concurrent investigational therapy or has received such therapy within the past 30 calendar days
* Has peripheral neuropathy >Grade 1
* Has had a major organ allograft or condition requiring chronic immunosuppression (ie, kidney, liver, lung, heart, bone marrow transplant, or autoimmune diseases). Patients who have received corneal transplants or cadaver skin or bone transplants are eligible.
* Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious viral (including clinically defined AIDS), bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent
* Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
* Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin, carcinoma in situ of uterine cervix, DCIS, which could affect the diagnosis or assessment of any of the study drugs
* In an obese patient to whom the Treating Physician would not be comfortable administering full doses of study drugs as calculated by the BSA. Obese patients will be treated based on actual body weight. Obese patients treated with full doses based on actual BSA are eligible.
* Is pregnant or breastfeeding
* Is deemed unable to comply with requirements of study
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00493870
|
{
"brief_title": "TAC Versus TC for Adjuvant Breast Cancer",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Drug: Docetaxel",
"Drug: Doxorubicin",
"Drug: Cyclophosphamide"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00493870",
"official_title": "Phase III Trial of TC Versus TAC in HER2-Negative Early Stage Breast Cancer Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-05-31",
"study_completion_date(actual)": "2020-03-30",
"study_start_date(actual)": "2007-05-29"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-03-02",
"last_updated_that_met_qc_criteria": "2007-06-27",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-06-28",
"first_submitted": "2007-06-27",
"first_submitted_that_met_qc_criteria": "2023-02-28"
}
}
}
|
#Study Description
Brief Summary
This phase II trial studies the side effects and how well abiraterone acetate, prednisone, and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as abiraterone acetate, leuprolide acetate, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving abiraterone acetate and leuprolide acetate or goserelin before or together with radiation therapy may be an effective treatment for prostate cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate the safety of abiraterone (abiraterone acetate) and prednisone with luteinizing hormone-releasing hormone agonist given as neoadjuvant and concurrent therapy with external beam radiation in patients with localized prostate cancer.
II. To determine whether pharmacologic suppression of the prostatic androgen axis by inhibition of androgen production with abiraterone can decrease tissue androgen levels to below those observed with gonadotropin-releasing hormone (GnRH) agonist suppression of testicular androgens.
SECONDARY OBJECTIVES:
I. To determine whether treatment with abiraterone acetate with luteinizing releasing hormone agonist will be more effective than agonist with bicalutamide in inducing inhibition of androgen-regulated gene expression and increased apoptotic cell death as assessed by immunohistochemistry, complementary deoxyribonucleic acid (cDNA) microarray analysis and reverse transcription-polymerase chain reaction (RT-PCR).
II. To evaluate time to prostate-specific antigen progression in patients treated with GnRH agonist with abiraterone acetate.
OUTLINE:
Patients receive abiraterone acetate orally and prednisone once daily for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 5 years.
#Intervention
- DRUG : abiraterone acetate
- Given PO
- Other Names :
- Zytiga
- DRUG : prednisone
- Given PO
- Other Names :
- DeCortin, Deltra
- DRUG : leuprolide acetate
- Given via injection
- Other Names :
- Enantone, Lupron, Lupron Depot
- OTHER : laboratory biomarker analysis
- Correlative study
- RADIATION : external beam radiation therapy
- Undergo radiotherapy
- DRUG : goserelin acetate
- Given via injection
- Other Names :
- Zoladex
|
#Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide written informed consent
* Patients must allow biopsy prior to neoadjuvant therapy and at the time of fiducial placement
* Written Authorization for Use and Release of Health and Research Study Information has been obtained
* Histologically proven adenocarcinoma of the prostate
* Patients must be candidates for short or long term androgen deprivation in combination with external beam radiotherapy (RT) based on the following criteria:
* Intermediate Risk Disease: T2b/c, or Gleason 7, or Prostate Specific Antigen 10 <= age <= 20
* High Risk Disease: Gleason 8 <= age <= 10, or Prostate specific antigen> 20, or T3/4
* Patients may not have received any prior pharmacologic therapy or radiation therapy (RT) for prostate cancer
* Eastern Cooperative Oncology Group (ECOG) performance status =< 2
* Karnofsky >= 60%
* Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the androgen axis will be determined following review of their case by the Principal Investigator
* White blood cell count: >= 3,000/mm^3
* Absolute granulocyte count: >= 1,000/mm^3
* Platelets: >= 100,000/mm^3
* Hemoglobin >= 10g/dL
* Potassium >= 3.5 mmol/L
* Serum creatinine: =< 1.5 x upper limit of normal (ULN)
* Aspartate aminotransferase (AST) < 2.5 x ULN
* Alanine transaminase (ALT) < 2.5 x ULN
* Total bilirubin: =< 1.5 x ULN (except for patients with documented Gilbert's disease)
Exclusion Criteria:
* Patients may not be receiving any investigational agents
* Concurrent enrollment in another clinical investigational drug or device study is prohibited
* The concurrent administration of other anticancer therapy, including cytotoxic or hormonal agents (except Luteinizing hormone releasing hormone agonists), or immunotherapy, is prohibited during neoadjuvant concurrent and adjuvant therapy
* Patients who are currently receiving active therapy for other neoplastic disorders will not be eligible
* Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible
* Patients with hypogonadism or severe androgen deficiency as defined by serum testosterone less than 100 ng/dL will not be eligible
* History of pituitary or adrenal dysfunction
* Patients who are receiving any androgens, estrogens or progestational agents, or who received any of these agents within the 6 months prior to evaluation will not be eligible
* Patients who are taking drugs which affect androgen metabolism (e.g. spironolactone, ketoconazole, finasteride, dutasteride) will not be eligible
* Concomitant therapy with any of the following listed is prohibited: 5 alpha-reductase inhibitor (finasteride, dutasteride); ketoconazole, diethylstilbestrol, and other preparations such as saw palmetto thought to have endocrine effects on prostate cancer; radiopharmaceuticals such as strontium (89Sr) or samarium (153Sm); Aldactone, Spironol (spironolactone); estrogens, testosterone, progesterones, herbal medications
* Patients who received any of these agents within the 6 months prior to evaluation will be reviewed for eligibility by the Principal Investigator on a case by case basis
* Use of other investigational drug therapy for any reason is prohibited
* Patients with inflammatory bowel disease or other autoimmune conditions which might affect the radiated colon or rectum
* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia which is symptomatic or requires active therapy, recent deep venous thrombosis, pulmonary emboli, cerebrovascular accident or ischemia will not be eligible
* Patients who have chronic active hepatitis or acute hepatitis will not be eligible
* Patients with dementia/psychiatric illness/social situations that would limit compliance with study requirements or would prohibit the understanding and/or giving of informed consent will not be eligible
* Patients with medical conditions, which, in the opinion of the investigators, would jeopardize either the patient or the integrity of the data obtained will not be eligible
* Uncontrolled hypertension within the screening period (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 95 mmHg)
* Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive therapy
* History of congestive heart failure of any severity
* Other active malignancy, except non-melanoma skin cancer and superficial bladder cancer
* History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
* Patients with diabetes not controlled with diet alone (i.e. requiring insulin or oral hypoglycemics)
* Patients unwilling to use contraceptives while on study
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01023061
|
{
"brief_title": "Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer",
"conditions": [
"Adenocarcinoma of the Prostate",
"Stage II Prostate Cancer",
"Stage III Prostate Cancer",
"Stage IV Prostate Cancer"
],
"interventions": [
"Other: laboratory biomarker analysis",
"Drug: goserelin acetate",
"Radiation: external beam radiation therapy",
"Drug: abiraterone acetate",
"Drug: prednisone",
"Drug: leuprolide acetate"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01023061",
"official_title": "Phase II Trial of Radiation With Androgen Deprivation: Abiraterone Acetate, Prednisone and Luteinizing Hormone Releasing Hormone Agonist Prior to Radiation Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-09",
"study_completion_date(actual)": "2015-09",
"study_start_date(actual)": "2010-03"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-06-06",
"last_updated_that_met_qc_criteria": "2009-11-30",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-12-02",
"first_submitted": "2009-11-30",
"first_submitted_that_met_qc_criteria": "2017-05-03"
}
}
}
|
#Study Description
Brief Summary
Rehabilitation of lower limbs after a stroke supported by robots aims to return to independence and minimize disability caused by the incident, but the results have been mixed. Objective of the study was to assess the changes in gait capabilities, muscle tone and daily activities in patients after a recent stroke who underwent a 6-week supervised rehabilitation process using exercises on the LUNA EMG neurorehabilitation robot. A total of 60 participants with impaired motor function and gait after subacute stroke were included in the study. Each patient was randomly assigned to an intervention (robot) or control group (RG or CG). All patients, except standard therapy, underwent 1 session of therapy per day, 5 days a week for 6 weeks. People with RG had 30 minutes of training sessions on the Luna EMG robot, while CG received exercises on the lower limb rotor. Patients were evaluated before the start of the study, and then after 2, 4 and 6 weeks of therapy using the Ashworth scale, Rivermead mobility index (RMI), Repty functional index, Time Up and Go test (TUG) and muscle circumference on the thigh.
#Intervention
- DEVICE : Luna EMG
- The duration of the overall therapeutic intervention in both groups will be the same.
- DEVICE : lower limb rotor
- The duration of the overall therapeutic intervention in both groups will be the same.
|
#Eligibility Criteria:
Inclusion Criteria:
* ischemic stroke,
* not later than 6 months ago,
* muscle strength of extensors and knee flexors on the Lovetta scale below 3,
* functional disorders of the lower limb,
* patient's condition allowing full understanding of commands
* continued/uninterrupted rehabilitation process for 28 days
Exclusion Criteria:
* cognitive impairment-lack of or poor cooperation between the patient and the therapist,
* stroke (more than 6 months after the incident),
* unstable clinical condition,
* muscle strength of knee extensors and flexors on the Lovett scale greater than or equal to 3,
* rigid fixed contractures within the lower limb,
* significant spasticity (Ashworth scale of 3 and above)
Sex :
ALL
Ages :
- Minimum Age : 29 Years
- Maximum Age : 91 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04497545
|
{
"brief_title": "The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke Patients",
"conditions": [
"Ischemic Stroke"
],
"interventions": [
"Device: lower limb rotor",
"Device: Luna EMG"
],
"location_countries": [
"Poland"
],
"nct_id": "NCT04497545",
"official_title": "The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-13",
"study_completion_date(actual)": "2020-01-13",
"study_start_date(actual)": "2019-02-24"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-08-04",
"last_updated_that_met_qc_criteria": "2020-08-01",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-04",
"first_submitted": "2020-07-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the present study is to analyse feasibility, safety and Incisional Hernia rate using a prophylactic sub lay non-absorbable mesh \[Parietex Progrip (Medtronic) \] in order to prevent Incisional Hernia following midline emergent laparotomy in clean and clean-contaminated wounds.
Detailed Description
The study is a double-blinded randomized trial, comparing the widely recommended midline laparotomy closure using a running slowly absorbable suture to closure with the aid of a permanent sub-lay mesh (Parietex Progrip), in patients undergoing midline laparotomy for clean-contaminated surgery. From January 2016 to June 2018, a series of 200 patients were included. All patients were operated in a single surgical Unit, located in Lacco Ameno (Naples) at the only Hospital of the island. All patients undergoing 'open' midline laparotomy for abdominal surgery in clean-contaminated fields were included. All patients subscribed informed consent. Authorization was requested from the local regional Ethics Committee. Exclusion criteria were: age \< 18 years; life expectancy \< 24 months (as estimated by the operating surgeon), pregnancy, immunosuppressant therapy within 2 weeks before surgery, clean, contaminated and dirty wounds, wound length\<10 cm. Patients were randomized in two groups (Group A, receiving primary closure; Group B, receiving mesh supported closure in a Sublay fashion). Randomization was obtained just before abdominal wall closure through number (1 to 200) extraction by Operative room nurse (Even: Group A vs Odd: Group B). All patients enrolled in the study were followed up sending a letter to their General Practitioner. Outpatient clinic controls were done by surgeons/surgical residents/General Practitioner blinded for the procedure.
Technical details Group A. Primary closure of midline laparotomy. The midline fascia is closed using a double layer running slowly absorbable suture. Above arcuate line, the posterior layer was performed suturing peritoneum and posterior rectus sheath; below arcuate line posterior layer was performed suturing peritoneum and trasversalis fascia. Anterior layer was performed suturing anterior rectus sheath. Suture length to wound length ratio of 4:1 as recommended (not routinely measured). Subcutaneous tissue and skin are closed according to the first surgeon's preference.
Group B. Sub-lay mesh supported closure A 4 cm space is created between posterior rectus sheath and rectus muscle, widening 2 cm at each side of midline. Both posterior rectus sheath edges are sutured using a running slowly absorbable suture. Above the arcuate line, the posterior layer was performed suturing peritoneum and posterior rectus sheath; below the arcuate line, the posterior layer was performed suturing peritoneum and trasversalis fascia. The anterior layer was performed suturing anterior rectus sheath. A suture length to wound length ratio of 4:1 is recommended (not routinely measured). A 4-cm Parietex Progrip Mesh strip was placed between the posterior rectus sheath and rectus muscle with an overlap of at least 2 cm at each side, sutureless. The not gripping face of the mesh was positioned on the posterior rectal sheat to allow the muscle to become in contact with the grips. In laparotomies \>20 cm two stripes of 15 cm each were designed. The midline anterior rectus sheath was closed using a running slowly absorbable suture covering the mesh. A suture length to wound length ratio of 4:1 is recommended (not routinely measured). Subcutaneous tissue and skin closure were up to the surgeon preference.
Endpoints Primary endpoint was Incisional Hernia rate. Patients were postoperatively examined at 3, 6, 12 and 24 months. Both clinical examination and ultrasound imaging were performed in all patients at follow-up. Physicians were blind about which Group (A or B) the patients had been placed. Incisional Hernia was clinically defined as any visible or palpable ''blowout'' in the midline abdominal scar. At 3, 6, 12 and 24 months ultrasound imaging was performed to examine the midline for all patients with symptomatic or asymptomatic, providing any valuable information about Incisional Hernia onset. Size and location of all ultrasound detected Incisional Hernia were registered, as well as any other patient's complaint. The ultrasonic criteria of Incisional Hernia were a visible gap within the abdominal wall and/or ''tissue moving through the abdominal wall by Valsalva manoeuvre'' and/or a detectable ''blowout''. Incisional Hernia was diagnosed if clinical criteria and/or ultrasound criteria were fulfilled. The study was not designed to discriminate single or multiple defects. The study will be completed at 2 years' follow up. Secondary endpoints included the incidence of wound events. Wound events were classified as surgical site infections according to Clavien Dindo criteria (superficial, deep or organ space). Surgical site events were reported according to the Ventral Hernia Working Group definitions. Actions for wound events were categorized as follows: antibiotics only, bedside wound interventions, percutaneous manoeuvres or surgical debridement.
Blinding Process
Patients, care providers, staff collecting data, and those assessing the endpoints were all blinded to treatment allocation. Patients were blinded to the surgical procedure performed until the final assessment of the study endpoints. Because the blinding of the operating surgeons was not feasible, they were not involved in the data collection and outcome assessment. Physicians in charge of patients' management were not involved in the operating room and were blinded to the intervention. The data were collected and analyzed by physicians who were not involved in the patient's management during the whole Randomized trial.
#Intervention
- PROCEDURE : positioning of polypropylene strips for prophylactic purposes in closing the middle laparotomies to prevent the incisional hernia
- Sub-lay mesh supported closure A 4 cm space is created between posterior rectus sheath and rectus muscle, widening 2 cm at each side of midline. Both posterior rectus sheath edges are sutured using a running slowly absorbable suture. Above arcuate line, posterior layer was performed suturing peritoneum and posterior rectus sheath; below arcuate line, posterior layer was performed suturing peritoneum and trasversalis fascia. Anterior layer was performed suturing anterior rectus sheath. A suture length to wound length ratio of 4:1 is recommended. A 4-cm Parietex Progrip Mesh strip was placed between the posterior rectus sheath and rectus muscle with an overlap of at least 2 cm at each side, suture less. In laparotomies \>20 cm two stripes of 15 cm each were designed. The midline anterior rectus sheath was closed using a running slowly absorbable suture, covering the mesh. A suture length to wound length ratio of 4:1 is recommended.
|
#Eligibility Criteria:
Inclusion Criteria:
* > 18 yearsyears
* Clean-contaminated wounds
* midline laparotomy >10 cm
* Informed consent
Exclusion Criteria:
* age < 18 years;
* life expectancy < 24 months (as estimated by the operating surgeon), -
* pregnancy
* immunosuppressant therapy within 2 weeks before surgery
* clean, contaminated and dirty wounds
* wound length<10 cm.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04436887
|
{
"brief_title": "Prophylactic Sub-lay Non-absorbable Mesh Following Midline Laparotomy: PROMETHEUS (PROphylactic Mesh Trial Evaluation UltraSound)",
"conditions": [
"Incisional Hernia",
"Wound Infection"
],
"interventions": [
"Procedure: positioning of polypropylene strips for prophylactic purposes in closing the middle laparotomies to prevent the incisional hernia"
],
"location_countries": null,
"nct_id": "NCT04436887",
"official_title": "Prophylactic Sub-lay Non-absorbable Mesh Following Emergent Midline Laparotomy Clean/Contaminated Field: Early Results of a Randomized Double-blind Prospective Trial: PROMETHEUS",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-06-01",
"study_completion_date(actual)": "2020-06-01",
"study_start_date(actual)": "2016-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-06-22",
"last_updated_that_met_qc_criteria": "2020-06-17",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-18",
"first_submitted": "2020-06-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to conduct a pilot trial of a Precision Dosing approach to alemtuzumab dosing for allogeneic hematopoietic cell transplantation of patients with non-malignant diseases. The investigators will measure the ability to use a population PK model of alemtuzumab to target patient Day 0 alemtuzumab levels to 0.15-0.6ug/mL in a pilot study of 20 patients.
Detailed Description
The hypothesis is that the model-informed dosing regimen will prospectively allow the precision dosing of alemtuzumab to target Day 0 levels to fall between 0.15-0.6ug/mL in greater than 80% of patients. The investigators have chosen a conservative pilot study approach, and the aim is to achieve Day 0 alemtuzumab levels between 0.15-0.6ug/mL in greater than 60% of 20 patients enrolled in this pilot study based on a Simon two-stage design as detailed below.
A Simon two-stage design (Simon, 1989) is being used. The null hypothesis that 30% of patients will achieve a Day 0 alemtuzumab level between 0.15-0.6ug/mL will be tested against a one-sided alternative that the alemtuzumab dose modification will result in 60% of patients achieving a Day 0 alemtuzumab level between 0.15-0.6ug/mL. In the first stage, 7 patients will be accrued. If there are 2 or fewer patients that achieve Day 0 alemtuzumab levels within the range of 0.15-0.6ug/mL, the study will be stopped. Otherwise, 13 additional patients will be accrued for a total of 20. The null hypothesis will be rejected if 11 or more patients achieve a Day 0 level of 0.15-0.6ug/mL within the total 20 patients. This design yields a type I error rate of 0.04 and power of 0.82 when the true response rate is 0.60. The investigators will enroll up to 30 patients in order allow for subject withdrawal, but will stop enrollment once 20 patients reach Day 0.
#Intervention
- DRUG : Alemtuzumab
- Alemtuzumab (Campath®) is a recombinant DNA-derived humanized monoclonal antibody directed against CD52. Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product. Alemtuzumab is a sterile, clear, colorless, isotonic pH 6.8-7.4 solution for injection. Alemtuzumab is supplied in single-use clear glass ampules containing 30 mg of Alemtuzumab in 3 mL of solution. Single use vial of alemtuzumab contains 30 mg alemtuzumab, 8 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate.
- Other Names :
- Campath
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who are undergoing RIC HCT with alemtuzumab, fludarabine, and melphalan at CCHMC for treatment of a non-malignant disease.
* Age >= 6 weeks to <= 30 years (at time of enrollment).
* For the first 7 patients, patients must have a 10/10 HLA matched related or unrelated stem cell donor, or be receiving a CD34+ selected stem cell product. After the first 7 patients, any donor match may be allowed after data review by the PI and medical monitor.
Exclusion Criteria:
* Patients with a history of anaphylaxis to alemtuzumab.
* Patients who have previously received alemtuzumab and have not cleared alemtuzumab prior to the start of the preparative regimen.
* Life expectancy less than 2 weeks.
* Patients receiving dialysis.
* Failure to sign informed consent and/or assent, or inability to undergo informed consent process.
* It is not medically advisable to obtain the specimens necessary for this study.
* Not able to tolerate subcutaneous dosing (patients with severe skin conditions such as epidermolysis bullosa).
Sex :
ALL
Ages :
- Minimum Age : 6 Weeks
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03302754
|
{
"brief_title": "Precision Dosing of Alemtuzumab",
"conditions": [
"Allogeneic Hematopoietic Cell Transplantation"
],
"interventions": [
"Drug: Alemtuzumab"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03302754",
"official_title": "Precision Dosing of Alemtuzumab for Allogeneic Hematopoietic Cell Transplantation in Non-Malignant Diseases",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-10",
"study_completion_date(actual)": "2019-03-10",
"study_start_date(actual)": "2017-10-05"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-10-04",
"last_updated_that_met_qc_criteria": "2017-10-04",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-05",
"first_submitted": "2017-09-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to collect information about the potential benefit and safety of low dose spironolactone for a patient with diastolic heart failure (DHF) and to determine whether spironolactone can cause the patient's condition to improve.
Detailed Description
Subjects with diastolic heart failure defined based on clinical symptoms, echocardiography diastology parameters and brain natriuretic peptide level will be randomized in a 1:1 fashion to either placebo or spironolactone 25mg daily for 6 months. They will be assessed over this 6 month period for improvement in exercise capacity, clinical symptoms, echocardiography diastology parameters, and biomarkers specific for heart failure. Safety of spironolactone in this patient population will also be assessed by recording adverse events and following electrolytes, blood urea nitrogen, and creatinine levels.
#Intervention
- DRUG : Spironolactone
- Research subjects are randomized to placebo versus spironolactone 25mg daily and followed for 6 months.
- Other Names :
- Aldactone
|
#Eligibility Criteria:
Inclusion Criteria:
* Women who are 18 years or older.
* Women with clinical heart failure for > 2 months.
* Women with left ventricular ejection fraction > 50% within 2 months of screening.
* Women with New York Heart Association class II or III heart failure symptoms.
* Brain Natriuretic Peptide > 62 pg/ml within 2 months of screening.
* Patient on angiotensin converting enzyme inhibitor or angiotensin receptor blocker therapy for at least 1 month.
* Blood Pressure no more than 150/95.
* Patient able to walk more than 50 meters at the time of enrollment.
* Signed informed consent.
Exclusion Criteria:
* Current treatment with spironolactone.
* Severe hepatic impairment.
* Creatinine > 2.5 mg/dl
* Potassium > 5.0 mEq/L
* Intolerance to spironolactone in the past.
* Significant valvular heart disease, pericardial disease, or severe chronic lung disease with cor pulmonale.
* Unstable angina or myocardial infarction within the past 4 weeks.
* Severe peripheral vascular disease or other physical conditions that would limit the walking distance.
* Pregnant or lactating females.
* Participation in any other drug trial within 30 days prior to randomization.
* Inability to provide informed consent.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00206232
|
{
"brief_title": "Novel Treatment for Diastolic Heart Failure in Women",
"conditions": [
"Heart Failure"
],
"interventions": [
"Drug: Spironolactone"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00206232",
"official_title": "Novel Treatment for Diastolic Heart Failure in Women",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-07",
"study_completion_date(actual)": "2010-07",
"study_start_date(actual)": "2004-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-02-18",
"last_updated_that_met_qc_criteria": "2005-09-12",
"last_verified": "2013-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-21",
"first_submitted": "2005-09-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators propose a two-year group randomized trial of physician practices to test the effectiveness of an interactive DVD that presents a culturally appropriate communication training program for patients called 'How To Talk To Your Doctor (and Get Your Doctor to Talk to YOU!)' in promoting safe prescription and use of Nonsteroidal anti-inflammatory drugs (NSAIDs) in the outpatient setting (HTTTYD-NSAIDs).
The outcome of interest is safer use of NSAIDs as reported by patients. The aims are to:
Aim 1. Develop an interactive DVD (How To Talk To Your Doctor about NSAIDs, HTTTYD-NSAIDs) that presents culturally appropriate 'stories' through which a viewer can learn risk factors for adverse effects related to NSAIDs; and communication behaviors for talking about NSAIDs with their doctor.
Aim 2. Conduct a group-randomized trial to test the following three hypotheses about the effectiveness of the interactive DVD in promoting safer use of NSAIDs:
Hypothesis 1: Intervention group patients will be more likely to report that they had a conversation with their doctor about safe NSAID use than control group patients.
Hypothesis 2: Intervention patients will report significantly fewer risky NSAID ingestion behaviors (e.g., concomitant use of OTC and prescription NSAIDs) than control patients.
Hypothesis 3: There will be no difference in the intervention's effectiveness between African American and White participants.
Detailed Description
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), expose patients to substantial risk of toxicity. Risks are compounded by the fact that patients may frequently take both Over-the-Counter (OTC) and prescription NSAIDs, a fact they often do not report to their physician. Further, our prior work suggests that African American patients may be at greater risk from NSAIDs than whites. While the consequences of unsafe NSAID use are well recognized, effective ways of improving safe use are as yet poorly established. Three findings from medical interaction research suggest that a solution may lie in improving doctor-patient communication. First, patients' communicative behaviors influence those of their doctors. Patients who actively participate by preparing beforehand for the visit, asking questions, and expressing concerns, get more information from their doctor, and in many cases receive more diagnostic and therapeutic action. Second, patients can indeed be easily taught to use active communication behaviors during medical encounters. Third, better communicators have better outcomes.A recent report of the Institute of Medicine (IOM) noted that medication-related injuries are frequent, costly and in many cases preventable and strongly recommended that measures be instituted to strengthen patients' capacities for sound medication self-management and communication.
#Intervention
- OTHER : Interactive DVD
- An interactive DVD (How To Talk To Your Doctor about NSAIDs, HTTTYD-NSAIDs) that presents culturally appropriate 'stories' through which a viewer can learn risk factors for adverse effects related to NSAIDs; and communication behaviors for talking about NSAIDs with their doctor.
- Other Names :
- DVD, Educational Materials, Narrative
- OTHER : Usual Care
- Usual Care
- Other Names :
- Routine care, Standard Care
|
#Eligibility Criteria:
Inclusion Criteria:
* 19 years or older
* Chronic NSAIDs (prescribed or recommended by their doctor)
* Seen by a primary care physician
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01352832
|
{
"brief_title": "The Alabama NSAIDs Patient Safety Survey, Phase II: Reducing Disparities in Risk Awareness and Communication",
"conditions": [
"Pain Management"
],
"interventions": [
"Other: Usual Care",
"Other: Interactive DVD"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01352832",
"official_title": "Phase II of The Alabama NSAID Patient Safety Survey: Reducing Disparities in Risk Awareness and Communication",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2012-03",
"study_start_date(actual)": "2011-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-03-11",
"last_updated_that_met_qc_criteria": "2011-05-11",
"last_verified": "2013-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-12",
"first_submitted": "2011-05-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This research study has been designed to test the efficacy of telephone-delivered Problem-Solving Treatment (PST) for improving the quality of life (QoL) in outpatients with stable heart failure (HF).
Detailed Description
Heart failure (HF) is the end stage of all cardiovascular diseases, and it imposes a huge burden in the United States in terms of morbidity, mortality, and economic cost. Although disease management programs have been developed to curb these costs and address the complexities of HF management, evaluations of these programs have yielded equivocal results.
With this study the Investigators plan to: (1) to determine the feasibility of telephone delivered PST for outpatients with HF and reduced QoL by obtaining estimates of yield, retention, patient acceptance, and patient satisfaction; (2) to determine whether telephone-delivered PST is associated with greater improvements in QoL than telephone-delivered Time Management over 8 weeks; and (3) to determine whether telephone-delivered PST is associated with greater reductions in depressive symptoms and/or greater improvements in self-efficacy or objectively assessed daily physical activity than telephone-delivered Time Management over 8 weeks.
#Intervention
- BEHAVIORAL : Problem-Solving Treatment
- BEHAVIORAL : Time Management
|
#Eligibility Criteria:
Inclusion Criteria:
* Outpatient
* Age > 21
* Exhibits symptoms of hear failure (NYHA Class II or III)
* Left ventricular ejection fraction (LVEF) >= 40%
* Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score < 60
Exclusion Criteria:
* Cannot speak English
* Lack telephone access
* Unwilling to be randomized, or
* Unavailable for the study period
* Awaiting a heart transplant (United Network for Organ Sharing Status 1A or 1B), or
* Planned (within 6 months) cardiac surgery
* Cognitive impairment indicative of dementia
* Recent (3 months)
* acute myocardial infarction,
* cardiac decompensation, or
* HF-related hospitalization.
* Use intravenous inotropic medication
* Use an assistive circulatory device
* Significantly reduced life expectancy due to co-morbidity (e.g., malignancy)
* Currently receiving mental health counseling;
* A history of:
* bipolar disorder,
* psychosis, or
* substance abuse/dependency
* Severe depressive symptoms or suicidality
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03288194
|
{
"brief_title": "Improving Quality of Life in Heart Failure",
"conditions": [
"Heart Failure",
"Quality of Life"
],
"interventions": [
"Behavioral: Problem-Solving Treatment",
"Behavioral: Time Management"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03288194",
"official_title": "Improving Quality of Life in Outpatients With Heart Failure: A Two-arm Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-04-24",
"study_completion_date(actual)": "2017-04-24",
"study_start_date(actual)": "2015-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-05-06",
"last_updated_that_met_qc_criteria": "2017-09-15",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-09-19",
"first_submitted": "2017-09-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the recurrence and postoperative complications rates after conjunctival autograft surgery using fibrin adhesive for primary pterygium
#Intervention
- PROCEDURE : Conjunctival autograft using fibrin glue
- Conjunctival autograft using fibrin glue in pterygium surgery
- Other Names :
- Pterygium surgery using fibrin glue
|
#Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of primary pterygium
* Symptomatic pterygium
* Limbal invasion
Exclusion Criteria:
* Secondary pterygium
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00949728
|
{
"brief_title": "Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia",
"conditions": [
"Pterygium",
"Primary"
],
"interventions": [
"Procedure: Conjunctival autograft using fibrin glue"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT00949728",
"official_title": "Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-08",
"study_completion_date(actual)": "2009-07",
"study_start_date(actual)": "2006-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-07-30",
"last_updated_that_met_qc_criteria": "2009-07-29",
"last_verified": "2009-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-07-30",
"first_submitted": "2009-07-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation administered as a single dose and then administered as multiple doses for 7 days. The effect of food on the safety, tolerability and pharmacokinetics of the ABT-072 tablet will also be evaluated.
Detailed Description
The study consists of two substudies. Substudy 1 is a two-period, single ascending dose (SAD) and multiple ascending dose (MAD) blinded, randomized, placebo-controlled, non-fasting study. Designated groups that participate in Period 1 (SAD) will also participate in Period 2 (MAD). Substudy 2 is an open-label, randomized two-period, crossover study to examine the effect of food on the pharmacokinetics of ABT 072.
#Intervention
- DRUG : ABT-072
- See Arms information for a detailed description.
- DRUG : Placebo
- See Arms information for a detailed description.
|
#Eligibility Criteria:
Inclusion Criteria:
* Overall healthy subjects, non-childbearing females included.
Exclusion Criteria:
* Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
* Pregnant or breast-feeding female.
* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
* Positive screen for drugs of abuse, alcohol, or cotinine.
* Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00982826
|
{
"brief_title": "Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072",
"conditions": [
"Hepatitis C"
],
"interventions": [
"Drug: ABT-072",
"Drug: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00982826",
"official_title": "A Blinded, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single and Multiple Doses (7 Days) of ABT-072 and an Open-label Study to Evaluate the Effect of Food on the Pharmacokinetic",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-12",
"study_completion_date(actual)": "2010-01",
"study_start_date(actual)": "2009-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-10-21",
"last_updated_that_met_qc_criteria": "2009-09-22",
"last_verified": "2010-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-09-23",
"first_submitted": "2009-09-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Hepatocellular carcinoma (HCC) is a common fatal malignant tumor, although with the popularity of health examination, most patients were diagnosed as HCC in advanced stages so far. Sorafenib is currently recognized worldwide as the only effective treatment for advanced HCC. However, sorafenib need long-term medication, and will bring a series of side effects, including, hand, foot and comprehensive syndrome (Hand-foot syndrome, HFS) limbs swelling, rash, peeling, pain.Occurrence rate of HFS is about 21%-51%, which seriously affect patient's quality of life.Besides, this side effects appeared to be dose-related.When severe HFS happened, sorafenib need to reduce dosage or discontinue administration, which could seriously affect the patient's survival. Therefore, investigators designed this prospective randomized controlled study to explore preventive effect of celecoxib for sorafenib related HFS, the influence on the quality of life in patients with, and also the synergistic anti-tumor effect of celecoxib in combination with sorafenib on HCC. This study will explore horizon of improving treatment for sorafenib in patients with advanced HCC,quality of life and tumor control.
#Intervention
- DRUG : Celecoxib
- Patients from experimental group will take celecoxib, except for sorafenib
- DRUG : Sorafenib
- Each group will receive sorafenib as basic treatment.
|
#Eligibility Criteria:
Inclusion Criteria:
* 1.Diagnosed with HCC according to the Primary liver cancer diagnosis and treatment practices published by the Ministry of Health in 2011 China
* 2.A Karnofsky Performance Status (KPS) score >=70 points
* 3.Age between 18 and 70 years
* 4.Child-Pugh classA or B (class B patients had scores no greater than 7 points). In addition, the baseline laboratory tests had to meet the following criteria: white blood cells (WBCs) >=1.5 × 109/L, platelets >=50 × 109/L, hemoglobin >=80 g/L, serum aspartate transaminase (AST) and alanine transaminase (ALT) <= 2 x the upper limit of normal (ULN), serum creatinine <= 1.5 x ULN, an international normalized ratio (INR)<1.5 or prothrombin time < the ULN + 4 seconds, albumin >=30 g/L, and total bilirubin <=34mmol/L
* 5.Patients with advanced hepatocellular carcinoma who failed first-line therapy with surgery，radiofrequency ablation
Exclusion Criteria:
* 1.Pugh Child-Pugh Grade C, or with massive ascites or had a history of hepatic encephalopathy, or previous history of gastrointestinal bleeding
* 2.Poor general condition or cachexia
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02961998
|
{
"brief_title": "Preventive Effect of Celecoxib on Sorafenib-related Hand Foot Syndrome, a Single Center, Randomized Controlled Clinical Trail",
"conditions": [
"Hepatocellular Carcinoma"
],
"interventions": [
"Drug: Celecoxib",
"Drug: Sorafenib"
],
"location_countries": null,
"nct_id": "NCT02961998",
"official_title": "Preventive Effect of Celecoxib on Sorafenib-related Hand Foot Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-07",
"study_completion_date(actual)": "2016-07",
"study_start_date(actual)": "2015-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-09-10",
"last_updated_that_met_qc_criteria": "2016-11-08",
"last_verified": "2019-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-11-11",
"first_submitted": "2016-11-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Low back pain is considered to be chronic if it has been present for longer than three months.
This pathology is extremely frequent with an annual incidence between 5 in 10 % of the general population. Thus she is frequently met in general medicine, in particular to the ageing subject. It is the 2nd motive for consultation.
The Chronic Low Back Pain is a mild pathology the forecast of which is in the favorable great majority of the cases but she pulled a socioeconomic cost mattering with a poly-consumption of care, in private individuals.
The primary objective of this study is to determine the impact of a 3 months SPA Therapy on the Chronic Low Back Pain in older adults (from 60 to 80 years old) realizing a SPA Therapy of 3 weeks to 'Neyrac-les-Bains'.
Detailed Description
Realization of the protocol :
1. Selection of the patients (realized during the consultation of programming in the beginning of the SPA Therapy). They are 2 thermal doctors of 'Neyrac-les-Bains' (1 general practitioner with formation of thermal medicine and a rheumatologist) which include the eligible patients in this study during the visit of the beginning of SPA Therapy.
2. They will put back to the patients the Inform Consent Form, the Form of non-opposition and the 1st questionnaire (J0). The nurse of the SPA Therapy will be at their disposal to help them to fill the questionnaire if need.
An urn will be arranged in the entrance hall of Neyrac- les-Bains to get back the filled questionnaires (J0 and J21).
Patients will follow the conventional SPA Therapy of 3 weeks without a specific changes or modification of the care provided.
Feedback :
Assessments conducted by the using of self - questionnaires:
* Delivered in the issue of the visit of inclusion and at the end of the Spa Therapy ;
* Sent by mail at 3 and 6 months
The expectations and fears will be evaluated by means of individual interview or focus groups. To avoid the biases bound to the questionnaire, the patients questioned in qualitative are different from patients receiving the questionnaire (not over the same period of SPA Therapy).
#Intervention
- OTHER : SPA Therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* - Both sexes
* 60 <= age <= 80 years
* Realizing a SPA Therapy of 3 weeks.
* Presenting a mechanical pain of the rachis lumbar vertebra > 3 months
* Possible irradiation up to the knee (cruralgia / sciatalgie truncated)
* Cooperation and understanding allowing to conform in a strict way to the conditions planned by the study
* Acceptance to participate in the study (non-opposition)
Exclusion Criteria:
* - < 60 years patients or > 80 years
* Inflammatory, tumoral, traumatic or infectious rheumatism
* Surgery of the back
* SPA Therapy dating less than 6 months
* Evolutionary slipped disc
* Disorders(confusions) of the concentration or the compression of the written or oral French language making impossible the realization of the study
* The pain estimated by the digital scale = 0 in the inclusion
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02894125
|
{
"brief_title": "Evaluation of the Effectiveness of a SPA Therapy to 'Neyrac-les-Bains' to the Old Subject (60-80 Years Old) With a Chronic Low Back Pain.",
"conditions": [
"Chronic Low Back Pain"
],
"interventions": [
"Other: SPA Therapy"
],
"location_countries": [
"France"
],
"nct_id": "NCT02894125",
"official_title": "Evaluation of the Effectiveness of a SPA Therapy to 'Neyrac-les-Bains' to the Old Subject (60-80 Years Old) With a Chronic Low Back Pain.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06",
"study_completion_date(actual)": "2016-08",
"study_start_date(actual)": "2015-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-09-12",
"last_updated_that_met_qc_criteria": "2016-09-05",
"last_verified": "2016-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-09",
"first_submitted": "2016-09-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic hepatitis C.
Detailed Description
The course of treatment in both groups shall be 12 weeks, and efficacy analysis, i.e. rate of rapid (after the 4th week) and early (after the 12th week) virologic response will be based on PCR data. For patients with treatment failure after the 12th week the antiviral therapy shall be discontinued. All patients who require further anti-viral treatment will receive a combination treatment with Algeron / Pegasys and ribavirin for another 12 or 36 weeks (depending on the HCV genotype). Sustained virologic response will be assessed 24 weeks after last dose of study treatment.
#Intervention
- DRUG : Algeron
- 1.5 µg/kg of body weight subcutaneously, once a week
- Other Names :
- Cepeginterferon alfa-2b
- DRUG : Pegasys
- 180 µg subcutaneously, once a week
- Other Names :
- Peginterferon alfa-2a
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent to participate in the study.
* Chronic HCV infection (genotypes 1а, 1b, 2, 3, 4) with detectable HCV RNA >6 month before the screening visit or abnormal ALT levels for >6 month before the screening visit.
* Male and female patients, 18 <= age <= 70 of age, inclusive.
* Body mass index of 18 - 30 kg/m2.
* Preserved protein synthetic liver function (INR < 1.7, albumin > 35 g/l).
* No signs of hepatic encephalopathy or abdominal fluid retention according to clinical and ultrasound examination.
* Fertile patients and their partners agree to use barrier contraception throughout the study treatment and 7 months after it.
* Patient must have documentation of fibroscan within 1 year before the screening visit or agree to have a fibroscan within the screening period.
Exclusion Criteria:
* Intolerance to IFN alfa, ribavirin or any components of this preparations confirmed by past medical history.
* Infection by hepatitis B, A, E virus or HIV (co-infection).
* Any other documented significant liver disease (drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, biliary cirrohosis, etc.).
* Past history of HCV treatment with IFN alfa or pegylated IFN alfa.
* Administration of injectable and non-injectable interferons and/or some interferon inducers for any indication (other than HCV) for one month before enrollment into the study.
* Cholestatic hepatitis (level of conjugated bilirubin, alkaline phosphatase, G-GTP exceeding the upper normal level by more than 5 times).
* Decompensated liver cirrhosis confirmed by laboratory findings (class B, С according to Child-Pugh) or ultrasound examination.
* Any documented autoimmune diseases (e.g., Crohn's disease, ulcerative colitis, systemic lupus erythematosus, idiopathic thrombocytopenic purpura, scleroderma, autoimmune haemolytic anemia, severe psoriasis).
* Hemoglobin not lower than low normal level; neutrophils < 1.5 х109/L; platelets < 90 х109/L; creatinin level exceeding the upper normal level by more than 1.5 times, ALT level exceeding the upper normal level by more than 10 times.
* Documented hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
* Severe depression, schizophrenia, other mental disorders, which from the investigator's point of view are a contraindication for anti-viral treatment.
* Epilepsy and/or disorder of function of the central nervous system.
* Abnormal thyroid function (TTH level beyond the normal values).
* Diagnosed or suspected hepatocellular carcinoma as evidenced by screening alfa-fetoprotein (AFP) of >= upper normal level.
* Antinuclear antibody (ANA) titer >=1:640 at screening and/or evidence of autoimmune hepatitis on liver biopsy.
* Malignant neoplasms.
* Pregnancy, lactation period.
* Severe comorbidities (for example, severe hypertension, severe coronary heart disease, decompensated diabetes mellitus) that represent a contraindication for anti-viral treatment.
* Documented rare hereditary diseases, such as intolerance of lactose, sucrose, fructose, lactase deficiency or glucose-galactose malabsorption.
* Known drug or alcohol abuse or signs of drug/alcohol abuse in present, which from the investigator's point of view are a contraindication for anti-viral treatment or restrict adherence to the treatment regimen.
* Simultaneous participation in other clinical studies less than 30 days before enrollment into this study or previous participation in this clinical study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01889433
|
{
"brief_title": "An Open-label Comparative Efficacy and Safety Study of Algeron (Cepeginterferon Alfa-2b) in Treatment-naive Patients With Chronic Hepatitis C",
"conditions": [
"Hepatitis",
"Hepatitis C"
],
"interventions": [
"Drug: Pegasys",
"Drug: Algeron"
],
"location_countries": [
"Russian Federation",
"India",
"Belarus",
"Thailand"
],
"nct_id": "NCT01889433",
"official_title": "An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon Alfa-2b) and Ribavirin With Pegasys (Peginterferon Alfa-2a) and Ribavirin for Treatment of Patients With Chronic Hepatitis C",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12-02",
"study_completion_date(actual)": "2015-12-02",
"study_start_date(actual)": "2013-07-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-07-16",
"last_updated_that_met_qc_criteria": "2013-06-27",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-28",
"first_submitted": "2013-06-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
1. This study will compare the first attempt success rate of cannulation in research participants randomized to using a new FDA approved AccuVein AV300 device for intravenous access with research participants randomized to standard cannulation methods.
2. This study will assess if insertion of intravenous cannula is faster when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique.
3. This study will assess if the number of skin punctures is fewer when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique.
Detailed Description
Patients agreeing to participate in this study will be randomized to one of two groups for intravenous access. One group will use the standard cannulation method and the other group will use the new FDA approved AccuVein AV300 device for cannulation.
After pre-anesthetic evaluation, the research participant will be brought to the operating room or magnetic resonance imaging (MRI) Suite and standard monitoring will be applied (EKG, SpO2, BP) if tolerated. Anesthesia will be induced via a face mask with sevoflurane in 100% O2. When the supervising anesthesiologist deems it appropriate, attempt at cannulation will begin.
A tourniquet will be applied. A 22-gauge cannula will be used. Randomization will take place before the patient is taken back to the Operating Room or MRI Suite. If the research participant has been randomized to the standard treatment group then cannulation will be attempted in the standard manner. If the research participant has been randomized to the AV300 device group then intravenous cannulation will be attempted using the AV300 device following the manufacturer's instructions.
A research team member will time cannulation access for all participants. Participation ends once successful cannulation is achieved or when a maximum of 4 skin punctures have been made.
Only the study coordinator will know which randomization group the patient has been assigned. Once the anesthesiologist has determined a potential IV access site, s/he will be informed to which group the patient was assigned. If the parent/guardian requests, s/he will be told after the procedure to which group the child was randomized.
#Intervention
- PROCEDURE : Cannulation using Accuvein device
- If the research participant has been randomized to the AV300 device group A, then intravenous cannulation will be attempted using the AV300 device following manufacturer's instructions by four anesthesiologists.
- PROCEDURE : Standard Cannulation method
- If the research participant has been randomized to the standard treatment group B then cannulation will be attempted in the standard manner. A research team member will time cannulation access for all participants. Participation ends once successful cannulation is achieved or when a maximum of 4 skin punctures have been made.
|
#Eligibility Criteria:
Inclusion Criteria:
* Infants and children under 18 years.
* American Society of Anesthesiologist (ASA) Physical Status I, II or III.
* Patients undergoing elective surgery,examination under anesthesia,or MRI who do not have existing intravenous access.
* Able to understand English.
* Parent/guardian willing to sign consent.
Exclusion Criteria:
* Existing intravenous access.
* Malformations or infections at the potential site of insertion.
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
* Need for emergency surgery.
Sex :
ALL
Ages :
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01042613
|
{
"brief_title": "A Comparison of the Success Rate Of Cannulation Between The Accuvein Apparatus And Standard Technique",
"conditions": [
"Cannulation"
],
"interventions": [
"Procedure: Standard Cannulation method",
"Procedure: Cannulation using Accuvein device"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01042613",
"official_title": "A Comparison of the Success Rate Of Cannulation Between The Accuvein Apparatus And Standard Technique",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-03",
"study_completion_date(actual)": "2011-03",
"study_start_date(actual)": "2010-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-12-07",
"last_updated_that_met_qc_criteria": "2010-01-04",
"last_verified": "2011-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-01-05",
"first_submitted": "2010-01-04",
"first_submitted_that_met_qc_criteria": "2011-11-02"
}
}
}
|
#Study Description
Brief Summary
Nurse-physician communication skills can be improve through inter-professional team training. Simulation is often used to conduct these training. However, constraints to conduct these sessions such as scheduling and logistic arrangements have been widely reported. Thus with the advancement of technology in education, the use of virtual environment to conduct the team training is being explored and evaluated.
Detailed Description
All recruited participants underwent a 3-hour nurse-physician communication training prior to the simulation session. Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) curriculum and pre-learning videos were introduced to the participants. Pre-test questionnaires were administered after the training. Participants were then randomized to the control (live simulation) or intervention group (virtual simulation).
Intervention group participants will undergo a virtual simulation session training via the multi-user virtual world by logging in into the 3D virtual environment while participants in the control group performed the simulations in a physical simulated ward setting. Each pair of 1 medical student and 1 nursing student participate in two role-playing simulation scenarios (15-20 minutes each) along with a facilitator who will provide a debrief (30-minutes). Prior to the simulation, participants were given a smart-watch to monitor their physiological parameters such as heart rate. Post-test questionnaires were administered after the simulation sessions.
After the simulation training, a 30-minutes team-based assessments were conducted based on a inter-professional bedside care scenario in pairs of one medical and one nursing student within their randomized group. The assessments were video recorded for evaluation by assessors who are blinded to the groupings. All participants were then invited to complete a follow-up questionnaire 2 months after the simulation training.
#Intervention
- OTHER : Create Real-life Experience And Teamwork In Virtual Environment (CREATIVE)
- 3D virtual hospital environment where participants can perform physical and social interaction and presence using avatars.
|
#Eligibility Criteria:
Inclusion Criteria:
i) Full time students undertaking National University of Singapore's
* Third or fourth year Bachelor of Science (Nursing)
* Third or fourth year Bachelor of Medicine & Bachelor of Surgery
ii) Completed acute care management modules
Exclusion Criteria:
i) Does not voluntarily agree to join the study
ii) Does not want their performance to be video-recorded
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04330924
|
{
"brief_title": "A Comparison Between Physical and Virtual Simulation: A Randomized Controlled Trial",
"conditions": [
"Interdisciplinary Communication"
],
"interventions": [
"Other: Create Real-life Experience And Teamwork In Virtual Environment (CREATIVE)"
],
"location_countries": [
"Singapore"
],
"nct_id": "NCT04330924",
"official_title": "Nurse-Physician Communication Team Training in Virtual Reality Versus Live Simulations: Randomized Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-31",
"study_completion_date(actual)": "2019-12-31",
"study_start_date(actual)": "2018-07-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-03",
"last_updated_that_met_qc_criteria": "2020-03-30",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-04-02",
"first_submitted": "2020-03-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is being done to determine typical breakfast consumption habits in various populations of exercisers. Participants will be asked a series of questions pertaining to their participation in regular exercise, their current breakfast consumption, food preferences, meal timing, and general knowledge of sports nutrition and pre-exercise breakfast consumption.
Detailed Description
Participants will complete a one-time survey regarding breakfast habits and beliefs and sports nutrition knowledge, as well as the type, frequency, and intensity of exercise engaged in on a weekly basis.
#Intervention
- OTHER : survey
- survey asking questions regarding breakfast habits and composition, sports nutrition knowledge and exercise habits
|
#Eligibility Criteria:
Inclusion Criteria:
* 18+ years old
* regular exerciser
Exclusion Criteria:
* younger than 18 years
* do not regularly exercise
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04497064
|
{
"brief_title": "Breakfast Knowledge, Beliefs, and Habits of Exercising Adults",
"conditions": [
"Nutrition"
],
"interventions": [
"Other: survey"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04497064",
"official_title": "Breakfast Knowledge, Beliefs, and Habits of Exercising Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-24",
"study_completion_date(actual)": "2020-03-24",
"study_start_date(actual)": "2020-01-30"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-09-07",
"last_updated_that_met_qc_criteria": "2020-07-29",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-04",
"first_submitted": "2020-07-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this prospective observational study is to evaluate the impact of preoperative breast MRI in patients with breast cancer selected for breast- conserving surgery. MRI is a more sensitive radiological modality than mammography and ultrasonography. Patients with small breast cancers are, based on conventional modalities, selected for breast-conserving surgery. If preoperative breast MRI reveal additional lesions in the breasts, and malignancy is confirmed histopathologically, this finding leads to a change of surgical method to mastectomy.
Detailed Description
The aim of the study is to evaluate the impact of preoperative breast MRI on primary surgical treatment in a highly specialized multidisciplinary breast cancer clinic. The clinic serves a population of 237.000. The diagnostic tools routinely used are conventional mammography, ultrasound with core needle biopsy, and clinical examination including palpation of breast and axillary nodes. If indicated, the examination includes ultrasound examination and fine needle biopsy of axillary glands. We offer all patients selected for breast-conserving surgery preoperative breast MRI.
We include consecutively breast cancer lesions in women aged 35-75 in a prospective study, collecting data from January 2009 to December 2010. The patients are all selected for breast-conserving surgery based on the criteria recommended by the Norwegian Breast Cancer Group. That is, tumor ≤ 4 cm, or acceptable tumor:breast ratio, and age \> 35. Multifocal lesions, defined as more than one tumor \> 1 cm apart, size of tumor \> 4 cm, or a large tumor:breast ratio, extensive ductal carcinoma in situ (DCIS), or known genetic disposition for breast cancer, indicates mastectomy according to these criterias. In addition, when postoperative radiation therapy is contraindicated, mastectomy is indicated. If the patients fill the criteria for breast-conserving surgery, they are offered preoperative breast MRI and included in the study. Patients who either choose mastectomy, or does not get a breast MRI for technical reasons, are excluded from the study. Two experienced breast radiologists evaluate the breast MRIs, and three experienced breast radiologists study the mammographies and perform the ultrasound examinations and biopsies. All additional MRI findings are examined by ultrasound-guided biopsy and given a histological diagnose before it influence the surgical method.
A formal application has been presented to the regional ethical commitee. Since this is an observational study of established practice, the commitee replied that approval was not required.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients >= 35 years and <= 75 years
* Indication for breast-conserving surgery according to criteria recommended by the Norwegian Breast Cancer Group:
* Tumor < 4 cm and acceptable tumor:breast ratio
* Tumor not infiltrating skin or pectoral fascia
* No multifocality (that is 2 foci or more, > 1 cm apart)
Exclusion Criteria:
* Patient choose mastectomy
* Technical problems with the MR machine
* Pacemaker
* Anxiety/claustrophobia
Sex :
FEMALE
Ages :
- Minimum Age : 35 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01391806
|
{
"brief_title": "The Impact of Preoperative Breast MRI in Patients With Breast Cancer Selected for Breast Conserving Surgery",
"conditions": [
"Breast Cancer"
],
"interventions": null,
"location_countries": [
"Norway"
],
"nct_id": "NCT01391806",
"official_title": "The Impact of Preoperative Breast MRI in Newly Diagnosed Breast Cancer. A Prospective Study of Treatment Outcome in Patients Selected for Breast Conserving Surgery in a Norwegian Multidisciplinary Breast Cancer Clinic.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-12",
"study_completion_date(actual)": "2010-12",
"study_start_date(actual)": "2009-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-07-12",
"last_updated_that_met_qc_criteria": "2011-07-11",
"last_verified": "2009-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-07-12",
"first_submitted": "2011-07-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. By learning the best way to involve family members in therapy, investigators hope to decrease the harmful effects of stroke.
Detailed Description
The objective of this study is to identify the potential benefits of a home-based, intervention designed to facilitate carepartners' roles in stroke survivor rehabilitation. Stroke survivors and caregivers will participate in pairs. Stroke survivors will receive constraint induced movement therapy (CIMT). Caregivers of stroke survivors will be randomized to traditional caregiver education or a web based intervention for the duration of stroke survivor therapy. A tablet will be provided to participants who do not have access to complete the web based intervention. All participants will be asked to complete questionnaires at the beginning of therapy, the end of therapy, and one month post therapy.
#Intervention
- BEHAVIORAL : CARE-CITE Education Program
- CARE-CITE is an online educational program developed to provide information that may help caregivers understand more about constraint-induced movement therapy (CIMT) and their potential roles in helping the stoke survivor gain as much benefit as possible from CIMT.
If participants do not have access to a computer or tablet, they will be loaned an electronic tablet for the 2-3 week period of the study to access the information.
Participants will be asked to review six educational modules over a period of 2-3 weeks while the stroke survivor receives CIMT.
Participants will attend three in home evaluation visits; one at the beginning of the stroke survivors therapy sessions, one at the end of his/her therapy visit series, and a third evaluation one month later in which they will be asked to complete questionnaires. Evaluation visits will take approximately 1 ½ hours to complete.
- BEHAVIORAL : Traditional Education
- Investigators will explain constraint-induced movement therapy (CIMT) to caregivers and stroke survivors during the first home therapy session for the stroke survivor and provide traditional educational information about CIMT during therapy sessions as needed.
- BEHAVIORAL : Constraint-Induced Movement Therapy (CIMT)
- Constraint-Induced Movement Therapy (CIMT) is one type of therapy that helps stroke survivors gain more use of their weaker arm.This therapy involves wearing a soft mitt (like a sock or oven mitt) on the stronger arm to remind the stroke survivor to use their weaker arm for daily activities and also intensive practice of tasks with the supervision of a therapist.
Participants will attend three in home evaluation visits; one at the beginning of your therapy sessions, one at the end of your therapy visit series and a third evaluation one month later. These evaluation sessions will involve an evaluation of arm function and answering three questionnaires about how well the weaker arm works and how the stroke has affected daily activities. The interview questions and assessment will take approximately 1 ½ hours to complete.
|
#Eligibility Criteria:
Inclusion Criteria:
Stroke Survivors
* One month to five years post ischemic or hemorrhagic event
* Minimal to moderate upper extremity deficits (ability to initiate wrist and finger extension)
* Mini-mental screening test score of greater than 24
* Presence of a care partner
Caregivers
* At least 18 years
* Ability to read and write English
* Mini-mental screening test score of greater than 24
Exclusion Criteria:
Stroke Survivors
* Severe cognitive deficits
Caregivers
* Significant cognitive deficits
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02703532
|
{
"brief_title": "Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke",
"conditions": [
"Stroke"
],
"interventions": [
"Behavioral: Traditional Education",
"Behavioral: Constraint-Induced Movement Therapy (CIMT)",
"Behavioral: CARE-CITE Education Program"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02703532",
"official_title": "Evaluation of a CarePartner-Integrated Telehealth Rehabilitation Program for Persons With Stroke",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-01-18",
"study_completion_date(actual)": "2019-01-18",
"study_start_date(actual)": "2016-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-28",
"last_updated_that_met_qc_criteria": "2016-03-04",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-03-09",
"first_submitted": "2016-03-04",
"first_submitted_that_met_qc_criteria": "2020-01-17"
}
}
}
|
#Study Description
Brief Summary
Tonsillectomy and adenoidectomy is one of the most common pediatric surgeries, and agitation and severe postoperative pain have been considered a very common complications. Dexmedetomidine mainly inhibits the release of norepinephrine by acting on the α-adrenergic receptor of the brainstem nucleus, which can produce good sedative effects. Hydromorphone has a longer duration of action than fentanyl, and it also has a certain sedative effect. The combination of the two is more conducive to the management of postanesthetic agitation and pain. This study was to compare the effect of different doses of dexmedetomidine combined with hydromorphone in the sedation and analgesia after pediatric tonsillectomy and adenoidectomy.
Detailed Description
The computer generates random numbers to allocate patients into different group. Trained research staff who are not involved in the study collect the data. The observer who only stayed in PACU was blinded to the allocation and responsible to record the data.
The primary measurement are pain scores, PAED scores, coughing was evaluated on a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm), and extubation time. The secondary measurements are the time to discharge from the post-anaesthesia care unit, and the number of postoperative desaturation.
A sample size of 57 was determined by analysis based on the assumption of the decline of extubation time from other similar study and α=0.05,β=0.2.
The continuous variables were presented as means ± SD and the categorical variables were expressed as frequency.
The outcome of interest is extubation time decline.
#Intervention
- DRUG : Dexmedetomidine 0.5μg／kg
- Group A received dexmedetomidine 0.5μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.
- Other Names :
- Dexmedetomidine Hydrochloride Injection
- DRUG : Dexmedetomidine 1μg／kg
- Group B received dexmedetomidine 1μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.
- Other Names :
- Dexmedetomidine Hydrochloride Injection
|
#Eligibility Criteria:
Inclusion Criteria:
* experienced tonsillectomy and adenoidectomy
* ASA physical status I-II
* weight 12 <= age <= 30 kg
Exclusion Criteria:
* respiratory disease
* circulatory or nervous system disease
* hepatic dysfunction
* known adverse reactions to hydromophine and dexmedetomidine
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 10 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03760809
|
{
"brief_title": "Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy",
"conditions": [
"Agitated; State, Acute Reaction to Stress"
],
"interventions": [
"Drug: Dexmedetomidine 0.5μg／kg",
"Drug: Dexmedetomidine 1μg／kg"
],
"location_countries": [
"China"
],
"nct_id": "NCT03760809",
"official_title": "The Effect of Different Dose of Dexmedetomidine Combined With Hydromorphone in Children With Tonsillectomy and Adenoidectomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-02-10",
"study_completion_date(actual)": "2019-04-01",
"study_start_date(actual)": "2019-01-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-06-22",
"last_updated_that_met_qc_criteria": "2018-11-29",
"last_verified": "2019-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-11-30",
"first_submitted": "2018-11-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims at investigating the complications of Cushing's disease in 'de novo' patients. A series of investigations will assay before treatment and every year thereafter during a 3 years follow-up period the various complications of the disease. These investigations will determine the presence and severity of cardiovascular, metabolic, and bone complications as well as the Quality of Life. Outcome of these complications after treatment, especially after pituitary surgery will be monitored, as well as cortisol levels.
Detailed Description
At inclusion the following will be investigated and recorded :
* demographic and personal medical history.
* Familial medical history related to osteoporosis, cardiovascular disorders and thromboembolism.
* Current medical treatment.
* Physical examination.
* Assessment of basal 24hrs urinary cortisol and salivary cortisol.
- At baseline (i.e. before specific treatment of Cortisol excess):
* physical examination,
* routine biology,
* HbA1C, fasting glucose and oral glucose load,
* cholesterol, triglyceride, HDL \& LDL,
* coagulation and fibrinolysis investigation,
* 24hrs urinary cortisol and salivary cortisol, urinary labstick test.
* EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US,
* ophthalmology examination,
* spine X-Ray, bone densitometry,
* QoL questionnaires (SF-36, QoLCushing, Beck BDI-II).
Every year during a 3 years follow-up the following will be investigated :
* Current medical treatment.
* Physical examination.
* Assessment of basal routine biology,
* HbA1C, fasting glucose,
* cholesterol, triglyceride, HDL \& LDL,
* coagulation and fibrinolysis investigation,
* 24hrs urinary cortisol and salivary cortisol, urinary labstick test.
* EKG, cardiac ultrasound, cardiac CT-scan (if abnormal initially), arterial and venous US,
* ophthalmology examination, bone densitometry,
* QoL questionnaires (SF-36, QoLCushing, Beck BDI-II).
#Intervention
- OTHER : Exams and questionnaires
- Blood sample 24hrs urinary cortisol and salivary cortisol, urinary labstick test, EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US ophthalmology examination spine X-Ray bone densitometry QoL questionnaires (SF-36, QoLCushing, Beck BDI-II)
|
#Eligibility Criteria:
Inclusion Criteria:
* Cushing's disease diagnosed by complementary explorations according to the National Program of Diagnosis and Care of the Cushing 's disease
Exclusion Criteria:
* other cause of Cushing's syndrome
* known inherited syndrome having for consequence an hormonal hypersecretion (NEM-1, complexe of carney, McCuneAlbright syndrome)
* patient does not understand french
* life expectancy of less than 6 months
* pregnant women
* dependent patient
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02568982
|
{
"brief_title": "Cushing's Disease Complications",
"conditions": [
"Cushing's Disease"
],
"interventions": [
"Other: Exams and questionnaires"
],
"location_countries": [
"France"
],
"nct_id": "NCT02568982",
"official_title": "Evolution of the Metabolic, Cardiovascular, Bone Complications and of the Quality of Life in Cushing's Disease",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-12-20",
"study_completion_date(actual)": "2019-12-20",
"study_start_date(actual)": "2015-09-21"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-29",
"last_updated_that_met_qc_criteria": "2015-10-05",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-10-06",
"first_submitted": "2015-07-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Randomized controlled trial of housing placement assistance for homeless persons with HIV
Detailed Description
Approximately 800 persons living with HIV/AIDS (PLWHA) reside in HIV emergency single-room-occupancy (SRO) hotels in New York City and do not have the ability to secure permanent housing on their own. The study evaluated a pilot program which fast-tracked PLWHA from HIV emergency SRO hotels into permanent housing. The Enhanced Housing Placement Assistance (EHPA) program had three components: 1) active recruitment of emergency SRO hotel residents with high need for housing; 2) assistance in the rapid (fast-track) acquisition of permanent housing; and 3) participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability. Participants were randomly assigned to either 1) EHPA or 2) usual care, which included standard connections to services and housing programs offered by the New York City HIV/AIDS Services Administration (HASA), Housing Opportunities for Persons With AIDS (HOPWA), or Ryan White services, and were followed over twelve months using a questionnaire developed with significant input from the target population of PLWHA residing in emergency SRO hotels.
#Intervention
- OTHER : Enhanced housing placement assistance
- assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability
- OTHER : Standard housing placement assistance
- standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White
|
#Eligibility Criteria:
Inclusion Criteria:
* Person living with HIV in New York City
* Residing in an New York City HASA single-adult single-room-occupancy (SRO) hotel
Exclusion Criteria:
* Inability to provide informed consent
* Inability to complete survey in English or Spanish
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03334825
|
{
"brief_title": "Enhanced Housing Placement Assistance",
"conditions": [
"HIV/AIDS",
"Housing Problems"
],
"interventions": [
"Other: Enhanced housing placement assistance",
"Other: Standard housing placement assistance"
],
"location_countries": null,
"nct_id": "NCT03334825",
"official_title": "An Enhanced Housing Placement Assistance (EHPA) Program for Homeless Persons Living With HIV/AIDS in New York City",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07-31",
"study_completion_date(actual)": "2017-07-31",
"study_start_date(actual)": "2012-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-08",
"last_updated_that_met_qc_criteria": "2017-11-03",
"last_verified": "2018-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-11-07",
"first_submitted": "2017-11-03",
"first_submitted_that_met_qc_criteria": "2018-09-06"
}
}
}
|
#Study Description
Brief Summary
The overall goal of this project is to improve the treatment of alcohol dependence in patients with serious mental illness (SMI). SMI for this study is defined as any patient with any of the following diagnoses: schizophrenia, schizoaffective disorder, and bipolar type I or type II disorder. Alcohol and other substance use disorders (SUDs) are common among individuals with SMI. SUD comorbidity is associated with many adverse consequences. However, to date, few reports have addressed the efficacy of pharmacological treatments for SUDs in this population. Naltrexone pharmacotherapy is an effective treatment for alcohol dependence, but it has not been systematically applied to the care of patients with SMI. The primary aim of this study is to determine the feasibility of long-acting injectable naltrexone administration in a clinical trial in patients with SMI who also have a diagnosis of alcohol dependence. Secondary aims include providing a preliminary assessment of the tolerability and safety of long-acting injectable naltrexone in patients with SMI who also have a diagnosis of alcohol dependence. An additional aim is to provide a preliminary assessment of the efficacy of long-acting injectable naltrexone in reducing alcohol use from baseline levels.
Detailed Description
The proposed project is a 1-year pilot program of research, which will examine the feasibility of a new, intramuscular (IM) long-acting form of naltrexone. The long-acting form of naltrexone may improve medication adherence, which has been shown to be critical to successful naltrexone treatment of alcohol dependence. The study is a 16-week, randomized, prospective, open-label trial, including a 12-week course of monthly naltrexone injections. A follow-up interview will be conducted 4 weeks after discontinuation of medication. Thirty subjects will be recruited. Voucher-based incentives will be provided to all subjects to ensure attendance for medication administration. Weekly motivational counseling sessions will be conducted and will focus on improving motivation to stop alcohol use. Study outcomes consist of self-report and biological measures of alcohol use; measures of psychiatric symptom severity and neurocognitive functioning; and genetic testing to examine functional polymorphism (Asn40Asp) differences in the subjects' μ-opioid receptors (OPRM1), which may predict response to naltrexone treatment.
#Intervention
- DRUG : long-lasting injectable naltrexone
|
#Eligibility Criteria:
Inclusion Criteria:
* Males or females, age 18 to 69, with a DSM-IV diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Type I or Type II Disorder.
* DSM-IV diagnosis of Alcohol Dependence in the last 12 months.
* Level of Drinking:
1. At least four days of drinking in the 30 days prior to consent and/or during screening period OR
2. For prospective subjects who are currently in an inpatient or residential facility or recently discharged within 30 days prior to consent: At least 4 days of drinking during the period of time immediately prior to inpatient admission and/or during post-discharge.
* Currently prescribed antipsychotic medications, mood stabilizers, or antidepressants.
* One negative urine screen for opiates prior to start of medication and a self-report of no opioid use for at least 1 week prior to starting medication.
* Currently involved in outpatient psychiatric treatment at one of the study sites (Hutchings Psychiatric Center, SUNY Upstate Adult Psychiatric Clinic, St. Joseph's Hospital, VA Medical Center) or at another location in the community.
Exclusion Criteria:
* Inability to give adequate informed consent;
* Currently taking disulfiram (Antabuse), naltrexone, or acamprosate (Campral);
* Current DSM-IV diagnosis of Opioid Dependence (criteria met in the last month);
* Current regular use of prescribed opioid analgesics, such as methadone, morphine, codeine, meperidine, and all other opioids. If the subject reports taking a prescribed opioid analgesic only occasionally, the study physician or nurse practitioner will contact the prescribing physician regarding the safety of study participation and the possibility of using an alternative. The principal investigator will make the final determination after obtaining the primary physician's recommendation regarding this criterion.
* Current daily use of non-prescribed opioids.
* Currently taking ibuprofen or other potentially hepatotoxic medications in amount and/or frequency judged by the Principal Investigator to pose clinically significant added risk of hepatic injury;
* Female patients of childbearing potential who are sexually active, not sterile, and who deny using birth control;
* Female patients who are pregnant or nursing;
* Significant unstable medical problems, including any significant unstable psychiatric disorders. The study physician conducting the medical history and physical exam will exclude such clinically unstable individuals;
* AST (aspartate aminotransferase test) levels: If AST is greater than 3x upper limit of normal;
* Subjects who do not attend required screening appointments. Subsequent exclusion from the study for reasons related to non-attendance will be based on the judgment of the principal investigator;
* In need of acute medical detoxification from alcohol in the judgment of the study physician based on results a score of 12 or more on the Clinical Institute Withdrawal Assessment of Alcohol Scale Based on DSM-III-R (CIWA-AD) and other information obtained;
* Scheduled surgery within 3 months of intake;
* Subjects who have pending legal proceedings whose outcome may lead to incarceration within 3 months.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 69 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00453609
|
{
"brief_title": "Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI)",
"conditions": [
"Schizophrenia",
"Schizoaffective Disorder",
"Bipolar Disorder",
"Alcohol Dependence"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00453609",
"official_title": "Injectable Naltrexone Treatment of Alcohol Dependence in Serious Mental Illness (SMI): An Open Prospective Pilot Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-10",
"study_completion_date(actual)": "2008-10",
"study_start_date(actual)": "2007-04"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-12-11",
"last_updated_that_met_qc_criteria": "2007-03-28",
"last_verified": "2008-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-03-29",
"first_submitted": "2007-03-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a study of the safety and efficacy of Econazole Nitrate Foam 1% and the Foam Vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation. The study will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for blinding purposes only.
#Intervention
- DRUG : Econazole Nitrate Foam 1%
- Econazole Nitrate Foam 1% applied once a day for 4 weeks
- DRUG : Vehicle Foam
- Vehicle Foam applied once a day for 4 week
- DRUG : Econazole Nitrate Cream 1%
- Econazole Nitrate Foam 1% applied once a day for 4 weeks
- OTHER : Placebo Cream
- Placebo cream applied once a day for 4 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Be at least 12 years and of either sex.
* Have a clinical diagnosis of interdigital tinea pedis involving at least 2 web spaces in total which extends no more than approximately 1 inch proximal to the web spaces or metatarsophalangeal joints with at least i) moderate scaling and ii) mild erythema defined as a Grade 2 and Grade 1, respectively on the Grading of Signs and Symptoms (Section 10.1) at baseline.
* Be willing and able to give informed consent/assent or have their parent/guardian do so, if applicable.
* Be willing and able to use the assigned study medication as directed and to commit to all follow-up visits for the duration of the study.
* Have microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte in the skin scrapings taken at the Baseline Visit. Subjects with a positive KOH may be entered into the study pending the results of the fungal
* culture.
* Be in good health and free of any disease or physical condition which might, in the Investigator's opinion, expose the subject to an unacceptable risk by study participation.
* Females must be non-pregnant (confirmed by a negative urine pregnancy test (UPT) at baseline), non-lactating and not intending to become pregnant during the course of the study.
Exclusion Criteria:
* Is pregnant nursing or planning a pregnancy during the study.
* Has used topical antifungals or topical corticosteroids on the feet within 30 days prior to the start of the study.
* Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
* Has used systemic antibacterials or systemic corticosteroids within 30 days prior to the start of the study. Systemic corticosteroids do not include intranasal, inhaled, and ophthalmic corticosteroids used for the management of allergies, pulmonary disorders or other conditions.
* Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
* Has concurrent tinea infection e.g. tinea versicolor, tinea cruris, moccasin-type tinea pedis, etc. (in the opinion of the Investigator).
* Onychomycosis, involving >= 20% of the area of either great toenail or involvement of more than five toenails in total.
* Has any other skin disease which might interfere with the evaluation of tinea pedis.
* Is currently enrolled in an investigational drug or device study.
* Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study.
* Is unreliable, including subjects with a history of drug or alcohol abuse.
* Has known hypersensitivity to any of the components of the study medications.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01358240
|
{
"brief_title": "Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis",
"conditions": [
"Tinea Pedis",
"Athlete's Foot"
],
"interventions": [
"Other: Placebo Cream",
"Drug: Econazole Nitrate Cream 1%",
"Drug: Vehicle Foam",
"Drug: Econazole Nitrate Foam 1%"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01358240",
"official_title": "A Multi-Center, Randomized, Double-Blind, Vehicle Controlled, Parallel Group Comparison of Econazole Nitrate Foam 1% vs Foam Vehicle and an Evaluator-Blinded Comparison of Econazole Nitrate Foam 1% and Econazole Nitrate Cream 1% in Subjects With Interdigital Tinea Pedis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-04",
"study_completion_date(actual)": "2012-08",
"study_start_date(actual)": "2011-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-09-28",
"last_updated_that_met_qc_criteria": "2011-05-20",
"last_verified": "2012-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-23",
"first_submitted": "2011-05-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators plan to use amoxicillin in capsule form, prepared by a pharmacist, for antibiotic prophylaxis to decrease the failure rate of mini-screw implants temporarily placed in the palate of patients involved in Phase II orthodontics treatments. The mini-screws will be 8 mm long 1.7 mm diameter titanium screws manufactured by Forestadent and are commercially available and currently widely used in orthodontic treatment in both private practice and educational settings. Since antibiotic prophylaxis is considered the standard of care with traditional dental implants, the investigators believe that such prophylaxis will decrease the failure rate of orthodontic mini-screw implants also.
Detailed Description
Subjects will be selected for the study based on treatment plans for Phase II orthodontics at Saint Louis University Center for Advanced Dental Education orthodontics program, which require the use of palatally placed mini-screw implants for anchorage control. If the patient is at or beyond the age of 18 years, they will be approached about this study. If the patient is under the age of 18 years, the parent or legal guardian of the patient will be approached. After the consult is completed, where the treatment plan has been explained and standard consent forms have been signed, a member of the research team will verbally confirm with the patient or the patient and parent/guardian that the patient cannot be excluded from the study based on exclusion criteria from the patient's medical history. Orthodontic treatment at SLU CADE involves monthly visits to the orthodontic clinic where patients receive orthodontic treatment, including leveling and aligning of teeth with archwires and fixed appliances on teeth, space closure, occlusion correction, and finishing and detailing. Mini-screw placement is not necessary nor included in all treatment plans given at SLU CADE orthodontics. The possible subjects for the study will patients who will receive mini-screw implants as a course of their treatment for orthodontic anchorage (standard of care).
Participants will be weighed so that appropriate dosing can be ensured and randomized 1:1 to receive either and antibiotic (Amoxicillin) or a placebo (glucose) 1 hour prior to mini-screw insertion (research related). Patients weighing less than 40 kg will be given 50mg/kg. The Amoxicillin and the placebo (glucose) will be prepared in capsule form by a pharmacist and made to look identical. The Amoxicillin or placebo will be dispensed at CADE and taken at CADE 1 hour prior to the procedure. Standard procedure for dispensing Amoxicillin at SLU CADE is to draw appropriate dosage from the dispensary and provide Amoxicillin to at risk patients prior to invasive dental procedures, in accordance with prophylaxis guidelines set form by the American Heart Association. Documentation of dosage and time of dispensing is noted in the patient record. However, in this study, documentation in the patient dental record will only reflect that either a placebo or Amoxicillin was given as part of a randomized controlled trial. Standard of care for orthodontic mini-screw implants includes oral hygiene instructions and 1 week of oral antibiotic mouth rinse use (.12% Chlorhexidine) and all participants in this study will follow standard of care in addition to the administration of either placebo or antibiotic. Randomization between control or experimental group will be conducted by the Research Chair, Hiroshi Ueno, and the PI will have no knowledge of to which group subjects are assigned.
Participants will be followed at time of mini-screw placement (T0), 1 month post procedure (T1), 3 months post-procedure (T2), and 6 months post-procedure (T3). The participant has standard of care appointments at these time points, so there are not any extra visits for research purposes. At these appointment, participants will undergo an intra-oral exam to determine mobility of the mini-screw(s), to check for inflammation at the site of mini-screw placement, assess oral hygiene at the site of mini-screw placement, and be asked to rate both their pain and tenderness related to the mini-screw. Pain is defined as spontaneous pain frim the mini-screw site. Tenderness is defined as pain resulting from palpation of the mini-screw. Mobility will be determined by placing a small amount of force on the mini-screw with a cotton plier. The amount of mobility will be assessed as having no mobility (Grade 0), having between 0mm and 1 mm of mobility (Grade 1), or having more than 1 mm of mobility (Grade 2). Inflammation will be assessed as having no redness or swelling at the site (Grade 0), having redness only at the site (Grade 1), or having both redness and swelling (Grade 2). Oral hygiene will be assessed as having no visible plaque at the site (Grade 0), having small amounts of plaque at the site (Grade 1), or having moderate to large amounts of plaque at the site (Grade 2). Pain and tenderness will be evaluated separately and will be assessed by asking the patient to rate their pain level on a scale of 0 to 10, 0 being no pain and 10 being unbearable, excruciating pain. A member of the research team will make these evaluations at each time point. All five of these would be assessed as part of the standard of care for mini-screw placement, regardless of participation in the research study or lack thereof. The only action related to the research that is not standard of care is the dispensing of either the antibiotic or the placebo at 1 hour prior to mini-screw placement.
Success of the mini-screw will be defined as number of survival with 'Mobility Grade 0 or 1' \& 'No Pain' \& 'Inflammation Grade 0 or 1'.
Failure of the mini-screw will be immediately determined as failed if the mini-screw is not present at one of the time points or upon an assessment of Grade 2 mobility. Grade 2 mobility will result in removal of the mini-screw.
If the mini-screw implants fail, the participants will have the mini-screw removed. It is up to assigned instructors as to whether or not mini-screws will be replaced. If the mini-screws will not be replaced, the patient will be removed from the study, but all data collected will be included in the research.
Standard of Care will be followed in all instances at time points T(0), T(1), T(2) and T(3).
The dependent variable will be success or failure, while the independent variable will be antibiotic prophylaxis or placebo. Failure will be defined as mobile or lost MSIs, and success will be defined as stability of the MSIs maintained after 6 months. 8mm long, 1.5 mm diameter, palatally placed MSIs provided by a single manufacturer (Forestadent) that are immediately force loaded or delayed in force loading will be included in the study. Data will be analyzed with SPSS for Windows (SPSS Inc., Chicago, Ill). A Chi Square test for independence will be used to determine association, if any, between the two categorical variables. This study will establish an alpha of 0.05 and a beta of 0.08322, and to achieve power of 0.91, a sample size of 100 subjects is the goal for recruiting.
#Intervention
- DRUG : Amoxicillin
- see previous descriptions
- DRUG : Placebo oral capsule
- see previous descriptions
|
#Eligibility Criteria:
Inclusion Criteria: Subjects will be selected for the study based on treatment plans for Phase II orthodontics at SLU CADE orthodontics program, which require the use of palatally placed mini-screw implants for anchorage control.
Exclusion Criteria:
* Patients with experience in previous MSI placements
* allergy to amoxicillin
* allergy to Beta-lactam based antibiotics
* medical syndrome diagnoses
* psychiatric disorders (ADHD, autism, manic-depressive disorder, etc.)
* a compromised immune system
* impaired or decreased kidney function
* Type I or Type II diabetes
* patients taking Probenicid or Allopurinol
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03582605
|
{
"brief_title": "Antibiotics Prior to Mini-screw Implant Insertion",
"conditions": [
"Inflammation at Mini-screw Insertion Site",
"Mobility, Mini-screw"
],
"interventions": [
"Drug: Placebo oral capsule",
"Drug: Amoxicillin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03582605",
"official_title": "Antibiotic Prophylaxis Prior to the Insertion of Orthodontic Mini-screw Implants: a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-10-01",
"study_completion_date(actual)": "2020-11-01",
"study_start_date(actual)": "2018-08-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-12",
"last_updated_that_met_qc_criteria": "2018-07-09",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-11",
"first_submitted": "2018-06-26",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.
Detailed Description
The current gold standard for sleep disordered breathing (SDB) diagnosis is in-laboratory polysomnography (PSG). A barrier of acceptance of Home Sleep Apnea Testing (HSAT) devices as a diagnostic test is their inability to accurately measure total sleep time (TST). A novel algorithm developed by ResMed, Ltd. allows the AL device to accurately calculate TST, however, this algorithm has not yet been validated.
The ApneaLink Air (AL) device is a type III HSAT device. The device is capable of recording up to four channels of data including: flow and snore via a nasal cannula attached to a pressure transducer, a respiratory effort belt, a pulse oximeter to measure pulse and oxygen saturation, and an actigraphy monitor to measure TST along with flow. The AL device has been validated against PSG for AHI, and Cheyne-Stoke respiration detection . Further validation of the effort belt is necessary to determine the accuracy of the AL ability to differentiate between obstructive and central apneic events.
#Intervention
- DIAGNOSTIC_TEST : ApneaLink Air
- ApneaLink Air to be used on each participant undergoing PSG
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant is 18 years or older
* Participant is willing to provide informed consent
* Participant is willing to participate in all study related procedures
Exclusion Criteria:
* Unable to cease positive airway pressure (PAP) therapy during PSG (if currently using)
* Requires use of oxygen therapy during sleep
* Diagnosis of uncontrolled clinically relevant sleep disorder (e.g., untreated insomnia or restless leg syndrome)
* Pregnant
* Participant is unsuitable to participate in the study in the opinion of the investigator
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03470493
|
{
"brief_title": "ApneaLink Air Home Sleep Testing (HST) Device Validation Study",
"conditions": [
"Sleep-disordered Breathing"
],
"interventions": [
"Diagnostic Test: ApneaLink Air"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03470493",
"official_title": "Comparison of the ApneaLink Air Home Sleep Testing Device to Polysomnography",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-06",
"study_completion_date(actual)": "2019-07-31",
"study_start_date(actual)": "2018-04-11"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-05-20",
"last_updated_that_met_qc_criteria": "2018-03-16",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-03-20",
"first_submitted": "2018-02-28",
"first_submitted_that_met_qc_criteria": "2021-04-28"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if patients initiating androgen deprivation therapy (ADT) for prostate cancer can be transitioned from degarelix acetate to leuprolide acetate after an initial three-month period without a rise in serum testosterone. The investigators expect testosterone will quickly and reliably reach castrate levels after initiation of ADT and will remain castrate during the transition, and there will be no 'testosterone surge' after leuprolide injection.
#Intervention
- DRUG : Degarelix acetate, Leuprolide acetate
- Degarelix acetate, 1 mo depot for 3 months Leuprolide acetate, 3 mo depot once
- Other Names :
- Firmagon, Eligard
|
#Eligibility Criteria:
Inclusion Criteria:
* >= 18 years
* Histologically confirmed adenocarcinoma of the prostate
* Androgen deprivation therapy is indicated
Exclusion Criteria:
* Baseline screening serum testosterone <150ng/dL
* Eastern Cooperative Oncology Group (ECOG) score > 2
* Diagnosed spinal or brain metastases
* Hormonal manipulation within previous 6 months
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01344564
|
{
"brief_title": "Initiation of Androgen Deprivation Therapy for Prostate Cancer Using Degarelix Followed by Leuprolide",
"conditions": [
"Prostate Cancer"
],
"interventions": [
"Drug: Degarelix acetate, Leuprolide acetate"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01344564",
"official_title": "Initiation of Androgen Deprivation Therapy for the Treatment of Prostate Cancer Using Degarelix Acetate Followed by Leuprolide Acetate",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-08",
"study_completion_date(actual)": "2012-08",
"study_start_date(actual)": "2011-04"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-03-18",
"last_updated_that_met_qc_criteria": "2011-04-28",
"last_verified": "2013-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-04-29",
"first_submitted": "2011-04-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation (3+3) study to evaluate the safety, tolerability, antitumor activity, PK and immunogenicity of MEDI0639.
Detailed Description
This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm, dose-escalation (3+3) study to evaluate the safety, tolerability, antitumor activity, PK, and immunogenicity of MEDI0639 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exist. Up to 63 subjects will be enrolled at approximately 3 to 5 study centers in North America.
#Intervention
- BIOLOGICAL : MEDI0639
- MEDI0639 is an immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. MEDI0639 selectively binds to DLL4 and blocks its ability to bind to and activate signaling through the Notch receptors.
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed solid tumors that are refractory to standard therapy or for which no standard therapy exist
* Age >= 18 years
* ECOG Performance Status of 0 or 1
* LVEF (measured by Echocardiogram) > 50%
* No gastrointestinal bleeding within 1 year of study entry.
* Adequate organ and marrow function:
* Hemoglobin >= 10g/dL
* Absolute Neutrophil Count >= 1500/mm3
* Platelet Count >= 100,000/mm3
* AST & ALT <= 2.5 x ULN
* Bilirubin <= 1.5 x ULN
* Cr Cl >= 50 mL/min (as determined by the Cockcroft-Gault equation or by 24-hour urine collection)
* Prior therapy against VEGF or VEGFRs including, but not limited to bevacizumab, sunitinib, sorafenib, pazopanib, motesanib (AMG706), or cediranib (AZD2171), is permitted so long as the agent does not have any known activity against DLL4 and the last dose received s at least 6 weeks prior to first dose of MEDI0639.
* Life expectancy >= 12 weeks
* Females of childbearing potential must be surgically sterile, have a sterile male partner, be premenarchal or at least 2 years postmenopausal, practice abstinence or otherwise must use 2 effective methods of contraception from the time of initiation of investigational product.
* Males, unless surgically sterile, must use 2 effective methods of contraception with a female partner and must agree to continue using such contraception for 90 days after the last dose of MEDI0639
Exclusion Criteria:
* Concurrent enrollment in another investigational clinical study
* Receipt of any investigational anticancer therapy within 4 weeks prior to the first dose of MEDI0639 or in the case of monoclonal antibodies, 6 weeks prior to the first dose of MEDI0639
* Concurrent or previous treatment with inhibitors of DLL4
* Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment
* Known bleeding diathesis, esophageal varices, or angioplasty
* Pulmonary hemorrhage or gross hemoptysis within 12 months
* Known arterial or venous thrombosis or pulmonary embolism within 2 years
* Concurrent use of systemic low molecular weight heparin or low dose warfarin
* Presence of brain metastases
* Cerebrovascular accident or transient ischemic attack within 2 years
* Cardiovascular events, such as myocardial infarction, unstable/severe angina, coronary/peripheral artery bypass graft, unstable cardiac arrhythmia requiring medication, congestive heart failure (NYHA > class II), within 2 years
* Tumors with squamous cell histology
* Major surgical procedure within 90 days
* Pregnancy or lactation
* Known HIV positive or Hepatitis A, B, or C infection
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01577745
|
{
"brief_title": "A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Advanced Solid Tumors",
"conditions": [
"Solid Tumors"
],
"interventions": [
"Biological: MEDI0639"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01577745",
"official_title": "A Phase 1, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI0639 in Adult Subjects With Advanced Solid Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2012-04"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-05-02",
"last_updated_that_met_qc_criteria": "2012-04-12",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-04-16",
"first_submitted": "2012-04-05",
"first_submitted_that_met_qc_criteria": "2017-03-21"
}
}
}
|
#Study Description
Brief Summary
This study evaluates the effectiveness of ultrasound in term pregnant patients posted for elective lower segment cesarean sections and compared them with non pregnant females posted for elective surgeries.
Detailed Description
There is increased risk of aspiration in pregnancy due to various reasons i.e. increased progesterone levels, decreased motilin levels and distortion of gastric antrum due to gravid uterus.Ultrasound was proposed to be point of care tool, to assess risk stomach. A comparison with respect to the effectiveness of ultrasound was made in this study. The visibility of gastric antrum by ultrasound in term pregnant females posted for elective lower segment cesarean sections was compared with non-pregnant females posted for elective surgeries.
The secondary aim of the study was to compare the gastric antrum in either groups qualitatively and quantitatively.
#Intervention
- OTHER : ultrasound
- Sonosite ultrasound (Sonosite, FUJIFILM M-Turbo, made in USA)
|
#Eligibility Criteria:
Inclusion Criteria:Study group- Term pregnant patients, aged between 18 <= age <= 45, ASA II & III, having BMI between 18.5 to 30 kg/m2, scheduled for elective lower segment cesarean section.
Control group- Non-pregnant female patients, aged between 18 <= age <= 45, ASA I & II, having BMI between 18.5 to 30 kg/m2, scheduled for elective surgery.
Exclusion Criteria:Subjects with-
* Gastrointestinal pathology
* On any medication delaying gastric motility
* Systemic lupus erythematosis
* Diabetes mellitus
* Gestational diabetes
* Hypothyroidism Those who were not willing to give consent
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03380637
|
{
"brief_title": "Ultrasound for Comparison of Gastric Antral Volume in Pregnants and Non-pregnants",
"conditions": [
"Pregnancy"
],
"interventions": [
"Other: ultrasound"
],
"location_countries": null,
"nct_id": "NCT03380637",
"official_title": "Ultrasound for Comparison of Gastric Volume in Pregnant Females Posted for Elective Lower Segment Cesarean Section With Non-pregnant Females Undergoing Elective Surgeries.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-10-10",
"study_completion_date(actual)": "2017-10-10",
"study_start_date(actual)": "2016-10-13"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-12-21",
"last_updated_that_met_qc_criteria": "2017-12-20",
"last_verified": "2017-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-12-21",
"first_submitted": "2017-12-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
48 patients with massive rotator cuff tears were treated with a standardized five step technique of arthroscopic guided mini-open tranosseous repair with bursal augmentation. Their follow up is noted
Detailed Description
48 patients with massive rotator cuff tears were treated with a standardized five-step technique of arthroscopic guided mini-opentranosseous repair with bursal augmentation . ( 22 ) males and ( 26 ) females. age had a range of (58-68 ) with a mean (of 61 ) . The rt side was involved in ( 22 ) the lt side was involved in (26 ) . (12 ) patients had diabetes while one was on dialysis.
All patients were evaluated clinically for the range of movements of the shoulder in foreword flexion, abduction, ext, and int rotation. The constant score and UCLA scores were used for functional evaluation. Patients with flexion less than 90% were included in the study.
Standard plain x-ray of the shoulder and MRI were performed for all patients to evaluate the CSA and the condition of the rotator cuff. Tears were considered Massive rotator cuff tears if two or more tendons were involved. The degree of fatty degeneration and retraction of the tendon was not a contraindication for repair.
Surgical approach The procedures were performed under general anesthesia in association with interscalene brachial plexus block. The patient was positioned on a beach chair and conventional portals were used for both glen humeral and subacromial space.
First step Identifying the tear size, quality, and if reducible on the footprint. minimal removal of the bursa and pulling of the tendon with a grasper to reach the footprint area with gentle tendon mobilization. if the tendon is of bad quality and friable with the application of the grasper or if it is nonreducible on the footprint we stop the procedure of repair and shift to tendon transfer.
Step two Acromioplasty with removing the anterior and lateral part of the acromion in type 2,3 so we can reach a wide space allowing the blunt trocher 4mm diameter to slide comfortably in different positions of shoulder abduction. minimal removal of coracoacrominalligement was done to prevent superior instability .mimimal removal of the fibers of the deltoid anterior to prevent detachment of the anterior fibers of the deltoid when performing anterior lateral mini-open approach.
Using a probe, the LHBT was palpated and mobilized, looking for any signs of degeneration and fraying or instability. The LHBT was inspected either through the subacromial portal tear or the glenohumeral portal.
For patients aged 65 years or older, a tenotomy was performed. Tenodesis was performed on younger and active patients. Tenotomy was performed close to the origin of the glenoid labrum. Tenodesis, when indicated, was performed using fixing nonabsorbable sutures to the insertion pectoralis tendon by a separate incision.
Lastely the footprint is prepared at a slow speed bear with special consideration to localize and prepare the whole length and breadth of the footprint.
Step three Antero-lateral mini-open approach was used through a longitudinal 4 cm skin incision in line with anterior acromion and splitting the anterolateral raphe of the deltoid muscle between the anterior and middle fibers. A blunt deltoid retractor was applied and involvement and configuration of the torn tendon was confirmed by rotating the arm and attempting anatomical reduction on the footprint. A Cobb dissector was used to further mobilize the tendon passing deep under the acromion and pushing gently the rotator tendon to the outside towards the greater tuberosity bone Step four Transosseous repair using the giant needle was used. 3 to 4 number two fiber wire sutures were passed equidistance through the tendon (fig ). The giant needle was introduced to penetrate the bone at equidistance of the footprint and emerged from the skin about 5 cm from the tip of the greater tuberosity. A right angle hook was used superficially to the bursa to retrieve the distance end of the sutures. Before tightening the sutures the subacrominal bursa was mobilized gently from medial and posterior towards the tendon ends.
Step five The subacromial bursa was used for biological augmentation of the repair by overlapping the site of repair of the tendon to the bone. This was done by applying the sliding knot involving both the bursa and the tendon. Tighting the sutures pulls the tendon down on the bone and overlaps the bursa on the healing sight (fig ).
Post-operative The patient Weard an abduction brace and began pendulum and passive range-of-motion exercises one day after surgery. They began active range-of-motion exercises six weeks after surgery, muscle-strengthening exercises at three months, and occupational or sports activities at six months.
#Intervention
- PROCEDURE : arthroscopic assisted mini-open 5 step repair
- First step Identifying the tear size , quality and if reducible on the foot print . minimal removal of the bursa and pulling of the tendon with a grasper to reach the foot print area with gentle mobilization of the tendon .
Step two Acromioplasty Using a probe, the LHBT was palpated and mobilized, looking for any signs of degeneration and fraying or instability . The LHBT was inspected either through the tear by the subacrominal portal or through the glenohumeral portal .
Step three Antero-lateral mini-open approach was used through a longitudinal 4 cm skin incision Step four Transosseous repair using the giant needle was used. 3 to 4 number two fiber wire sutures was passed equidistance through the tendon Step five The subarominal bursa was used for biological augmentation of the repair
|
#Eligibility Criteria:
Inclusion Criteria:
* a case with massive rotator cuff tear that is repairable (judged intraoperative by arthroscope that the tear returns to its footprint)
* ages from 60 to 84
Exclusion Criteria:
* Osteoarthritis
* associated fractures
* younger than 60 orolder than 84
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 84 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT06242158
|
{
"brief_title": "5 Step Mini-open Method of Massive Rotator Cuff Repair",
"conditions": [
"Massive Rotator Cuff Tears"
],
"interventions": [
"Procedure: arthroscopic assisted mini-open 5 step repair"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT06242158",
"official_title": "The 5-step Mini-open Method of Massive Rotator Cuff Repair and Clinical and Radiological Outcome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-30",
"study_completion_date(actual)": "2023-12-30",
"study_start_date(actual)": "2019-09-19"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-05",
"last_updated_that_met_qc_criteria": "2024-01-27",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-02-05",
"first_submitted": "2024-01-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This randomized phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with sarcoma that has spread from the primary site to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with metastatic or unresectable sarcoma.
Detailed Description
PRIMARY OBJECTIVE:
I. To evaluate the confirmed response rate of single agent nivolumab and dual agent nivolumab plus ipilimumab in patients with locally advanced/unresectable or metastatic soft tissue sarcoma.
SECONDARY OBJECTIVES:
I. To evaluate adverse event rates (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\]4.0) within each treatment arm.
II. To evaluate duration of response, clinical benefit rate, time to progression, progression-free survival, and overall survival within each treatment arm.
CORRELATIVE SCIENCE OBJECTIVES:
I. To potentially detect an early signal of confirmed response rate within a histologically defined patient cohort.
II. To assess the potential association between programmed cell death 1 ligand 1 (PD-L1) expression (by immunohistochemistry \[IHC\]) and clinical outcome, within each treatment.
III. To evaluate associations between selected biomarker measured in serial peripheral blood and with clinical efficacy, within each treatment.
IV. To evaluate the association between selected biomarker measured in tumor tissue with clinical efficacy, within each treatment.
V. To evaluate the association between baseline tumor mutational burden and neoantigen production with clinical efficacy within each treatment.
EXPLORATORY PHASE II OBJECTIVES (CROSSOVER TREATMENT):
I. To evaluate secondary endpoints within patients crossing over to dual agent nivolumab plus ipilimumab after experiencing progressive disease while receiving single agent nivolumab.
II. To evaluate correlative science objectives endpoints within patients crossing over to dual agent nivolumab plus ipilimumab after experiencing progressive disease while receiving single agent nivolumab.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to Arm II.
ARM II: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
After completion of study treatment, patients are followed up at 4 weeks and then every 6 months 3 years.
#Intervention
- BIOLOGICAL : Ipilimumab
- Given IV
- Other Names :
- Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, Ipilimumab Biosimilar CS1002, MDX-010, MDX-CTLA4, Yervoy
- OTHER : Laboratory Biomarker Analysis
- Correlative studies
- BIOLOGICAL : Nivolumab
- Given IV
- Other Names :
- BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo
- OTHER : Quality-of-Life Assessment
- Ancillary studies
- Other Names :
- Quality of Life Assessment
|
#Eligibility Criteria:
Inclusion Criteria:
* PRE-REGISTRATION ELIGIBILITY CRITERIA:
* Patients must have a formalin-fixed, paraffin-embedded (FFPE) tumor block OR 1 representative hematoxylin and eosin (H&E) and 20 unstained sarcoma tissue slides available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility
* REGISTRATION ELIGIBILITY CRITERIA:
* Patients must have histologically confirmed bone or soft tissue sarcoma by central pathology review
* Patients must have histologically confirmed liposarcoma (LPS) (only dedifferentiated and pleomorphic; well differentiated not eligible), undifferentiated pleomorphic sarcoma (UPS)/malignant fibrous histiocytoma (MFH), or gastrointestinal stromal tumor (GIST)
* Measurable disease
* Locally advanced/unresectable or metastatic disease
* >= 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy
* No prior therapy with ipilimumab or nivolumab, or any agent targeting programmed cell death 1 (PD-1), PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)
* No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before study registration; no treatment with nitrosourea or mitomycin =< 42 days before study registration; for GIST, tyrosine kinase inhibitor can be continued for up to 3 days prior to initiation of study treatment
* Patients should have resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, version 4.0, grade 1 or less
* No history of the following:
* Active known or suspected autoimmune disease
* Patients with human immunodeficiency virus (HIV) are eligible if the lymphocytes > 350 cluster of differentiation (CD)4+ cells and no detectable viral load
* Symptomatic, untreated, or uncontrolled brain metastases present
* Active autoimmune colitis
* Autoimmune panhypopituitarism
* Autoimmune adrenal insufficiency
* Known active hepatitis B or C
* Hepatitis B can be defined as:
* Hepatitis B surface antigen (HBsAg) > 6 months
* Serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) 20,000 IU/ml (105 copies/ml), lower values 2,000 <= age <= 20,000 IU/ml (104 <= age <= 105 copies/ml) are often seen in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B
* Persistent or intermittent elevation in alanine aminotransferase (ALT)/alanine aminotransferase (AST) levels
* Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation
* Hepatitis C can be defined as:
* Hepatitis C antibody (Ab) positive
* Presence of hepatitis C virus (HCV) ribonucleic acid (RNA)
* Known active pulmonary disease with hypoxia defined as:
* Oxygen saturation < 85% on room air or
* Oxygen saturation < 88% despite supplemental oxygen
* No systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration
* Not pregnant and not nursing because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects; therefore for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Absolute neutrophil count (ANC) >= 1,500/mm^3
* Platelet count >= 100,000/mm^3
* Creatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance > 45 mL/min using the lean body mass formula only (Modified Cockcroft and Gault; Shargel and Yu 1985)
* Total bilirubin =< 1.5 x upper limit of normal (ULN) in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); also, if hyperbilirubinemia is clearly attributed to liver metastases total bilirubin =< 3 x ULN is permitted
* AST/ALT =< 3 x upper limit of normal (ULN)
* Thyroid stimulating hormone (TSH) within normal limits (WNL); supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH if free T4 is normal and patient is clinically euthyroid, patient is eligible
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Measurable disease
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Locally advanced/unresectable or metastatic disease
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patient MUST have had progressive disease (radiographic or clinical) while on arm 1 single agent nivolumab while registered to A091401
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patients removed from any immunotherapy for reasons other than progressive disease, including arm 1 single agent nivolumab of A091401, are NOT eligible for re-registration
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patients must have completed a minimum of 10 weeks of single agent nivolumab on arm 1 of A091401 to be eligible for re-registration
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patients must have completed study drug on arm 1 of A091401 (i.e., last dose of nivolumab) =< 12 months of re-registration to crossover dual agent therapy
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): No treatment with immunotherapy =< 21 days before re-registration; no treatment with biologic therapy, chemotherapy, investigational agent for malignancy, or radiation =< 28 days before re-registration; no treatment with nitrosourea or mitomycin =< 42 days before re-registration
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Patients should have resolution of any toxic effects of prior therapy (except fatigue and alopecia) to NCI CTCAE, version 4.0, grade 1 or less, including immune toxicity
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): No systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of re-registration
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Not pregnant and not nursing because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to re-registration is required
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): ECOG performance status 0 or 1
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): ANC >= 1,500/mm^3
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Platelet count >= 100,000/mm^3
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Creatinine =< 1.5 ULN OR calc. creatinine clearance > 45 mL/min (using lean body mass formula only [Modified Cockcroft and Gault; Shargel and Yu 1985])
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): Total bilirubin =< 1.5 x ULN in absence of Gilbert disease (total bilirubin =< 3 x ULN with Gilbert); if hyperbilirubinemia is clearly attributed to liver metastases, total bilirubin =< 3 x ULN is permitted
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): AST/ALT =< 3 x ULN
* RE-REGISTRATION ELIGIBILITY CRITERIA (FOR PATIENTS WHO CROSSOVER FROM ARM 1 NIVOLUMAB ALONE TO DUAL AGENT NIVOLUMAB AND IPILIMUMAB UPON PROGRESSION): TSH WNL; supplementation is acceptable to achieve a TSH WNL; in patients with abnormal TSH, if free T4 is normal and patient is clinically euthyroid, patient is eligible
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02500797
|
{
"brief_title": "Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery",
"conditions": [
"Locally Advanced Bone Sarcoma",
"Locally Advanced Dedifferentiated Liposarcoma",
"Locally Advanced Gastrointestinal Stromal Tumor",
"Locally Advanced Soft Tissue Sarcoma",
"Metastatic Bone Sarcoma",
"Metastatic Liposarcoma",
"Metastatic Soft Tissue Sarcoma",
"Metastatic Undifferentiated Pleomorphic Sarcoma",
"Metastatic Unresectable Sarcoma",
"Pleomorphic Liposarcoma",
"Stage III Bone Sarcoma AJCC v7",
"Stage III Soft Tissue Sarcoma AJCC v7",
"Stage IV Bone Sarcoma AJCC v7",
"Stage IV Soft Tissue Sarcoma AJCC v7",
"Stage IVA Bone Sarcoma AJCC v7",
"Stage IVB Bone Sarcoma AJCC v7",
"Unresectable Bone Sarcoma",
"Unresectable Dedifferentiated Liposarcoma",
"Unresectable Liposarcoma",
"Unresectable Malignant Gastrointestinal Stromal Tumor",
"Unresectable Soft Tissue Sarcoma"
],
"interventions": [
"Other: Laboratory Biomarker Analysis",
"Biological: Ipilimumab",
"Other: Quality-of-Life Assessment",
"Biological: Nivolumab"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02500797",
"official_title": "Randomized Phase II Study of Nivolumab With or Without Ipilimumab in Patients With Metastatic or Unresectable Sarcoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-01",
"study_completion_date(actual)": "2023-04-01",
"study_start_date(actual)": "2015-08-13"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-17",
"last_updated_that_met_qc_criteria": "2015-07-15",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-07-17",
"first_submitted": "2015-07-15",
"first_submitted_that_met_qc_criteria": "2020-05-20"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine the relationships between sedative exposure during pediatric critical illness and long-term neurocognitive outcomes. We will test for drug- and dose-dependent relationships between sedative exposure and neurocognitive outcomes along the early developmental spectrum and will control for baseline and environmental factors, as well as the severity and course of illness.
Hypotheses:
1. Greater exposure to benzodiazepines and/or ketamine will be associated with lower IQ even when controlling for severity of illness, hospital course, and baseline factors. In addition, benzodiazepines and/or ketamine will negatively affect other aspects of neurocognitive function.
2. Younger children exposed to benzodiazepines and/or ketamine will have worse neurocognitive outcomes than older children with similar sedative exposure and severity of illness.
Detailed Description
Ensuring the safety and comfort of the more than 100,000 critically ill infants and young children supported on mechanical ventilation in the US each year is integral to the practice of pediatric critical care. Humane care of these young patients requires the use of sedating medications, most commonly combinations of opioids and benzodiazepines. Unfortunately, sedative use also carries risk. Animal studies found that even transient administration of benzodiazepines and other sedatives during periods of developmental synaptogenesis caused widespread neuronal apoptosis and residual learning and memory deficits. Sedation is administered for days to weeks in \>90% of acutely-ill, ventilated infants and children. Thus, a commonly used treatment in critically ill young children may itself have detrimental, age-dependent long-term effects.
An opportunity to increase the understanding of the long-term cognitive effects of sedation during critical illness in children has been provided by the cluster randomized, controlled trial of a sedation protocol, Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), U01 HL086622, PI Curley, 31 sites, n=2,816. This trial determined whether the trial's sedation protocol used at intervention sites decreased the duration of mechanical ventilation and sedative exposure among children with acute respiratory failure due to a primary pulmonary process. Control sites continued usual sedation practice. We collected detailed data on doses and durations of sedative medications, in-hospital course, and post-discharge quality of life.
The purpose of RESTORE-cognition is to determine the relationships between sedative exposure during pediatric critical illness and long-term neurocognitive outcomes. We will assess multiple domains of neurocognitive function 2.5-5 years post-discharge in 500 RESTORE subjects with normal baseline cognitive function aged 2 weeks to 8 years at pediatric intensive care unit admission. In addition, we will study 310 matched, healthy siblings of RESTORE subjects to provide data on an unexposed group with similar baseline biological characteristics and environment. Our goal is to increase our understanding of the relationships between sedative exposure, critical illness, and long-term neurocognitive outcomes in infants and young children.
|
#Eligibility Criteria:
Inclusion Criteria:
RESTORE subjects
* Age <=8 years and PCPC=1 at RESTORE PICU admission
* PCPC <=3 at RESTORE hospital discharge Sibling control subjects
Inclusion criteria:
* Age 4 <= age <= 17 at time of testing
* PCPC=1
* Same biological parents as primary subject
* Lives with the primary subject
Exclusion Criteria:
RESTORE subjects
* Hospital readmission that includes MV and sedation
* History of cardiac arrest, traumatic brain injury (TBI) with loss of consciousness, genetic disorder, premature birth <32 weeks gestational age, or birth weight <2500 g Sibling control subjects
* Adopted or step siblings
* History of MV and sedation, receipt of general anesthesia, cardiac arrest, TBI with loss of consciousness, genetic disorder, premature birth <32 weeks gestational age, or birth weight <2500 gm.
Sex :
ALL
Ages :
- Minimum Age : 30 Months
- Maximum Age : 13 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02225041
|
{
"brief_title": "Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood",
"conditions": [
"Intellectual Disability",
"Perceptual Disorders",
"Memory Disorders"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT02225041",
"official_title": "Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12",
"study_completion_date(actual)": "2018-12",
"study_start_date(actual)": "2014-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-06-18",
"last_updated_that_met_qc_criteria": "2014-08-21",
"last_verified": "2019-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-08-25",
"first_submitted": "2014-07-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).
#Intervention
- DRUG : Fingolimod 0.5 mg
- Patients self-administered fingolimod 0.5 mg capsules orally once daily.
- Other Names :
- FTY720
- DRUG : Fingolimod 1.25 mg
- Patients self-administered fingolimod 1.25 mg capsules orally once daily.
- Other Names :
- FTY720
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients should complete the 24 month core study
Exclusion Criteria:
* Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
* Pregnant or nursing women
Other protocol-defined inclusion/exclusion criteria may apply.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 58 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00662649
|
{
"brief_title": "Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis",
"conditions": [
"Multiple Sclerosis"
],
"interventions": [
"Drug: Fingolimod 0.5 mg",
"Drug: Fingolimod 1.25 mg"
],
"location_countries": [
"Netherlands",
"Poland",
"Germany",
"Romania",
"Estonia",
"Switzerland",
"Finland",
"United Kingdom",
"France",
"Israel",
"Sweden",
"South Africa",
"Russian Federation",
"Australia",
"Hungary",
"Turkey",
"Slovakia",
"Ireland",
"Czech Republic",
"Canada",
"Belgium",
"Greece"
],
"nct_id": "NCT00662649",
"official_title": "An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06",
"study_completion_date(actual)": "2011-06",
"study_start_date(actual)": "2008-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-07-12",
"last_updated_that_met_qc_criteria": "2008-04-17",
"last_verified": "2012-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-04-21",
"first_submitted": "2008-04-17",
"first_submitted_that_met_qc_criteria": "2012-06-09"
}
}
}
|
#Study Description
Brief Summary
To test the hypothesis that preoperative injections along the levator ani muscles and pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical reconstructive surgery. A three-arm, double-blinded, randomized controlled trial of a total of 75 women will be performed.
The study population will be adult women (\>18 years of age) with uterovaginal or vaginal vault prolapse who have been scheduled for native tissue vaginal reconstructive surgery which includes an apical support procedure. Participants will be enrolled prior to surgery. The procedure will involved four injection sites: the bilateral levator ani muscles via a transobturator approach and bilateral pudendal nerves via a transvaginal approach. Random assignment will occur to one of three study arms: combined arm (20 milliliters bupivacaine/dexamethasone solution divided between the 4 injection sites), bupivacaine arm (20 milliliters bupivacaine divided between the 4 injection sites), or placebo arm (20 milliliters saline divided between the 4 injection sites).
Detailed Description
The primary purpose of this three arm, randomized clinical trial is to test the hypothesis that preoperative injections along the levator ani muscles and pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal native tissue apical reconstructive surgery.
Hypothesis: concurrent bilateral transobturator levator ani muscle injections and transvaginal pudendal nerve blocks with bupivacaine and dexamethasone performed prior to vaginal apical support procedures will result in improved pain scores at 24 hours postoperatively.
Participants will be randomized to three arms: bupivacaine/dexamethasone group, bupivacaine group, and placebo group. Block randomization will occur and will be stratified by surgery type to ensure that similar numbers of each procedure are randomized to each study arm.
All 3 groups will receive pudendal nerve blocks and transobturator levator ani muscle injections as outlined in detail below (with either bupivacaine/dexamethasone, bupivacaine alone or saline depending on randomization). The interventions will be performed after the participant is positioned in lithotomy position and after sterile preparation of the vagina and perineum per standard protocol. These injections will be performed at the start of the procedure prior to any vaginal repair and be administered by either the attending surgeon or the urogynecology fellow. After the interventions below, the vaginal reconstructive procedures will be performed as usual by the attending surgeon and surgical team. There are both fellows and residents who participate in these vaginal reconstructive surgeries, however for study purposes, resident physicians will not be permitted to administer either the pudendal nerve block or the transobturator injections. There are four attending surgeons and four fellow physicians who will be administering the injections. While all surgeons are familiar with the anatomy and have performed these procedures, each physician will be instructed on the intended procedures and additionally will be directly observed in the operating room for at least one procedure to ensure consistency in technique. All participants will undergo a standardized general anesthesia regimen.
After the study intervention, all participants will then undergo the scheduled vaginal reconstructive procedure as standard. Infiltration of the vaginal epithelium with lidocaine is common in vaginal repairs. The maximum doses of lidocaine and bupivacaine are additive. The amount of local infiltration to 50 milliliters of 0.5% lidocaine with epinephrine. This dose is equal to 250mg of lidocaine which, when also taking into account the 50mg of bupivacaine, is within a safe dosing range for a participant weighing 50kg.
Administration of all four injections involved in the study protocol and described above take approximately 5 additional minutes in total at the start of the case. After the injections are performed, there will be no further interventions.
Other assessments that will be performed as part of the study protocol are outlined below:
Baseline assessments: Pain assessment, assessment of presence of any baseline nausea or vomiting, baseline activities assessment will all be performed in preoperative area on the day of surgery prior to randomization.
Postoperative pain score assessment: 3 hours, 24 hours, 48 hours, 72 hours, and 1 week postoperatively. Postoperative pain measured by the numerical rating scale (NRS). The NRS is a publicly available pain assessment tool that consists of an eleven point scale ranging from 0 to 10 (0 = no pain and 10 = worst possible pain) presented visually on a horizontal line. Participants are asked to report a number or mark on the scale. Previous studies have demonstrated its reliability, validity and ease of administration. The NRS was chosen because a systematic review article demonstrated higher compliance rates, better responsiveness and ease of use relative to visual analog scales. Additionally, the NRS has been shown to have strong validity and low error rates when used in an elderly (\>60 years) postoperative patient population.
Postoperative nausea and vomiting assessment: 3 hours postoperatively The intensity of postoperative nausea and vomiting (PONV) using the PONV Intensity scale. The PONV scale is a four question assessment designed to measure clinically significant nausea and vomiting. It was initially validated in a general surgery population and has been validated in early postoperative gynecology patients. Clinically important nausea and vomiting is defined as a score greater than or equal to 50. This scale takes approximately 1 minute to complete and is publicly available. The amount of inpatient anti-emetic consumption will also be assessed. Any anti-emetic administered from surgery end time will be recorded as well as the dosage. Anti-emetic type and dosage will be recorded until the time of discharge.
Voiding status at time of foley catheter removal. All patients routinely have some assessment of voiding function prior to discharge. Whether each participant passed or failed a voiding trial after surgery will be recorded in the database. If a participant fails, the standard of care is do be discharged to home after learning self-catheterization or with a foley catheter. In the event that a participant fails a postoperative voiding trial, whether participants receive a foley catheter or were performing self-catheterization will be recorded. As this is a routine part of postoperative care, the research protocol will not interfere with the performance or outcomes of a voiding trial. Results will be documented, however no specific assessment tool will be used.
Time to resume normal activities measured by the activities assessment scale (AAS): 1 week, 2 weeks, 6 weeks and 12 weeks postoperatively The AAS was initially designed to assess functional activity in the perioperative period in the general surgery population. It has since been deemed a valid and reliable measure to assess postoperative activity level in a Female Pelvic Medicine and Reconstructive Surgery patient population. It has the ability to measure perioperative function and takes approximately 3-5 minutes to complete. It consists of a 13 item questionnaire assessing various types of physical activity and the degree of difficulty associated with each activity. The types of activities assessed fall into three subscales: sedentary activities (questions 1-4), ambulatory activities (questions 6-8), and work or exercise activities (questions 11-13). Respondents also have the option to indicate that these activities were not performed for another indication (this item is not scored). The time frame for all questions is the previous 24 hours. Given that many patients are instructed to avoid strenuous work or exercise activity in the postoperative period, the subscales of sedentary activities and ambulatory activities, which patients are encouraged to perform as tolerated in the postoperative period, will be of most interest.
Consumption of analgesic medications: during inpatient hospital stay and for first 72 hours postoperatively Narcotic consumption will be measured in morphine equivalents. The amount of narcotics will be obtained from the inpatient hospital record. All narcotics received from the surgery end time to the time of discharge will be included. Morphine equivalents will be calculated with online calculator available at http://www.agencymeddirectors.wa.gov/Calculator/DoseCalculator.htm. Similarly, the amount of NSAIDs will be obtained from the inpatient hospital record. All NSAIDs received from the surgery end time to the time of discharge will be included. To assess both the amount of narcotic and NSAID consumption after discharge, the participant will be provided with a diary form to record how many daily tablets of narcotic and NSAIDs are taken. This form will be completed from postoperative days 1-3.
For all forms, the participants will be instructed to mail the forms back to the office once completed (in a pre-address envelope provided as part of the study). Participants will also have the option of brining the forms in to the office at the time of a participant's postoperative visit.
Participants, physicians and any nursing personnel involved in patient care will remain masked until 12 weeks postoperatively.
#Intervention
- DRUG : Dexamethasone
- Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
- Other Names :
- Decadron
- DRUG : Bupivacaine
- Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
- Other Names :
- Marcaine
- PROCEDURE : Bilateral Pudendal Nerve Block
- Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approximately 1cm through the vaginal mucosa into the sacrospinous ligament. The needle will be aspirated to ensure no intravascular needle placement. With a negative aspirate, 5 milliliters of solution are injected. This same procedure will be performed on the contralateral side.
- PROCEDURE : Bilateral Levator Ani Muscle Injection
- Performed transperineally. With thumb, superomedial aspect of obturator foramen is palpated 2-3 cm lateral to the clitoris. The index and middle finger are in the vagina to confirm obturator foramen. A spinal needle is inserted through the the obturator foramen into the obturator internus muscle. The needle is angled slightly posteriorly towards the ischial spine, parallel to the arcus tendineus levator ani and arcus tendineus fascia pelvis. The needle is advanced to the level of the ischial spine, the vaginal hand ensuring that the needle has not perforated the vaginal wall. Once the needle tip is at a depth of the ischial spine, aspiration is performed to ensure no intravascular needle placement. 5 milliliters of solution is injected along the length of the needle tract.
- DRUG : Saline
- Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
- Other Names :
- Normal Saline
|
#Eligibility Criteria:
Inclusion Criteria:
* Women ages >= 18 years who are scheduled for a vaginal native tissue repair with apical support procedure including uterosacral ligament suspension, sacrospinous ligament fixation, or colpectomy and colpocleisis with or without levator myorrhaphy
* Concomitant procedures including hysterectomy, anterior and posterior colporrhaphies , perineorrhaphies and midurethral sling placements are acceptable and do not result in exclusion
* Available for at least 12 weeks of follow-up
* Able to undergoing general anesthesia
Exclusion Criteria:
* Planned mesh-augmented apical support procedure (placement of synthetic midurethral sling is acceptable and not considered an exclusion criteria)
* Planned mesh excision
* Laparoscopic, robotic or abdominal surgery
* Known adverse reaction or allergy to intervention medication
* Evidence of fistula or known infection (vulvovaginal cellulitis, abscess, abdominopelvic infection, or systemic fungal infection)
* Chronic pelvic pain as an active issue
* Daily opiate consumption for any indication
* History of pelvic radiation
* Chronic steroid use
* Diabetes mellitus
* Known HIV/AIDS or immunosuppression secondary to transplant related medications
* Planned surgery under regional anesthesia
* Non-English speaking or inability to complete questionnaires
* Bleeding disorders that would impair a patient's clotting ability
* Weight less than 50kg
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03040011
|
{
"brief_title": "Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery",
"conditions": [
"Pelvic Organ Prolapse",
"Surgery",
"Postoperative Pain"
],
"interventions": [
"Drug: Dexamethasone",
"Procedure: Bilateral Pudendal Nerve Block",
"Drug: Bupivacaine",
"Procedure: Bilateral Levator Ani Muscle Injection",
"Drug: Saline"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03040011",
"official_title": "Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block With Bupivacaine and Dexamethasone for Improved Pain Control After Vaginal Reconstructive Surgery: A Three-Arm Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-11",
"study_completion_date(actual)": "2019-08-05",
"study_start_date(actual)": "2017-06-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-03-09",
"last_updated_that_met_qc_criteria": "2017-01-31",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-01",
"first_submitted": "2017-01-25",
"first_submitted_that_met_qc_criteria": "2020-03-06"
}
}
}
|
#Study Description
Brief Summary
This study will evaluate transcutaneous electro stimulation device developed by Siano for adequacy, safety and efficacy for the treatment and/or prevention of migraine pain for migraine sufferers.
Detailed Description
This study will gather information regarding performance of Avital transcutaneous electro stimulation device developed by Siano. Electrostimulation in the form of weak electrical pulses arranged in specific patterns (programs), is delivered through adhesive electrodes attached to patient's skin. A set of stimulation programs, out of which one is placebo, is stored in device memory.The device is controlled wirelessly using a dedicated smartphone application. Participants will be instructed to attach and activate the device at the onset of a migraine attack and manually adjust stimulation intensity to a level where it is perceivable but not painful. Upon each activation, a program will be automatically picked for execution in random order. Randomization is performed within and between subjects. Subjects will not be aware of the executed program. Subjects are requested to refrain from use of migraine relief drugs prior to treatment and during the first two hours of the treated attack. Throughout the course of electrostimulation, participants will be requested to rate their migraine pain level via te same smartphone application, using Visual Analog Scale (VAS).
Overall experimental duration for each participant will be determined by the goal of using the Avital device for 10-20 migraine attacks.
Data containing activation times, executed programs, stimulation intensity and user feedback will be transmitted via the smartphone to a central database for analysis. All data are completely de-identified and linked to a unique code assigned to each device. The link between participant's ID and this code will be securely maintained by the research coordinator. Database will be overseen by Siano staff responsible for monitoring the clinical study. The electronic database will be used to generate outcome measures.
In the course of this study the investigators will obtain controlled data on the safety and efficacy of transcutaneous electro stimulation for migraine treatment using Siano developed transcutaneous electro stimulation device.
#Intervention
- DEVICE : Randomized treatment/placebo delivery of transcutaneous electro stimulation via a dedicated device Avital.
- Transcutaneous electro stimulation
|
#Eligibility Criteria:
Inclusion Criteria:
* Matches International Headache Society criteria for migraine with and without aura
* Reports 2 <= age <= 8 migraine attacks per month
Exclusion Criteria:
* Has other significant pain problem (e.g.cancer pain, fibromyalgia or other head or facial disorder) that in the opinion of the investigator may confound the study assessments
* Has severe cardiac or cerebrovascular disease
* Has uncontrolled high blood pressure (systolic >160 diastolic > 100 after 3 repeated measurements within 24 hours)
* Is currently implanted with an electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator)
* Known epilepsy
* Use of Cannabis including medical use.
* Has chronic migraine (more than 15 headache days per month).
* Has undergone nerve block (occipital or other) in the head or neck within the last 2 months.
* Has received Botox injections within the last 6 months.
* Is pregnant or thinking of becoming pregnant during the study period, or of childbearing years and is unwilling to use an accepted form of birth control.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02453399
|
{
"brief_title": "Relief of Migraine Pain Through Electro Stimulation",
"conditions": [
"Migraine Headache"
],
"interventions": null,
"location_countries": [
"Israel"
],
"nct_id": "NCT02453399",
"official_title": "Relief of Migraine Pain Through Transcutaneous Electro Stimulation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-04",
"study_completion_date(actual)": "2016-05",
"study_start_date(actual)": "2015-07"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-12-08",
"last_updated_that_met_qc_criteria": "2015-05-20",
"last_verified": "2016-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-05-25",
"first_submitted": "2015-05-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
There is an urgent need to develop non-hormonal innovative preventive measures under the control of women that can prevent unintended pregnancy. Based on our experimental data, the use of a gel formulation containing SLS could represent a potent and safe topical vaginal spermicide. The impact of such a preventive tool on public health will be enormous. After successfully completing supportive Phase I/II safety trials, the next step is a prospective pilot clinical trial to evaluate the safety and effectiveness of our gel formulation as a spermicidal agent and for preventing unintended pregnancy in healthy women.
Detailed Description
Study objectives (Outcomes):
The primary objective (Primary outcome) of this clinical trial is to evaluate the spermicidal efficacy in vitro and in post-coital test of gel formulation containing or not 2% SLS, when applied once intravaginally in healthy volunteers (women with their stable male sexual partners).
The secondary objective (Secondary outcome) of the study is to evaluate the safety and preliminary efficacy in preventing pregnancy of the gel formulation containing 2% SLS when used repeatedly before each sexual intercourse for a period of 3 months.
Study design: Pilot trial First phase- During volunteers screening for eligibility, male sexual partners will submit sperm samples; half of the sperm sample will be used for spermogram, and the other half of the sperm sample will be used (if normal spermogram) for in vitro testing of the spermicidal efficacy of the gel formulation components. If eligible, the man and his eligible female sex partner will be enrolled. Eligible women of the eligible male sex partners will have one vaginal gel application up to 30 min before planned sexual intercourse (vaginal penile penetration) with male ejaculating inside the vagina. Women will come to the clinic within a maximum of 12h period after the sexual intercourse for post-coital test. The gel must not be applied during menstrual period. The use of other vaginal products and male condom by participants is prohibited during the study period. A diary will be given to participants to record information concerning the internal use, if any, of any vaginal product (including tampons). This pilot trial will be performed in 1 center at the facilities of the Clinical Research of the CHU de Québec-Université Laval, CHUL.
Second phase- Couples agreeing to use the product repeatedly will continue to use the gel-SLS before each and every sexual intercourse, except during menstruation, for a period of 3 months. Women will report safety parameters after each vaginal use of the gel-SLS and will be followed regularly at the facilities of the Clinical Research of the CHU de Québec-Université Laval, CHUL.
#Intervention
- OTHER : vaginal gel containing or not sodium lauryl sulfate
- Prevention
- Other Names :
- Prevention
|
#Eligibility Criteria:
Inclusion Criteria:
Woman
* Healthy woman seeking to space or delay pregnancy aged between 18 and 49 years
* Sexually active
* Willing to give written informed consent to participate in the trial
* Normal physical and gynecological examination
* Negative urine pregnancy test at screening
* Willing to engage in planned heterosexual vaginal intercourse with ejaculation inside the vagina
* Female participant in first phase of the study must be already using and agreeing continuous use of a reliable method of contraception defined as use of hormonal contraception (pill, patch or injection, in accordance with the approved product label) during treatment with the study product and must agree to maintain the contraceptive method for at least 2 weeks after discontinuation of study product if not participating in second phase of the study. If the female participant participates in the second phase of the study, she must stop using the method of contraception during product application and use only the test product provided (vaginal gel-SLS).
Man
* Healthy man aged 18 years and older
* Sexually active
* Normal spermogram at inclusion
* Normal physical examination
* Willing to give written informed consent to participate in the trial
* Willing to engage in planned heterosexual vaginal intercourse with ejaculation inside the vagina for post coital test.
Exclusion Criteria:
Woman
* Abnormal physical/gynecological examination
* Pregnant at enrolment
* Lactating or breastfeeding
* History of vaginitis during the last 3 months
* History of using vaginal medications during the last 3 months
* History of STIs (genital herpes, HIV, gonorrhea, chlamydiasis, syphilis, vulvo-vaginal or cervical HPV) during the last 12 months
* STIs at time of screening
* Abnormal laboratory findings with clinical significance
* Allergy to applicator material (polyethylene), to gel polymer (polyoxyethylene-polyoxypropylene)
* History of toxic shock syndrome (TSS)
* Use of other contraceptive methods during the study period other than the ones accepted in the study including intrauterine device (IUD), diaphragm, spermicide, contraceptive ring and fertility awareness methods (first phase of the study, no contraception during the second phase)
* Post-menopausal (12 months of spontaneous amenorrhea and >=40 years) or physically incapable of becoming pregnant with documented permanent sterilization or history of infertility without anterior pregnancy.
* Women seeking for efficient contraception
* Current enrolment in any other clinical trial involving investigational drug, vaccine or medical device.
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol specified assessments.
Man
* Abnormal physical examination
* Abnormal spermogram
* Surgical sterilization
* History of urinary infections during the last 3 months
* History of STIs (genital herpes, HIV, gonorrhea, chlamydiasis, syphilis, HPV) during the last 12 months
* STIs at time of screening
* Abnormal laboratory findings with clinical significance
* Allergy to gel polymer (polyoxyethylene-polyoxypropylene)
* Current enrolment in any other clinical trial involving investigational drug, vaccine or medical device.
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol specified assessments.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03833115
|
{
"brief_title": "Spermicidal Efficacy Of A Vaginal Gel",
"conditions": [
"Contraception"
],
"interventions": [
"Other: vaginal gel containing or not sodium lauryl sulfate"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03833115",
"official_title": "A Pilot Descriptive Study On The Spermicidal Efficacy Of A Vaginal Gel Containing Or Not Sodium Lauryl Sulfate In Healthy Women And Their Male Partners",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-04",
"study_completion_date(actual)": "2020-12-04",
"study_start_date(actual)": "2018-02-23"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-02-18",
"last_updated_that_met_qc_criteria": "2019-02-04",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-06",
"first_submitted": "2019-01-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This project will employ functional brain imaging to study the mechanism and immediate and long-term effects of psilocybin, a serotonin receptor 2A agonist, on cortical and cortico-subcortical brain networks in healthy adults.
Detailed Description
Psilocybin shows promise as a safe, transformational therapeutic across several psychiatric conditions. However, little is know about its mechanism of action. This study aims to establish a neuroimaging paradigm for use in future clinical research testing the effectiveness of psilocybin in various clinical applications.
In this study, we will assess both acute (during psilocybin exposure) and sustained (one week post-exposure) effects of 5-HT2A receptor agonism on brain circuits using resting state functional connectivity and precision functional mapping (PFM). Using a randomized, controlled crossover study design, a small number of healthy volunteers will receive either psilocybin or methylphenidate (MTP) and will undergo MRI (structural, task, blood flow, extended resting state). After two weeks, participants will return for a second exposure with the alternate of what they received in the first session. This study involves up to five separate imaging sessions.
Functional connectivity will be measured using the following PFM approach:
1. Extended functional magnetic resonance imaging (fMRI) image acquisition
2. Aggressive data cleaning
3. Analysis designed to examine functional brain connectivity at the individual level
This will allow us to map the effects of 5-HT2A receptor agonism on cortical and cortico-subcortical brain networks at the individual level with precision that is unparalleled in the current literature. This is the first step in developing a precision neuroimaging approach for mechanistic understanding of psilocybin's therapeutic effects.
If successful, this pharmacoimaging paradigm will have potential utility across psychiatric conditions, allowing us to better understand whether and how psilocybin might 'bend the curve' in treatment course, preventing persistent suffering, disability, and suicide.
#Intervention
- DRUG : Psilocybin
- Psilocybin is a naturally occurring psychedelic compound produced by psilocybin mushrooms, and has been shown to have antidepressant and anti-anxiety effects after one dose of 25 mg. Common side effects are slight elevations in blood pressure and heart rate. Participants will be randomized to receive either psilocybin or control at two separate imaging timepoints in this study.
- Other Names :
- psilocin
- DRUG : Methylphenidate
- Methylphenidate is a stimulant medication used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy, and is used as an active control for this study because it is metabolized similarly to psilocybin and has similar effects on heart rate and blood pressure. Participants will be randomized to receive either psilocybin or control at two separate imaging timepoints in this study.
- Other Names :
- Metadate, Methylin, Ritalin, Concerta
|
#Eligibility Criteria:
Inclusion Criteria:
* men and woman between 18 and 40 years;
* Have used a psychedelic substance within the previous 5 years but not within the last 6 months
* No active psychiatric conditions requiring treatment with psychotropic medications (may be included if psychiatric condition is stable and participant is willing to discontinue medication for 1 month prior to participation with permission from their treating provider);
* Able to provide informed consent.
Exclusion Criteria:
* Presence of medical conditions that may confound results of imaging study or that are contraindications to psilocybin exposure (e.g. neurological, renal, hypertension, metabolic or cardiovascular disease or pregnancy);
* No prior exposure to classic psychedelics (psilocybin, LSD, ayahuasca, mescaline);
* Presence of psychiatric conditions that may confound interpretation of results or that are contraindications to psilocybin exposure (e.g. major mood disorder, current substance use disorder, personal or immediate family history (parents, siblings) of any schizophrenia spectrum disorders);
* Use of psychotropic medication during the study;
* Presence of contraindications to MRI scanning (implantable devices, bone hardware, IUD).
* Prior adverse reactions to psychedelics, based on the Challenging Experiences Questionnaire administered during initial screening
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04501653
|
{
"brief_title": "Precision Functional Brain Mapping in Psilocybin",
"conditions": [
"Psilocybin"
],
"interventions": [
"Drug: Psilocybin",
"Drug: Methylphenidate"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04501653",
"official_title": "Precision Functional Brain Mapping to Understand the Mechanisms of Psilocybin",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-03-19",
"study_completion_date(actual)": "2023-03-19",
"study_start_date(actual)": "2021-06-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-01",
"last_updated_that_met_qc_criteria": "2020-08-03",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-06",
"first_submitted": "2020-08-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Participants who exhibit sufficient ADHD symptom improvement in a prior study of active TNS will be invited to continue in a 12-month extension study, designed to collect additional data on long-term response and tolerability and to provide participants ongoing clinical benefit from treatment.
Detailed Description
Children, ages 8-12 years, participated in a 5 week double-blind, sham-controlled study of active Trigeminal Nerve Stimulation (TNS). Participants randomized to sham in the double-blind, were then invited into a 4-week open TNS trial. Participants who met positive response criteria to active TNS, either during the original double-blind study or the open-treatment followup, were invited to continue their TNS treatment in a 12-month open extension phase.
Participants who continued in the 12-month extension returned for study visits every 3 months to assess ongoing response and safety/tolerability data. Unless otherwise noted, baseline line assessments in the 12-month extension are taken from the final visit of the preceding active treatment trial, i.e. the visit at which positive response criteria were met.
#Intervention
- DEVICE : Active TNS
|
#Eligibility Criteria:
Inclusion Criteria:
* male and female children ages 8 <= age <= 13 with DSM-5 ADHD, and current presentation, as determined by KSADS and clinical interview
* received active TNS therapy in a previous trial and demonstrated a CGI-I score <= 2.
* parents able and willing to monitor proper use of the TNS device and complete all required rating scales
* parent and participants able to compete study rating scales and other measures in English
Exclusion Criteria:
* none
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Maximum Age : 13 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03888391
|
{
"brief_title": "12 Month Open Extension of TNS for ADHD.",
"conditions": [
"Attention Deficit Hyperactivity Disorder (ADHD)"
],
"interventions": [
"Device: Active TNS"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03888391",
"official_title": "12 Month Open Extension Study of TNS for ADHD .",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-30",
"study_completion_date(actual)": "2018-05-30",
"study_start_date(actual)": "2014-12-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-29",
"last_updated_that_met_qc_criteria": "2019-03-21",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-25",
"first_submitted": "2019-03-20",
"first_submitted_that_met_qc_criteria": "2019-04-03"
}
}
}
|
#Study Description
Brief Summary
This study aims to evaluate the clinical and radiographic outcomes for mandibular implant-supported overdenture using two different types of locator attachment after 3 years of using the two types of locator attachments
#Intervention
- PROCEDURE : implant supported overdenture
- patients would be delivered mandibular implant overdenture using conventional locator and Locator RTX attachments
|
#Eligibility Criteria:
Inclusion Criteria:
* 1. All selected patients have two implants placed in the mandibular interforaminal region.
2. All selected patients have a healthy mucosa and with no clinical complications.
3. All patients are cooperative and approve the proposed treatment protocol
Exclusion Criteria:
* 1. Patients who reject to participate in the study. 2.Patients who need implant placement as a result of previous implant failure
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT06109519
|
{
"brief_title": "Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant Supported Overdenture",
"conditions": [
"Prosthesis User"
],
"interventions": [
"Procedure: implant supported overdenture"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT06109519",
"official_title": "A Comparative Clinical Study for Two Types of Locator Attachments for Mandibular Implant-supported Overdenture; A 3-year Radiographic and Clinical Follow-up Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-07",
"study_completion_date(actual)": "2023-09-16",
"study_start_date(actual)": "2020-02-16"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-31",
"last_updated_that_met_qc_criteria": "2023-10-25",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-31",
"first_submitted": "2023-10-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study is designed as a two-group parallel randomized controlled trial (N=50) to test effects of 8-weeks of Qigong/Tai Chi (QTC) intervention compared to QTC plus HRVB on HRV parameters (primary), and cardiometabolic risk factors and sequelae (secondary) (e.g., BMI, waist circumference/percent body fat, sleep quality, stress, anxiety/depression, emotional regulation, eating behaviors, and cognitive performance).
Detailed Description
Heart rate variability biofeedback (HRVB) will be investigated as a target to optimize Qigong/Tai Chi (QTC) practices based on the expectation that learning to, and practicing changing heart rate variability (HRV) using HRVB, in addition to QTC, will result in higher levels of HRV and coherence than just the QTC alone. This study is designed as a two-group parallel randomized controlled trial to test effects of QTC compared to QTC plus HRVB on HRV parameters (primary), and cardiometabolic risk factors and sequelae (secondary). Fifty participants will be recruited and randomized to one of these groups and receive daily text prompts for 8 weeks to practice (using video links) Tai Chi Easy for 10-30 minutes (length of practice, the participants' choice). Half of the participants randomized to the HRVB enhancement will also be coached to practice HRVB to achieve coherence in their heart beat rhythms prior to practice (QTC plus HRVB group). Data collection at baseline and post intervention will assess body mass index (BMI, waist circumference/percent body fat, sleep quality, stress, eating behaviors, emotion regulation, mood (depression and anxiety), cognitive performance and changes in HRV parameters (high frequency power and coherence).
#Intervention
- BEHAVIORAL : Qigong/Tai Chi
- Participants will engage in 8 weeks of gentle movement/mindfulness videos provided in a daily text prompt, asking that this be practices most days of the week. A choice of practice video links will be provided, ranging from 10-30 minutes in length, and later confirmation texts will be employed to document if practiced, and what length was chosen.
- BEHAVIORAL : Heart rate variability biofeedback
- Randomized participants will be coached to practice a breathing technique that focuses attention on the sensations in the heart area, slowing and deepening the breath, and activating through memory or imagery a positive emotion. This practice is used along with a feedback device that provides information on achievement of the heart rate variability target, 'coherence' that represents a neurocardiac state associated with vagal tone, or balance.
|
#Eligibility Criteria:
Inclusion Criteria:
* 31.5 inch or above waist circumference women
* 35.5 inch or above waist circumference men
* Has a smartphone or tablet
Exclusion Criteria:
* Those who are unable to stand for 10-minute segments (e.g., wheelchair or walker bound and too weak), and/or unable to walk
* People who have been regularly practicing any form of meditative movement and or HRVB training regularly (i.e., 2 or more times per month for the past 6 months)
* Individuals with diagnosed severe heart arrhythmias, heart transplant, or those with pacemakers would be excluded because either of those interferes with accurately assessing HRV parameters.
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05687240
|
{
"brief_title": "Heart Focused Movement Effects on Cardiometabolic Risk",
"conditions": [
"Cardiometabolic Risk Factors"
],
"interventions": [
"Behavioral: Heart rate variability biofeedback",
"Behavioral: Qigong/Tai Chi"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05687240",
"official_title": "Effects of QiGong and Tai Chi (QTC) and Heart Rate Variability Biofeedback (HRVB) on Older Adults' Cardiometabolic Risk",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-30",
"study_completion_date(actual)": "2023-07-31",
"study_start_date(actual)": "2020-12-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-12",
"last_updated_that_met_qc_criteria": "2023-01-06",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-01-18",
"first_submitted": "2021-06-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Phase I/II open label first in human single center clinical study, is to evaluate the safety and the efficacy of BonoFill as bone filler containing the patient own (autologous) adipose tissue derived cells (HATDCs) in reconstructing the Bone Void in the maxillofacial area approximately 6 month follow up after implantation in the following two clinical indications:
1. Bone augmentation (e.g. sinus augmentation)
2. Bone grafting after removal of cysts from jaws
Detailed Description
Primary endpoint: The implantation of BonoFill to the maxillary or mandible defect/void is safe under the following conditions: No chronic bone infection (Osteomyelitis); no significant changes in complete blood count (CBC) and in general health.
Secondary endpoint: The implantation of BonoFill to the maxillary or mandible void is efficient under the following conditions: Following BonoFill implantation, the bone regeneration in the operated site was significantly accelerated. Also, the bone defects/voids were filled with a significant amount of bone tissue.
#Intervention
- PROCEDURE : Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study
- Liposuction - will be performed on Visit 2, BonoFill will be based on subject's autologous Human Adipose Tissue Derived Cells (HATDCs).
BonoFill Transplantation will be performed on Visit 6. BonoFill will be administrated to the subject in a single session at one tested cell dose.
- Other Names :
- BonoFill is an Biological, cell therapy Product that complies with the definition of Somatic Cell Therapies, BonoFill is an autologous Human Adipose Tissue Derived Cells (HATDCs) based product, combined with OraGraft® mineral particles.
|
#Eligibility Criteria:
Inclusion Criteria:
The inclusion criteria defining the eligible subjects are divided to two groups according clinical indications:
Sinus augmentation
* Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs physical examination and safety lab tests
* Subjects that have a rehabilitation dentist and rehabilitation program
* Up to dated panoramic X-Ray.
* Subjects who provided written informed consent to participate in the study, able to understand study procedure and agree for follow up procedures
* Healthy conditions of Maxillary Sinuses and Oral Mucosa.
* Sub-antral bone at least 4 mm as measured on CBCT/CT.
* Have a good oral hygiene condition as per investigator discretion.
Bone grafting after removal of cysts from jaws
* Healthy subject.
* Subjects that have a rehabilitation dental treatment.
* Limited to cysts diagnosed as: radicular cysts, residual cysts, congenital cysts, developmental and acquired cysts.
* Subjects referred to oral & maxillofacial Dpt for removal of cysts after diagnosis of the cyst type.
* Healthy bone determined by X-ray.
* Have a good oral hygiene condition.
* Subject that does not participate in other clinical study.
* Subject able to read and understand and sign the informed consent
Exclusion Criteria:
* Subjects with recorded medical history diseases as: diabetes mellitus, heart diseases, renal failure, osteoporosis.
* Subject treated with systemic steroid treatment
* Subjects with known autoimmune diseases, such as: Addison's disease Celiac disease - sprue (gluten-sensitive enteropathy), Dermatomyositis Graves disease, Hashimoto's thyroiditis, Multiple sclerosis, Myasthenia gravis Pernicious anemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome Systemic lupus erythematosus, Type I diabetes.
* Subjects that have Vitiligo and/or known scar healing problems (keloid formation).
* Subjects treated with anticoagulation medication (such as Coumadin, Plavix and other similar medications)
* Subjects treated with Oral Bisphosphonate drugs (such as Fosalan and other similar medications)
* Subjects with a history of Chemotherapy or Radiotherapy treatment
* In case of sinus augmentation - Unhealthy conditions of Maxillary Sinuses.
* Subjects with current active infection or illness
* Subjects participating in another clinical trial 30 days prior to and during the study period
* Pregnant or lactating woman. Pregnancy will be verified by urine test during screening
* Known history of any significant medical disorder, which in the investigator's judgment contraindicates the subject's participation
* Subjects with any known allergy for anesthesia
* Positive serology for either HIV, hepatitis B or hepatitis C
* Abnormal clinically significant as per investigator's judgment laboratory test and exams findings
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02153268
|
{
"brief_title": "Filling Bone Defects/Voids With Autologous BonoFill For Maxillofacial Bone Regeneration",
"conditions": [
"Bone Void in the Maxillofacial Area"
],
"interventions": [
"Procedure: Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study"
],
"location_countries": [
"Israel"
],
"nct_id": "NCT02153268",
"official_title": "Phase I/II Open Label FIH Single Center Clinical Study Aimed to Evaluate the Safety and the Efficacy of BonoFill in Reconstructing the Bone.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-12",
"study_completion_date(actual)": "2016-12",
"study_start_date(actual)": "2014-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-12",
"last_updated_that_met_qc_criteria": "2014-06-02",
"last_verified": "2017-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-06-03",
"first_submitted": "2014-04-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will measure the amount of lidocaine and tetracaine in the blood after 2-, 4-, and 12-hour application of 4 Synera patches and a 4 hour application of 4 patches without heat.
Detailed Description
The purpose of this study was to evaluate the pharmacokinetic profiles of lidocaine and tetracaine after 2-, 4-, and 12-hour application of 4 Synera® patches and a 4-hour application of 4 lidocaine/tetracaine patches without heat in healthy adult subjects and to monitor the frequency and nature of adverse events. In addition to determining the pharmacokinetics for a one-time application of 4 Synera® patches, steady-state pharmacokinetics were modeled and residual patch concentrations of lidocaine and tetracaine were determined.
#Intervention
- DRUG : Synera
- Subjects received 4 Synera® patches for 2 hours in Session 1 and 4 patches for 12 hours in Session 4. During Study Session 2, subjects were randomly assigned to 4-hour applications of either 4 Synera® patches or 4 lidocaine/tetracaine patches without heat ('no heat patches') and were crossed over during Study Session 3.
- Other Names :
- Lidocaine 70 mg/Tetracaine 70 mg topical patch
|
#Eligibility Criteria:
Inclusion Criteria:
* be at least 18 years
* be a nonsmoker
* have a body mass index (BMI) >= 18.5 and < 30.0
Exclusion Criteria:
* known or suspected hypersensitivity, allergies, or other contraindications to any compound present in the study drug, including lidocaine, tetracaine, or other local anesthetics.
* have a defect, injury or a dermatological disease or condition in the skin area where the study drug was to be applied.
* have a history or current evidence of any hepatic impairment.
* have failed the urine drug screen.
* have used or been administered a local or systemic anesthetic, including over-the-counter products, within the past 14 days.
* have donated blood or plasma within the past 30 days.
* have participated in a clinical research study within the past 30 days.
* are pregnant, breastfeeding, or was a female of childbearing potential and not practicing adequate birth control
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01602757
|
{
"brief_title": "Pharmacokinetic Study of Synera in Healthy Volunteers",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Synera"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01602757",
"official_title": "An Open-Label Pharmacokinetic Study of the Synera Patch Applied for 2-, 4-, and 12-hours and a Lidocaine/Tetracaine Patch Without Heat Applied for 4 Hours in Healthy Adult Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-03",
"study_completion_date(actual)": "2010-03",
"study_start_date(actual)": "2010-02"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-10-17",
"last_updated_that_met_qc_criteria": "2012-05-17",
"last_verified": "2012-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-21",
"first_submitted": "2012-05-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To compare the efficacy of Quetiapine SR versus placebo over 8 weeks in unipolar non-psychotic adult outpatients depression and comorbid fibromyalgia. This will be measured by the last observation carried forward (LOCF) mean change from baseline to week 8 on the Hamilton Depression Scale (HAM-D) total score.
For the purposes of this study, response regarding improvement in depressive symptoms will be defined as a 50% decrease in HAM-D scores over 8 weeks. Furthermore, proportion of patients achieving remission is defined as an HAM-D total score of 7 at end of treatment. The anxiety comorbid symptoms often associated with major depression will be assessed with the HAM-A (14 items) scale. Proportion of patients responding and achieving remission of anxiety symptoms are defined respectively as a reduction of 50% in the HAM-A total score from baseline and a HAM-A total score of 7 at the end of treatment.
Detailed Description
Secondary Endpoints include
* Change from baseline to week 8 in Brief Pain Inventory (short form) total score.
* Changes from baseline to week 8 in HAM-A total scores Changes from baseline to week 8 in CGI Severity of illness scores. Clinical Global Impression - Improvement (CGI-I) score from randomisation to Week 8 Change from baseline in the Fibromyalgia Impact Questionnaire (FIQ). Change from baseline in the Sleep Scale from the Medical Outcome Study (MOS). Change from baseline in the Sheehan Disability Scale (SDS). Change from baseline in the Quality of Life Enjoyment and Satisfaction Questionnaire- Short Form (Q-LES-Q-SF).
Change from baseline in the Patient Health Questionaire-15 (PHQ-15). Change from baseline in the Global Assessment Scale (GAS).
The side effects and the tolerability profiles of Quetiapine SR at the dose range used in the study will be assessed at every visit following the initial visit.
#Intervention
- DRUG : Quetiapine Fumarate Sustained Release
- 50 mg/day for the first 2 days and then up to 150mg/day. After two weeks the dose will be doubled up to 300mg at night at the discretion of the investigator
- Other Names :
- Seroquel XR
- DRUG : Placebo
- 1 tablet at HS for 2 days then 3 tablets at HS for 2 weeks
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with a DSM IV diagnosis of major depression and fibromyalgia confirmed by using the American College of Rheumatology criteria. Male or female between the ages of 18 and 65.
* Patients who score at least 22 on the 17-item HAM-D scale and at least 4 (i.e., moderately ill) on the Clinical Global Impression (CGI) severity scale. Both criteria have to be met at screening and baseline (Study Day 0).
Exclusion Criteria:
* Patients with DSM-IV Axis 1 disorder other than MDD and Chronic Pain Disorder within 6 months of enrolment.
* History of inadequate response to adequate treatment (6 weeks) with 2 or more classes of antidepressants during current depressive episode.
* Patients who, in the investigator's opinion, pose a risk for suicide.
* History of suicide attempt within 3 years of entering study.
* Current depressive episode secondary to general medical condition excluding Fibromyalgia.
* History or presence of bipolar disorder or psychosis.
* Post traumatic stress disorder, anorexia nervosa or bulimia nervosa.
* Patients with diagnosis of DSM-IV Axis II disorder which has a major impact on the patient's current psychiatric status.
* Present DSM IV diagnosis of substance abuse or dependence within 6 months prior of the screening visit (except dependence in full remission, and except caffeine, nicotine or opiate dependence)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00675896
|
{
"brief_title": "A Study of Quetiapine Fumarate Sustained Release in Major Depression With Comorbid Fibromyalgia Syndrome",
"conditions": [
"Major Depression"
],
"interventions": [
"Drug: Placebo",
"Drug: Quetiapine Fumarate Sustained Release"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00675896",
"official_title": "A Double Blind, Randomized Placebo Controlled Study of the Efficacy, Safety and Tolerability of Quetiapine Fumarate Sustained Release(Seroquel SRTM) in the Treatment of Major Depression With Comorbid Fibromyalgia Syndrome.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06",
"study_completion_date(actual)": "2011-07",
"study_start_date(actual)": "2007-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-07-06",
"last_updated_that_met_qc_criteria": "2008-05-09",
"last_verified": "2011-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-05-12",
"first_submitted": "2008-05-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to compare the ventilation Distribution between tidal Volume 6ml/kgBW and tidal volume 10ml/kgBW in laparoscopic nephrectomy patients
Detailed Description
Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Non-invasive blood pressure (NIBP) monitor, electrocardiogram (ECG) and pulse-oximeter was set on the subjects in the operation room. Anesthesia procedure was epidural regional block. After given premedication (midazolam 0.05 mg/kgBW and fentanyl 1-2 ug/kgBW), induced with propofol, 1-2 mg/kgbb, endotracheal tube intubation was done facilitated by atracurium 0.5 mg/kgbb. Mechanical ventilation was set up with volume control mode, (Positive End Expiratory Pressure) PEEP 5cmH2O (5 centimeters of water), O2 fraction (FiO2) 30-50%, target carbondioxide (CO2) 35-45%. Volume tidal was given according to the group (6 mL/kgBW or 10 ml/kgBW). Hemodynamic, ventilation parameter, Electrical Impedance Tomography (EIT) parameter were recorded. If desaturation happened intraoperatively will be managed by increasing FiO2 and recruitment maneuver until oxygen saturation (SpO2) \>95%. Data was analyzed using Statistical Program for Social Sciences (SPSS), for numeric data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square or Fisher Exact Test. Significant value is p\<0.05.
#Intervention
- PROCEDURE : Tidal volume 6 ml/kgBW
- Tidal volume 6ml/kgBW was given to subjects after endotracheal tube was inserted properly.
- PROCEDURE : Tidal volume 10 ml/kgBW
- Tidal volume 10 ml/kgBW was given to subjects after endotracheal tube was inserted properly.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects aged 18 <= age <= 60 years
* Subjects with good health condition (did not suffer from cancer, diabetes mellitus, kidney diseases, cardiovascular diseases, liver diseases, hematologic disorders, HIV, hepatitis)
* Subjects had the same blood type with the renal recipients and had passed cross match test
* Subjects were willing to be renal donors.
Exclusion Criteria:
* Subjects with pulmonary diseases or PaO2 (arterial partial pressure of oxygen) /FiO2 < 300 mmHg
* Subjects with Body Mass Index (BMI) > 30 kg/m2
* Subjects who had mechanical ventilation 2 weeks prior to the surgery
* Subjects with congestive heart failure
* Subjects with neuromuscular diseases.
Drop out criteria:
* Subjects with intraoperative pulmonary complications not due to ventilation
* Subjects with intraoperative cardiac arrest
* Subjects with desaturation that could not be managed by FiO2 increase, PEEP or recruitment maneuver, and required tidal volume changes.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02834039
|
{
"brief_title": "Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW",
"conditions": [
"Laparoscopic Nephrectomy"
],
"interventions": [
"Procedure: Tidal volume 6 ml/kgBW",
"Procedure: Tidal volume 10 ml/kgBW"
],
"location_countries": [
"Indonesia"
],
"nct_id": "NCT02834039",
"official_title": "Comparison of Ventilation Distribution Between Tidal Volume 6ml/kgBW and 10ml/kgBW in Laparoscopic Nephrectomy Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-02-28",
"study_completion_date(actual)": "2017-03-31",
"study_start_date(actual)": "2016-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-08-18",
"last_updated_that_met_qc_criteria": "2016-07-14",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-15",
"first_submitted": "2016-07-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a monocentre randomized pilot study. All patients received two consecutive RRT: CVVHD with MCO filter (Ultraflux® EMiC®2) and post-Continuous Veno-Venous Hemodiafiltration (CVVHDF) with HFF(AV1000S®) in a controlled randomized (1:1) blinded manner. Crossover randomized to sequence (A+B or B+A) for 48 h total without washout.
Detailed Description
This is a monocentre randomized pilot study. All patients received CVVHD with MCO filter (Ultraflux® EMiC®2) and post-Continuous Veno-Venous Hemodiafiltration (CVVHDF) with HFF(AV1000S®) in a controlled randomized (1:1) blinded manner. Crossover randomized to sequence (A+B or B+A) for 48 h total without washout.
The efficiency of the filters for small and middle molecules was compared in septic shock patients with AKI stage 3.
#Intervention
- DEVICE : Ultraflux® EMiC®2
- Ultraflux® EMiC®2-CVVHD runs in septic shock patients with AKI KDIGO 3 for 24 hours. and patients were randomised to start Ultraflux® EMiC®2-CVVHD in the first day or in the second day from the RRT start; more precisely, crossover randomized to sequence consists in Ultraflux® EMiC®2-CVVHD (first day)+ HFF-CVVHDF(second day) and HFF-CVVHDF (first day) + Ultraflux® EMiC®2-CVVHD (second day) for 48 h total without washout
- Other Names :
- HFF-CVVHDF
|
#Eligibility Criteria:
Inclusion Criteria:
* Age > 18 years;
* septic shock according to ACCP/SCCM criteria
* AKI KDIGO stage 3
* clinical decision to begin citrate based-RRT for at least 48 hours
* Hb >= 9 g/dL
* Obtain the informed consent
Exclusion Criteria:
* Pre-existing chronic renal insufficiency
* Weight > 125 kg Life expectancy <24 hr
* Declared do Not Resuscitate or Comfort Measures
* Platelets < 20 [10^3/ul] or active bleeding
* Pregnancy
* Contraindication to citrate
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04834921
|
{
"brief_title": "MCO Membrane Efficiency in Septic Shock Patients",
"conditions": [
"Septic Shock",
"Acute Kidney Injury"
],
"interventions": [
"Device: Ultraflux® EMiC®2"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT04834921",
"official_title": "Randomized Blinded Controlled Pilot Study on Clinical Assessment of Continuous Hemodialysis With a High Molecular Flux Membrane",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-21",
"study_completion_date(actual)": "2021-01-31",
"study_start_date(actual)": "2017-12-31"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-04-12",
"last_updated_that_met_qc_criteria": "2021-04-04",
"last_verified": "2021-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-08",
"first_submitted": "2021-03-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Cardiac magnetic resonance imaging has emerged as a potential valuable test for the early detection of Pulmonary Arterial Hypertension. A number of reports have provided some preliminary evidence that Pulmonary Artery (PA) stiffness may be accurately detected by imaging of the pulmonary artery in order to measure PA stiffness. In addition, cardiac MRI could play provide early and effective treatment for Pulmonary Arterial Hypertension (PAH).
|
#Eligibility Criteria:
Inclusion Criteria:
Consecutive patients aged >= 18 years with PAH as dictated by a comprehensive examination and echocardiography will be included for enrollment.
Exclusion Criteria:
* Age < 18 years
* Pregnancy
* Mechanical ventilation
* Acute or chronic renal failure (creatinine clearance < 30 ml/min or requiring renal replacement therapy)
* Inability to perform MRI (i.e. claustrophobia, severe obesity (> 150 kg), device incompatible with MRI)
* Significant arrhythmia that precludes adequate ECG-gating for the MRI (i.e. atrial fibrillation with highly variable cycle lengths)
* Prior heart or lung transplantation
* Left ventricular systolic (ejection fraction < 50%) or diastolic failure (based on Framingham criteria for heart failure with preserved ejection fraction)
* Significant left-sided valvular disease (>= moderate aortic stenosis, mitral stenosis, aortic regurgitation, mitral regurgitation) or prior valve surgery
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01451255
|
{
"brief_title": "Early Detection of Pulmonary Arterial Hypertension Using Cardiac Magnetic Resonance Imaging",
"conditions": [
"Pulmonary Hypertension",
"Pulmonary Arterial Hypertension"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01451255",
"official_title": "Early Detection of Pulmonary Arterial Hypertension Using Cardiac Magnetic Resonance Imaging",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-06",
"study_completion_date(actual)": "2014-06",
"study_start_date(actual)": "2011-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-17",
"last_updated_that_met_qc_criteria": "2011-10-12",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-10-13",
"first_submitted": "2011-10-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.
#Intervention
- DRUG : Bevacizumab
- Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.
- Other Names :
- Avastin
- DRUG : Docetaxel
- Docetaxel 60 or 75 milligram per meter square (mg/m\^2) on Day 1 every 21 days.
- DRUG : Erlotinib
- Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.
- DRUG : Pemetrexed
- Pemetrexed 500 mg/m\^2 IV over 10 minutes on Day 1 every 21 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed non-squamous NSCLC
* Documented progression of disease (locally recurrent or metastatic) per investigator assessment following first-line treatment with 4 <= age <= 6 cycles of Bevacizumab plus a platinum doublet-containing chemotherapy regimen and a minimum of 2 cycles of Bevacizumab (monotherapy) maintenance treatment prior to first progression of disease
* No treatment interruption of Bevacizumab treatment greater than 2 consecutive cycles (42 days) between the start of first-line treatment to start of Cycle 1 of second line treatment
* Randomization within 4 weeks of progression of disease
* At least one unidimensionally measurable lesion meeting RECIST v1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2
* Participants with adequate hematological, liver, and renal function
* Female participants must not be pregnant or breast-feeding. Female participants of childbearing potential and fertile male participants must agree to use a highly effective contraceptive during the trial and for a period of at least 6 months following the last administration of trial drug(s)
Exclusion Criteria:
* Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
* Epidermal growth factor receptor (EGFR)-mutation-positive disease according to local laboratory testing
* History of hemoptysis greater than or equal to (>=) grade 2 within 3 months of randomization
* History or evidence of inherited bleeding diathesis or coagulopathy with a risk of bleeding and active gastrointestinal bleeding
* Major cardiac disease
* Treatment with any other investigational agent within 28 days prior to randomization
* Known hypersensitivity to bevacizumab or any of its excipients, or any SOC drugs foreseen
* Malignancy other than NSCLC within 5 years prior to randomization and evidence of any other disease that contraindicates the use of an investigational or SOC drug
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01351415
|
{
"brief_title": "A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)",
"conditions": [
"Non-Squamous Non-Small Cell Lung Cancer"
],
"interventions": [
"Drug: Docetaxel",
"Drug: Erlotinib",
"Drug: Pemetrexed",
"Drug: Bevacizumab"
],
"location_countries": [
"France",
"Japan",
"Slovakia",
"Mexico",
"United States",
"Netherlands",
"Germany",
"United Arab Emirates",
"Oman",
"Greece",
"Austria",
"Spain",
"Brazil",
"Argentina",
"Italy",
"Lebanon",
"Belgium",
"Denmark"
],
"nct_id": "NCT01351415",
"official_title": "An Open-label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease (PD) in Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC) After First Line Treatment With Bevacizumab Plus a Platinum Doublet-containing Chemotherapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-25",
"study_completion_date(actual)": "2016-06-25",
"study_start_date(actual)": "2011-06-25"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-09-18",
"last_updated_that_met_qc_criteria": "2011-05-09",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-10",
"first_submitted": "2011-05-09",
"first_submitted_that_met_qc_criteria": "2017-08-17"
}
}
}
|
#Study Description
Brief Summary
1 - study morphological and morphometric features of the glenoid cavity in human scapulae bone and its function.
2- study morphological and morphometric features of the acetabulum in human hip bone and its function.
Detailed Description
study morphological features of the glenoid cavity and to measure various dimensions of the glenoid in dry human scapulae bone and correlation to its function.
The knowledge of normal anatomical features and variations of the shape and size of glenoid cavity are prerequisites for complete understanding of the mechanics of shoulder joint, this information has clinical application in shoulder arthroplasty, gleno-humeral instability and rotator cuff tear management.
study morphological features of the acetabulum and to measure various dimensions of the acetabulum in dry human hip bone and correlation to its function.
Knowledge of the dimensions of acetabulum are vital to understand the mechanics of hip joint, and will assist the prosthetists to construct the suitable prostheses
#Intervention
- OTHER : measure various dimensions of the glenoid
- measurement of Superior-Inferior glenoid diameter ,Anterior-Posterior glenoid diameter and study shape of the glenoid cavity .
- OTHER : measure various dimensions of the acetabulum
- measurement of transverse diameter of the acetabulum ,vertical diameter of the acetabulum, depth of the acetabulum ,Width of acetabular notch and study shape of anterior acetabular ridge and ends of lunate surface .
|
#Eligibility Criteria:
Inclusion Criteria:
* The scapulae with clear and intact glenoid cavity will be used for the study. The hip bones with clear and intact acetabulum will be used for the study
Exclusion Criteria:
* Bones with gross damage or anomalies will be excluded from the study.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04850859
|
{
"brief_title": "Study on Human Glenoid Cavity and Acetabulum",
"conditions": [
"Glenoid Cavity",
"Acetabulum"
],
"interventions": [
"Other: measure various dimensions of the acetabulum",
"Other: measure various dimensions of the glenoid"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04850859",
"official_title": "Morphological and Morphometric Study on Human Glenoid Cavity and Acetabulum With Correlation to Their Functions",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-09-01",
"study_completion_date(actual)": "2022-05-01",
"study_start_date(actual)": "2021-06-01"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-06-01",
"last_updated_that_met_qc_criteria": "2021-04-14",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-04-20",
"first_submitted": "2021-04-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The study is designed to investigate the safety and tolerability of KBL693 in healthy volunteers. KBL693 has been developed as a potential new treatment for moderate to severe asthma..
Detailed Description
This is a randomized, double-blind, placebo-controlled, single centre Phase I study.
Eighteen (18) subjects are planned to be randomised at 1 site across the 2 parts of the study as follows:
* Cohort 1: 680 mg/day
* Cohort 2: 6800 mg/day
#Intervention
- DRUG : KBL693
- Part 1: 680 mg/day of KBL693 or Placebo;
Route of Administration: Oral
- Other Names :
- Placebo
- DRUG : KBL693
- Part 2: 6800 mg/day of KBL693 or Placebo;
Route of Administration: Oral
- Other Names :
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers (also referred to as participants) who can read and understand, and are willing to sign the informed consent form
* Willing and able to comply with clinic visits (including confinement to CTU) and study-related procedures
* Male or female healthy volunteers aged >=18 and <=65 years at Screening
* Body mass index (BMI) of >=18.0 kg/m2 to <=32 kg/m2 (both inclusive) at Screening
* Normal hemodynamic parameters: systolic blood pressure (BP) >=90 mmHg and <=140 mmHg; diastolic BP >=50 mmHg and <=90 mmHg; heart rate (HR) >=40 bpm and <=100 bpm at Screening and Day -1. Measurements may be repeated up to 3 times at the discretion of the investigator.
Please note: participants with out of range values, which are not clinically significant as per the principal investigator's (PI) discretion, will be allowed. The PI may delegate this responsibility to a suitably qualified and trained study team member.
* The participant is, in the opinion of the PI (or delegate), generally healthy based on assessment of medical history, physical examination, vital signs, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other relevant laboratory tests
* Baseline laboratory test values within reference ranges based on the blood and urine samples taken at Screening and on Day -1. Out of normal ranges values may be accepted by the PI, if not clinically significant
* Have regular bowel movements (e.g., once daily)
* Male participants must agree to practise true abstinence; be surgically sterilised (performed at least 6 months prior); or agree to use of a condom if sexually active with a female partner of childbearing potential, from Screening through 90 days after the final dose of the investigational product (IP).
* Women of child-bearing potential must agree to practise true abstinence or agree to use effective contraception from Screening through 90 days after the final dose of the IP.
Effective contraception includes:
1. Oral contraceptives ('the pill') for at least 1 month prior to Day 1, plus use of a condom
2. Depot or injectable birth control or implantable contraception (e.g., Implanon) plus use of a condom
3. Intrauterine device plus use of a condom
4. Vasectomised male partner (performed at least 6 months prior) who has been documented to no longer produce sperm
* Women of non-child-bearing potential:
1. Must have documented evidence of surgical sterilization at least 6 months prior to Screening visit e.g., tubal ligation, hysterectomy.
2. Must be post-menopausal for at least 12 months prior to Screening, as documented by measurement of follicle stimulating hormone level (>=40 mIU/mL).
Exclusion Criteria:
* Female participants who are pregnant or lactating
* The participant's corrected QT interval (QTcF) (Fridericia's correction) is >450 msec (males), and >470 msec (females) at Screening or on Day -1. An out-of-range or abnormal ECG will be repeated at PI's discretion. In total, 3 ECGs should be recorded consecutively at Screening and on Day -1, and the PI (or delegate) must evaluate the triplicate ECG. If the participant's QTcF is >450 msec (males) or >470 msec (females) on at least 2 ECGs or have structural cardiac abnormalities, the participant must be excluded
* The participant has taken prescription (including antibiotics) or non-prescription medication, herbal remedies, vitamins or minerals, any probiotic drinks and yeast supplements (e.g. Mutaflor®, Bioflor®) within 14 days prior to the first dose of study product unless in the opinion of the PI the medication will not compromise participant safety or interfere with study procedures or data validity. Participant may be rescreened after a washout period of 14 days. Please note use of oral contraceptives and paracetamol up to 2 g/day and/or nonsteroidal anti-inflammatory drugs for symptomatic relief of minor symptoms are allowed
* Participant has functional GI disorders
* Participant is a current smoker or has used nicotine containing products within 6 months prior to Screening visit
* The participant has a substance abuse-related disorder or has a history of drug, alcohol and/or substance abuse deemed significant by the PI
* The participant has taken any IP within 30 days prior to the first dose of study product or 5 half-lives, whichever is longer
* The participant has a history of significant hypersensitivity or anaphylaxis involving any drug (including ampicillin, clindamycin or imipenem), any constituent of the IP, food or other precipitating agent (e.g. bee sting). Please note participants with clinically stable mild allergic conditions such as hay fever and mild eczema may be enrolled at the discretion of the PI
* Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus antibody (anti-HCV)at Screening visit.
* Positive screen for drugs of abuse and cotinine at Screening or on Day -1. Positive screen for alcohol on Day -1.
* The participant is, in the opinion of the PI, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04307173
|
{
"brief_title": "Study of Multiple Ascending Dose of KBL693 in Healthy Participants",
"conditions": [
"Moderate to Severe Asthma"
],
"interventions": [
"Drug: KBL693"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT04307173",
"official_title": "A Phase I Randomised Double-Blind Placebo-Controlled Study of Multiple Ascending Dose of KBL693 in Healthy Participants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-10-30",
"study_completion_date(actual)": "2020-11-12",
"study_start_date(actual)": "2020-08-14"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-02-21",
"last_updated_that_met_qc_criteria": "2020-03-10",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-13",
"first_submitted": "2020-02-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Stress-precipitated Smoking Behavior.
Detailed Description
The study will be performed in subjects who are heavy cigarette smokers currently not seeking treatment for tobacco use disorder.
The study is a crossover design study (within-subject analysis), which allows for subjects to be their own control.
Each period of the crossover consists of a 7-day out-patient treatment period followed by a single out-patient testing day on Day 8. Subjects will participate in a laboratory session following the McKee Stress-Smoking Lapse Test. Upon completion, subjects will undergo a 7 day washout period followed by the second period of the crossover design and a 7-day follow-up visit.
#Intervention
- DRUG : CERC-501
- CERC-501
- DRUG : Placebo
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria
* Provides written informed consent and agrees to complete required clinic visits
* Male or female 21 <= age <= 60 of age inclusive
* Body mass index (BMI) 18.5 to 40 kg/m2 inclusive
* Smokes at least 10 cigarettes per day on average for the past 6 months
* Fagerstrom score >=3 at screening
* Currently not seeking smoking cessation therapy
* Urine dip test for cotinine concentration >150 ng/mL
* In otherwise good general health without any unstable medical conditions (as determined by medical history, medication history, physical examination, 10- or 12 lead ECG, vital signs, and clinical laboratory testing)
* Able to read, write, and speak English
* Females must be either:
1. Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or-
2. Women of childbearing potential (WOCBP) must meet the criteria below:
i. Uses an acceptable double-barrier method of contraception as determined by the Investigator -and- ii. Is not lactating, has a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test prior to dosing on Days 1 and 8 of each treatment period.
* Male subjects must agree to use a condom if partner is of childbearing potential
Exclusion Criteria
* Have used tobacco or other nicotine containing products other than cigarettes (e.g., nicotine patches, pipe, cigars, snuff, chewing tobacco or e-cigarettes) within the past 30 days
* Any substance use disorder other than nicotine or caffeine as assessed by the Structured Clinical Interview-IV Axis I Disorders (SCID) for Diagnostic and Statistical Manual of Mental Disorders (DSM)
* Current neurological conditions that interfere with study conduct, assessment or treatment in any significant fashion
* Any lifetime history of bipolar I, II; schizophrenia or any other psychotic disorders; personality disorders, impulse control disorders as assessed by the SCID-IV
* Current psychiatric conditions that interfere with study conduct, assessment, or treatment in any significant fashion, such as major depressive disorder (MDD), eating disorders, post-traumatic stress disorder, etc. We will screen for worsening of symptoms of depression and/or suicidality at each medication appointment and lab sessions by having participants complete the Beck Depression Inventory (BDI) and the Columbia-Suicide Severity Rating Scale (C-SSRS). If there is a worsening of symptoms of depression and/or suicidality, the participants will speak a licensed psychologist for evaluation.
* Recent active or past history of gastric disease such as peptic ulcer disease, gastritis, upper gastrointestinal bleeding, or any gastrointestinal malignancy or precancerous condition
* Active, comorbid disease that might limit the ability of the subject to participate in the study as determined by the Study MD (i.e., poorly controlled diabetes mellitus, congestive heart failure, etc.)
* Clinically significant clinical laboratory test taken during screening
* Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >=2 times the upper limit of normal (ULN)
* Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C positive as determined by serology testing at Screening
* Positive ethanol breath test at screening or prior to dosing on Days 1 and 8 of each treatment period
* Positive urine drug test at screening or and/or prior to dosing on Days 1 and 8 of each treatment period except for cannabis
* History of severe allergies or multiple adverse drug reactions
* Known hypersensitivity to CERC-501
* Current use of a proton pump inhibitor or histamine 2 blocker
* Use of any investigational medication within 2 months prior to the start of this study or scheduled to receive an investigational drug other than the study drug during the course of this study
* Current use of any psychoactive medications including: antipsychotics, benzodiazepines, mood stabilizers, selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) or other antidepressants mood stabilizers
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02800928
|
{
"brief_title": "Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?",
"conditions": [
"Smoking"
],
"interventions": [
"Drug: Placebo",
"Drug: CERC-501"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02800928",
"official_title": "Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-01-02",
"study_completion_date(actual)": "2018-01-02",
"study_start_date(actual)": "2016-06-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-08-13",
"last_updated_that_met_qc_criteria": "2016-06-10",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-15",
"first_submitted": "2016-06-08",
"first_submitted_that_met_qc_criteria": "2019-07-23"
}
}
}
|
#Study Description
Brief Summary
This is an early phase (Phase IIa), randomized, double-blind, parallel group, multi-centre study for subjects with trauma (physical injury) who are at risk for developing Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS). The primary purpose of the study is to evaluate the safety and tolerability of SB-681323, which is a potent, selective inhibitor of p38 alpha (MAPK) (prevents inflammation of tissue), in comparison to a placebo.
Detailed Description
The acute respiratory distress syndrome (ARDS) is a form of severe lung injury (ALI) characterized by hypoxemic respiratory failure (the lungs are unable to absorb oxygen to the arterial blood) and non-cardiogenic pulmonary edema (accumulation of fluid in the lungs). The syndrome may be caused by direct or indirect injury to the lungs. It is associated with a mortality rate of up to 40-50%. There are no marketed pharmacologic therapies for this devastating syndrome.
This study aims to assess the safety and tolerability of SB-681323, which is a potent, selective inhibitor of p38 alpha mitogen-activated protein kinase.
The rationale behind the development of this drug is that there are elevated levels of circulating pro-inflammatory agents, such as cytokines which are biological agents that increase levels of inflammation in the lungs. These agents are part of an 'inflammatory loop' and it may be beneficial to the condition to dampen this loop.
p38 mitogen activated protein kinase (MAPK) plays a major role in the regulation and activation of intracellular proteins which are subsequently involved in the regulation of the cytokines. The pathway is activated by 'stress', such as injury, causing the inflammation. Therefore, 'dampening' this system should reduce the level of inflammation.
This study will investigate the anti-inflammatory activity, efficacy (effectiveness at achieving the desired effect) and safety of SB-681323.
To measure the efficacy of the drug, biomarkers will be measured. Biomarkers are biological agents in the body that are effected by the presence of specific injury or inflammation and are directly or indirectly linked to a regulatory system of event in the body. They are used to measure for the presence and severity of the condition in question. This study will investigate biomarkers linked directly or indirectly to the p38 alpha regulatory mechanism/system. We will be measuring biomarkers such as serum inflammatory biomarkers, coagulation (blood clotting) system biomarkers, biomarkers of endothelial cell / neutrophil interaction and biomarkers of lung epithelial cell injury.
#Intervention
- DRUG : SB-681323 Intravenous 3mg
- 3 mg SB-681323 Intravenous administration infused over 4 hours
- DRUG : SB-681323 Intravenous 7.5 mg
- 7.5 mg SB-681323 Intravenous administration infused over 24 hours
- DRUG : SB-681323 Intravenous 7.5mg
- 7.5 mg SB-681323 Intravenous administration infused over 4 hours
- DRUG : SB-681323 Intravenous 10mg
- 10 mg SB-681323 Intravenous administration infused over 24 hours
- OTHER : Placebo
- Placebo to match intervention
|
#Eligibility Criteria:
Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
* Male or female, 18 - 80 years (inclusive) with major trauma admitted to the Intensive Care Unit (ICU).
* Injury Severity score (ISS) >16 to <70 (exclusive)
* A female subject is eligible to participate if she is of non-child-bearing potential or of:
* Child-bearing potential and agrees to use one of the approved contraception methods (oral contraceptive, either combined or progesterone alone, injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device (IUD) or intrauterine system (IUS) with less than 1% non-effectiveness, documented male partner sterilization, double barrier method, i.e. condom and occlusive cap plus spermicidal agent) for an appropriate period of time (as determined by the product label or investigator, if applicable. Female subjects must agree to use contraception until one week post-last dose, if applicable.
* Male subjects must agree to use one of the approved contraception methods (abstinence, defined as sexual inactivity consistent with the preferred and usual lifestyle of the subject, condom during non-vaginal intercourse with any partner (male or female), condom and occlusive cap plus spermicidal agent during sexual intercourse with a female) if applicable. This criterion must be followed from the time of the first dose of study medication until one week post-last dose, if applicable.
* BMI within the range 19.0 - 35.0 kg/m2 inclusive (clinical estimate of height and weight is acceptable).
* The subject or legal decision maker is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
* The subject must be randomized into the study within 24 <= age <= 26 hours from the time of trauma.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
* Known positive Hepatitis B surface antigen or Hepatitis C antibody.
* Known positive test for HIV antibody.
* A known history of substance abuse, alcohol abuse, or regular alcohol consumption within 6 months of the study defined as:
* an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
* History of sensitivity to any of the study medications, or components thereof, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
* Haemoglobin < 7g/dL.
* Pregnant females as determined by positive serum or urine hCG test prior to dosing.
* Lactating females.
* Unwillingness or inability to follow the procedures outlined in the protocol.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
* Diagnosis of ALI at admission.
* Head trauma (Abbreviated Injury Score [AIS]>3), liver trauma (AIS>2), or trauma that in the opinion of the Principle Investigator or GSK medical monitor is deemed unsurvivable.
* Known history of neuromuscular disease or cord injury at C5 or above.
* Elevated ALT or AST > 1.5 ULN.
* History of bone marrow or solid organ transplant.
* Known history of auto-immune disorder in which immunosuppressive agents, other than prednisone, were required within the last 6 weeks.
* Known to be receiving oral or intravenous corticosteroids within 7 days of admission.
* Subject with active tuberculosis or being treated for active tuberculosis.
* Known history of malignancy within the past 5 years with the exception of successfully treated squamous cell or basal cell cancer of the skin.
* Arterial blood pH less than 7.1 or serum HCO3 - <15 before infusion is started.
* Persistent cardiovascular instability requiring therapy with more than one vasopressor.
* A patient will be excluded if in the judgement of the Principle Investigator or GSK medical monitor their participation could jeopardize the health of the subject or the integrity of the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00996840
|
{
"brief_title": "SB-681323 IV for Subjects at Risk of Acute Lung Injury or ARDS",
"conditions": [
"Lung Injury, Acute"
],
"interventions": [
"Other: Placebo",
"Drug: SB-681323 Intravenous 10mg",
"Drug: SB-681323 Intravenous 7.5mg",
"Drug: SB-681323 Intravenous 3mg",
"Drug: SB-681323 Intravenous 7.5 mg"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00996840",
"official_title": "Assessment of the Anti-Inflammatory Activity, Efficacy and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury (ALI) or Acute Respiratory Distress Syndrome (ARDS).",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-02-09",
"study_completion_date(actual)": "2013-02-09",
"study_start_date(actual)": "2009-10-16"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-10-18",
"last_updated_that_met_qc_criteria": "2009-10-15",
"last_verified": "2017-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-10-16",
"first_submitted": "2009-10-15",
"first_submitted_that_met_qc_criteria": "2017-10-17"
}
}
}
|
#Study Description
Brief Summary
We will evaluate the end to end remote monitoring system in a less controlled environment and concurrently develop the infrastructure to support the back end of the system
Detailed Description
The overall objective of our research is to test, adapt, refine and validate the BodyGuardian technology and related end-to-end remote monitoring system to be used outside usual medical care environments to reduce hospital readmissions and facilitate independent living for heart failure patients. An important component of our overall strategy for continued development and refinement of the remote monitoring system is the incorporation of iterative behavioral evaluations to facilitate assessment and refinement in order to optimize adherence, utilization, and usability for patients as well as efficiency and functionality for providers.
|
#Eligibility Criteria:
Inclusion Criteria:
* Outpatients
* Stable New York Heart Association Class I-III HF (defined as no admissions for > 1 year)
* Recruited from the Mayo Heart Failure Clinic, including 15 men and 15 women
* Age > 50 years
* Reside in Olmsted County
Exclusion Criteria:
* Hospital admission for HF within past year
* Dementia
* Overall life expectancy < 2 months
* Blindness
* Pregnancy or women able to become pregnant
* Skin allergy to adhesives
* Inadequate cell phone coverage (international patients or international travel during study period)
* Documented Ejection Fraction of >40%
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01975402
|
{
"brief_title": "Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population",
"conditions": [
"Congestive Heart Failure"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT01975402",
"official_title": "Evaluation of the BodyGuardian End-to-end Remote Monitoring Platform in an Outpatient Heart Failure Population",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-31",
"study_completion_date(actual)": "2019-03-31",
"study_start_date(actual)": "2013-11"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-21",
"last_updated_that_met_qc_criteria": "2013-11-01",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-11-03",
"first_submitted": "2013-10-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A randomized controlled trial conducted on 688 sexually experienced adolescents, with 337 participants assigned to the routine program, and 351 to the new intervention developed from an assessment of their needs. All participants will complete a self-administered questionnaire and an interview on their knowledge of sexually transmitted infections (STIs)/Human Immunodeficiency Virus (HIV), self-efficacy, skills in negotiating for sexual abstinence or condom use, and sexual behaviors at baseline and at 6- and 12-months' post- intervention. All will be tested for STIs. Participants in the intervention group will receive 4 individual counseling sessions on STIs/HIV knowledge, life skills, secondary abstinence, safer sex and healthy relationships over 1 year. They will also be referred to counselors for proactive social and emotional support delivered through electronic media and other means. The control group will receive the usual counseling session at first and follow-up clinic visit.
Detailed Description
The reasons for conducting this study in a clinical setting is threefold.
1. This is group of adolescents that has a high risk for transmitting STIs to the community. Prior to this intervention, the investigators did a preliminary study and found a high number of sex partners (median: 4, range: 1-25) and high prevalence of unprotected sex (90%) and STIs (60%) in this group. Other factors in this group that facilitate the transmission of STIs is that 36% continued to engage in unprotected sex and half of the boys (49%) and three quarters of the girls (77%) delayed seeking treatment for more than a week after experiencing symptoms of STIs. The rate at which STIs spread in a population depends upon the average number of new cases of infection generated by an infected person (the basic or case reproduction ratio (Ro). This ratio, in turn, depends upon the efficiency of transmission, (b), the mean rate of change of sexual partners (c), and the average duration of infectiousness (D) as expressed in the form: Ro=b\*c\*D. Given their high number of sex partners and the long duration of infectiousness owing to their delay in seeking treatment, they would form an important group for spreading STIs to the general population.
2. The investigators are able to adopt a rigorous study design, that is, a randomized controlled trial in a clinical setting to evaluate the efficacy of the intervention, and validate self-reported behaviors with laboratory tests for STIs. In contrast, it is less feasible to conduct the study in schools presently because of the sensitivity of the topic, conservative attitudes of parents and possible biases of self-reported sexual behavior in schools. School-based interventions will also exclude school drop outs, who were found in this ongoing study, to be significantly, more likely to engage in sexual activity.
3. The investigators have conducted needs assessment of this group and this would help in developing interventions specifically for them. For instance, the investigators found that both males and females lack the confidence of using condoms correctly. The investigators incorporated a session on instilling skills for condom use in our intervention.
#Intervention
- BEHAVIORAL : Adolescent Behavioral Intervention
- Session 1 focuses on STI/HIV education and self-reflection. Session 2 aims to increase the awareness of STI/HIV preventive strategies by instilling condom use and negotiation skills. Motivational Interviewing is used during the behavioural counselling. Session 3 reviews the goal on safer sex set by the participant and examines the successful strategies on safer sex and identifies triggers for relapse. Success stories are shared to renew their motivation. Session 4 reinforces the progress of the participant by recapitulating the knowledge and motivation explored in previous sessions. The online sessions, by phone/SMS/Whatsapp are conducted 2 months after the second and third sessions to find out if they face any difficulties and to reinforce prevention information covered previously.
|
#Eligibility Criteria:
Inclusion Criteria:
* Singaporean citizens or permanent residents
* Sexually active for the past 1 year
* Heterosexual
* Attending the clinic for the first time
* Able to commit for one year in Singapore
Exclusion Criteria:
* Involved in criminal investigation
Sex :
ALL
Ages :
- Minimum Age : 16 Years
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT02461940
|
{
"brief_title": "STI/HIV Prevention Intervention for Adolescents in Singapore",
"conditions": [
"Sexually Transmitted Infections"
],
"interventions": [
"Behavioral: Adolescent Behavioral Intervention"
],
"location_countries": null,
"nct_id": "NCT02461940",
"official_title": "A Randomized Controlled Trial of an STI/HIV/AIDS Prevention Intervention for Adolescents Attending a Public STI Clinic in Singapore",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-01",
"study_completion_date(actual)": "2016-01",
"study_start_date(actual)": "2009-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-05-10",
"last_updated_that_met_qc_criteria": "2015-05-30",
"last_verified": "2016-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-06-03",
"first_submitted": "2015-05-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aims to evaluate if the 1-hour rule-in/rule-out algorithm for a high-sensitivity cardiac troponin T (hs-cTnT) is safe and effective for use in the primary care where the patients have a lower pretest probability of an acute myocardial infarction (MI). During this study troponins will be collected at 0-, 1- and 4/6-hours, where absolute changes in the values will decide whether the patient need hospitalization or not.
Detailed Description
Many patients seek Oslo Accident and Emergency Outpatient Clinic (OAEOC) with chest pain. The majority of these patients have symptoms suggestive of a benign non-cardiac chest pain. These patients do not need a directly transfer to the hospital, but can be admitted to the Observation Unit at the OAEOC for further pre-hospital testing, including serial troponins for a safe rule-out of acute MI. The main goal of this study is to improve the current routine at the Observation Unit at OAEOC by introducing the 1-hour algorithm for hs-cTnT for a faster rule-in/rule-out of acute MI.
All recruited patients will have serial troponins drawn at 0, 1- and 4/6 hours, with the main hypothesis that the absolute changes within 1 hour can be used as surrogates for the changes and conclusions drawn after 4/6 hours. The cut-off levels used within the 0/1-hour algorithm are assay specific as specified in the 2015 European Society of Cardiology Guidelines for the management of acute NSTEMI.
#Intervention
- PROCEDURE : 1-hour hs-cTnT
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients at the outpatient clinic with suspected non-cardiac chest pain/symptoms who need further testing for a safe rule-out of an acute MI
* Written informed consent
Exclusion Criteria:
* Acute STEMI (ST-elevation myocardial infarction) (directly to the hospital)
* Strong suspicion of an acute NSTEMI/unstable angina (directly to the hospital)
* Terminal kidney disease with a glomerular filtration rate (GFR) < 30
* Unable to communicate in Norwegian, Swedish, Danish or English language
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02983123
|
{
"brief_title": "One-hour Troponin in a Low-prevalence Population of Acute Coronary Syndrome",
"conditions": [
"Non-ST Elevation Myocardial Infarction",
"Acute Coronary Syndrome",
"Angina, Unstable",
"NSTEMI - Non-ST Segment Elevation MI"
],
"interventions": [
"Procedure: 1-hour hs-cTnT"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT02983123",
"official_title": "Introduction of an 1-hour Algorithm for High-sensitivity Cardiac-specific Troponin T for Faster Assessment of NSTEMI in a Low-prevalence Population at Oslo Accident and Emergency Outpatient Clinic",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-22",
"study_completion_date(actual)": "2018-10-22",
"study_start_date(actual)": "2016-11-15"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-03-14",
"last_updated_that_met_qc_criteria": "2016-12-01",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-06",
"first_submitted": "2016-11-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Many people with diabetes and/or high blood pressure (hypertension) are not very active. When people are more active, they can reduce the chances of having a heart attack or stroke. Walking more is a cheap and effective way to be more active and to lower the risk of heart attacks and strokes. The problem is that many people do not walk enough! The investigators will study if people with diabetes and/or hypertension walk more when the doctor gives them a prescription with the number of steps they should be walking every day. The investigators will compare this group, called 'active', to another group, called 'control', in which doctors and their patients do what they usually do, over a period of one year.
The investigators will measure the number of steps the investigators walk everyday with a step counter or pedometer. In the step count prescription group, the doctors will give to the 'active' group a pedometer, a step count record book, and step count prescriptions. The overall goal is to gradually increase daily steps. The speed of the increase in step count will be slower for less active people. At each visit the doctor will look at the step count record book. The doctor will then give a new step count prescription to the patients. Patients of the two groups will see their doctor about four times during the year, which is how often they usually see their doctor. At the end of one year, the investigators will see the difference in the hardness of the arteries between the 'active' and the 'control' groups, using simple and safe measurements, similar to ultrasound in pregnant ladies. People with hard arteries are more likely to have a heart attack or stroke.
The investigators suspect that patients who get the step count prescriptions will walk more and their arteries will be less hard than the control group. Our study will help find out if this is true. In that case, doctors should take the time to prescribe steps for all their patients with diabetes and/or hypertension.
Detailed Description
BACKGROUND: High walking levels reduce myocardial infarction, stroke, and mortality rates in overweight/obese patients with diabetes and/or hypertension, but our own work, led by Nominated Principal Applicant K. Dasgupta, indicates low daily step counts in these patients, at approximately 5,000 steps/day on average with a further 15% reduction during fall and winter. A meta-analysis of physical activity programs indicates that pedometer-based monitoring programs can lead to higher daily step counts, but evidence for impact on arterial health is limited, as is evidence for the effectiveness of a pedometer-based strategy specifically implemented into the usual clinical care of patients with diabetes and/or hypertension. The SMARTER trial will address these knowledge gaps.
PRIMARY RESEARCH QUESTION: Among sedentary overweight/obese adults with diabetes and/or hypertension do physician-delivered step count prescriptions integrated into usual care reduce arterial stiffness more than usual care alone, over a one-year period? Arterial stiffness (primary outcome), a summative indicator of arterial health, is more precise and reliable than individual risk factors. An analysis of the Framingham Heart Study demonstrated that, even after adjustment for traditional risk factors, increased arterial stiffness was independently associated with a 48% increase in vascular disease risk. Co-Principal Applicant S. Daskalopoulou is an expert in the noninvasive assessment of arterial stiffness and has a well-equipped Vascular Lab funded through a CFI grant.
STUDY DESIGN: Randomized, allocation concealed, single-blind (outcome assessors), intervention allocation ratio 1:1, multisite clinical trial. This design will allow for the level A evidence necessary to justify widespread change in clinical practice.
TRIAL SYNOPSIS: Given that the majority of diabetes and hypertension patients are managed in primary care settings, the SMARTER trial interventions will be delivered through the large network of primary care clinics accessible to Co-Principal Applicant E. Rosenberg as well as diabetes and internal medicine clinics throughout Montreal where patients may receive their primary diabetes and hypertension follow-up. Twenty-four collaborating physicians have been identified. Physicians/clinic staff will obtain assent from candidates within their practice for contact by the SMARTER coordinator. The number of collaborating physicians continues to be increased, including physicians at primary care, diabetes, hypertension, internal medicine, and endocrinology clinics. Eligibility: Candidates will be adults with 25≤BMI\<40 kg/m2 followed for diabetes and/or hypertension and sedentary to somewhat active. Evaluations: Formal trial evaluations, conducted at baseline and 12 months, will include assessments of arterial stiffness (carotid femoral pulse wave velocity measured noninvasively with applanation tonometry); step counts (pedometer with concealed window) and physical activity (accelerometer) worn for one week; fitness (exercise stress test; ˙VO2max); anthropometric parameters; and individual vascular risk factors. Intervention arm: The physician gives the active trial participants a pedometer, log book, and a step count prescription based on the baseline daily step count. The time frame for a \> 3,000 steps/day net increase is 10 months for sedentary participants (\<5,000 steps/day), 7 months for low active participants (5,000-7,499 steps/day), and 5 months for somewhat active participants (7,500-9,999 steps/day). There will be four clinic visits over one year. Control arm: Same visit frequency with advice to engage in 30-60 minutes of activity on most days of the week. Sample Size: Allowing for a loss to follow-up of up to 17% based on our previous studies, investigators will require a sample size of 364 individuals (i.e. 182 per arm) to detect a 10% difference in change in arterial stiffness between our active and control arms to an accuracy of +/- 5% over a one-year period. Analysis: Intention-to-treat. Between-arm differences in 'after minus before changes' with 95% CIs for main analysis.
Addedum to stress testing: Due to timeline limitations, we were obliged to forego stress testing assessments as of October 20, 2014. This does not impact our primary outcome. Moreover, stress testing is not required when engaging in a walking program in type 2 diabetes. We will be able to assess impacts of the intervention on fitness (secondary outcome) in a subgroup of patients (i.e., those who completed assessments before October 20, 2014).
IMPORTANCE: With increasing numbers of diabetes and hypertension patients, there is a pressing need for effective and efficient clinical practice strategies to help physicians support their patients to achieve the arterial health benefits of higher physical activity levels. The SMARTER trial seeks to provide such a tool. If effectiveness is demonstrated, all efforts will be made for the inclusion of our approach in Clinical Practice Guidelines for diabetes and hypertension, and investigators will develop training tools (manuals, websites, CD-ROMs) to allow maximal uptake of our proposed strategy.
AN OBSERVATIONAL SUBSTUDY: Novel Real-Time Measurement of Physical Activity Patterns in Type 2 Diabetes and Hypertension Through GPS Monitoring and Accelerometry
In addition to the main clinical trial, we are conducting additional measurements among consenting type 2 diabetes patients in order to examine the effects of the walkability of their home neighbourhood on their baseline step count and time at different physical activity intensities (accelerometer measurement already being performed through SMARTER). The additional measurements include wearing a Geographical Positioning Systems (GPS) device for the 7-day period that they wear the pedometer with concealed viewing window and accelerometer. The GPS device collects time-stamped location information such that X,Y coordinates are collected. These are used to determine the times that they are within or outside neighbourhood buffer zones.
For the assessment of neighbourhood walkability,the parameters assessed include population density, pedestrian-friendly design and diversity of destinations - commonly referred to in the urban planning literature as the 3D's. The variables that best capture density, design, and diversity include residential density, street connectivity and land use mix. Residential density is defined as the number of residences per square kilometre of residential land area. Street connectivity is defined as the number of ≥3-way intersections per square kilometre in neighbourhood, where a greater number of intersections facilitates movement between origins (e.g., residences) and destinations (e.g., shops and parks).Land-use mix is a measure of the number of different land uses located within a neighbourhood.Land use mix is assessed via an entropy score - a value between zero and one that captures the degree of heterogeneity of land uses in a neighbourhood. A subcomponent of land use mix that may be a particularly important for encouraging individuals to walk within their neighbourhood and that is easily incorporated into the design of new neighbourhoods is greenspace/recreational land area.
We are using Geographical Information System (GIS) mapping (computer-based assessment of neighbourhood characteristics derived from existing data sources that have some spatially referenced identification, such as a home address) to measure these facets of neighbourhood walkability.In brief, each of the variables will be derived by geocoding participants six-digit home postal codes, constructing 1-kilometre polygonal buffers zones around each participants home address (i.e., a geographical zone around the centroid of the postal code area) and calculating the measures of interest for each neighbourhood using tools within a GIS software package (ArcGIS) and publically available shape files.
Means and standard deviations will be used to describe the number of steps per day occurring specifically in home neighbourhoods (i.e., as determined through GPS) and overall. Multiple linear regression analyses will be used to assess the relationship between 1) home neighbourhood environments and the number of steps taken per day in the home neighbourhood and 2) home neighbourhood environments and the number of steps taken per day taken in any location. These analyses will be repeated with time at moderate to vigorous activity in lieu of steps as the outcome variable. Several variables measured through SMARTER will be considered for exclusion in models (e.g., age, sex, educational level, BMI).
This observational substudy is partly funded by an operating grant from the Heart and Stroke Foundation (Quebec) awarded to K. Dasgupta (Principal Investigator) and Nancy Ross (Co-Principal Investigator on substudy) and is being led by Samantha Hajna, their doctoral candidate student.
#Intervention
- BEHAVIORAL : Step count prescription
- Treating physicians will provide a pedometer, pedometer log, and step count prescription. The aim is a net increase of at least 3,000 steps/day over one year. The time frame for this increase will be 10 months for sedentary participants (\<5,000 steps/day), 7 months for low active participants (5,000-7,499 steps/day), and 5 months for somewhat active participants (7,500-9,999 steps/day). If goals are not met, the doctor and participant will review barriers and facilitators, and a more individualized prescription will be formulated (e.g. lower incremental step count targets or slower rate of dose escalation). For participants who meet goals, the doctor and participant will together decide whether to aim for a further increase.
- BEHAVIORAL : Usual care
- The control trial arm will receive usual care alone, over a one-year period (i.e. no step count prescription but, in accordance with guidelines, including advice to engage in 30-60 minutes of activity on most days of the week).
|
#Eligibility Criteria:
Inclusion Criteria:
* Followed by a SMARTER collaborating doctor
* BMI >= 25 kg/m2 but < 40 kg/m2 (i.e. overweight to class II obese)
* Type 2 diabetes and/or hypertension
* Conversant in either English or French
Exclusion Criteria:
* >= 150 minutes of leisure time physical activity per week be self- report
* Acute or chronic co-morbid conditions that may affect the ability or likelihood to adhere to trial procedures (e.g. inflammatory arthritis, active malignancy, major depression or other significant psychiatric disorders, and/or significant visual impairment)
* Pregnancy/planning a pregnancy
* Baseline step count averaging >= 10,000 steps/day at baseline assessment
* Arrhythmia that prevents accurate assessment of carotid-femoral pulse wave velocity (e.g., atrial fibrillation)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 95 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01475201
|
{
"brief_title": "Step Monitoring to Improve ARTERial Health",
"conditions": [
"Type 2 Diabetes",
"Hypertension"
],
"interventions": [
"Behavioral: Usual care",
"Behavioral: Step count prescription"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT01475201",
"official_title": "Step Monitoring to Improve ARTERial Health",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-03",
"study_completion_date(actual)": "2016-03",
"study_start_date(actual)": "2012-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-03-23",
"last_updated_that_met_qc_criteria": "2011-11-18",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-11-21",
"first_submitted": "2011-11-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The specific aims of the study are to:
1. Assess the feasibility of a TytoCare telehealth device with remote audio/video connection for evaluation of children with medical complexity in the home environment.
2. Evaluate the usability of a TytoCare telehealth device in transmitting real time images (otoscope, oropharyngeal exam, camera), temperature, and sound (stethoscope for heart and breath sounds)
3. Compare the impact of the TytoCare telehealth device versus traditional telephone assessment on patient management and user satisfaction
Detailed Description
Eligible children of interested parent(s) will be randomly assigned to either the control group (standard care) or the intervention group (Tyto device). Randomization will be performed using an online randomization program to generate group assignments for the 25 subjects. Subjects will be stratified by whether they have a tracheostomy or not and be assigned 1.5:1 to achieve 15 children in the device group and 10 children in the control group. Informed consent will be obtained for children in each group.
Children/families in the control group will continue to get usual care through the CCCMC program, and will be able to access their providers via telephone for urgent care needs and scheduled follow up. For evaluation purposes, data collection will include the monthly encounter tracking that is done routinely as part of the CCCMC program, and research surveys completed by both parents and HCPs. Parents will complete a Parent Survey by phone once each month for the 3-month study period. The CCCMC HCPs will complete the Provider Survey electronic survey with each telephone encounter where the HCP would have liked to use the device.
For those assigned to the device group, parents will be instructed to contact their CCCMC HCP as usual, see bullet points above, when health concerns arise and their HCP will decide if she would like a telehealth visit. Telehealth/video visits may also be scheduled in advance as a matter of routine follow-up care. In the event that an exam is deemed necessary by the HCP, the parent or caregiver will be directed to connect via the remote exam device. The provider will conduct a 2-way live interactive audio/video visit with the patient. The parent or caregiver will use the remote exam device to provide temperature, lung sounds, heart sounds, oropharyngeal exam, skin exam and/or ear exam as clinically indicated. Direction for necessary treatment, referral to an ED, clinic or inpatient care will be at the discretion of the CCCMC provider. For evaluation purposes, in addition to the monthly encounter tracking that is done as part of the CCCMC program, both parents and HCPs will complete surveys. Parents will complete a Parent Survey by phone once each month for the 3-month study period. The CCCMC HCPs will complete the Provider Survey via a Qualtrics link with each telehealth encounter.
Additional data collected will include subject demographics, and encounter data that is routinely collected as a part of the CCCMC program. Images of patient encounters will be transmitted in real time via the telemedicine device encrypted software. Provider Survey data will be gathered via Qualtrics. Tyto will retain / store data obtained from device group encounters in a de-identified way for development purposes only.
#Intervention
- DEVICE : TytoCare Device
- Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient aged 1 month to 18 years
* Patient currently enrolled in CCCMC program at ACH-OL
* Parental permission/consent
* English-speaking (at least one parent)
* Internet connected home wi-fi
Exclusion Criteria
* Unable to comply with study requirements
Sex :
ALL
Ages :
- Minimum Age : 1 Month
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02849938
|
{
"brief_title": "Evaluating the Value of Telehealth for Care of Children With Medical Complexity",
"conditions": [
"Cerebral Palsy"
],
"interventions": [
"Device: TytoCare Device"
],
"location_countries": null,
"nct_id": "NCT02849938",
"official_title": "Evaluating the Value of Telehealth for Care of Children With Medical Complexity",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-01-31",
"study_completion_date(actual)": "2017-03-20",
"study_start_date(actual)": "2016-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-08",
"last_updated_that_met_qc_criteria": "2016-07-28",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-29",
"first_submitted": "2016-07-27",
"first_submitted_that_met_qc_criteria": "2019-01-16"
}
}
}
|
#Study Description
Brief Summary
This study incorporates metacognitive strategy training into semantic feature analysis treatment. Semantic feature analysis treatment has a strong evidence base and capacity to improve word retrieval by encouraging circumlocution. Circumlocution facilitates self-cued naming and assists listener comprehension when naming fails. However, semantic feature analysis treatment does not include direct techniques to teach patients with aphasia to generalize the use of semantic feature analysis treatment's circumlocution procedure. Therefore, this study proposes that combining semantic feature analysis treatment and metacognitive strategy training will stimulate the semantic system and increase patients with aphasias' use of circumlocution across divergent contexts.
This study aims to measure the treatment's effect on naming accuracy for trained and untrained items. The study also aim to measure the treatment's effect on people with aphasias' knowledge of the strategy components and changes in verbalizations during retrieval attempts. The central hypothesis is that strategy training will increase patients with aphasias' explicit knowledge about circumlocution and enable them to use it to (1) self-facilitate naming, and (2) produce more informative connected speech.
Detailed Description
Every 40 seconds, someone in the United States suffers from a stroke. Approximately 25% of stroke survivors acquire aphasia, a communication disorder that can result in a partial or total loss of spoken and written language ability, which significantly and negatively impacts quality of life and societal participation. The ability to verbally label objects, referred to as 'naming' in the literature, is impaired in all patients with aphasia. Naming is, therefore, a common focus of treatment. Naming treatments improve people with aphasias' naming ability for items that are directly trained during therapy. However, these same treatments face two critical limitations: (1) inconsistent generalization to untrained items, and (2) little to no generalization to spontaneous, connected speech. As it is impossible to train the entire universe of objects during a patient's course of therapy, generalization of gains beyond what is trained in therapy is crucial.
Recent work shows that patients with aphasias' learning success depends on their ability to develop optimal strategies that support learning, but that they do not develop these strategies independently. There is also evidence that through explicit strategy training, patients with aphasia can learn to implement and generalize the use of strategies that are known to support learning, and carry over their use across multiple environments. As such, it is predicted that naming treatment outcomes would be greatly improved by incorporating strategy training into treatment.
This study proposes to incorporate strategy training into naming treatment to improve generalization. Circumlocution, a verbal behavior in which patients with aphasia describe an object's features if they are unable to name it, is known to facilitate naming and assist listener comprehension. Semantic Feature Analysis is a well-regarded naming treatment thought to encourage circumlocution. Semantic Feature Analysis treatment does not include direct techniques that teach patients with aphasia how to generalize the use of the treatment's circumlocution procedure. In fact, no studies have explicitly trained patients with aphasia how to use the circumlocution procedure they learn in Semantic Feature Analysis treatment during everyday communication. Rather, it is assumed that patients with aphasia will implicitly learn how to use the procedure, through repeated practice and habituation alone. This study proposes that strategy training is the integral missing piece that will successfully result in people with aphasias' generalized application of the semantic feature analysis procedure.
The objective of the proposed research is to determine whether naming treatment that incorporates strategy training results in people with aphasias' increased use of circumlocution. The central hypothesis is that strategy training will increase patients with aphasias' explicit knowledge about circumlocution and enable them to use it to (1) self-facilitate naming, and (2) produce more informative connected speech. It is predicted that increased use of circumlocution will result in generalization at both the impairment level (naming) and participation level (effective communication).
#Intervention
- BEHAVIORAL : Strategy training
- The strategy training of focus in this study is metacognitive strategy training intended to build awareness of naming and methods to overcome instances of difficult naming. Strategy training involves (a) teaching the participant to identify instances in which they are unable to name objects, (b) learn a 6-feature framework (e.g. group, use, action) that has been identified to support semantic feature activation in aphasia, (c) learn and practice strategies to utilize the framework in instances of word finding difficulty
|
#Eligibility Criteria:
Inclusion criteria:
* Experienced a single left-hemisphere stroke,
* Have aphasia due to stroke,
* Be in the chronic stages of their aphasia, at least 6 months post onset of stroke.
* Be between the ages of 18 and 89 years, and
* Be a proficient English speaker,
* Have no history of neurodegenerative disease, motor speech disorder, significant mental illness, psychiatric disorder, drug/alcohol abuse, or neurological condition that could influence their cognitive, language, and memory systems.
Exclusion criteria:
* Experienced multiple strokes;
* Be in the acute stage of their aphasia, <6 months post onset of stroke;
* Have a diagnosis of neurodegenerative disease, significant mental illness, psychiatric disorder, drug/alcohol abuse, or neurological condition that could influence cognitive, language, and memory systems
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 89 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05307796
|
{
"brief_title": "Incorporating Strategy Training Into Naming Treatment in Aphasia",
"conditions": [
"Aphasia"
],
"interventions": [
"Behavioral: Strategy training"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05307796",
"official_title": "Incorporating Strategy Training Into Naming Treatment to Improve Generalization in Aphasia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-11",
"study_completion_date(actual)": "2022-05-11",
"study_start_date(actual)": "2021-08-30"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-13",
"last_updated_that_met_qc_criteria": "2022-03-23",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-01",
"first_submitted": "2022-03-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objectives of this trial are to investigate safety and tolerability of BI 1595043 in healthy male subjects following administration of multiple rising doses over 14 days.
Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1595043 after single and multiple dosing.
#Intervention
- DRUG : BI 1595043
- BI 1595043
- DRUG : Placebo
- Placebo
- DRUG : Midazolam
- Midazolam
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* Age of 18 <= age <= 50 (inclusive)
* BMI of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
* Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
* Use of adequate contraception, i.e. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea
* Sexually abstinent
* Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (i.e. condom) Unprotected sexual intercourse (i.e. without use of condom) with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion
Exclusion Criteria:
* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Further exclusion criteria apply
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04789304
|
{
"brief_title": "A Study to Test How Healthy Men Tolerate Different Doses of BI 1595043",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Placebo",
"Drug: Midazolam",
"Drug: BI 1595043"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT04789304",
"official_title": "Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1595043 (Double-blind, Randomised, Placebocontrolled, Parallel Group Design) in Healthy Male Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-14",
"study_completion_date(actual)": "2022-01-14",
"study_start_date(actual)": "2021-04-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-21",
"last_updated_that_met_qc_criteria": "2021-03-08",
"last_verified": "2023-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-09",
"first_submitted": "2021-03-08",
"first_submitted_that_met_qc_criteria": "2023-07-05"
}
}
}
|
#Study Description
Brief Summary
The goal of this study is to learn about the effects of combining alcohol with cannabis concentrate products which contain high levels of THC. The main question\[s\] it aims to answer are, 1) How does the order in which someone consumes THC and alcohol in a given co-use session impact outcomes such as blood alcohol level, heart rate or subjective drug effects, and 2) how does THC percentage in cannabis influence outcomes following alcohol and cannabis co-administration. Participants will be scheduled for our mobile lab to come to their residence. During the session, they will:
* consume a standardized dose of alcohol as well as use their own preferred cannabis concentrate product.
* they will then remain in our mobile lab for about 4 hours and complete some surveys as well as do some cognitive tasks on an iPad every 30 minutes.
* They will also have their blood drawn three times throughout the session, and will periodically be asked to blood into a breathalyzer to measure blood alcohol level.
Researchers will compare people who use alcohol prior to cannabis to those who use cannabis prior to alcohol to determine whether order of use impacts outcomes.
Detailed Description
Individuals who drink alcohol commonly report co-using cannabis, and the increasing availability of new formulations of highly potent cannabis products on the legal market means that alcohol is likely being combined with cannabis products that contain high levels of delta-9-tetrahydrocannabinol (THC). There is limited existing research on the acute effects of cannabis products containing high amounts of THC, such as cannabis concentrates, which often contain up to 90% THC. Existing laboratory data suggests that consuming alcohol and cannabis together (compared to alcohol alone) is associated with reduced BAC, delayed time to peak blood alcohol concentration (BAC), longer duration of intoxication, and increased subjective intoxication, but it is unknown how cannabis concentrates may interact with alcohol to influence these outcomes. There is also a lack of research regarding whether timing or order of use matters, though recent survey data from our group and others suggests that using alcohol before cannabis may confer additional risk compared to using cannabis prior to alcohol. The present study leverages a federally-compliant mobile laboratory design to explore the acute effects of self-administered cannabis concentrates alongside a standardized dose of alcohol. The investigators will recruit a community sample of individuals who regularly use alcohol and cannabis to participate study sessions in our mobile laboratory. The sessions will involve individuals consuming cannabis concentrates of their choice (that they acquire themselves) along with a standardized dose of alcohol. Half of the participants will use the alcohol before cannabis, and the other half will use the cannabis before alcohol. The investigators will measure intoxication and biological outcomes every 30 minutes for 4 hours. The investigators will also measure differences between those who used alcohol before cannabis and those who used cannabis before alcohol.
#Intervention
- OTHER : commercially available cannabis administered prior to commercially available alcohol
- Self administration of cannabis prior to researcher administered alcohol
- OTHER : commercially available alcohol administered prior to commercially available cannabis
- Researcher administered alcohol prior to self-administration of cannabis
|
#Eligibility Criteria:
Inclusion Criteria:
* 21 <= age <= 65 years,
* Heavy drinkers (for men, >4 drinks in one occasion, or >14 drinks per week; for women, >3 drinks in one occasion, or >7 drinks per week)
* Regular users of legal-market cannabis (at least 3x/week in past 3 months)
* Have experience using cannabis concentrates within the last year
* Willing to obtain a concentrate product of their choice for use in the study.
Exclusion Criteria:
* Diagnosed with or seeking treatment for alcohol use disorder (AUD) or other substance use disorder (SUD)
* Pregnant, breastfeeding or trying to become pregnant
* Meet criteria for psychotic, bipolar or major depressive disorder with suicidal ideation, or history of these disorders
* Current use of psychotropic (except anti-depressants) or steroid medications
* Report illicit drug use in past 60-days or fail drug screen (drug screen tests for the presence of amphetamines, benzodiazepines, cocaine, THC, methamphetamine and opioids; only THC is allowed to be present in urine in order to be eligible to participate in the study
* Major medical condition contraindicating alcohol and/or cannabis consumption (e.g., liver disease, heart disease, or being told by a doctor that it is unsafe to consume alcohol or cannabis due to a medical condition)
* Have participated in another research study in the past 8 weeks.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05999344
|
{
"brief_title": "Alcohol and Cannabis Concentrates Co-Administration",
"conditions": [
"Alcohol Use Disorder",
"Cannabis Use"
],
"interventions": [
"Other: commercially available alcohol administered prior to commercially available cannabis",
"Other: commercially available cannabis administered prior to commercially available alcohol"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05999344",
"official_title": "Exploring Intoxication During Acute Alcohol and Cannabis Concentrate Co-Administration: A Focus on Cannabinoid Content and Order Effects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-08-01",
"study_completion_date(actual)": "2024-08-01",
"study_start_date(actual)": "2021-12-16"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-06",
"last_updated_that_met_qc_criteria": "2023-08-11",
"last_verified": "2024-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-08-21",
"first_submitted": "2023-08-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Dexlansoprazole from Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed release Capsules (Takeda Pharmaceuticals America Inc., USA)
Detailed Description
Primary Pharmacokinetic Parameters: Cmax, Area under cover (AUC0→t and AUC0→∞ ) Secondary Pharmacokinetic Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the 90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for untransformed data of Ke, tmax and t1/2e. The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax, AUC0→t and AUC0→∞ to be within 80.00-125.00%.
A comprehensive final report will be issued upon the completion of the study.
#Intervention
- DRUG : Doxirazole
- 1 capsule contains 60 mg Dexlansoprazole
- Other Names :
- Dexilant
- DRUG : Dexilant
- 1 capsule contains 60 mg Dexlansoprazole
|
#Eligibility Criteria:
Inclusion Criteria:
* 1. Healthy male or female, age 18 <= age <= 55, inclusive. 2. Body weight within 15% of normal range according to the accepted normal values for body mass index (BMI).
3. Medical demographics without evidence of clinically significant deviation from normal medical condition.
4. Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
5. Subject does not have allergy to the drugs under investigation.
Exclusion Criteria:
* 1. Subjects with known allergy to the products tested. 2. Subjects whose values of BMI were outside the accepted normal ranges. 3. Female subjects who were pregnant, nursing or taking birth control pills. 4. Medical demographics with evidence of clinically significant deviation from normal medical condition.
5. Results of laboratory tests which are clinically significant. 6. Acute infection within one week preceding first study drug administration. 7. History of drug or alcohol abuse. 8. Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
9. Subject is on a special diet (for example subject is vegetarian). 10. Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
11. Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
12. Subject has a history of severe diseases which have direct impact on the study.
13. Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
14. Subject intends to be hospitalized within 3 months after first study drug administration.
15. Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days, or 750 ml of blood in 30 days, 1000 ml in 90 days, 1250 ml in 120 days, 1500 ml in 180 days, 2000 ml in 270 days, 2500 ml of blood in 1 year.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02529787
|
{
"brief_title": "A Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg Delayed Release (DR) Capsules (Takeda Pharmaceuticals America Inc., USA)",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Doxirazole",
"Drug: Dexilant"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT02529787",
"official_title": "Comparative Open-label,Randomized, Fasting, Single Dose, Two-way Crossover Bioequivalence Study of Dexlansoprazole From Doxirazole 60 mg Capsules (Hikma Pharma,Egypt)and Dexilant 60 mg DR Capsules (Takeda Pharmaceuticals America Inc., USA)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-02",
"study_completion_date(actual)": "2013-03",
"study_start_date(actual)": "2013-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-08-20",
"last_updated_that_met_qc_criteria": "2015-08-19",
"last_verified": "2015-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-08-20",
"first_submitted": "2015-08-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI)following single dose administration of FF/VI via the novel dry powder inhaler in healthy subjects.
Detailed Description
The study will be an open-label, randomised, 3-way cross-over single dose study in 24 healthy subjects to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) following single dose administration of FF/VI via the novel dry powder inhaler. In each of 3 treatment periods, subjects will receive 4 inhalations of 50/25 mcg, 100/25 mcg, 200/25 mcg FF/VI. Blood samples will be taken for pharmacokinetic analysis and safety (12-lead ECGs, clinical laboratory test, vital signs, adverse events) will be monitored following each dose.
#Intervention
- DRUG : Fluticasone furoate 50 mcg (4 inhalations)
- 4 inhalations of 50 mcg strength
- DRUG : Fluticasone furoate 100 mcg (4 inhalations)
- 4 inhalations of 100 mcg strength
- DRUG : Fluticasone furoate 200 mcg (4 inhalations)
- 4 inhalations of 200 mcg strength
- DRUG : Vilanterol 25 mcg (4 inhalations)
- 4 inhalations of 25 mcg strength
|
#Eligibility Criteria:
Inclusion Criteria:
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <or= 1.5xULN
* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
* Male or female between 18 and 65 years inclusive.
* A female subject is eligible to participate if she is of:
Non-child-bearing potential defined as post-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea.
Child-bearing potential and agrees to use one of the approved contraception methods until 16 weeks after the last dose.
* Male subjects with female partners of child-bearing potential must agree to use one of the approved contraception methods until 16 weeks after the last dose.
* Body Mass Index (BMI) within range 18.5 <= age <= 29.0 kg/m2 (inclusive).
* Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Average QTcF < 450 msec.
* No clinically significant abnormality on the Holter electrocardiogram (ECG) at screening.
* Subjects who are current non-smokers, who have not used any tobacco products in the 12 month period preceding the screening visit, and have a pack history of < or = 5 pack years.
* Able to satisfactorily use the dry powder inhaler.
Exclusion Criteria:
* As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age.
* The subject has a history of breathing problems in adult life (e.g. history of asthmatic symptomatology). Screening lung function tests (forced expiratory volume in 1 minute (FEV1)) will be performed to confirm normal lung function parameters (>or=85% predicted).
* Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit.
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
* A positive HIV antibody.
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
* History of heavy regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >21 units for males or >14 units for females.
* History or regular use of tobacco- or nicotine-containing products within 12 months prior to screening.
* Positive carbon monoxide or alcohol breath test at screening or on admission to the unit.
* A positive pre-study urine drug screen or when randomly tested during the study.
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
* The subject has taken systemic, oral or depot corticosteroids less than 12 weeks before the screening visit.
* The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
* History of sensitivity or adverse reaction to any of the study medications including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or an intranasal, inhaled or systemic corticosteroid; known suspected sensitivity to the constituents of the new powder inhaler (lactose or magnesium stearate) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates participation.
* History of severe milk protein allergy.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months of the start of the study.
* Pregnant females as determined by positive serum hCG test at screening or by positive serum/urine hCG test prior to dosing.
* Lactating females.
* Unwillingness or inability to follow the procedures outlined in the protocol.
* Subject is mentally or legally incapacitated.
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01213849
|
{
"brief_title": "Dose Proportionality Study: Blood Levels of Fluticasone Furoate (FF) and Vilanterol (VI) Following Different Doses of FF/VI Via an Inhaler",
"conditions": [
"Asthma"
],
"interventions": [
"Drug: Fluticasone furoate 100 mcg (4 inhalations)",
"Drug: Fluticasone furoate 200 mcg (4 inhalations)",
"Drug: Fluticasone furoate 50 mcg (4 inhalations)",
"Drug: Vilanterol 25 mcg (4 inhalations)"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT01213849",
"official_title": "An Open-label, Randomised, 3-way Crossover Single Dose Study to Demonstrate Dose Proportionality of Fluticasone Furoate (FF) and Equivalence of Vilanterol (VI) When Administered as FF/VI Inhalation Powder From the Novel Dry Powder Inhaler in Healthy Subjects.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-11-25",
"study_completion_date(actual)": "2010-11-25",
"study_start_date(actual)": "2010-10-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-06-14",
"last_updated_that_met_qc_criteria": "2010-10-01",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-10-04",
"first_submitted": "2010-10-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine if the administration of GSK958108 can delay ejaculation in patients with primary premature ejaculation as measured by the ejaculatory latency time (ELT) using the masturbation model and sexual visual stimulation, and to evaluate the safety and tolerability of GSK958108 in healthy men with PE
#Intervention
- DRUG : GSK958108
- Coated Tablets 1 mg
- DRUG : Placebo
- Coated tablets
|
#Eligibility Criteria:
Inclusion Criteria:
* Heterosexual male subject with self-reported moderate or severe primary Premature ejaculation with ejaculation occurring on or before penetration, or shortly there after with minimal stimulation
* Baseline Ejaculation Latency time < 3 minutes
* Subjects must agree to use a contraception methods as per protocol
* Body weight > or = 50 kg and Body Mass Index within the range 19.0 <= age <= 29.9 Kg/m2
* Subject with normal visual acuity (with appropriate correction if needed)
* Subject able to cooperate in all study procedure including the eye examination with use of mydriatics
Exclusion Criteria:
* Erectile dysfunction
* History of migraine
* Current clinically relevant abnormality
* History of psychiatric illness or suicidal attempts or behaviours
* History of any eye disorder or colour blind, excluding myopia and presbyopia
* Cardiac conduction disorder or other clinically significant cardiac disease
* Positive at pre-study drug/alcohol screen and to Hepatitis or HIV tests
* Regular consumption of alcohol
* History of sensitivity or intolerance to drugs
* Consumption of red wine, seville oranges, grapefruit or grapefruit juice [and/or pummelos, exotic citrus fruits, grapefruit hybrids] from 7 days prior to the first dose of study medication
* Subject has received or is continuing to receive any treatment for premature ejaculation in the four weeks prior to the study start
* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements prior to the first dose of study medication
* Participation in another clinical trial in the previous month
* Exposure to more than four new experimental drugs within the previous 12 months
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Unwillingness or inability to follow the procedures outlined in the protocol.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT00861484
|
{
"brief_title": "Proof of Mechanism in ELT",
"conditions": [
"Premature Ejaculation"
],
"interventions": [
"Drug: GSK958108",
"Drug: Placebo"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT00861484",
"official_title": "A Double Blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of a Single Oral Dose of GSK958108 on Ejaculatory Latency Time (ELT) in Male Patient Suffering From Premature Ejaculation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-12-11",
"study_completion_date(actual)": "2009-12-11",
"study_start_date(actual)": "2008-11-26"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-06-14",
"last_updated_that_met_qc_criteria": "2009-03-12",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-03-13",
"first_submitted": "2009-03-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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