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#Study Description
Brief Summary
The investigators hypothesize that many cancer patients desire discussions of cost as part of their care, but that preferences for having cost discussions with their physicians vary. Further, the investigators hypothesize that providers can introduce the topic of cost into clinical conversations in a balanced way and that this will improve shared decision making and patient uptake of offers of financial counseling which will lead to improved financial well-being, patient satisfaction with providers, and satisfaction with treatment decisions.
Aim 1: Further understand patient preferences and attendant associations for cost discussions through a patient survey of newly diagnosed breast cancer patients.
Aim 2: Study the influence of provider communication about cost on shared decision making, uptake of financial counseling, financial well-being and satisfaction through an intervention to encourage discussion of cost by breast cancer surgeons with subsequent referral to financial counseling.
Detailed Description
Newly diagnosed breast cancer patients over the age of 18 will be eligible for participation. All stages of disease will be included. Eligible participants will be approached in clinic. Those interested will provide written, informed consent at the time of their clinic visit. All participants will be asked to complete baseline surveys consisting of the InCharge Financial Distress/Financial Well Being scale (IFDFW),\[24\] the Maximizer-Minimizer Scale,\[25\] and a three question, 5-point Likert scale survey about desire for cost information (1: How concerned are participants about the cost of their cancer care? 2: How interested are participants in discussing cost of care with their doctors? 3: How interested are participants in meeting with a financial counselor about the costs of their care?) Demographic information including age, race and ethnicity, marital status, number of children, current employment status of self and spouse, and education level will be included. To decrease participant burden and encourage study participation, only the three question survey will be required to be completed prior to the visit. The other survey components (IFDFW and Max-Min Scale) can be completed after the visit, but prior to seeing a financial counselor. Participants will be offered a $10 giftcard of their choice (grocery store, Starbucks, Amazon, or gas) at each survey timepoint ($20 total) for participation.
For this study, the investigators will use a pre and post design with 100 total participants. All visits will be audiorecorded, transcribed, and coded for whether cost was discussed in the control group and whether the intervention was successfully implemented in the intervention group as well as shared decision making using the observer-OPTION scale. The first 50 patients will have usual care with providers conducting the visit in their typical manner.
From our past studies, study team discusses cost in 15% of visits, though these discussion tend to be very superficial. The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) The investigators will recommend treatments for the participants' cancer based on what the investigators think gives them the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for their doctors to know what their costs will be, but the investigators will do our best to give participants some general information. 4) The investigators have resources available to help participants get more specific information so that participants can plan appropriately. 5) Do participants have any specific concerns about cost that participants would like to share with me? The investigators will encourage study team to have this discussion at the beginning of the consult, but the exact timing will be according to study team judgment.
After the visit, all patients will complete a patient satisfaction survey and will be offered a referral to a financial counselor at our institution. Financial counseling will take place per our usual institutional protocols either in person or over the phone. Our financial counselors are aware that they may see an increased volume of patients during the study period and the investigators will provide funding to cover the increased need. Volume will be tracked during the study period and compared to the non-study period and between the groups.
At the first three to six-month follow-up visit with the surgeon, participants will again complete the IFDFW, a validated patient satisfaction scale\[26\], and the Satisfaction with Decision Scale.\[27\].
Data will have personal health identifiers removed from the data for the analysis portion of the study. PHI will not be reused without first seeking IRB approval.
The investigators will enroll 100 patients in two consecutive groups of 50. This gives us 80% power with a two sided significance level of 0.05 for seeing a 27-30% improvement (0.27-0.3 higher score) in our primary outcome of financial well-being as measured by the IFDFW in the intervention group at 3-6 months after the initial visit; the average pre-score on the IFDFW is 5.52 in past studies with improvements of 0.32-1.18 seen in past studies of education interventions to improve financial well-being.\[24\] This level of difference may not be achievable with this small study, but will provide data for powering a larger study.
Maximizer-Minimizer status, uptake of financial counseling, patient satisfaction, decision satisfaction, and demographic variables will be evaluated for associations with financial well-being using logistic regression methods.
#Intervention
- OTHER : Cost Discussion
- The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) We will recommend treatments for your cancer based on what we think gives you the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for your doctors to know what your costs will be, but we will do our best to give you some general information. 4) We have resources available to help you get more specific information so that you can plan appropriately. 5) Do you have any specific concerns about cost that you'd like to share with me?
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.
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
|
NCT03780491
|
{
"brief_title": "Understanding and Addressing Patient and Provider Preferences Around Discussions of Cost of Breast Cancer Care",
"conditions": [
"Breast Cancer"
],
"interventions": [
"Other: Cost Discussion"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03780491",
"official_title": "Understanding and Addressing Patient and Provider Preferences Around Discussions of Cost of Breast Cancer Care",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-11-16",
"study_completion_date(actual)": "2020-11-16",
"study_start_date(actual)": "2018-11-05"
},
"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)": "2020-11-20",
"last_updated_that_met_qc_criteria": "2018-12-17",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-12-19",
"first_submitted": "2018-12-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this prospective open labeled randomized study was to compare the 'laryngoscopic glottis view' as well as 'ease of intubation' between the two blades in routine intubations in non-difficult airways.
Detailed Description
One hundred and fifty patients with predicted non difficult airway were randomly assigned into two groups. After induction of anaesthesia laryngoscopy was performed with respective blades and trachea intubated. Parameters monitored were: glottis view obtained during laryngoscopy (Cormack Lehane grade), ease of intubation, intubation attempts, total duration of laryngoscopy in seconds and encountered complications.
#Intervention
- OTHER : Miller group
- Miller blade was used for laryngoscopy
- OTHER : Macintosh group
- Macintosh blade was used for laryngoscopy
|
#Eligibility Criteria:
Inclusion Criteria:
* All ASA I & II grade patients undergoing elective surgery requiring general anesthesia with oral endotracheal intubation
Exclusion Criteria:
* Patients with anticipated difficult airway
* Cervical spine disorders
* Anesthesia requiring rapid sequence induction
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
|
NCT02664532
|
{
"brief_title": "Miller Straight Blade vs Macintosh Blade",
"conditions": [
"Intubation; Difficult"
],
"interventions": [
"Other: Macintosh group",
"Other: Miller group"
],
"location_countries": null,
"nct_id": "NCT02664532",
"official_title": "Miller Straight Blade With Paraglossal Technique Compared to the Macintosh Blade in Respect to Visualization of Larynx and Ease of Intubation",
"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)": "2010-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-11",
"last_updated_that_met_qc_criteria": "2016-01-22",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-01-27",
"first_submitted": "2016-01-10",
"first_submitted_that_met_qc_criteria": "2016-02-12"
}
}
}
|
#Study Description
Brief Summary
Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). Around one-third of the patients, however, do not respond to conventional immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent renal failure. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cell, for example, tacrolimus, may be effective in the treatment of primary glomerulonephritis. The investigators plan to an open-label single-arm study the efficacy and safety of long-acting tacrolimus in the treatment of treatment-resistant lupus nephritis. Twenty-five patients with biopsy-proven lupus nephritis will be recruited. They will be treated with oral prednisolone and long-acting tacrolimus for 6 months, followed by 6 months of maintenance steroid and azathioprine. Proteinuria, renal function, clinical and serologic lupus activity will be monitored. This study will explore the potential role of long-acting tacrolimus in resistant lupus nephritis, which has a poor prognosis and no effective treatment at the moment.
#Intervention
- DRUG : Long-acting tacrolimus (Advagraf, Astellas Pharma)
- Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age over 18 with informed consent.
* Fulfill the revised American College of Rheumatology criteria for SLE
* Biopsy-proven class III, IV, or V lupus nephritis within the past 24 months.
* Could not achieve complete remission after at least 4 months of conventional therapy (oral steroid plus cyclosphosphamide or mycophenolate mofetil).
* NB. Complete response is defined as proteinuria less than 0.5 g/day, with normal urinary sediment, a normal serum albumin concentration, and serum creatinine <15% above the base-line value.
* Female patients of child-bearing age and male patients agree to maintain effective birth control practice during the study.
Exclusion Criteria:
* Abnormal liver function tests
* Hepatitis B surface antigen or hepatitis C antibody positive
* Diabetic
* Receiving NSAID or other agents known to influence urinary
* Protein excretion
* Allergic or intolerant to macrolide antibiotics or tacrolimus
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
|
NCT01206569
|
{
"brief_title": "Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis",
"conditions": [
"Lupus Nephritis"
],
"interventions": [
"Drug: Long-acting tacrolimus (Advagraf, Astellas Pharma)"
],
"location_countries": [
"Hong Kong"
],
"nct_id": "NCT01206569",
"official_title": "Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2012-02",
"study_start_date(actual)": "2010-09"
},
"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)": "2012-12-04",
"last_updated_that_met_qc_criteria": "2010-09-21",
"last_verified": "2012-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-09-22",
"first_submitted": "2010-09-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of multiple doses of COR-001 or placebo
#Intervention
- DRUG : COR-001
- OTHER : Placebo
|
#Eligibility Criteria:
INCLUSION CRITERIA
* Age greater than or equal to 18 years at the time of signing of the ICF.
* The patient agrees to comply with the contraception and reproduction restrictions of the study
* Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents (ESA) drugs continuously prescribed for a minimum of 8 weeks prior to Screening
* At least 2 ferritin values during Screening > 300 ng/mL
* At least 2 transferrin saturation (TSAT) values during Screening between 15% and 50% (inclusive)
EXCLUSION CRITERIA:
* Use of systemic immunosuppressive drugs during the Screening Period or anticipated use of such drugs any time during the study
* Clinical evidence or suspicion of active or smoldering infection by clinical or serologic criteria
* Actively treated or active malignancy
* Known or suspected occult or active bleeding
* Received a red blood cell or whole blood transfusion within 2 months prior to Screening or anticipated to receive a blood transfusion at any time during 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
|
NCT02868229
|
{
"brief_title": "Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001",
"conditions": [
"Anemia"
],
"interventions": [
"Other: Placebo",
"Drug: COR-001"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02868229",
"official_title": "A Phase 1/2 Randomized, Double-blind, Placebo Controlled, Cohort Dose-escalation Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-11",
"study_completion_date(actual)": "2018-12-11",
"study_start_date(actual)": "2016-09-12"
},
"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)": "2021-07-30",
"last_updated_that_met_qc_criteria": "2016-08-11",
"last_verified": "2021-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-08-16",
"first_submitted": "2016-08-09",
"first_submitted_that_met_qc_criteria": "2021-07-09"
}
}
}
|
#Study Description
Brief Summary
The study will assess a novel active drug vs. placebo on ability to reduce smoking and aid cessation during a one-week 'practice' quit period for each condition in smokers with a high interest in quitting (i.e. crossover design). Medication effects on reducing withdrawal and cognitive impairment will help assess the mechanism to support quit smoking attempts.
Detailed Description
We aim to test the proof of principal that an alpha-7 PAM drug, JNJ-39393406, promotes smoking cessation when compared to placebo. We have developed, tested, and validated an efficient Phase 2a screening procedure that optimally combines the validity of randomized clinical trials with the practicality of lab- based medication studies. Notably, it employs a within-subject, cross-over design comparing active versus placebo effects on quitting smoking to maximize statistical power without a large sample, in contrast to the large samples needed for between-groups randomized treatment conditions. Using this procedure, we will evaluate effects of JNJ-39393406 vs. placebo on short-term smoking abstinence in smokers who already have a high interest in quitting soon. We predict that, compared with placebo, JNJ-39393406 will increase days of abstinence, identifying initial evidence of efficacy for smoking cessation. Our main dependent measure is days of very stringent biochemically validated (expired CO\<5 ppm) 24-hr smoking abstinence, with post-quit withdrawal and cognitive function as secondary measures. Potential for adverse side-effects will be assessed at each visit.
#Intervention
- DRUG : Active JNJ Drug
- 200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
- Other Names :
- JNJ-39393406
- DRUG : Placebo pill
- Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
#Eligibility Criteria:
Inclusion Criteria:
Healthy male and female dependent smokers wanting to quit soon
*
Exclusion Criteria:
* Use of non-smoked nicotine products
* Already enrolled in cessation program.
* Recent alcohol or substance dependence (<= 3 months)
* Women who are pregnant, planning a pregnancy, or lactating; all female participants shall undergo a pregnancy test at screening and will be excluded if positive.
* Serious or unstable medical disorder within the past 3 months
* Epilepsy
* Current diagnosis (within last 6-months) of abnormal cardiac rhythms; unstable cardiovascular disease e.g. stroke, myocardial infarction in the last 6 months
* Evidence impaired liver function test (LFT)
* Evidence of kidney failure
* Any subject with a history of hematological cancers examples: leukemia, lymphoma etc.
* Any clinically significant hematological laboratory abnormality.
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
|
NCT02217527
|
{
"brief_title": "Test of Novel Drug for Smoking Cessation",
"conditions": [
"Smoking Cessation"
],
"interventions": [
"Drug: Placebo pill",
"Drug: Active JNJ Drug"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02217527",
"official_title": "Development of a Novel Therapeutic for Smoking Cessation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07",
"study_completion_date(actual)": "2018-01",
"study_start_date(actual)": "2014-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-08-15",
"last_updated_that_met_qc_criteria": "2014-08-14",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-08-15",
"first_submitted": "2014-07-24",
"first_submitted_that_met_qc_criteria": "2018-07-16"
}
}
}
|
#Study Description
Brief Summary
Multiple system atrophy (MSA) is a disorder of the nervous system of unclear cause. In MSA there is degeneration (progressive loss) of nerve cells in several brain and spinal cord regions. The result is a variety of symptoms, from physical (parkinsonism, ataxia, incoordination, falls, slowness) to autonomic (fainting, bladder incontinence, sexual dysfunction) to sleep problems (dream enactment, sleep apnea).
This research aims to help us better understand the patterns and timing of nerve degeneration relatively early in the disease, and how this affects symptoms and progression. For instance:
1. Does MSA affect certain nerves that stimulate heart pumping? If so, does the severity of loss of heart nerves affect disease progression and survival?
2. It is thought that MSA does not affect memory and thinking much, unlike other diseases (such as Parkinson's). Is this accurate? Is there loss of nerves that transmit acetylcholine (a neurochemical important in mental functioning)?
3. What can we learn about mood and sleep in MSA, through visualizing the serotonin system in the brain? How does this relate to symptoms that subjects report in these often underappreciated areas?
To answer these and other questions, investigators will take images of specific nerves in the brain and heart using Positron Emission Tomography (PET) scans. Such imaging gives us information that cannot be obtained from MRIs and CT scans. We will measure the levels of several nerve cell types: serotonin, acetylcholine, and norepinephrine. Subjects will also have many standardized assessments including quality-of-life and symptom assessments, neurological examination, autonomic assessments, neuropsychological assessments, coordination tests, and even assessments of vision and sense of smell. By pooling these results from many MSA patients, and comparing with other diseases (such as Parkinson's disease) we hope to gain a better understanding of what is happening early in MSA. Such knowledge could be very valuable in future efforts to develop better therapies in this rare disease.
Detailed Description
Positron Emission Tomography (PET) imaging involves injection of radioactive tracers (small amounts of biologically active molecules with radioactive atoms attached) and scanning the body to see where the tracers localize, and how intensely they 'stick' there.
The tracers are used in such small amounts that they do not affect brain or body functions. The amount of radioactivity used is also very small and disappears quickly. Overall radiation exposure for participants is low and well within accepted safety levels for the human body.
|
#Eligibility Criteria:
Inclusion Criteria:
Participants aged 30 <= age <= 80 years with a diagnosis of Possible or Probable MSA of the parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C)
Participants who are less than 4 years from the time of documented MSA diagnosis
Participants who are willing and able to give informed consent
'Normal' cognition as assessed by Mini Mental State Examination
Exclusion Criteria:
Pregnant or lactating females
Participants with a clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the study or might affect the results of the study. These include conditions causing significant CNS or autonomic dysfunction, including congestive heart failure, recent (<6 months) myocardial infarction, thrombocytopenia (<50 x 10(9)/L), immunosuppressed state, severe uncontrolled hypertension, severe cardiopulmonary disease, severe anemia (hemoglobin <8g/dl), severe liver or kidney disease (creatinine >2.3 mg/dl) uncontrolled diabetes mellitus (HbA1c >10g%), alcoholism, malignant neoplasms, amyloidosis, uncontrolled hypothyroidism, unstable peripheral neuropathies, concurrent infections, orthopedic problems that compromise mobility and activities of daily living, severe cerebrovascular accidents (causing symptoms such as hemiplegia, aphasia and non-dominant parietal lobe syndrome), and neurotoxins or neuroactive drug exposure, parkinsonism due to drugs (including neuroleptics, L-methyldopa, reserpine, metoclopramide).
Females who are pregnant
Subjects known to have porphyria
The regular use of neuroleptics within the six months prior to the initial evaluation. Occasional use of a neuroleptic as an anti-emetic in the past is allowed, providing not more than three doses were taken within the previous 12 months
Diseases more consistent with Lewy Body dementia, progressive supranuclear palsy, essential tremor, inherited cerebellar degeneration, or postencephalitic parkinsonism
Subjects receiving psychostimulants, antimuscarinics (trihexphenidyl, benztropine, and tricyclic antidepressants), acetylcholinesterase inhibitors, trazodone or modafinil will be excluded as they may interfere with study measures. Subjects with prior exposure to disallowed medications may be eligible if there has been an interval of > 2months for these medications, at the discretion of the investigators
Dementia (DSM-IV criteria - Amer. Psych. Association, 1994). The score on the Mini-Mental State Examination must be >24
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02035761
|
{
"brief_title": "PET Imaging Study of Neurochemical and Autonomic Disorders in Multiple System Atrophy (MSA)",
"conditions": [
"Multiple System Atrophy - Parkinsonian Subtype (MSA-P)",
"Multiple System Atrophy - Cerebellar Subtype (MSA-C)"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT02035761",
"official_title": "Pathogenesis and Diagnosis of Multiple System Atrophy (MSA): PET Study of Neurochemical and Autonomic Disorders in MSA",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-09",
"study_completion_date(actual)": "2018-09",
"study_start_date(actual)": "2011-07"
},
"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)": "2018-11-05",
"last_updated_that_met_qc_criteria": "2014-01-13",
"last_verified": "2018-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-14",
"first_submitted": "2014-01-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patellar crepitus is a complication of total knee arthroplasty (TKA).The development of patellar crepitus after TKA are related to many factors such as femoral component design, surgical errors, and postoperative patellar baja. However, it is unclear whether patella resurfacing or patella non-resurfacing are associate with patellar crepitus. The primary objective of this study are to compare the prevalence of patellar crepitus and the mean value of vibroacoustic signal between patellar-resurfacing and patellar non-resurfacing in TKA. The secondary objective is to study the association between patellar crepitus and vibroacoustic signal.
#Intervention
- PROCEDURE : patellar resurfacing
- patellar component insert with cement
|
#Eligibility Criteria:
Inclusion Criteria:
* primary osteoarthritis of knee
Exclusion Criteria:
* rheumatoid arthritis
* morbid obesity
* severe patellofemoral joint destruction
* patella maltracking
* patellofemoral incongruent
* inflammatory arthritis
* refuse to participation
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02997579
|
{
"brief_title": "Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients",
"conditions": [
"Patellar Crepitus",
"Vibroacoustic Signal"
],
"interventions": [
"Procedure: patellar resurfacing"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT02997579",
"official_title": "Prospective Randomized Controlled Trial: Comparison of Vibration Arthrometry Between Patella Resurfacing and Patella Non-resurfacing in Total Knee Replacement Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-15",
"study_completion_date(actual)": "2019-01",
"study_start_date(actual)": "2016-12-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-01-07",
"last_updated_that_met_qc_criteria": "2016-12-19",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-12-20",
"first_submitted": "2016-12-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The researchers hypothesized that the aid of the resuscitator by the technique Air Stacking increase lung volume, promoting increased lung compliance and improvement of the ventilatory pattern. In addition, Air Stacking does not depend on patient collaboration. The objective of this study was to compare the effects of breath stacking and air stacking techniques on respiratory mechanics and ventilatory pattern in patients admitted to the ICU
#Intervention
- PROCEDURE : Breath Stacking
- Patients were connected to a unidirectional valve coupled to artificial airway (tracheostomy), with bacteriological filter. The ventilator was coupled to the unidirectional valve to measure inspiratory volume mobilized in each cycle and a connection to adapt a manometer. The patient performed successive inspirations for a maximum period of 30 seconds or until unidirectional valve opening or volume increase was observed for 2 consecutive efforts. Ten cycles of the technique were performed, with an interval of 30 seconds.
- PROCEDURE : Air Stacking
- The same system of monitoring and adaptation of the ventilometer and manometer was carried out. A manual resuscitator coupled to a unidirectional valve was used, both connected to the tracheostomy, with a filter interface. Slow and successive inspirations were performed through slow compression of the resuscitator until the maximum inspiratory pressure reached 40 cmH2O. Ten cycles of the technique were performed, with an interval of 30 seconds.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients without mechanical ventilation for more than 72 hours
* Mucus hypersecretion (defined as the need for suctioning < 2-h intervals)
Exclusion Criteria:
* bronchospasm.
* Pleural effusion or pneumothorax undrained.
* Bronchopleural or tracheoesophageal fistula.
* Neuromuscular disease.
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
|
NCT04012489
|
{
"brief_title": "Breath and Air Stacking on Respiratory Mechanics in Tracheostomized Patients",
"conditions": [
"Mechanical Ventilation",
"Lung Infection"
],
"interventions": [
"Procedure: Breath Stacking",
"Procedure: Air Stacking"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT04012489",
"official_title": "Comparison Between Breath Stacking and Air Stacking on Respiratory Mechanics and Ventilatory Pattern in Tracheostomized Patients: Randomized Crossover Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-18",
"study_completion_date(actual)": "2019-05-14",
"study_start_date(actual)": "2018-02-25"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-07-09",
"last_updated_that_met_qc_criteria": "2019-07-04",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-09",
"first_submitted": "2019-07-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Letrozole is a chemical compound, CGS 20267 which is a third-generation, nonsteroidal aromatase inhibitor.
Letrozole blocks estrogen synthesis by directly affecting the hypothalamic-pituitary-ovarian axis, subsequently, increases gonadotropins which increase pregnancy rates. Possible positive outcomes of aromatase inhibitors over selective estrogen-receptor modulators include a more physiologic hormonal stimulation of the endometrium which increases receptivity, a lower multiple-pregnancy through single follicle growth, a lesser side-effect especially vasomotor and mood symptoms, and more prompt clearance from blood, hence, reducing the probabilities of periconceptional exposure
Detailed Description
The first pilot study for the clinical use of letrozole for ovarian induction in polycystic ovary syndrome (PCOS) patients was done in 2000.
In large randomized study, letrozole was superior to clomiphene as a treatment for anovulatory infertility in women with the polycystic ovary syndrome. Letrozole was also associated with higher live-birth and ovulation rates.
Ovulation induction with letrozole is associated with an ovulation rate of 70%-84% and a pregnancy rate of 20%-27% per cycle.
While in another study which Compare the Effect of Letrozole Alone with Letrozole Plus N-Acetylcysteine on Pregnancy Rate in Patients with Polycystic Ovarian Syndrome, the pregnancy rate was 7.5% in letrozole alone group .
Human chorionic gonadotropin (HCG) hormone will replace the naturally surging luteinizing hormone at mid-cycle, subsequently, will lead to full maturation of oocytes resulting in ovulation. Additionally, HCG will also enhance the endometrial quality by stimulating the corpus luteum. HCG is a hormone that is produced mainly by the placental syncytiotrophoblasts cells, it is also produced by other organs in minute amounts (Liver, colon and pituitary gland). HCG main function is maintaining pregnancy through stimulating the corpus luteum to produce progesterone.
This hormone is the cornerstone drug for inducing final maturation of follicles during a diversity of infertility treatment protocols.
In order to diagnose Polycystic ovarian syndrome two out of three Rotterdam criteria should be present. These criteria are: chronic anovulation, clinical and/or biochemical evidence of hyperandrogenism, and polycystic ovaries by ultrasound .
incidence of PCOS from 6% to 21% when the ESHRE/ASRM 2003 criteria were applied. Infertility (clinical definition) is currently defined as 1 year of unwanted non-conception with unprotected intercourse in the fertile phase of the menstrual cycles
#Intervention
- DRUG : Letrozole tablets
- To determine if the usage of All interventions are effective for simple induction of ovulation in polycystic ovarian syndrome in infertile couples.
- Other Names :
- HCG
|
#Eligibility Criteria:
Inclusion Criteria:
* Infertile women with PCOS
* Normal hysterosalpingography
* Normal semen analysis according to WHO parameters are major prerequisites
Exclusion Criteria:
* Infertile women with causes other than PCOS,
* Ages <18 or >35 years
* women taken confounding medications like other infertility drugs
* Insulin sensitizers or hormones
* Abnormal hysterosalpingography
* Subnormal semen analysis
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT06367712
|
{
"brief_title": "Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol",
"conditions": [
"PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries"
],
"interventions": [
"Drug: Letrozole tablets"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT06367712",
"official_title": "The Effect of Using Letrozole Alone Protocol Versus Using Letrozole and HCG Protocol on Induction of Ovulation in Polycystic Ovarian Syndrome Patients: A Prospective Cohort Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-11-01",
"study_completion_date(actual)": "2023-11-10",
"study_start_date(actual)": "2022-11-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-16",
"last_updated_that_met_qc_criteria": "2024-04-11",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-04-16",
"first_submitted": "2024-04-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to provide researchers with information that will help them prepare for a future study to test the efficacy of two anti-HIV vaginal gels. This study will also estimate how likely people living in certain areas are to become infected with HIV and other infections passed during sex.
Detailed Description
This study is designed to prepare for the implementation of a second study, HPTN 035: A Phase II/III Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and PRO 2000/5 Gel (P) for the Prevention of HIV Infection in Women. HPTN 035 requires an average HIV seroincidence rate of 5-6 percent among enrolled participants. The primary objective of the present study is to estimate the rates of HIV seroincidence among women targeted for inclusion in HPTN 035.
Women will be enrolled in this study for 6 to 12 months. Study visits will take place monthly. At each visit, participants will complete a medical/menstrual history and undergo pregnancy testing. Each quarter, participants will undergo a structured interview about sexual practices and will receive HIV and STD tests, education, and counseling. Participants will also undergo a pelvic exam with wet mount testing for bacterial vaginosis, candidiasis, and trichomoniasis. Colposcopic evaluations will be performed at selected sites. Pap smears will be performed at sites with the capacity and expertise to prepare and interpret the smears and provide appropriate follow-up care to participants with abnormal results.
|
#Eligibility Criteria:
Inclusion criteria:
* Sexually active (defined as having had vaginal intercourse at least once in the 3 months prior to screening).
* HIV-uninfected at screening.
* Able and willing to provide adequate locator information for study retention purposes.
Exclusion criteria:
* History of adverse reaction to latex.
* Non-therapeutic injection drug use in the 12 months prior to screening.
* Vaginal intercourse more than an average of 2 times per day in the 2 weeks prior to screening.
* Plans to travel away from the study site for more than 3 consecutive months in the next 12 months.
* Plans to relocate away from the study site in the next 12 months.
* Pregnancy or plans to become pregnant in the next 12 months.
* Pregnancy within 42 days prior to enrollment.
* Enrollment in any other study of a vaginally-applied product.
* Clinically apparent pelvic exam finding involving deep epithelial disruption.
* Diagnosis with a current STD and/or other reproductive tract infection requiring treatment.
* Conditions that would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00048282
|
{
"brief_title": "HIV Prevention Preparedness Study",
"conditions": [
"HIV Infections",
"HIV Seronegativity"
],
"interventions": null,
"location_countries": [
"Zambia",
"Tanzania",
"South Africa"
],
"nct_id": "NCT00048282",
"official_title": "HIV Prevention Preparedness Study",
"recruitment_information": null,
"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)": "2010-05-14",
"last_updated_that_met_qc_criteria": "2002-10-29",
"last_verified": "2006-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2002-10-30",
"first_submitted": "2002-10-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Today, the most commonly used position is the seated position with 45° of shoulder abduction (Abd) in the scapular plane, known as the most functional isokinetic assessment of shoulder-rotator strength (1). However, considering the architectural feature of the rotator muscles, a position where the maximum sarcomere length is obtained, in which the maximum muscle strength is produced, has not been investigated. Ward et al. showed that the shoulder position, in which the sarcomere length of the muscles was between 2.0 - 2.6 µm, was 25⁰ Abd and 20⁰ external rotation (ER) as a result of their study on the rotator cuff muscles architecture (2). The test position selected in isokinetic measurements is the main factor for outcome measurements and the repeatability of the measurements directly depends on the selected position (3). This study was planned to investigate the effects of the position where the shoulder is at 25⁰ Abd and 20⁰ ER to develop the most suitable isokinetic strength evaluation position based on muscle architecture for shoulder rotator muscles.Using IsoMed 2000 device (D. \& R. Ferstl GmbH, Hemau, Germany) we conducted the isokinetic test of concentric (CON) and eccentric (ECC) shoulder internal (IR) and external (ER) strength at the angular velocity of 60˚/s in both Method I (scapular position) and Method II (25⁰ Abd and 20⁰ ER). There were seven days between the testing sessions, and both tests were conducted at the same time of day. The same examiner with experience in performing isokinetic testing with IsoMed 2000 tested all subjects in both testing sessions
#Intervention
- DEVICE : Isokinetic test
- Using IsoMed 2000 device (D. \& R. Ferstl GmbH, Hemau, Germany) we conducted the isokinetic test of concentric (CON) and eccentric (ECC) shoulder internal (IR) and external (ER) strength at the angular velocity of 60˚/s in both Method I (scapular position) and Method II (25⁰ Abd and 20⁰ ER). There were seven days between the testing sessions, and both tests were conducted at the same time of day. The same examiner with experience in performing isokinetic testing with IsoMed 2000 tested all subjects in both testing sessions.
|
#Eligibility Criteria:
Inclusion Criteria:
* Being between the ages of 18 <= age <= 25
* Body mass index (BMI) being between 18.5 <= age <= 24.9 kg / m 2
* Volunteering to participate in the study
* Having the skills to do the tests and exercises to be applied
Exclusion Criteria:
* Having a history of upper extremity injury within the past year
* Having a sensory problem that prevents participation in the study
* Have any musculoskeletal, neurological, respiratory, or cardiovascular risk factors that limit exercise
* Having a history of malignant disease
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04755257
|
{
"brief_title": "Development of the Muscle Architecture Based Isokinetic Strength Assessment Position for Shoulder Rotator Muscles",
"conditions": [
"Muscle Architecture",
"Shoulder",
"Isokinetic",
"Rotator Muscle"
],
"interventions": null,
"location_countries": [
"Turkey"
],
"nct_id": "NCT04755257",
"official_title": "Development of the Muscle Architecture Based Isokinetic Strength Assessment Position for Shoulder Rotator Muscles",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-15",
"study_completion_date(actual)": "2020-05-15",
"study_start_date(actual)": "2019-11-15"
},
"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)": "2021-02-16",
"last_updated_that_met_qc_criteria": "2021-02-11",
"last_verified": "2021-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-16",
"first_submitted": "2021-02-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323 in a relevant population. The data from this study will be used along with other data to aid in choosing the most appropriate dose for the later phase study.
Detailed Description
A randomized, double blind, double dummy, parallel group, placebo controlled study to evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of SB424323 (250 mg, 375 mg and 500 mg) administered twice daily for 16 weeks, on top of aspirin (325 mg, qd) in men and women with non valvular atrial fibrillation at a low or intermediate risk for stroke
#Intervention
- DRUG : SB424323
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with non valvular atrial fibrillation and any of the following:
* <= 60 years with no heart disease.
* 60 years with heart disease but no risk factors.
* >=60 years and <=75 years with no risk factors and no heart disease.
* Must be able to take aspirin.
Exclusion Criteria:
* Previous heart attack or stroke.
* History of high blood pressure, diabetes or a prior blood clot.
* Liver or kidney disease.
* Need for anti-thrombotic or anti-platelet drugs.
* Need for cardiovascular medicines.
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
|
NCT00240643
|
{
"brief_title": "Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke",
"conditions": [
"Fibrillation, Atrial",
"Atrial Fibrillation"
],
"interventions": null,
"location_countries": [
"Netherlands",
"United States",
"Germany",
"Romania",
"Estonia",
"United Kingdom",
"France",
"Sweden",
"Taiwan",
"Thailand",
"Hungary",
"Argentina",
"Italy",
"Denmark",
"Mexico",
"New Zealand",
"Norway",
"Brazil",
"Latvia",
"Korea, Republic of",
"India",
"Canada",
"Spain",
"Belgium",
"Greece"
],
"nct_id": "NCT00240643",
"official_title": "A Randomized, Double Blind, Double Dummy, Parallel Group, Placebo Controlled Study to Evaluate the Pharmacodynamic and Pharmacokinetic Response and Safety and Tolerability of SB424323 (250mg, 375mg and 500 mg) Administered Twice Daily for 16 Weeks, on Top of Asprin (325mg, qd) in Men and Women With Non Valvular Atrial Fibrillation at a Low or Intermediate Risk for Stroke",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-12",
"study_completion_date(actual)": "2006-12",
"study_start_date(actual)": "2005-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-01-16",
"last_updated_that_met_qc_criteria": "2005-10-14",
"last_verified": "2017-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-10-18",
"first_submitted": "2005-10-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Antiretroviral therapy (ART) can reduce HIV to very low levels in the blood, but it cannot cure HIV infection because a small amount of virus remains in cells as a hidden (latent) form. The purpose of this study was to evaluate the safety and efficacy of single dose and multiple dose administration of romidepsin (RMD) in HIV-infected adults.
Detailed Description
A major challenge in eradicating HIV-1 infection is the persistence of virus in long-lived cells, such as latently infected memory CD4 T cells. One approach for eliminating the HIV-1 reservoir is to activate viral replication in these latently infected CD4 T cells by targeting cellular mechanisms that repress proviral transcription. Histone deacetylase inhibitors (HDACis), such as RMD, induce HIV-1 expression by increasing acetylation and facilitating transcriptional activation of HIV-1. RMD administered in combination with ART may serve as an important component of a strategy to eradicate the HIV-1 latent reservoir. The purpose of this study was to evaluate the safety and efficacy of single dose and multiple dose administration of RMD in HIV-infected adults.
Participants were sequentially enrolled into four cohorts and randomly assigned to receive either RMD or placebo. The cohorts differed in the dose of RMD given. Participants in Cohorts 1, 2, and 3 had one intravenous (IV) infusion of RMD or placebo at Day 0. Participants in Cohort 4 had four IV infusions of RMD or placebo at Days 0, 14, 28, and 42.
For participants in Cohorts 1, 2, and 3, study duration was 4 weeks. For participants in Cohort 4, study duration was a minimum of 24 weeks and a maximum of 48 weeks.
Participants attended several study visits, which could include a physical examination, blood and urine collection, pharmacokinetic (PK) sampling, and an electrocardiogram (ECG).
#Intervention
- DRUG : Romidepsin
- RMD administered over 4 hours via an intravenous (IV) catheter.
- Other Names :
- RMD, Istodax
- DRUG : Placebo for Romidepsin
- Placebo for RMD administered over 4 hours via an IV catheter.
- Other Names :
- 0.9% NaCl, 0.9% sodium chloride
|
#Eligibility Criteria:
Inclusion Criteria: Cohorts 1, 2, & 3
* HIV-1 infection, documented by any licensed rapid HIV test or HIV E/CIA test kit at any time prior to study entry & confirmed by a licensed Western blot or a 2nd antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA
* Receiving 2 (or more) nucleoside or nucleotide reverse transcriptase inhibitors with raltegravir, dolutegravir, or efavirenz for at least 90 days prior to study entry with no intention to change for the duration of the study
* Documentation of at least 2 historical HIV-1 RNA measurements <50 copies/mL while on ART obtained by standard ultrasensitive assay. Documentation of the 1st measurement must be from a result obtained between 365 <= age <= 91 days, inclusive, prior to study entry. Documentation of the 2nd measurement must be from a result obtained between 730 <= age <= 366 days, inclusive, prior to study entry. In addition, there must be no HIV-1 RNA values >=50 copies/mL for at least 365 days prior to study entry.
* CD4 cell count >=300 cells/mm^3 obtained within 90 <= age <= 50 days prior to study entry at any US laboratory that has a CLIA certification or equivalent
* HIV-1 RNA level of <50 copies/mL obtained by standard ultrasensitive assay within 90 <= age <= 50 days prior to study entry
* HIV-1 RNA level of >=0.4 copies/mL obtained by SCA within 90 <= age <= 50 days prior to study entry. This result must be available prior to the pre-entry visit
* The following laboratory values obtained within 21 <= age <= 0 days prior to study entry by any laboratory that has a CLIA certification or equivalent
* ANC >=1500 cells/mm^3
* Hemoglobin >=12.0 g/dL for men & >11.0 g/dL for women
* Platelet count >=120,000/mm^3
* The following laboratory values obtained within 21 <= age <= 7 days prior to study entry by any laboratory that has a CLIA certification or equivalent
* CrCl >=60 mL/min
* Potassium & magnesium within normal limits
* AST (SGOT) <2.0 x ULN
* ALT (SGPT) <2.0 x ULN
* Alkaline phosphatase <2.0 x ULN
* Total bilirubin <2.5 x ULN
* HCV antibody negative result within 90 <= age <= 50 days prior to study entry or, for study candidates who are HCV antibody positive (based on testing performed at any time prior to study entry), a negative HCV RNA result obtained within 90 <= age <= 50 days prior to study entry
* Negative HBsAg result obtained within 90 <= age <= 50 days prior to study entry or a positive HBsAb result at any time prior to study entry
* For females of reproductive potential, negative serum or urine pregnancy test (latter with sensitivity of <=25 mIU/mL) at the screening visit, pre-entry visit within 21 <= age <= 7 days prior to study entry, & at entry prior to romidepsin infusion, by any US laboratory that has a CLIA certification or equivalent
* Female candidates of reproductive potential must refrain from participating in active attempts to become pregnant, &, if participating in sexual activity that could lead to pregnancy, must agree to use at least 2 reliable forms of contraception that are non-estrogen based. All female participants of reproductive potential must be instructed to use contraceptives for 6 months/180 days after completing RMD or placebo infusion
* Karnofsky performance score >=80 within 21 <= age <= 7 days prior to study entry
* Men and women age >= 18 years
* Ability & willingness to provide written informed consent
* Investigator anticipates that a fully active alternative ART regimen could be constructed in the event of virologic failure on the current ART regimen
Exclusion Criteria: Cohorts 1, 2, & 3
* History of or current malignancy requiring cytotoxic therapy
* Bacterial, fungal, or viral infection (other than HIV) requiring systemic therapy within 30 days prior to entry
* History of or current CMV end organ disease (eg, retinitis)
* History of or current AIDS-related syndromes or symptoms that pose a perceived excessive risk for study drug-related morbidity, as determined by the investigator
* Chronic, acute, or recurrent infections that are current & serious in the opinion of the investigator & for which the participant has not completed at least 14 consecutive days of therapy within 30 days prior to study entry and/or is not clinically stable
* Active autoimmune disorders including but not limited to: inflammatory bowel diseases, scleroderma, severe psoriasis as determined by the investigator, systemic lupus erythematosus, rheumatoid arthritis & optic neuritis
* History of seizure disorders
* History of anticonvulsant use within 60 days prior to study entry
* History of MI within 6 months prior to study entry, history of QTc prolongation (defined as ECG with QTc intervals >450 ms) at any time prior to study entry, NYHA class III or IV heart failure at any time prior to study entry, or family history of prolonged QTc syndrome
* Breastfeeding
* Use of immunomodulators (eg, interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry
* Any vaccination within 30 days prior to entry or intent to receive an elective vaccination (eg, flu shot, hepatitis A or B vaccine) during the course of the study
* Intent to use cytokines (e.g., IL-2 or IL-12) during the course of the study. Prior administration of cytokines is not an exclusion criterion; however, at least 60 days between the most recent cycle of any cytokine and study entry is required
* Within 60 days prior to study entry, use of systemic azole antifungals (voriconazole, itraconazole, ketoconazole); dexamethasone; macrolide antibiotics (azithromycin, clarithromycin, erythromycin); ARVs that are inhibitors of, or are metabolized by, CYP3A4 (atazanavir, ritonavir, nelfinavir, indinavir, saquinavir, darunavir, lopinavir, rilpivirine, maraviroc); cobicistat; warfarin; nefazodone; rifamycins (rifabutin, rifampin, rifapentine); St. John's Wort; carbamazepine; phenytoin; phenobarbital; amiodarone; dofetilide; pimozide; procainamide; quinidine; sotalol; & birth control products containing estrogen; drugs that are p-glycoprotein inhibitors; & drugs that prolong the QTc interval with a risk of Torsades de Pointes
* Known allergy, sensitivity, or any hypersensitivity to components of RMD or its formulation
* Use of histone deacetylase inhibitors (eg, vorinostat, valproic acid) at any time prior to study entry
* Active illicit drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
* Acute or serious illness requiring systemic treatment and/or hospitalization that is not resolved within 30 days prior to entry
* Psychosocial conditions that would prevent study compliance and follow-up, as determined by the investigator
* Documented opportunistic infections within 60 days prior to entry
Inclusion Criteria: Cohort 4, Step 1
* HIV-1 infection, documented by any licensed rapid HIV test or HIV E/CIA test kit at any time prior to study entry & confirmed by a licensed Western blot or a 2nd antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA
* Receiving 2 or more nucleoside or nucleotide reverse transcriptase inhibitors with raltegravir or dolutegravir for at least 90 days prior to study entry with no intention to change for the duration of the study
* Documentation of at least 2 historical HIV-1 RNA measurements <50 copies/mL while on ART obtained by standard ultrasensitive assay. Documentation of the first measurement must be from a result obtained between 365 <= age <= 61 days, inclusive, prior to study entry. Documentation of the second measurement must be from a result obtained between 730 <= age <= 366 days, inclusive, prior to study entry. In addition, there must be no HIV-1 RNA values >=50 copies/mL for at least 365 days prior to study entry
* CD4 cell count >=300 cells/mm^3 obtained between 36 <= age <= 60 days prior to study entry (screening visit) at any US laboratory that has a CLIA certification or equivalent
* HIV-1 RNA level of <50 copies/mL obtained by standard ultrasensitive assay at screening (between 36 <= age <= 60 days prior to study entry)
* The following laboratory values obtained at pre-entry (between 3 <= age <= 14 days prior to study entry) by any laboratory that has a CLIA certification or equivalent
* ANC >=1500 cells/mm^3
* Hemoglobin >=12.0 g/dL for men & >11.0 g/dL for women
* Platelet count >=120,000/mm^3
* CrCl >=60 mL/min
* Potassium & magnesium within normal limits
* AST (SGOT) <2.0 x ULN
* ALT (SGPT) <2.0 x ULN
* Alkaline phosphatase <2.0 x ULN
* Total bilirubin <2.5 x ULN
* HCV antibody negative result at screening (between 36 <= age <= 60 days prior to study entry) or, for study candidates who are HCV antibody positive (based on testing performed at any time prior to study entry), a negative HCV RNA result obtained at screening
* Negative HBsAg result obtained at screening (between 36 <= age <= 60 days prior to study entry) or a positive HBsAb result at any time prior to study entry
* For females of reproductive potential, negative urine pregnancy test (with a sensitivity of <=25 mIU/mL) at screening (between 36 <= age <= 60 days prior to study entry), at pre-entry (between 3 <= age <= 14 days prior to study entry), & at entry prior to infusion, by any US laboratory that has a CLIA certification or equivalent
* Female candidates of reproductive potential must refrain from participating in active attempts to become pregnant, &, if participating in sexual activity that could lead to pregnancy, must agree to use at least 2 reliable forms of contraception that are non-estrogen based. All participants of reproductive potential will be instructed to use contraceptives for 6 months or 180 days after completing RMD/placebo infusion
* Karnofsky performance score >=80 at pre-entry (between 3 <= age <= 14 days prior to study entry)
* Men and women age >= 18 years
* Ability & willingness to provide written informed consent
* Investigator anticipates that a fully active alternative ART regimen could be constructed in the event of virologic failure on the current ART regimen
Exclusion Criteria: Cohort 4, Step 1
* History of or current malignancy requiring cytotoxic therapy
* Bacterial, fungal or viral infection (other than HIV) requiring systemic therapy within 30 days prior to entry
* History of or current CMV end organ disease (eg, retinitis)
* History of or current AIDS-related syndromes or symptoms that pose a perceived excessive risk for study drug-related morbidity, as determined by the investigator
* Chronic, acute, or recurrent infections that are current & serious, in the opinion of the investigator, for which the participant has not completed at least 14 consecutive days of therapy within 30 days prior to study entry and/or is not clinically stable
* Active autoimmune disorders including but not limited to inflammatory bowel diseases, scleroderma, severe psoriasis as determined by the investigator, systemic lupus erythematosus, rheumatoid arthritis, & optic neuritis
* History of seizure disorders
* History of anticonvulsant use within 60 days prior to study entry
* History of MI within 6 months prior to study entry, history of QTc prolongation (defined as ECG with QTc intervals >450 ms) at any time prior to study entry, NYHA class III or IV heart failure at any time prior to study entry, or family history of prolonged QTc syndrome
* Breastfeeding
* Use of immunomodulators (eg, interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry
* Any vaccination within 30 days prior to entry or intent to receive an elective vaccination (eg, flu shot, hepatitis A or B vaccine) during the course of the study
* Intent to use cytokines (eg, IL-2 or IL-12) during the course of the study
* Within 60 days prior to study entry, use of systemic azole antifungals (voriconazole, itraconazole, ketoconazole), dexamethasone, macrolide antibiotics (azithromycin, clarithromycin, erythromycin), antiretrovirals that are inhibitors of, or are metabolized by CYP3A4 (atazanavir, ritonavir, nelfinavir, indinavir, saquinavir, darunavir, lopinavir, rilpivirine, maraviroc), cobicistat, warfarin, nefazodone, rifamycins (rifabutin, rifampin, rifapentine), St. John's Wort, carbamazepine, phenytoin, phenobarbital, amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, & birth control products containing estrogen, drugs that are p-glycoprotein inhibitors, & drugs that prolong the QTc interval with a risk of Torsades de Pointes
* Known allergy/sensitivity or any hypersensitivity to components of RMD or its formulation
* Use of histone deacetylase inhibitors (eg, vorinostat, valproic acid) at any time prior to study entry
* Active illicit drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
* Acute or serious illness requiring systemic treatment and/or hospitalization that is not resolved within 30 days prior to entry
* Psychosocial conditions that would prevent study compliance & follow-up as determined by the investigator
* Documented opportunistic infections within 60 days prior to entry
* Use of any of the medications listed in the Prohibited Medications table in the protocol
See the protocol for Inclusion and Exclusion Criteria for Cohort 4, Steps 2, 3, and 4.
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
|
NCT01933594
|
{
"brief_title": "Evaluating the Safety and Efficacy of Romidepsin in Combination With Antiretroviral Therapy in HIV-Infected Adults With Suppressed Viral Load",
"conditions": [
"HIV Infections"
],
"interventions": [
"Drug: Placebo for Romidepsin",
"Drug: Romidepsin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01933594",
"official_title": "A Phase I/II Study of Romidepsin in HIV-Infected Adults With Suppressed Viremia on Antiretroviral Therapy to Assess Safety, Tolerability, and Activation of HIV-1 Expression",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-16",
"study_completion_date(actual)": "2018-04-16",
"study_start_date(actual)": "2014-05-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-01",
"last_updated_that_met_qc_criteria": "2013-08-28",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-09-02",
"first_submitted": "2013-08-28",
"first_submitted_that_met_qc_criteria": "2019-05-01"
}
}
}
|
#Study Description
Brief Summary
DS-6051b is an orally administered inhibitor of the tyrosine kinases (ROS1) and neurotropic tyrosine kinase receptors (NTRK). This phase 1 first-in-human study evaluates safety and tolerability of DS-6051b in cancer subjects and identify a recommended phase 2 dose (RP2D). In addition, this study will also assess the pharmacokinetic (PK)/pharmacodynamic (PD) profiles and preliminary efficacy of DS-6051b.
Detailed Description
The Dose Escalation part (Part 1) of this study will evaluate safety and tolerability, and determine the tentative RP2D. Plasma exposure of DS-6051a and the exposure - QT interval prolongation relationship will also be assessed. Approximately 30 subjects with advanced solid tumors harboring ROS1 or NTRK1, NTRK2, or NTRK3 rearrangement, neuroendocrine carcinoma, or with advanced solid tumors and tumor-induced pain will be enrolled.
The Food Effect (FE) part of this study is to determine the effect of food on the PK of DS-6051a following administration of a single oral dose of DS-6051b. The safety and tolerability of DS-6051b administered with or without food will also be assessed.
After the safety profile of DS-6051b is adequately evaluated, the Dose Expansion part (Part 2) will be initiated to further assess the safety and tolerability, and preliminarily evaluate the efficacy of DS-6051b at the tentative RP2D. Approximately 40 cancer subjects carrying a ROS1 or NTRK1, NTRK2, or NTRK3 rearrangement will be enrolled.
#Intervention
- DRUG : DS6051b
- DS-6051b 50 mg and 200 mg capsules for oral administration
- Other Names :
- Investigational product, DS-6051a (a free base of 6051b)
|
#Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of advanced solid tumors that have relapsed from or are refractory to standard treatment or for which no standard treatment is available
* Part 1 Dose Escalation subjects must meet 1 of the following criteria:
* Solid tumors with documented ROS1, NTRK1, NTRK2, or NTRK3 rearrangement
* Neuroendocrine tumors
* Solid tumors with tumor-induced pain
* Part 2 Dose Expansion subjects must meet 1 of the following criteria:
* NSCLC with documented ROS1, NTRK1, NTRK2, or NTRK3 rearrangement
* k-RAS wild-type CRC with documented NTRK1, NTRK2, or NTRK3 rearrangement
* Other solid tumors with documented ROS1, NTRK1, NTRK2, or NTRK3 rearrangement
* Pulmonary LCNEC;
* Male or female >=18 years
* Eastern Cooperative Oncology Group performance status 0 to 1
* Adequate organ function
* Adequate blood clotting function
* Women of childbearing potential must have a negative pregnancy test
* Willingness to provide archival tumor samples
* Other inclusion criteria may apply
Exclusion Criteria:
* Hematological malignancies
* Known positive HIV infection, or active hepatitis B or C infection
* Comorbidity that would interfere with therapy
* Receipt of an allogeneic bone marrow or allogeneic stem cell transplant
* Concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor
* History of myocardial infarction and unstable angina within 6 months before study drug treatment; symptomatic congestive heart failure (Congestive Heart Failure New York Heart Association Class III or IV); congenital long QT syndrome; or ventricular arrhythmias defined as grade >=2 according to NCI CTCAE, v4
* Clinically active primary central nervous system tumors or brain metastases with the exception of subjects with glioblastoma multiform that carry ROS1 rearrangement
* Unresolved toxicities from previous anticancer therapy
* Systemic treatment with anticancer therapy within 3 weeks before study drug treatment
* Therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment or palliative radiation therapy within 2 weeks before study drug treatment
* Participation in a therapeutic clinical study within 3 weeks for biological treatments, and within 2 weeks or 5 half-lives, whichever is longer, for small molecule agents, before study drug treatment
* Concomitant treatment with strong inhibitors or inducers of CYP3A4 and P-glycoprotein
* Clinically significant malabsorption syndrome or other gastrointestinal disease that would impact drug absorption
* QTcF values higher than 450 ms at screening
* Breastfeeding
* Other exclusion criteria may apply
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
|
NCT02279433
|
{
"brief_title": "A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b",
"conditions": [
"Solid Tumors"
],
"interventions": [
"Drug: DS6051b"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02279433",
"official_title": "A Phase 1/1B Multi-Center, Non Randomized, Open-Label, Multiple Dose First-In-Human Study Of DS-6051b, An Oral ROS1 And NTRK Inhibitor, In Subjects With Metastatic and/or Unresectable Solid Tumors",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03",
"study_completion_date(actual)": "2019-03",
"study_start_date(actual)": "2014-09"
},
"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)": "2020-09-22",
"last_updated_that_met_qc_criteria": "2014-10-28",
"last_verified": "2020-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-10-31",
"first_submitted": "2014-10-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to characterize the interactive effects of acute intravenous (IV) alcohol and nicotine administration in male and female smokers and nonsmokers who use alcohol.
#Intervention
- DRUG : Nicotine
- 1.0 microg/kg/min IV x 10 minutes
- DRUG : Ethanol
- IV
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or Female, 21 <= age <= 50 old.
Exclusion Criteria:
* Alcohol or Nicotine Naive
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00616746
|
{
"brief_title": "Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans",
"conditions": [
"Alcohol Consumption",
"Tobacco Use"
],
"interventions": [
"Drug: Nicotine",
"Drug: Ethanol"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00616746",
"official_title": "Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": "2010-06",
"study_start_date(actual)": "2007-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "TRIPLE",
"phase": [
"EARLY_PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-07-08",
"last_updated_that_met_qc_criteria": "2008-02-04",
"last_verified": "2014-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-02-15",
"first_submitted": "2008-02-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Health literacy is an integral part of the pathway for the successful transfer of information between patients and providers. Parents of children with Attention Deficit/ Hyperactivity Disorder (ADHD) play an essential role in chronic care as they offer critical information to providers that drives appropriate education and disease management. We propose the development and evaluation of an electronic data entry tool that enables parents to communicate data essential to treatment of their children, regardless of their own literacy skills. The research plan addresses a question central to patient-centered information management: how does health literacy influence parents' report of data on ADHD and the process-level events that result from parent-provider communication? The following specific aims organize the clinical study: proposal: 1) To assess the effect of health literacy on successful completion of parent-reported ADHD health information in both paper-based and PCHR formats, and, 2): To determine the association between health literacy and process-level outcomes for ADHD that stem from parent-provider exchange of information. The formal evaluation will study a diverse cohort of parents in a randomized trial of data entry (paper versus PCHR) for ADHD-specific information. Primary care records for children of this cohort will be analyzed for the prior 12 month period. Both a retrospective examination of documented ADHD processes of care and a prospective evaluation of the utility of data from the PCHR will occur. Literacy level is a primary variable of interest throughout the evaluation.
#Intervention
- OTHER : Use of paper forms to write down information
- Parents will be asked to write down information specific to their child's ADHD using paper forms.
- OTHER : Computer
- Parents will use a computer to complete data entry on information specific to their child's ADHD care
|
#Eligibility Criteria:
Inclusion Criteria:
* Primary language of parent/guardian is English or Spanish
* Parent/guardian reports that child has been diagnosed with ADHD
* Current child age is between 5 years and 12 years
* Child in question resides with the parental subject primarily
* Parent/guardian reports that they are the primary caretaker of the child
* Parent/guardian reports that they are the person who communicates with the primary care provider
* Parent/guardian reports that child is currently taking medication for ADHD or has taken it within the last 3 months
Exclusion Criteria:
* Parent reports that child in question has been diagnosed with mental retardation, autism, pervasive developmental disorder, Aspergers, or bipolar 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:
Yes
|
NCT00543257
|
{
"brief_title": "Parents at the Center: Information Management in ADHD - Clinical Trial",
"conditions": [
"Health Literacy",
"Attention Deficit Disorder With Hyperactivity",
"Computer Literacy",
"Information Management",
"Parents"
],
"interventions": [
"Other: Use of paper forms to write down information",
"Other: Computer"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00543257",
"official_title": "Parents at the Center: Information Management in ADHD - Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-03",
"study_completion_date(actual)": "2014-06",
"study_start_date(actual)": "2007-12"
},
"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)": "2017-10-06",
"last_updated_that_met_qc_criteria": "2007-10-10",
"last_verified": "2017-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-10-12",
"first_submitted": "2007-10-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Abdominal exploration leave an ugly scar that live with the baby forever, laparoscopy can solve the problem to some extent by making a smaller scar but takes more time and need special surgical skills. Umbilical incision can combine the advantage of open and laparoscopy and avoid the drawbacks of both.
Detailed Description
six cases were subjected to the study 2 cases have duodenal atresia, one case has annular pancreas, one case has jujenal atresia chritmas tree, one case has jujenal web and a case of malrotation. all of them had made exploration by the umbilical incision, and no drains had been used.
#Intervention
- PROCEDURE : umbilical incision
- exploration through umbilical incision
|
#Eligibility Criteria:
Inclusion Criteria:
* neonate diagnosed radiologically
Exclusion Criteria:
* unclear diagnosis
Sex :
ALL
Ages :
- Minimum Age : 20 Hours
- Maximum Age : 20 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03256669
|
{
"brief_title": "Umblical Incision for Neonatal Surgery",
"conditions": [
"Neonatal Surgery"
],
"interventions": [
"Procedure: umbilical incision"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT03256669",
"official_title": "Umblical Incision for Neonatal Surgey; is it Suitable",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-08-01",
"study_completion_date(actual)": "2018-04-01",
"study_start_date(actual)": "2017-01-01"
},
"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)": "2018-04-09",
"last_updated_that_met_qc_criteria": "2017-08-20",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-08-22",
"first_submitted": "2017-07-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to test the following hypotheses:
* that the function and/or regulation of AQP2 and/or ENaC in the principal cells is abnormal in essential hypertension.
* if an abnormal function of the principal cells is present in essential hypertension, this will become more pronounced at high and low sodium intake.
#Intervention
- BEHAVIORAL : high sodium diet
- 250-350 mmol
- Other Names :
- For four days
- BEHAVIORAL : Low Sodium Diet
- 25-35 mmol
- Other Names :
- For four days
|
#Eligibility Criteria:
Inclusion Criteria:
* Caucasian men and women
* Age 18 <= age <= 65 years
* Arterial hypertension
* Body mass index between 18.5 and 30 kg/m2
Exclusion Criteria:
* Secondary hypertension
* Isolated systolic hypertension
* History or clinical signs of AMI, atrial fibrillation, disease of the heart valves, or chronic heart failure.
* Malignant disease
* Prior apoplexy
* alcohol or drug abuse
* Drug use except antihypertensives and oral contraceptives
* Abnormal biochemical screening of the blood regarding: red and white blood count, s-creatinine (> 200 micromol/L), b-hemoglobin, p-Sodium, p- potassium, p-albumine, p-bilirubin, p-alanine aminotransferase, p-alkaline phosphatase, p-cholesterol and b-glucose.
* Abnormal screening of the urine regarding: Blood, albumine and glucose.
* abnormal electrocardiogram
* Blood donation within one month of the first examination day
* Unwillingness to participate
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
|
NCT00345124
|
{
"brief_title": "The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension",
"conditions": [
"Essential Hypertension and Healthy Controls"
],
"interventions": null,
"location_countries": [
"Denmark"
],
"nct_id": "NCT00345124",
"official_title": "The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension, During Basal Conditions and After Hypertonic Saline Infusion.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-05",
"study_completion_date(actual)": "2009-08",
"study_start_date(actual)": "2006-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-06-28",
"last_updated_that_met_qc_criteria": "2006-06-24",
"last_verified": "2011-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-06-27",
"first_submitted": "2006-06-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In allergic rhinitis patients with severe symptoms, control of severe allergic reactions is limited with saline nasal irrigation. Therefore, there have been several attempts to use saline nasal irrigation in combination with other treatments to treat allergic rhinitis. This study tries to explore the effect of nasal irrigation with Chinese herbal medicines on allergic rhinitis.
Detailed Description
In this study, patients with allergic rhinitis over 20 years old were collected from the clinics of Otolaryngology and Traditional Chinese Medicine clinics. The subjects were randomly divided into two groups. They used the devices of NeiMed sinus rinse to irrigate the nose with 240 cc of Chinese herbal medicine solution or placebo each morning and evening for 2 months. Subjects in both groups filled questionnaires, and received acoustic rhinometry, rhinomanometry, and eustachian tube function tests before and after nasal irrigation. This study tries to explore the effect of nasal irrigation with Chinese herbal medicines on allergic rhinitis.
#Intervention
- DRUG : Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol
- The bilateral nasal cavity was irrigated with a plastic bottle containing 1 gram of Szechwan Lovage Rhizome, 1 gram of Biod Magnolia Bud, 0.5 gram of Taiwan Angelica Root, 0.5 gram of Wild Mint Herb, 1.5 gram of Baikal Skullcap Root, and 0.5 gram of Borneol dissolved in 240 ml of warm normal saline once a day for 2 months.
- DRUG : edible caramel
- The bilateral nasal cavity was irrigated with a plastic bottle containing edible caramel dissolved in 240 ml of warm normal saline once a day for 2 months.
|
#Eligibility Criteria:
Inclusion Criteria:
* Allergic rhinitis patients diagnosed based on the history and allergen test
Exclusion Criteria:
* Those younger than 20 years, Immunocompromised patients Pregnant women or breastfeeding women Those with a history of allergy to traditional Chinese medicine Those with liver and kidney insufficiency Those who cannot cooperate with nasal irrigation
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
|
NCT05901532
|
{
"brief_title": "Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis",
"conditions": [
"Rhinitis, Allergic",
"Nasal Lavage",
"Medicine, Chinese Traditional"
],
"interventions": [
"Drug: edible caramel",
"Drug: Szechwan Lovage Rhizome, Biod Magnolia Bud, Taiwan Angelica Root, Wild Mint Herb, Baikal Skullcap Root, and Borneol"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT05901532",
"official_title": "Nasal Irrigation With Chinese Herbal Medicine as an Adjunctive Treatment in Allergic Rhinitis: Phase 2 Randomized, Double-blinded, Placebo-controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-04-30",
"study_completion_date(actual)": "2023-02-28",
"study_start_date(actual)": "2020-11-01"
},
"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)": "2023-10-26",
"last_updated_that_met_qc_criteria": "2023-06-12",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-06-13",
"first_submitted": "2023-05-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main purpose of this study is to assess the long-term safety and tolerability of paliperidone 6-month PP6M (Dose 1 or Dose 2 \[milligram\] mg eq.) and to provide access to PP6M in participants with schizophrenia completing the R092670PSY3015 study without relapse.
#Intervention
- DRUG : PP6M injection Dose 1
- Participants will receive Dose 1 PP6M intramuscular (IM) injection at Visit 1 (Day) then once every 6 month up to 24 months.
- Other Names :
- R092670
- DRUG : PP6M injection Dose 2
- Participants will receive Dose 2 PP6M IM injection at Visit 1 (Day) then once every 6 month up to 24 months.
- Other Names :
- R092670
|
#Eligibility Criteria:
Inclusion Criteria:
* Completed the Double-blind Phase of Study R092670PSY3015 without relapse and continue to be willing to be treated with paliperidone palmitate 6 month injection (PP6M)
* Must, in the opinion of the investigator, be able to continue treatment at the same dose level (moderate or higher dose) as used during the Double-blind Phase of Study R092670PSY3015 at the time of screening for this study
* A woman of childbearing potential: a) Must have a negative pregnancy test on Day 1; b) Use contraception consistent with local regulations. A man must agree that during the study and for a minimum 12 months after receiving the last dose of the study intervention: a) His female partner(s) will use highly effective method pf contraception
* Sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study; and must be able to provide his or her own consent (that is, consent cannot be provided by a legal representative of the participant)
* In the opinion of the investigator, the patient would be able to participate for the duration of this study
Exclusion Criteria:
* Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Completed R092670PSY3015 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the participant
* If a man, has plans to father a child while enrolled in this study or within 12 months after the last dose of study intervention. Must not, if a woman, have plans to become pregnant while enrolled in this study or within 12 months after the last dose of study intervention
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
|
NCT04072575
|
{
"brief_title": "A Study of Paliperidone Palmitate 6-Month Formulation",
"conditions": [
"Schizophrenia"
],
"interventions": [
"Drug: PP6M injection Dose 2",
"Drug: PP6M injection Dose 1"
],
"location_countries": [
"Ukraine",
"Poland",
"Russian Federation",
"Argentina",
"Italy",
"Hong Kong"
],
"nct_id": "NCT04072575",
"official_title": "Single-arm, Open-label Extension to a Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-03",
"study_completion_date(actual)": "2022-05-03",
"study_start_date(actual)": "2019-09-19"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-05-31",
"last_updated_that_met_qc_criteria": "2019-08-27",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-08-28",
"first_submitted": "2019-08-16",
"first_submitted_that_met_qc_criteria": "2023-05-03"
}
}
}
|
#Study Description
Brief Summary
An experimental trial will be conducted whereby a Supplemental Nutrition Assistance Program (SNAP)-like food benefit program will be implemented in 240 SNAP eligible households. Baseline and follow up measures will include three 24-hour dietary recalls; household food purchase receipt collection; and household food security questions. The individual level measures will be collected from the adult most responsible for food shopping and a child in the household. After baseline measures are completed households will be randomized to one of three conditions: 1) restriction (not allowed to buy sugar sweetened beverages, sweet baked goods, or candies with food benefits); 2) restriction paired with an incentive (30% financial incentive on fruits and vegetables and restriction of purchase of sugar sweetened beverages, sweet baked goods, or candy with food benefits); or 3) control (no incentive or restrictions). Households in all conditions will be given a debit card that will have funds added monthly for a five month period. The dollar amount placed on the card monthly will be similar to the amount the household would receive if enrolled in SNAP. All participants will be instructed to use the debit card for food purchases only, and they'll be told they shouldn't use the card to purchase items currently non-eligible for purchase with SNAP benefits (e.g. alcohol, food from restaurants). Those in the restriction condition will also be told they cannot use the card to buy sugar sweetened beverages, sweet baked goods, or candies. They may purchase these foods using their own money, but not the debit card. Those in the restriction plus incentive condition will receive the instructions provided to the restriction group plus they will be told that they'll receive a 30% bonus for fruits and vegetables purchased using their debit card. Analyses will determine whether the nutritional quality of the diet at follow-up differs between experimental groups.
#Intervention
- BEHAVIORAL : Restricted
- Certain foods and beverages are not allowed to be purchased with food benefit dollars.
- BEHAVIORAL : Restriction plus Incentive
- Certain foods and beverages are not allowed to be purchased with food benefit dollars; 30% of the total dollars spent toward the purchase of certain foods result are added to their food benefit dollars.
|
#Eligibility Criteria:
Inclusion Criteria:
* SNAP-eligible household
* at least one child between the ages of 3 <= age <= 11
* Less than or equal to 6 people in the household
* Primary food shopper
* Ability and willingness to collect and submit household food purchase receipts for 22 weeks
* Willingness to attend two study visits
* willingness to complete three dietary recalls at both baseline and follow-up
* not planning to apply for SNAP in the next 5 months
* ability to speak and understand either Spanish or English
Exclusion Criteria:
* households that are not SNAP-eligible
* no children in household between the ages of 3 <= age <= 11
* not primary food shopper
* 7 or more people in household
* inability to collect and submit household food purchase receipts for 22 weeks
* unwillingness to comply with study measures
* inability to speak or understand Spanish or English
* planning on applying for SNAP within the next 5 months.
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03363048
|
{
"brief_title": "Grocery Assistance Program Study for Families",
"conditions": [
"Nutritional Quality",
"Food Insecurity",
"Food Legislation",
"Healthy Diet",
"Food Stamp Program"
],
"interventions": [
"Behavioral: Restriction plus Incentive",
"Behavioral: Restricted"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03363048",
"official_title": "Effects of Subsidies and Prohibitions on Household Nutrition in a Food Benefit Program",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-10-06",
"study_completion_date(actual)": "2019-10-06",
"study_start_date(actual)": "2018-05-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-11-10",
"last_updated_that_met_qc_criteria": "2017-11-29",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-12-05",
"first_submitted": "2017-11-29",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this study is to use single photon emission computed tomography (SPECT) and functional magnetic resonance imaging (f-MRI) of the brain to study the response of both normal participants and participants with Osteoarthritis (OA) of the knee to acupuncture.
Detailed Description
Recent experimental studies in both animal and humans have begun to demonstrate some measurable physiologic effects that are associated with acupuncture, suggesting the possibility of a neurophysiologic explanation. In addition, brain research continues to uncover a complex set of endogenous neurologic control systems, such that it has become clear that the brain plays a major role in the modulation of pain perception and control. If acupuncture can be demonstrated to have a consistent effect on specific areas of the brain, it will become possible to explore the potential efficacy of acupuncture based on measurable neurophysiologic responses.
#Intervention
- PROCEDURE : acupuncture
|
#Eligibility Criteria:
Inclusion criteria:
* Seen in an outpatient clinical setting
* Have active knee OA of >6 months including Kellgren x-ray changes >2 from an x-ray report <12 months old or new x-ray interpretation
* Moderate unilateral only pain (average >4/10 on a 0 <= age <= 10 likert scale) for more than 5 out of 7 days
* Have the capacity to understand the requirements of the study and complete the baseline studies in a reasonable time frame, as determined by the interviewer
Exclusion criteria:
* Having had acupuncture before (must be acupuncture naïve)
* Any history of claustrophobia that could affect the subject's ability to tolerate the f-MRI study
* Hip or ankle disease by history or exam severe enough to cause pain >2/10 daily
* Bleeding disorder or current use of warfarin or heparin by patient history
* Other primary causes of chronic knee pain, per the referring physician, including chondromalacia patella, torn meniscus or ligament injury.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00070824
|
{
"brief_title": "Functional Brain Imaging - Acupuncture and Osteoarthritis",
"conditions": [
"Osteoarthritis"
],
"interventions": [
"Procedure: acupuncture"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00070824",
"official_title": "Functional Brain Imaging - Acupuncture and Osteoarthritis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2007-04",
"study_start_date(actual)": "2004-01"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-09-10",
"last_updated_that_met_qc_criteria": "2003-10-10",
"last_verified": "2007-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2003-10-13",
"first_submitted": "2003-10-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to examine the efficacy of a brief motivational intervention for alcohol use in incarcerated women.
Detailed Description
Hazardous alcohol use continues to be a problem of major significance throughout the United States. Alcohol use is a prevalent condition that independently acts as an important behavioral cofactor for HIV infection in women, contributing to both sexual and drug risk. The rationale for a brief intervention with incarcerated women who hazardously use alcohol and have HIV risk behaviors is compelling. For such women, we believe that the negative effects of drinking may be increased. An intervention that successfully connects alcohol use with HIV risk behaviors may be sufficient to tip the decisional balance in favor of reducing risk-prone alcohol consumption. If alcohol consumption is reduced more generally in a person's life, this may improve judgment in pursuing behaviors which risk other negative consequences. Hazardous alcohol, and high-risk drug and sexual activities may be manifestations of a general behavior pattern among incarcerated women, and strategies that engage such individuals are needed. Given the strong association between hazardous alcohol use and high HIV risk sexual and drug activities, interventions that attempt to lower the prevalence of HIV drug and sexual risk activities by lowering alcohol consumption are well justified. Brief alcohol interventions have been efficacious in reducing alcohol use across many populations over the past decade.
Comparison(s): Participants are assigned, in this 6 month study, to an assessment-only condition or an assessment plus motivational interview condition. Two motivational interview sessions are conducted during the first month of study participation.
#Intervention
- BEHAVIORAL : motivational interviewing
- Assessment plus motivational interview condition -- two motivational interview sessions are conducted during the first month of this six month study participation.
|
#Eligibility Criteria:
Inclusion Criteria:
* incarcerated women
* current hazardous drinking
* current HIV risk behavior
Exclusion Criteria:
*
Sex :
FEMALE
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
|
NCT00237003
|
{
"brief_title": "A Brief Alcohol Intervention for Incarcerated Women",
"conditions": [
"Alcohol Use",
"Incarceration"
],
"interventions": [
"Behavioral: motivational interviewing"
],
"location_countries": null,
"nct_id": "NCT00237003",
"official_title": "A Brief Alcohol Intervention for Incarcerated Women",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-08",
"study_completion_date(actual)": "2009-08",
"study_start_date(actual)": "2003-09"
},
"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)": "2010-05-12",
"last_updated_that_met_qc_criteria": "2005-10-11",
"last_verified": "2010-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-10-12",
"first_submitted": "2005-10-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study
Detailed Description
This RWS study is to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China, to generate local real world data from a Chinese BPH population.
The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥50 years of age with a prostate volume ≥ 30cm3 and ≤80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.
#Intervention
- DEVICE : Rezūm System
- The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra.
|
#Eligibility Criteria:
Inclusion Criteria:
* The subjects will provide written informed consent form and agree to data collection.
* The subjects who were diagnosed as BPH and treated by Rezūm procedure in Hainan medical pilot zone will be enrolled in this study.
Exclusion Criteria:
* This is a retrospective study without any formal exclusion criteria.
Sex :
MALE
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04823221
|
{
"brief_title": "To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China",
"conditions": [
"Benign Prostatic Hyperplasia (BPH)"
],
"interventions": [
"Device: Rezūm System"
],
"location_countries": [
"China"
],
"nct_id": "NCT04823221",
"official_title": "A Real World Study to Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China (Rezūm RWS Study)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-08-01",
"study_completion_date(actual)": "2021-08-01",
"study_start_date(actual)": "2021-07-10"
},
"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)": "2022-03-02",
"last_updated_that_met_qc_criteria": "2021-03-29",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-03-30",
"first_submitted": "2021-03-26",
"first_submitted_that_met_qc_criteria": "2021-12-07"
}
}
}
|
#Study Description
Brief Summary
This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male and female subjects. There is no formal hypothesis, however, it is expected that the coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase the systemic exposure of BMS-626529.
#Intervention
- DRUG : BMS-663068
- BMS-663068
- DRUG : Darunavir
- Darunavir
- DRUG : Cobicistat
- Cobicistat
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female
* Nonsmoking subjects
* Ages 18 <= age <= 50
* Inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive
* Women of childbearing potential
* Must agree to follow instructions for methods of contraception for the duration of the study plus 34 days post-treatment completion
Exclusion Criteria:
* Any history of acute or chronic medical and surgical illness.
* Personal of family history of hemophilia A or B
* Other protocol defined exclusion criteria could apply
Sex :
ALL
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
|
NCT02277600
|
{
"brief_title": "A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)",
"conditions": [
"Infection, Human Immunodeficiency Virus"
],
"interventions": [
"Drug: Cobicistat",
"Drug: Darunavir",
"Drug: BMS-663068"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02277600",
"official_title": "Open-Label, Single-Sequence, Two-Cohort Study to Evaluate the Effect of Darunavir/Cobicistat and Cobicistat on BMS-626529 in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-01-12",
"study_completion_date(actual)": "2015-01-12",
"study_start_date(actual)": "2014-11-05"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-01-24",
"last_updated_that_met_qc_criteria": "2014-10-28",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-10-29",
"first_submitted": "2014-10-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be \[ 4 x 9.5 Gy = 38 Gy \] delivered in 5 alternative days.
#Intervention
- OTHER : SBRT
- hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be \[ 4 x 9.5 Gy = 38 Gy \] delivered in 5 alternative days, corresponding to an NTD2 between 95 and 119 Gy for an α/β estimate between 3 and 1.5 Gy.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age <= 85years.
* WHO performance status <= 2.
* PSA>10 and <= 20 ng/ml or Gleason Score 7 or T2a-T2c.
* Histologically proven prostate adenocarcinoma
* No pathologic lymph nodes on CT/ MRI scan.
* No distant metastases.
* No previous prostate surgery other than TURP (at least 6 weeks interval before initiation of RT).
* No malignant tumours in the previous 5 years.
* IPSS 0 <= age <= 7.
* Combined HT according to risk factors.
* Informed consent.
Exclusion Criteria:
* Prostate size greater than 60cc.
* Previous TURP less than 6 weeks before radiotherapy.
* Previous prostate surgery other than TURP.
* Diabetes *.
* Use of anticoagulants drugs *.
* Chronic inflammatory bowel disease *.
* Previous pelvic irradiation.
* Inability to obtain written informed consent.
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:
No
|
NCT03873090
|
{
"brief_title": "SBRT in 4 Fractions for Prostate Cancer",
"conditions": [
"Prostate Cancer"
],
"interventions": [
"Other: SBRT"
],
"location_countries": null,
"nct_id": "NCT03873090",
"official_title": "Phase I-II Study of High Dose SBRT in 4 Fractions for Intermediate Risk Prostate Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-23",
"study_completion_date(actual)": "2018-05-23",
"study_start_date(actual)": "2013-06-12"
},
"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)": "2019-03-13",
"last_updated_that_met_qc_criteria": "2019-03-11",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-03-13",
"first_submitted": "2019-02-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes management.
#Intervention
- OTHER : SMBG to guide clinical decisions
- The investigator will base clinical decisions on A1c and modal day analysis of SMBG.
- OTHER : SMBG and CGM
- The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data.
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects >=18 and <=75 years
* Clinical diagnosis of diabetes
* Diabetes duration >= 1 year
* HbA1c >=7.2%
* Diabetes can be treated with any therapy including medical nutrition therapy alone and any pharmaceutical therapy
Exclusion Criteria:
* Taken prednisone or cortisone medications in the previous 30 days
* Currently pregnant or planning pregnancy during the study period
* Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
* Unable to follow the study protocol
* Unable to speak, read and write in English
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
|
NCT01072565
|
{
"brief_title": "Modal Day Analysis of Self Monitoring Blood Glucose Versus Continuous Glucose Monitoring",
"conditions": [
"Type 2 Diabetes"
],
"interventions": [
"Other: SMBG to guide clinical decisions",
"Other: SMBG and CGM"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01072565",
"official_title": "Optimization of SMBG Employing Modal Day Analysis: Examining Clinical Decision-making Processes Using Blinded FreeStyle Navigator Continuous Glucose Monitoring System (CGM)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-01",
"study_completion_date(actual)": "2012-01",
"study_start_date(actual)": "2010-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-11-26",
"last_updated_that_met_qc_criteria": "2010-02-19",
"last_verified": "2013-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-02-22",
"first_submitted": "2010-02-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a Phase 1, randomized, double-blind (sponsor open), placebo controlled study in adult Chinese participants with T2DM who are receiving metformin as background antihyperglycemic medication.
#Intervention
- DRUG : PF-06882961
- Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD)
- DRUG : Placebo
- 3 matching placebo tablets taken twice daily (BID) except Day 1 (QD)
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with T2DM who are taking metformin monotherapy as their only antihyperglycemic treatment
* HbA1c greater than or equal to 7% and less than or equal to 10.5%
* Total body weight >50 kg (110 lb) with BMI of 22.5 to 45.4 kg/m^2
Exclusion Criteria:
* Any condition possibly affecting drug absorption
* Diagnosis of Type 1 diabetes mellitus or secondary forms of diabetes
* History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of Screening
* Any malignancy not considered cured
* Personal or family history of MTC or MEN2, or participants with suspected MTC
* Acute pancreatitis or history of chronic pancreatitis
* Acute gallbladder disease
* Known history of HIV, hepatitis B, hepatitis C or syphilis, or positive testing of them
* Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
* Clinically relevant ECG abnormalities
* Positive urine drug test
* Clinical relevant laboratory tests abnormalities
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT04889157
|
{
"brief_title": "A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of PF-06882961 in Chinese Adults With Type 2 Diabetes Mellitus",
"conditions": [
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: PF-06882961",
"Drug: Placebo"
],
"location_countries": [
"China"
],
"nct_id": "NCT04889157",
"official_title": "AN 8-WEEK, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED PHASE 1 STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF PF-06882961 IN CHINESE ADULTS WITH TYPE 2 DIABETES MELLITUS",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-02-17",
"study_completion_date(actual)": "2022-02-17",
"study_start_date(actual)": "2021-07-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-01",
"last_updated_that_met_qc_criteria": "2021-05-12",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-05-17",
"first_submitted": "2021-05-12",
"first_submitted_that_met_qc_criteria": "2024-06-18"
}
}
}
|
#Study Description
Brief Summary
This study aimed to explore the effects of a 12-week combined exercise on ghrelin O acyl transferase, acylated ghrelin and desacylated ghrelin levels in obese girls.
Detailed Description
Little is known about on ghrelin O acyl transferase (GOAT), acylated ghrelin (AG) and desacylated ghrelin (DAG) levels during long-term exercise in adolescent population. Our previous study showed that combined exercise program in overweight children increases DAG with unchanged AG. This study aimed to explore the effects of a 12-week combined exercise on GOAT, AG, and DAG in obese girls.
#Intervention
- OTHER : Combined exercise program
- Combined exercise programme, consisting of warm-up, aerobic exercise, resistance training, and cool-down, 3 days a week after school for 50 minutes from 17;30 under supervision by a trainer plus 300 kcal deficit diet
- OTHER : Control
- 300 kcal deficit diet only
|
#Eligibility Criteria:
Inclusion Criteria:
* girls between 16 and 18 years
* being classified as being overweight or obese defined with the 85th percentile of body mass index or above based on the 2007 growth chart for Korean children aged 2 <= age <= 18 years.
* After consultation with a physician, they were required to be considered physically healthy enough to engage in regular exercise after school.
Exclusion Criteria:
* participation in any weight-management programme in the past 6 months
* engagement in other exercise programs except for regular physical education at school
* smoking
* amenorrhea for consecutive 2 months or more
* being treated for hereditary diseases, mental disorder, hypertension, diabetes mellitus, or musculoskeletal impairments
* taking any medication or supplements for weight control
Sex :
FEMALE
Ages :
- Minimum Age : 16 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04447391
|
{
"brief_title": "Effects of a 12-week Combined Exercise Program on Ghrelins in Obese Adolescent Girls",
"conditions": [
"Ghrelin"
],
"interventions": [
"Other: Control",
"Other: Combined exercise program"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT04447391",
"official_title": "Effects of a 12-week Combined Exercise Program on Acylated and Desacyl Ghrelin, and Ghrelin O Acyl Transferase in Obese Adolescent Girls",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12-30",
"study_completion_date(actual)": "2015-12-31",
"study_start_date(actual)": "2015-09-10"
},
"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)": "2020-06-26",
"last_updated_that_met_qc_criteria": "2020-06-22",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-06-25",
"first_submitted": "2020-06-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This randomized phase II trial studies how well giving temozolomide and irinotecan hydrochloride together with or without bevacizumab works in treating young patients with recurrent or refractory medulloblastoma or central nervous system (CNS) primitive neuroectodermal tumors. Drugs used in chemotherapy, such as temozolomide and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether temozolomide and irinotecan hydrochloride are more effective with or without bevacizumab in treating medulloblastoma or CNS primitive neuroectodermal tumors.
Detailed Description
PRIMARY OBJECTIVES:
l. To compare the overall survival (OS) of subjects receiving the combination of temozolomide and irinotecan with that of subjects receiving temozolomide, irinotecan (irinotecan hydrochloride), and bevacizumab for recurrent medulloblastoma (MB)/primitive neuroectodermal tumor (PNET) of childhood.
SECONDARY OBJECTIVES:
I. To assess the response rate for each treatment arm amongst patients who are enrolled with measurable disease.
II. To determine event-free survival (EFS) for each patient compared across regimens.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive temozolomide orally (PO) and irinotecan hydrochloride IV over 90 minutes on days 1-5.
ARM II: Patients receive temozolomide PO and irinotecan hydrochloride IV as in arm I and bevacizumab IV over 30-90 minutes on days 1 and 15.
In both arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 5 years.
#Intervention
- BIOLOGICAL : Bevacizumab
- Given IV
- Other Names :
- ABP 215, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF rhuMAb, Avastin, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-awwb, Bevacizumab-bvzr, BP102, BP102 Biosimilar, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, Mvasi, MYL-1402O, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, Zirabev
- DRUG : Irinotecan Hydrochloride
- Given IV
- Other Names :
- Campto, Camptosar, Camptothecin 11, Camptothecin-11, CPT 11, CPT-11, Irinomedac, Irinotecan Hydrochloride Trihydrate, Irinotecan Monohydrochloride Trihydrate, U-101440E
- DRUG : Temozolomide
- Given PO
- Other Names :
- CCRG-81045, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temodal, Temodar, Temomedac, TMZ
|
#Eligibility Criteria:
Inclusion Criteria:
* Medulloblastoma or PNET of childhood that has relapsed or become refractory to standard chemotherapy; patients with pineoblastoma are eligible
* Patients must have had histologic verification of the malignancy at original diagnosis or at the time of recurrence
* Patients must have clear residual disease, defined as tumor that is measurable in two perpendicular diameters on magnetic resonance imaging (MRI) OR diffuse leptomeningeal disease OR clear MRI evidence of disease that may not be measurable in two perpendicular diameters
* All patients must have a brain MRI with and without gadolinium and a spine MRI with gadolinium performed within 2 weeks prior to study enrollment
* Patients must have a Lansky or Karnofsky performance status score of >= 50%, corresponding to Eastern Cooperative Oncology Group (ECOG) categories of 0, 1, or 2 (use Karnofsky for patients > 16 years and Lansky for patients =< 16 years)
* Patients must have a life expectancy of >= 8 weeks
* Patients must have experienced at least one and at most two relapses prior to study enrollment; patients with primary refractory disease are eligible
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Myelosuppressive chemotherapy: Must not have received within 3 weeks of entry onto this study (6 weeks if prior nitrosourea)
* Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent; at least 3 weeks for biologic agents with a long half life, such as antibodies
* External beam radiation therapy (XRT): Must not have received craniospinal radiotherapy within 24 weeks prior to study entry; the tumor designated as 'measurable' for protocol purposes must not have received radiation within 12 weeks prior to study entry); focal radiation to areas of symptomatic metastatic disease must not be given within 14 days of study entry
* Stem cell transplant (SCT): For autologous SCT, >= 3 months must have elapsed prior to study entry
* Study specific limitations on prior therapy:
* Patients must not have previously received bevacizumab, irinotecan, temozolomide or other anti-vascular endothelial growth factor (VEGF) inhibitor
* Patients must not be taking enzyme-inducing antiepileptic medicines within 1 week of study entry
* Patients must have recovered from any surgical procedure before enrolling on this study:
* Patients with a major surgical procedure within 28 days prior to enrollment should be excluded
* Patients with an intermediate surgical procedure within 14 days prior to enrollment should be excluded
* For minor surgical procedures (including Broviac line or infusaport placement), patients should not receive the first planned dose of bevacizumab until the wound is healed and at least 7 days have elapsed
* There should be no anticipation of need for major surgical procedures during the course of the study
* Examples of major, intermediate, or minor surgical procedures:
* Major procedures: Major craniotomy for tumor resection; organ resection; bowel wall anastomosis; arteriovenous grafts; exploratory laparotomy; thoracotomy
* Intermediate procedures: Ventriculoperitoneal (VP)-shunt placement; stereotactic brain biopsy
* Minor procedures: Incision and drainage of superficial skin abscesses; punch biopsy of skin lesions; superficial skin wound suturing; bone marrow aspirate and/or biopsy; fine needle aspirations; Broviac line or infusaport placement; paracentesis or thoracocentesis
* Please note: Lumbar punctures or placement of peripherally inserted central catheter (PICC) lines are not considered minor procedures and may occur at any time prior to or during therapy
* Hypertension must be well controlled (=< 95th percentile for age and height if patient is =< 17 years) on stable doses of medication
* Concomitant medications restrictions:
* Growth factor(s): Must not have received within 7 days of entry onto this study
* Steroids: Patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 7 days
* Study Specific: Patients must not be currently taking nonsteroidal anti-inflammatory drugs (NSAIDs), clopidrogel, dipyridamole or aspirin therapy > 81 mg/day
* Peripheral absolute neutrophil count (ANC) >= 1000/uL (must not have received filgrastim [G-CSF] within the prior 7 days)
* Platelet count >= 100,000/uL (transfusion independent)
* Hemoglobin >= 8.0 gm/dL (may receive packed red blood cell [PRBC] transfusions)
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min OR a serum creatinine based on age/gender as follows:
* =< 0.4 mg/dL (for patients aged 1 month to < 6 months)
* =< 0.5 mg/dL (for patients aged 6 months to < 1 year)
* =< 0.6 mg/dL (for patients aged 1 to < 2 years)
* =< 0.8 mg/dL (for patients aged 2 to < 6 years)
* =< 1 mg/dL (for patients aged 6 to < 10 years)
* =< 1.2 mg/dL (for patients aged 10 to < 13 years)
* =< 1.4 mg/dL (for female patients aged >= 13 years)
* =< 1.5 mg/dL (for male patients aged 13 to < 16 years)
* =< 1.7 mg/dL (for male patients aged >= 16 years)
* Urine protein should be screened by dipstick analysis; if protein >= 2+ on dipstick, then urine protein creatinine (UPC) ratio should be calculated; if UPC ratio > 0.5, 24-hour urine protein should be obtained and the level should be < 1000 mg/24 hours for patient enrollment
* Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x upper limit of normal (ULN) for age
* Central nervous system function defined as
* Patients with a seizure disorder may be enrolled if well-controlled and on non-enzyme inducing anticonvulsants
* Adequate coagulation defined as
* International normalized ratio (INR)/prothrombin time (PT) =< 1.5 x upper limit of normal
Exclusion Criteria:
* Patients with a serious or non-healing wound, ulcer, or bone fracture are not eligible for this study
* Patients must not have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study entry
* Patients must not have a known bleeding diathesis or coagulopathy
* Patients must not have had significant vascular disease (eg, aortic aneurysm requiring surgical repair, deep venous or arterial thrombosis) within the last 6 months prior to study entry
* Patients must not have a known thrombophilic condition (i.e. protein S, protein C or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome); testing is not required in patients without thrombophilic history
* Patients must not have evidence of new CNS hemorrhage on baseline MRI obtained within 14 days prior to study enrollment
* Patients with a history of stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure within the past 6 months are not eligible
* Patients must not have serious and inadequately controlled cardiac arrhythmia
* Female patients who are pregnant are not eligible for this study
* Female patients who are breastfeeding are not eligible for this study unless they agree not to breastfeed
* Female patients of childbearing potential must have a negative pregnancy test
* Sexually active patients of childbearing potential must agree to use an effective method of contraception during the study and for at least 6 months after the completion of bevacizumab therapy
* Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
Sex :
ALL
Ages :
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01217437
|
{
"brief_title": "Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors",
"conditions": [
"Central Nervous System Neoplasm",
"Pineoblastoma",
"Recurrent Medulloblastoma",
"Recurrent Primitive Neuroectodermal Tumor",
"Refractory Medulloblastoma",
"Refractory Peripheral Primitive Neuroectodermal Tumor"
],
"interventions": [
"Drug: Temozolomide",
"Drug: Irinotecan Hydrochloride",
"Biological: Bevacizumab"
],
"location_countries": [
"United States",
"New Zealand",
"Canada",
"Australia",
"Puerto Rico"
],
"nct_id": "NCT01217437",
"official_title": "Temozolomide With Irinotecan Versus Temozolomide, Irinotecan Plus Bevacizumab (NSC# 704865) for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, a COG Randomized Phase II Screening Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-31",
"study_completion_date(actual)": "2021-06-30",
"study_start_date(actual)": "2010-11-22"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-07-23",
"last_updated_that_met_qc_criteria": "2010-10-07",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-10-08",
"first_submitted": "2010-10-07",
"first_submitted_that_met_qc_criteria": "2019-08-19"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to see if it is safe to give C4-V3, a possible HIV vaccine, alone or in conjunction with 4 different doses of interleukin-12 (IL-12), to HIV-infected patients who are taking anti-HIV drugs that have lowered the amount of HIV in patients' blood. (This study has been changed so that vaccine is administered alone or with 4 different doses of IL-12.) Immune cells known as cytotoxic T lymphocytes (CTLs) help destroy HIV-infected cells. However, in most patients, CTLs decrease over time. This allows HIV levels to rise and AIDS symptoms to develop. The C4-V3 vaccine contains small pieces of HIV protein that can boost CTL levels, allowing the body's immune system to fight HIV. Giving IL-12, a normal part of the immune system, with C4-V3 may make the vaccine more effective.
Detailed Description
Cytotoxic T lymphocyte (CTL) responses are important to the initial decrease in HIV viral load seen in the first several months after acute infection. These beneficial CTL responses diminish with disease progression and cannot be recovered with antiretroviral therapy alone. Recent studies suggest a vaccine may help restore CTL responses. This study tests the effectiveness of the C4-V3 vaccine, a synthetic peptide vaccine representing 4 epitopes from HIV gp120, including an HLA B7-restricted CTL epitope. Administering IL-12, an immunostimulatory cytokine, in conjunction with C4-V3 may enhance HIV-1 specific immune responses and global immune function.
All patients continue their antiretroviral regimen during the study. Twelve patients are assigned equally to 1 of 3 cohorts; all patients receive 4 doses of C4-V3. Cohort 1 receives C4-V3 alone; once all 4 patients have received 2 doses and completed 8 weeks of treatment, toxicity data are reviewed. Barring serious adverse events, 4 patients are enrolled in Cohort 2 to receive C4-V3 plus a low dose of IL-12 near the vaccine injection sites. Once all 4 patients have received 2 doses of C4-V3/IL-12 and completed 8 weeks of treatment, toxicity data are reviewed. Barring serious adverse events, 4 patients are enrolled in Cohort 3 to receive C4-V3 plus a higher dose of IL-12 administered as above. \[AS PER AMENDMENT 8/1/00: Twenty patients are assigned equally to 1 of 5 cohorts; all patients receive 4 doses of C4-V3. Cohort 1 receives C4-V3 alone; once all 4 patients have received 2 doses and completed 6 weeks of treatment, toxicity data are reviewed. Barring serious adverse events, 4 additional patients are enrolled in Cohort 2 to receive C4-V3 plus a low dose (dose level 1) of IL-12. Barring serious adverse events, 4 additional patients are enrolled in Cohort 3 to receive C4-V3 plus a higher dose (dose level 2) of IL-12. Barring serious adverse events, 4 additional patients are enrolled in Cohort 4 to receive C4-V3 plus a higher dose (dose level 3) of IL-12. Barring serious adverse events, 4 patients are enrolled in Cohort 5 to receive C4-V3 plus a higher dose (dose level 4) of IL-12.\] Patients are followed for safety evaluations and changes in viral load through Week 48. If toxicity related to C4-V3 or IL-12 persists through Week 48, the affected patients are followed until resolution of the toxicity.
#Intervention
- DRUG : Interleukin-12
- BIOLOGICAL : HIV-1 C4-V3 Polyvalent Peptide Vaccine
|
#Eligibility Criteria:
Inclusion Criteria
Patients may be eligible for this study if they:
* Are at least 18 years.
* Are HIV-positive.
* Have 2 HIV measurements below 50 copies/ml taken at least 24 hours apart within 90 days prior to study entry.
* Have a CD4 count above 400 cells/mm3 within 30 days prior to study entry.
* Have been taking any combination of FDA-approved anti-HIV drugs for at least 3 months prior to study entry. (This study has been changed so that patients taking any combination of FDA-approved drugs for at least 3 months prior to study entry are included.)
* Test positive for HLA-B7.
* Agree to practice sexual abstinence or use 2 effective methods of birth control during the study and for 3 months after the study. (This study has been changed so that patients are required to use 2 effective methods of birth control.)
Exclusion Criteria
Patients will not be eligible for this study if they:
* Have ever received IL-12.
* Have received any vaccine within 30 days prior to study entry.
* Have chronic lung disease.
* Have participated in any other HIV vaccine trial.
* Have a history of autoimmune disease.
* Have gastrointestinal bleeding or peptic ulcer disease.
* Have received allergy skin testing or other allergy treatments within 30 days prior to study entry.
* Have received immunomodulatory or cytotoxic treatments within 30 days prior to study entry or will need to receive these treatments during the study.
* Have certain serious medical conditions or have received certain medications.
* Are pregnant or breast-feeding.
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
|
NCT00005779
|
{
"brief_title": "Safety of the Candidate Vaccine C4-V3 Alone or With Interleukin-12 (IL-12) in HIV-Infected Patients Receiving Effective Anti-HIV Drug Therapy",
"conditions": [
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00005779",
"official_title": "A Phase I, Limited-Center, Sequential Cohort Trial of HIV Vaccine (Polyvalent Peptide Vaccine C4-V3) in Conjunction With Interleukin-12 in Subjects With Maximal Suppression of HIV Replication and CD4 Count > 400 Cells/mm3",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2004-05",
"study_start_date(actual)": null
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-11-01",
"last_updated_that_met_qc_criteria": "2001-08-30",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-08-31",
"first_submitted": "2000-06-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Study of the effects of smoked cannabis consumption on performance on a driving simulator and reaction time. The study aims to explore the relationship between concentrations of cannabis in the blood, driving performance and reaction time.
Detailed Description
This study will examine:
* The relationship between THC blood levels and driving performance measured on a York Driving simulator
* The relationship between THC blood levels and reaction times as measured on the psychomotor vigilance test (PVT)
* the pharmacokinetics of THC in occasional and chronic cannabis consumers
* Determine the minimum blood concentration level of THC and 11-OH-THC, below which no effect of cannabis is observed
* Determine whether the polymorphism of CYP2C9 (\* 3) is associated with the AUC, Cmax, and higher THC T1/2
* Determine if the polymorphism of CYP2C9 (\* 3) is associated with different pharmacodynamic effects at a given THC level on performance measured by driving simulation
#Intervention
- DRUG : Cannabis (THC) in cigarettes of 30mg, 10mg and placebo
- Smoked THC containing cigarettes. Randomly allocated dosage 30mg, 10mg et placebo.
Both chronic and occasional cannabis consuming volunteers will be allocated to smoking a cigarette containing (1) no THC (placebo), (2) a joint containing 1% THC (10 mg THC, i.e. low-dose) and (3) a joint containing 3% (30 mg THC) mixed with 1 g tobacco.
Each cigarette will be followed by 24 hours testing in laboratory conditions. Each period is separated by 7 days (3 testing periods over 3 weeks). Each volunteer will undergo performance testing (driving simulator and PVT) before administration of the substance (T0).
Blood samples and repeat performance testing will be carried out at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours.
|
#Eligibility Criteria:
Inclusion criteria:
* Healthy volunteer of male gender from 18 <= age <= 25
* Normal medical examination
* Driving license owner
* BMI between 18.5 and 25
* moderate tobacco consumption
* moderate consumption of coffee, tea, cola (<= 225mg caffeine per day)
* Cannabis user for at least 1 year
* Occasional (1 <= age <= 2 joints per week) or chronic (1 <= age <= 2 joints per day) cannabis consumers
* Availability during the study
* Signed consent
Exclusion criteria:
* Participation in another clinical study
* Having taken any psychotropic medication in the past one month
* Having taken any narcotic (alcohol, psychotropic drugs, other narcotics) other than THC in the past 3 days (negative urinary test at inclusion)
* Alcohol blood level positive at inclusion
* Excessive alcohol consumption (AUDIT score > 7)
* Dependence, present or past, to any psychotropic product (alcohol, psychoactive drugs, other narcotic)
* Depression
* Sleep disorders
* Any psychiatric history, including psychosis
* Deprived of their liberty by judicial or administrative decision
* Lack of medical insurance
* Professional use of motorized vehicles
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 25 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02061020
|
{
"brief_title": "Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol (THC) and the Ability to Drive in Chronic or Occasional Cannabis Users",
"conditions": [
"Occasional (1-2 Joints Per Week) and Chronic (1-2 Joints Per Day) Cannabis Users"
],
"interventions": [
"Drug: Cannabis (THC) in cigarettes of 30mg, 10mg and placebo"
],
"location_countries": [
"France"
],
"nct_id": "NCT02061020",
"official_title": "Pilot Study of the Relationship Between Dose-concentration-effect of Delta-9-tetrahydrocannabinol and the Ability to Drive in Chronic or Occasional Cannabis Users",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-07",
"study_completion_date(actual)": "2016-03",
"study_start_date(actual)": "2014-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-06-09",
"last_updated_that_met_qc_criteria": "2014-02-11",
"last_verified": "2016-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-02-12",
"first_submitted": "2013-12-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal tumours. Ideal time interval between the end of NRCT and surgery is still debated; a 6-8 weeks time interval is considered optimal, but shorter or longer intervals have been associated with better oncological outcomes. Moreover, there is a lack of data about clinical postoperative outcomes and different time intervals after the end of NRCT. Here, effect that different time intervals have on postoperative complications with particular regard to the anastomotic dehiscence have been evaluated.
Methods One hundred-sixty-seven patients underwent surgery after long-course NRCT. Three different time intervals were considered: (0-42; 43-56; \>57 days).
Detailed Description
Neoadjuvant radio-chemotherapy (NRCT) represents a milestone in the treatment of selected rectal adenocarcinoma. Even though a 6-8 weeks' time interval after the end of NRCT and surgery is considered ideal, the optimal time for surgery is still controversial.
#Intervention
- PROCEDURE : Rectal Resection
- Low Anterior Resection and Abdominoperineal Resection
|
#Eligibility Criteria:
Inclusion Criteria:
* patients with rectal adenocarcinoma who underwent to resection after combined NRCT at University Campus Bio-Medico di Roma from January 2005 to March 2015.
To evaluate the anastomotic dehiscence were excluded patients undergone to Abdomino-perineal resection (APR) and 4 patients for whom data were not available.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04013347
|
{
"brief_title": "Outcomes of Resection at Different Times Between the End of Neoadjuvant Treatment and Surgery",
"conditions": [
"Neoadjuvant Chemoradiotherapy",
"Rectal Tumor",
"Surgery",
"Surgery--Complications"
],
"interventions": [
"Procedure: Rectal Resection"
],
"location_countries": null,
"nct_id": "NCT04013347",
"official_title": "Evaluation of Anatomopathological, Oncological and Surgical Outcomes in Relation to the Different Times Between the End of Neoadjuvant Treatment and Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-03-01",
"study_completion_date(actual)": "2017-03-21",
"study_start_date(actual)": "2005-01-01"
},
"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)": "2019-07-09",
"last_updated_that_met_qc_criteria": "2019-07-06",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-09",
"first_submitted": "2019-06-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This clinical trial evaluates the use of a blood test (Guardant Shield™) for colorectal cancer screening. Colorectal cancer is the third leading cancer and cause of death in the United States. Screening may help doctors find colorectal cancer early when it is easier to treat yet nearly a third of all people eligible for screening have never had a screening test performed. Currently, doctors use a stool- based test such as the fecal immunochemical test (FIT) and visual tests such as a colonoscopy. Blood based testing such as Guardant Shield™, may provide a quick and effective way to screen patients that are hard to reach or with limited access (underserved).
Detailed Description
PRIMARY OBJECTIVES:
I. Recruit women age 45 years and older who are in need of colorectal cancer screening from minority and underserved populations via a community mammography van.
II. Obtain data regarding knowledge, attitudes and beliefs about colorectal cancer screening.
OUTLINE:
Participants undergo blood specimen collection and complete survey on study. Participants may optionally undergo standard of care FIT testing on study.
#Intervention
- PROCEDURE : Biospecimen Collection
- Undergo blood sample collection
- Other Names :
- Biological Sample Collection, Biospecimen Collected, Specimen Collection
- OTHER : Survey Administration
- Complete survey
|
#Eligibility Criteria:
Inclusion Criteria:
* Women aged 45 years and older who are in need of colorectal screening
* Do not have a history of cancer
* Able to read and understand English
* Have a provider to receive the results of the test and who will follow-up test results
* Able to provide informed consent
Sex :
FEMALE
Ages :
- Minimum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05716477
|
{
"brief_title": "Blood Test (Guardant Shield™) for Screening of Colorectal Cancer in Underserved Patients",
"conditions": [
"Colorectal Carcinoma"
],
"interventions": [
"Other: Survey Administration",
"Procedure: Biospecimen Collection"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05716477",
"official_title": "The Ohio State University Guardant Shield™ Colorectal Cancer Screening Project",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-11-30",
"study_completion_date(actual)": "2024-11-30",
"study_start_date(actual)": "2022-12-23"
},
"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)": "2025-01-09",
"last_updated_that_met_qc_criteria": "2023-01-27",
"last_verified": "2023-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-02-08",
"first_submitted": "2023-01-19",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population.
Detailed Description
This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population. The BIS system will be used on-label as approved in the respective study site countries to monitor and non-invasively measure and interpret brain wave activity directly related to the effects of anesthetic agents. The study's purpose is to evaluate the relationship between BIS parameters, age, and depth of anesthesia in patients undergoing surgery under general anesthesia.
#Intervention
- DEVICE : Bispectral (BIS™) Complete Monitoring System
- The BIS™ Complete Monitoring System is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS technology converts raw EEG data acquired from the frontal cortex into a single number to measure the level of consciousness, called the BIS index. A bilateral sensor is to be placed on the patient's forehead to collect the EEG signals and transmit them back to the system.
|
#Eligibility Criteria:
Inclusion Criteria:
A potential subject may be included for participation in the study if the subject has/is:
* >=18 years
* American Society of Anesthesiologists (ASA) physical status I-III
* Able and willing to participate in the study and sign the informed consent form
* Will undergo non-ambulatory elective surgery under general anesthesia
* Has an expected surgery time >2 hours
Exclusion Criteria:
A potential subject will be excluded from participating in the study if the subject has/is:
* Pregnant
* Unwilling to undergo EEG measurement
* Undergone brain surgery procedure or had a cerebrovascular accident or severe head trauma in the last 10 years
* Alcohol or illicit drug use, which prevents normal functioning in society or has led to organ toxicity. Chronic use of opioids, narcotics, or analgesics, which may limit a subject's responsiveness to analgesic dosages.
* Known or suspected electroencephalograph abnormality (e.g., epilepsy or scarring)
* Presence of a major psychiatric condition such as Bipolar disorder/ schizophrenia/ Alzheimer's disease/ dementia/ Parkinson's disease /major depression
* Severe visual or auditory disorder
* Cannot understand or is unwilling to perform the study assessments, according to the investigator's judgment
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
|
NCT04765046
|
{
"brief_title": "The Influence of Age on EEG Signals and Consciousness During Anesthesia",
"conditions": [
"Anesthesia"
],
"interventions": [
"Device: Bispectral (BIS™) Complete Monitoring System"
],
"location_countries": [
"Israel",
"Netherlands"
],
"nct_id": "NCT04765046",
"official_title": "The Influence of Age on EEG Signals and Consciousness During Anesthesia (TIARA)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-04-03",
"study_completion_date(actual)": "2023-04-03",
"study_start_date(actual)": "2021-08-18"
},
"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)": "2024-07-03",
"last_updated_that_met_qc_criteria": "2021-02-19",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-21",
"first_submitted": "2021-01-08",
"first_submitted_that_met_qc_criteria": "2024-06-28"
}
}
}
|
#Study Description
Brief Summary
This Phase 1/2 open-label study will combine methods for conducting MDMA-assisted therapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners (intimate or non-intimate significant other who does not have a current diagnosis of PTSD) in order to explore whether combined treatment is effective. Each therapy team will have one therapist trained and experienced in MDMA assisted psychotherapy and one therapist trained and experienced in CBCT. During the first experimental session, both participants will receive 75 mg of MDMA followed 1.5 to 2 hours later by an optional supplemental half-dose of 37.5 mg. During the second experimental session, an initial dose of either 100 or 75 mg of MDMA will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 37.5 mg. The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in CAPS-5 total severity scores in PTSD participants.
Detailed Description
PTSD is a stress-related psychiatric condition that may occur following a traumatic event such as war, disaster, sexual abuse, violence, terrorism, and accidents. PTSD negatively impacts a person's daily life, resulting in relationship difficulties, difficulty in finding and maintaining a job, reduced cognitive and psychosocial functioning, substance abuse, high-cost healthcare use, and increased depression and suicide risk.
3,4-methylenedioxymethamphetamine is a drug that releases serotonin, norepinephrine and dopamine in the brain and indirectly increases levels of the neurohormones oxytocin, arginine vasopressin and cortisol. In the context of psychotherapy, MDMA has been noted to reduce defenses and fear of emotional injury while enhancing communication and capacity for introspection.
Cognitive-Behavioral Conjoint Therapy (CBCT) for PTSD is a three-phase, 15-session, manualized treatment. This Phase 1/2 open-label study will combine methods for conducting MDMA-assisted therapy with methods from the CBCT for PTSD in order to treat 10 participants with chronic PTSD and their partners (intimate or non-intimate significant other who does not have a current diagnosis of PTSD) in order to explore whether combined treatment is effective. Each therapy team will have one therapist trained and experienced in MDMA assisted therapy and one therapist trained and experienced in CBCT. During the first experimental session, both participants will receive 75 mg of MDMA followed 1.5 to 2 hours later by an optional supplemental half-dose of 37.5 mg. During the second experimental session, an initial dose of either 100 or 75 mg of MDMA will be administered to both participants followed by an optional supplemental half-dose of either 50 mg or 37.5 mg. The primary objective of this study is to assess changes in PTSD symptoms from Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity scores in PTSD participants.
#Intervention
- DRUG : MDMA
- Two sessions of MDMA-assisted therapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
- Other Names :
- 3,4-Methylenedioxymethamphetamine, midomafetamine
- BEHAVIORAL : CBCT
- A three-phase, 15-session, manualized treatment from the CBCT manual
- Other Names :
- Cognitive behavioral conjoint therapy
- BEHAVIORAL : Therapy
- Non-directive therapy (from the Multidisciplinary Association for Psychedelic Studies MDMA-assisted therapy treatment manual)
|
#Eligibility Criteria:
Inclusion Criteria:
* All inclusion criteria for the PTSD and Concerned Significant Other (CSO) are identical except for first two items, marked below:
* PTSD+ participant: Meet DSM-5 criteria for current PTSD and satisfies PTSD criteria via CAPS
* CSO participant: Meet criteria for V62.89 Other Problem Related to Psychosocial Circumstances under Diagnostic and Statistical Manual 5 (DSM-5), as determined through clinical interview, for current psychosocial circumstances contributing to relationship distress with intimate or non-intimate partner
* Are at least 18 years
* If in psychotherapy, willing and able to maintain that schedule without changing it
* Are willing to refrain from taking any psychiatric medications during the study period, with the exception of gabapentin when prescribed for pain control.
* Willing to remain overnight at the study site
* Are willing to be driven home the morning after the experimental sessions, after the integrative therapy session
* Are willing to commit to medication dosing, experimental sessions, follow-up sessions, to complete evaluation instruments and commit to be contacted for all necessary telephone contacts
* Are willing to remain overnight at the study site after each experimental session until after the integrative session occurring the next morning
* Must have a negative pregnancy test at study entry and prior to each experimental session if able to bear children, and must agree to use adequate birth control through 10 days after the last dose of MDMA.
* Must provide a contact (relative, spouse, close friend or other caregiver other than the CSO participant) who is willing and able to be reached by the Clinical Investigators in the event of a participant becoming suicidal.
* Must agree to inform the Clinical Investigators within 48 hours of any medical conditions and procedures
* Are proficient in speaking and reading English
* Agree to have all clinic visit and Integrative Sessions recorded to audio and video
* Agree to not participate in any other interventional clinical trials during the duration of this study
Exclusion Criteria:
* The following exclusions are identical for PTSD+ and CSO participants except for the following, marked below:
* CSO participant only: Have diagnosis of current PTSD not in remission
* Are pregnant or nursing, or are women of child bearing potential who are not practicing an effective means of birth control
* Have evidence or history of significant medical disorders
* Have hypertension
* Have liver disease; asymptomatic participants with Hepatitis C who have previously undergone evaluation and successful treatment is permitted.
* History of hyponatremia or hyperthermia
* Weigh less than 48 kg
* Are abusing illegal drugs
* Are not able to give adequate informed consent
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
|
NCT02876172
|
{
"brief_title": "MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD",
"conditions": [
"Posttraumatic Stress Disorder"
],
"interventions": [
"Behavioral: CBCT",
"Drug: MDMA",
"Behavioral: Therapy"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02876172",
"official_title": "A Phase 1/2 Open-Label Treatment Development Study of Methylenedioxymethamphetamine (MDMA)-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic Posttraumatic Stress Disorder (PTSD)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-16",
"study_completion_date(actual)": "2018-05-29",
"study_start_date(actual)": "2016-07-03"
},
"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)": "2024-01-24",
"last_updated_that_met_qc_criteria": "2016-08-18",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-08-23",
"first_submitted": "2016-08-16",
"first_submitted_that_met_qc_criteria": "2021-07-15"
}
}
}
|
#Study Description
Brief Summary
Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.
#Intervention
- DRUG : Loteprednol Etabonate
- Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.
- DRUG : Vehicle of Ophthalmic Loteprednol Etabonate
- Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects at least 18 years
* Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
* Subjects who are candidate for routine, uncomplicated cataract surgery.
* Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening.
* Subjects must be willing and able to comply with all treatment and follow- up procedures.
Exclusion Criteria:
* Subjects who have known hypersensitivity or contraindication to the study drug or its components.
* Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
* Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
* Subjects with elevated intraocular pressure (>= 21 mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
* Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
* Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit.
* Women who are pregnant or breast feeding.
* Subjects who have participated in an investigational drug or device study within the last 30 days.
* Subjects previously randomized in this study.
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
|
NCT00699153
|
{
"brief_title": "Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery",
"conditions": [
"Ocular Inflammation"
],
"interventions": [
"Drug: Vehicle of Ophthalmic Loteprednol Etabonate",
"Drug: Loteprednol Etabonate"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00699153",
"official_title": "Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-05",
"study_completion_date(actual)": "2009-06",
"study_start_date(actual)": "2008-06"
},
"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)": "2015-03-24",
"last_updated_that_met_qc_criteria": "2008-06-16",
"last_verified": "2015-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-06-17",
"first_submitted": "2008-06-13",
"first_submitted_that_met_qc_criteria": "2010-09-01"
}
}
}
|
#Study Description
Brief Summary
The primary purpose of this study is to evaluate the pharmacokinetic (PK) and systemic exposure of JNJ-63549109 and JNJ-64167896 after a single oral dose of JNJ-64041575 in adult participants with various degrees of renal function (mildly, moderately, or severely impaired, or end-stage renal disease \[ESRD\] with or without hemodialysis) compared to adult participants with normal renal function.
#Intervention
- DRUG : JNJ-64041575
- All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4\*250 mg tablets) on Day 1.
- Other Names :
- ALS-008176, lumicitabine
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant must have a body mass index (BMI: body weight in kilogram (kg) divided by the square of height in meters) of 18.0 to 36.0 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg, inclusive, at screening
* Contraceptive use by female participants, male participants and their female partners should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies if these are stricter than what is proposed in these inclusion criteria in the protocol
Participants with normal renal function (Group 1):
*Participant must have an estimated glomerular filtration rate (eGFR) >= 90 milliliter per minute (mL/min)
Participants with renal impairment (Groups 2 to 4):
* The following classifications of renal function are used: Mild renal impairment (eGFR greater than or equal to [>=] 60 to less than [<] 90 mL/min), Moderate renal impairment (eGFR >= 30 to <60 mL/min), Severe renal impairment (eGFR >=15 to <30 mL/min)
Participants with end-stage renal disease (ESRD) with or without hemodialysis (Group 5):
* Participant must have an eGFR <15 mL/min if not on hemodialysis
* Participant on hemodialysis treatment must have been on the same hemodialysis regimen for at least 3 months before screening
Exclusion Criteria:
All participants (Groups 1 to 5):
* Participant has any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug (example, Crohn's disease), with the exception of renal impairment
* Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Participant with a history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy diagnosed in previous studies with experimental drugs
* Participant has known allergies, hypersensitivity, or intolerance to JNJ-64041575 or its excipients
* Participants with evidence of an active infection
* Participant is a woman who is pregnant or breastfeeding
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03189498
|
{
"brief_title": "A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Participants With Various Degrees of Renal Function",
"conditions": [
"Renal Insufficiency"
],
"interventions": [
"Drug: JNJ-64041575"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT03189498",
"official_title": "A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-64041575 in Adult Subjects With Various Degrees of Renal Function",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-06",
"study_completion_date(actual)": "2017-12-06",
"study_start_date(actual)": "2017-07-11"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-04-17",
"last_updated_that_met_qc_criteria": "2017-06-15",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-06-16",
"first_submitted": "2017-06-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a phase II therapeutic study of adding exemestane therapy in post-menopausal women with advanced non-small cell lung cancer (NSCLC) who are progressing while on treatment with an immune checkpoint antibody (pembrolizumab, atezolizumab, or nivolumab).
#Intervention
- DRUG : Exemestane
- One 25 mg tablet once daily for a minimum of 6 weeks
- Other Names :
- Aromasin
|
#Eligibility Criteria:
Inclusion Criteria
* Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component) with most recent treatment being an FDA approved immune checkpoint inhibitor (pembrolizumab, atezolizumab, or nivolumab) NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis
* Sufficient tumor tissue available from original diagnosis or subsequent biopsy for analysis of estrogen receptor and aromatase - tumor block or a minimum of 5 unstained slides
* Failed at least 1 prior FDA approved treatment for advanced NSCLC. Patients with EGFR/ALK/ROS1 rearrangements should have received an FDA-approved TKI prior to enrollment on this trial.
* Measureable disease by RECIST version 1.1
* Post-menopausal defined as
* Age >= 55 years and 1 year or more of amenorrhea
* Age < 55 years and 1 year or more of amenorrhea with an estradiol assay < 20 pg/mL
* Surgical menopause with bilateral oophorectomy
* ECOG performance status 0, 1 or 2
* Life expectancy of 3 months or more in the opinion of the enrolling investigator and documented in the medical record
* Adequate organ function within 14 days of study enrollment defined as:
* Hematology:
** Absolute neutrophil count (ANC) >= 1500/mm³, Platelets >= 100,000/mm³, Hemoglobin >= 8 g/dL
* Biochemistry:
* Total Bilirubin within normal institutional limits
* AST/SGOT and ALT/SGPT <= 2.5 x upper limit of normal (ULN), except if there is known hepatic metastasis, wherein transaminases may be <= 5 x institutional ULN.
* Serum creatinine <= 1.5 mg/dl or glomerular filtration rate > 50 ml/min
* Must have recovered to CTCAE v 4 Grade 1 or better from the acute effects of any prior surgery, chemotherapy or radiation therapy. Chronic residual toxicity (i.e. peripheral neuropathy) is permitted.
* A minimum time period must elapse between the end of a previous treatment and start of study therapy:
* 1 week from the completion of radiation therapy for brain metastases
* 4 weeks from the completion of chemotherapy or any experimental therapy
* 4 weeks from prior major surgery (such as open biopsy or significant traumatic injury)
* Voluntary written consent before any research related procedures or therapy
Exclusion Criteria
* Known active CNS disease - If patient has history of brain metastases, the brain lesions must have been treated with radiation and/or surgery - patients should be neurologically stable and requiring <=10mg oral prednisone equivalence of steroids per day
* Any toxicity from immune-related toxicity from prior immune therapy that would preclude further treatment with anti-PD-1/PDL-1 inhibitor or ongoing IR toxicity >= Grade 2
* Requiring > 10 mg prednisone equivalence of steroids per day for immune-related toxicity
* Inability or unwilling to swallow study drug
* Any gastrointestinal condition causing malabsorption or obstruction (eg, celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome)
* Currently using hormone replacement therapy (oral or patch) or/and phytoestrogen supplements (i.e. black cohosh)
* Known hypersensitivity to exemestane or its excipients
* Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment
* Prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free interval
* Concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort as these may significantly reduce the availability of exemestane
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02666105
|
{
"brief_title": "Exemestane in Post-Menopausal Women With NSCLC",
"conditions": [
"Non-Small Cell Lung Cancer"
],
"interventions": [
"Drug: Exemestane"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02666105",
"official_title": "Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-02-28",
"study_completion_date(actual)": "2022-02-28",
"study_start_date(actual)": "2018-09-27"
},
"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)": "2023-05-31",
"last_updated_that_met_qc_criteria": "2016-01-25",
"last_verified": "2023-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-01-28",
"first_submitted": "2016-01-22",
"first_submitted_that_met_qc_criteria": "2023-05-03"
}
}
}
|
#Study Description
Brief Summary
This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.
#Intervention
- DRUG : Olmesartan medoxomil
- Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.
- DRUG : Losartan
- Medications are taken once daily before breakfast with water.
- DRUG : Furosemide oral tablets
- If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator
|
#Eligibility Criteria:
Inclusion Criteria:
* Mean sitting BP prior to randomization of 140 <= age <= 180/90 <= age <= 109 mmHg;
* Renal impairment prior to randomization of mild (50 <= CLcr >= 80 mL/min) to moderate (30 <= CLcr >=50 mL/min) severity
Exclusion Criteria:
* Malignant hypertension or sitting BP greater than 180/109 mmHg;
* Severe heart failure, severe renal disease;
* Recent history of myocardial infarction, stroke or transient ischemic attack;
* History, clinical or current evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial;
* Hypersensitivity or contraindications to ARBs or ACE inhibitors or any cross allergy;
* Treatment with dis-allowed medication;
* Pregnant or breastfeeding females or females of childbearing potential without adequate contraception;
* History of drug and/or alcohol abuse
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
|
NCT00151827
|
{
"brief_title": "Olmesartan Medoxomil in Hypertension and Renal Impairment",
"conditions": [
"Essential Hypertension",
"Renal Impairment"
],
"interventions": [
"Drug: Furosemide oral tablets",
"Drug: Losartan",
"Drug: Olmesartan medoxomil"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT00151827",
"official_title": "Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-07",
"study_completion_date(actual)": "2005-07",
"study_start_date(actual)": "2003-08"
},
"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)": "2010-10-14",
"last_updated_that_met_qc_criteria": "2005-09-08",
"last_verified": "2010-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-09",
"first_submitted": "2005-09-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Work hypothesis
A diet rich in sardine will improve the metabolic control in type 2 diabetes patients.
#Intervention
- OTHER : Sardine diet
- Diet rich in sardine: 100g/day of sardine 5 times a week
|
#Eligibility Criteria:
Inclusion Criteria:
* Age > 40 years and < 85
* BMI >= 25 and < 35
* Patients diagnosed with type 2 diabetes at onset or treated only by diet
* HbA1c between 6.0 and 8.0% (based on the last measured and documented laboratory measurement of the previous 3 months)
* Usual consumption <= 3 fish per week
Exclusion Criteria:
* T2D treated with antidiabetic oral drugs and/or insulin
* Current or previous (within 3 months) intake of omega 3 suplements
* Known allergy or intolerance to fish or fish protein
* Diagnosis of active neoplasic disease
* Suffering from an acute illness which requires a recovery period higher than one week
* Currently chronic treatment with oral steroids or nonesteroidal anti-inflammatory for more than 5 days, at least 1 month before randomization
* Pregnant or breast-feeding patients
* Serious acute vascular events (cardiac or cerebral) diagnosed previous 2 months before the randomization
* Current or previous (within 6 months) participation in another study
* Chronic renal insufficiency (creatinine >1,5 mg/dl)
* Any conditions that the investigator considers may render the patient unable to complete the study
During the interventional study, based on current standards of T2D care, doctors will introduce anti-diabetic oral drugs or insulin into the patient's treatment, where they consider it to be necessary.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02294526
|
{
"brief_title": "A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus Patients",
"conditions": [
"Type 2 Diabetes"
],
"interventions": [
"Other: Sardine diet"
],
"location_countries": null,
"nct_id": "NCT02294526",
"official_title": "PILCHARDUS STUDY: A Sardine Diet Intervention Study to Assess Benefits to the Metabolic Profile in Type 2 Diabetes Mellitus 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)": "2012-11"
},
"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)": "2015-01-29",
"last_updated_that_met_qc_criteria": "2014-11-16",
"last_verified": "2014-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-11-19",
"first_submitted": "2014-10-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to decide the best dose of the study drug, PU-H71, that can be given in combination with the standard chemotherapy drug, nab-paclitaxel (Abraxane).
#Intervention
- DRUG : PU-H71
- PU-H71 will be given as an intravenous infusion on Day 1 of a 21 day cycle
- DRUG : Nab-paclitaxel
- nab-paclitaxel will be administered at a dose of 260mg/m2 intravenously on Day 1
- Other Names :
- Abraxane
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* Signed informed consent
* Patients must have histologically confirmed HER2-negative breast cancer (defined as IHC 0 or 1+ and/or fluorescence in situ hybridization [FISH] < 2.0), that is metastatic in stage
* For estrogen receptor (ER)-positive breast cancer, patients must be considered refractory to endocrine therapy, having received and progressed through at least one prior line of endocrine therapy, or are intolerant of endocrine therapy
* All patients must have progressed on at least one line of cytotoxic therapy for metastatic disease
* Patients must have evidence of progressive disease
* Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
* Hematologic parameters: white blood cell (WBC) count of >= 3000/ul, absolute neutrophil count (ANC) >= 1500/ul, platelets >= 100,000/ul, hemoglobin >= 9.0 g/dl
* Non-hematologic parameters: bilirubin <= 1.5 mg/dl, AST/ALT <= 3.0 x upper limit of normal (ULN) (<= 5.0 x ULN if liver metastases are involved)
* Serum creatinine < 1.5 xULN or CrCl > 40 mL/min (measured or calculated using the Cockcroft-Gault formula)
* An Eastern Cooperative Oncology Group performance status of 0 <= age <= 2
* Life expectancy of 3 months or more as assessed by the investigator
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
* Negative β-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause.
* Women of childbearing potential must agree and commit to the use of a highly effective method of contraception. Men must agree and commit to use a barrier method of contraception while on treatment and for 3 months after last dose of investigational products.
Exclusion Criteria:
* Symptomatic brain or CNS metastases. Previously treated and stable CNS disease is allowed.
* Any of the following for the treatment of cancer within 2 weeks of first study treatment: chemotherapy, immunotherapy, experimental therapy, or biologic therapy.
* Radiation therapy (other than palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment
* Any major surgical procedure within 4 weeks of first study treatment
* Prior treatment with Abraxane
* Active liver disease, including viral or other hepatitis, or cirrhosis
* Pregnancy or lactation
* Other active infections aside from hepatitis
* Any other significant medical condition not under control, including any acute coronary syndrome within the past 6 months.
* Patients with a permanent pacemaker
* Patients with a QTc > 480 ms in the baseline EKG
* Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable/evaluable disease
* Peripheral neuropathy of grade >= 2 per NCI CTCAE, Version 4.0, at the time of or within 3 weeks prior to the first study therapy
* Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results in the judgment of the investigator
* History of an invasive second primary malignancy diagnosed within the previous 3 years, except for appropriately treated stage I endometrial or cervical carcinoma or prostate carcinoma treated surgically, and non-melanoma skin cancer.
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
|
NCT03166085
|
{
"brief_title": "PU-H71 With Nab-paclitaxel (Abraxane) in Metastatic Breast Cancer",
"conditions": [
"Metastatic Breast Cancer"
],
"interventions": [
"Drug: PU-H71",
"Drug: Nab-paclitaxel"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03166085",
"official_title": "A Phase 1b Study of PU-H71 With Nab-paclitaxel (Abraxane) in Patients With HER2-Negative Metastatic Breast Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-14",
"study_completion_date(actual)": "2021-12-14",
"study_start_date(actual)": "2017-05-23"
},
"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)": "2021-12-20",
"last_updated_that_met_qc_criteria": "2017-05-23",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-05-24",
"first_submitted": "2017-05-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
OBJECTIVE: Investigate structural changes in the human gut microbiota and associated changes in metabolic markers in urine, saliva, blood and fecal samples following metformin treatment.
DESIGN: An, 18 week, one-armed cross over intervention trial consisting of a 6-week pre-intervention period, 6-week intervention period and a 6-week post-intervention period. 25 healthy young men will be included in the trial.
INTERVENTION: Six-week Metformin treatment to young healthy men.
Detailed Description
An, 18 weeks, one-armed cross over intervention trial consisting of a 6-weeks pre-intervention period, 6-weeks intervention period and a 6-weeks post-intervention period. 25 healthy young men will be included in the trial. The pre-intervention period is the control period with no treatment. During the intervention period participants will receive 500 mg of metformin once daily the 1st week, then 500 mg twice daily the 2nd week, 1000 mg + 500 mg daily the 3rd week and 1000 mg + 1000 mg daily the remaining three weeks. Post-interventional investigators will examine gut microbiota of the participants 6 weeks after completion of the intervention period.
MESUREMENTS: Altered composition of gut microbiota as investigated by 16S rRNA sequencing is the primary outcome of this study. Secondary outcomes are to investigate changes in metabolic and inflammatory markers in blood and fecal samples. Blood, urine, saliva and fecal samples will be stored for future studies.
#Intervention
- DRUG : Metformin
|
#Eligibility Criteria:
Inclusion Criteria:
* Male
* HbA1c < 5.7 % (39 mmol/mol)
* Caucasian (self-report of parental ethnicity)
* Weight stabile with 18.5 kg/m2 < BMI < 27.0 kg/m2
* Normal kidney function as evaluated by normal p-creatinine for age
Exclusion Criteria:
* Oral intake of any form of prescribed medication two months prior to recruitment
* Chronic or acute illness
* Previous gastro-intestinal operation excluding appendicitis
* Any other significant medical reason for exclusion as determined by the investigator
* Unable to give informed consent
* Need of medical treatment during the study period
Sex :
MALE
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
|
NCT02546050
|
{
"brief_title": "The Effect of Metformin on Composition of Human Gut Bacteria",
"conditions": [
"Healthy"
],
"interventions": [
"Drug: Metformin"
],
"location_countries": [
"Denmark"
],
"nct_id": "NCT02546050",
"official_title": "Effects of Metformin on Human Gut Microbiota",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-02",
"study_completion_date(actual)": "2016-02",
"study_start_date(actual)": "2015-06"
},
"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)": "2016-02-17",
"last_updated_that_met_qc_criteria": "2015-09-07",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-09-10",
"first_submitted": "2015-07-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a randomised, open-label, confined, cross-over study to evaluate the nicotine pharmacokinetics (PK) of modern oral nicotine pouches and nicotine lozenges carried out in 36 healthy adult subjects who smoke cigarettes and who may have experience using smokeless tobacco (loose or pouches).
Detailed Description
Starting on Day 1, subjects will check-in at the clinical site to complete procedures to confirm eligibility. Following basic check-in procedures (e.g., urine pregnancy test, urine drug screen, alcohol test and vital signs), subjects will continue with a 7-day confinement. Subjects will be randomized to a product sequence (using a Williams design).
Test sessions will occur every day during the remainder of the study. The active period of each test session will last for approximately 4 hours after the start of Investigational Product (IP) use. During each test session, a subject will be required to use their randomized IP and during the session, PK blood draws and a subjective effects questionnaire will be collected.
The day prior to each test session, subjects will participate in a product familiarization period in which they will use one pouch or lozenge of their randomized IP. The product familiarization period will occur after the scheduled test session (or after enrollment and randomization on Day 1) and before the 12-hour tobacco and nicotine abstinence period. Subjects should use the IP pouch for at least 30 minutes or allow the lozenge to dissolve slowly.
Subjects will provide usual brand (UB) cigarettes for use during study confinement and have access to their UB cigarettes for ad libitum use with the exception of 1) during the test session, 2) during the the minimum 12-hour tobacco and nicotine abstinence period prior to each test session and 3) a minimum of one hour after IP use during the product familiarization period. Each UB cigarette must be requested from site staff and used butts returned to site staff for accountability.
#Intervention
- OTHER : Product A
- A 4mg nicotine pouch product
- OTHER : Product B
- A 4mg nicotine pouch product
- OTHER : Product C
- A 2mg nicotine lozenge product
- OTHER : Product D
- A 2mg nicotine lozenge product
- OTHER : Product E
- A 2mg nicotine lozenge product
- OTHER : Product F
- A 2mg nicotine lozenge product
|
#Eligibility Criteria:
Inclusion Criteria:
* Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
* Generally healthy males or females, 21 <= age <= 60 of age, inclusive, at the time of consent.
* Smoke manufactured combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco.
* Smokers who self-report use of a smokeless tobacco product (loose or pouch) prior to screening may also be enrolled.
* Smokes an average of at least 10 cigarettes per day (CPD) and inhale the smoke, for at least 6 months prior to screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of screening), or clinical study participation (prior to 30 days of screening) will be allowed at the discretion of an investigator.
* Agrees to smoke the same Usual Brand (UB) cigarette throughout the study period. The UB cigarette is defined as the reported cigarette brand and style currently smoked most frequently by the subject. If a subject reports use of a different UB cigarette at check in, that subject may continue provided they use that same UB cigarette throughout the study.
* Expired breath carbon monoxide (ECO) level is >= 10 ppm and <= 100 ppm at screening.
* Positive urine cotinine test at screening.
* Willing to use the UB cigarette and nicotine pouch or lozenge IPs during the study period.
* Willing to abstain from tobacco and nicotine use for at least 12 hours prior to start of each of six test sessions.
* If female and of non-childbearing potential, must meet one of the following criteria:
1. Surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion); or
2. In a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels (>=40 mIU/mL).
* If female and of childbearing potential, must agree to use one of the accepted contraceptive regimens from at least 30 days prior to the first administration of the IP during the study, and for at least 30 days after the last dose of the IP. An acceptable method of contraception includes one of the following:
1. Abstinence from heterosexual intercourse;
2. Hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch);
3. Intrauterine device (with or without hormones); or
4. Use of a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of the study medication.
* Agrees to an in-clinic confinement of 7 days (6 nights).
Exclusion Criteria:
* Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of an investigator, makes the study subject unsuitable to participate in this clinical study.
* History, presence of, or clinical laboratory test results indicating diabetes.
* Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the screening visit. As-needed treatment, such as inhalers, may be included at an investigator's discretion pending approval from the Medical Monitor.
* History or presence of bleeding or clotting disorders.
* Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
* Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes at screening and at check-in Day 1.
* Weight of <= 110 pounds.
* Hemoglobin level is < 12.5 g/dL for females or <13.0 g/dL for males at screening.
* Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
* Positive urine drug screen without evidence of a prescription or urine alcohol test at Day 1 (check-in), with the exception of for tetrahydrocannabinol (THC). If positive for THC, a cannabis intoxication evaluation will be performed at check-in, and inclusion will be at the discretion of an investigator.
* Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
* Self reports use of the study IP (nicotine pouches or lozenges) currently or in the past.
* Recreationally uses vapor products (e.g., e-cigarettes, tank systems) more than one day per week, for the past 6 months prior to screening.
* Current, regular user (i.e., > 5 times per month) of any tobacco products other than combustible cigarettes or smokeless tobacco within the last 6 months prior to screening.
* Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (<=) 30 days prior to the signing of informed consent.
* Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or self-reports a previous attempt within (<=) 30 days prior to the signing the informed consent.
* Any use of aspirin (>= 325 mg/day) or anticoagulants within (<=) 30 days prior to the signing of informed consent.
* Individuals >= 35 years currently using systemic, estrogen-containing contraception or hormone replacement therapy.
* Whole blood donation within 8 weeks (<= 56 days) prior to the signing of informed consent and between screening and check-in Day 1.
* Plasma donation within (<=) 7 days prior to the signing of informed consent and between screening and check-in Day 1.
* Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
* Participation in another clinical trial within (<=) 30 days prior to the signing of informed consent. The 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing of informed consent in the current study.
* Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol result at screening or check-in Day 1.
* Determined by an investigator to be inappropriate for this study.
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
|
NCT04755348
|
{
"brief_title": "A Study to Assess the Pharmacokinetics of Oral Nicotine Pouches and Lozenges in Healthy Adults",
"conditions": [
"Tobacco Use",
"Tobacco Smoking",
"Cigarette Smoking"
],
"interventions": [
"Other: Product F",
"Other: Product D",
"Other: Product C",
"Other: Product B",
"Other: Product A",
"Other: Product E"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04755348",
"official_title": "A Single Dose, Randomised, Crossover Study to Assess the Pharmacokinetics of Oral Nicotine Pouches and Lozenges in Healthy Adults",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-03-20",
"study_completion_date(actual)": "2021-03-25",
"study_start_date(actual)": "2021-02-18"
},
"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)": "2021-03-30",
"last_updated_that_met_qc_criteria": "2021-02-11",
"last_verified": "2021-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-16",
"first_submitted": "2021-02-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Capsaicin to Control Pain Following Third Molar Extraction
Summary: This study will test the effectiveness of the drug capsaicin in controlling pain after third molar (wisdom tooth) extraction. Capsaicin, the ingredient in chili peppers that makes them 'hot,' belongs to a class of drugs called vanilloids, which have been found to temporarily inactivate pain-sensing nerves. If capsaicin alleviates pain in dental surgery, it may have potential for use in many types of surgery and painful illnesses.
Healthy normal volunteers between 16 and 40 years of age who require third molar (wisdom tooth) extraction may be eligible for this study. Participants undergo the following procedures in three visits:
Visit 1
Patients have touch (sensory) testing inside the mouth using three methods: 1) applying a temperature probe onto the gums and having the patient rate how warm it is; 2) applying a gentle stroke across the gums with the bristles of a small paint brush and having the patient say whether or not it feels painful; and 3) applying a light touch to the gums with a small needle and having the patient rate the pain intensity following the touch. Following touch testing, the patient's mouth is numbed with an anesthetic and a small piece of gum tissue next to the lower wisdom tooth is removed (biopsied). Then, a small amount of either capsaicin or placebo (saline, or salt water) is injected next to the wisdom tooth.
Visit 2
Following repeat the touch testing, patients are sedated with an injection of midazolam. They then have another biopsy under local anesthesia on the same side of the mouth as the first biopsy. Their mouth is again numbed with an anesthetic, and they are given either a pain-relieving medicine called Toradol or a placebo injected into the arm. One lower wisdom tooth is then extracted. After the extraction, pain ratings are recorded every 20 minutes for up to 6 hours. During this time, patients are monitored for vital signs, numbness, pain, and side effects. Patients who request pain-relief medication are given acetaminophen and codeine. At the end of the study, they are discharged from the clinic and given acetaminophen and codeine to take at home, as instructed. They are provided a pain diary to record pain ratings and any adverse reactions that might occur until the last visit.
Visit 3
Patients return for a follow-up evaluation 48 hours after discharge from the clinic. At the end of the evaluation, they are discharged home with flurbiprofen for pain relief. Remaining wisdom teeth are removed 'off-study' no sooner than 1 week following the first visit.
Detailed Description
Successful preemptive analgesic strategies are superior to traditional pain management schemes in the management of post-operative pain. The premise of this double-blind, placebo and positive-controlled clinical study is to evaluate the efficacy of vanilloid agonists as preemptive agents in an oral surgery tissue injury model. Vanilloids are a class of small organic compounds; the most familiar of which is capsaicin, the active ingredient in hot pepper. Binding of capsaicin to the vanilloid-1 receptor produces initial activation and then long-acting desensitization of pain specific neurons. We propose to produce a selective, long-term inactivation of peripheral pain transmission through the local application of capsaicin in the oral mucosa in an effort to prevent or reduce post-operative pain in the oral surgery model. Healthy subjects will be recruited, and following local anesthesia and conscious sedation, will be given an intramucosal injection of either capsaicin or placebo, or as a positive control, intravenous ketorolac. Subjects will rate pain and time of analgesic rescue medication request will be noted. Small biopsies will be removed from the extraction site prior to drug injection and at 48 hr post-operatively. Tissue levels of neurogenic inflammatory mediators and sensory neuron content will be compared pre- and post-operatively. A decrease in post-operative pain and decrease in analgesic use will be taken as a positive effect of the vanilloid for decreasing post-operative pain. We anticipate that through the long term blockade of pain specific fibers pre-operatively that there will be significant attenuation of post-operative pain development following surgery. This has significant implications for reducing pain and suffering, decreasing analgesic use, and reducing post-operative complications following surgery.
#Intervention
- DRUG : Capsaicin (Intramucosal Injection)
|
#Eligibility Criteria:
INCLUSION CRITERIA:
Male or female volunteers referred for mandibular third molar extraction with a minimal difficulty rating score of 2 - 3 at the time of screening; rating will be verified by the oral surgeon at time of surgery. (Rating scale: 1 = erupted; 2 = soft tissue impaction; 3 = partial bony impaction; 4 = full bony impaction).
Age between 16 <= age <= 40.
ASA status 1 or 2, deemed in good general health (able to tolerate outpatient conscious sedation safely).
Willing to wait up to 4 hours for post-operative observation.
Willing to return at 48 hours for a second tissue biopsy.
EXCLUSION CRITERIA:
ASA status 3 <= age <= 5 and Emergency operation (E) that do not get a physician clearance; i.e. systemic disturbances that limits the patient's activity.
Pregnant or breast-feeding mothers.
Allergy to investigational drugs or to red chili peppers.
Chronic use of analgesics (not limited to, but including: non-steroidal anti-inflammatory medications, steroids, anti-depressants, anti-convulsants).
Presence of chronic disease (e.g. cardiovascular disease, liver disease, kidney disease, diabetes, etc.).
No exclusions will be made based on race, gender, or religion.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00088686
|
{
"brief_title": "Capsaicin to Control Pain Following Third Molar Extraction",
"conditions": [
"Healthy",
"Tooth Extraction"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00088686",
"official_title": "Evaluation of Vanilloid Receptor Inactivation for Preemptive Analgesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2005-10",
"study_start_date(actual)": "2004-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-03-04",
"last_updated_that_met_qc_criteria": "2004-07-30",
"last_verified": "2005-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2004-08-02",
"first_submitted": "2004-07-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
AIMS To determine the effect of high and low sucrose diets on liver fat in healthy adult men with liver fat levels below 5%
Detailed Description
DESIGN Randomized, cross-over design with two 7-day dietary interventions separated by a 4 week wash-out period. Dietary intervention will be based on iso-energetic substitution of sucrose for starch in a weight-maintaining diet. The two experimental conditions are: high sucrose diet at 25% of total energy intake (this is approximately the 95th percentile for UK intake of non-milk extrinsic sugars (NMES)); and low sucrose diet at 10% of total energy intake. Otherwise the macronutrient balance in both conditions will be based on UK average habitual intake.
POPULATION 10 healthy males aged between 20 and 40 years, with a BMI between 20-25kg/m2, with normal liver fat levels (\<5%) and fasting plasma glucose and no evidence of insulin resistance will be recruited. No pre-existing morbidity including cardiac, hepatic or renal disease, history of diabetes, hypertension or hyperlipidemia. Usual physical activity of subjects to range from sedentary to a maximum of meeting the UK minimum activity recommendations (30 min moderate exercise 5 d/week). Habitual alcohol intake of less than 2 units per day.
TREATMENT Pre-intervention: Participants will be asked to record habitual dietary intake by completion of a 7-day food diary and be asked to wear an accelerometer armband to assess physical activity before each intervention week. Resting energy expenditure will also be assessed by indirect calorimetry.
7 day dietary interventions: Participants will be resident at the clinical research facility at Hammersmith Hospital during each intervention week for 5 out of the 7 days and all food will be provided at the facility. At the weekends, participants will have to leave the unit but food will be provided for those two days so that the diet can be continued at home.
At the start and end of each 7 day intervention: Weight, height and waist circumference will be taken; percentage liver fat and total and regional body composition will be measured by MRI. Fasting and post prandial plasma glucose, insulin and lipids will be measured and blood pressure.
#Intervention
- DIETARY_SUPPLEMENT : Sucrose
|
#Eligibility Criteria:
Inclusion Criteria:
Healthy men aged between 20 and 40 years with BMI between 20 <= age <= 25 kg/m2 and with normal liver fat levels (<5%), normal fasting glucose (less than 5.5mmol/l) and HbA1C less than 5.7% will be eligible to volunteer.
Exclusion Criteria:
* Type 1 diabetes, Type 2 diabetes, hypertension or hyperlipidaemia
* Gained or lost >= 3kg weight in the past three months
* Use of medication likely to interfere with metabolism, appetite regulation, glucose homeostasis and hormonal balance
* Regular consumer of sugar sweetened beverages
* Any chronic illness
* Cardiovascular, hepatic or renal disease
* Excess alcohol intake (>2 units per day)
* Exceeding UK minimum activity recommendation (30min moderate exercise 5d/wk)
* Current smokers (smoked within last 6 months)
* Any gastrointestinal disorder e.g. Crohn's disease, coeliac disease or irritable bowel syndrome
* A history of drug or alcohol abuse in the last 2 years
* Pancreatitis
* Unable to have MRI (eg. metallic or magnetic implants, claustrophobia)
Sex :
MALE
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
|
NCT02015442
|
{
"brief_title": "Effect of Sucrose on Liver Fat",
"conditions": [
"Healthy Volunteers"
],
"interventions": [
"Dietary Supplement: Sucrose"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT02015442",
"official_title": "Effect of Eucaloric High and Low Sucrose Diets on Liver Fat in Healthy Adult Men With Liver Fat Levels Below 5%",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-10",
"study_completion_date(actual)": "2016-10",
"study_start_date(actual)": "2014-01"
},
"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)": "2019-11-14",
"last_updated_that_met_qc_criteria": "2013-12-18",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-12-19",
"first_submitted": "2013-12-13",
"first_submitted_that_met_qc_criteria": "2019-11-11"
}
}
}
|
#Study Description
Brief Summary
This double-blinded, randomised and controlled trial evaluates the efficacy of oxygen-enriched ELO drinking water as an adjuvant modality in diabetes care for enhancement of glycemic control in patients with Type 2 diabetes mellitus. Adults with type 2 diabetes will be randomized to drink 1.5 L of either ELO water or normal drinking water for 24 weeks. The primary outcome is improvement in glycaemic control.
Detailed Description
Global diabetes mellitus prevalence is rapidly increasing. In 2015, IDF reported that Singapore has 12.8% of its population diagnosed with diabetes mellitus, of which more than 90 percent are type 2 diabetes with underlying insulin resistance. With the aging population and increasing prevalence of obesity and sedentary lifestyles, the prevalence is expected to continue to rise.
In vitro studies demonstrated that hypoxia creates a state of insulin resistance through HIF (Hypoxia Inducible Factor) transcription factor expression in adipocytes. Insulin sensitivity was shown to improve in type 2 diabetes patients and overweight non diabetic patients placed in a hyperbaric oxygen chamber.Increased water intake has been associated with lower HbA1c in the general population , and also with lower post-prandial glucose in type 2 diabetic individuals.
This study aims to evaluate the effects of 1.5 L daily of ELO water, a drinking water enriched with molecular oxygen in a stable form, with a similar volume of bottled drinking water, on glycaemic control in adults with type 2 diabetes in Singapore.
#Intervention
- DIETARY_SUPPLEMENT : ELO Water
- oxygen-enriched water
- DIETARY_SUPPLEMENT : Placebo drinking water
- bottled drinking water
|
#Eligibility Criteria:
Inclusion Criteria:
Type 2 diabetes mellitus with HbA1c 8.0% to 11%, within the last 6 months
Exclusion Criteria:
* Type 1 diabetes patients
* Pregnant or lactating women
* Comorbid conditions requiring fluid restriction to below 1.5 L daily
* Terminal illness with life expectancy less than 1 year
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04127890
|
{
"brief_title": "ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control",
"conditions": [
"Diabetes Mellitus"
],
"interventions": [
"Dietary Supplement: Placebo drinking water",
"Dietary Supplement: ELO Water"
],
"location_countries": [
"Singapore"
],
"nct_id": "NCT04127890",
"official_title": "ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control (EDEN Study) - A Double-Blinded Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-28",
"study_completion_date(actual)": "2018-05-28",
"study_start_date(actual)": "2017-03-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-27",
"last_updated_that_met_qc_criteria": "2019-10-13",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-16",
"first_submitted": "2019-10-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I disorder.
#Intervention
- DRUG : olanzapine
- 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).
- Other Names :
- LY170053, Zyprexa
- DRUG : placebo
- placebo, capsules, by mouth every evening, daily, for 6 weeks.
- DRUG : divalproex
- dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 52 days (Study Period I and Study Period II).
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with a mixed episode of bipolar I disorder.
* Have had at least one previous manic or mixed episode associated with bipolar disorder
* You must be between 18 and 60 years.
* You must be able to visit the doctor's office three times in the first week and then once every week for the next five weeks.
* If you are a female, you must have a negative pregnancy test and be using an effective method of contraception.
Exclusion Criteria:
* You have a diagnosis of schizophrenia, schizoaffective disorder or substance abuse or dependence.
* You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood.
* Have required a recent thyroid hormone supplement to treat hypothyroidism (must have been on a stable dose of the medication for at least 2 months prior to Visit 3).
* You are allergic to any of the medications involved in this study.
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
|
NCT00402324
|
{
"brief_title": "A Comparison of Olanzapine in Combination With a Mood Stabilizer vs Mood Stabilizer Alone, in Mixed Bipolar Patients",
"conditions": [
"Bipolar I Disorder"
],
"interventions": [
"Drug: placebo",
"Drug: olanzapine",
"Drug: divalproex"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00402324",
"official_title": "A Double-Blind Placebo Controlled Trial of Divalproex and Olanzapine in Bipolar I Disorder, Mixed Episode",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-02",
"study_completion_date(actual)": "2008-02",
"study_start_date(actual)": "2006-12"
},
"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)": "2009-06-03",
"last_updated_that_met_qc_criteria": "2006-11-17",
"last_verified": "2009-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-11-22",
"first_submitted": "2006-11-17",
"first_submitted_that_met_qc_criteria": "2009-04-03"
}
}
}
|
#Study Description
Brief Summary
This study is designed to analyze the effect exosomes derived from red blood cell units have on blood coagulation and platelet function. It is an in vitro study using healthy volunteers' blood.
Detailed Description
The blood of 25 healthy volunteers will be exposed to exosomes derived from red blood cell units. The effects on coagulation and platelet function will be measured using thromboelastometry (ROTEM®) and FACS analysis.
#Intervention
- OTHER : in vitro study
- Exosomes will be mixed with healthy volunteers' blood in vitro
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy volunteers
Exclusion Criteria:
* pregnancy
* drug use
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:
Yes
|
NCT02594345
|
{
"brief_title": "Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation",
"conditions": [
"Blood Coagulation",
"Platelet Function"
],
"interventions": [
"Other: in vitro study"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT02594345",
"official_title": "In Vitro Study of the Effect of Exosomes Derived From Red Blood Cell Units on Platelet Function and Blood Coagulation in Healthy Volunteers' Blood",
"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)": "2015-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-02-23",
"last_updated_that_met_qc_criteria": "2015-10-30",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-11-03",
"first_submitted": "2015-10-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To determine if an intensive cardiac rehabilitation program with periodic reinforcements improve the compliance/adherence to secondary preventive measures (physical exercise, mediterranean diet, tobacco abstinence, pharmacological treatment) after an acute coronary syndrome with or without ST segment elevation versus an standard cardiac rehabilitation program
#Intervention
- OTHER : Intensive cardiac rehabilitation program in less time
- 2 weeks, 5 days a week, and reinforcement sessions at 3, 6 and 9 months
|
#Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Equal or older 18 years
* Acute coronary syndrome with or without ST elevation within last two months
* Being able to do physical exercise
* Being able to understand the educative sessions
* Being able to understand patient information in the consent form
Exclusion Criteria:
* Hemodynamic instability
* Left ventricular ejection fraction (LVEF) < or = 35%
* Heart failure class III -IV (New York Heart Association (NYHA) Functional Classification)
* Refractory angina
* Any pathology for which physical exercise is not indicated
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
|
NCT02619422
|
{
"brief_title": "More Intensive Cardiac Rehabilitation Programs in Less Time",
"conditions": [
"Acute Coronary Syndrome"
],
"interventions": [
"Other: Intensive cardiac rehabilitation program in less time"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT02619422",
"official_title": "Multicenter, Prospective, Randomized, Open, Blinded for the End Point Evaluator to Compare Compliance to Secondary Prevention Measures After Acute Coronary Syndrome and Intensive Cardiac Rehabilitation Program vs Standard Program",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-02",
"study_completion_date(actual)": "2018-02-28",
"study_start_date(actual)": "2015-10"
},
"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)": "2018-06-06",
"last_updated_that_met_qc_criteria": "2015-11-30",
"last_verified": "2018-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-02",
"first_submitted": "2015-10-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study describes modulation of neuroproprioceptive facilitation and inhibition physical therapy on serum level of neuroactive steroids in multiple sclerosis.
Detailed Description
In the parallel group, single blind, randomized controlled trial, participant underwent two kinds of neuroproprioceptive PT (MPAT and VRL). At baseline and after the end of the two months' therapeutic program, a blinded assessor evaluated clinical outcomes and data from serum level.
#Intervention
- BEHAVIORAL : Neuroproprioceptive facilitation and inhibition physical therapy
- All groups underwent two months' therapy, 16 face-to-face sessions (1 hour, twice a week for two months).
|
#Eligibility Criteria:
Inclusion Criteria:
* prevailed spastic paraparesis, stable clinical status and treatment in the preceding 3 months determined by neurologist,
* Expanded Disability Status Scale score (EDSS) max. 7.5
Exclusion Criteria:
* other neurological disease or conditions disabling movement
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
|
NCT04379193
|
{
"brief_title": "Physical Therapy and Neuroactive Steroids Therapy Does Not Modulate Serum Level of Neuroactive Steroids",
"conditions": [
"Multiple Sclerosis"
],
"interventions": [
"Behavioral: Neuroproprioceptive facilitation and inhibition physical therapy"
],
"location_countries": null,
"nct_id": "NCT04379193",
"official_title": "Ambulatory Neuroproprioceptive Facilitation and Inhibition Physical Therapy Does Not Modulate Serum Level of Neuroactive Steroids",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-05-20",
"study_completion_date(actual)": "2019-09-01",
"study_start_date(actual)": "2015-05-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-05-07",
"last_updated_that_met_qc_criteria": "2020-05-05",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-05-07",
"first_submitted": "2020-05-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In recent years, fathers have become increasingly involved in research, but research on fathers still lags behind research on mothers. During the transition to parenthood, a complex network of relationships emerges between father, mother and baby. During the process of becoming parents, mothers and fathers begin to bond with their unborn children. The prenatal period is hypothesized to be predictive of later postnatal attachment and perception of parenting. Paternal involvement at birth is associated with positive child health outcomes and parental well-being.
#Intervention
- OTHER : accompany the birth
- Fathers will accompany their husbands during the birth process
|
#Eligibility Criteria:
Inclusion Criteria:
* Spouses of primiparous pregnant women who had spontaneous pregnancies and were admitted to the delivery room for normal labor were included in the study.
Exclusion Criteria:
* women without husbands
Sex :
MALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06062667
|
{
"brief_title": "The Effect of Fathers' Birth Experience on Paternal Attachment and Parenting Perception: Randomized Controlled Trial",
"conditions": [
"Birth, First"
],
"interventions": [
"Other: accompany the birth"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06062667",
"official_title": "Effect Of Fathers' Bırth Experıence On Paternal Attachment And Parentıng Perceptıon: A Randomızed Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-10-01",
"study_completion_date(actual)": "2023-10-01",
"study_start_date(actual)": "2023-03-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "HEALTH_SERVICES_RESEARCH",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-28",
"last_updated_that_met_qc_criteria": "2023-09-28",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-10-02",
"first_submitted": "2023-09-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether, after a period of abstinence, adding 6 weeks of gabapentin (a medication approved to treat seizures) to a standard 16-week naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence) treatment protocol is helpful in decreasing relapse to drinking compared to naltrexone alone or placebo. All participants will receive alcohol counseling.
Detailed Description
Subjects will enter the trial after maintaining 4 days of abstinence. During this period multiple assessments will be collected. After entering the double blind treatment portion of the study, they will be evaluated weekly for the first month, then bi-weekly until week 12 and again at week 16. There will be two follow-up visits at weeks 28 and 40. Urinary riboflavin and pill counts will be utilized to determine compliance with the medication regime.
Comparison(s): Naltrexone (50 mg/day) alone for 16-weeks; naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks, or inactive placebos. All subjects will receive up to 20 sessions of individual alcohol counseling.
#Intervention
- DRUG : Naltrexone
- Naltrexone (50 mg/day) plus gabapentin placebo in divided doses for the first 6weeks. Naltrexone (50 mg/day) for rest of 16-weeks
- DRUG : Naltrexone plus Gabapentin
- naltrexone (50 mg/day) for 16-weeks plus gabapentin (up to 1200 mg/day in divided doses) for the first 6 weeks
- OTHER : Inactive Placebo
- Placebo
|
#Eligibility Criteria:
Inclusion Criteria:
* Meet criteria for primary alcohol dependence including loss of control of drinking
* No more than one previous inpatient medical detoxification
* Consumes on average 5 standard drinks for men and 4 standard drinks for women
* Able to maintain sobriety for 4 days (with or without detox medications).
* Able to read and understand questionnaires and Informed Consent
* Lives within 50 miles of the study site
Exclusion Criteria:
* Currently meets DSM-IV criteria for any other psychoactive substance dependency disorder except nicotine dependence
* Ever abused opiates
* Any psychoactive substance abuse, except marijuana and nicotine within the last 30 days as evidenced by subject report, collateral report, or urine drug screen.
* Meets DSM-IV criteria for current Axis I disorder of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, dissociative disorder or eating disorder, schizophrenia, or any other psychotic disorder or organic mental disorder.
* Has current suicidal or homicidal ideation
* Need for maintenance or acute treatment with any psychoactive medication including antiseizure medications.
* Current use of disulfiram.
* Clinically significant medical problems, such as cardiovascular, renal, GI or endocrine problem that would impair participation or limit medication ingestion.
* Hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 3.0 times normal at screening and/or after 5 days of abstinence.
* Sexually active females of child bearing potential who are pregnant (by urine HCG), nursing or who are not using a reliable form of birth control.
* Has current charges pending for a violent crime (not including DUI related offenses).
* Does not have a stable living situation and a reliable source of collateral reporting.
* Has taken an opiate antagonist drug in the last month.
* Has taken gabapentin in the last month or has experienced adverse effects from it at any time in the past.
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
|
NCT00183196
|
{
"brief_title": "Effectiveness of Gabapentin When Used With Naltrexone to Treat Alcohol Dependence Compared to Placebo and Naltrexone Alone",
"conditions": [
"Alcohol Dependence"
],
"interventions": [
"Other: Inactive Placebo",
"Drug: Naltrexone plus Gabapentin",
"Drug: Naltrexone"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00183196",
"official_title": "Gabapentin as an Adjunct to Naltrexone for Alcoholism",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-12",
"study_completion_date(actual)": "2009-06",
"study_start_date(actual)": "2003-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-06-07",
"last_updated_that_met_qc_criteria": "2005-09-13",
"last_verified": "2018-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-16",
"first_submitted": "2005-09-13",
"first_submitted_that_met_qc_criteria": "2013-04-23"
}
}
}
|
#Study Description
Brief Summary
Objectives of the trial were to assess the optimal timing of chemotherapy with or after ATRA and the role of maintenance therapy.
Detailed Description
Induction treatment was stratified by age and initial WBC count. Patients ≤65 years of age with a WBC count less than 5,000/µL were randomized to receive the reference ATRA treatment of our previous trial (APL91 trial) {Fenaux, 1993 #2088}, ie, 45 mg/m2/d ATRA followed by CT (ATRA→CT group) or ATRA plus CT (ATRA+CT). In the ATRA→CT group, patients received 45 mg/m2/d ATRA orally until CR, with a maximum of 90 days. After CR achievement, they received a course of 60 mg/m2/d daunorubicin (DNR) for 3 days and 200 mg/m2/d AraC for 7 days (course I). However, course I was added to ATRA if the WBC count was increased to greater than 6,000/µL, 10,000/µL, or 15,000/µL by day 5, 10, and 15 of ATRA treatment, respectively, be-cause, from our experience, patients were at risk of ATRA syndrome above those thresholds{de Botton, 2003 #1127; De Botton, 1998 #1604}. Patients randomized to the ATRA+CT group received the same combination of ATRA and CT, with course I of CT starting on day 3 of ATRA treatment.
Patients with a WBC count greater than 5,000/µL at presentation (irrespective of their age) and patients 66 to 75 years of age with a WBC count ≤ 5,000/µL were not ran-domized but received ATRA plus CT course I from day 1 (high WBC group) and the same schedule as in the ATRA→CT group (elderly group), respectively.
Treatment of coagulopathy during the induction phase was based on platelet support to maintain the platelet count at a level greater than 50,000 /µL until the disappea-rance of coagulopathy. The use of heparin, tranexamic acid, fresh frozen plasma, and fibrinogen transfusions was optional.
CR patients received 2 CT consolidation courses, including course II (identical to course I) and course III, consisting of 45 mg/m2/d DNR for 3 days and 1 g/m2 AraC every 12 hours for 4 days. The elderly group only received course II.
Three to 4 weeks after hematological recovery from this consolidation CT, patients who were still in CR were randomized both to receive or not receive intermittent ATRA (45 mg/m2/d, 15 days every 3 months) and to receive or not receive continuous CT with 6 mercaptopurine (90 mg/m2/d, orally) and methotrexate (15 mg/m2/wk, oral-ly), according to a 2-by-2 factorial design stratified on the initial induction treatment group. Maintenance treatment was scheduled for 2 years. Randomizations for induc-tion and maintenance, stratified on center, were performed through a centralized tele-phone assignment procedure.
#Intervention
- DRUG : ATRA
- early introduction of ATRA
- DRUG : ATRA and or Chemo as maintenance
- patients were randomized both to receive or not receive intermittent ATRA (45 mg/m2/d, 15 days every 3 months) and to receive or not receive continuous CT with 6 mercaptopurine (90 mg/m2/d, orally) and methotrexate (15 mg/m2/wk, orally), according to a 2-by-2 factorial design stratified on the initial induction treatment group
- Other Names :
- ATRA
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of APL, based on morphology criteria
* Age 75 years or less; and
* Written informed consent. Diagnosis had to be subsequently confirmed by presence of t(15;17) or PML-RAR gene rearrangement. In the absence of t(15;17) and if no analysis of the rearrangement could be made, review of initial marrow slides by an independent morphologist was mandatory.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00599937
|
{
"brief_title": "APL93: Timing of CxT and Role of Maintenance",
"conditions": [
"Leukemia, Promyelocytic, Acute"
],
"interventions": [
"Drug: ATRA",
"Drug: ATRA and or Chemo as maintenance"
],
"location_countries": null,
"nct_id": "NCT00599937",
"official_title": "Assessment of the Optimal Timing of Chemotherapy With or After ATRA and the Role of Maintenance",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "1998-12",
"study_completion_date(actual)": "1998-12",
"study_start_date(actual)": "1993-01"
},
"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)": "2008-01-24",
"last_updated_that_met_qc_criteria": "2008-01-23",
"last_verified": "2007-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-24",
"first_submitted": "2007-12-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
By use of several questionaires, this study aimed at an investigation of the changes in motivation, symptoms, self-esteem and coping style in adolescent patients with anorexia nervosa.. The psychometric properties of the Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) and its relation to coping style and self-esteem were assessed. After a treatment period of nine months, clinical AN diagnosis and the body mass index (BMI) were re-assessed. Besides construct validity of the ANSOCQ, its predictive validity in terms of predicting the outcome of AN was assessed.
Detailed Description
N=92 adolescents referred to an eating disorders clinic meeting criteria for anorexia nervosa (AN) gave written informed consent to participate in this study and completed the ANSOCQ, the Eating Disorder Inventory (EDI-2), the Eating Attitudes Test (EAT), the Body Image Questionnaire (BIQ), two questionnaires measuring Self-Related Cognitions (SRC) and the Coping Across Situations Questionnaire (CASQ). After a treatment period of nine months, clinical AN diagnosis and the body mass index (BMI) were re-assessed. Exploratory factor analysis and logistic regressions were performed.
|
#Eligibility Criteria:
Inclusion Criteria:
* Consecutive cohort of patients aged 12 <= age <= 19 years with a certified diagnosis of anorexia nervosa
Exclusion Criteria:
* none
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT02828956
|
{
"brief_title": "Motivation to Change, Coping, and Self-Esteem in Adolescent Anorexia Nervosa",
"conditions": [
"Personality Features in Anorexia Nervosa"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT02828956",
"official_title": "Motivation to Change, Coping, and Self-Esteem in Adolescent Anorexia Nervosa",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-12",
"study_completion_date(actual)": "2014-12",
"study_start_date(actual)": "2010-01"
},
"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)": "2016-07-12",
"last_updated_that_met_qc_criteria": "2016-07-11",
"last_verified": "2016-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-07-12",
"first_submitted": "2016-07-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients with pacemakers often have undiagnosed heart muscle weakness. When a pacemaker battery has run down, it is easily replaced by a short procedure. In those with heart muscle weakness, who use their pacemaker most of the time (rather than acting just as a back-up) the investigators want to find out if adding a further lead to their pacemaker system improves their heart's function, kidney function and exercise capacity.
Detailed Description
Background
1. Chronic heart failure Chronic heart failure (CHF) is a common syndrome of breathlessness and fatigue associated with left ventricular systolic dysfunction. It affects 2% of individuals between 50 and 60 years of age, and increases in prevalence to 10% over the age of 80 years.
2. Cardiac resynchronisation therapy Cardiac resynchronisation therapy (CRT) involves the implantation of a pacemaker capable of stimulating the heart (specifically the left ventricle) from both the front of the heart, the right ventricle RV (as is usual with conventional pacemakers) and from the back of the heart (known as the lateral wall) via the coronary sinus, aiming to improve the timing of cardiac contraction (dyssynchrony) and hence the pumping function of the heart in order to improve symptoms of breathlessness and fatigue.
Early data in patients with left bundle branch block and severe heart failure, suggested improved exercise capacity and left ventricular function. More recent data have demonstrated not only improved symptoms, but also reduced hospital admissions, and improved overall mortality.
Current guidelines drawn up using the data from randomised trials, suggest that CRT should be offered to patients with left bundle branch block with a QRS \> 150ms and severe (class III and IV) heart failure despite optimal medical therapy. Patients with a QRS duration of between 120 and 150ms should be assessed for mechanical dyssynchrony before being offered a device.
3. Heart failure in the pacemaker population
* Prevalence In 307 patients with pacemakers, 94 (31%) had left ventricular ejection fraction (LVEF) \< 40% and 83 (27%) had symptoms of heart failure. RV pacing is associated with an increase in heart failure-related hospitalisation and mortality, and in patients with left ventricular dysfunction the presence of a right ventricular apical pacemaker is a strong predictor of future deterioration in left ventricular function.
* Aetiology of pacemaker-related heart failure Many patients receiving RV pacemakers are elderly with a background of ischaemic heart disease or hypertension, both of which contribute to the development of heart failure. In addition RV pacing induces dyssynchrony, no different to that of left bundle branch block (LBBB). Dyssynchrony leads to altered regional blood flow and wall stress. The severity of these perfusion abnormalities, the regional wall motion abnormalities and the associated deterioration in global left ventricular function are directly related to the duration of pacing. These changes can be identified after only 18 months of pacing. The induction of dyssynchrony by RV apical pacing seems therefore to lead to adverse LV remodeling, LV dilatation, asymmetrical hypertrophy.
* Management of pacemaker-related heart failure In any one patient the exact aetiology of a deterioration of LV dysfunction is often unclear. What has become routine practice however, is an attempt to avoid RV pacing unless absolutely necessary and several programmes within commercially available devices now exist to facilitate this. The options in patients with a high degree of heart block on the other hand remain limited to aggressive medical therapy with beta-blockers and angiotensin converting enzyme inhibitors.
The effects of upgrading conventional pacemaker systems to those capable of delivering resynchronisation therapy have been incompletely investigated. There have only been retrospective series examining the impact of upgrading conventional pacemakers to CRT systems. Early data demonstrated the safety of adapting standard pacemakers to provide biventricular stimulation and suggested improvements in LV function. One study, involving 20 patients with chronic atrial fibrillation and AV nodal ablation, showed that adding an LV lead was associated with improved LV systolic function, reduced hospitalisations and improved quality of life. Other reports examining the impact of CRT in patients with chronic RV pacing on acute echocardiographic variables of LV systolic function and reductions in electromechanical delay and beneficial haemodynamic effects of biventricular pacing in 15 and 20 patients with pre-existing RV pacemakers. More recently a cross-over study of 44 patients requiring generator replacement demonstrated improved symptoms and LV function with 3 months of CRT when compared with 3 months of RV pacing. There are also data from small series demonstrating improvements of echocardiographic strain variables (in 12 patients) and symptoms in patients with significant CHF upgraded from conventional pacemakers to CRT systems
4. Aim of this study We propose to randomise 50 patients with ventricular dysfunction listed for pulse generator replacement to receive either a standard right ventricular generator replacement, or to be upgraded to a resynchronisation device. These patients will then be reassessed at six months to establish the effects of this policy on left ventricular function and exercise capacity.
Experimental design
1. Patients All patients will have undergone an echocardiogram, exercise test and renal function check as part of the survey of all patients undergoing pacemaker battery change at Leeds General Infirmary. If reducing or avoiding RV pacing to below 80% is not possible, patients with LV dysfunction (LVEF \< 50%) will be invited to participate in the randomised controlled trial of standard generator replacement or upgrade to CRT.
2. Procedures Patients will then be randomised to receive either an upgraded system or a pacemaker generator replacement as standard. Following the implant, subjects will be seen at 6 weeks and three months in the pacemaker clinic as is usual. The 6 monthly visit will include repeat echocardiography, an exercise test with metabolic gas exchange, repeat blood tests, 24 hour urine collection and symptom assessment.
* Devices Patients will either receive a standard pacemaker appropriate to their pacing indication, but with the capacity of keeping RV pacing to a minimum if possible, or will be implanted with an LV lead and a generator capable of providing resynchronisation pacing.
* Risk of the implant procedure From large registries, left ventricular lead implantation is successful in 92% and the procedure is safe with fewer than 8% requiring re-operation and around 10% complication rate. In our experience of \> 100 upgrades for severe symptomatic heart failure, we have had no deaths, one re-operation for an initial failure to place the LV lead, and no infections.
* Patients with atrial fibrillation The presence of atrial fibrillation reduces the benefit from CRT in randomised controlled trials. However, registries continue to demonstrate similar overall benefits on symptoms and left ventricular function and hospitalisation for both groups, albeit with no improvement in the rate of maintenance of sinus rhythm following CRT. Recent data have suggested that patients with AV node ablation and atrial fibrillation, have a similar symptomatic response rate as patients in sinus rhythm whereas those without AV node ablation do not benefit. It is therefore postulated that the benefits of CRT are dependant upon a high percentage of resynchronisation pacing (\> 90%) and that patients with atrial fibrillation with an intact AV node fail to respond because of intermittent intrinsic conduction. In the present investigation however, our patients will be have demonstrated dependency upon ventricular pacing for rate support. We will therefore include patients with atrial fibrillation in our study, albeit with a stratified randomisation to ensure they are equally distributed between the upgrade and standard generator change arm.
3. Endpoints The primary endpoint will be an improvement in left ventricular function as measured by left by echocardiography. Secondary endpoints will include changes in exercise capacity, renal function and quality of life score.
4. Power calculations
* Left ventricular function Previous short term studies provide some guide as to the potential benefit of upgrading RV pacing systems to CRT. In patients with important heart failure a population of 20 patients crossed over at three months demonstrated an improvement in exercise capacity of 1.5ml.kg.min-1 from 12.5 (2.9)ml.kg.min-1 to 14 (3.0)ml.kg.min-1. There was also an improvement in LVEF from 26.1(8)% to 34.8(9)% and a reduction in BNP from 2405pmol.l-1 (not normally distributed) to 1667pmol.l-1. Each of these changes was significant to less than the 0.02 level.
* Exercise capacity Although patients randomised into the present proposal will have better baseline exercise capacity and less severe ventricular dysfunction than patients recruited to previous studies of CRT, we will avoid the potential disadvantage of cross-over, and will follow them up for longer. We therefore expect similar magnitudes of benefit (5% improvement in LV function and 1.5 ml.kg.min¬-1). We estimate an LV lead implant failure rate of around 8%, and a loss to follow up of 5%. Hence we estimate that to identify a significant difference with a power of 90% between RV pacing and CRT after six months that we need to recruit 50 patients (25 to each arm). Results will be analysed on an intention to treat basis.
#Intervention
- PROCEDURE : Cardiac resynchronisation therapy
- Upgrade to CRT at the time of generator replacement
|
#Eligibility Criteria:
Inclusion Criteria:
* Left ventricular dysfunction < 50%
* Ability and willingness to sign consent form
* Dependent upon RV pacing with no reprogramming options
Exclusion Criteria:
* Severe heart failure symptoms indicated for CRT
* Other serious life-threatening co-morbidity
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
|
NCT01652248
|
{
"brief_title": "Pacemaker Upgrade to Cardiac Resynchronisation Therapy in Patients With Left Ventricular Dysfunction Dependant Upon Right Ventricular Pacing",
"conditions": [
"Left Ventricular Function Systolic Dysfunction"
],
"interventions": [
"Procedure: Cardiac resynchronisation therapy"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT01652248",
"official_title": "Pacemaker Upgrade to Cardiac Resynchronisation Therapy in Patients With Left Ventricular Dysfunction Dependant Upon Right Ventricular Pacing.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-12",
"study_completion_date(actual)": "2012-05",
"study_start_date(actual)": "2008-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-12-03",
"last_updated_that_met_qc_criteria": "2012-07-25",
"last_verified": "2015-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-07-30",
"first_submitted": "2012-07-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Uterine artery embolization (UAE) is a minimally invasive treatment for women with symptomatic fibroids. It is similar to hysterectomy in term of satisfaction and symptoms improvement, with fewer complications and at lower cost. However, the majority of women undergoing UFE experience important pain after the procedure despite optimal analgesia, with one third reporting pain equal or worse than labor. Pain is the more common cause of prolonged hospital stay or readmission. There is need for a simple, efficient way to reduce post-procedural pain.
For this prospective randomized study, the hypothesis is that an anesthetic drug, lidocaine, injected in the uterine arteries diminishes pain post-UFE. Patients will be randomized in 3 groups: control, lidocaine injected during embolization, and lidocaine injected after embolization. Pain will be evaluated using a validated scale at 4h and 24h post-intervention. Hospital length-of-stay and total narcotic dose administered will be evaluated in the three groups.
This is the first Canadian study evaluating lidocaine use for pain control in UFE patients. Results will be transferable to clinical practice, considering the use of lidocaine is simple and cost is negligible. It could have a great impact on pain management in women undergoing UFE in all practice settings.
#Intervention
- DRUG : Lidocaine per-embolization
- 10mL of 1% lidocaine will be mixed with the embolization particles. Lidocaine will therefore be injected during the embolization.
- Other Names :
- Local anesthetic, Amide-type anesthetic, Lidocaine hydrochloride, 00884154
- DRUG : Lidocaine post-embolization
- 10mL of 1% lidocaine will be injected in both uterine arteries after the embolization endpoint is achieved.
- Other Names :
- Local anesthetic, Amide-type anesthetic, Lidocaine hydrochloride, 00884154
|
#Eligibility Criteria:
Inclusion Criteria:
* Indication for uterine fibroid embolization: bulk symptoms, pain or heavy menstrual bleeding attributed to fibroids, with imaging confirmation;
* Patient must be able to provide written, informed consent
Exclusion Criteria:
* Documented of allergy or intolerance to lidocaine or other amide-type anesthetics;
* Personal or familial history of malignant familial hyperthermia;
* Documented history of second or third atrio-ventricular heart block
* Contra-indication to uterine fibroid embolization : active infection, suspected malignancy, coagulopathy, pregnancy or desire to preserve fertility, large pedunculated sub-serosal fibroid.
* History of previous uterine fibroid embolization.
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
|
NCT02293447
|
{
"brief_title": "Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization",
"conditions": [
"Uterine Leiomyomas"
],
"interventions": [
"Drug: Lidocaine per-embolization",
"Drug: Lidocaine post-embolization"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT02293447",
"official_title": "Intra-arterial Lidocaine for Pain Control Post Uterine Fibroid Embolization : a Single-center Prospective Randomized Study",
"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)": "2014-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-05-12",
"last_updated_that_met_qc_criteria": "2014-11-13",
"last_verified": "2016-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-11-18",
"first_submitted": "2014-11-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Diagnosis of oral squamous cell carcinoma is always too late. Due to this delay for diagnosis, prognosis is very bad. It has been demonstrate that systematic oral examination decrease mortality in tobacco and alcohol consumers population (Sankaranarayanan and al. Lancet 2005, 4, 1927-1933 ). An other study has demonstrate that autofluorescence is a useful technic for detection of dysplasia and squamous cell carcinoma that cannot be seen with conventional oral examination((Poh CF Wink Cancer Res on 2006 ( 22 ): 6616-22; Poh CF Head Neck 2007 ( 1 ) 7 71-6).However autofluorescence has never been evaluated has a screening tool for systematic oral examination and the reproductibility has never been studied.
Detailed Description
The study of Sankaranarayanan and al. (Lancet on 2005, 4, 1927-1933) demonstrated the influence on the decline of mortality of a realized systematic screening, by a simple visual inspection of the oral cavity in alcohol-smoker patients. The sensibility of the visual inspection to diagnose the oral cancers is estimated at 85 % and the specificity in 97 %. However some lésions are not diagnosed with common oral examination(Downer MC Oral Oncol. 2004 ( 3 ) 264-73). The examination in autofluorescence coupled with the visual inspection could be a solution to improve early diagnosis of potentially malignant disorders . Indeed, dysplasia and cancerous lesions can be revealing by an autofluorescence examination (Lane PM J Biomed opt on 2006 ( 2 ): 024006). Other works demonstrated that infra-clinical lesions could be revealed by the autofluorescence (Poh CF Wink Cancer Res on 2006 ( 22 ): 6616-22; Poh CF Head Neck 2007 ( 1 ) 7 71-6). On the other hand the sensibility and the specificity of the autofluorescence in situation of screening were not estimated and studies carried out on sick subjects tend to overestimate the metrological performances of a technique. Besides the reliability of the technique (reproducibility) was not studied. For these reasons, it is recommended to realize in situation of screening in an alcohol-smoker population:
* a study of reliability to estimate the reproducibility inter-observer of the examination of the oral cavity in tissular autofluorescence and,
* a feasibility study to estimate the potential contribution of the autofluorescence with regard to a simple visual inspection in the screening of the potential malignant disorders.
#Intervention
- PROCEDURE : buccal cavity examination
- autofluorescence examination
|
#Eligibility Criteria:
Inclusion Criteria:
* patients hospitalized for alcoholic weaning
* consumption activates of tobacco or stop for less than one year
* consent form signed
Exclusion Criteria:
* patient presenting a disorder of the haemostasis (plaques < 50G / L; INR > 3, haemophilia, moderate or severe Willebrand disease),
* absorption of acid acetylsalicylic in seven days before inclusion,
* the patient with oral cavity precancerous pathology, dysplasia or known cancer 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
|
NCT01167790
|
{
"brief_title": "Autofluorescence for the Screening of Precancerous and Malignant Lesions",
"conditions": [
"Precancerous Lesions of the Oral Mucosa"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT01167790",
"official_title": "Interest of Oral Tissue Autofluorescence for the Screening of Precancerous Lesions and Cancer in Population With Tobacco and Alcohol Abuse.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-03",
"study_completion_date(actual)": "2012-03",
"study_start_date(actual)": "2010-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-06-14",
"last_updated_that_met_qc_criteria": "2010-07-21",
"last_verified": "2012-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-07-22",
"first_submitted": "2010-07-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A randomized, double-blind, placebo-controlled, single-ascending dose, phase Ia study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamics, and immunogenicity of STSA-1301 Subcutaneous Injection in healthy subjects.
#Intervention
- DRUG : STSA-1301 subcutaneous injection
- Subjects will receive the administration dose on Day 0 following protocol requirements.
- DRUG : Placebo
- Subjects will receive the administration dose on Day 0 following protocol requirements.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects, male and female, aged between 18 and 65 years, inclusive;
* Body mass index: 18.0～28.0 kg/m2, inclusive; weight >=50 kg for males and >=45kg for females at enrollment;
* Subjects (including their partners) agree to take highly effective contraceptive measures during the study, and they have no birth plan or sperm donation plan within 3 months after the end of the study;
* Medical histories, physical examinations, laboratory examinations and study-related examinations and tests of the subjects show normal results or mild abnormalities with no clinical significance before enrollment, and the Investigator judges that they are eligible;
* Subjects are aware of the risks of the study, and voluntarily participate in the clinical study and sign an informed consent form (ICF).
Exclusion Criteria:
* Pregnant or lactating women;
* History of cardiovascular, respiratory, kidney, liver, metabolism, endocrine, gastrointestinal, blood, nerve, skin and mental illness, cancer or other major disease that in the judgment of the Investigator might put the subject as risk on this study.
* After splenectomy or any major surgery within 6 months prior to screening;
* Subjects have an active infection or have a serious infection (leading to hospitalization or requiring parenteral antibiotic therapy) within 6 weeks prior to the first dose; subjects with clinically active or chronic uncontrolled bacterial, viral or fungal infections at screening;
* Total IgG was less than the lower limit of normal at screening. Subjects with absolute neutrophil count <1.5X109/L and/or absolute lymphocyte count <1.0X109/L;
* Subjects have a history of malignancy;
* Subjects who are allergic to this product or any of its ingredients, history of eczema, asthma or other allergic diseases;
* Subjects are TIGRA (T cell interferon gamma release assay) positive at screening. If TIGRA is not available, a PPD skin test may be used instead and chest imaging performed at screening showing evidence of latent/active tuberculosis (TB);
* Positive screening test results for human immunodeficiency virus (HIV) antibodies, syphilis specific antibody, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (Anti-HCV);
* Presence of electrocardiogram (ECG) abnormalities during the screening period, as defined by an Investigator;
* Subjects have any conditions affecting blood collection;
* Subjects whose daily consumption of coffee, tea and/or cola is more than 750 mL in the last 3 months before enrollment;
* Subject who have nicotine consumption more than 5 cigarettes or the equivalent amount of tobacco per day within 3 months prior to screening;
* Subjects whose daily consumption of alcohol at the time of screening or at any time within the prior 6 months is more than 2 standard drinks, where 1 standard drink = 360 mL or 12 oz (1 can) of regular-strength (5%) beer; 150 mL or 5 oz wine; 45 mL or 1.5 oz liquor/spirits (40%); abnormal alcohol test results at screening or baseline;
* History of drug abuse within 1 year prior to screening; subjects with a positive urine drug abuse screen at screening or baseline;
* Blood loss or donation>400mL within 3 months prior to screening or history of transfusion or use of any blood products within 3 months prior to enrollment;
* Participation as a subject in any drug or vaccine or medical device clinical trial within 3 months prior to screening;
* Vaccination or planned vaccination within 4 weeks prior to screening to 3 months after end of dosing;
* Subjects who have taken drugs that may affect immune function within 6 months before screening, have received any monoclonal antibody or biological agent for treatment within the previous 3 months, and have previous treatment with any prescribed medications, over-the-counter (OTC) medications, herbal medicines or other supplements within 14 days prior to screening;
* Subjects with any factors that would, in the Investigator's judgment, preclude them from participating in this study.
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
|
NCT06148389
|
{
"brief_title": "The Safety and Tolerability of STSA-1301 Subcutaneous Injection in Healthy Subjects",
"conditions": [
"Primary Immune Thrombocytopenia"
],
"interventions": [
"Drug: Placebo",
"Drug: STSA-1301 subcutaneous injection"
],
"location_countries": [
"China"
],
"nct_id": "NCT06148389",
"official_title": "A Randomized, Double-Blind, Placebo-Controlled, Single-ascending Dose, Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics, and Immunogenicity of STSA-1301 Subcutaneous Injection in Healthy Subjects",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-04-03",
"study_completion_date(actual)": "2024-04-03",
"study_start_date(actual)": "2023-11-16"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-08-12",
"last_updated_that_met_qc_criteria": "2023-11-19",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2023-11-28",
"first_submitted": "2023-10-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Randomised controlled trial comparing standard outpatient clinic treatment with multi-disciplinary clinic treatment for functional gastrointestinal disorders. Patients will be followed up to end of clinic treatment and 12 months beyond the end of treatment. Symptoms, quality of life, costs to the healthcare system and psychological outcomes will be assessed.
#Intervention
- OTHER : Multi-disciplinary clinic model
- Clinic model incorporating multiple disciplines for the treatment of functional gut disorders. Disciplines include: gastroenterologists, psychiatrists, psychologists, hypnotherapists, behavioural therapists and dieticians. End of clinic case conference involving clinical disciplines will also occur to coordinate care.
- OTHER : Standard outpatient care
- Standard care provided in outpatient clinics staffed by GI doctors only
|
#Eligibility Criteria:
Inclusion Criteria:
* Functional gastrointestinal disorder as defined by Rome IV
Exclusion Criteria:
* Diagnosed or suspicion of organic gastrointestinal disorder (ie Coeliac, IBD)
* Age <18 or >80
* Non-English speaking
* Patient's from outside of metropolitan Melbourne who cannot attend clinic visits
* Prominent eating disorder
* Chronic opioid dependence
* Medications which can explain functional gut symptoms
* Surgery of GI tract that can explain functional gut symptoms
* Major, non-GI, organ dysfunction
* Pregnancy
* Major Psychiatric disorder
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:
Yes
|
NCT03078634
|
{
"brief_title": "The Multi-disciplinary Treatment of Functional Gut Disorders Study",
"conditions": [
"Irritable Bowel Syndrome",
"Functional Dyspepsia",
"Constipation - Functional",
"Faecal Incontinence",
"Functional Abdominal Pain Syndrome",
"Other Rome IV Functional Gastrointestinal Disorders"
],
"interventions": [
"Other: Multi-disciplinary clinic model",
"Other: Standard outpatient care"
],
"location_countries": [
"Australia"
],
"nct_id": "NCT03078634",
"official_title": "The MANTRA Study: The Multi-disciplinary Treatment of Functional Gut Disorders Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-02-28",
"study_completion_date(actual)": "2020-04-28",
"study_start_date(actual)": "2017-03-16"
},
"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)": "2023-11-29",
"last_updated_that_met_qc_criteria": "2017-03-07",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-03-13",
"first_submitted": "2017-02-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is primarily to evaluate implant survival rate of Astra Tech Fixture ST placed in the posterior maxilla. A one-stage surgical protocol will be used and the implants will be loaded four weeks after implant installation (early loading). Marginal bone levels, plaque and status of the periimplant mucosa will also be evaluated. The subjects will be followed for three years.
#Intervention
- DEVICE : Astra Tech Fixture ST
- Astra Tech Fixture ST Ø 3.5 and 4.5 cm in lengths of 9, 11, 13, 15, 17 and 19 mm.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 - 75
* Unilateral or bilateral edentulism in the posterior maxilla, last tooth should be the canine or the first bicuspid
* Willing to give informed consent
Exclusion Criteria:
* Bone height < 5 mm, in the planned implant area
* Bone width < 5 mm, in the planned implant area
* Previous bone augmentation procedure in the planned implant area
* Previous failures of endosseous implants
* Untreated caries and/or periodontal disease of residual dentition
* History or presence of any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
* Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* Current alcohol or drug abuse
* Unable or unwilling to return for follow-up visits for 3 years
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
|
NCT00748241
|
{
"brief_title": "Study to Evaluate Implant Survival Rate of Astra Tech Fixture ST in the Posterior Maxilla With One-stage Surgery and Early Loading",
"conditions": [
"Jaw, Edentulous, Partially"
],
"interventions": [
"Device: Astra Tech Fixture ST"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00748241",
"official_title": "An Open Prospective Study to Evaluate the Survival Rate and Marginal Bone Response of Astra Tech Dental Implants, Fixture ST, in Patients With Tooth Loss in the Posterior Maxilla.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-08",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2000-09"
},
"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)": "2012-02-15",
"last_updated_that_met_qc_criteria": "2008-09-05",
"last_verified": "2012-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-08",
"first_submitted": "2008-09-05",
"first_submitted_that_met_qc_criteria": "2012-01-12"
}
}
}
|
#Study Description
Brief Summary
An atrial septal defect (ASD) is a hole in the heart that can lead to heart failure. Depending on the size and severity of the ASD, They can be treated during a heart catheterization with a special device that can permanently seal the ASD, but knowing the exact size and severity of the ASD is crucial. Newer MRI techniques may provide a better way at diagnosing the size and severity of an ASD. We compared MRI to other standard clinical ways for evaluating an ASD.
Detailed Description
Background: Atrial septal defect (ASD) flow can be measured indirectly by velocity-encoded cardiovascular magnetic resonance (veCMR) of the pulmonary artery and aorta (Qp/Qs). Imaging the secundum ASD en face could potentially enable direct flow measurement and, additionally, provide valuable information regarding ASD size, shape, location, and proximity to other structures.
Methods: Patients referred for possible transcatheter ASD closure underwent a comprehensive standard evaluation including transesophageal and/or intracardiac echocardiography (ICE), and invasive oximetry. CMR was performed in parallel and included direct en face veCMR after an optimal double-oblique imaging plane was determined accounting for ASD flow direction and cardiac-cycle interatrial septal motion.
We hypothesized that En face veCMR using an optimized imaging plane can accurately determine ASD flow, size, and morphology, and that it would provide information incremental to comprehensive standard evaluation.
|
#Eligibility Criteria:
Inclusion Criteria:
* Suspected Atrial Septal Defect (ASD) undergoing evaluation for possible transcatheter closure
Exclusion Criteria:
* Contraindications to magnetic resonance imaging
* known sinus venosus or primum defects
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
|
NCT00498446
|
{
"brief_title": "Magnetic Resonance Imaging of Atrial Septal Defects",
"conditions": [
"Atrial Septal Defect"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00498446",
"official_title": "Imaging of Atrial Septal Defects by Velocity Encoded Cardiovascular Magnetic Resonance",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2004-07",
"study_start_date(actual)": "2002-07"
},
"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)": "2023-10-26",
"last_updated_that_met_qc_criteria": "2007-07-09",
"last_verified": "2007-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-07-10",
"first_submitted": "2007-07-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to demonstrate the superiority of SonoVue®-enhanced ultrasound versus unenhanced ultrasound for characterization of Focal Liver Lesions using final diagnosis based on histology or combined imaging/clinical data as truth standard.
Detailed Description
Unit of analysis for the outcome measures was the lesion, equivalent to the subject, since each subject had a single lesion that was to be characterized.
#Intervention
- DRUG : SonoVue-enhanced ultrasound
- Contrast-enhanced ultrasound (CE-US) examination of the target lesion. Drug: SonoVue® Dose of 2.4 mL bolus injection administered intravenously. Maximum of 2 injections (4.8 mL)
- Other Names :
- sulfur hexafluoride microbubbles
- OTHER : Unenhanced ultrasound
- -Unenhanced: Gray scale and Doppler (color or power imaging) ultrasound investigations of the target lesion. Drug: None
|
#Eligibility Criteria:
Inclusion Criteria:
* Male/female.
* Provides written Informed Consent and is willing to comply with protocol requirements.
* Is at least 18 years.
* Has at least 1 focal liver lesion (FLL) (target lesion) requiring work-up for characterization. Target lesions may include those:
* Incidentally detected,
* In subjects with chronic hepatitis or liver cirrhosis,
* In subjects with known history of malignancy.
* Is scheduled for surgical removal or biopsy of the target lesion from 24 hours to 30 days after the SonoVue® administration OR
* In case tissue biopsy is not indicated nor surgery planned, is scheduled for or has performed a contrast-enhanced (CE) CT and/or CE-MRI of the target lesion from 30 days to 48 hours prior to or from 24 hours to 30 days after the administration of SonoVue®.
Exclusion Criteria:
* Has an acoustic window insufficient for adequate ultrasound examination of the liver.
* Has a FLL that cannot be identified with unenhanced ultrasound.
* Has received or is scheduled for antineoplastic chemotherapy or an invasive procedure in the time period between test procedures and truth standard assessments which may have modified the target lesion.
* Is receiving any other contrast medium, within the 48 hours before and up to 24 hours following the administration of SonoVue®.
* Has previously been enrolled in and completed this study.
* Known right to left cardiac shunt, bidirectional or transient.
* Has any known allergy to 1 or more of the ingredients of the investigational product (sulfur hexafluoride or to any components of SonoVue®).
* Has any contraindication to 1 of the planned imaging procedures (ultrasound, CT or MRI), e.g., implants, claustrophobia, inadequate medical conditions etc.
* Has received an investigational compound within 30 days before admission into this study.
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
* Is determined by the Investigator that the subject is clinically unsuitable for the study.
* Is a pregnant or lactating female. Exclude the possibility of pregnancy by:
* testing on site at the institution serum beta-human chorionic gonadotropin (βHCG) within 24 hours prior to the start of SonoVue® administration,
* surgical history (e.g., tubal ligation or hysterectomy),
* post menopausal with a minimum 1 year without menses.
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
|
NCT00788697
|
{
"brief_title": "SonoVue®-Enhanced Ultrasound Versus Unenhanced US for Focal Liver Lesion Characterization",
"conditions": [
"Liver Neoplasms"
],
"interventions": [
"Drug: SonoVue-enhanced ultrasound",
"Other: Unenhanced ultrasound"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00788697",
"official_title": "Characterization of Focal Liver Lesions With SONOVUE®-Enhanced Ultrasound Imaging: A Phase III, Intrapatient Comparative Study Versus Un-enhanced Ultrasound Imaging Using Histology or Combined Imaging/Clinical Data as Truth Standard",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-07",
"study_completion_date(actual)": "2013-07",
"study_start_date(actual)": "2009-09"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-12-12",
"last_updated_that_met_qc_criteria": "2008-11-10",
"last_verified": "2017-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-11-11",
"first_submitted": "2008-11-07",
"first_submitted_that_met_qc_criteria": "2017-05-17"
}
}
}
|
#Study Description
Brief Summary
This study was designed to test the hypothesis that, irrespective of the degree of interstiaI lung disease and/or pulmonary arterial hypertension, the combined measurement of lung diffusing capacity for nitric oxide and carbon monoxide, might be useful to provide a mechanistic interpretation of changes of diffusion subcomponents in systemic sclerosis (SSc).
Detailed Description
In systemic sclerosis (SSc) the impairment of lung function is generally inferred from measurements of forced vital capacity (FVC) and standard lung diffusing capacity for carbon monoxide (DLCO). However, FVC measurement does not provide an accurate estimate of lung restriction and DLCO does not allow separate the alveolar membrane (DMCO) from erythrocyte (DeCO) diffusive conductance for CO. Previous studies have shown that DMCO and DeCO may change irrespective of overt intersitial lung disease (ILD) and/or pulmonary arterial hypertension (PAH). These changes may be consistent with a limitation of alveolar-capillary erythrocyte recruitment which impairs DM.This study was designed to test the hypothesis that, irrespective of the degree of ILD and/or PAH, combined DLNO-DLCO measurement might be useful to provide a mechanistic interpretation of DM and De changes in SSc.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients fulfilling the 2013 American College of Rheumatology/European League Against Rheumatism criteria for a definite diagnosis of SSc with a total score >=9
Exclusion Criteria:
* unstable subjects and/or who have suffered from respiratory exacerbations in the previous 4-wk
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03601520
|
{
"brief_title": "Mechanisms of Pulmonary Diffusion Limitation in Systemic Sclerosis",
"conditions": [
"Diffusion Limitation of Pulmonary Gas Exchange in Systemic Sclerosis"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT03601520",
"official_title": "Mechanisms of Pulmonary Diffusion Limitation in Systemic Sclerosis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-10-31",
"study_completion_date(actual)": "2017-11-15",
"study_start_date(actual)": "2014-03-01"
},
"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)": "2018-07-27",
"last_updated_that_met_qc_criteria": "2018-07-17",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-07-26",
"first_submitted": "2018-07-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of our study is to examine the effect of nutritional education given to university students with premenstrual syndrome (PMS) on premenstrual symptom severity, nutrient intake and anthropometric measures. Our hypothesis is that nutrition education reduces symptoms in students with PMS. The effect of nutrition education on premenstrual syndrome was evaluated. The sample for this study included 83 female students, with 43 in the experimental and 40 in the control group, who were studying at the health sciences faculty of a state university and met the inclusion criteria. Experimental and control groups were formed by randomized method. Nutrition training was given to the experimental group. Participant data were collected before and four months after nutrition training. The data were collected with the personal information form, Premenstrual Syndrome Scale and food consumption record form. Nutrient amounts were determined in the Nutrition Information System (BEBİS) program.
Detailed Description
1. INTRODUCTION Premenstrual Syndrome (PMS) is a condition in which physical, psychological and emotional symptoms related to the menstrual cycle of women are seen together. These symptoms experienced by many women occur before menstruation and disappear with menstrual bleeding. Imbalance in estrogen and progesterone levels, stress and malnutrition are among the factors affecting PMS.
PMS, which has many symptoms such as changes in appetite, increased body weight, abdominal pain, back pain, headache, breast swelling and sensitivity, irritability, and fatigue, has incidence in Turkey in the range of 58.1% to 91.8%. It is known that individuals who do not exercise regularly, eat too much salt and sugar, and have high stress levels experience more PMS symptoms. While the presence of PMS in women causes an increase in health expenditures, loss of labor and low quality of life, in addition to these, it causes low concentration, absenteeism from school and academic failure.
The etiology of premenstrual syndrome is not fully known, but one of the most emphasized reasons is hormone imbalance. Since the pathophysiology of PMS is not known exactly, the aim is to alleviate the severity of the symptoms during treatment of this syndrome. Non-pharmacological treatment methods such as exercise and diet are used. Studies reported that there is a positive relationship between increasing body mass index (BMI) and the risk of PMS. The incidence and severity of PMS is accepted to increase with simple carbohydrate consumption, and the aim is to reduce simple carbohydrate consumption and increase complex carbohydrate and fiber consumption in the treatment of PMS. It is reported that the consumption of foods with high fat content is a diet that increases the severity of PMS. Excessive consumption of salt, sugar, caffeine and alcohol negatively affects PMS.
Studies conducted so far revealed various causes of PMS, and the effect of malnutrition on the etiology of PMS was mentioned. However, there are a few studies on providing nutrition training to individuals with PMS. Studies were conducted to show that excessive consumption of certain foods such as salt, sugar and caffeine, and insufficient intake of calcium, magnesium, B group vitamins and many other nutrients increase the severity of PMS. However, studies to reduce the severity of PMS by providing nutrition training to women with PMS are limited. This study was carried out to examine the effect of nutritional education given to nursing students studying at university on premenstrual symptom severity, nutrient intake and anthropometric measures.
Research hypotheses:
H1: Nutrition education has an impact on anthropometric measurements. H2: Nutrition education affects nutrient intake. H3: Nutrition education is effective in reducing the severity of premenstrual syndrome
2. METHODS 2.1. Participants and Recruitment The population of this randomized controlled experimental study consisted of 117 female students who scored 111 and higher on the premenstrual syndrome scale (PMSS). The sample of the study included 83 nursing students, 43 in the experimental group and 40 in the control group, who agreed to participate in the study and were eligible for the inclusion criteria. The groups were created using the randomization technique, and a computer program was used for randomization (https://www.randomizer.org/). The rate of participation in the research was 71%. Female students who volunteered to participate in the study, who had regular menstrual cycles and were over 18 years old were included in the study. Students with chronic disease, dieting in the last 3 months and using oral contraceptives were excluded from the study.
The reason for conducting the study with female students is to minimize confounding factors such as pregnancy, lactation, and the use of oral contraceptives.
2.2. Study Design The first data in the study were collected between June 3 and June 10, 2019 with a questionnaire prepared by the researchers, the Premenstrual Syndrome Scale, and a 24-hour retrospective food consumption record. After the first evaluation, nutrition training was given to the experimental group, and no intervention was made to the control group. Anthropometric measurements of the participants and a 24-hour retrospective food consumption record were completed again 4 months after the nutrition training (between September 23 and September 30, 2019) and PMSS was re-applied. With the information obtained, the effect of nutrition education on anthropometric measurements, daily nutrients and premenstrual symptom severity was examined.
2.3. Instruments 2.3.1. Question form. In the questionnaire, there were questions about the students' age, class of education, current place of residence, anthropometric measurements including body weight, height, waist and hip circumference, smoking status, exercise status, coffee and salt consumption, skipping meals status, skipped meals, reason for skipping meals and what they consumed in the last 24 hours.
2.3.2. Anthropometric measurements. Anthropometric measurements including body weight, height, waist and hip circumference of the participants were taken. Participant weight was measured with a portable digital scale in light clothing and without shoes, and height without shoes was measured with the aid of a meter fixed to the wall with the feet side by side and on the head Frankfort plane. For the waist circumference measurement, the midpoint of the lowest rib of the individual and the crista iliac crest were found and the circumference passing through the midpoint was measured with an inelastic tape measure. Hip circumference was measured with a non-stretch tape measure at the highest point of the hip circumference, standing by the side of the participant. BMI was calculated by the ratio of body weight in kg to the square of height in meters.
2.3.3. Premenstrual syndrome scale. The Premenstrual Syndrome Scale (PMSS), developed by Gençdoğan20 based on DSM-III and DSM-IVR criteria, consists of 44 questions. The PMSS is Likert type and its items are scored between 1 and 5 points. Lowest points of 44 and highest points of 220 can be obtained on the PMSS. The scale has a total of 9 subscales: depressive feeling, anxiety, fatigue, irritability, depressive thoughts, pain, changes in appetite, changes in sleeping habits and swelling. A higher score on the scale indicates that the severity of premenstrual syndrome is high. When the score of the total PMSS and subscales is higher than 50% of the total score, it is considered to indicate PMS. In the original study, the Cronbach alpha value for the whole scale was 0.75, in this study the Cronbach alpha value was 0.90 before nutrition education and 0.96 after the education. For premenstrual syndrome subscales, the Cronbach alpha values before and after the intervention were depressive feeling 0.85-0.89, anxiety 0.77-0.86, fatigue 0.81-0.87, irritability 0.88-0.92, depressive thoughts 0.82-0.91, pain 0.74-0.79, changes in appetite 0.55-0.58, changes in sleeping habits 0.77-0.79 and swelling 0.85-0.81.
2.4. Intervention-Nutrition Education In the experimental group, 43 students were divided into 4 groups, and each group received an hour of nutrition education. The education was carried out in classrooms where the students were trained, supported by a power point presentation. Nutritional sources of nutrients were taught, the relationship of some specific foods such as salt and coffee with premenstrual syndrome, the number of meals, meal time and importance of body weight control in premenstrual syndrome were emphasized. On the 30th and 60th days after the nutrition education, an e-mail was sent to the participants to inform them about nutrition in order to reinforce the education.
2.5. Ethical Issues Before starting the study, permission was obtained from Gençdoğan to use the PMS scale. In order to conduct the research, permission of the institution was obtained from Ordu University where the research was conducted (decision dated 26 April 2019 and numbered ....). Ethics committee approval was obtained from Ordu University Non-Interventional Clinical Research Ethics Committee (May 23, 2019 and numbered 2019/82). After the participants were informed about the study, their informed written consent was obtained. In this study, the principles of the Declaration of Helsinki were followed.
#Intervention
- OTHER : Nutrition education
- Nutrition education will be given to improve PMS
|
#Eligibility Criteria:
Inclusion Criteria:
* Volunteer to participate in the study
* be woman
* have a regular menstrual cycle
* be >= 18 years
Exclusion Criteria:
* have a chronic illness
* have been on a diet in the last 3 months
* using oral contraceptives
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
|
NCT05144568
|
{
"brief_title": "The Effect of Nutrition Education on Premenstrual Syndrome",
"conditions": [
"Premenstrual Syndrome"
],
"interventions": [
"Other: Nutrition education"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05144568",
"official_title": "The Effect of Nutrition Education on Premenstrual Syndrome: Randomized Controlled Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-09-30",
"study_completion_date(actual)": "2019-09-30",
"study_start_date(actual)": "2019-06-03"
},
"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)": "2021-12-03",
"last_updated_that_met_qc_criteria": "2021-11-22",
"last_verified": "2021-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-12-03",
"first_submitted": "2021-10-18",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Endometrial cancer is the second common gynecologic malignancy in Taiwan. The prevalence has been overcome the epithelial ovarian cancer because of the change of life style to western style recently. Most patients with endometrial cancer are stage I \& II, the most histology is still 'endometrioid adenocarcinoma' (type I endometrial cancer). In statistics, advanced stage (FIGO stage III and IV) is approximately 16% of all cases.
Most patients has good outcome of endometrial cancer because their surgical stage is belonged to 'early stage'. However, the recurrence, distant metastases and mortality are high if the diseases is confirmed to be advanced stage. The adjuvant therapies after staging/debulking operation are systemic chemotherapy and whole pelvic radiation therapy/ brachytherapy. Whether the adjuvant therapy can cure the disease of not is still controversial.
Because of the rarity of the advanced endometrial cancer, varies adjuvant therapeutic modalities, eg. chemotherapy only, pelvic radiation therapy only, combination of chemotherapy and radiation therapy or sequential 'sandwich' therapy were ever used for such group patients in each medical center. But the case number is insufficient and limited to show the survival or progression free benefit during the statistics. Besides, the surgical procedures and adjuvant therapy for early endometrial cancer is still remained to be determined. The investigators are also interested to analyze the factors affecting their survival.
The investigators will perform a retrospective study to review the data of patients with endometrial cancer in Department of Obstetrics \& Gynecology in Far Eastern Memorial Hospital.
|
#Eligibility Criteria:
Inclusion Criteria:
* Time interval: from 1991 to date.
* Comprehensive surgical staging or debulking procedure.
* All female patients with endometrial cancer who underwent surgery for endometrial cancer at Far Eastern Memorial Hospital.
Exclusion Criteria:
* Not comprehensive staging/debulking procedure.
* Patients who died of postoperative complications within 30 days after surgery were excluded from the survival analysis.
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT01886040
|
{
"brief_title": "Factors Affecting the Prognosis of Patients With Endometrial Cancer",
"conditions": [
"Endometrial Cancer"
],
"interventions": null,
"location_countries": [
"Taiwan"
],
"nct_id": "NCT01886040",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-05",
"study_completion_date(actual)": "2016-05",
"study_start_date(actual)": "2013-06"
},
"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)": "2016-09-07",
"last_updated_that_met_qc_criteria": "2013-06-24",
"last_verified": "2016-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-25",
"first_submitted": "2013-06-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aimed to investigate the influence of the glycemic control of type 2 diabetes (DM2) and of cetirizine (OCTs inhibitor) on gabapentin kinetics disposition and pharmacodynamics (PK-PD) in patients with neuropathic pain. Thus, non-diabetic patients (Control Group, n=10), patients with controlled diabetes (n=9) and patients with uncontrolled diabetes (n=10), all with neuropathic pain of intensity ≥ 4 in pain visual analog scale (0-10) were investigated.
Detailed Description
Gabapentin (GBP), anticonvulsant used to neuropathic pain treatment, is mainly eliminated unchanged in urine. Renal active tubular secretion has been suggested to contribute on GBP excretion by renal excretion. Studies performed on rats with experimental diabetes suggest that hyperglycemia reduces the activity of organic cation transporters (Oct). Thus, the aim of the study was to investigate the role of OCTs on kinetic disposition and pharmacodynamics of GBP in patients with neuropathic pain and to verify the regulation of these transporters' activity by glycemic control in diabetes. A cross-over clinical study was performed in patients with neuropathic pain (n=10, Control) to evaluate the influence of CTZ on GBP kinetic disposition. To evaluate the effect of glycemic control, patients with controlled DM2 (DC, n=9) and uncontrolled DM2 (DNC, n=10) were investigated. All participants investigated had neuropathic pain of intensity ≥ 4 evaluated by analogue visual scale (EVA) and were treated with oral single-dose of 300 mg of GBP (Phase 1) or cetirizine (20 mg/day) for 5 days and single-dose of GBP on the last day (Phase 2). Only participants of Control group participated of Phase 2. Serial blood and urine samples were collected up to 36 hours after GBP administration. The intensity of pain was evaluated at the same time of blood sampling, using the visual analog scale. GBP concentration in plasma and urine was validated by JPLC-UV. All participants were genotyped for polymorphisms SLC22A2 808G\>T and SLC22A4 1507C\>T. The pharmacokinetic parameters were estimated by non-compartmental analysis.
#Intervention
- PROCEDURE : Serial Blood Samples
- Serial blood samples were collected at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours after gabapentin administration, for all patients.
- PROCEDURE : Serial Urine Samples
- Serial urine samples were collected at intervals 0-8 hours, 8-16 hours, 16-24 hours and 24-36 hours after gabapentin administration, for all patients.
- DRUG : Gabapentin 300 mg
- All patients were treated with oral single dose of gabapentin 300 mg.
- DRUG : Cetirizine Hydrochloride 10 mg
- Patients of control group were treated with cetirizine hydrochloride, 10 mg, twice as day, orally, for five days.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients, both gender
* Patients with neuropathic pain with score >= 4 in visual analog scale
* Patients with controlled type 2 diabetes (glycated hemoglobin <= 8.0%) and diabetic neuropathy with score >= 4 in visual analog scale
* Patients with uncontrolled type 2 diabetes (glycated hemoglobin >= 8.0%) and diabetic neuropathy with score >= 4 in visual analog scale
* Patients that suspend the use of analgesics for 10 times half-life before starting the protocol
Exclusion Criteria:
* Patients with acute or chronicle severe renal failure (creatinine clearance <= 30 mL/min)
* Patients with gastrointestinal diseases
* Patients with history of alcohol and drug abuse
* Patients with acute myocardial insufficiency
* Patients with another kind of chronicle pain as severe as neuropathic pain
* Patients in chronicle use of drugs that interact with gabapentin (antacids and cimetidine)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 59 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT03047278
|
{
"brief_title": "Transporters for Organic Cations and Glycemic Control in Patients With Neuropathic Pain.",
"conditions": [
"Neuropathic Pain",
"Type 2 Diabetes Mellitus",
"Diabetic Neuropathy, Painful"
],
"interventions": [
"Drug: Gabapentin 300 mg",
"Procedure: Serial Urine Samples",
"Procedure: Serial Blood Samples",
"Drug: Cetirizine Hydrochloride 10 mg"
],
"location_countries": null,
"nct_id": "NCT03047278",
"official_title": "Gabapentin Kinetic Disposition and Renal Excretion: Role of Transporters for Organic Cations and the Effect of Glycemic Control in Patients With Neuropathic Pain.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05-01",
"study_completion_date(actual)": "2019-07-01",
"study_start_date(actual)": "2015-11-01"
},
"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)": "2019-07-05",
"last_updated_that_met_qc_criteria": "2017-02-07",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-02-08",
"first_submitted": "2017-02-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A-007 is an investigational therapy which may be effective in the treatment of pre-cancerous cervical dysplasia (abnormal cell growth). The purpose of this study is to evaluate the safety and efficacy of A-007, when used to treat high-grade cervical dysplasia.
Detailed Description
This is a randomized, double-blind, placebo-controlled study. It will randomize patients in a 1:1 ratio to topical cervical treatment with A-007, or placebo gel. Following biopsy confirmation of High Grade Squamous Intraepithelial Lesions (HSIL), women will treat themselves with gel applied to the cervix via an intravaginal applicator. Patients will apply gel once daily for 5 consecutive days of a 28-day cycle for 2 cycles. Women will return to clinic for safety assessments, colposcopy, cytology, and virologic and immunologic testing.
#Intervention
- DRUG : placebo
- 5 days of 28 day cycle for 2 cycles
- DRUG : A007
- 5 days of 28 day cycle
|
#Eligibility Criteria:
Inclusion Criteria:
Patients may be enrolled in the study only if they meet all of the following criteria:
* 18 years or older
* The patient or her authorized representative must sign and date an Ethical Review Board-approved informed consent document. All aspects of the protocol must be explained and written informed consent obtained.
* Patients must have histological proof of HSIL (CIN 2/3) disease documented.
* Cervical swabs must test positive for HPV (by Hybrid Capture 2).
* Patients must have a Hb >= 9 g/dl, a peripheral WBC >= 3000 mm3 and platelet counts >= 100,000 mm3.
* Normal hepatic and renal functions - AST and ALT < 2.5 x ULN and creatinine < 1.5 x ULN, respectively.
* Females of childbearing potential must use one of the following birth control methods during the treatment period and 2 weeks thereafter: oral, implantable, injectable contraceptives; abstinence (celibacy). Contraceptive sponges, IUD, spermicides, sponges, condoms, or partner's vasectomy are not acceptable methods of birth control.
Exclusion Criteria:
Patients will be excluded from the study for any of the following preexisting reasons:
* Patients with LSIL (CIN 1) or invasive squamous cell carcinoma (SCC).
* SIL (CIN) involving the endocervix as determined by endocervical curettage, or otherwise not amenable to adequate colposcopic follow-up evaluations, i.e. unsatisfactory colposcopy.
* CIN 3 involving more than two cervical quadrants on colposcopy.
* Patients treated for cervical SIL within the past year.
* Patients with other malignancy (except for non-melanoma skin) within the past 5 years.
* Patients with any active infections (including HIV) other than HPV.
* Patients with known clinically relevant immunological deficiency.
* Concurrent treatment with cytotoxic, radiation, or immuno-stimulative therapy, or with systemic corticosteroids at a dose of > 5 mg/d of prednisone (or its equivalent).
* Participation in another investigational medication trial concurrently or within 30 days, or prior participation in an HPV vaccine trial. Treatment within the last 30 days with a medication that has not received regulatory approval at the time of study entry.
* Concomitant use of topical vaginal medications.
* Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
* History of allergy or hypersensitivity to cosmetics, toiletries, or other topical or dermatologic products.
* Pregnant or lactating females who are nursing and will not consent to cease nursing.
* Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
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
|
NCT00285207
|
{
"brief_title": "Safety and Efficacy of A-007 Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix",
"conditions": [
"Cervical Intraepithelial Neoplasia",
"Uterine Cervical Dysplasia"
],
"interventions": [
"Drug: A007",
"Drug: placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00285207",
"official_title": "A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Trial of the Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenyl-hydrazone (A-007) Topical Gel in the Treatment of High-Grade Squamous Intraepithelial Lesions (HSIL) of the Cervix",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-04",
"study_completion_date(actual)": "2008-06",
"study_start_date(actual)": "2006-01"
},
"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)": "2010-10-11",
"last_updated_that_met_qc_criteria": "2006-01-30",
"last_verified": "2010-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-02-01",
"first_submitted": "2006-01-30",
"first_submitted_that_met_qc_criteria": "2010-09-23"
}
}
}
|
#Study Description
Brief Summary
The goal of this clinical research study is to compare the effectiveness of liposomal amphotericin B given three times per week , versus liposomal amphotericin B given once per week, versus oral voriconazole in the prevention of fungal infections in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes MDS who are receiving chemotherapy. The safety of these treatments will also be studied and compared.
Detailed Description
Ambisome and voriconazole are drugs that have been used to fight fungal infections, which typically occur during chemotherapy as a result of lowered immune system functioning. Ambisome works by binding to the sterol component of the fungal cell membrane. This causes 'holes' to appear in the membrane, which leads to death of the fungal cell. Voriconazole inhibits an essential step of the biosynthesis of an important component of the fungal cell wall (ergosterol). This causes the impairment of the fungal cell wall.
Before you can start treatment on this study, you will have 'screening tests.' These tests will help the doctor decide if you are eligible to take part in this study. You will be asked questions about your medical history. You will have a complete physical exam and a chest x-ray. You will have computed tomography (CT) scans of the chest. You will also have about 1 teaspoon of blood drawn for routine tests. Test results from the pregnancy test that you will have before your leukemia treatment will be looked at for this study. You will not have a pregnancy test performed for this study.
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to one of 3 treatment groups (Group 1, Group 2, or Group 3). Participants in Groups 1 and 2 will receive treatment with ambisome. Participants in Group 3 will receive treatment with voriconazole. Participants in all 3 groups will begin treatment 24 hours after the last dose of chemotherapy.
If you are assigned to Group 1, you will receive ambisome by vein as a continuous infusion over 2 hours 1 time per day, 3 times each week.
If you are assigned to Group 2, you will receive ambisome by vein as a continuous infusion over 2 hours 1 time per week.
If you are assigned to Group 3, you will take 2 pills by mouth (1 hour after breakfast) and 2 pills by mouth (1 hour after dinner) for 1 day, which amounts to 4 pills in total on Day 1. You will then take 1 pill by mouth (1 hour after breakfast) and 1 pill by mouth (1 hour after dinner) everyday for the remainder of this study, which amounts to 2 pills in total each day.
You will have about 1 teaspoon of blood drawn for routine tests 2 times each week. You will also receive treatment with standard of care medications. These medications (which will be specified by your doctor) will be used to help decrease the risk of developing bacterial infections and viral infections.
If you develop a fever during treatment on this study, you will have a chest x-ray and a CT scan of the chest within 3 days after the fever started.
You may remain on this study for up to 35 days (if you are receiving chemotherapy for the first time) and up to 42 days (if you have had prior chemotherapy). Your participation may end on this study if your study doctor thinks it is necessary, if other antifungal therapy is required, or if you develop any intolerable side effects.
#Intervention
- DRUG : Voriconazole
- 400 mg by mouth twice daily on day 1, followed by 200 mg by mouth twice daily
- Other Names :
- Vfend
- DRUG : Liposomal amphotericin B
- 3 mg/kg intravenously three times per week over 2 hours +/- 15 minutes
- Other Names :
- Ambisome
- DRUG : Liposomal amphotericin B
- 9 mg/kg intravenously once per week over 2 hours +/- 15 minutes
- Other Names :
- Ambisome
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of AML or high risk MDS undergoing induction chemotherapy or first salvage chemotherapy.
* Age >=18 years.
* Patients must sign an informed consent.
Exclusion Criteria:
* Patients with history of anaphylaxis attributed to azole or amphotericin B compounds.
* Patients with clinical or other evidence that indicates that they have proven or probable invasive fungal infection prior to enrollment.
* Patients with total bilirubin levels > 3 times the upper normal limits (i.e. > 3.0 mg/dl); or serum glutamic pyruvic transaminase (SGPT)> 5 times upper limit normal.
* Patients with serum creatinine > 2.0 mg/dl.
* Patients receiving any medication that is contraindicated with the use of voriconazole.
* Patients who have participated in this study during induction chemotherapy.
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
|
NCT00418951
|
{
"brief_title": "Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections",
"conditions": [
"Acute Myelogenous Leukemia",
"Myelodysplastic Syndrome"
],
"interventions": [
"Drug: Voriconazole",
"Drug: Liposomal amphotericin B"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00418951",
"official_title": "Open, Randomized Comparative Trial of Two Different Schedules of Liposomal Amphotericin B Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-10",
"study_completion_date(actual)": "2009-10",
"study_start_date(actual)": "2006-11"
},
"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)": "2012-08-07",
"last_updated_that_met_qc_criteria": "2007-01-03",
"last_verified": "2012-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-01-05",
"first_submitted": "2007-01-03",
"first_submitted_that_met_qc_criteria": "2011-04-15"
}
}
}
|
#Study Description
Brief Summary
Peak isometric strength of quadriceps (QI) has been used to help determine an athletes ability to safely return back to sport following an anterior cruciate ligament (ACL) reconstruction surgery. However, rate of force development (RFD) of the quadriceps, or how fast the quadriceps are able to reach their peak strength, is rarely used as part of this decision despite the role it plays in protecting the knee. This retrospective data only study will look back at the limb symmetry index (LSI) of patients post ACL reconstruction for the Noyes Hop Test, QI, and RFD. The hypothesis is that RFD does not recover at the same rate as Noyes Hop Test and QI.
|
#Eligibility Criteria:
Inclusion Criteria:
* No pain (at baseline) or edema/effusion
* Full knee range of motion
* Post Op: 20 weeks - 2 years
* Non antalgic gait
Exclusion Criteria:
* History of low back pain or other lower extremity injury within 1 year, skeletal immature, pregnant, concomitant ligament injury
Sex :
ALL
Ages :
- Minimum Age : 14 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04005274
|
{
"brief_title": "Rate of Force Development vs Isometric Strength of Quadriceps",
"conditions": [
"Post ACL Reconstruction"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT04005274",
"official_title": "Is Rate of Force Development (RFD) Superior to Isometric Strength (QS) of the Quadriceps as a Predictor of Functional Performance After Anterior Cruciate Ligament Reconstruction",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-08",
"study_completion_date(actual)": "2019-04-08",
"study_start_date(actual)": "2019-03-08"
},
"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)": "2019-07-02",
"last_updated_that_met_qc_criteria": "2019-07-01",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-02",
"first_submitted": "2019-06-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to evaluate whether loco-regional analgesia reduces post operative pain compared to intravenous analgesia, in patients undergoing cardiac surgery in minithoracotomy. All patients will be randomized to receive locoregional analgesia (treatment group) or intravenous analgesia (control group), at the end of the cardiac intervention.
#Intervention
- DEVICE : Loco-regional catheter
- it is an intra-fascial catheter for realing of the drug locally
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing minithoracotomy for cardiac surgery, > 18 years
Exclusion Criteria:
* psychiatric diseases, which might limit pain evaluation; urgent surgery; patients on ECMO; lack of consent
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
|
NCT01903551
|
{
"brief_title": "Loco-regional Analgesia for Post-operative Pain Management in Cardiac Surgery",
"conditions": [
"Pain, Postoperative"
],
"interventions": [
"Device: Loco-regional catheter"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT01903551",
"official_title": "Phase 3 Study of Post-operative Pain Management With Loco-regional Analgesia in Minithoracotomy for Cardiac Surgery. A Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-06",
"study_completion_date(actual)": "2016-04",
"study_start_date(actual)": "2013-05"
},
"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)": "2016-10-26",
"last_updated_that_met_qc_criteria": "2013-07-18",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-07-19",
"first_submitted": "2013-07-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to determine the effect on glycemic responses of adding various doses of OatWell28XF to Quaker Instant Oatmeal in order to: 1) describe the dose-response curve and 2) If possible, identify the minimum level of OatWell28XF which, when added to a serving of Quaker Instant Oatmeal, would result in a glycemic response at least 20% less than that elicited by a β-glucan-free cereal.
#Intervention
- OTHER : Oatmeal + OatWell28XF
- Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence
- OTHER : Oatmeal
- OTHER : Hot cereal
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant females, 18 <= age <= 75 years, inclusive
* Body mass index (BMI) >= 20.0 and < 35 kg/m² at screening (visit 1).
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
* Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
* Normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
* Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
* Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
* Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
Exclusion Criteria:
* Failure to meet any one of the inclusion criteria
* Known history of AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary or GI disorders.
* Use of medications known to influence carbohydrate metabolism, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Major trauma or surgical event within 3 months of screening.
* Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
* Known intolerance, sensitivity or allergy to any ingredients in the study products.
* Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc).
* Uncontrolled hypertension (systolic blood pressure >=160 mm Hg or diastolic blood pressure >=100 mm Hg as defined by the average blood pressure measured at screening.
* Change in body weight of >3.5kg within 4 weeks of the screening visit.
* Presence of any signs or symptoms of an active infection within 5 d prior to any test visit. If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved and any treatment (i.e. antibiotic therapy) has been completed at least 5 d prior to each test visit.
* History of cancer in the prior two years, except for non-melanoma skin cancer.
* Recent history (within 12 months of screening) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as > 14 drinks per week (1 drink=12 oz beer, 5 oz wine, or 1.5 oz distilled spirits).
* Exposure to any non-registered drug product within 30 d prior to screening.
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:
Yes
|
NCT02818452
|
{
"brief_title": "Glycemic Impact of Oatmeal Plus OatWellXF28",
"conditions": [
"Glycemic Responses"
],
"interventions": [
"Other: Oatmeal",
"Other: Oatmeal + OatWell28XF",
"Other: Hot cereal"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT02818452",
"official_title": "Affecting the Glycemic Impact of Quaker Instant Oatmeal by Adding OatWell28XF: a Dose-Response Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-08",
"study_completion_date(actual)": "2016-08",
"study_start_date(actual)": "2016-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-12-07",
"last_updated_that_met_qc_criteria": "2016-06-27",
"last_verified": "2016-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-29",
"first_submitted": "2016-06-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Calcium hydroxide is generally preferred in endodontics as an intracanal medicament due to its antimicrobial and biological effects. However, the antimicrobial effect of calcium hydroxide is limited. A new calcium silicate-based root canal medicament has been developed as an alternative to calcium hydroxide-based medicaments.
The aim of this study was to investigate the effects of calcium silicate-based root canal medicament on antibacterial, antifungal activity, and postoperative pain in root canal-treated teeth with periapical lesions.
Detailed Description
Sixty patients were randomly divided into two groups using a web-based program according to the selected medicament (calcium silicate-based root canal medicament or calcium hydroxide-based root canal medicament).
After the removal of gutta-percha from the root canals, the first samples were collected using paper points to evaluate antibacterial and antifungal effects. The root canals were then chemomechanically prepared, followed by final irrigation activation, and the second samples were collected. The selected root canal medicament was placed in the canals, and the patients were given a form to record their postoperative pain levels over one week.
At the second appointment, the medicaments were removed, and third samples were collected using paper points to assess antibacterial and antifungal effects. The root canal treatments of the patients were then completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms.
#Intervention
- DRUG : Calcium Silicate
- Root canal filling was removed with endodontic file. Sterile paper points were placed at working length to assess antibacterial and antifungal effects before the medicament was placed. Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and second samples were collected in the same manner. The calcium silicate-based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to evaluate the patients' postoperative pain levels over one week. At the second appointment, the medicament was removed, and third samples were collected to assess antibacterial effects. The root canal treatments of the patients were completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms.
- Other Names :
- calcium silicate based medicament group
- DRUG : Calcium hydroxide
- Root canal filling was removed with endodontic file. Sterile paper points were placed at working length to assess antibacterial and antifungal effects before the medicament was placed. Subsequently, the root canals were chemomechanically prepared, final irrigation activation was performed, and second samples were collected in the same manner. The calcium hydroxide-based root canal medicament was placed in the canals, and the teeth were sealed with temporary fillings. A form was provided to evaluate the patients' postoperative pain levels over one week. At the second appointment, the medicament was removed, and third samples were collected to assess antibacterial effects. The root canal treatments of the patients were completed. The antibacterial and antifungal effects of the medicaments were evaluated using PCR, and the patients' postoperative pain levels were recorded using follow-up forms.
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy patients with aged between 18 <= age <= 60.
* Incisor, canine, and premolar teeth that had previously undergone root canal treatment
* Incisor, canine, and premolar teeth with a diagnosis of chronic apical abscess or asymptomatic apical periodontitis
* teeth with only 1 root canal
* the patients had not used any antibiotics for 3 months before treatment
Exclusion Criteria:
* the presence of a root fracture
* teeth with any swelling
* ankyloses,
* periodontal pockets deeper than 4 mm.
* teeth which a rubber dam could not be performed
* patients with allergy to ibuprofen or ciprofloxacin were also excluded.
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
|
NCT06779370
|
{
"brief_title": "Effect of Calcium Silicate-Based Root Canal Medicament After Retreatment",
"conditions": [
"Antibacterial Agents",
"Postoperative Dental Pain",
"Antifungal Agents"
],
"interventions": [
"Drug: Calcium hydroxide",
"Drug: Calcium Silicate"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06779370",
"official_title": "Evaluation of the Effect of Calcium Silicate-Based Root Canal Medicament on Antifungal-Antibacterial Activity and Post-Operative Pain After Retreatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-12-12",
"study_completion_date(actual)": "2025-01-10",
"study_start_date(actual)": "2024-06-12"
},
"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)": "2025-01-16",
"last_updated_that_met_qc_criteria": "2025-01-12",
"last_verified": "2025-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2025-01-16",
"first_submitted": "2025-01-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the effect of multiple doses of BMS-986322 on the pharmacokinetics (PK) of Loestrin components in healthy female participants.
#Intervention
- DRUG : BMS-986322
- Specified dose on specified days
- DRUG : Loestrin
- Specified dose on specified days
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy participants, defined as having no clinically significant active or ongoing medical condition, physical examination abnormality, abnormal ECG finding, and abnormal clinical laboratory determinations that in the opinion of the investigator would compromise the conduct, results, or interpretation of the study findings.
* Have a negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 4 weeks prior to the start of study intervention.
* Have a normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) >= 80 milliliter (mL)/minute (min)/1.732m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Exclusion Criteria:
* Any significant acute or chronic medical illness.
* Any acute infection or febrile illness within 7 days before Day 1 of Cycle 2.
* Any history or risk for tuberculosis (TB), specifically participants with 1) current clinical, radiographic or laboratory evidence of active TB; 2) history of active TB unless there is documentation that the prior anti-TB treatment was appropriate in duration and type; latent TB that has not been successfully treated.
Other protocol-defined inclusion/exclusion criteria apply.
Sex :
FEMALE
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
|
NCT05579574
|
{
"brief_title": "A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants",
"conditions": [
"Healthy Participants"
],
"interventions": [
"Drug: BMS-986322",
"Drug: Loestrin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05579574",
"official_title": "An Open-Label, Single-Sequence, Crossover Study to Investigate the Interaction of Multiple Doses of BMS-986322 at Steady State and Multiple Doses of a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Participants",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-01",
"study_completion_date(actual)": "2023-06-01",
"study_start_date(actual)": "2022-10-21"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-08-18",
"last_updated_that_met_qc_criteria": "2022-10-11",
"last_verified": "2023-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-10-14",
"first_submitted": "2022-10-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Children's Hospital Multan is a tertiary care teaching hospital in South Punjab, the poorest and most backward area of Punjab, Pakistan, where a significant number of newborns suffer from birth asphyxia. Therefore, this study was planned with the objective of investigating the effectiveness of magnesium sulphate in severe birth asphyxia, hypothesizing that in cases of birth asphyxia, neonates who are treated with magnesium sulphate have a higher sucking reflex than those who are not treated with magnesium sulphate.
#Intervention
- DRUG : Magnesium Sulphate infusion
- Magnesium sulphate 24 hours apart by intravenous infusion at 250 mg/kg/dose (0.5 mL/kg/dose of injection magnesium sulphate 50% w/v diluted in 5 mL/kg of 5% glucose) over a duration of half an hour by an infusion pump
|
#Eligibility Criteria:
Inclusion Criteria:
* Full-term babies (>=37 weeks of gestation)
* Both genders
* Severe birth asphyxia
* Admitted within six hours of life.
Exclusion Criteria:
* Premature babies
* Congenital malformations
* Babies born to mothers who received general anesthesia
* Babies whose mothers received magnesium sulfate, pethidine, and other drugs in the past 7 days.
Sex :
ALL
Ages :
- Minimum Age : 1 Hour
- Maximum Age : 6 Hours
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT06468475
|
{
"brief_title": "Enhancing Neonatal Sucking Reflex: A Study on the Efficacy of Magnesium Sulphate in Severe Birth Asphyxia",
"conditions": [
"Birth Asphyxia"
],
"interventions": [
"Drug: Magnesium Sulphate infusion"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT06468475",
"official_title": "Enhancing Neonatal Sucking Reflex: A Study on the Efficacy of Magnesium Sulphate in Severe Birth Asphyxia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-03-31",
"study_completion_date(actual)": "2024-03-31",
"study_start_date(actual)": "2023-10-01"
},
"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)": "2024-06-24",
"last_updated_that_met_qc_criteria": "2024-06-15",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-06-21",
"first_submitted": "2024-06-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of the study is to evaluate the safety and tolerability of switching from intravenous (IV) complement component 5 (C5) inhibitors to subcutaneous (SC) Zilucoplan in study participants with generalized myasthenia gravis (gMG)
#Intervention
- DRUG : zilucoplan (RA101495)
- Subcutaneous injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Participant has been treated with an intravenous (IV) complement component 5 (C5) inhibitor approved for the treatment of generalized myasthenia gravis (gMG) at the recommended dose regimen for at least 3 months (for eculizumab) or 4 months (for ravulizumab) prior to Screening with a clinically stable disease as per the Investigator's judgment.
* Participant is willing to switch from his/her current IV C5 inhibitor to subcutaneous (SC) zilucoplan (ZLP)
* Participant has a documented diagnosis of gMG (Myasthenia Gravis Foundation of America; MGFA Class II-IVa) at Screening based on participant history and supported by previous evaluations
* Participant has a well-documented record of positive serology for acetylcholine receptor binding autoantibodies prior to Screening
* Participant has no more than a 2-point change in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at Baseline compared with the Screening Visit
* Participant has had no change in corticosteroid dose during the Screening Period and no change in corticosteroid dose is anticipated to occur during the 12-week Main Treatment Period
* Participant has had no change in immunosuppressive therapy, including dose, during the Screening Period and no change in immunosuppressive therapy is anticipated to occur during the 12-week Main Treatment Period
* Participant has a record of vaccination with at least 1 dose of a quadrivalent meningococcal vaccine and meningococcal serotype B vaccine at least 14 days prior to the first dose of ZLP if not vaccinated within 3 years prior to the start of study medication
* Male and/or female
* A male participant is recommended to agree to use contraception during the study and for at least 40 days (5 half lives) after the last dose of study medication, and refrain from donating sperm during this period.
* A female participant is eligible to participate if she is not pregnant; not breastfeeding, and at least one of the following conditions applies:
* Not a woman of childbearing potential (WOCBP) OR
* A WOCBP who agrees to follow the contraceptive guidance during the study and for at least 40 days (5 half lives) after the last dose of study medication.
* Participant is capable of giving signed informed consent
Exclusion Criteria:
* Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study
* Participant has a known hypersensitivity to any components of the study medication as stated in this protocol
* Participant has had a thymectomy within 6 months prior to Baseline or has one scheduled to occur during the 12-week Main Treatment Period
* Participant has a history of meningococcal disease
* Participant has or has had a current or recent systemic infection within 2 weeks prior to Baseline or an infection requiring IV antibiotics within 4 weeks prior to Baseline
* Participant has active malignancy (except curatively resected squamous or basal cell carcinoma of the skin) requiring surgery, chemotherapy, or radiation within the prior 12 months (participants with a history of malignancy who have undergone curative resection or otherwise not requiring treatment for at least 12 months prior to Screening with no detectable recurrence are allowed).
* Participant has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation with at least some intent to act in the past 6 months as indicated by a positive response ('Yes') to either question 4 or question 5 of the 'Screening/Baseline' version of the C-SSRS at Screening.
* Participant has alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) >2.5x upper limit of normal (ULN)
* Participant has bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
* Participant has current unstable liver or biliary disease per Investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
* QTc interval >450msec for male participants, QTc >470msec for female participants, or QTc >480 msec in participants with bundle branch block
* Participant has had recent surgery requiring general anesthesia within 2 weeks prior to Screening or is expected to have surgery requiring general anesthesia during the 12-week Main Treatment Period
* Participant has received a treatment with an experimental drug within 30 days or 5 half lives of the experimental drug (whichever is longer) prior to Baseline
* Participant has received treatment with rituximab within 6 months prior to Baseline or treatment is planned to occur during the study
* Participant has received treatment with intravenous immunoglobulin G (IVIG), SC immunoglobulin, or plasma exchange PLEX 4 weeks prior to Baseline or participant is on chronic IVIG, SC immunoglobulin, or PLEX
* Participant has previously participated in this study or participant has previously been assigned to treatment in a study of the medication under investigation in this study
* Participant has participated in another study of an investigational study medication (and/or an investigational device) within the previous 30 days or is currently participating in another study of an investigational study medication (and/or an investigational device)
* Participant has known positive serology for muscle-specific kinase
Sex :
ALL
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:
No
|
NCT05514873
|
{
"brief_title": "An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors",
"conditions": [
"Generalized Myasthenia Gravis"
],
"interventions": [
"Drug: zilucoplan (RA101495)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05514873",
"official_title": "A Phase 3b, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of Zilucoplan in Participants With Generalized Myasthenia Gravis Switching From Intravenous Complement Component 5 Inhibitors to Subcutaneous Zilucoplan",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-03-13",
"study_completion_date(actual)": "2024-10-23",
"study_start_date(actual)": "2022-10-31"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-30",
"last_updated_that_met_qc_criteria": "2022-08-22",
"last_verified": "2024-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-08-25",
"first_submitted": "2022-08-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to assess the profile of cytokines IL-1beta, IL-6, IL-8, IL-10, IL-12 and TNF-alpha under inhalation anesthesia with isoflurane and intravenous anesthesia with propofol in healthy patients subjected to minimally invasive elective surgeries.
Detailed Description
Twenty ASA-I patients, subjected to otorhinolaryngology surgery, were randomly allocated in one group to receive anesthesia with isoflurane 1 MAC (minimum alveolar concentration) (n = 20). Other group with twenty ASA-I patients received propofol 2 to 4 microgram mL-1 (n = 20).
Fentanyl 5 mg kg-1 and rocuronium bromide 0.6 mg kg-1 were also administered to all patients. Venous blood (10 mL) was collected from each patient at each of the following times: before the beginning of surgery and anesthesia (T1), 2 h after the beginning of surgery (T2), and on the day after the anesthetic-surgical procedure (T3).
Plasma concentrations of interleukins IL-1beta, IL-6, IL-8, IL-10 and IL-12 and tumor necrosis factor (TNF-alpha) were measured in each sample through flow cytometry technique by using the method Cytometric Bead Array (CBA). Venous blood samples from fifteen volunteers not subjected to stress were also collected as control, and the same cytokines were measured.
#Intervention
- DRUG : Propofol and isoflurane
- Comparison of two anesthetic drugs
- Other Names :
- Diprivan, isoflurane
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients in good health American Society of Anesthesia status physical I
* Elective minor surgery
* General anesthesia
Exclusion Criteria:
* Smokers
* Alcoholics
* Previous medication or radiation
Sex :
ALL
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
|
NCT01111227
|
{
"brief_title": "Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane",
"conditions": [
"Patients in Good Health"
],
"interventions": null,
"location_countries": [
"Brazil"
],
"nct_id": "NCT01111227",
"official_title": "Inflammatory Cytokines Profile in Individuals Subjected to Surgical Procedures Using Propofol or Isoflurane.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-12",
"study_completion_date(actual)": "2009-12",
"study_start_date(actual)": "2008-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-04-27",
"last_updated_that_met_qc_criteria": "2010-04-26",
"last_verified": "2010-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-04-27",
"first_submitted": "2010-03-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study was to evaluate the impact of the co-morbidities profile on treatment response to biological therapy in inflammatory bowel disease (IBD) participants.
Detailed Description
This was a retrospective, non-interventional, observational study that included participants diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) who started treatment with biologics between June 2011 and June 2013. The study looked at the impact of the co-morbidities on the treatment response in IBD participants.
The study enrolled 310 patients included both UC and CD patients.
This multicenter trial was conducted in Spain. Investigator collected retrospective data in a single visit from participants who started biologic treatment between June 2011 and June 2013. Time since participants started biological treatment until study visit or until lack of treatment response or until treatment change constituted the reference period for the study.
#Intervention
- OTHER : No Intervention
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult participants (aged >=18).
* Were diagnosed with UC or CD according to the 'World Gastroenterology Organization Practice Guidelines for the Diagnosis and Management of inflammatory bowel disease (IBD) in 2010'.
* Who were naive to biologics that started treatment with biologics between June 2011 and June 2013.
* Participants in whom biological treatment was prescribed according to clinical practice.
* Who gave written informed consent.
Exclusion Criteria:
* Were participating in a clinical trial during the study reference period.
* Participant that, according to investigator's criteria was not capable to understand and fill in the study questionnaires or to give written informed consent.
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
|
NCT02861118
|
{
"brief_title": "A Retrospective Observational Study to Assess the Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease",
"conditions": [
"Inflammatory Bowel Disease"
],
"interventions": [
"Other: No Intervention"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT02861118",
"official_title": "Impact of Co-morbidities on Treatment Response in Inflammatory Bowel Disease: VERNE Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-04-04",
"study_completion_date(actual)": "2018-04-04",
"study_start_date(actual)": "2016-10-26"
},
"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)": "2019-08-14",
"last_updated_that_met_qc_criteria": "2016-08-05",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-08-10",
"first_submitted": "2016-08-05",
"first_submitted_that_met_qc_criteria": "2019-07-09"
}
}
}
|
#Study Description
Brief Summary
The objective of this post-market, prospective study is to evaluate the clinical acceptability, blood leakage, risk for blood exposure, need for digital compression, insertion success, and clinical utility of the ViaValve™ Safety IV Catheter compared to standard hospital PIVCs currently being used.
#Intervention
- DEVICE : ViaValve™ Safety IV Catheter
- Safety peripheral IV catheter with a blood control feature
- DEVICE : ProtectIV® Plus Safety IV Catheter
- Safety peripheral IV catheter with no blood control feature
|
#Eligibility Criteria:
Inclusion Criteria:
* A peripheral intravenous catheter will need to be inserted in order to gain access to a vein or artery to sample blood, monitor blood pressure, or administer fluids intravenous infusion as part of treatment.
* Willing and able to sign an Informed Consent (patient or legally authorized representative).
Exclusion Criteria:
* Body morphology (e.g., size) precludes the use of a peripheral intravenous catheter.
* Fluid to be infused is not appropriate for peripheral intravenous catheters.
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
|
NCT02119351
|
{
"brief_title": "A Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter",
"conditions": [
"Peripheral Intravenous Catheter"
],
"interventions": [
"Device: ProtectIV® Plus Safety IV Catheter",
"Device: ViaValve™ Safety IV Catheter"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT02119351",
"official_title": "A Post-market, Randomized Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-12",
"study_completion_date(actual)": "2013-12",
"study_start_date(actual)": "2013-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-04-21",
"last_updated_that_met_qc_criteria": "2014-04-18",
"last_verified": "2014-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-04-21",
"first_submitted": "2013-07-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In a previous study (https://osf.io/qdznc), the research team found that an 8-minute version of a single-session intervention for loneliness was more effective than a 23-minute version of it. The present work aims to further explore the relationship between intervention duration and effectiveness.
In this online trial, participants will be randomized to a 15-minute single-session depression intervention called the Action Brings Change (ABC) Program, a 10-minute version of it, a 6-minute version of it, or a 2-minute version of it. The main analysis will evaluate how change in depressive symptoms over eight weeks differs across conditions.
#Intervention
- BEHAVIORAL : Action Brings Change Project (15-minute adult version)
- The ABC Project is a self-guided online single-session intervention based on principles of behavioral activation. In a slightly different form intended for adolescents, it has demonstrated efficacy in several studies. Its adult version has also shown some efficacy.
- Other Names :
- ABC Project (15-min)
- BEHAVIORAL : Action Brings Change Project (10-minute adult version)
- This is a 10-minute shortened version of the 15-minute adult version of the ABC Project. The research team created it and pilot-tested it.
- Other Names :
- ABC Project (10-min)
- BEHAVIORAL : Action Brings Change Project (6-minute adult version)
- This is a 6-minute shortened version of the 15-minute adult version of the ABC Project. The research team created it and pilot-tested it.
- Other Names :
- ABC Project (6-min)
- BEHAVIORAL : Action Brings Change Project (2-minute adult version)
- This is a 2-minute shortened version of the 15-minute adult version of the ABC Project. The research team created it and pilot-tested it.
- Other Names :
- ABC Project (2-min)
|
#Eligibility Criteria:
Inclusion Criteria: Participants must be:
* Located in the United States
* At least 18 years
* Patient Health Questionnaire-8 (PHQ-8) score of at least 10 (moderate or more severe) at screener.
* Able to read and speak fluent English
* Able to access to the internet via a computer, tablet or smartphone for the next eight weeks
Exclusion Criteria:
* Participants who have completed the first session of the study before or completed another study testing a depression intervention from our laboratory via the same participant recruitment platform in the past two months.
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
|
NCT06313736
|
{
"brief_title": "What SSI Duration is Most Effective? An Online Experiment With American Adults",
"conditions": [
"Depression"
],
"interventions": [
"Behavioral: Action Brings Change Project (6-minute adult version)",
"Behavioral: Action Brings Change Project (10-minute adult version)",
"Behavioral: Action Brings Change Project (15-minute adult version)",
"Behavioral: Action Brings Change Project (2-minute adult version)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT06313736",
"official_title": "How Long Should a Behavioral Activation Single-session Intervention be? A Four-armed Trial Comparing Effectiveness by Intervention Duration",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-05-22",
"study_completion_date(actual)": "2024-05-22",
"study_start_date(actual)": "2024-03-20"
},
"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)": "2024-09-19",
"last_updated_that_met_qc_criteria": "2024-03-11",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-03-15",
"first_submitted": "2024-03-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the safety and effectiveness of Aceclidine/Brimonidine (LNZ101) compared with Aceclidine (LNZ100) and vehicle in the treatment of Presbyopia.
#Intervention
- DRUG : Aceclidine+Brimonidine combination ophthalmic solution
- LNZ101-combination ophthalmic solution
- Other Names :
- LNZ101, Brimonidine and Aceclidine
- DRUG : Aceclidine ophthalmic solution
- LNZ100- aceclidine ophthalmic solution
- Other Names :
- LNZ100, Aceclidine
- DRUG : Vehicle proprietary ophthalmic solution
- Proprietary Vehicle ophthalmic solution
- Other Names :
- Vehicle
|
#Eligibility Criteria:
Inclusion Criteria:
* Be able and willing to provide written informed consent and sign Health Information Portability and Accountability Act (HIPAA) form prior to any study procedure being performed;
* Be able and willing to follow all instructions and attend study visits;
* Be 45 <= age <= 75 years of either sex and any race or ethnicity at Visit 1;
* Have +1.00 to -4.00 diopter(D) of sphere (so that spherical equivalent (SE) results in myopia no more severe than -4.00D MRSE. See Inclusion 5 below) in both eyes determined by manifest refraction documented at Visit 1;
* Have <= 2.00D of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at Visit 1;
* Be presbyopic as determined at Visit 1
Exclusion Criteria:
* Be a female of childbearing potential who is currently pregnant, nursing or planning a pregnancy;
* Have known contraindications or sensitivity to the use of any of the study medications(s) or their components;
* Have an active ocular infection at Visit 1 (bacterial, viral or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis, scleritis, uveitis) in either eye;
* Have moderate or severe dry eye defined as total corneal fluorescein staining at Visit 1;
* Have clinically significant abnormal lens findings in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of Visit 1
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05431543
|
{
"brief_title": "Evaluation of the Safety and Effectiveness of Aceclidine (LNZ101) and Aceclidine + Brimonidine (LNZ100) in the Treatment of Presbyopia",
"conditions": [
"Presbyopia",
"Refractive Errors",
"Eye Diseases"
],
"interventions": [
"Drug: Vehicle proprietary ophthalmic solution",
"Drug: Aceclidine+Brimonidine combination ophthalmic solution",
"Drug: Aceclidine ophthalmic solution"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05431543",
"official_title": "A Multicenter, Double-Masked Evaluation of the Safety and Effectiveness of Aceclidine + Brimonidine (LNZ101) and Aceclidine (LNZ100) in the Treatment of Presbyopia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-12-14",
"study_completion_date(actual)": "2022-12-14",
"study_start_date(actual)": "2022-08-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-09-05",
"last_updated_that_met_qc_criteria": "2022-06-20",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-06-24",
"first_submitted": "2022-06-20",
"first_submitted_that_met_qc_criteria": "2024-08-14"
}
}
}
|
#Study Description
Brief Summary
Whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in caesarean section can effectively reduce the incidence of hypotension and fetal complications.
Detailed Description
Spinal anesthesia in the cesarean section often causes significant peripheral vascular dilatation, decreases blood pressure and cardiac output reduction which leads to maternal nausea, vomiting, dizziness and uteroplacental hypoperfusion. Infusion therapy and the use of vasopressor can prevent and treat the incidence of hypotension. Appropriate fluid therapy can not only maintain maternal tissue perfusion, but also reduce uteroplacental hypoperfusion. In the present study, perioperative goal directed fluid therapy is used. The non-invasive continuous hemodynamic monitor is used in this study, and the parameters (blood pressure (BP), stroke volume(SV), stroke volume variation (SVV), cardiac output (CO)) are used to determine the parameters of the blood transfusion in cesarean section as infusion guidelines. The application of Clearsight system to the pre-infusion of target-guided crystalloid solution is compared with the infusion of quantitative crystalline solution in the hope of reducing the incidence of maternal hypotension, reducing the use of vasopressin, improving uteroplacental perfusion and reducing the incidence of fetal acidosis.
#Intervention
- DRUG : Fluid therapy
- Goal directed Fluid therapy: Within 30 minutes before spinal anaesthesia, repeat 'Ringer's Injection' 3ml/kg within 3 minutes with 1-min gap until ΔSV\<5%
- Other Names :
- "Ringer's Injection"
- PROCEDURE : Spinal anaesthesia
- Inject marcaine and fentanyl to CSF for anaesthesia
|
#Eligibility Criteria:
Inclusion criteria:
* 20 <= age <= 45 y/o parturient
* Receive spinal anesthesia (SA) or combined spinal-epidural anesthesia (CSA) to undergo cesarean section
Exclusion criteria:
* Emergent C/S
* BMI>35kg/m2
* Height <150cm or >175 cm
* Patients with major cardiovascular disease, preeclampsia or eclampsia.
* Gestational age < 36wks
* Multiple pregnancy
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT03013140
|
{
"brief_title": "Preloading to Prevent Hypotension During Cesarean Section",
"conditions": [
"Obstetric Anesthesia Problems"
],
"interventions": [
"Drug: Fluid therapy",
"Procedure: Spinal anaesthesia"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT03013140",
"official_title": "Pre-optimization of Fluid Status to Prevent Hypotension by Non-invasive Arterial Pressure Monitor During Cesarean Section",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-29",
"study_completion_date(actual)": "2019-06-09",
"study_start_date(actual)": "2017-02-03"
},
"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)": "2020-01-09",
"last_updated_that_met_qc_criteria": "2017-01-05",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-01-06",
"first_submitted": "2016-12-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In Human, the oral sphere is the first and main place where sensory stimuli are received and perceived. The phenomena occuring during food breakdown and sensory perception are complex and in this system saliva plays a major role.
In the neonatal period, severe digestive diseases require the cessation of all oral feeding and the use of enteral or parenteral nutrition for prolonged periods to ensure the growth and development of children while their disease is active. The early stages of sensory oral exposures and their consequences on the development of eating habits of these children are poorly documented. It is likely that the process of acquisition of preferences and eating habits is atypical because of a 'bypass' of the oral sphere during the early stages of feeding. Thus, if not orally fed, children do not get exposed to a wide variety of tastes and textures in the first year of life, which may impact on their oral acceptance at a later age. These oral disorders (OD) are expressed by a refusal to eat, a heightened gag reflex, a refusal of certain consistencies and difficulties in chewing and swallowing. Few data are available on food typically accepted by these children.
Finally, oral sensory phenotypes of OD children (gustatory sensitivity ...) have not been described yet. It is likely that they may differ significantly from those of healthy (NOD).
In this context, a population of OD children is particularly interesting for studying the effects of the absence of these learning stages and their consequences in the development of sensory perception and eating habits.
The investigators formulate the hypothesis that the lack of exposure to a standard oral diet would modify the development of their 'oro-sensory systems' including saliva.
Studying such a population is a great opportunity to assess the influence of non oral food exposures and diet on saliva characteristics.
Saliva has recently received attention as a potential easy to collect source of biomarkers in several conditions excluding OD.
The potential impact of OD on salivary composition has never been studied. Several studies linking saliva and perception or preferences have been conducted in the UMR CSGA (Unité Mixte de Recherche du Centre des Sciences du Goût et de l'Alimentation). They have already contributed to highlight the great inter-individual variability for a number of saliva markers and a change in saliva protein profiles in response to taste stimulation They also underlined the remarkable intra-stability for saliva flow and composition during a one year study.
This study intends to prove the concept that it is relevant to relate saliva characteristics to food intake behaviour or food habits The first hypothesis to be tested in this study is that salivary profiles (biological signatures) can discriminate two groups of children differing by their orality.
The second hypothesis to be tested is that these specific biological biological signatures may be correlated to certain food habits associated or not with oral disorders.
#Intervention
- OTHER : Taking of saliva before and after gustatory stimulation
- Taking of saliva before and after gustatory stimulation (3 drops of citric acid 2.4 g / L)
|
#Eligibility Criteria:
Inclusion Criteria:
Oral disorder children group:
* Oral disorder children, of any etiology, defined as follows:
difficulty to wean the nutritional support within 50% of energy intake recommended by age oral more than 3 months of exclusive artificial feeding during the first 6 months of life
* Children aged 2 <= age <= 15
* Children with a maximum of 50% of their energy intake provided by the oral route (3 or 4 patients with 0% intake, defined as an internal control)
* Whose parents gave consent for study participation
No oral disorder children group:
* No oral disorder children
* whose parents signed an informed consent for the participation of their child to the study
Exclusion Criteria:
Oral disorder children group:
* Child refusing to participate
* Absence of parents consent
* Less than 3 months of artificial feeding during the first 6 months of life,
* Immunosuppressive medication that might interfere with the saliva composition,
* Children not covered by the social security
No oral disorder children group:
* Child refusing to participate
* Absence of parents consent
* History of or current enteral or parenteral feeding.
* Children not covered by the social security
No oral disorder children are matched to Oral disorder children on age and sex.
Sex :
ALL
Ages :
- Minimum Age : 2 Years
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01532323
|
{
"brief_title": "Oral Sphere: Salivary Markers and Food. A Prospective Study in Children Expressing Oral Disorders",
"conditions": [
"Oral Disorder"
],
"interventions": [
"Other: Taking of saliva before and after gustatory stimulation"
],
"location_countries": [
"France"
],
"nct_id": "NCT01532323",
"official_title": "Oral Sphere: Salivary Markers and Food. A Prospective Study in Children Expressing Oral Disorders",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-07",
"study_completion_date(actual)": "2013-07",
"study_start_date(actual)": "2011-12"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-05-28",
"last_updated_that_met_qc_criteria": "2012-02-09",
"last_verified": "2013-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-02-14",
"first_submitted": "2012-01-31",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of thie study to assess tear film parameters such as tear meniscus height (TMH), tear meniscus area (TMA), and tear meniscus depth (TMD). In addition, corneal pachymetry and epithelial thickness maps in SLE patients and compared to healthy subjects of similar age and gender.
Detailed Description
Systemic lupus erythematous (SLE) is a relapsing and remitting autoimmune connective tissue disorder that can affect many organs such as skin, joints, kidneys, eye, and brain (1) . SLE has a global prevalence of 0.3 to 23.2 cases per 100,000. Women are more likely than men to develop the disease. Four out of the following 11 diagnostic criteria are sufficient for the diagnosis of SLE, malar rash, discoid rash, oral ulcers, non-erosive arthritis, serositis, photosensitivity, renal disorder, neurological disorder, hematological disorder, immunological disorder, and presence of antinuclear antibodies. (2,3)
Ocular manifestations occur in about one third of SLE patients with keratoconjunctivitis sicca being the most common manifestation which is characterized by decreased tear film aqueous layer. Scleritis, retinal vasculitis (which is often associated with CNS lupus), and papillitis are considered as the most serious ocular manifestations. (4)
Corneal involvement in SLE affects the superficial epithelium, resulting in superficial punctate keratitis, which is believed to be caused by Sjögren\'s syndrome (SS). However, some cases of non-infiltrative and infiltrative peripheral ulcerative keratitis have been identified (5) .
Schirmer\'s test and fluorescein breakup time test (FBUT) are two common clinical tests used to analyze tear film. (6,7) Using an in vivo, non- contact technique, anterior segment optical coherence tomography (AS- OCT) is now used to image the tear film, measure the lower tear film height and area, measure corneal thickness (pachymetry), and measure surface epithelial thickness. (8,9)
#Intervention
- DIAGNOSTIC_TEST : Anterior Segment OCT
- AS-OCT for SLE patients with dry eye, SLE patients without dry eye and compare them with normal subjects.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >=18 years..
* Patients with SLE diagnosed by a rheumatologist with no ocular involvement upon clinical examination
Exclusion Criteria:
* 1. Patients with history of intraocular surgery as cataract surgery ,retinal detachment surgery, anti-glucoma surgery.
2. Patients with history of any corneal refractive surgery as LASIK, PRK. 3. Patients with significant media opacity as corneal opacity, cataract. 4. Patients with ocular diseases as glaucoma, uveitis. 5. Patients with any retinal affection as pathological myopia, macular hole, age related macular degeneration and retinal vascular occlusion.
6. Patients with systemic diseases as diabetes mellitus, hypertension, abnormal kidney function.
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
|
NCT04873739
|
{
"brief_title": "AS-OCT Study of Cornea and Tear Film Parameters in SLE Patients",
"conditions": [
"Systemic Lupus Erythematosus"
],
"interventions": [
"Diagnostic Test: Anterior Segment OCT"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04873739",
"official_title": "Anterior Segment Optical Coherence Tomography Study of Cornea and Tear Film Parameters in Systemic Lupus Erythematous Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-02-01",
"study_completion_date(actual)": "2021-03-30",
"study_start_date(actual)": "2020-07-01"
},
"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)": "2022-02-03",
"last_updated_that_met_qc_criteria": "2021-04-30",
"last_verified": "2021-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-05-05",
"first_submitted": "2021-04-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
There is no consensus on the surgical treatment of unremitting, painful flatfeet in children. Subtalar arthroereisis has gained notoriety although there is a paucity of literature on its biomechanical effects. The goal of the investigators was to compare a group treated with subtalar arthroereisis with another group undergoing lateral column calcaneal lengthening. The investigators hypothesis was that the results of arthroereisis would be equivalent to the more established method of calcaneal lengthening.
Detailed Description
The purpose of this prospective, non-randomized study was to evaluate two different surgical treatments for symptomatic planovalgus feet: lateral column lengthening osteotomy and subtalar arthroereisis. The goal of the investigators was to compare the outcomes of these two surgeries and determine whether both treatments resulted in clinical improvement. This was accomplished through the use of pre- and post-operative kinematics, pedobarography, radiographic measurements, and validated outcome measures. The investigators were particularly interested in analyzing the kinematic changes to quantify the changes in the foot mobility and alignment during ambulation, as it has not been previously studied to our knowledge. The investigators hypothesis was that both procedures would show significant improvement and be equivalent in their results.
A prospective trial was conducted. The investigators enrolled fifteen patients (mean age 12.8y, 24 feet) with painful, planovalgus feet refractory to conservative treatment. Seven patients (13 feet) were enrolled in the arthroereisis group, and eight patients (11 feet) were enrolled in the calcaneal lengthening group. Though not specifically excluded, none of the enrolled patients had an underlying neuromuscular diagnosis. Kinematic motion analysis was performed on each patient prior to surgery and at one year of follow-up. Pedobarometry studies, radiographs, and validated outcome questionnaires (Oxford Ankle-Foot Questionnaire for Children) were also performed to evaluate the outcomes of both groups.
|
#Eligibility Criteria:
Inclusion Criteria:
* Planovalgus foot deformity
* Patient normally ambulates without use of assistive devices
* Patient is between the ages of 7 and 17 at the initial evaluation
Exclusion Criteria:
* Hip flexion contractures greater than 15 deg.
* Knee flexion contractures greater than 10 deg.
* Ankle dorsiflexion less than 0 deg. (plantarflexion contracture)
* Taking medication which effects motor control
* Inability to follow instructions to perform study
Sex :
ALL
Ages :
- Minimum Age : 7 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT02055495
|
{
"brief_title": "Arthroereisis Versus Lateral Column Lengthening in the Treatment of Planovalgus Feet",
"conditions": [
"Flatfeet"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT02055495",
"official_title": "Prospective Comparison of Subtalar Arthroereisis To Lateral Column Lengthening for Painful Flatfeet",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-02",
"study_completion_date(actual)": "2014-02",
"study_start_date(actual)": "2010-03"
},
"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)": "2014-08-08",
"last_updated_that_met_qc_criteria": "2014-02-03",
"last_verified": "2014-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-02-05",
"first_submitted": "2014-02-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this post-marketing surveillance study is to collect information on efficacy and safety for prophylactic administration of zanamivir in clinical practice in family or persons living with patients with influenza virus infection.
#Intervention
- DRUG : Zanamivir hydrate
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who meet the study population criteria
Exclusion Criteria:
* Subjects with a history of hypersensitivity to the ingredients of zanamivir
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01390792
|
{
"brief_title": "Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)",
"conditions": [
"Influenza, Human"
],
"interventions": [
"Drug: Zanamivir hydrate"
],
"location_countries": null,
"nct_id": "NCT01390792",
"official_title": "Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-02",
"study_completion_date(actual)": "2009-05",
"study_start_date(actual)": "2007-01"
},
"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)": "2017-05-16",
"last_updated_that_met_qc_criteria": "2011-07-07",
"last_verified": "2017-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-07-11",
"first_submitted": "2011-07-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Primary Objective:
To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Silver Frutal.
#Intervention
- DRUG : LACTIC ACID(ND)
- Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 5 weeks (treatment period).
|
#Eligibility Criteria:
Inclusion criteria:
* Phototype Skin II and III Integral skin test in the region
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion
Exclusion criteria:
* Lactation or pregnancy
* Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
* Diseases which can cause immunosuppresion, such as diabetes, HIV
* Use of photosensitivity drugs
* History of sensitivity or photosensitivity for topic products
* Cutaneous active disease which can modify the study results
* History or activity of photodermatosis
* Personal or family antecedents of cutaneous neoplasia photo induced
* Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
* Intense exposure solar in the test region
* Use of new drugs and/or cosmetics during the study
* Previous participation in studies using the same product in test
* Relevant history or confirmation of alcohol or other drugs abuse
* Intolerance detected or suspected for some component of the sample tested
* Medecin or sponsor employees or their close family.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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
|
NCT00933075
|
{
"brief_title": "Dermacyd Silver Frutal (Lactic Acid) - Photo Evaluation.",
"conditions": [
"Hygiene"
],
"interventions": [
"Drug: LACTIC ACID(ND)"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT00933075",
"official_title": "Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Silver Frutal (Lactic Acid).",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-07",
"study_completion_date(actual)": "2009-07",
"study_start_date(actual)": "2009-06"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-09-14",
"last_updated_that_met_qc_criteria": "2009-07-03",
"last_verified": "2010-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-07-07",
"first_submitted": "2009-07-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
An altered permeability has been proposed to play an important role in the pathogenesis of several gastrointestinal disorders, such as irritable bowel syndrome and inflammatory bowel disease. Nutrients derived from food are able to influence the permeability of the intestine and can therefore also affect gastrointestinal symptoms. In this study, the investigators will investigate the effects of capsaicine and cinnamaldehyde, which can be found in hot peppers and cinnamon, respectively, on gastrointestinal physiology.
Objective:
To obtain more information about the effects of capsaicin and cinnamaldehyde on the intestine, these substances will be infused directly in the duodenum. Hereafter, the permeability of the intestine, gallbladder motility and the effects on satiety will be assessed.
Hypothesis:
Duodenal capsaicin and cinnamaldehyde infusion induces changes in the intestinal epithelial barrier function by selectively acting on TRPV1 and TRPA1 receptors and releasing serotonin from enterochromaffin cells as determined by the multi sugar permeability test
#Intervention
- DIETARY_SUPPLEMENT : Capsaicin
- 1.5 mg capsaicin administered intraduodenally
- DIETARY_SUPPLEMENT : Cinnamaldehyde
- 70 mg per intervention administered intraduodenally
- DIETARY_SUPPLEMENT : Placebo
- Physiological saline
|
#Eligibility Criteria:
Inclusion Criteria:
* Based on medical history and previous examination, no gastrointestinal complaints can be defined.
* Age between 18 and 65 years. This study will include healthy adult subjects. Subjects > 65 years have an increased risk for comorbidities, therefore, subjects > 65 years will not be included. Furthermore, age has an influence on the homeostasis of the intestinal mucosa [21], which can potentially influence outcome parameters of the study.
* BMI between 20 and 30 kg/m2
Exclusion Criteria:
* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
* Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
* Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
* Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic), pregnancy, lactation
* Excessive alcohol consumption (>20 alcoholic consumptions per week)
* Smoking
* Blood donation within 3 months before the study period
* Self-admitted HIV-positive state
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
|
NCT01667523
|
{
"brief_title": "The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability",
"conditions": [
"Healthy"
],
"interventions": [
"Dietary Supplement: Cinnamaldehyde",
"Dietary Supplement: Placebo",
"Dietary Supplement: Capsaicin"
],
"location_countries": [
"Netherlands"
],
"nct_id": "NCT01667523",
"official_title": "The Effect of Capsaicin and Cinnamaldehyde on Intestinal Permeability, Gallbladder Motility and Satiety",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06",
"study_completion_date(actual)": "2011-12",
"study_start_date(actual)": "2011-02"
},
"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)": "2012-08-17",
"last_updated_that_met_qc_criteria": "2012-08-16",
"last_verified": "2012-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-08-17",
"first_submitted": "2011-04-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objectives of this study are to pilot test a protocol of weekly assessments of motivation to quit and other relevant constructs combined with information about how to enroll in cessation programs, which will allow initial quantification of motivation to quit during cancer treatment and develop hypotheses about the impact of motivation on the decision to enroll in services.
#Intervention
- OTHER : There is no intervention for this study
- There is no intervention or exposure for this study
|
#Eligibility Criteria:
Inclusion Criteria:
* An adult (18+)
* Current smoker defined by: Has smoked 100 cigarettes in their lifetime (may be multi-tobacco users as long as they also use combustible cigarettes).
* Any type of cancer (except non-melanoma skin cancer)
* Anticipates receiving any of the following cancer treatments in the 3 months following enrollment: chemotherapy, surgery, immunotherapy, bone marrow or stem cell transplant, hormone therapy, or radiation
* Access to the Internet
Exclusion Criteria:
* Not smoked 100 cigarettes in their lifetime
* < 18 years in age
* Diagnosed with non-melanoma skin cancer
* Not diagnosed with cancer
* Does not anticipate receiving cancer treatments in the 3 months following enrollment
* Has been previously enrolled in an existing Cancer Center Tobacco Treatment Program (TTP)
* Not comfortable reading and responding to questions in English
* No consistent access to the Internet
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
|
NCT05370859
|
{
"brief_title": "mMe: Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients",
"conditions": [
"Smoking Behaviors",
"Cancer",
"Motivation"
],
"interventions": [
"Other: There is no intervention for this study"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05370859",
"official_title": "Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-02-13",
"study_completion_date(actual)": "2024-02-13",
"study_start_date(actual)": "2022-07-18"
},
"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)": "2024-04-03",
"last_updated_that_met_qc_criteria": "2022-05-06",
"last_verified": "2024-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-05-12",
"first_submitted": "2022-04-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
GSK1160724 is a potent mAChR antagonist, which is being developed for treatment of chronic obstructive pulmonary disease (COPD)
#Intervention
- DRUG : GSK1160724
- GSK1160724 will be available with dosing strengths of 10, 50 and 125 micrograms/blister for inhalation using the DISKUS inhaler.
- DRUG : Tiotropium bromide
- Tiotropium bromide capsules will be supplied with a dose of 18 micrograms administered via a HandiHaler device.
- DRUG : Placebo
- Subjects will receive placebo.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female subjects. Female subjects must be of non-child bearing potential.
* Aged between 18 <= age <= 55 years inclusive
* Non-smokers
* Normal spirometry
* A signed and dated written informed consent is obtained from the subject
* The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form
* Available to complete the study
* The subject is greater than or equal to 50kg with a body mass index within the range 19.0 to 29.9 kg/m2 inclusive
* Response to ipratropium bromide
Exclusion Criteria:
* Any clinically relevant and important abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead or Holter)
* A history of breathing problems
* A mean QTc(B) value > 450ms, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90 <= age <= 210ms or an ECG that is not suitable for QT measurements at screening
* A history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmHg at screening
* A mean heart rate outside the range 40 <= age <= 90 bpm inclusive at screening
* History of use of tobacco- or nicotine-containing products within 6 months of screening, and/or positive urine cotinine test results at screening
* Where participation in the study would result in donation of blood in excess of 500mL within a 56 day period at screening
* The subject is currently taking regular (or a course of) medication, whether prescribed or not, including herbal remedies such as St John's Wort etc.
The subject has taken:
* prescription medications for 14 days prior to first dose of study drug, or
* Over-the-counter (OTC) medications/preparations (including herbal remedies, etc.) excluding simple analgesics for 48 hours prior to first dose of study drug,unless it is judged by the Investigator not to compromise the subject's safety or influence the outcome of the study.
* The subject has participated in a study with a new molecular entity or any other trial within a period of 3 months prior first dose of study drug
* The subject has tested positive for hepatitis C antibody (third generation enzyme immunoassay), hepatitis B surface antigen or HIV antibodies (if tested according to site SOP's) at screening.
* The subject has tested positive for drugs-of-abuse at screening
* The subject has tested positive for urine alcohol (including ethanol) at screening The detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study
* The subject is unable to use the DISKUS™ and/or HandiHaler inhaler devices correctly at screening
* The subject has a suspected history of alcohol abuse within the six months previous to the screening visit
* The subject has a known allergy or hypersensitivity to magnesium stearate, milk protein or the excipient lactose monohydrate, iodine, ipratropium bromide, tiotropium bromide, atropine and/or any of its derivatives
* The subject has a significant clinical history of prostatic hypertrophy or narrow angle glaucoma
* The subject has received an allogeneic bone marrow transplant
* The subject has claustrophobia that may be aggravated by entering the whole body plethysmography cabinet
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
|
NCT00555022
|
{
"brief_title": "Effect of GSK1160724 In Healthy Volunteers",
"conditions": [
"Pulmonary Disease, Chronic Obstructive"
],
"interventions": [
"Drug: Placebo",
"Drug: GSK1160724",
"Drug: Tiotropium bromide"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00555022",
"official_title": "A Randomized Double-blind, Placebo-controlled, Crossover, Dose Escalation Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK1160724 and Tiotropium Bromide",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-04-07",
"study_completion_date(actual)": "2008-04-07",
"study_start_date(actual)": "2007-12-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": null,
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-09-08",
"last_updated_that_met_qc_criteria": "2007-11-06",
"last_verified": "2017-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-11-07",
"first_submitted": "2007-11-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of our study is to verify the validity and reliability of the Turkish version of B-GYA.
Detailed Description
Dementia refers to a condition in which individuals with brain damage have multiple cognitive deficits with impairment in activities of daily living (ADL). Therefore, the assessment of ADL is one of the main criteria for evaluating dementia. ADL disorders are often observed by caregivers before they are identified by psychometric testing, thus suggesting that ADL assessment can contribute to the early detection of dementia.
Evaluation of ADL has become increasingly important with the introduction of new drugs for Alzheimer's disease (AD), as well as being a helpful tool in diagnosis. Current guidelines have recognized the need for therapeutic intervention in AD to measure and document treatment effects on ADL. It has been emphasized that internationally validated and approved test tools to evaluate dementia are important for multinational clinical drug trials that evaluate the efficacy of anti-dementia drugs. Therefore, it is of great importance to find ADL scales that can be used internationally. Various ADL scales have been developed, such as Lawton's instrumental ADL (IADL), functional activities questionnaire (FAQ), ADCS-ADL, and Bayer ADL (B-ADL). Of these, W-ADL was developed based on an international pilot study to evaluate ADL deficits in patients from different cultural backgrounds.
Specifically, through a collaborative study conducted in four different countries during the development of the RDA, the researchers prepared 141 items and selected 25 of them that could be used internationally. The target group of the scale included elderly patients suffering from mild to moderate dementia or cognitive impairment. European countries: In the United Kingdom, Germany, and Spain, the validation study of the B-ADL was carried out in three stages. The aim of our research is to verify the validity and reliability of the Turkish version of B-ADL.
#Intervention
- DIAGNOSTIC_TEST : Assessment
- The Standardized Mini-Mental Test and Clinical Dementia Rating Scale will be administered by the physician to the healthy individuals with dementia to be included in the study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Individuals aged 60 and over
* Being literate
* Having given consent to participate in the study
* Individuals diagnosed with Alzheimer's according to the international diagnostic criteria of the American National Neurological and Communication Disorders Stroke and Alzheimer's Association (NINCDS-ADRDA) and in mild and moderate stages (<2) according to the Clinical Dementia Rating: CDR will be included in the study.
Exclusion Criteria:
* Those who did not give consent to participate in the study
* CDR>2
* Except for behavioral or functional symptoms associated with dementia, individuals with medical, psychiatric, neurological conditions, or physical disabilities that may significantly affect the performance of ADL will be excluded from the study.
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 95 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05449626
|
{
"brief_title": "Validity and Reliability of Turkish Version of Bayer Activities of Daily Living Scale",
"conditions": [
"Alzheimer Disease",
"Activities of Daily Living"
],
"interventions": [
"Diagnostic Test: Assessment"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05449626",
"official_title": "Validity and Reliability of Turkish Version of Bayer Activities of Daily Living Scale",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-06",
"study_completion_date(actual)": "2023-01-06",
"study_start_date(actual)": "2022-07-26"
},
"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)": "2023-07-03",
"last_updated_that_met_qc_criteria": "2022-07-04",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-08",
"first_submitted": "2022-07-04",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Since plaque control forms the basis for caries prevention, the type of toothpaste and its constituents becomes more important.
Toothpaste containing fluoride are widely popular and fluorides have been historically reported to have effects against dental caries. However, the fluoride safe doses are still discussed ,because fluoride has toxicity and causing fluorosis.
The aim of the current research is to find alternative agent that can be used without side effects.
Detailed Description
Participants will be examined to ensure that they have met the smple entrey criteria,then the participants will be randomly assigned to four groups each one according to a group:
1. A group of children using low-fluoridated toothpaste (500ppm)
2. A group of children using fluoridated toothpaste (1450ppm)
3. A group of children using theobromine toothpaste (2%)
4. A group of children using low-fluoridated toothpaste (4%) The researcher will teach the participants how to brush using (tell-show-do)technique.
* The brushing method that will be used is the fones technique.
* Brushing duration must be 2minutes.
* Frequency of brushing must be twice a day
* The amount of toothpaste used is pea size.
Mechanism of examination and follow up:
A thorough scaling and plaque removal was conducted and the children were advised to brush their teeth using their regular toothpaste for a week before starting the research.
Gingival will be evaluated with gingival index (loe and silness)
#Intervention
- OTHER : Evaluation of the effectiveness of low- fluoridated toothpaste.
- Children will be given low- fluoridated toothpaste, plaque score in groups will be assess pre given toothpaste in baseline,aweek,2week,and after 3weeks by using the TMQHPI for both buccal and lingual surface.
Gingivalitis will be assess pre given toothpaste,aweek,2weeks,and after 3weeks by using gingival index (loe and silness).
- OTHER : Evaluation of the effectiveness of fluoridated toothpaste.
- Children will be given e fluoridated toothpaste, plaque score in groups will be assess pre given toothpaste in baseline,aweek,2week,and after 3weeks by using the TMQHPI for both buccal and lingual surface.
Gingivalitis will be assess pre given toothpaste,aweek,2weeks,and after 3weeks by using gingival index (loe and silness).
- OTHER : Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste.
- Children will be given theobromine toothpaste(2%),plaque score in groups will be assess pre given toothpaste in baseline,aweek,2week,and after 3weeks by using the TMQHPI for both buccal and lingual surface.
Gingivalitis will be assess pre given toothpaste,aweek,2weeks,and after 3weeks by using gingival index (loe and silness).
- OTHER : Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste.
- Children will be given theobromine toothpaste(4%),plaque score in groups will be assess pre given toothpaste in baseline,aweek,2week,and after 3weeks by using the TMQHPI for both buccal and lingual surface.
Gingivalitis will be assess pre given toothpaste,aweek,2weeks,and after 3weeks by using gingival index (loe and silness).
|
#Eligibility Criteria:
Inclusion Criteria:
* Children of age group 6to 9 years.
* Participant must have least 20 teeth free from dental cries on both buccal and lingual surfaces of the teeth.
* Cooperative children having behavioral rating (positive or definitively positive)according to frankel's behavior rating scale.
* Children who are not on any medication prior or during the study period
Exclusion Criteria:
* children with systemic diseases and medically compromising conditions.
* children undergoing orthodontic treatment or with an intraoral prosthesis.
* children who could not brush their teeth or rinse on their own.
* Allergic to any of the toothpaste ingredient used the study.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 9 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05187507
|
{
"brief_title": "Effectiveness of Theobromine Toothpaste",
"conditions": [
"Dental Plaque",
"Dental Care"
],
"interventions": [
"Other: Evaluation of the effectiveness of low- fluoridated toothpaste.",
"Other: Evaluation of the effectiveness of theobromine toothpaste (2%) toothpaste.",
"Other: Evaluation of the effectiveness of fluoridated toothpaste.",
"Other: Evaluation of the effectiveness of theobromine toothpaste(4%) toothpaste."
],
"location_countries": [
"Syrian Arab Republic"
],
"nct_id": "NCT05187507",
"official_title": "The Effectiveness Evaluation of the Theobromine Containing Toothpastes in Controlling Dental Plaque in Children Aged 6-9years(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)": "2021-09-25"
},
"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)": "2022-01-11",
"last_updated_that_met_qc_criteria": "2021-12-24",
"last_verified": "2021-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-01-11",
"first_submitted": "2021-12-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The importance of narrative skills is evident in their role in language development and their relation to important academic skills namely reading, comprehension, and writing. Narratives are also essential for competent social skills, and children with delayed language development are usually found to have less proficient social communication skills. Research demonstrates the effects of narrative language intervention on improved narrative structure and complexity in addition to improved receptive and expressive use of syntax, morphology and general language use in children with narrative language impairment in various types of communication disorders. Given the importance of narrative language abilities in language development and due to lack of research targeting the assessment and intervention of narrative language skills of Arabic speaking children with language impairments, this study is dedicated towards the assessment of narrative language in Arabic speaking children and the development of a comprehensive intervention program targeting narrative language skills and its application on children with hearing impairment and developmental language disorder.
Detailed Description
A narrative refers to the ability to produce a fictional or real account of temporally sequenced meaningful occurrences and experiences. Studies have shown that narrative competence increases with age alongside language, cognitive and social skills. Development of narrative abilities starts during the preschool years, expands during the school age years, and continues to develop through adolescence and even adulthood.
Children with developmental language disorder (DLD) are known to have impaired narrative skills. Narratives of children with DLD are characterized by incomplete episodes, poor coherence, less expression of cognitive states, less complex sentences with fewer dependent clauses, and less complex morpho-syntax when compared to their peers.
Research has also shown that hearing impairment is another communication disorder in which narrative skills are particularly vulnerable. Narratives of children with hearing loss demonstrate comprehension and production deficits and they have a statistically significant lower performance in tests assessing narrative structure.
The aim of this work is to develop a narrative language intervention program and to apply it on children with developmental language disorder and children with hearing impairment to detect its efficacy on improving their narrative and language skills.
This study will be conducted on 44 children with hearing impairment, and 44 children with developmental language disorder attending the Unit of Phoniatrics, in the outpatient clinic of Alexandria Main University hospital. Sample size was calculated to achieve 80% power with a target significance level at 5% to detect the efficacy of the proposed narrative intervention program in improvement of narrative language skills of Egyptian children with hearing impairment and developmental language disorder.
The narrative intervention program will include an introductory section on the elements of story grammar to introduce the children to narratives and give them explicit instructions about the concepts of narrative macrostructure. The program will include 24 illustrated story sequences with a minimum of 5 sequences representing the main story elements: characters and setting; problems; internal response; actions; and consequence. Story icons will be designed to represent the main 5 elements to accompany storytelling and act as visual prompts. Each story will reflect specific content with several target vocabulary words and complex morphosyntax.
The following procedure will be implemented with each story: Modeling, answering comprehension questions, retelling with icons and colored illustrations, retelling with icons only, and retelling without icons.
All subjects meeting the specified inclusion and exclusion criteria will be assessed by the specified protocol of assessment to evaluate narrative skills, language skills and cognitive abilities before and after intervention.
The results of this study will be tabulated and analyzed with the use of appropriate statistical methods and appropriate figures and diagrams.
#Intervention
- BEHAVIORAL : Narrative language intervention program
- Narrative language targets improving narrative macrostructure and microstructure.
The program will include 24 illustrated story sequences with a minimum of 5 sequences representing the main story elements: characters and setting; problems; internal response; actions; and consequence. Story icons will be designed to represent the main 5 elements to accompany storytelling and act as visual prompts.
Each story will reflect specific content with several target vocabulary words and complex morphosyntax. Each story will be followed by comprehension questions to facilitate understanding and answering question about stories.
The following procedure will be implemented with each story: Modeling, answering comprehension questions, retelling with icons and colored illustrations, retelling with icons only, and retelling without icons. This procedure is adapted from story champs intervention program
- BEHAVIORAL : Conventional language intervention
- Language rehabilitation targets improving semantics, syntax, pragmatics and phonology.
|
#Eligibility Criteria:
Inclusion Criteria:
* Children with developmental language disorder of both sexes in the age group (5 <= age <= 12).
* Hearing-impaired children of both sexes with sensorineural hearing loss using auditory verbal communication in the age group (5 to 12) years with a minimum 2 years of experience with their hearing aids or cochlear implants with good benefit (hearing threshold less than 40 dB across all frequencies).
* Hearing impaired children using hearing aids with pure tone average thresholds at 500, 1000, and 2000 Hz between 50 and 75 dB in unaided conditions.
* Children with expressive language skills of at least 3 word length sentences.
Exclusion Criteria:
* Children with intellectual disability.
* Children with neurodevelopmental disorders (example; ASD).
* Children with additional sensory deprivation (impaired vision).
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT05445687
|
{
"brief_title": "Rehabilitation of Narrative Language in Children With Hearing Impairment and Developmental Language Disorder",
"conditions": [
"Hearing Impaired Children",
"Developmental Language Disorder"
],
"interventions": [
"Behavioral: Narrative language intervention program",
"Behavioral: Conventional language intervention"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05445687",
"official_title": "Assessment and Rehabilitation of Narrative Language in Children With Hearing Impairment and Developmental Language Disorder",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-05-19",
"study_completion_date(actual)": "2024-05-19",
"study_start_date(actual)": "2022-04-19"
},
"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)": "2024-07-30",
"last_updated_that_met_qc_criteria": "2022-06-30",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-06",
"first_submitted": "2022-06-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This pilot study will assess the acceptability and feasibility a novel mHealth app designed for smokers who are ambivalent about quitting and have been diagnosed with HIV.
Detailed Description
This study will use a randomized, parallel, two-arm trial to compare outcomes between people assigned to use a 'standard care' mHealth app versus a similar app with additional content targeted to people living with HIV. A total of up to 50 people will be enrolled and followed for three months to assess outcomes.
#Intervention
- DEVICE : mHealth Intervention
- Mobile health (mHealth) app to motivate and support quitting smoking.
|
#Eligibility Criteria:
Inclusion Criteria Include:
* 18 years or older;
* Comfortable speaking and reading in English;
* Smoked at least 100 cigarettes in their lifetime;
* Smoked, even a puff, in the past 7 days;
* Smoked at least 5 cigarettes a day;
* Are interested in quitting smoking someday, but not in the next month;
* Have an iPhone Operating System (iOS) or Android smart phone which they use at least weekly;
* Are willing to upgrade their phone operating system, if needed;
* Agree to download and try the app;
* Do not use Virtual Private Network (VPN) on their smart phone;
* Live in the United States and have a valid U.S.-based mailing address and phone number;
* Have been diagnosed with HIV
Exclusion Criteria Include:
* Refusing to answer all screening questions
* History of dementia or psychosis
* Visual impairments that preclude their ability to view content on their smart phone and lack adaptive devices to view content
* Contraindications for nicotine replacement therapy (NRT) use (e.g., based on medical history or daily smoking level)
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
|
NCT05339659
|
{
"brief_title": "Randomized Pilot Study of a mHealth App for Ambivalent Smokers Living With HIV",
"conditions": [
"Smoking",
"Smoking Cessation"
],
"interventions": [
"Device: mHealth Intervention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT05339659",
"official_title": "Design and Testing of a mHealth App for Ambivalent Smokers Living With HIV: A Randomized Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-05-20",
"study_completion_date(actual)": "2023-05-20",
"study_start_date(actual)": "2022-06-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "DEVICE_FEASIBILITY",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-04-01",
"last_updated_that_met_qc_criteria": "2022-04-15",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-04-21",
"first_submitted": "2022-04-11",
"first_submitted_that_met_qc_criteria": "2024-03-28"
}
}
}
|
#Study Description
Brief Summary
Blocking sensation from the femoral nerve by injecting local anesthetic around the nerve plays an important role in pain control after total knee replacement. However, femoral nerve block has been associated with increased risk of falls due to weakness of the thigh muscle. This prospective, randomized controlled trial asks the question whether blocking the more distal branch of the femoral nerve (saphenous nerve) will result in less muscle motor block, and thus less risk of falls. The study also aims to compare pain control after both techniques.
Detailed Description
If the patient is willing to participate and signs the consent, he/she will be randomized to one of the two treatment groups:
1. Femoral nerve block
2. Adductor canal block
The standard of care anesthesia regimen for this surgery is as follows:
All Patients will receive their Multimodal Perioperative Pain Protocol (MP3) medication as per routine care in the patient receiving area. All blocks are performed in the pre-operative holding area with standard ASA monitors applied. Typically, patients receive 1-2 mg of midazolam and 50-100 mcg of fentanyl for sedation during the placement of the block. Standard operating procedure of the block room will be followed. Block time out will be preformed according to standard operating procedure. All blocks will be done under ultrasound guidance. Sonosite (S nerve) machine will be used with a high frequency linear (HFL) US probe with 6-13 MHZ frequency. Both CFNB and ACB will take be performed according to the SOP in the investigators department.
For CFNB: Images of the femoral nerve will be obtained in the short axis. 1% lidocaine will be used for local infiltration of the skin. A 2 inch 18 G touhy needle ( B Braun) will be advanced in plane under US guidance . Confirmation may take place with Quadricpes muscle twitches and patella movement between 0.3 and 0.4mA (2Hz; 0.1ms). A bolus of 20 ml of Ropivicaine 0.5% will be injected. A non stimulating catheter will be advanced through the needle to a distance of 3-4 cm beyond the needle tip. Catheter will be secured in place using benzoin, Steristrips, and a tegaderm.
For the ACB: ultrasound survey at the medial part of the thigh will take place, halfway between the superior anterior iliac spine and the patella. In a short axis view, the femoral artery will be identified underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery. The needle will be introduced in-plane and 2 to 3 mL of LA bolus (0.2% ropivicaine) will be used to verify correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal. A bolus of total volume of 20 ml of Ropivicaine 0.5% will be injected through the needle. The catheter will then be introduced and advanced 2-3 cm beyond the tip of the needle.
At the conclusion of surgery a large obaque dressing will be applied from the femoral crease to the mid thigh region so that the catheter location will be concealed. Both catheters will be connected to a pump that will infuse local anesthetic. Ropivicaine 0.2% at 8 ml/hour. There is usually a period of time before the patient transport to the operating room during which the investigators will be able to evaluate if the block is effective and sufficient for surgery.
Patients will receive either general or spinal anesthesia in the operating room. All patients will receive prophylaxis for nausea and vomiting during surgery. Regimen for prophylaxis include a single dose of dexamethasone after induction of anesthesia and a single dose of Ondansetron 20 minutes before recovery from anesthesia. This study is not deviating from the standard of care anesthetic regimen for this surgical procedure at Penn Presbyterian Medical Center. Only the type of blocks will be different between the two groups.
Postoperative analgesia All PACU analgesia will follow standard of care protocol for post operative care at PPMC. Hydromorphone 0.2 mg iv q5 minutes as necessary. The infusion of the local anesthetic will start in the PACU.
In the PACU, patients are assessed for pain with the Visual Analog Scale (pain scale of 1 to 10) at routine time points for the duration of their stay. The worse VAS score will be recorded.
Postoperative Analgesia
Postoperative analgesia will follow the MP3 protocol. The protocol includes administration of around the clock acetaminophen, Celebrex, gabapentin, immediate and extended release oxycodone.
#Intervention
- PROCEDURE : adductor canal block
- ultrasound guided saphenous nerve block in the adductor canal
- PROCEDURE : femoral nerve block
- ultrasound guided femoral nerve block
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients scheduled for primary total knee arthroplasty
* American Society of Anesthesiologists (ASA) physical status I -III
* mentally competent and able to give consent for enrollment in the study
Exclusion Criteria:
* Patient younger than 18 years
* Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).
* Revision surgery will be excluded.
* Impaired kidney functions and patient with coagulopathy will also be excluded.
* Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 3 months prior to the surgery.
* BMI of 40 or more
* Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)
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
|
NCT02314832
|
{
"brief_title": "Risk of Falling After CFNB Versus ACB",
"conditions": [
"Falls",
"Total Knee Arthroplasty (TKA)",
"Osteoarthritis"
],
"interventions": [
"Procedure: femoral nerve block",
"Procedure: adductor canal block"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02314832",
"official_title": "Comparison Between the Risk Falls After Total Knee Arthroplasty With Use of Femoral Nerve Block Versus Adductor Canal Block",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-01",
"study_completion_date(actual)": "2015-03",
"study_start_date(actual)": "2014-09"
},
"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)": "2017-03-30",
"last_updated_that_met_qc_criteria": "2014-12-10",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-12-11",
"first_submitted": "2014-07-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To compare the safety and efficacy profiles of Revanesse Shape + with Lidocaine versus Juvederm Voluma with Lidocaine for subcutaneous and/or supraperiosteal injection to improve appearance through the correction of age-related mid-face volume deficit in patients 22 years of age through 65 years of age.
Midface volume deficit / lipoatrophy (loss of subcutaneous adipose tissue that is most apparent in the face) may be associated with acquired conditions, the aging process, or based on genetic causes.
Detailed Description
This is a randomized, multicenter, double blind, split-face study in subjects seeking to correct mid-face volume deficit. Subjects will be treated with Revanesse Shape + with Lidocaine on one side of the face and Juvederm Voluma with Lidocaine on the other side of the face. The side of the face for each device will be randomly assigned. The Evaluating Investigator performing the evaluations and the subject will be blinded to the treatment; injections of the study device will be performed by an unblinded Treating Investigator.
At each visit, the blinded Evaluating Investigator evaluations and subject evaluations of the treated areas will be performed and recorded.
The initial treatment will be done at Visit 1 and a touch-up if necessary at Visit 3/Month 1. One optimal correction touch-up can be administered for subjects who experience asymmetrical cheeks after Visit 5/Month 3 and before Visit 7/Month 12 . The Blinded Evaluating Investigator will confirm the asymmetry with at least a 1-grade difference between cheeks. The touch up will be offered on the under-corrected side with the same product that was initially implanted. In addition, subjects will have a safety follow-up telephone call 3 days (± 2 days) after any optimal correction touch-up to correct asymmetry administered between Visit 5/Month 3 and Visit 7/Month 12.
Subjects will be retreated at the Month 12 Visit if a ≥ 1 grade change or return to baseline of the MMVS scores on one or both sides of the face.
Treatment Phase
* Visit 1 - (Day 1) - Baseline and treatment
* Day 3 (+2/-1 days) - Safety follow-up telephone call
* Visit 2 - Week 2 (Day 14 ± 2 days) - Safety follow-up visit
* Visit 3 - Month 1 (Day 30 ± 2 days) - interim visit, optimal correction touch-up if needed
* If touch up administered at Visit 3:
* Safety follow-up telephone call 3 days after touch-up (± 2 days)
* Visit 3a - Day 14 ± 2 days after touch-up - Safety follow-up visit Safety and Effectiveness Phase
* Visit 4 - Month 2 (Day 60 ± 2 days) - interim visit
* Visit 5 - Month 3 (Day 90 ± 2 days) - interim visit
* Visit 6 - Month 6 (Day 180 ± 4 days) - interim visit Extended Follow-up Phase
* Visit 7 - Month 12 (Day 360 ± 4 days) - interim visit Retreatment if needed
* If Retreatment administered at Visit 7:
* Safety follow-up telephone call 3 days after retreatment (± 2 days)
* Visit 7a - Day 14 ± 2 days after retreatment - Safety follow-up visit
* Visit 8 - Month 15 (Day 450 ± 4 days) - End of Study Visit Optimal Correction Touch-up to correct asymmetry
* Visit 6a - After Visit 5/Month 3 and before Visit 7/Month 12) - optimal correction touch-up to correct asymmetry
* 3 days after touch-up (± 2 days) - Safety follow-up telephone call
Evaluations include:
Medicis Mid-face Volume Scale (MMVS) score Global Aesthetic Improvement Score (GAIS) by subject and Evaluating Investigator Nasolabial Folds Wrinkle Severity Rating Score (WSRS) Safety will be assessed by monitoring adverse events (AEs) at all study visits. In addition, other mid-face safety evaluations including firmness, function (movement), mass formation and sensation will be performed at baseline and follow up visits.
Other evaluations include subject overall satisfaction of facial appearance, subject satisfaction with mid-facial region, subject look of mid-face, subject feel of mid-face, subject self-perception of age, subject happiness with contour/shape of mid-face, subject self confidence, subject recommendation to a friend, and subject self perception of age since baseline.
Other analysis includes subject comfort and Unblinded Treating Investigator Ease of Use assessment.
#Intervention
- DEVICE : Revanesse Shape + with Lidocaine
- Revanesse Shape + with Lidocaine. Participants had 1 cheek treated with Revanesse Shape + with Lidocaine
- DEVICE : Juvederm Voluma with Lidocaine.
- Juvederm Voluma with Lidocaine. Participants had 1 cheek treated with Juvederm Voluma with Lidocaine
|
#Eligibility Criteria:
Inclusion Criteria:
* Men or non-pregnant, non-breastfeeding women 22 years through 65 years.
* Subjects seeking augmentation therapy for the mid-face with a MMVS score of 3 (moderate loss of fullness with slight hollowing) or 4 (substantial loss of fullness in the mid-face area, clearly apparent hollowing) on each side of the face as independently assessed by the blinded Evaluating Investigator and the unblinded Treating Investigator
* If female and of childbearing potential, a negative urine pregnancy test at Baseline (Day 1) and the subject agrees to use adequate contraception during the study period.
* Ability to understand and comply with the requirements of the study.
* Willingness and ability to provide written informed consent.
* Willing to abstain from any other facial procedures or treatments affecting facial volume deficit at any time during the study
Exclusion Criteria:
* MMVS score of 1 (fairly full) or 2 (mild loss of fullness) on either side of the face.
* Women who are pregnant or lactating or anticipate becoming pregnant during the study period.
* Have ever undergone facial plastic surgery (with the exception of rhinoplasty more than 2 years prior to enrollment), tissue grafting, or tissue augmentation with silicone, fat, or other permanent (Ex: polymethylmethacrylate (Bellafill)), or semi-permanent dermal fillers (Ex: calcium hydroxylapatite (Radiesse®)) or planning to undergo any of these procedures at any time during the study.
* Have undergone temporary facial dermal filler injections with hyaluronic acid-based fillers within 12 months, porcine-based collagen fillers within 12 months, or neuromodulator injections, mesotherapy, or resurfacing (laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, microneedling or other ablative or non-ablative procedures) within 6 months on the face or neck prior to study entry or planning to undergo any of these procedures at any time during the study.
* History of use of threads below the lower orbital rim within the preceding 6 months or planning their use at any time during the study
* History of use of injectable deoxycholate (Kybella®) anywhere on the face or neck within preceding 6 months or planning to undergo treatment at any time during the study
* Evidence of scar-related disease or delayed healing activity to the mid-face within the past 1 year.
* Has acute or chronic skin disease or scars at the intended treatment sites.
* History of keloid formation or hypertrophic scars.
* History or the presence of any disease that may result in changes in facial contour or edema of the face during the course of the study, (e.g., inflammation, infection, facial psoriasis, herpes zoster, acanthosis, cancer, pre-cancer, actinic keratosis, etc.)
* Presence of active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection on the face.
* Have severe malocclusion or dentofacial or maxillofacial deformities as judged by the Treating Investigator. Subjects planning to undergo extensive dental procedures such as dental implants, multiple tooth extractions, or oral surgery should not participate. Minor dental procedures such as teeth cleaning and repair of caries are not exclusionary.
* Is on an ongoing regimen of anticoagulation therapy (e.g., warfarin), thrombolytics, or inhibitors of platelet aggregation
* Nonsteroidal anti inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or gingko) within 10 days of undergoing study device injections. Subjects who will withhold such therapy for 10 days before AND after any injection session may participate.
* Prescription, oral or topical anti-wrinkle products in the treatment area within 90 days prior to treatment and throughout the study. (Use of sunscreens and continued therapy with OTC topical treatments (e.g., alpha hydroxyl acids, glycolic acids, retinoids) are allowed if regimen was established >= 90 days prior to treatment).
* History of allergy, anaphylaxis or hypersensitivity to injectable hyaluronic acid products, local anesthetics of the amide type such as lidocaine, or gram positive bacterial proteins or is planning to undergo desensitization therapy during the study.
* History or presence of multiple severe allergies or severe allergies manifested by a history of anaphylaxis.
* History of known streptococcal disease.
* Immunocompromised, immunosuppressed or current use of immunosuppressive therapy that in the opinion of the investigator precludes participating in the trial.
* Clinically significant organic disease including cardiovascular, hepatic, pulmonary, neurologic, or renal disease or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, precludes participation in the trial.
* History or presence of porphyria
* Have untreated epilepsy
* History of connective tissue diseases such as rheumatoid arthritis, systemic lupus erythematosus, polymyositis (PM), dermatomyositis (DM) or scleroderma
* Have bleeding disorders
* Presence of wound on the face
* Received any investigational product within 30 days of signing the ICF.
* Facial tattoo that may interfere with MMVS evaluation.
* Presence of facial hair that could interfere with MMVS evaluation. Subjects with facial hair must agree to maintain the same style and length of facial hair throughout the duration of the study.
* Systemic (oral/injectable) corticosteroids, anabolic steroids or immunosuppressive medications within 30 days prior to treatment and topical steroids on the face within 14 days prior to treatment start and throughout the study.
* Previous treatment for MVD within the past year.
* History of malignancy within 5 years of study entry. Subjects with a history of malignancy that has been fully treated without evidence of recurrence for at least five years prior to study entry may participate. (Subjects with a history of basal cell carcinoma or squamous cell carcinoma outside of the treatment area that has been fully removed by surgical means may participate at any time).
* Currently has a cancerous or pre-cancerous lesion on the treatment area or has had radiation exposure in the treatment area in the last 24 months.
* The presence of any condition, which in the opinion of the investigator, that makes the subject unable to complete the study per protocol (e.g., subjects not likely to avoid other facial cosmetic treatments, subjects not likely to stay in the study because of other commitments, concomitant conditions or past history; subjects anticipated to be unreliable; or subjects who have a concomitant condition that might confuse or confound study treatments or assessments).
* The intention to lose a significant amount of weight (more than 10 pounds) during the study.
* Presence of moderate or severe abnormal rating for firmness or detection of any abnormal mid-face structure, such as a scar or lump at baseline.
* Presence of abnormal rating in mid-face function with inability to effectively puff cheeks, smile broadly, or chew at baseline.
* Presence of abnormal rating in mid-face sensation with inability to feel 0.4G monofilament or cotton wisp at any site on the mid-face at baseline
* Presence of abnormal vision assessments at baseline, e.g., Snellen Acuity Test worse than 20/40 (with corrections, if applicable), abnormal confrontational visual field test, or abnormal ocular motility test).
Sex :
ALL
Ages :
- Minimum Age : 22 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04927052
|
{
"brief_title": "A Study to Evaluate the Safety and Efficacy of Revanesse Shape + With Lidocaine Versus Juvederm Voluma With Lidocaine for the Correction of Age-Related Midface Volume Deficit / Lipoatrophy at 6 and 12 Months Post-treatment",
"conditions": [
"Volume Deficit in the Mid-face"
],
"interventions": [
"Device: Revanesse Shape + with Lidocaine",
"Device: Juvederm Voluma with Lidocaine."
],
"location_countries": [
"Canada"
],
"nct_id": "NCT04927052",
"official_title": "A Multicenter, Double-Blind, Randomized, Split-Face Study to Evaluate the Safety and Efficacy of Revanesse Shape + With Lidocaine Versus Juvederm Voluma With Lidocaine for the Correction of Age-Related Midface Volume Deficit / Lipoatrophy at 6 and 12 Months Post-treatment",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-08-30",
"study_completion_date(actual)": "2023-08-30",
"study_start_date(actual)": "2021-04-21"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-11-29",
"last_updated_that_met_qc_criteria": "2021-06-08",
"last_verified": "2023-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-06-15",
"first_submitted": "2021-06-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Osteogenesis imperfecta (OI) is a rare genetic disorder of increased bone fragility and low bone mass. It is conceivable that children and adolescents with OI are less active than healthy peers because of frequent fractures, immobilization,functionals limitations and no adapted physicals activity(APA). The hypothesis is that an Adapted physique activity could improve access of activity for patients with Osteogenesis Imperfecta (OI).
The aim of the study is to evaluate benefice of APA,improve aerobic capacity, cardiovascular and bone benefits, and gain of quality of life.
Children with OI between 6 and 18 years old will have a program of supervised 'adapted training program' during one year. The program is adapted at each individual and without risk for the patient.
#Intervention
- OTHER : Adapted sports practices
- Adapted sports practices for 30 minutes twice a week
|
#Eligibility Criteria:
Inclusion Criteria:
* Child with osteogenesis imperfecta
* Child followed in the Reference centre for constitutional bone diseases in the Hôpital Femme Mère Enfant
* Parent (s) / legal guardian who has been informed of the study and has accepted participation in the study by signing the consent.
* Patient benefiting from a social security scheme
Exclusion Criteria:
* Medical and surgical contraindications to adapted physical activity.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04119388
|
{
"brief_title": "Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta",
"conditions": [
"Osteogenesis Imperfecta"
],
"interventions": [
"Other: Adapted sports practices"
],
"location_countries": [
"France"
],
"nct_id": "NCT04119388",
"official_title": "Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-14",
"study_completion_date(actual)": "2022-10-14",
"study_start_date(actual)": "2019-11-04"
},
"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)": "2023-01-26",
"last_updated_that_met_qc_criteria": "2019-10-07",
"last_verified": "2023-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-08",
"first_submitted": "2019-10-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The PATHWAYS for Health Equity research program builds on the 5-year FORGE AHEAD Indigenous diabetes quality improvement research program (2013 - 2017).
PATHWAYS for Health Equity, a 3-year research program (2017 - 2019), is a great opportunity to continue our important collaborative diabetes quality improvement research with an increasing number of Indigenous partnering communities and researchers and key stakeholders (collaborators, policymakers and knowledge-users). Four partnering First Nations communities will join the Pathways program to develop community-driven quality improvement initiatives championed by a Community Facilitator and supported by a Community Data Coordinator.
Detailed Description
GOAL
To improve the health and health equity of Indigenous peoples by strengthening the effectiveness, sustainability and scalability of a promising community-driven and culturally-relevant quality improvement strategy through meaningful conversations and engagement with our community partners.
OBJECTIVES
1. Engage community partners and key stakeholders to support meaningful participation and leadership
2. Review, improve and adapt the diabetes quality improvement strategy with community partners
3. Evaluate the effectiveness of the adapted diabetes quality improvement strategy
4. Develop community-driven plans for sustainability and scale-up for the adapted diabetes quality improvement strategy
WHY IS PATHWAYS IMPORTANT?
In Canada, there are significant inequalities between the health status of Indigenous peoples and the general population concerning diabetes. Community-driven initiatives using promising diabetes quality improvement strategies can potentially reform local healthcare in Indigenous communities and improve care for those living with diabetes.
WHAT IS INVOLVED IN PATHWAYS?
Community-based champions called Community Facilitators and Community Data Coordinators will be trained to provide leadership and support to community-based teams to make priority improvements to diabetes programs/ services and clinical care. The 18-month quality improvement intervention includes:
* educational workshops on diabetes and quality improvement
* support, communication, and coaching for action planning and quality improvement
* readiness consultation tools
* diabetes registry \& surveillance system
An evaluation consisting of interviews and questionnaires may be used to understand the process of adapting the diabetes quality improvement strategy to each community's context and factors that influence the program's success.
Our strong, multidisciplinary and cross-jurisdictional PATHWAYS Team includes Indigenous community representatives and healthcare providers, nonIndigenous healthcare providers, clinician scientists and academic researchers, as well as policy decision-makers and knowledge-user organizations.
The timely program will provide community leaders and knowledge-users with policy recommendations and a quality improvement strategy that can be implemented, sustained and spread to Indigenous community settings and regions across Canada and internationally.
COMMUNITY PARTNERS
Four community partners will be engaged and will partner in the Pathways program (two in Ontario and two in Atlantic Canada). Formal Community Research Agreements will represent participation and partnership.
#Intervention
- OTHER : Quality Improvement Strategy
- Quality improvement strategy The 18 month Quality Improvement Strategy includes 3 months preparation, 12 months intervention, 3 months local knowledge translation. The intervention includes Readiness Consultations to assist in understanding available resources to address and adopt diabetes and chronic disease prevention and care strategies. Community teams receive a series of 3 workshops (in-person/virtual) followed by action periods where the team carry out and evaluate PDSAs they develop to improve diabetes care. Coaching is provided by Western during the 3-4 month action periods. FNDSS is a webbased secure community portal system for communities to develop a diabetes registry/surveillance system and generate reports and plan QI initiatives.
|
#Eligibility Criteria:
Inclusion Criteria:
Indigenous Communities in Canada:
* On-reserve community
* Community Band Council approval to participate and collaboration
* Community healthcare facility approval or willingness to participate including both prevention and management/treatment arms if separate
* Signed Community Research Agreement (including Financial Agreement) by the custodian of community medical charts, health leadership, and community leadership (if required). Access to community medical charts is required for FNDSS
Patient Chart Inclusion Criteria for chart audit component:
* Age >= 18 years.
* Diagnosed with type 2 diabetes
Exclusion Criteria:
Indigenous Communities:
* Communities that are unlikely to comply with the protocol (uncooperative attitude, unlikelihood of completing the program)
* Healthcare facility unwilling to participate or uncooperative.
Patient Chart Exclusion Criteria for chart audit component:
* Less than 18 years
* Diagnosed with type 1 or gestational diabetes
* Life expectancy is less than 6 months
* Inactive patient (no clinic visit in the last 12 months)
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
|
NCT03315728
|
{
"brief_title": "Pathways for Health Equity Quality Improvement Strategy",
"conditions": [
"Diabetes Mellitus Type 2 With Hyperglycemia"
],
"interventions": [
"Other: Quality Improvement Strategy"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT03315728",
"official_title": "Transformation of Indigenous Primary Healthcare Delivery: Enhancement and Adaptation of Community-driven Innovations and Scale-up Toolkits",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03-31",
"study_completion_date(actual)": "2022-03-31",
"study_start_date(actual)": "2017-10-26"
},
"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)": "2022-04-27",
"last_updated_that_met_qc_criteria": "2017-10-16",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-20",
"first_submitted": "2017-10-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators aim to evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of atresia. Each child will be required to bite and chew a standardized biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine the tolerated food texture of children.
Detailed Description
The diet of children with normal feeding skills includes a combination of liquid, semisolid and/or solid foods. Chewing dysfunction (CD) in children may cause restrictions in solid food intake, thereby may result in insufficient food intake and delay in growth. It is aim to evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of atresia. Each child will be required to bite and chew a standardized biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine the tolerated food texture of children.
#Intervention
- OTHER : Chewing evaluation
- Each child was required to bite and chew a standardized biscuit while chewing video recording. Chewing function was scored with the Karaduman Chewing Performance Scale (KCPS).
|
#Eligibility Criteria:
Inclusion Criteria:
* Children with repaired esophageal atresia-tracheoesophageal fistula, without airway aspiration, intact airway closure
Exclusion Criteria:
* Children without repaired esophageal atresia-tracheoesophageal fistula, with airway aspiration, insufficient airway closure
Sex :
ALL
Ages :
- Minimum Age : 24 Months
- Maximum Age : 192 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT03026491
|
{
"brief_title": "Chewing in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula",
"conditions": [
"Chewing Problem"
],
"interventions": [
"Other: Chewing evaluation"
],
"location_countries": null,
"nct_id": "NCT03026491",
"official_title": "Chewing Function in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-03-01",
"study_completion_date(actual)": "2017-04-01",
"study_start_date(actual)": "2017-01-01"
},
"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)": "2017-08-09",
"last_updated_that_met_qc_criteria": "2017-01-19",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-01-20",
"first_submitted": "2017-01-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
this study is intended to find out the therapeutic efficacy of the siddha drug Kandhaga Rasayanam in Padarthamarai ( Ring worm infection )
#Intervention
- DRUG : kandhaga rasayanam
- KANDHAGA RASAYANAM is a siddha herbo mineral drug with sulphur as a sole mineral ingredient. It is chosen from the classic Siddha text Siddha Vaidhya Thirattu.
- Other Names :
- Siddha herbo mineral drug KR.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients clinically diagnosed with tinea infection.
* direct microscopy skin scraping test positive.
Exclusion Criteria:
* pregnant or nursing women.
* use of other topical or oral antifungals, immunosuppressive drugs, anthelmintic drugs either currently or during 2 weeks preceeding initiation of drug trial.
* allergy or hyperensitivity to any component of the drug.
* clinical case of eczema, lichen planus, pityriasis versicolor, drug induced eruptions, urticaria, intertrigo, tinea ungium.
* diabetic patients.
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
|
NCT02238912
|
{
"brief_title": "Evaluation of Preclinical Toxicity andTherapeutic Efficacy of Kandhaga Rasayanam in Padarthamarai",
"conditions": [
"Tinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are Studied"
],
"interventions": [
"Drug: kandhaga rasayanam"
],
"location_countries": [
"India"
],
"nct_id": "NCT02238912",
"official_title": "Evaluation of Preclinical Toxicity of a Siddha Formulation Kandhaga Rasayanam ( KR ) and Its Therapeutic Efficacy in Padarthamarai ( Dermatophytoses ) by an Open Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-04",
"study_completion_date(actual)": null,
"study_start_date(actual)": "2012-06"
},
"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)": "2014-09-12",
"last_updated_that_met_qc_criteria": "2014-09-10",
"last_verified": "2014-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-09-12",
"first_submitted": "2014-09-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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