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#Study Description
Brief Summary
The purpose of this research study is to evaluate a new investigational drug (TPI 287) for neuroblastoma and medulloblastoma both alone and in combination with temozolomide (a currently approved drug). An investigational drug is one that has not yet been approved by the Food and Drug Administration. This investigational drug is called TPI 287. This study will look at the safety and tolerability of TPI 287 both alone and in combination with temozolomide, and look to establish a safe dose of this agent. The study will also look at the tumor's response to these drugs, but this is not the primary objective of this study.
TPI 287 was shown to be effective in stopping tumor growth and was also shown to be safe in three different animal species. TPI 287 has been tested in humans in four clinical trials, and approximately 100 subjects with various types of cancers have received the drug. All of these subjects that have received TPI 287 have been adults. TPI 287 has not been tested in a pediatric population before this study.
Temozolomide was tested in recurrent neuroblastoma and showed activity in a recently published study. Preclinical studies of TPI in combination with temozolomide have shown at minimum an additive effect. The ability of temozolomide and TPI 287 to be effective in combination is suggested by these two drugs showing even greater activity when used together.
Detailed Description
Neuroblastoma:
Neuroblastoma is the most common pediatric extracranial solid tumor and accounts for 7% to 10% of childhood cancers (American Cancer Society 2008; Bernstein et al. 1992). Whereas the prognosis for infants with neuroblastoma is generally good, currently only 30% of children diagnosed after 12-15 months of age survive despite aggressive multimodal therapies (Brodeur et al 1993; Park et al 2008). High-dose chemotherapy (HDC) followed by hematopoietic stem cell transplantation (HSCT) and maintenance therapy with retinoic acid improves survival by 35% in children presenting with metastatic NB, but the 5-year event-free survival remains below 50% (Matthay et al, 1999; Hartmann, et al, 1999). Consequently, the evaluation of new drugs is strongly needed in this disease.
1.2
Medulloblastoma:
Medulloblastoma is the most common malignant brain tumor in children and accounts for 16% of all brain tumors in children 0-14 years old and 6% in adolescents 15-19 years old (CBTRUS 2008). Current therapies for children with disseminated disease are associated with severe long-term toxicities, and lead to cure in only a minority of cases. (Partap et al, 2007). Thus, the development of new therapies-especially ones with more favorable toxicity profiles-would represent a significant improvement in the treatment of this disease. Although there have been reports that the survival rate of children with chemosensitive relapsed medulloblastoma can approach 40% following intensive chemotherapy combined with autologous stem cell support, more recent data looking at survival of all patients relapsing after modern combination chemotherapy and radiation is also on the order of 10-15%. (Rood, et al, 2004) As such, new therapeutic approaches are needed to treat these children.
1.3 The Investigational Product TPI 287 1.3.1
Preclinical Studies:
Tapestry Pharmaceuticals, Inc. developed a novel anti-microtubule agent, TPI 287, for which Archer Biosciences, Inc. is now the sponsor. TPI 287 is synthetically manufactured from naturally occurring taxanes extracted from yew starting material. The synthesis involves modifications of the side chain to make the drug more lipophilic, and modification of the baccatin ring structure with the intent of circumventing MDR-based resistance and allowing for binding to mutant tubulin. Selection of TPI 287 was also made on the basis of the very high potency of this drug against several neuroblastoma cell lines and xenograft models (see below).
In vitro, TPI 287 was shown to have comparable cytotoxicity to paclitaxel in several MDR- cell lines, but was 5 - 3900-fold more active than several comparator compounds in MDR+ cells lines. In MCF-7-AR breast cancer cells, which display MDR-based resistance, TPI 287 was 20-times more active than paclitaxel. Similar findings were observed in MDR+ cells derived from colorectal, breast and prostate cancers, as well as from neuroblastoma, as noted.TPI 287 was also evaluated in a variety of xenograft models. As in vitro, TPI 287 was superior to paclitaxel in vivo in the MCF-7-AR xenograft. TPI 287 also had superior activity when compared to SN-38 in the HCT-15 and HCT-116 colon cancer xenografts; when compared to docetaxel in the PC3 prostate cancer xenograft; and when compared to docetaxel and doxorubicin in the MV522 NSCLC xenograft.
Activity against glioblastoma was shown in transplanted xenografts, and efficacy was demonstrable using both IV and oral administration. In addition, in an orthotopic xenograft using U251 cells implanted in the brains of nude mice, treatment with either TPI 287, temozolomide, or combinations were compared to control animals, evaluating median survival (10 animals per group) as well as animals whose survival extended beyond 110 days. The results of this study, repeated for corroboration at an outside facility, are shown in Table 4. Significant synergy and improvement in long term survival can be seen with the combination of temozolomide (TMZ) plus TPI 287.Potent activity had also been shown against neuroblastoma cell lines as previously noted, and this was also demonstratable in transplanted xenografts, showing greater activity than paclitaxel, docetaxel or nab-paclitaxel. Studies recently completed (Sholler, et al, personal communication) show TPI 287 has activity against additional neuroblastoma cell lines as well as medulloblastoma cell lines and increased efficacy when TPI 287 is combined with TMZ in neuroblastoma.Toxicology studies demonstrated that TPI 287 was generally well tolerated. The MTD in the rat was 48 mg/kg and in the dog, 12.5 mg/kg. Toxicity was primarily characterized by bone marrow suppression and mucositis.
#Intervention
- DRUG : TPI 287
- Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically proven neuroblastoma and confirmation of refractory or recurrent disease or medulloblastoma with histologic confirmation at diagnosis or at the time of recurrence/progression
* Patients must be age >12 months and diagnosed before the age of 21
* Life expectancy must be more than 3 months
* If measurable disease, this must be demonstrated by residual abnormal tissue at a primary or metastatic site measuring more than 1 cm in any dimension by standardized imaging (CT or MRI). For patients with neuroblastoma who only have skeletal disease, there must be at least two persisting skeletal foci on meta-iodobenzylguanidine (MIBG) follow-up scans
* Current disease state must be one for which there is currently no known curative therapy
* Lansky Play Score must be more than 30 and/or ECOG performance status must be 0 to 2
* For patients with medulloblastoma receiving steroids, the dose must be stable (i.e. not increasing) for at least one week before starting study
* Patients without bone marrow metastases must have an ANC > 750/μl and platelet count >50,000/μl
* Adequate liver function must be demonstrated, defined as:
* Total bilirubin <= 1.5 x upper limit of normal (ULN) for age AND
* SGPT (ALT) < 10 x upper limit of normal (ULN) for age
* No other significant organ toxicity defined as > Grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events version 3 (NCI-CTCAE V3.0 (http://ctep.cancer.gov/forms/CTCAEv3.pdf))
* A negative urine pregnancy test is required for female participants of child bearing potential (>=13 years or after the onset of menses)
* Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ('the pill'), an intrauterine device (IUD), levonorgestrol implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these can not be used, contraceptive foam with a condom is recommended
* Informed Consent: All patients and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines
* Patients may have received microtubulin inhibitors and/or temozolomide during previous therapies
Exclusion Criteria:
* Patients who have received any chemotherapy administered within the last 21 days
* Patients who have received radiotherapy within the last 30 days
* Patients who have received myeloablative therapy within the previous 3 months
* Patients receiving anti-tumor therapy for their disease or any investigational drug concurrently
* Patients with serious infection or a life-threatening illness (unrelated to tumor) that is > Grade 2 (NCI CTCAE V3.0), or active, serious infections requiring parenteral antibiotic therapy within 4 weeks prior to screening
* Any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a patient's ability to sign or the legal guardian's ability to sign the informed consent, and patient's ability to cooperate and participate in the study
* Patients with known hypersensitivity to any of the components of the drugs to be administered on study
* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study
Sex :
ALL
Ages :
- Minimum Age : 12 Months
- Maximum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00867568
|
{
"brief_title": "TPI 287 in Patients With Refractory or Recurrent Neuroblastoma or Medulloblastoma",
"conditions": [
"Neuroblastoma",
"Medulloblastoma",
"Relapse"
],
"interventions": [
"Drug: TPI 287"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00867568",
"official_title": "A Phase 1 Trial of TPI 287 as a Single Agent and in Combination With Temozolomide in Patients With Refractory or Recurrent Neuroblastoma or Medulloblastoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-09",
"study_completion_date(actual)": "2016-02",
"study_start_date(actual)": "2009-03"
},
"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)": "2024-08-06",
"last_updated_that_met_qc_criteria": "2009-03-23",
"last_verified": "2024-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-03-24",
"first_submitted": "2009-03-23",
"first_submitted_that_met_qc_criteria": "2016-09-09"
}
}
}
|
#Study Description
Brief Summary
Non-invasive ventilation or BiPAP®, which is a form of breathing support delivered through a facemask, is a successful treatment for the respiratory complications of amyotrophic lateral sclerosis (ALS). It has been shown to prolong survival, improve quality of life, and improve cognitive function. It is widely used among patients with ALS who have advanced breathing difficulties. It is not known whether there is benefit to using non-invasive ventilation earlier in the disease course.
There is evidence that non-invasive ventilation may slow down the decline in breathing function. If this were true then it would make sense to start non-invasive ventilation use earlier than the current clinically accepted practices.
The purpose of this study is to determine whether using non-invasive ventilation early in the course of disease can slow the decline in breathing function.
Patients remain in the study for 6 months and are asked to make 7 clinic visits during which time they will undergo pulmonary function tests and complete questionnaires.
Detailed Description
This is a randomized, crossover trial for patient with ALS and mild respiratory involvement. Patients with forced vital capacity above 60% of the predicted value can join. Patients will be assigned to either start using non-invasive ventilation at night or continue their usual care. After three months, patients will switch over to the other treatment group. For example, a patient who was initially assigned to continue their usual care would begin using non-invasive ventilation after three months.
#Intervention
- DEVICE : noninvasive positive pressure ventilation
|
#Eligibility Criteria:
Inclusion Criteria:
* Probable or definite ALS by El Escorial criteria
* age >17 years
* FVC >60
* minimal respiratory symptoms (no orthopnea or dyspnea at rest)
* ability to provide informed consent
Exclusion Criteria:
* Presence of another neurodegenerative disease
* arterial CO2 above 45 mmHg
* O2 below 60 mmHg
* coexisting chronic lung disease unrelated to ALS
* presence of an unstable medical condition such as coronary artery disease, liver failure, renal failure or cancer in the 30 days preceding enrollment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00386464
|
{
"brief_title": "Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement",
"conditions": [
"Amyotrophic Lateral Sclerosis"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00386464",
"official_title": "Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2007-09",
"study_start_date(actual)": "2002-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2007-11-09",
"last_updated_that_met_qc_criteria": "2006-10-10",
"last_verified": "2007-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-10-11",
"first_submitted": "2006-10-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Diffusion Weighted Imaging (DWI) MRI will assist in differentiating poor prognosis bone oedema more effectively than traditional T2 weighted MRI in patients with early Rheumatoid Arthritis (RA).
Detailed Description
Assess DWI MRI in patients with early Rheumatoid Arthritis to determine whether the MRI method will assist in differentiating poor prognosis bone oedema more effectively than traditional T2 weighted MRI.
Aim 1: To compare DWI MRI with T2 weighted MRI for the discrimination of different types of bone oedema lesions in patients with early RA.
Aim 2: To examine the association between the presence of different types of bone oedema lesions detected on DWI MRI and T2 weighted MRI and the development of subsequent joint bone erosion as detected on i) MRI and ii) standard plain radiographs.
|
#Eligibility Criteria:
Inclusion Criteria:
* Subject has Rheumatoid Arthritis as defined by the ACR/Eular criteria
* Subject is able to understand and comply with study protocol
* Active disease as defined by DAS28> 3.0
* Disease duration less than 12 months
* If female, subject is either not of childbearing potential, or is of childbearing potential and is practicing an approved method of birth control throughout the study
* subject is judged to be in good health as determined by the PI based upon results of medical history, laboratory profile and physical examination.
* Prednisone dose 10mg or less, dose stable for 28 days prior to baseline
Exclusion Criteria:
* Inflammatory arthropathy other than Rheumatoid Arthritis
* Inactive disease as evidenced by DAS 28 CRP and / or ESR < 2.5
* Prednisone dose greater than 10mg within 28 days prior to baseline
* Intra-articular steroid within 28 days prior to baseline visit
* IV Methyl-prednisone within 28 days prior to baseline visit
* Any contra-indication to Magnetic Resonance Imaging
* Permanent Pacemaker
* Intracerebral aneurysm clip
* Claustrophobia to the extent that patient cannot manage MRI investigations
* Implanted metallic device
* Cochlear implant
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
|
NCT01482507
|
{
"brief_title": "Examination of the Effectiveness of Diffusion Weighted Magnetic Resonance Imaging for Identifying Poor Prognosis in Patients With Rheumatoid Arthritis",
"conditions": [
"Rheumatoid Arthritis"
],
"interventions": null,
"location_countries": [
"Australia"
],
"nct_id": "NCT01482507",
"official_title": "Examination of the Effectiveness of Diffusion Weighted Magnetic Resonance Imaging for Identifying Poor Prognosis in Patients With Rheumatoid Arthritis",
"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)": "2011-08"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-04-06",
"last_updated_that_met_qc_criteria": "2011-11-29",
"last_verified": "2011-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-11-30",
"first_submitted": "2011-11-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description
This study will be conducted in a partially blind fashion: it will be observer-blind as to which vaccine was administered, and open as to the vaccination schedule. One group of children on the 0, 1, 2-schedule will receive a Rabies vaccine as a control. One group on the same schedule will receive the RTS,S/AS02D experimental vaccine as an active comparator.
#Intervention
- BIOLOGICAL : GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
- 2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
- Other Names :
- RTS, S vaccine
- BIOLOGICAL : Rabipur
- 3-dose intramuscular injection.
|
#Eligibility Criteria:
Inclusion Criteria:
* A male or female child between 5 months and 17 months of age at the time of first vaccination.
* Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* Proof that child has received a full 3-dose regimen of licensed Hepatitis B vaccine in infancy.
Exclusion Criteria:
* Acute disease at the time of enrolment.
* Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
* Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
* Planned administration/administration of a vaccine (not in the scope of the study) within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled Yellow fever or Measles vaccine.
* Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the study vaccine, or planned use during the study period.
* Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Simultaneous participation in any other clinical trial;
* Previous participation in any other malaria vaccine trial;
* Any twins
* History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Sex :
ALL
Ages :
- Minimum Age : 5 Months
- Maximum Age : 17 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00360230
|
{
"brief_title": "Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children",
"conditions": [
"Malaria"
],
"interventions": [
"Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049",
"Biological: Rabipur"
],
"location_countries": [
"Ghana"
],
"nct_id": "NCT00360230",
"official_title": "A Partially-blind (Observer-blind) Study to Evaluate the Safety and Immunogenicity of 3 Different Vaccination Schedules With 2 GSK Biologicals' Candidate Plasmodium Falciparum Vaccines in Children Aged 5 to 17 Months Living in Ghana",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-08-25",
"study_completion_date(actual)": "2008-05-30",
"study_start_date(actual)": "2006-08-30"
},
"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)": "2018-02-19",
"last_updated_that_met_qc_criteria": "2006-08-03",
"last_verified": "2017-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-08-04",
"first_submitted": "2006-07-31",
"first_submitted_that_met_qc_criteria": "2017-08-10"
}
}
}
|
#Study Description
Brief Summary
The objective of this study is to learn how to improve treatment for clients who are working hard in treatment at the McLean Hospital Obsessive Compulsive Disorder Institute (OCDI), but who are not making the progress that would typically be expected. Therefore, the investigators will be comparing the performance of such clients in a treatment as usual (TAU)-Exposure and Response Prevention (ERP) session with their performance in an Acceptance and Commitment Therapy (ACT)-focused ERP session that follows an ACT booster session. The investigators hypothesize that clients will perform significantly better in the ACT-focused ERP session than they will in the TAU-ERP session. More specifically, the investigators hypothesize that clients and an independent rater will report that in the ACT-focused ERP session, clients performed significantly fewer rituals and/or avoidance behaviors, experienced comparable levels of distress, exerted significantly more effort, had significantly less difficulty getting started with the ERP, were significantly less influenced by their uncomfortable thoughts/feelings, were significantly more willing to experience discomfort, were significantly more focused on working towards what is important to the client. The investigators also hypothesize that an independent rater will rate clients as significantly more compliant with the ACT-focused ERP session than with the TAU-ERP session. The investigators also hypothesize that clients will rate the ACT-focused ERP session as significantly more preferable and acceptable than the TAU-ERP session, and that they will report being significantly more willing to do the ACT-focused ERP session again.
#Intervention
- BEHAVIORAL : ACT-Focused ERP
- BEHAVIORAL : TAU-ERP
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants will be adults at least 18 years currently enrolled in the residential or day treatment program at the OCDI.
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
|
NCT01679457
|
{
"brief_title": "Assessing Models of Exposure Therapy",
"conditions": [
"Obsessive-compulsive Disorders and Symptoms"
],
"interventions": [
"Behavioral: TAU-ERP",
"Behavioral: ACT-Focused ERP"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01679457",
"official_title": "Assessing Models of Exposure Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-08",
"study_completion_date(actual)": "2019-08",
"study_start_date(actual)": "2012-09"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-08-25",
"last_updated_that_met_qc_criteria": "2012-09-05",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-09-06",
"first_submitted": "2012-08-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.
#Intervention
- DRUG : IncobotulinumtoxinA (400 Units)
- Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection.
- DRUG : Placebo Comparator
- Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Age from 18 <= age <= 80 yrs
* Lower limb spasticity
* Time since stroke greater than 3 months
* Need for 400 U Botulinum toxin type A
Exclusion Criteria:
* Body weight below 50kg
* Fixed contractures of the lower limb
* Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A
* Infection at the injection site
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
|
NCT01464307
|
{
"brief_title": "Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke",
"conditions": [
"Post-stroke Spasticity of the Lower Limb"
],
"interventions": [
"Drug: IncobotulinumtoxinA (400 Units)",
"Drug: Placebo Comparator"
],
"location_countries": [
"France",
"United States",
"Poland",
"Germany",
"Canada",
"Russian Federation",
"Spain",
"Italy",
"Czech Republic"
],
"nct_id": "NCT01464307",
"official_title": "Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Lower Limb",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2014-08",
"study_completion_date(actual)": "2015-05",
"study_start_date(actual)": "2011-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-11-06",
"last_updated_that_met_qc_criteria": "2011-11-01",
"last_verified": "2016-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-11-03",
"first_submitted": "2011-11-01",
"first_submitted_that_met_qc_criteria": "2016-11-04"
}
}
}
|
#Study Description
Brief Summary
The investigators long term-goal is to help YMCA programs across the nation successfully acheive the Y of USA 'Healthy Eating and Physical Activity Standards'. Our objective here is threefold. First, the investigators will work with South Carolina YMCA leadership to achieve the 'Healthy Eating and Physical Activity Standards' and implement our HEPA Strategies in YMCA programs across the state, evaluate the uptake of and adherence to the standards and strategies, and identify factors that influence their implementation. Second, the investigators will evaluate the impact of acheiving the standards on children's MVPA and the serving and consumption of FV and water during the programs. Third, the investigators will evaluate the costs associated with and the cost-effectiveness of meeting the standards in terms of improvements in activity and healthy eating.
Detailed Description
The investigators research team developed a conceptual framework that identifies critical modifiable levers within Out of School Time programs that can be altered and/or strengthened to reach policy or standards goals. These include the policy environment at the national, state and local levels; characteristics of the individual site, program leadership, staff, and children; and existing outside organizational partnerships. This framework was informed by complex systems change, social ecology, systemic capacity building , and the literature on the impact of public health policy that identifies key elements of the system to be targeted as well as possible influences on those elements.
Viewing OST programs as complex systems, 'Healthy Eating and Physical Activity Standards' represent one of many leverage points within a system. Existing efforts to implement standards rest solely upon the voluntary adoption of the standards, with little to no other changes to the OST program setting. It is clear from our preliminary work and comprehensive reviews that OST programs are falling short of meeting goals set forth in the standards.
#Intervention
- BEHAVIORAL : Healthy Eating and Physical Activity
- Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards.
- Other Names :
- HEPA
|
#Eligibility Criteria:
Inclusion Criteria:
* All children enrolled in participating afterschool programs will be eligible to take part in the study.
Exclusion Criteria:
* Any physical/orthopedic impairment that would limit a child's ability to participate in regular physical activity (e.g., wheelchair user).
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:
Yes
|
NCT02394717
|
{
"brief_title": "Policy to Practice: Statewide Rollout of YMCA Childhood Obesity Standards",
"conditions": [
"Childhood Obesity"
],
"interventions": [
"Behavioral: Healthy Eating and Physical Activity"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02394717",
"official_title": "Policy to Practice: Statewide Rollout of YMCA Childhood Obesity Standards",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-05",
"study_completion_date(actual)": "2018-05",
"study_start_date(actual)": "2014-08"
},
"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)": "2020-11-18",
"last_updated_that_met_qc_criteria": "2015-03-19",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-03-20",
"first_submitted": "2015-03-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Studies on radiation induced patients' skin lesions in interventional radiology highlighted the need for optimized and personalized patient dosimetry and adapted patient follow-up. Measurements using Gafchromic® films or thermoluminescent dosimeters have long been the only way to accurately evaluate the maximum absorbed dose to the patient skin. However as these dose measurements are tedious and expensive, they could not be systematically applicable in clinical practice. Therefore, more practical calculation methods have been developed. These software programs calculate the skin dose using dosimetric information from images DICOM header or radiation dose structured reports (RDSRs). Validation studies of these software programs are rare and when existent have many limitations.
Radiation Dose Monitor (RDM from Medsquare) is a software program for archiving and monitoring of radiation dose (DACS, Dosimetry Archiving Communication System) used in routine in the investigator's hospitals. A new functionality developed in RDM allows quick estimation without in-vivo measurements of the absorbed dose to the skin of the patient. Comparing RDM calculations with in-vivo measurements will enable this software validation so that it can be used in clinical routine.
Main objective: to validate RDM software for calculating patient skin dose in interventional radiology.
Detailed Description
Methodology:
The study will consist of:
* Placing a rectangular dosimeter film (dimensions: 21 x 30 cm², 1mm thick) on the examination table under the sheet before installing the patient. This film is then read using a desktop scanner and specific software to determine the absorbed dose to the patient's skin. The film is not in direct contact with the patient and will not modify the standard procedure of interventional radiology.
* Collecting the weight and height of the patient
* Collecting the dosimetric information indicated in the dose report (RDSR) generated by the radiology equipment and automatically sent to the RDM DACS server at the end of the procedure (air kerma at the interventional reference point, dose area product, fluoroscopy time, X-ray tube, table and detector positions, field size, beam filtration, high voltage kV and mA current). This data is currently archived in a regulatory way, without modifying the usual patients' care pathway. This dosimetric information in addition to the technical information related to the equipment (radiology equipment brand and model, kerma calibration factor, examination table and mattress thickness) will be used as input data to the RDM software for skin dose calculations.
These last two points are realized in the classic framework of the patient care pathway and do not modify the standard procedure.
The comparison between measured and calculated absorbed dose for the validation of the calculation software will be done anonymously. The information collected does not permit the patient identification.
#Intervention
- PROCEDURE : Interventional radiology : skin dose measurements
- Therapeutic interventional radiology procedure for the following anatomical regions:
* cerebral (neuroradiology)
* thoracic (cardiology, lungs)
* abdominal
Assessment of peak skin dose and dose mapping with use of Gafchromic film dosimeter and the estimation of the absorbed dose to the skin with use of RDM software program.
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients (>= 18 years) who have a therapeutic interventional radiology procedure for the following anatomical regions:
* cerebral (neuroradiology)
* thoracic (cardiology, lungs)
* abdominal
* Patient informed and having expressed his non-opposition to participate in the research
Exclusion Criteria:
* Patients <18 years
* Diagnostic interventional radiology procedure
* Demented patients unable to receive information regarding their inclusion in the research protocol.
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
|
NCT04246125
|
{
"brief_title": "Patient Skin Dose in Interventional Radiology",
"conditions": [
"Aneurysm",
"Arteriovenous Malformations",
"Coronary Occlusion",
"Lung Neoplasms",
"Liver Neoplasms"
],
"interventions": [
"Procedure: Interventional radiology : skin dose measurements"
],
"location_countries": [
"France"
],
"nct_id": "NCT04246125",
"official_title": "Evaluation of the Patient Skin Dose in Interventional Radiology",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-06-07",
"study_completion_date(actual)": "2022-06-07",
"study_start_date(actual)": "2020-10-13"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-02-16",
"last_updated_that_met_qc_criteria": "2020-01-28",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-01-29",
"first_submitted": "2020-01-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
Detailed Description
This is a multicenter, controlled, randomized, monocular trial evaluating the safety and effectiveness of the Bausch \& Lomb DVisc40 dispersive OVD compared to the Alcon VISCOAT® dispersive OVD when used in cataract surgery. Subjects will be randomized to one of the two treatment groups in a 1:1 ratio (DVisc40:VISCOAT®).
#Intervention
- DEVICE : Bausch & Lomb DVisc40
- Ophthalmic viscosurgical device
- DEVICE : Alcon VISCOAT®
- Ophthalmic viscosurgical device
|
#Eligibility Criteria:
Inclusion Criteria:
* The subject must be at least 45 years and have a clinically documented diagnosis of age-related non-complicated cataract that is considered amenable to treatment with standard phacoemulsification cataract extraction and IOL implantation.
2. The subject must have the capability to provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
3. The subject must be willing and able to return for all scheduled follow-up examinations through 90 days following surgery.
Study #877 Protocol DVisc40 28JUL2017 V1.0 CONFIDENTIAL Page 16 of 53 4. The subject must have clear intraocular media other than the cataract in the operative eye.
Exclusion Criteria:
* 1. The subject has participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
2. The subject has any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye.
3. The subject has anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation) in the operative eye.
4. The subject has any condition which prevents reliable specular microscopy in the operative eye.
Sex :
ALL
Ages :
- Minimum Age : 45 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03511638
|
{
"brief_title": "Bausch & Lomb Ophthalmic Viscosurgical Device (OVD) Dispersive (DVisc40)",
"conditions": [
"Cataract"
],
"interventions": [
"Device: Alcon VISCOAT®",
"Device: Bausch & Lomb DVisc40"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03511638",
"official_title": "A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-04-01",
"study_completion_date(actual)": "2019-04-01",
"study_start_date(actual)": "2018-05-09"
},
"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)": "2021-10-22",
"last_updated_that_met_qc_criteria": "2018-04-26",
"last_verified": "2021-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-04-30",
"first_submitted": "2017-11-17",
"first_submitted_that_met_qc_criteria": "2021-09-24"
}
}
}
|
#Study Description
Brief Summary
This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis of the eyelashes (inadequate or not enough eyelashes). There will be two different types of subjects participating in the study 1)those with inadequate eyelashes due to natural causes or 2) those with inadequate eyelashes following a complete course of chemotherapy treatment. There will be two treatment periods of six months each. Subjects will receive either the study medication or vehicle in either of the two treatment periods.
#Intervention
- DRUG : Bimatoprost 0.03% solution
- Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
- Other Names :
- LATISSE™
- DRUG : Vehicle solution
- Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
- Other Names :
- LATISSE™
|
#Eligibility Criteria:
Inclusion Criteria:
* Subjects who have inadequate eyelashes due to natural causes and are not satisfied with their eyelash appearance.
* For the post-chemotherapy population: subjects who have inadequate eyelashes following a complete course of chemotherapy treatment and are not satisfied with their eyelash appearance, are considered free of cancer and are well enough to complete the study.
Exclusion Criteria:
* Subjects with unequal right and left eyelashes, any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants, eyelash extension application.
* Any use of over the counter or prescription use eyelash growth products.
* Subjects requiring eye drop medications for glaucoma.
* Females who are pregnant, nursing or planning a pregnancy during the study or who are of childbearing potential and not using a reliable method of contraception.
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
|
NCT00907426
|
{
"brief_title": "Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin",
"conditions": [
"Hypotrichosis"
],
"interventions": [
"Drug: Bimatoprost 0.03% solution",
"Drug: Vehicle solution"
],
"location_countries": [
"United Kingdom",
"United States"
],
"nct_id": "NCT00907426",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-11",
"study_completion_date(actual)": "2011-05",
"study_start_date(actual)": "2009-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2012-09-19",
"last_updated_that_met_qc_criteria": "2009-05-21",
"last_verified": "2012-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-05-22",
"first_submitted": "2009-05-20",
"first_submitted_that_met_qc_criteria": "2012-08-21"
}
}
}
|
#Study Description
Brief Summary
The aim of the SARS-CoV-2-CZ-PREVAL-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in specific subjects cohorts.
Detailed Description
The aim of the SARS-CoV-2-CZ-PREVAL-II Study is to quantify the prevalence of participants with antibodies against SARS-CoV-2 and/or cell immunity against SARS-CoV-2 in four specific cohorts: participants with chronic illness, healthy volunteers participating in the Study of the Czech Academy of Science, healthcare workers, and healthy volunteers that participated in the 'Herd Immunity Study SARS-CoV-2-CZ-Preval' in May 2020.
The primary aim of the study is to estimate the number of people with anti-SARS-CoV-2-antibodies, i.e., people with COVID-19 history, or with vaccination against COVID-19.
Antibodies test will focus on two main proteins of virus SARS-CoV-2: S-protein and N-protein.
The secondary aims of the study are:
* quantitative analysis of cellular immunity and the other relevant markers,
* estimation of the proportion of participants with asymptomatic COVID-19 infection
* quantification of anti-SARS-CoV-2 antibodies and cell immunity according to individual risk factors.
#Intervention
- DIAGNOSTIC_TEST : Quantitative analysis of SARS-CoV-2 antibodies
- The study will evaluate the current presence of infection, specific antibodies at least in the IgG class in blood plasma or serum (antibody tests focusing on two SARS-CoV-2 proteins: S-protein and N-protein).
- DIAGNOSTIC_TEST : Cellular immunity
- Quantification of the level of cellular immunity from venous blood collected in approximately 30% of examined individuals.
|
#Eligibility Criteria:
Inclusion Criteria:
* signed Informed consent
* willingness to complete the study questionnaire
* demographic criteria - age 18 years and more
* clinical criteria - without acute health problems
* time criteria - sample collection in the defined period time
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:
Yes
|
NCT05096962
|
{
"brief_title": "COVID-19: SARS-CoV-2-CZ-PREVAL-II Study",
"conditions": [
"COVID-19",
"SARS-CoV-2 Infection"
],
"interventions": [
"Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies",
"Diagnostic Test: Cellular immunity"
],
"location_countries": [
"Czechia"
],
"nct_id": "NCT05096962",
"official_title": "SARS-CoV-2-CZ-PREVAL-II Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-10-31",
"study_completion_date(actual)": "2022-02-24",
"study_start_date(actual)": "2021-09-13"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-11-28",
"last_updated_that_met_qc_criteria": "2021-10-22",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-10-27",
"first_submitted": "2021-10-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Alcohol is abused commonly, but there is no remedy for alcohol intoxication. This project is looking at the substance iomazenil and its effect on alcohol intoxication and alcohol's effects on driving using a driving simulator.
Detailed Description
Alcohol is abused commonly, but there is no antidote for alcohol intoxication the way naltrexone or naloxone is an antidote for opioids. A medication that has the potential to block alcohol actions in the Central Nervous System could act as a unique medication in the treatment of alcohol intoxication and alcoholism. This project is evaluating the benzodiazepine partial inverse agonist, iomazenil, as an agent that could reverse alcohol's effects on subjective intoxication, alcohol's effects on driving using a driving simulator and on measures of electrophysiology in the laboratory in healthy subjects.
#Intervention
- DRUG : Active Ethanol
- Target BrAC of 0.1% reached over 30 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 5 drinks. Administered over a total of 90 minutes.
- DRUG : Active Iomazenil
- Active iomazenil, administered intravenously at a dose of 3.7 ug/kg. Administered over 10 minutes, beginning 10 minutes after the start of the ethanol/placebo clamp.
- DRUG : Placebo
- Control: no alcohol, administered for a total of 90 minutes.
- DRUG : Placebo
- Control: no iomazenil, administered for a total of 10 minutes
|
#Eligibility Criteria:
Inclusion Criteria:
* Males
* 21 <= age <= 35 years
* Medically healthy
Exclusion Criteria:
* Under the age of 21 or greater than the age 35
* History of seizures
Sex :
MALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01590277
|
{
"brief_title": "Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans",
"conditions": [
"Active Ethanol and Active Iomazenil",
"Active Ethanol and Placebo Iomazenil",
"Placebo Ethanol and Active Iomazenil",
"Placebo Ethanol and Placebo Iomazenil",
"Alcohol Effect",
"Driving Under the Influence",
"Alcohol Impairment"
],
"interventions": [
"Drug: Placebo",
"Drug: Active Ethanol",
"Drug: Active Iomazenil"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01590277",
"official_title": "Ability of Partial Inverse Agonist, Iomazenil, to Block Ethanol Effects in Humans",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-11-02",
"study_completion_date(actual)": "2018-11-02",
"study_start_date(actual)": "2012-12-14"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "QUADRUPLE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-10-09",
"last_updated_that_met_qc_criteria": "2012-04-30",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-05-02",
"first_submitted": "2012-04-30",
"first_submitted_that_met_qc_criteria": "2024-09-18"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to compare X-ray images obtained using the GM85 digital radiography machine at the standard full dose to X-ray images obtained using the GM85 digital radiography machine along with the Samsung S-Vue system, which is a image post-processing engine that allows images to be obtained using a lower dose. The study also aims to determine the lowest dose of radiation that can be used to get a good, readable x-ray of the chest in pediatric patients using Samsung S-Vue system.
#Intervention
- DIAGNOSTIC_TEST : Full Dose Chest X-Ray
- Full dose X ray at Day 1
- Other Names :
- GM85
- DIAGNOSTIC_TEST : Low Dose Chest X-Ray
- Low dose X ray within 3 months from full dose
- Other Names :
- GM85
|
#Eligibility Criteria:
Inclusion Criteria:
* Standard weight/height outpatients who require two X-ray exams within 3 months in the US
* BMI is >5% and < 85% for participants over the age of 2;for participants less than 2 weight for length will be measured
Exclusion Criteria:
* Obese and underweight children as defined as BMI ,<5% or >85% according the World Health Organization growth chart for participants > 2 years; and for participants less than 2 years,weight for length will be measured
Sex :
ALL
Ages :
- Minimum Age : 1 Month
- Maximum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03935737
|
{
"brief_title": "Validation of a New Post Image Processing Engine (S-Vue™) for the Reduction of Ionizing Radiation Dose on X-ray Examination in Pediatric Patients",
"conditions": [
"Chest X-ray for Clinical Evaluation"
],
"interventions": [
"Diagnostic Test: Low Dose Chest X-Ray",
"Diagnostic Test: Full Dose Chest X-Ray"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03935737",
"official_title": "Validation of a New Post Image Processing Engine (S-Vue™) for the Reduction of Ionizing Radiation Dose on X-ray Examination in Pediatric Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-22",
"study_completion_date(actual)": "2019-03-22",
"study_start_date(actual)": "2018-10-26"
},
"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)": "2020-03-24",
"last_updated_that_met_qc_criteria": "2019-05-01",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-05-02",
"first_submitted": "2019-04-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators are interested in enrolling patients with rheumatoid arthritis (RA) who had a difficult time getting their disease under control even after trying multiple RA therapies. The investigators believe that there may be common patterns in the genes of this group of RA patients compared to those with more 'textbook RA.' Understanding genetic factors can help doctors to know in advance who may not respond to conventional therapies and start with treatments that work. Learning about underlying genes that influence treatment may help the investigators to identify new targets for therapy, to ultimately improve the lives of patients with RA and inflammatory arthritis.
Detailed Description
The investigators are looking for patients with rheumatoid arthritis (RA) with an inadequate response to tumor necrosis factor inhibitor (TNFi) and another biologic disease modifying anti-rheumatic drug (bDMARD) or small molecule approved for treating RA. The investigators are conducting this research to learn more about RA and the genetic patterns associated with patients whose RA cannot be well controlled with most RA treatments. Investigators anticipate that these patients will differ from 'classic' RA patients in their biomarker and genetic composition and that they represent a mixed group of individuals who may be similar in ways that are not currently being measured.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age > 18 years
* RA diagnosed by a rheumatologist
* Poor control of RA disease activity with tumor necrosis factor inhibitor (TNFi) and another biologic therapy or small molecule approved for RA
Exclusion Criteria:
* If the reason for failed TNFi therapy was due to a contraindication or adverse reaction
* Unable to provide blood sample
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 95 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05447182
|
{
"brief_title": "People-Powered Medicine (PPM): Rheumatoid Arthritis Non-responders to Biologic Therapies (RANT)",
"conditions": [
"Rheumatoid Arthritis"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT05447182",
"official_title": "People-Powered Medicine (PPM): Rheumatoid Arthritis Non-responders to Biologic Therapies (RANT)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-06-30",
"study_completion_date(actual)": "2023-10-31",
"study_start_date(actual)": "2021-07-06"
},
"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)": "2024-02-05",
"last_updated_that_met_qc_criteria": "2022-07-01",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-07-07",
"first_submitted": "2021-08-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Evidence from literature support the use of Botulinum toxin A (BoNT-A) for upper limb spasticity management in children with cerebral palsy (CP). Constraint Induced Movement Therapy (CIMT) and Bilateral Intensive Training (BIT) are indicated as effective and complimentary treatments to improve motor function in these children. In a recent trial combined noninvasiv brain stimulation and CIMT enhanced therapy induced functional gains.
In this clinical trial the aim was to evaluate the effects of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT when integrated with BoNT-A treatment in children with unilateral CP.
Detailed Description
Although BoNT-A is effective in spasticity management there is inconclusive evidence to support its usage for improvement in upper limb activity and function. Combination of BoNT-A and occupational therapy (OT) is found to be more effective then OT alone in reducing impairment, improving activity level and goal achievement. Intensive hybrid training models of CIMT and BIT and noninvasive brain stimulation are promising treatments on motor learning in children with CP. The aim of this clinical trial is to show the additional gains that could be provided by an integrated treatment of transcranial direct current stimulation (t-DCS) plus intensive hybrid training model of modified CIMT and BIT to BoNT-A injections in children with unilateral CP.
#Intervention
- DRUG : Botulinum toxin type A
- Other Names :
- Botox, Dysport
- DEVICE : transcranial direct current stimulation
- Other Names :
- noninvasiv brain stimulation
- OTHER : hybrid training model of CIMT and BIT
- OTHER : usual care
- Other Names :
- physical therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* diagnosis of unilateral cerebral palsy
* able to activate wrist and finger extensors
* being scheduled for BoNT-A treatment for upper limb
Exclusion Criteria:
* significant loss of wrist and or fingers
* history of orthopedic surgery to plegic upper limb
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT03302871
|
{
"brief_title": "Integrated Management Enhances Functional Gains in Children With Cerebral Palsy Treated by BoNT-A",
"conditions": [
"Cerebral Palsy"
],
"interventions": [
"Drug: Botulinum toxin type A",
"Device: transcranial direct current stimulation",
"Other: usual care",
"Other: hybrid training model of CIMT and BIT"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT03302871",
"official_title": "Integrated Management With Brain Stimulation and Hybrid Training Enhances Functional Gains in Children With Cerebral Palsy Treated by Botulinum Toxin A",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-01-30",
"study_completion_date(actual)": "2020-01-30",
"study_start_date(actual)": "2016-01-18"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-24",
"last_updated_that_met_qc_criteria": "2017-10-02",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-10-05",
"first_submitted": "2017-10-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Older adults are becoming a growing proportion of people utilising mental health services. However, the needs of this population are poorly understood despite the evidence that mental health conditions are manifested differently in old age. One of those conditions is Post Traumatic Stress Disorder (PTSD) which has been associated with an increased risk of adverse outcomes in old age, including health problems, difficulties in daily functioning, less satisfaction with life and multiple psychiatric co-morbidities, such as depression and anxiety. Despite the serious consequences, PTSD symptoms in old age tend to be underreported or misperceived as a physical illness or part of an ageing process.
Traumatic life experiences do not necessarily lead to PTSD. Psychological resources, including emotional stability and social support, allow individuals to find appropriate coping strategies and maintain well-being in old age. Group identification, defined as a sense of belonging to a specific group, influences the response to social support and may be important in predicting distress in old age. On the other hand, socioeconomic deprivation is likely to increase this distress as exposure to traumatic events is more prevalent in disadvantaged populations.
The present study will investigate the impact of those factors on PTSD symptoms in later life. The researcher will recruit 85 older adults from the Older People Psychological Therapies Service, who are in receipt of psychological treatment for PTSD, anxiety or depression. Participants will be asked to provide basic demographic information, which will be used to describe the participant characteristics and to estimate the degree of socioeconomic deprivation. Participants will also complete five measures to screen for cognitive impairment and measure PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification.
The findings will help improve the diagnostic process and development of psychological treatments for PTSD in older adults by expanding our knowledge of this condition in later life.
Detailed Description
Aim of the study:
To investigate the importance and relative contribution of interpersonal and intra-individual factors, including lifetime trauma exposure, emotion regulation, social group belonging and socioeconomic deprivation in predicting PTSD symptoms in older adults.
Primary research questions:
1. Will greater lifetime trauma exposure predict higher levels of PTSD symptoms in older adults?
2. Will greater difficulties in emotion regulation predict higher levels of PTSD symptoms in older adults?
3. Will a lower number of group identifications predict higher levels of PTSD symptoms in older adults?
4. Will higher levels of socioeconomic deprivation predict higher levels of PTSD symptoms in older adults?
Secondary research questions:
1. What is the relative contribution of lifetime trauma exposure in predicting levels of PTSD symptoms in older adults?
2. What is the relative contribution of difficulties in emotion regulation in predicting levels of PTSD symptoms in older adults?
3. What is the relative contribution of group identifications in predicting levels of PTSD symptoms in older adults?
4. What is the relative contribution of socioeconomic deprivation in predicting levels of PTSD symptoms in older adults?
Design:
The study will employ a cross-sectional, within-groups design. An opportunistic clinical sample of older adults, aged 65 and over, in receipt of psychological treatment for PTSD, anxiety or depression in the Older People Psychological Therapies Service in NHS Tayside will be recruited. Participants will be asked to provide basic demographic information and to complete five measures, screening for cognitive impermanent and measuring PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification. Correlation and multiple regression analyses will be used to answer the research hypotheses.
#Intervention
- OTHER : Psychological measures
- Participants will be asked to provide basic demographic information and to complete five measures, screening for cognitive impermanent and measuring PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification.
|
#Eligibility Criteria:
Inclusion Criteria:
* Aged 65 years and over
* In receipt of psychological treatment for PTSD, anxiety or depression
* Fluent English speaker
* Ability to give consent
Exclusion Criteria:
* Cognitive impairment (MoCA <=20)
* Under investigation for or a confirmed diagnosis of dementia
* Currently experiencing an episode of a serious mental illness, e.g. psychosis
* Ongoing substance misuse
* Ongoing serious risk issues (i.e. risk of harm to self and others, suicidality)
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
|
NCT03821259
|
{
"brief_title": "Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life",
"conditions": [
"Post Traumatic Stress Disorder"
],
"interventions": [
"Other: Psychological measures"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT03821259",
"official_title": "Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life: the Contribution of Cumulative Trauma Exposure, Emotion Regulation, Group Identifications, and Socioeconomic Deprivation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-17",
"study_completion_date(actual)": "2019-05-17",
"study_start_date(actual)": "2018-11-06"
},
"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)": "2020-07-13",
"last_updated_that_met_qc_criteria": "2019-01-28",
"last_verified": "2020-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-01-29",
"first_submitted": "2018-12-19",
"first_submitted_that_met_qc_criteria": "2020-06-10"
}
}
}
|
#Study Description
Brief Summary
The goal of this observational study is determine if reduced ventricular ejection fraction is a factor that determines a pro-oxidant imbalance in patients subjected to cardiac surgery with cardiopulmonary bypass.
The main questions are:
* 1. Preoperative reduced left ventricular function determines higher blood and atrial tissue oxidative stress in patients subjected to cardiopulmonary bypass
* 2. Oxidative stress markers in atrial tissue of cardiac surgical patients with develop atrial fibrillation The main tasks participants will be asked to do is register the symptoms of arrhythmia and heart failure. Also, obtain a electrocardiographic register if any present palpitations or chest pain with clinical significance This study not present a comparison group.
Detailed Description
1. Atrial fibrillation detection: continuous ECG monitoring was performed 24 to 48 h after CBP. Whenever arrhythmia symptoms occurred, a 12-lead ECG was performed every 12 h for 5 days. The presence of ECG-documented atrial fibrillation for at least 1 min was considered as a postoperative atrial fibrillation event.
2. Samples and Biopsies: All patients were subjected to the same surgical procedure, including the same induction and anesthesia protocol, and the execution by the same medical team. Surgical access was via a median sternotomy incision, and all anastomoses were sutured by hand. Protection of myocardial tissue was accomplished with crystalloid cold potassium cardioplegic solution. In cardiac surgery, at the time of pericardiocentesis, samples of right appendage (approximately 200mg) were obtained immediately before starting extracorporeal circulation. They were immediately frozen in liquid nitrogen and stored at -80°C. Blood samples were collected in chilled vacutainers containing 4 mM disodium EDTA and centrifuged at 3000 × g for 10 min. Plasma samples from each patient were stored at -80°C until performing the biochemical determinations.
3. Pre-operative Echocardiographic images: All echocardiographic analyses were performed at the Echocardiography Unit of the National Thorax Institute using GE Vivid E9 equipment at the baseline visit (7 days before surgery). The strain analyses were performed using a semi-automated speckle tracking technique (EchoPAC, GE Medical Systems, Milwaukee, Wisconsin) using a model of the entire LV (the 3 apical views). Inadequately tracked segments were excluded. A 3D full-volume acquisition of the LV using a matrix array transducer with the highest possible volume rate was be attempted in all patients. LV volumes and LVEF were measured offline (3DLVQ, EchoPAC, GE Medical Systems, Milwaukee, Wisconsin), with an abnormal LVEF identified as \<40 %.
4. Biochemical parameters of oxidative stress. Determinations in plasma and atrial tissue samples (obtained during cardiac surgery, at the time of pericardiocentesis) and treated under the same experimental conditions.
#Intervention
- DIAGNOSTIC_TEST : Detection of peri-operative atrial fibrillation
- atrial tissue and plasma from patients with atrial fibrillation detection were analyzed for determine lipid and protein oxidation, and detect markers of myocardial injury.
- Other Names :
- Detection of oxidative stress markers of protein and lipid peroxidation
|
#Eligibility Criteria:
Inclusion Criteria:
* age >=18 years, chronic heart failure (WHO-functional class II, III) for at least 3 months before surgery. At the baseline visit, 7 <= age <= 10 days before surgery, the patients were classified by echocardiography as HF with pLVEF (LVEF >40%) or HF with rLVEF (LVEF <=40%).
Exclusion Criteria:
* Patients with history or evidence of AF, previous myocardial infarction, current use of amiodarone, severe congestive heart failure (New York Heart Association class III or IV), presence of prosthetic valves, congenital valvular disease, chronic rheumatic, neoplastic diseases, liver insufficiency, severe chronic kidney disease (serum creatinine >2.5 mg/dl), recent infections ( 2 weeks) and emergency surgery or repair of cyanotic heart disease.
In addition, patients receiving nonsteroidal anti-inflammatory drugs, corticosteroids, antioxidants, vitamins, or fish oil supplements, three months before surgery were also excluded.
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
|
NCT06256965
|
{
"brief_title": "Cardiopulmonary Bypass and Ventricular Remodeling",
"conditions": [
"Atrial Fibrillation",
"Heart Failure"
],
"interventions": [
"Diagnostic Test: Detection of peri-operative atrial fibrillation"
],
"location_countries": [
"Chile"
],
"nct_id": "NCT06256965",
"official_title": "Left Ventricular Ejection Fraction and Oxidative Stress Markers in Patients Subjected to Car-diac Surgery With Cardiopulmonary Bypass",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-11-15",
"study_completion_date(actual)": "2022-06-13",
"study_start_date(actual)": "2021-10-04"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-02-13",
"last_updated_that_met_qc_criteria": "2024-02-05",
"last_verified": "2024-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-02-13",
"first_submitted": "2024-02-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of Traumastem to help stop bleeding in participants undergoing open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery as compared to Surgicel® Original (Surgicel; in some countries marketed as Tabotamp®)
#Intervention
- DEVICE : Oxidized cellulose strip
- Single use, intra-operative application to the target bleeding site
- DEVICE : Oxidized regenerated cellulose strip
- A substance used to promote hemostasis (stops bleeding) based on oxidized regenerated cellulose
- Other Names :
- Tabotamp®
|
#Eligibility Criteria:
INCLUSION CRITERIA AT SCREENING:
* Participants and/or legal representative has/have provided signed informed consent. An assent form should be signed by Participants less than 18 years, if possible;
* Participants undergoing planned (non-emergency) open cardiac, intra-abdominal (including retroperitoneal) and pelvic surgery;
* Participants of childbearing potential present with a negative serum pregnancy test, and agree to employ adequate birth control measures for the duration of the study. Acceptable contraception methods are restricted to abstinence, barrier contraceptives, intrauterine contraceptive devices or licensed hormonal products;
* Participants are willing and able to comply with the requirements of the clinical investigation plan (CIP).
INCLUSION CRITERIA INTRA-OPERATIVE:
* Soft tissue, vascular/anastomotic or parenchymal bleeding is present after primary surgical hemostasis has been achieved. The TBS is defined as intra-operative bleeding where conventional methods for achieving hemostasis are ineffective (based on the type of tissue) or impractical (based on the location) and where treatment with topical hemostatic adjuncts such as Traumastem is deemed appropriate for use.
EXCLUSION CRITERIA:
* Emergency surgery;
* Transplantation surgery;
* Minimally invasive surgery;
* Neurological and ophthalmological surgery;
* Major arterial bleeding at the target bleeding site (TBS);
* Major intra-operative complications that require resuscitation or deviation from the planned surgical procedure;
* Severe local inflammation at the operating field;
* Any prior radiation therapy to the operating field;
* Known severe congenital or acquired immunodeficiency (eg, human immunodeficiency virus [HIV] infection or long-term [> 3 months] treatment with immunosuppressive drugs);
* Known hypersensitivity to components of the investigational device;
* Participant is pregnant or lactating at the time of enrollment or becomes pregnant prior to the planned surgery. If the participant becomes pregnant during the 30 days following treatment exposure, attempts will be made to follow her through completion of the pregnancy. The investigator will record a narrative description of the course of the pregnancy and its outcome;
* Participant has a clinically significant medical, psychiatric, or cognitive illness, or drug/alcohol abuse that, in the opinion of the investigator, would affect participant's safety or compliance;
* Participant has participated in another clinical study involving an investigational device/drug within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational device/drug during the course of this study.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01637025
|
{
"brief_title": "Oxidized Cellulose hEmostAsis evaluatioN",
"conditions": [
"Intra-operative Bleeding"
],
"interventions": [
"Device: Oxidized regenerated cellulose strip",
"Device: Oxidized cellulose strip"
],
"location_countries": [
"Germany",
"Hungary",
"Czech Republic",
"Poland"
],
"nct_id": "NCT01637025",
"official_title": "A Prospective, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Traumastem as an Adjunct to Hemostasis for Tissue Bleeding in Open Cardiac, Intra-abdominal (Including Retroperitoneal) and Pelvic Surgery",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-11",
"study_completion_date(actual)": "2012-11",
"study_start_date(actual)": "2012-05"
},
"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)": "2013-01-24",
"last_updated_that_met_qc_criteria": "2012-07-06",
"last_verified": "2013-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-07-10",
"first_submitted": "2012-07-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to conduct a randomized controlled trail to compare and analyze the effects of both whole body vibrator (WBV) and proprioceptive training through Tai Chi program on static and dynamic postural balance variables of the elderly population. The purpose of the study is to determine that whether whole body vibrator is more evident or proprioceptive training is more effective for promoting functional independency and improving balance in older adults. Hence distinguishing choices to prevent fall and advancing functional independency by using the appropriate intervention without using extreme loads.
Detailed Description
Elderly population is defined as 'people aged 65 or above'. Aging is a complex and challenging process of physiological changes and it is associated with decline of biological functions. Increasing age is linked with impairments in visual, proprioception, vestibular systems, decline in muscular strength and control of the lower limbs, balance/postural control, and of the mobility patterns which are known to be substantial hazards for fall, and these parameters have been found to be dynamically more disabled with getting older. Among all these factors, there is obvious decline in normal functioning and balance related issues, common in elderly population due to proprioceptive function loss that is the person is unable to sense his joint position and motion which ultimately results in mobility impairments.
Therefore, researchers have been looking for new approaches that are more feasible to improve the independence and physical mobility in older individuals and over the past decade the whole body vibrator (WBV) have been seeking attention for the beneficence of the elderly population. It is a neuromuscular training modality used to improve muscle strength, power, balance, mobility, cardiorespiratory rehabilitation, improves neuromuscular and musculoskeletal functions and general health both in healthy and as well as in orthopedic patients and neurologically diseased elderly population .Bilateral proprioceptive training is also used for impaired balance, proprioception loss and decreased ROM in elderly population. Proprioceptive receptors are present in our skin, muscles, tendons and joints with the help of which we can sense position and movement of limbs and trunk, sense of force and sense of heaviness in the absence of vision. The mechanoreceptors of the proprioception cause activation of central nervous system by initiating action potential through release of stored sodium in to the cells, this afferent sensory stimuli to the central nervous system is essential for the control of body movements
#Intervention
- OTHER : Whole body vibration group
- WBV will be provided with a frequency of 6-26Hz with amplitude of 1-3mm 4-5 bouts(60 sec each) for 3 times a week
- OTHER : Bilateral proprioceptive training
- Static balance training will be provided in first week for 3-4 times for 10 mints of single session. 3 times a week In 2nd and 3rd week dynamic balance training for 3 times with a session of 10 mints.
In 4th week progressive balance training will be done with same frequency and duration.
Tai chai exercises will be given for 20 mints 3 times a week
|
#Eligibility Criteria:
Inclusion Criteria:
* Participants with balance and proprioception problems
* Those having BBS score between 21 <= age <= 54
* Intact cognition: MMSE >25
Exclusion Criteria:
* Subjects with recent trauma or any other neurodegenerative disorder.
* Subjects with cognitive and hearing impairments
* Subjects who cannot follow my command.
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05060042
|
{
"brief_title": "Comparison of Whole Body Vibration With Bilateral Proprioceptive Training in Elderly",
"conditions": [
"Elderly Population"
],
"interventions": [
"Other: Bilateral proprioceptive training",
"Other: Whole body vibration group"
],
"location_countries": [
"Pakistan"
],
"nct_id": "NCT05060042",
"official_title": "Comparison of Whole Body Vibration With Bilateral Proprioceptive Training in Elderly Population",
"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)": "2021-10-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-12-12",
"last_updated_that_met_qc_criteria": "2021-09-17",
"last_verified": "2022-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-09-28",
"first_submitted": "2021-09-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this proposal is clinical validation of an electrochemical biochip for rapid pathogen identification and antibiotic susceptibility determination.
Detailed Description
Point-of-care identification of pathogens and determination of antibiotic susceptibility will significantly improve the clinical management of urinary tract infection. We have previously developed a biochip based on microfabrication technology capable of rapid detection of pathogens. The specific objectives of the current proposal are: 1) Determination of microbial constituents in spinal cord injury (SCI) patients and development of additional species-specific probes against these pathogens; 2) Development of a rapid antibiotic susceptibility and molecular pyuria assay using the electrochemical biochip; and 3) Clinical validation of the biochip as a diagnostic test for urinary tract infection.
Within a single protocol, two non-interventional studies were conducted at different time points to achieve the aforementioned objectives. Sensitivity and specificity of the electrochemical biosensor based assay was demonstrated in each study.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients suspected or at risk for complicated urinary tract infections
Exclusion Criteria:
* Gross contamination of urine samples at the time of collection
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
|
NCT00591240
|
{
"brief_title": "A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection",
"conditions": [
"Urinary Tract Infections",
"Bladder, Neurogenic"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00591240",
"official_title": "A Biochip for Rapid Diagnosis of Complicated Urinary Tract Infection",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-06",
"study_completion_date(actual)": "2011-06",
"study_start_date(actual)": "2007-07"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-06-27",
"last_updated_that_met_qc_criteria": "2008-01-10",
"last_verified": "2016-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-01-11",
"first_submitted": "2007-12-27",
"first_submitted_that_met_qc_criteria": "2016-06-24"
}
}
}
|
#Study Description
Brief Summary
Sleeping under hypoxic conditions can impair cognition and autonomic nervous activity. A short daytime nap can modify these changes. Here we propose a randomized, cross-over study to evaluate the heart rate variability during a 90 min nap in a normobaric hypoxic chamber. In addition, we will investigate sleep architecture, vigilance, attention and memory.
#Intervention
- OTHER : Normoxia
- Nap in hypoxia chamber at 20.9% oxygen (36 m asl)
- OTHER : Hypoxia 1
- Nap in hypoxia chamber at 15.0% oxygen (simulates 2660 m asl)
- OTHER : Hypoxia 2
- Nap in hypoxia chamber at 12.8% oxygen (simulates 4000 m asl)
|
#Eligibility Criteria:
Inclusion Criteria:
* Men and women
* Age 25 <= age <= 45 years
* BMI 20 - 28 kg/m^2
Exclusion Criteria:
* Severe, manifest illnesses in need of treatment
* Postoperative phases
* Acute and chronic infections
* Sleep disorders such as sleep apnea, insomnia or somnolence
* Altitude exposure (> 2500 m asl) within 6 months before enrollment
* Regular migraines
* Smoking
* Athletes
* Significant weight change within 1 month before enrollment
* Inability to understand significance and scope of the study
* Drug or alcohol abuse
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04146857
|
{
"brief_title": "Autonomic Activity During Nap Under Hypoxia",
"conditions": [
"Hypoxia",
"Sleep",
"Healthy"
],
"interventions": [
"Other: Hypoxia 2",
"Other: Hypoxia 1",
"Other: Normoxia"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT04146857",
"official_title": "Effects of Normobaric Hypoxia on Autonomic Activity During a Nap in Healthy Adults (NAPOXIA)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-12-30",
"study_completion_date(actual)": "2020-12-30",
"study_start_date(actual)": "2019-10-30"
},
"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)": "2022-07-11",
"last_updated_that_met_qc_criteria": "2019-10-30",
"last_verified": "2022-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-31",
"first_submitted": "2019-10-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The Major goals of this project was to assess the natural history of disease in chronic hepatitis C patients with normal ALT and to determine the virologic and host factors associated with disease severity.
#Intervention
- PROCEDURE : liver biopsy
- Liver biopsy every 5 years
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with chronic hepatitis C and persistently normal liver enzymes
* able to give consent
Exclusion Criteria:
* decompensated liver disease
* any prior antiviral or immunosuppressive therapy
* other liver disease besides hepatitis C
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
|
NCT00187473
|
{
"brief_title": "Natural History of Hepatitis C in Patients With Normal Liver Tests",
"conditions": [
"Chronic Hepatitis C"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00187473",
"official_title": "Determinants of Disease Severity in Patients With Chronic Hepatitis C and Normal Serum Aminotransferases (Normal Liver Tests)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-12-31",
"study_completion_date(actual)": "2021-12-31",
"study_start_date(actual)": "2000-06"
},
"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)": "2024-01-12",
"last_updated_that_met_qc_criteria": "2005-09-13",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2005-09-16",
"first_submitted": "2005-09-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Aim: This study was planned to determine the effect of transtheoretical model-based motivational interviewing on patients\' self-efficacy and disease adherence in patients receiving haemodialysis treatment.
Study design and methods: This study was conducted between June 2022 and April 2023 according to the experimental research model with pre-test and post-test control group. The research was completed with a total of 60 hemodialysis patients, 30 in the experimental group and 30 in the control group.
#Intervention
- BEHAVIORAL : Transtheoretical Model Based Motivational Interviewing
- Transtheoretical Model Based Motivational Interviewing was applied to haemodialysis patients in 6 sessions.
- OTHER : routine clinical care
- routine clinical care
|
#Eligibility Criteria:
Inclusion Criteria:
Being on hemodialysis treatment Being able to read and writeH
Exclusion Criteria:
Not knowing how to read or write, Having a psychological disorder that prevents speaking
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
|
NCT06706843
|
{
"brief_title": "The Effect of Transtheoretical Model-based Motivational Interview on Self-efficacy and Illness Compliance",
"conditions": [
"Hemodialysis Units, Hospital"
],
"interventions": [
"Other: routine clinical care",
"Behavioral: Transtheoretical Model Based Motivational Interviewing"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06706843",
"official_title": "The Effect of Transtheoretical Model-based Motivational Interview on Self-efficacy and Illness Compliance",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-30",
"study_completion_date(actual)": "2023-03-30",
"study_start_date(actual)": "2022-06-30"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-27",
"last_updated_that_met_qc_criteria": "2024-11-22",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-11-27",
"first_submitted": "2024-09-27",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To explore the analysis of factors causing indwelling urinary catheter-related infections in ICU patients and their nursing strategies, and to provide reference for clinical nursing work. 291 patients with indwelling urinary catheters in the second area of ICU of our hospital from January 1, 2023 to September 30, 2023 were selected as research subjects. They were divided into infection group and non-infection group according to the presence or absence of urinary tract infection. Non-infection group The first group consisted of patients without urinary tract infection (278 cases), and the infection group consisted of patients with urinary tract infection (13 cases). A retrospective analysis method was used to analyze the causes of catheter-related urinary tract infection and the infecting bacteria of the two groups of patients. A single factor analysis was performed on various factors and other related factors, and corresponding nursing strategies were summarized and proposed.
#Intervention
- OTHER : There were no interventions in retrospective analysis
- A retrospective analysis method was used to analyze the causes of catheter-related urinary tract infection and the infecting bacteria of the two groups of patients. A single factor analysis was performed on various factors and other related factors, and corresponding nursing strategies were summarized and proposed.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age > 14 years
* Patients with indwelling urinary tube during hospitalization
* Length of stay in ICU > 48h
* Complete hospitalization data
Exclusion Criteria:
* Had urinary tract infection before hospitalization
* Indwelling catheter < 72h
* Severe liver and kidney failure and death within 48 hours of admission
Sex :
ALL
Ages :
- Minimum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT06295627
|
{
"brief_title": "The Analysis of Factors Causing Indwelling Urinary Catheter-related Infections in ICU Patients and Their Nursing Strategies",
"conditions": [
"Catheter-associated Urinary Tract Infection"
],
"interventions": [
"Other: There were no interventions in retrospective analysis"
],
"location_countries": [
"China"
],
"nct_id": "NCT06295627",
"official_title": "The Analysis of Factors Causing Indwelling Urinary Catheter-related Infections in ICU Patients and Their Nursing Strategies",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-09-30",
"study_completion_date(actual)": "2024-01-15",
"study_start_date(actual)": "2023-01-30"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-06",
"last_updated_that_met_qc_criteria": "2024-03-03",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-03-06",
"first_submitted": "2024-02-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In order to better understand the source(s) and the mechanism(s) of HIV persistence and to potentially lead to further suppression of HIV from viral reservoirs, we propose to examine the effect of co-administration of enfuvirtide, an entry inhibitor of HIV, on diminution of the size of the viral reservoir in infected individuals who are receiving effective antiviral therapy for extended periods of time (\> 5 years).
#Intervention
- DRUG : enfuvirtide
- 1ml BID
|
#Eligibility Criteria:
Inclusion Criteria:
* Patient must be HIV infected
* Patient must be > 18 years
* Patient must be taking standard combination antiretroviral therapy with 2 <= age <= 3 NRTIs and 1 <= age <= 2 PIs or a NNRTIs for at least five years
* Patient must have a viral load < 50 copies/mL (using the standard available methods of detection) during the entire time on standard combination antiretroviral therapy except for initial fall of viral load
* Patient must have a CD4 count above 400 cells/mm3 in last 3 months
* Female patient must agree to use two methods of birth control or abstinence during the period of the study
* Patient has to have signed full informed consent
Exclusion Criteria:
* Patient who would have difficulty participating in a trial due to non-adherence or substance abuse
* Patient who have taken mono or dual antiretroviral therapy
* Patient who have had a viral load > 50 copies/mL on any antiretroviral regimen
* Patient with any of the following abnormal laboratory test results in screening:
* Hemaglobin < 100 g/L
* Neutrophil count < 750 cells/uL
* Platelet count < 50,000 cells/L
* AST or ALT > 5X the upper limit of normal
* Creatinine > 250 umol/L
* Patient with a malignancy
* Patient with other significant underlying disease (non-HIV) that might impinge upon disease progression or death
* Patient with an active AIDS-defining illnesses in the past six months
* Patients who are pregnant
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
|
NCT00334022
|
{
"brief_title": "Fuzeon Viral Decay Pilot Study",
"conditions": [
"HIV-1"
],
"interventions": [
"Drug: enfuvirtide"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00334022",
"official_title": "A Pilot Randomized Controlled Trial of Adding Enfuvirtide to Standard Combination Antiretroviral Therapy in HIV-infected Individuals With Full Virologic Suppression to Further Suppress Proviral HIV DNA",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-07",
"study_completion_date(actual)": "2010-01",
"study_start_date(actual)": "2006-02"
},
"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)": "2012-06-05",
"last_updated_that_met_qc_criteria": "2006-06-02",
"last_verified": "2012-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-06-06",
"first_submitted": "2006-06-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Tuberculosis (TB) remains the major cause of morbidity and mortality among patients with HIV. Sub-optimal diagnostics contributes towards poor patient outcome and there is an urgent need to identify non-sputum-based point-of-care diagnostic tests. The urine based lateral flow lipoarabinomannan TB diagnostic test (LF-LAM) is a simple, inexpensive point-of-care test. In 2015, the World Health Organization endorsed LF-LAM for conditional use among patients with advanced HIV, but uptake of the test in clinical practices has been poor.
The investigators aim to identify point-of-care (POC) strategies that can improve TB case detection and clinical outcomes among patients with advanced HIV. The project includes a main study and two sub-studies.
The main study is a multicenter stepped wedge cluster-randomized controlled trial of LF-LAM implementation among patients with advanced HIV with 8-weeks follow-up. LF-LAM will be added to standard care and implemented stepwise at three hospitals in Ghana. Education in national TB treatment guidelines in collaboration with the Tuberculosis Control programme in Ghana, and Clinical audit of clinical staff with feedback, will be used to assess and strengthen LF-LAM implementation. The primary outcome time to TB treatment, for which a sample size of 690 participants will provide \>90% power to detect a minimum of 7 days reduction. Secondary outcomes are: TB related morbidity, TB case detection, time to TB diagnosis and overall early mortality at 8 weeks. The HIV-associated TB epidemiology including genotypic analyses of M. tuberculosis isolates obtained through the main study will be described. In sub study A, focused ultrasound of lungs, heart and abdomen will be performed in a sub cohort of 100 participants. In sub study B, the investigators will establish a biobank and data warehouse for storage of blood, urine and sputum samples collected from participants that enter the study at Korle-Bu Teaching hospital.
It is expected that LF-LAM will lead to earlier diagnosis and treatment of TB. Findings may further guide scaling-up of LF-LAM. The HIV-associated epidemic including genotypic properties and resistance properties which is important for improved management will be detailed. The investigators further expect to evaluate the potential of bedside ultrasound as a clinical tool in management of HIV/TB co-infected patients. The unique Ghanaian HIV-cohort and biobank may facilitate rapid evaluation of future prognostic biomarkers and new point-of-care TB diagnostic tests.
#Intervention
- DIAGNOSTIC_TEST : LF-LAM
- Open label multi-center stepped wedge cluster-randomized controlled trial with implementation of LF-LAM. All clusters (i.e. HIV/ART clinic attached wards) start with standard of care and are then randomized to switch to the intervention phase at predefined time points.
- Other Names :
- Lateral flow urine lipoarabinomannan assay, Determine TM TB LAM Ag test
|
#Eligibility Criteria:
Inclusion Criteria:
* HIV-positive
* 18 years and above
* Able to give informed consent
* Admitted at the wards attached to the research site ART/HIV-clinic
* Eligible for LF-LAM testing (defined by WHO in the LF-LAM policy update 2019): CD4-cell-count <=200 cells/μL (the last measured CD4-cell-count); or a WHO clinical stage 3 or 4 event at presentation for care; or seriously ill defined by WHO (respiratory rate > 30/min, temperature > 39°C, heart rate > 120/min or unable to walk unaided); or a positive WHO TB symptom screening including one of the following symptoms: current cough, fever, weight loss, or night sweats
Exclusion Criteria:
* Anti-tuberculous treatment including preventive treatment with Isoniazide within the last 60 days
* Earlier participation in the same 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
|
NCT04122404
|
{
"brief_title": "POC Strategies to Improve TB Care in Advanced HIV Disease",
"conditions": [
"Extrapulmonary Tuberculosis",
"Tuberculosis, Pulmonary",
"Human Immunodeficiency Virus (HIV)",
"Acquired Immunodeficiency Syndrome"
],
"interventions": [
"Diagnostic Test: LF-LAM"
],
"location_countries": [
"Ghana"
],
"nct_id": "NCT04122404",
"official_title": "Point-of-care Strategies to Improve Tuberculosis Care Among Severely Immunosuppressed HIV-infected Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-01-30",
"study_completion_date(actual)": "2022-01-30",
"study_start_date(actual)": "2019-10-14"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "SEQUENTIAL",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-05-23",
"last_updated_that_met_qc_criteria": "2019-10-08",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-10-10",
"first_submitted": "2019-10-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In Intensive Care Medicine, critical incidents are not rare and may result in fatal outcome. High fidelity patient simulators are commonly used in training curricula for healthcare professionals especially in anesthesiology, emergency medicine, and intensive care medicine. Several different course concepts have previously been published. As we know from recently published data, up to 80% of all critical incidents in the field of medicine are caused by human error. The authors of the present study aimed to investigate the effects of two different course concepts (one addressing technical skills in intensive care medicine and on addressing non-technical skills) on stress and performance. Stress and performance are measured in a pre-intervention and a post-intervention testing scenario.
#Intervention
- OTHER : Medical simulator training
- Contains seminars on airway management, general anesthesia, peri-arrest arrhythmias, and advanced life support. Furthermore, participants train in simulator scenarios. In the debriefing instructors discuss management of the critical incidents using videotapes of the scenarios.
- OTHER : Simulator based crew resource management course
- Contains seminars on human error and non-technical skills. Furthermore, participants train in simulator scenarios. In the debriefing instructors discuss usage of non-technical skills as well as behaviour of the participants using videotapes of the scenarios.
|
#Eligibility Criteria:
Inclusion Criteria:
* Physician with experience in intensive care medicine.
Exclusion Criteria:
* No experience in intensive care medicine
* previously taken part in simulator training
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00704470
|
{
"brief_title": "Performance and Stress During Full Scale Simulator Training",
"conditions": [
"Performance in Simulated Emergencies",
"Stress During Simulator Scenario",
"Behaviour of Physicians in Simulated Emergencies"
],
"interventions": [
"Other: Simulator based crew resource management course",
"Other: Medical simulator training"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT00704470",
"official_title": "Excellence in Performance and Stress Reduction During Two Different Full Scale Simulator Training Courses: A Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2005-10",
"study_completion_date(actual)": "2005-10",
"study_start_date(actual)": "2005-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-06-27",
"last_updated_that_met_qc_criteria": "2008-06-24",
"last_verified": "2008-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-06-25",
"first_submitted": "2008-06-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The present prospective, randomized, controlled, double-blinded trial investigates the effects of intermittent theta-burst stimulation (iTBS) during the early rehabilitation after stroke. Patients with hemipresis will receive either sham or real iTBS over their affected hemispheres before occupational therapy for 8 days. Motor recovery is assessed one day after the intervention phase and three months after enrollment.
Detailed Description
To date, rehabilitation of stroke with hemiparesis mainly includes physiotherapy and occupational therapy. Yet, the majority of patients retain movement impairment relevant for activities of daily living. One explanation for this deficit is the insufficient recovery of connectivity between brain regions after stroke. It is possible to modulate this process by repetitive transcranial magnetic stimulation (rTMS) using the protocol of intermittent theta-burst stimulation (iTBS). Previous data indicate that modulation of the motor cortex with iTBS enhances the effects of subsequent motor training. The present study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery, compared with physiotherapy after sham stimulation. In the first weeks and after three months, motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of stroke patients.
Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 20/12/2016): Specification of exclusion criteria.
Amendment (approved by the Ethics-Committee of the Medical Faculty of the University of Cologne, 15/11/2018): Change of inclusion and exclusion criteria.
#Intervention
- DEVICE : Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol
- iTBS applied over ipsilesional M1
- DEVICE : Magstim Super Rapid2 System, sham-stimulation (in iTBS)
- iTBS applied with tilted coil over parieto-occipital vertex
|
#Eligibility Criteria:
Inclusion Criteria:
* written consent
* age: 40 <= age <= 90 years
* ischemic stroke
* hemiparesis with impaired hand motor function
Exclusion Criteria:
* Subjects who are legally detained in an official institute (§20 MPG)
* Participation in clinical trial within the last 12 weeks
* Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker)
* Medication pump (e.g. insulin pump)
* Metal splinters in eye or head
* Pregnancy / breastfeeding
* Severe Neurodegenerative disease
* Severe Neuroinflammatory disease
* History of seizures / epilepsy
* Physical addiction to alcohol, medication, or drugs (excluded: nicotine)
* Insufficient compliance
* Present or past malignant tumor involving the central nervous system
* Severe Psychiatric disease
* Clinically manifest bilateral hemiparesis or infarcts in the primary motor cortex or along the tractus corticospinalis in the hemisphere ipsilateral to the hemiparesis
* Pre-existing cerebral infarctions with hemiparesis or pre-existing cerebral infarctions in the primary motor cortex or along the tractus corticospinalis, excluding microangiopathic changes (e.g. clinically asymptomatic lacunae <1cm)
* Known brain lesion (surgical, traumatic)
* Evidence for enhanced cerebral pressure
* Severe cardial dysfunction
* life expectancy < 12 months
* NIHSS Score > 20
* Blood glucose imbalances resistant to treatment (<50 mg/dl or >300 mg/dl)
* Elevated blood pressure resistant to treatment (RR > 185/110mmHg)
* Systemic Thrombolysis using r-tPA or thrombectomy within the last 24 hours before enrollment in study
* Medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02910024
|
{
"brief_title": "Theta-Burst-Stimulation in Early Rehabilitation of Stroke",
"conditions": [
"Stroke"
],
"interventions": [
"Device: Magstim Super Rapid2 System, sham-stimulation (in iTBS)",
"Device: Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT02910024",
"official_title": "Theta-Burst-Stimulation in Der frühen Rehabilitation Von Schlaganfallpatienten",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-09-15",
"study_completion_date(actual)": "2022-09-15",
"study_start_date(actual)": "2016-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2",
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-09-21",
"last_updated_that_met_qc_criteria": "2016-09-19",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-21",
"first_submitted": "2016-09-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This project aims to evaluate different approaches to increase Hepatitis C screening among primary care patients at Penn Medicine through a centralized screening outreach program. In a pragmatic trial, we will evaluate different approaches to increase completion of screening among eligible patients, including changing the default from opt-in to opt-out and incorporating behavioral science principles into the outreach communication.
Detailed Description
The hepatitis C virus (HCV) is the leading cause of liver transplant and hepatocellular carcinoma in the US. New direct-acting antivirals are available that can eradicate the disease in over 95% of those that are treated, with minimal side effects. As a result of new therapies and a five-fold higher risk among baby boomers, the US Preventive Services Task Force and CDC now recommend HCV screening for all patients born between 1945 and 1965. Of the estimated 3.2 million people chronically infected with HCV, about 75% were born during this time frame. Despite this, national rates of screening among this group remain low at less than 30%. If more people could get screened, we could potentially identify more undiagnosed disease and help navigate to treatment.
At Penn Medicine primary care practices, HCV screening rates have risen from 37% in 2014 to 61% in 2017, likely from a combination of provider educational efforts and EHR alerts. There is also significant practice variation ranging from 4% to 99% screening rates. While EHR alerts have been shown to increase HCV screening rates, there is potential to complement this with direct outreach to patients homes, as has been incorporated into cancer screening initiatives. Additionally, there is a mandate from the state of Pennsylvania requiring health care providers to offer HCV testing to all primary care patients. There is an opportunity to provide direct outreach to all eligible primary care patients at Penn Medicine, while also evaluating different approaches to increasing HCV screening rates.
Insights from behavioral science have been shown to increase participation in health promoting behaviors in a variety of ways. Switching from opt-in to opt-out framing has been shown to triple patient participation in remote monitoring and CRC screening. Additionally, messaging that incorporates social norms, reciprocity, and precommitment have also been shown to increase participation. However, it is not clear how these approaches would translate to HCV screening.
#Intervention
- BEHAVIORAL : Opt-Out
- Opt-In messaging prompts participants to contact their primary care provider to receive Hepatitis C screening whereas Opt-Out messaging includes a signed laboratory order for Hepatitis C screening.
- BEHAVIORAL : Letter
- Participants receive messaging prompting them to contact their primary care provider to receive Hepatitis C screening, either as a letter or an electronic message on the MyPennMedicine patient portal.
- BEHAVIORAL : Behavioral Economic Messaging
- Participants receive standard messaging about HCV and ways to get screened and messaging that incorporates behavioral economic principles such as norms, reciprocity, anticipated regret, and pre-commitment to get screening.
- BEHAVIORAL : Usual Care Messaging
- Participants receive standard messaging about HCV and ways to get screening.
|
#Eligibility Criteria:
Inclusion Criteria:
* at least 2 visits to primary care provider within 2 years
* born between 1945 and 1965
Exclusion Criteria:
* have had 1 HCV antibody test, viral load test or are considered up-to-date on HCV screening by health maintenance
Sex :
ALL
Ages :
- Minimum Age : 53 Years
- Maximum Age : 73 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03712553
|
{
"brief_title": "Behavioral Science and Hepatitis C Screening Outreach",
"conditions": [
"Hepatitis C"
],
"interventions": [
"Behavioral: Usual Care Messaging",
"Behavioral: Letter",
"Behavioral: Opt-Out",
"Behavioral: Behavioral Economic Messaging"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03712553",
"official_title": "Behavioral Science and Hepatitis C Screening Outreach",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-10-15",
"study_completion_date(actual)": "2020-10-15",
"study_start_date(actual)": "2019-03-15"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "SCREENING",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-12-01",
"last_updated_that_met_qc_criteria": "2018-10-16",
"last_verified": "2020-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-10-19",
"first_submitted": "2018-10-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Although open repair (OR) is currently reported as the gold standard of treatment, fenestrated endovascular repair (FEVAR) is being increasingly applied for the treatment of proximal abdominal aortic aneurysms (p-AAA) such as hostile-necked, juxta-, para- and supra-renal aortic aneurysms.1 Nevertheless, advantages of FEVAR in terms of lowering postoperative complications, should be balanced with the need of both complex device configurations and operators with large endovascular expertise. The aim of this study is to report the experience of Data from patients treated will be prospectively collected. All post-operative results will be recorded. Major adverse event (MAE) are defined as the presence of one of the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, respiratory failure, stroke and renal insufficiency.
Furthermore, the pre-operative contrast-enhanced computed tomography scans (CTA) of all patients, stored in the hospital PACS, will be analyzed on the dedicated workstation with OsiriX software (Pixmeo sarl, Bernex, Switzerland) currently employed in our Unit for imaging assessment.
Patients will undergo standard control with the execution of a Doppler ultrasound and creatinine serum levels at 1, 6, 12, 24, 36, 48 and 60 months. A CTA will also be performed at 12 months as per standard clinical practice.
of p-AAA treatment.
Detailed Description
Primary end-point is to evaluate the mortality and major adverse events (MAE) at 30 days, 2 years and 5 years prospectively in the cohort of patients p-AAA treated by means of open repair in the next 100 patients that will be treated between 2018 and 2020 in the Vascular Surgery Unit of the San Raffaele Hospital.
Data from patients treated will be prospectively collected. All post-operative results will be recorded. Major adverse event (MAE) are defined as the presence of one of the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, respiratory failure, stroke and renal insufficiency.
Patients will undergo standard control with the execution of a Doppler ultrasound and creatinine serum levels at 1, 6, 12, 24, 36, 48 and 60 months. A CTA will also be performed at 12 months as per standard clinical practice The 100 patients that will be enrolled until December 2020 will also sign an 'ad hoc' consents, specific for this study.
Sensitive patient information will not be available during data analysis. The clinical study will be carried out according to the ethical principles of the Declaration of Helsinki and following the active regulations on observational studies.
Expected results are:
* death at 30 days: 2%
* any MAE at 30 day: 25% Patients characteristics and anatomical data on the visceral vessels will be analyzed on Wizard Statistics software to investigate the presence of statistically significant Pearson correlations among the identified variables.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients age >=18 years,
* Patient undergoing treatment of p-AAA pathology at San Raffaele Hospital
Exclusion Criteria:
* Incomplete imaging quality not including the arterial segments to be studied (visceral vessels) or with a high slice thickness (> 1.5 mm).
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
|
NCT03608683
|
{
"brief_title": "Evaluation of the Treatment of Abdominal Aortic Pathology With Hostile Necks, Para-/Juxra-renal and Sovrarenal Pathology at Short, Mid and Long Term",
"conditions": [
"Proximal Abdominal Aortic Aneurysms"
],
"interventions": null,
"location_countries": [
"Italy"
],
"nct_id": "NCT03608683",
"official_title": "Evaluation of Open Surgical Treatment of Abdominal Aortic Pathology With Hostile Necks, Para-/Juxra-renal and Sovrarenal Pathology at Short, Mid and Long Term",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-31",
"study_completion_date(actual)": "2023-12-31",
"study_start_date(actual)": "2018-07-04"
},
"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)": "2024-01-24",
"last_updated_that_met_qc_criteria": "2018-07-31",
"last_verified": "2023-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-08-01",
"first_submitted": "2018-07-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate the therapeutic effect of Dapsone and Placebo gel in the treatment of acne vulgaris.
Detailed Description
A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group study comparing Dapsone to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne Vulgaris
#Intervention
- DRUG : Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)
- Topical gel
- DRUG : ACZONE® (dapsone) gel, 7.5% (Allergan, INC.)
- Topical gel
- OTHER : Placebo for Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)
- Topical gel
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male or non-pregnant female aged >= 12 and <= 40 years with a clinical diagnosis of acne vulgaris.
* Subjects who are 18 years or older (up to the age of 40 inclusive) must have provided IRB approved written informed consent. Subjects ages 12 <= age <= 17 of age inclusive must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian). In addition, all Subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization.
* Subjects must have a minimum >= 25 non-inflammatory lesions (i.e., open and closed comedones) AND >= 20 inflammatory lesions (i.e., papules and pustules) AND <= 2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area. All lesions will be counted, including those present on the nose. Subjects may have acne lesions on other areas of the body which will also be excluded from the count, treatment, and the Investigator's Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).
* Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).
* Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period for acne vulgaris, other than the Investigational Product.
* Female Subjects of childbearing potential (excluding women who are premenarchal, surgically sterilized or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug . For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3 months) NuvaRing® (vaginal contraceptive);Implanon™ (contraceptive implant), double barrier methods (e.g. condom and spermicide),Intrauterine Device (IUD), Essure, or abstinence. If a subject who was abstinent becomes sexually active during the study, a 2nd acceptable method of birth control should be documented. A sterile sexual partner is NOT considered an adequate form of birth control. Hormonal contraceptives should not be initiated or changed during the study.
* All male Subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration to 30 days after the last administration of study drug. Abstinence is an acceptable method of birth control. Female partners should use an acceptable method of birth control as described in the above Item Number 6.
* Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
* Subjects must be in good health and free from any clinically significant disease, including but not limited to, conditions that may interfere with the evaluation of acne vulgaris. Such conditions include, but are not limited to the following: autoimmune disease, rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneiform eruptions caused by make-up, medication, facial psoriasis and facial eczema.
* Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.
Exclusion Criteria:
* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
* Subjects with a history of hypersensitivity or allergy to dapsone and/or any of the study medication ingredients and its excipients.
* Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
* Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
* Subjects who have performed wax depilation of the face within 14 days prior to baseline.
* Subjects who have used within 6 months prior to baseline or use during the study of oral retinoids (e.g. Accutane®), or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
* Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
* Subjects who have used any of the following procedures on the face within 1 month prior to baseline or use during the study:
1. cryodestruction or chemodestruction,
2. dermabrasion,
3. photodynamic therapy,
4. acne surgery,
5. intralesional steroids, or
6. X-ray therapy.
* Subjects who have used any of the following treatments within 1 month prior to baseline or during the study:
1. systemic steroids,
2. spironolactone,
3. systemic antibiotics,
4. systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or
5. systemic anti-inflammatory agents
* Subjects who have used any of the following treatments within 2 weeks prior to baseline or during the study:
1. topical steroids,
2. topical retinoids,
3. topical acne treatments including over-the-counter preparations,
4. topical anti-inflammatory agents, or
5. topical antibiotics.
* Subjects who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline.
* Subjects who have unstable medical disorders that are clinically significant or have lifethreateningdiseases.
* Subjects who have on-going malignancies requiring systemic treatment will be excluded from study participation. In addition, Subjects who have any malignancy of the skin of the facial area will also be excluded.
* Subjects who engage in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold.
* Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or of drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates).
* Subjects who have participated in an investigational drug study (i.e., Subjects have been treated with an investigational drug) within 30 days prior to baseline will be excluded from study participation. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion.
* Subjects who have been previously enrolled in this study.
* Subjects who have had laser therapy, electrodesiccation and phototherapy (e.g., ClearLight®) to the facial area within 180 days prior to study entry.
* Subjects who have had cosmetic procedures (e.g., facials) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry. Cosmetic procedures and facials are prohibited throughout the study.
* Subjects who currently have or have recently had bacterial folliculitis on the face.
* Subjects with a baseline irritation score of 3 = severe (marked, intense).
* Subjects with known G6PD deficiency, or congenital or idiopathic methemoglobinemia.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT04015375
|
{
"brief_title": "Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris",
"conditions": [
"Acne Vulgaris"
],
"interventions": [
"Drug: Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)",
"Other: Placebo for Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)",
"Drug: ACZONE® (dapsone) gel, 7.5% (Allergan, INC.)"
],
"location_countries": [
"Belize",
"United States"
],
"nct_id": "NCT04015375",
"official_title": "A Multi-center,Double-blind,Randomized,Three-arm,Placebo-controlled,Parallel-group Study, Comparing Dapsone Gel,7.5% (Torrent Pharma) to Aczone® Gel,7.5% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-03",
"study_completion_date(actual)": "2020-02-22",
"study_start_date(actual)": "2019-07-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-02",
"last_updated_that_met_qc_criteria": "2019-07-06",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-07-11",
"first_submitted": "2019-07-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Chronic heart failure is an important public health problem as it is a leading cause of disability, hospitalization, death, and costs. People who live with advanced chronic heart failure suffer from numerous symptoms that affect their daily lives. The investigators are conducting a randomized clinical trial to evaluate a symptom management and psychosocial care intervention to improve health status (symptom burden, functioning, and quality of life). The results will be directly relevant to patients and families who suffer with this illness, as well as to providers, payers, and other researchers.
#Intervention
- OTHER : CASA Intervention
- CASA Intervention
The CASA (Collaborative Care to Alleviate Symptoms and Adjust to Illness) intervention includes 3 components:
A nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, pain, and depression.
A social worker provides structured counseling targeting adjustment to illness and depression if present.
A collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider, cardiologist and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker.
Most of the nurse and social worker visits are by phone.
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older
* Able to read and understand English
* Consistent access to a telephone
* Patients have a primary care or other provider who is willing to facilitate intervention medical recommendations
* A diagnosis of heart failure with at least one of the following:
[hospitalization primarily for heart failure in the year prior (including current); taking at least 20 mg oral furosemide (or equivalent) daily in a single or divided dose; Brain natriuretic peptide(BNP) >= 100 or N-terminal prohormone of brain natriuretic peptide(NT-proBNP) >= 500; EF<=40%]
* Report a low health status (KCCQ-SF<=70)
* Bothered by at least one target symptom:
[Pain; Depression; Fatigue; Breathlessness]
Exclusion Criteria:
* Previous diagnosis of dementia
* Active substance abuse or dependence, defined by either a diagnosis of abuse or dependence or an AUDIT-C >= 8, or self-reported substance abuse in the past 3 months
* Comorbid metastatic cancer
* Nursing home resident
* Heart Transplant recipient
* LVAD recipient
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
|
NCT01739686
|
{
"brief_title": "Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial",
"conditions": [
"Chronic Heart Failure"
],
"interventions": [
"Other: CASA Intervention"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01739686",
"official_title": "Collaborative Care to Alleviate Symptoms and Adjust to Illness in Chronic Heart Failure (CASA) Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-12",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2012-08"
},
"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)": "2017-08-01",
"last_updated_that_met_qc_criteria": "2012-11-29",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-12-03",
"first_submitted": "2012-11-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America.
The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients.
The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).
#Intervention
- DRUG : turoctocog alfa
- The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.
- DRUG : turoctocog alfa
- Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)
|
#Eligibility Criteria:
Inclusion Criteria:
* Informed Consent obtained before any trial-related activities
* Completion of trial NN7008 <= age <= 3543 or paediatric trial NN7008 <= age <= 3545 or Japanese trial NN7008 <= age <= 3600 or pharmacokinetic trial NN7008 <= age <= 3893 or NN7008 <= age <= 4015
Exclusion Criteria:
* Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008 <= age <= 3522, NN7008 <= age <= 3543, NN7008 <= age <= 3545, NN7008 <= age <= 3600, NN7008 <= age <= 3893 or NN7008 <= age <= 4015 after administration of trial product
Sex :
MALE
Ages :
- Minimum Age : 6 Months
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT00984126
|
{
"brief_title": "Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015",
"conditions": [
"Congenital Bleeding Disorder",
"Haemophilia A"
],
"interventions": [
"Drug: turoctocog alfa"
],
"location_countries": [
"United States",
"Poland",
"Germany",
"Serbia",
"Macedonia, The Former Yugoslav Republic of",
"Switzerland",
"United Kingdom",
"Japan",
"Israel",
"Taiwan",
"Russian Federation",
"Italy",
"Turkey",
"Croatia",
"Brazil",
"Latvia",
"Lithuania",
"Malaysia",
"Spain",
"Puerto Rico"
],
"nct_id": "NCT00984126",
"official_title": "Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-06-28",
"study_completion_date(actual)": "2016-06-29",
"study_start_date(actual)": "2009-10-26"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-07-27",
"last_updated_that_met_qc_criteria": "2009-09-24",
"last_verified": "2017-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-09-25",
"first_submitted": "2009-09-21",
"first_submitted_that_met_qc_criteria": "2017-06-27"
}
}
}
|
#Study Description
Brief Summary
The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101. AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months or within the last \>3 to 6 months.
Detailed Description
This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratympanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months (Stratum A), or between \>3 and 6 months (Stratum B) from onset).
#Intervention
- DRUG : AM-101
- AM-101 gel for intratympanic injection
- DRUG : Placebo
- Placebo gel for intratympanic injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Persistent subjective peripheral tinnitus (unilateral or bilateral) following traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer than 3 months (Stratum A) or between >3 months and 6 months (Stratum B) prior to randomization, as documented by medical report or by documented medical history. Upon implementation of protocol amendment 6, subjects with tinnitus following traumatic cochlear injury will only be eligible if they are affected only unilaterally.
* Age >= 18 years and <= 75 years;
* Negative pregnancy test (woman of childbearing potential);
* Willing and able to use adequate hearing protection, respectively to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured;
* Willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
* Fluctuating tinnitus;
* Intermittent tinnitus;
* Tinnitus resulting from traumatic head or neck injury;
* Presence of chronic tinnitus;
* Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss;
* History of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma;
* Ongoing acute or chronic otitis media or otitis externa;
* Other treatment of tinnitus for the study duration;
* Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction;
* Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
* Women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months;
* Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization.
Other protocol-defined exclusion criteria may apply.
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
|
NCT02040194
|
{
"brief_title": "AM-101 in the Treatment of Acute Tinnitus 3",
"conditions": [
"Tinnitus"
],
"interventions": [
"Drug: Placebo",
"Drug: AM-101"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT02040194",
"official_title": "Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-12-28",
"study_completion_date(actual)": "2017-12-28",
"study_start_date(actual)": "2014-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-09-14",
"last_updated_that_met_qc_criteria": "2014-01-17",
"last_verified": "2023-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-01-20",
"first_submitted": "2014-01-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The overall goal of this project is to look at the effects of long-term, sustained sleep restriction (SR) in adults, and assess the effects on mood and cognitive and physical performance.
Detailed Description
Chronic Sleep Restriction (SR) is highly prevalent in today's modern society. Artificial light, portable electronic devices, and 24-h services have allowed individuals to remain active throughout the night, leading to reductions in sleep duration. SSD has been linked to obesity and our laboratory has been interested in establishing whether sleep could be a causal factor in the etiology of obesity. Given the increasing prevalence of obesity over the past 5 decades, coinciding with the marked reduction in sleep duration, further exploration into the role of sleep as a risk factor for obesity could provide additional ammunition in the fight to prevent further increases in the incidence of obesity.
This study will be a randomized, crossover, outpatient SR study with 2 phases of 6 weeks each, with a 6 week wash-out period between the phases. Sleep duration in each phase will be the participant's regular bed- and wake times during the habitual sleep (HS) phase and HS minus 1.5 hours in the SR phase. During the HS phase, participants will be asked to follow a fixed bedtime routine based on their screening sleep schedule. During the SR phase, participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time.
#Intervention
- BEHAVIORAL : Sleep Restriction (SR)
- Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
|
#Eligibility Criteria:
Inclusion Criteria:
* BMI 25 <= age <= 29.9 kg/m2
* Have at least one obese parent
* Habitually sleep 7 <= age <= 9 hours a night
* Free of any current and past sleep and psychiatric disorders, including eating disorders, diabetes or Cardiovascular disease (CVD) (i.e., normal scores on: Pittsburgh Quality of Sleep Questionnaire Epworth Sleepiness Scale, Berlin Questionnaire, Sleep Disorders Inventory Questionnaire, Beck Depression Inventory, Composite Scale of Morningness/Eveningness, Three Factor Eating Questionnaire)
* All racial/ethnic groups
Exclusion Criteria:
* Smokers (any cigarettes or ex-smoker < 3 years)
* Neurological, medical or psychiatric disorder
* Diabetics
* Eating and/or sleep disorders
* Contraindications for MRI scanning
* Travel across time zones within 4 weeks
* History of drug and alcohol abuse
* Shift worker (or rotating shift worker)
* Caffeine intake > 300 mg/d
* Heavy equipment operators
* Commercial long-distance drivers
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02960776
|
{
"brief_title": "Impact of Sleep Restriction on Performance in Adults",
"conditions": [
"Sleep",
"Obesity",
"Sleep Restriction"
],
"interventions": [
"Behavioral: Sleep Restriction (SR)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02960776",
"official_title": "Effect of Long Term Sleep Restriction on Energy Balance",
"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)": "2016-11-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-12-03",
"last_updated_that_met_qc_criteria": "2016-11-08",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-11-10",
"first_submitted": "2016-11-07",
"first_submitted_that_met_qc_criteria": "2024-06-13"
}
}
}
|
#Study Description
Brief Summary
The investigators specific aim is to evaluate the changes in breath ammonia in comparison to blood ammonia and other physiologic markers after a moderate oral protein challenge in healthy subjects and subjects with liver cirrhosis.
Detailed Description
Ammonia is an important molecule relevant to numerous diseases, especially to the millions of patients with cirrhosis worldwide. Venous blood ammonia via limb phlebotomy, can at best roughly estimate whole body ammonia, but says little or nothing about intestinal production, and cannot 'source' ammonia to any particular organ or body compartment. Unfortunately, there are no presently available better tests. Therefore, despite these acknowledged limitations, venous ammonia the 'bronze standard' benchmark by which new metrics are assessed.
The present protocol attempts to address both concerns and build upon the investigators prior high protein experience. By using a standard moderate protein challenge, the investigators can evaluate the breath ammonia responsiveness in healthy subjects and those with cirrhosis. This protocol leverages the power of breath research to evaluate responses to oral challenges. This remains a key asset of breath research.
Since the protocol proposes a moderate protein challenge, the investigators can evaluate disease states with minimal or no risk. As with past high protein studies, lactulose (10gm) will still be added to provoke a hydrogen response.
#Intervention
- DIETARY_SUPPLEMENT : EAS Myoplex Protein Drink + 10gm lactulose
|
#Eligibility Criteria:
Inclusion Criteria:
* <18 and <75 yrs of age
Exclusion Criteria:
* Diabetic, smoker, substance 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:
Yes
|
NCT02650245
|
{
"brief_title": "Breath and Blood Ammonia Response to an Oral Protein Challenge",
"conditions": [
"Cirrhosis"
],
"interventions": [
"Dietary Supplement: EAS Myoplex Protein Drink + 10gm lactulose"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02650245",
"official_title": "Breath and Blood Ammonia Response to an Oral Protein Challenge",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-04",
"study_completion_date(actual)": "2016-04",
"study_start_date(actual)": "2015-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-10-13",
"last_updated_that_met_qc_criteria": "2016-01-06",
"last_verified": "2016-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-01-08",
"first_submitted": "2015-10-15",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
HIV continues to spread among Black men who have sex with men (MSM), but few interventions target high-risk Black men who have sex with men and women (MSMW). Black MSMW with histories of childhood sexual abuse (CSA) may be an especially vulnerable population for: a) high-risk sexual behaviors; b) negative psychological sequelae (e.g., depressive or posttraumatic stress disorder (PTSD) symptoms); and c) neurobiological abnormalities in cardiovascular, neuroendocrine and/or immune systems (e.g., cortisol and norepinephrine), and HIV/AIDS progression. The purpose of this study was to test an HIV risk reduction intervention, guided by the Social Learning Theory, the Ecological Model, and the concept of allostatic load, a composite of the cumulative effects of stress on biological systems including psychoneuroimmunologic markers. The investigators tested the 6-session Enhanced Sexual Health Intervention for Men (ES-HIM) on 88 non-gay identifying HIV-positive Black MSMW with histories of CSA. The outcomes were to reduce high-risk sexual behaviors (i.e., unprotected anal and vaginal sex and number of sex partners) and negative psychological symptoms of depression and PTSD. Links between these outcomes and biomarkers of stress were also explored. Randomization to either the ES-HIM or a health promotion control group occurred with study participants assessed at baseline, post, 3- and 6-months.
Detailed Description
The purpose of this small randomized clinical trial was to develop and test the Enhanced Sexual Health Intervention for Men (ES-HIM), designed for non-gay identifying HIV-positive African American MSMW with histories of childhood sexual abuse (CSA). The investigators compared ES-HIM to an attention matched general Health Promotion intervention (HP) on efficacy in reducing: a) sexual risk behaviors (i.e., unprotected anal and vaginal sex and number of sex partners); b) psychological symptoms of PTSD and depression; and c) a biological composite of primary neurohormonal mediators of the stress response (cortisol and catecholamines). The investigators also explored the intervention effects on neopterin, an indicator of HIV disease progression, as an outcome.
Project Aims
1. To determine the impact of the ES-HIM intervention on HIV sexual risk behaviors among non-gay identifying HIV-positive African American men who have sex with men and women (MSMW) who have histories of childhood sexual abuse (CSA). The investigators hypothesize that compared to the Health Promotion comparison condition, the ES-HIM condition will be more effective in decreasing unprotected anal and vaginal sex (i.e., increase condom use) and number of sexual partners at immediate post-intervention and at 3- and 6-months post-intervention.
2. To determine the impact of the ES-HIM intervention on negative psychological symptoms over time among non-gay identifying HIV-positive African American MSMW who have histories of CSA. The investigators hypothesized that compared to the Health Promotion condition, the ES-HIM condition will be more effective in decreasing depressive and posttraumatic stress symptoms at immediate post-intervention and at 3- and 6-months post-intervention.
In addition to these aims, the investigators also explored associations between HIV sexual risk behaviors (i.e., unprotected anal and vaginal sex), negative psychological symptoms (i.e., depressive \& posttraumatic stress symptoms) and biomarkers of allostatic load over time among ES-HIM participants.
Research Methods
The University of California, Los Angeles (UCLA) ES-HIM Project was a 4-year study conducted from 2007-2011 to develop and test an HIV risk and stress reduction intervention. Institutional Review Board (IRB) approval for the protection of human subjects in research at UCLA and a Certificate of Confidentiality from the National Institutes of Health (NIH) were obtained.
Intervention Procedures
HIV-positive African American MSMW were recruited through fliers posted at participating community-based organizations, as well as through outreach at community events, bars, clubs, and other locations where the target population may be present. Once interested potential participants were screened and deemed eligible, informed consent was obtained. After informed consent, participants were asked to complete a baseline survey, as well as complete locator forms. Upon completion of the baseline survey, participants were randomized into the ES-HIM active intervention group or the Health Promotion control condition. Both the ES-HIM and the Health Promotion included six sessions, with each session lasting two hours; two sessions were administered per week for three consecutive weeks. The primary aims of the ES-HIM intervention were to increase condom use and decrease symptoms of depression and posttraumatic stress. Within these six, 120-minute sessions, active ES-HIM intervention participants had the opportunity to discuss their sexual experiences and issues of masculinity and stigma associated with being African American, HIV-positive, and a non-gay identifying MSMW. The Health Promotion condition focused on improving general health and concentrated on diet, exercise, relaxation/sleep hygiene, and medication adherence. Both the ES-HIM and Health Promotion curricula were delivered by trained Facilitators.
Data Collection
Enrolled participants were administered surveys via Audio-Computer Assisted Self Interview (A-CASI) at four time points: baseline, immediate post-intervention (upon completion of the sixth ES-HIM or Health Promotion session), and at 3- and 6-months post-intervention. Also, participants were asked to provide 12-hour urine collections for biomarkers of stress and a one time urine sample for neopterin at baseline and 3- and 6-months post-intervention. Non-urinary biomarkers, including height and weight (body mass index), heart rate, blood pressure, and waist-to-hip ratio measurements were collected at these same time points. Data collection (i.e., survey administration, urine container drop-off, and non-urinary biomarker measurements) were administered in confidential settings at collaborative community agencies and/or UCLA.
#Intervention
- BEHAVIORAL : Enhanced Sexual Health Intervention for Men (ES-HIM)
- ES-HIM is a six-session intervention for HIV-positive Black bisexual men who have histories of child sexual abuse. Guided by cognitive behavioral approaches and an ecological framework, ES-HIM effects sexual behavior change and psychological health improvement. Sexual risk reduction is framed from the perspective of being a triple minority (i.e., HIV-positive, ethnic and sexual minority). Issues of stigma and social isolation were discussed in regard to these identities. Sexual ownership focusing on individual responsibility for one's health and well-being was prioritized along with caring for sexual partners, family and community. Decisions regarding sexual behaviors and consequences were framed within a culturally congruent social context. Topics included: 1) the influence of gender and ethnicity; (2) early socialization regarding gender and culture, as well as adult experiences; (3) HIV stigma; and (4) recognizing stressors, including histories of personal trauma.
- Other Names :
- ES-HIM
- BEHAVIORAL : Health Promotion (HP) Comparison Arm
- Health Promotion Intervention (HP) is the comparison arm. It is designed to control for the Hawthorne effect and reduce the likelihood that effects of ES-HIM could be attributed to special attention and group interaction. HP addresses health issues, including certain cancers, hypertension, diabetes, and heart disease, all of which are common among African American men, but did not focus on sexual behavior. Participants were taught that these diseases could be prevented by changing personal behaviors (e.g., increasing physical activity and healthy dietary practices, ceasing cigarette smoking and alcohol and drug abuse), or managed with early detection and screening behaviors.
- Other Names :
- HP
|
#Eligibility Criteria:
Inclusion Criteria:
* At least 18 years
* Male
* English speaking
* HIV-positive
* non-gay identifying
* Black/African American
* Sexually active and engaged in unprotected anal and/or vaginal sex with both a male and female partner in the previous 90 days
* Have a history of child sexual abuse
Exclusion Criteria:
* Younger than 18 years
* Female
* Non-English speaking
* HIV-negative or unknown HIV-serostatus
* Race/Ethnicity other than Black / African American
* Not sexually active, uses condoms and/or lacks both male and female partners in past 90 days
* No history of child sexual abuse
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01641146
|
{
"brief_title": "An HIV Intervention for Black Men at Risk - The Enhanced Sexual Health Intervention for Men (ES-HIM)",
"conditions": [
"HIV",
"Depression",
"Posttraumatic Stress Disorder"
],
"interventions": [
"Behavioral: Enhanced Sexual Health Intervention for Men (ES-HIM)",
"Behavioral: Health Promotion (HP) Comparison Arm"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01641146",
"official_title": "An HIV Intervention for Black Men at Risk",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-09",
"study_completion_date(actual)": "2011-05",
"study_start_date(actual)": "2008-12"
},
"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)": "2016-11-28",
"last_updated_that_met_qc_criteria": "2012-07-11",
"last_verified": "2016-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2012-07-16",
"first_submitted": "2012-07-05",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
As part of the clinical routine of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin at Campus Virchow-Klinikum intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children (\<=1 year).
|
#Eligibility Criteria:
Inclusion Criteria:
* Children <= 1 year undergoing surgery procedure
Exclusion Criteria:
* Incomplete patient record documentation
* Pre-existing neurological/psychological conditions
Sex :
ALL
Ages :
- Minimum Age : 1 Month
- Maximum Age : 12 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT04093661
|
{
"brief_title": "Electroencephalogram Dynamics in Children <=1 Year During Anesthetic Procedures",
"conditions": [
"Depth of Anesthesia"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT04093661",
"official_title": "Retrospective Analysis of Intraoperative Electroencephalography Characteristics in Children Under One Year of Age",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-29",
"study_completion_date(actual)": "2019-11-29",
"study_start_date(actual)": "2019-09-16"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-01-18",
"last_updated_that_met_qc_criteria": "2019-09-16",
"last_verified": "2020-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-18",
"first_submitted": "2019-09-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To define the toxicity and maximum-tolerated dose of weekly oral etoposide (VP-16) in patients with AIDS-related Kaposi's sarcoma; to determine the clinical pharmacology of orally administered VP-16 in AIDS patients. A secondary objective is to obtain preliminary data for determining the effect of oral VP-16 on Kaposi's sarcoma.
VP-16 is an antitumor agent. Previous problems with VP-16 include the route of administration and the toxicities. VP-16 has been given intravenously for 3 consecutive days in a 21-day cycle for lung cancer and testicular cancer. VP-16 has also been used in lymphoma therapy. Oral VP-16 would eliminate the need for an intravenous catheter and so a patient could avoid the pain, inconvenience, and potential complications associated with medications administered intravenously. The relative ease of outpatient administration and the potentially significant antitumor activity of oral VP-16 motivates this study. The possibility of weekly drug administration is the other focus of this study.
Detailed Description
VP-16 is an antitumor agent. Previous problems with VP-16 include the route of administration and the toxicities. VP-16 has been given intravenously for 3 consecutive days in a 21-day cycle for lung cancer and testicular cancer. VP-16 has also been used in lymphoma therapy. Oral VP-16 would eliminate the need for an intravenous catheter and so a patient could avoid the pain, inconvenience, and potential complications associated with medications administered intravenously. The relative ease of outpatient administration and the potentially significant antitumor activity of oral VP-16 motivates this study. The possibility of weekly drug administration is the other focus of this study.
Four patients are entered at each dose level starting with level 1. Patients are not entered into the next higher dose level until at least two patients at the previous dose level have completed at least 3 weeks of therapy with grade 2 or less maximum tolerated dose-defining toxicities. Treatment is repeated weekly for 52 weeks until either a grade 3 or 4 toxicity occurs, or until a patient shows a complete response or progressive disease. Patients with a complete response are continued on drug for 4 additional weeks from the time that complete response is first documented. Patients with progressive disease are withdrawn from study. Patients with partial response or stable disease continue until either unacceptable toxicity occurs or a complete response or progression of disease is reached.
#Intervention
- DRUG : Etoposide
|
#Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
AMENDED:
* 04 <= age <= 21-91 Zidovudine (AZT) allowed after completing 8 weeks on the study. Patients on reduced doses of VP-16 must have tolerated at least 4 consecutive weeks at the reduced dose before starting AZT. Zidovudine will not be provided by the NIAID Clinical Product Research Repository.
AMENDED:
* Zidovudine (AZT) allowed after completing 12 weeks on study.
Allowed:
* Aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis (PCP).
Concurrent Treatment:
Allowed:
* Local radiotherapy or laser therapy to cosmetically apparent, non-indicator lesions provided the dose to any one lesion does not exceed 300 rads and the total surface area of all lesions treated does not exceed 10 cm2.
Risk Behavior:
Allowed:
* All risk groups.
Patients must:
* Have AIDS-related Kaposi's sarcoma.
* Be ineligible for protocols of higher priority at study center.
* Be willing to sign an informed consent or have guardian willing to sign.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Active opportunistic infection not specifically allowed.
* Concurrent neoplasm not specifically allowed.
* Significant neurologic, cardiac, or liver disease.
Concurrent Medication:
Excluded:
* Therapy with potentially myelosuppressive, hepatotoxic, or nephrotoxic drugs for an opportunistic infection.
Patients with the following are excluded:
* Active opportunistic infection not specifically allowed.
* Ongoing therapy, including maintenance therapy, for an opportunistic infection with potentially myelosuppressive, hepatotoxic, or nephrotoxic drugs.
* Concurrent neoplasm not specifically allowed.
* Significant neurologic, cardiac, or liver disease.
Prior Medication:
Excluded:
* Biologic response modifiers or corticosteroids within 14 days prior to study entry.
* Cytotoxic chemotherapy within 30 days prior to study entry.
* Ribavirin within 6 weeks prior to study entry.
* Azidothymidine (AZT), alpha-interferon, didanosine (ddI), ganciclovir (DHPG), or any other antiretroviral drugs within 1 week prior to study entry.
Prior Treatment:
Excluded within 30 days prior to study entry:
* Radiation therapy with > 4000 rads.
* Total skin electron beam therapy.
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
|
NCT00000660
|
{
"brief_title": "Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma",
"conditions": [
"Sarcoma, Kaposi",
"HIV Infections"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT00000660",
"official_title": "Phase I Study of Weekly Oral VP-16 for AIDS-Associated Kaposi's Sarcoma",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "1992-07",
"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)": "2021-11-03",
"last_updated_that_met_qc_criteria": "2001-08-30",
"last_verified": "2021-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2001-08-31",
"first_submitted": "1999-11-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients presenting with subacute, less than 6 months of evolution, adhesive capsulitis are randomly attributed to the control or study group. Both groups receive a series of 3 suprascapular nerve blocks under ultrasound guidance with either 5ml saline or 5ml ropivacaine 2mg/ml ( ref) at 1 week interval. Testing consists of glenohumeral range of motion (ROM) (anterior elevation, lateral elevation, external and internal rotation) measured by goniometer, Constant score and visual analog scale (VAS) pain score. Evaluations are done immediately before and one hour after every suprascapular block and at 4 weeks after the third suprascapular block.
All suprascapular nerve blocks are performed by one physician and the evaluations are done by a occupational therapist or MD experienced in glenohumeral function evaluations. All practitioners are blinded to the assigned group.
All patients continue their pre-study treatment of physiotherapy and per os pain medication. Patients keep a record of analgesics and NSAID use during the trial. Drop-out rate is measured.
Detailed Description
Introduction: Adhesive capsulitis is a painful and debilitating condition affecting adult shoulders. Although relatively rare the condition is more common in diabetic patients and effective pain diminishing treatments without the use of corticosteroids are needed.
Methods and Material: Patients presenting with subacute, less than 6 months of evolution, adhesive capsulitis are randomly attributed to the control or study group. Both groups receive a series of 3 successive suprascapular nerve blocks under live ultrasound guidance with either 5ml saline or 5ml ropivacaine 2mg/ml conducted at 1 week interval. Testing consists of glenohumeral ROM (anterior elevation, lateral elevation, external and internal rotation) measured by goniometer, Constant score, VAS pain score. Evaluations are done immediately before and one hour after every 'suprascapular block' and at 4 weeks after the third suprascapular block.
All suprascapular blocks are performed by one physician and the evaluations by either a occupational therapist or MD experienced in glenohumeral function evaluations. All practitioners are blinded to the assigned group.
All patients continue their physiotherapy, consisting of electrotherapy, range of motion, stretching and strengthening exercises and their per os medication. Patients keep record of analgesics and NSAID use during the trial. Drop-out rate is measured during the entire study protocol.
#Intervention
- DRUG : Ropivacaine Monohydrochloride
- Suprascapular nerve block under ultrasound control: injection of 5ml Ropivacaine HCL 2mg /ml
- DRUG : Placebo - Concentrate
- Placebo suprascapular nerve block under ultrasound control: injection of 5ml physiological / isotonic saline
|
#Eligibility Criteria:
Inclusion Criteria:
* subacute adhesive capsulitis: pain evolving for less than 6 months before enrollment
Exclusion Criteria:
* other conditions involving the shoulder ( rheumatoid or septic arthritis, Hill-Sachs lesions,osteoarthritis of the shoulder, or malignancies in the shoulder region);
* neurologic deficits affecting shoulder function in normal daily activities (such as history of stroke, multiple sclerosis, parkinson disease...)
* shoulder pain caused by cervical radiculopathy
* a history of drug allergy to ropivacaïne
* pregnancy or lactation
* cognitive impairment with inability to fill out a protocol
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
|
NCT02944526
|
{
"brief_title": "The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial",
"conditions": [
"Adhesive Capsulitis",
"Frozen Shoulder",
"Nerve Block"
],
"interventions": [
"Drug: Placebo - Concentrate",
"Drug: Ropivacaine Monohydrochloride"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT02944526",
"official_title": "The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-09-16",
"study_completion_date(actual)": "2020-09-30",
"study_start_date(actual)": "2016-11"
},
"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)": "2020-10-27",
"last_updated_that_met_qc_criteria": "2016-10-24",
"last_verified": "2020-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-10-26",
"first_submitted": "2016-10-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The overall goal of this study is to determine the feasibility of initiating hypothermia in cardiac arrest patients as soon as possible in the field. In this pilot study we will randomize 125 patients after return of spontaneous circulation (ROSC) to hypothermia with rapid infusion of 2 liters of 4oC Normal Saline IV solution over 20 to 30 minutes, IV sedation and muscle paralysis or to standard of care following ROSC. The primary objectives of this study will be to determine whether temperature of 33-34oC can be achieved and maintained using this strategy. The primary outcome measures will include: temperature changes of the patients at time of admission to the hospital. Secondary analysis will include determining if the proportion of patients discharged from the hospital is increased in the group receiving hypothermia. If this initial pilot study can demonstrate feasibility in achieving and maintaining hypothermia, a larger randomized clinical trial to test the hypothesis that hypothermia initiation in the field will increase the proportion of patients surviving following cardiac arrest will be planned.
#Intervention
- DRUG : Up to 2 liter infusion of cold 4 degree C normal saline
- Patients randomized to field cooling will receive up to 2 liters of 4oC normal saline. Control patients will receive standard of care following resuscitation.
|
#Eligibility Criteria:
Inclusion Criteria:
* Resuscitated out-of-hospital cardiac arrest defined as having a palpable pulse comatose IV access Intubated
Exclusion Criteria:
* age less than 18 traumatic cause of cardiac arrest
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
|
NCT00329563
|
{
"brief_title": "Pilot Community Clinical Study of Hypothermia in Cardiac Arrest",
"conditions": [
"Cardiac Arrest"
],
"interventions": [
"Drug: Up to 2 liter infusion of cold 4 degree C normal saline"
],
"location_countries": null,
"nct_id": "NCT00329563",
"official_title": "Pilot Community Clinical Study of Hypothermia in Cardiac Arrest",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2006-03",
"study_start_date(actual)": "2004-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-04-17",
"last_updated_that_met_qc_criteria": "2006-05-22",
"last_verified": "2017-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-05-24",
"first_submitted": "2006-05-22",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Sjogren's syndrome is an autoimmune chronic disease. It has two forms Primary Sjogren's syndrome charactrized by dry eyes and dry mouth. Secondary Sjogren's syndrome characterized by rheumatoid diseases as rheumatoid arthritis, scleroderma and lupus erythematosus. SS patients are most liable to oral candidiasis , so they need prophylaxis aganist oral candidiasis. Probiotic bacteria are live microorganisms that when administered in adequate amounts confer benefits to health.Probiotics are commonly used as a prophylaxis aganist oral candidosis.
#Intervention
- DRUG : Probiotic Product - Cap
- probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus
|
#Eligibility Criteria:
Inclusion Criteria:
* primary or scondary Sjogren's syndrome
Exclusion Criteria:
* allergy to milk derivatives previous intake of antifungals
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT03840538
|
{
"brief_title": "Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome",
"conditions": [
"Sjogren's Syndrome"
],
"interventions": [
"Drug: Probiotic Product - Cap"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT03840538",
"official_title": "Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-01",
"study_completion_date(actual)": "2019-01-01",
"study_start_date(actual)": "2018-01-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-02-15",
"last_updated_that_met_qc_criteria": "2019-02-13",
"last_verified": "2019-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-02-15",
"first_submitted": "2019-02-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Multicenter, prospective, phase 3 randomized non-blinded interventional trial of fluid treatment strategies in the first 24 hours for patients with sepsis-induced hypotension. The aim of the study is to determine the impact of a restrictive fluids strategy (vasopressors first followed by rescue fluids) as compared to a liberal fluid strategy (fluids first followed by rescue vasopressors) on 90-day in-hospital mortality in patients with sepsis-induced hypotension.
Detailed Description
Primary Hypothesis: Restrictive (vs liberal) fluid treatment strategy during the first 24 hours of resuscitation for sepsis-induced hypotension will reduce 90-day in-hospital mortality.
1. We will emphasize early screening and protocol initiation, and enroll a maximum of 2320 patients with suspected sepsis-induced hypotension.
* All patients will receive at least 1 liter of fluids prior to meeting study inclusion criteria (and no more than 3 liters prior to randomization).
* Patients will be enrolled within 4 hours of meeting study inclusion criteria
* Any type of isotonic crystalloid (normal saline, ringers lactate, or a balanced solution such as plasmalyte) is permitted.
2. Restrictive Fluids (Early Vasopressors) Group
* Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg
* 'Rescue fluids' may be administered as 500ml boluses if predefined rescue criteria are met
3. Liberal Fluids (Fluids First)
* 2 liter infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter).
* Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop
* 'Rescue vasopressors' may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met
#Intervention
- DRUG : Early Vasopressors
- Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. 'Rescue fluids' may be administered as 500ml boluses if predefined rescue criteria are met.
- Other Names :
- Norepinephrine
- OTHER : Early Fluids
- Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. 'Rescue vasopressors' may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted.
- Other Names :
- Balanced crystalloid solution
|
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years
* A suspected or confirmed infection (broadly defined by administration or planned administration of antibiotics)
* Sepsis-induced hypotension defined as systolic blood pressure < 100 mmHg or MAP < 65 mmHg after a minimum of at least 1 liter of fluid (*Fluids inclusive of pre-hospital fluids; blood pressure must be below any known or reported pre-morbid baseline).
Exclusion Criteria:
* More than 4 hours elapsed since meeting inclusion criteria or 24 hours elapsed since admission to the hospital
* Patient already received 3 liters of intravenous fluid (includes prehospital volumes)
* Unable to obtain informed consent
* Known pregnancy
* Hypotension suspected to be due to non-sepsis cause (e.g. hemorrhagic shock)
* Blood pressure is at known or reported baseline level
* Severe Volume Depletion from an acute condition other than sepsis. In the judgment of the treating physician, the patient has an acute condition other than sepsis causing (or indicative) of *severe volume depletion; Examples include: Diabetic ketoacidosis, high volume vomiting or diarrhea, hyperosmolar hyperglycemic state, and nonexertional hyperthermia (heat stroke); severe is defined by the need for substantial intravenous fluid administration as part of routine clinical care
* Pulmonary edema or clinical signs of new fluid overload (e.g. bilateral crackles, new oxygen requirement, new peripheral edema, fluid overload on chest x-ray)
* Treating physician unwilling to give additional fluids as directed by the liberal protocol
* Treating physician unwilling to use vasopressors as directed by the restrictive protocol.
* Current or imminent decision to withhold most/all life-sustaining treatment; this does not exclude those patients committed to full support except cardiopulmonary resuscitation
* Immediate surgical intervention planned such that study procedures could not be followed
* Prior enrollment 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
|
NCT03434028
|
{
"brief_title": "Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis",
"conditions": [
"Septic Shock"
],
"interventions": [
"Other: Early Fluids",
"Drug: Early Vasopressors"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03434028",
"official_title": "Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-10",
"study_completion_date(actual)": "2022-08-24",
"study_start_date(actual)": "2018-03-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-07-06",
"last_updated_that_met_qc_criteria": "2018-02-09",
"last_verified": "2023-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-02-15",
"first_submitted": "2018-02-09",
"first_submitted_that_met_qc_criteria": "2023-06-15"
}
}
}
|
#Study Description
Brief Summary
The objective of the study was to determine the efficacy and tolerability of 20 mg of Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis.
#Intervention
- DRUG : Bilastine
- 20 mg (encapsulated) tablets QD/14 days
- DRUG : Desloratadine
- 5 mg (encapsulated) tablets QD/14 days
- Other Names :
- Aerius
- DRUG : Placebo
- (encapsulated) Tablets QD/14 days
|
#Eligibility Criteria:
Inclusion Criteria:
* The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering.
* Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination..
Exclusion Criteria:
* Patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed.
* Patients were not allowed to take forbidden medications or not comply the study requirements.
* Patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded.
* Pregnant or breast-feeding women were also excluded.
* Women of childbearing potential had a pregnancy test done
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT01400828
|
{
"brief_title": "Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis",
"conditions": [
"Seasonal Allergic Rhinitis"
],
"interventions": [
"Drug: Placebo",
"Drug: Bilastine",
"Drug: Desloratadine"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT01400828",
"official_title": "Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg After 14-day Oral Administration in Patients With Seasonal Allergic Rhinitis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-06",
"study_completion_date(actual)": "2014-05",
"study_start_date(actual)": "2011-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-07-10",
"last_updated_that_met_qc_criteria": "2011-07-21",
"last_verified": "2014-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-07-22",
"first_submitted": "2011-07-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The primary objective of this study is to compare the incidence of side effects of buccal and sublingual misoprostol when combined with mifepristone for medical abortions of less than 9 weeks gestation. The secondary outcome is to compare the complete abortion rate and induction-abortion interval between the two methods of administration of misoprostol.
Detailed Description
After mifepristone was approved by the United States Food and Drug Administration in 2000, the combination of mifepristone 200 mg and vaginal use of misoprostol 800 mcg became almost a standard of care in early medical abortion up to 63 days of gestation. When combined with mifepristone for medical abortion in the first trimester, vaginal administration of misoprostol is more effective, faster, and has a lower rate of ongoing pregnancy, and fewer gastrointestinal side effects than oral misoprostol.
Although misoprostol is more effective when given vaginally, most women prefer the oral route because this can avoid the uncomfortable vaginal examination and provide more privacy during medical induction. Another concern about vaginal administration is the potential risk of infection. In late March 2006, analyses of serious uterine infections following medical abortions by a regimen of oral mifepristone followed by vaginal misoprostol led Planned Parenthood Federation of America health centres to change the route of misoprostol administration. Given these concerns, alternative administration via sublingual (holding pills under the tongue) and buccal (holding pills in the cheek) routes have been investigated, as the misoprostol is absorbed directly and avoids the gastrointestinal system similar to vaginal administration.
A pharmacokinetic study showed that sublingual administration of misoprostol resulted in the greatest bioavailability when compared with oral or vaginal administration. In a randomized, cross-over pharmacokinetic study of 10 women by Schaff and colleagues of sublingual versus buccal misoprostol 800 mcg, the mean misoprostol plasma concentration-time curves at 4 hours and the maximum concentration were significantly higher for sublingual administration than the buccal route. However, buccal misoprostol administration resulted in fewer symptoms and was found to be more acceptable by women.
Buccal misoprostol 800 mcg after mifepristone 200 mg for terminating pregnancy through 63 days of gestation has a higher success rate and less ongoing pregnancy when compared with oral misoprostol, especially in pregnancies of 57-63 days. Adverse effect profiles were similar, although fever and chills were reported approximately 10% more often among women who took buccal misoprostol. When used for abortion through 56 days of gestation, buccal administration of misoprostol after mifepristone appears to be a highly effective and acceptable alternative compared with vaginal administration, and with similar adverse effects profile.
Medical abortions of less than 9 weeks gestation using sublingual misoprostol 800 mcg after mifepristone 200 mg has achieved complete abortion rate of 98.2% but is associated with more gastrointestinal side effects, fever, and chills when compared with vaginal route.
Both buccal and sublingual administration of misoprostol following mifepristone have been shown to be effective in inducing first trimester medical abortions, but with different side effects profile. No clinical trials have been conducted comparing buccal and sublingual administration of misoprostol in first trimester medical abortion. The purpose of the present study is to compare the incidence of side effects of buccal and sublingual misoprostol when combined with mifepristone.
#Intervention
- DRUG : Misoprostol
- sublingual 800mcg misoprostol 48 hours after oral 200mg mifepristone
- DRUG : Misoprostol
- buccal misoprostol 800mcg 48 hours after oral 200mg mifepristone
|
#Eligibility Criteria:
Inclusion Criteria:
* good general health
* older than the age of legal consent (i.e. >18 years)
* requesting medical abortion and eligible for abortion
* on Day 1 of the study (day of mifepristone administration) the duration of pregnancy not more than 63 days as confirmed by pelvic ultrasound examination
* intrauterine pregnancy (intrauterine amniotic sac seen in US)
* willing to use other than hormonal or intra-uterine contraception until the first menses after termination of pregnancy
* if treatment fails she agrees to termination of pregnancy with the surgical method
* willing and able to participate after the study has been explained
* haemoglobin higher than 10g/L
Exclusion Criteria:
* a history or evidence of adrenal pathology, steroid-dependent cancer, porphyria, diastolic pressure over 95mm Hg, bronchial asthma, arterial hypotension.
* a history or evidence of thrombo-embolism, severe or recurrent liver disease or pruritus of pregnancy
* the regular use of prescription drugs before admission to the study
* the presence of an IUCD in utero
* breast-feeding
* multiple pregnancies
* heavy smokers
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
|
NCT01156688
|
{
"brief_title": "A Prospective Randomized Comparison Trial on the Use of Mifepristone With Sublingual or Buccal Misoprostol for Medical Abortions of Less Than 9 Weeks Gestation",
"conditions": [
"Abortion, Legal"
],
"interventions": [
"Drug: Misoprostol"
],
"location_countries": [
"Hong Kong"
],
"nct_id": "NCT01156688",
"official_title": "A Prospective Randomized Comparison Trial on the Use of Mifepristone With Sublingual or Buccal Misoprostol for Medical Abortions of Less Than 9 Weeks Gestation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-08",
"study_completion_date(actual)": "2011-08",
"study_start_date(actual)": "2010-08"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2011-08-05",
"last_updated_that_met_qc_criteria": "2010-07-01",
"last_verified": "2011-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-07-05",
"first_submitted": "2010-06-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
To evaluate change in coagulation tests during a 48-h period after initiation VV-ECMO and VA-ECMO.
(ECMO= Extra Corporeal Membrane Oxygenator) Assessment of bleeding during Veno-Venous Extracoporeal Membrane Oxygenator (VV-ECMO) and Veno-Arterial Extracoporeal Membrane Oxygenator (VA-ECMO).
Detailed Description
This is a multi-center, prospective, pilot cohort study, performed in the Intensive Care Units (ICUs) of the Ghent University Hospital, CHU Liège, University Hospital Brussels, and University Hospital Munster.
Each group will contain 20 subjects; in total there will be 40 subjects 2 groups of 20 patients GROUP 1: VV-ECMO n = 20 GROUP 2: VA-ECMO n = 20
* Demographics: age, sex, comorbidities, medication, reason for ECMO therapy
* Simplified Acute Physiology Score (SAPS) 3 at time of ICU admission.
* Components of the Sequential Organ Failure Assessment score daily (based on worst value of each component of the score)
* ECMO characteristics (place of cannulation, type of cannulas, oxygenator, bloodflow, gasflow and pressure registrations)
* Incidence and severity of bleeding, scored according to the GUSTO and BARC scores
* Coagulation profile: At inclusion (before heparine infusion is started), 2h after start of therapy, 24h, and 48h, and at specific moments of clinical suspicion of profound altered hemostasis. We defined a coagulation profile as a set of tests that includes
* prothrombin time (PT), international normalized ratio (INR)
* activated partial thromboplastin time (aPTT) and heparin ratio
* the fibrinogen level
* platelets
* ACT (iACT®, ...)
* D-dimer
* ROTEM (extem, intem, heptem) or TEG (Utrecht)
* AT III
* anti Xa
* Temperature daily (H/L) (core)
* Patient characteristics that may influence coagulation or the results of coagulation tests: body weight, Body Mass Index, drugs, C-reactive protein (as a marker for inflammation), Hemoglobin level, LDH, unconjugated bilirubin, (or haptoglobine or plasma free haemoglobin, if tested)
* Heparin dose
#Intervention
- DIAGNOSTIC_TEST : Standard coagulation profile
- prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount
- DIAGNOSTIC_TEST : Specific coagulation tests
- AT III, anti Xa, ACT, ROTEM
- OTHER : Bleeding Scores
- Global Utilization of Streptokinase and Tpa for Occluded arteries definition of bleeding (GUSTO) AND Bleeding Academic Research Consortium Definition for Bleeding (BARC)
|
#Eligibility Criteria:
Inclusion Criteria:
* GROUP 1: patients who will be initiated on VV-ECMO within a 12-h period
* GROUP 2: patients who will be initiated on VA-ECMO within a 12-h period
* >= 18 years
* Signed Informed Consent, signed by subject or authorized representative
Exclusion criteria:
Expected survival <48-h Known coagulopathy Pregnancy
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
|
NCT04912336
|
{
"brief_title": "Extracorporeal Life Support and Modification of Hemostasis",
"conditions": [
"Bleeding Disorder",
"Extra Corporeal Life Support",
"Thrombosis"
],
"interventions": [
"Diagnostic Test: Specific coagulation tests",
"Diagnostic Test: Standard coagulation profile",
"Other: Bleeding Scores"
],
"location_countries": [
"Germany",
"Belgium"
],
"nct_id": "NCT04912336",
"official_title": "Extra Corporeal Life Support and Modification of Hemostasis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-01-16",
"study_completion_date(actual)": "2024-04-30",
"study_start_date(actual)": "2021-05-28"
},
"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)": "2024-07-30",
"last_updated_that_met_qc_criteria": "2021-06-02",
"last_verified": "2024-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-06-03",
"first_submitted": "2021-05-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients undergoing allogeneic blood and marrow transplantation (HSCT) experience a prolonged period of dysfunctional immunity. Systematic reimmunization is necessary at appropriate time intervals following transplantation to re-establish immunity. Vaccination practices after HSCT remain varied and data sparse. Tick-borne encephalitis (TBE) is one of the most severe infections of the central nervous system caused by a tick-borne flavivirus. There is no specific treatment, and prevention with the vaccine is the only intervention available. To assess the efficacy of TBE vaccination in adult allogeneic HSCT recipients compared to an age-matched and sex-matched control group of healthy volunteers without previous TBE vaccination, a prospective open-label phase II pilot study on humoral and cellular immune responses after use of TBE vaccine (FSME Immun) will be performed. As primary end point the outcome of the neutralization test (NT) against TBE will be assessed in a total of 26 HSCT patients one year after HSCT and in 26 healthy volunteers, namely four weeks after the second vaccination. Therefore, the number of subjects with NT titres against TBE virus \>10, assumed to be the threshold for antibody-mediated protection will be evaluated. As secondary endpoints, antibody concentrations of TBE enzyme-linked immunosorbent assay before and four weeks after the second and third vaccination and antibody concentrations of NT against TBE four weeks after primary immunization. To evaluate cellular immune responses, lymphocyte proliferations assays and cytokine detection assays will be performed. In a subgroup analysis, these secondary endpoints will be compared between healthy volunteers, HSCT patients without immunosuppressive treatment and HSCT patients receiving immunosuppressive agents. Additionally, immune reconstitution by analysis of peripheral blood lymphocyte subsets and serum immunoglobulin levels will be evaluated prior to vaccination, after twelve weeks and prior to the third vaccination in HSCT patients only.
#Intervention
- BIOLOGICAL : TBE virus vaccine
- TBE virus vaccine FSME Immun is used in both arms for the study population and the control group
- Other Names :
- FSME Immun
|
#Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects will be eligible for participation in this study if they:
* Are >=18 years on the day of screening
* Had undergone an allogeneic HSCT 11 to 13 months ago (study population)
* Are clinical healthy without previous TBE vaccination (control group)
* Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
* If female and capable of bearing children - have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study
Exclusion Criteria:
* Subjects will be excluded from participation in this study if they:
* Have received a TBE vaccination following HSCT
* Suffer from extremely severe acute graft-versus host disease and therefore receive prednisone >0.5 mg/kg bodyweight as part of a combination therapy or a three agent immunosuppressive treatment (because in these HSCT patients any type of vaccination has to be postponed until immunosuppression is reduced to a double combination or prednisone <0.5 mg/kg bodyweight)
* Suffer from or have a history of previous TBE virus infection or vaccination, previous dengue virus infection or vaccination against yellow fever or Japanese encephalitis
* Have any acute febrile illness in the 2 weeks prior to or at the time of enrolment
* Have a history of severe allergic reactions or anaphylaxis after vaccination
* If female, are pregnant or lactating.
* If belonging to the healthy control group, are immunosuppressed (suffer from or have a history of immune mediated diseases, long-term use of corticosteroids, hemodialysis, chronic renal insufficiency, liver cirrhosis Child-Pugh class C, hematooncological malignant disease, solid organ transplant, HSCT)
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
|
NCT01991067
|
{
"brief_title": "Humoral and Cellular Immunity for TBE Vaccination in Allogeneic HSCT Recipients",
"conditions": [
"Tick Borne Encephalitis"
],
"interventions": [
"Biological: TBE virus vaccine"
],
"location_countries": [
"Austria"
],
"nct_id": "NCT01991067",
"official_title": "Characterization of Humoral and Cellular Immunity for Tick-borne Encephalitis (TBE) Vaccination in Allogeneic Blood and Marrow Graft Recipients: a Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-10-28",
"study_completion_date(actual)": "2018-10-28",
"study_start_date(actual)": "2014-07"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-02-03",
"last_updated_that_met_qc_criteria": "2013-11-17",
"last_verified": "2022-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-11-25",
"first_submitted": "2013-11-06",
"first_submitted_that_met_qc_criteria": "2020-06-26"
}
}
}
|
#Study Description
Brief Summary
Salvia hispanic (Salba) is postulated to increase satiety. This study determines the optimal amount of Salba as well as whether liquid or solid enriched products will produce maximum satiety. The results can gauge the effectiveness of Salba in weight loss programs. The study has a randomized, double-blind crossover design which includes 10 test meals and capillary blood sampling to perform glucose and insulin analyses (to determine blood glucose response and blood insulin response).
Detailed Description
There are many factors that are involved in the ability of foods to suppress appetite, for instance the fiber, fat and protein contents of the food. The novel whole grain Salvia hispanica may significantly lower appetite compared to refined carbohydrates and other whole grains because of its composition. First, Salvia hispanica's high fiber content may help lower postprandial glycemia. Whole grains are much higher in fiber than refined carbohydrates. High fiber foods are thought to be more satiating because they have lower energy densities and delay gastric emptying, causing glucose to be released more slowly into the circulation. This, in turn, is hypothesized to increase satiety by preventing a sudden drop in blood glucose levels, which would normally trigger hunger . Another mechanism by which fiber may promote satiety, independent of glycemic responses, is through the secretion of gut hormones that signal fullness . Furthermore, Salvia hispanica may be more satiating than other whole grains due to its higher fat and protein contents. Protein and fat also prolong satiety due to mechanisms such as delayed gastric emptying and secretion of gut hormones .
Results from preliminary studies confirm the satiating effects of Salvia hispanica, as they demonstrate that this grain induces increased subjective satiety and reduced postprandial glycemia. It is presumed that if a food is satiating, it will decrease subsequent intake of other foods because hunger is suppressed. A lower caloric intake, in turn, would help promote weight loss.
Salvia hispanica may also encourage weight loss via another mechanism. Preliminary studies suggested that this grain has a lower glycemic index value than white flour. Consumption of low-GI foods compared to high-GI foods has been suggested to reduce obesity by discouraging fat deposition and promoting fat oxidation . Thus, Salvia hispanica could potentially promote weight loss by reducing both hunger and the amount of body fat stored.
In order to study Salvia hispanica's ability to promote weight loss, feasibility studies must first be done to determine what amount is optimal for satiety and also whether enriched products are most satiating in liquid or solid form.
#Intervention
- DIETARY_SUPPLEMENT : White Bread
- About 100g of white bread consisting of 50g of available carbohydrates, served with 250mL water
- DIETARY_SUPPLEMENT : White bread with added 7.32g Salvia hispanica
- About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water
- DIETARY_SUPPLEMENT : White bread with added 15.58g Salvia hispanica
- About 100g of white bread consisting of 50g of available carbohydrates and 7.32g Salvia hispanica, served with 250mL water
- DIETARY_SUPPLEMENT : White bread with added Salvia hispanica
- About 100g of white bread consisting of 50g of available carbohydrates and 24g Salvia hispanica, served with 250mL water
- DIETARY_SUPPLEMENT : Rice milk
- Rice milk containing 50g of available carbohydrates
- DIETARY_SUPPLEMENT : Enriched rice milk containing 7.32g Salvia hispanica
- Rice milk containing 50g of available carbohydrates with 7.32g added Salvia hispanica
- DIETARY_SUPPLEMENT : Enriched rice milk containing 15.58g Salvia hispanica
- Rice milk containing 50g of available carbohydrates with 15.58g added Salvia hispanica
- DIETARY_SUPPLEMENT : Enriched rice milk containing 24g Salvia hispanica
- Rice milk containing 50g of available carbohydrates with 24g added Salvia hispanica
|
#Eligibility Criteria:
Inclusion Criteria:
* BMI 20 <= age <= 35 kg/m2
Exclusion Criteria:
* Endocrine disease (adrenal disorders, glucose homeostasis disorders, metabolic bone diseases, pituitary gland disorders, parathyroid gland disorders, thyroid disorders)
* Pregnancy
* Use of drugs that influence carbohydrate metabolism (e.g. systemic glucocorticoids, beta blockers, thiazide diuretics)
* Use of fiber supplements
* Substance abuse (including regular smoking)
* Digestive or malabsorption disorders (malabsorption syndrome, Crohn's disease, stomach ulcer, duodenal ulcer or intestinal parasites)
* Presence of any significant disease or condition, including emotional or psychiatric disorders, that, in the opinion of the investigator, is likely to alter the metabolic state or interfere with the subject's ability to complete the study
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
|
NCT00728065
|
{
"brief_title": "The Effects of Salvia Hispanica-Enriched Foods on Glycemic and Insulinemic Responses and Subjective Satiety",
"conditions": [
"Post Prandial Blood Glucose"
],
"interventions": [
"Dietary Supplement: Enriched rice milk containing 24g Salvia hispanica",
"Dietary Supplement: White bread with added Salvia hispanica",
"Dietary Supplement: White bread with added 7.32g Salvia hispanica",
"Dietary Supplement: Enriched rice milk containing 15.58g Salvia hispanica",
"Dietary Supplement: White bread with added 15.58g Salvia hispanica",
"Dietary Supplement: White Bread",
"Dietary Supplement: Enriched rice milk containing 7.32g Salvia hispanica",
"Dietary Supplement: Rice milk"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT00728065",
"official_title": "The Effects of Salvia Hispanica-Enriched Foods on Glycemic and Insulinemic Responses and Subjective Satiety",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-09",
"study_completion_date(actual)": "2009-02",
"study_start_date(actual)": "2007-12"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2009-02-18",
"last_updated_that_met_qc_criteria": "2008-08-04",
"last_verified": "2009-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-08-05",
"first_submitted": "2008-08-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The hypothesis of this study is that a chronic program of physical strength
training, associates to effects of low level laser therapy (LLLT) can,
possibly, provide changes in genic expression of muscle and to promote an
enhancement of anaerobic muscle performance in humans.
#Intervention
- DEVICE : Photon stimulation by low level laser therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* healthy young male volunteers;
* non-athletic physical activity;
* Body Mass Index (BMI) under 26;
* no prescription medicine or dietary supplement use (such as muscle mass builders.
Exclusion Criteria:
* metabolic disease;
* joint, bone and muscles of lower limbs with any disease
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 28 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01113021
|
{
"brief_title": "Study of Effects of Low Level Laser Therapy in the Physical Training and the Muscle Responses in Humans.",
"conditions": [
"Healthy Young Male Volunteers",
"Non Athletes",
"Free of Metabolic Disease",
"Joint, Bone and Muscles of Lower Limbs Free of Any Disease"
],
"interventions": [
"Device: Photon stimulation by low level laser therapy"
],
"location_countries": [
"Brazil"
],
"nct_id": "NCT01113021",
"official_title": "Phase 1. Muscle Genic Expression Under Strength Training and Photostimulated by Laser.",
"recruitment_information": null,
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-04-29",
"last_updated_that_met_qc_criteria": "2010-04-28",
"last_verified": "2008-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-04-29",
"first_submitted": "2010-04-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This clinical trial studies spiritual care in improving quality of life of patients, caregivers, and hospital staff. Spiritual care may help understand the impact cancer and its treatment has on patients, caregivers and hospital staff.
Detailed Description
OBJECTIVES:
I. To improve the quality of spiritual care provided by palliative care teams. II. To measure the effectiveness of integrating spiritual care recommendations in palliative care at City of Hope (COH) and the impact it has on cancer patients, families, and hospital staff.
OUTLINE:
The expanded psychosocial/spiritual assessment administered by social workers includes a spiritual history and a spiritual needs screening. Social worker knowledge and competence is surveyed at baseline, immediately after the course, and after a bedside chaplain-mentoring process. Inpatient cancer patients' and their caregivers' perceptions about spiritual care is surveyed at baseline prior to the social work curriculum and after the course has been completed and the new psychosocial/spiritual assessment has been implemented. Data collected from patients, family members, and staff includes number of unduplicated palliative care patients screened for spiritual concerns, spiritual history, number and type of spiritual issues, number of referrals to the chaplain, number seen by the chaplain, number of unduplicated palliative care patients with documented spiritual care plan, number of staff development sessions offered and topics, attendance per topic, advance directives, and referrals to hospice.
#Intervention
- PROCEDURE : spiritual therapy
- Undergo palliative spiritual care
- Other Names :
- spirituality
- OTHER : questionnaire administration
- Ancillary studies
- OTHER : survey administration
- Ancillary studies
- OTHER : counseling intervention
- Undergo palliative spiritual care
- Other Names :
- counseling and communications studies
- OTHER : psychosocial support for caregiver
- Undergo palliative spiritual care
- PROCEDURE : psychosocial assessment and care
- Undergo palliative spiritual care
- Other Names :
- psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment, psychosocial studies
|
#Eligibility Criteria:
Inclusion Criteria:
* Admitted during the study quarter
* Admitted >= 5 days
* English speaking
* Alert and able to answer questions
Exclusion Criteria:
* Non-cancer diagnosis
* Previously accrued to 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:
Yes
|
NCT01432431
|
{
"brief_title": "Spiritual Care in Improving Quality of Life of Patients, Caregivers, and Hospital Staff",
"conditions": [
"Malignant Neoplasm"
],
"interventions": [
"Procedure: psychosocial assessment and care",
"Other: counseling intervention",
"Procedure: spiritual therapy",
"Other: questionnaire administration",
"Other: survey administration",
"Other: psychosocial support for caregiver"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01432431",
"official_title": "Archstone Spiritual Care Demonstration Project: Outcomes for Patients, Families, and Staff",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-09",
"study_completion_date(actual)": "2013-09",
"study_start_date(actual)": "2011-10"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-09-05",
"last_updated_that_met_qc_criteria": "2011-09-09",
"last_verified": "2013-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-09-13",
"first_submitted": "2011-09-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Understanding the neural and biological mechanisms by which reproductive hormones influence mood is critically important for public health given that postpartum depression (PPD) is the leading cause of morbidity and mortality associated with childbirth and has negative effects on infants. Using a hormone-withdrawal challenge to precipitate mood symptoms will improve our ability to identify the biological mechanisms underlying both the triggering of and susceptibility to depressive disorders in women; and will permit the prediction of those at risk for PPD and other reproductive-related mood disorders.
Detailed Description
Affective disorders, such as PPD and other reproductive-related mood disorders, are common and constitute a significant burden for women, children, and society. However, little is known about the neurobiological mechanisms underlying depressive disorders in women. The long-term goal of this research is to 1) advance our understanding of the biological mechanisms underlying both the triggering of and susceptibility to depressive disorders in women; and 2) permit the prediction of those at risk for PPD. The objective of the current project is to examine whether those with a past episode of PPD (at 'high risk' for recurrence) show differences in emotional arousal and reward processing domains relative to healthy control women (without a history of PPD) under baseline and hormone withdrawal-precipitated conditions. The central hypothesis is that reproductive hormone changes are associated with dysregulation of the neural circuits underlying emotional arousal and reward processing and consequent depressive symptoms in high-risk women. The rationale for the proposed study is that employing a scaled down model of puerperal hormonal events in high-risk women permits the identification of a group of individuals homogeneous for reproductive related affective dysfunction and, hence, the best opportunity for disentangling the specific changes in brain function due to reproductive hormones from those accompanying reproductive hormone-precipitated affective dysfunction. Moreover, identifying a neurophysiologic biomarker for hormone-related affective dysfunction provides a clear pathway for examining mechanisms of susceptibility to affective dysfunction across disorders. The investigators plan to accomplish the objectives of this application by pursuing the following specific aims: 1) to assess the effects of simulated postpartum reproductive hormone withdrawal, compared to baseline, on corticolimbic circuit activation in high-risk and control women; and 2) to examine the effects of reproductive hormone withdrawal, compared to baseline, on reward circuit activation in high-risk and control women. An additional exploratory aim is to identify a neural biomarker, characterized by corticolimbic and reward circuit dysfunction, that can be used to predict the onset of PPD. The proposed study involves experimentally manipulating reproductive hormones in euthymic women to create a scaled down version of the changes that occur at the puerperium. This endocrine manipulation paradigm will be used to examine the neurocircuitry underlying the regulation of affect and reward processing under baseline and hormone withdrawal-precipitated conditions among women who are expected to experience hormone-related affective dysregulation (n=15) and controls (n=15). In short, the investigators expect that relative to baseline, high-risk women will show greater dysregulation in neural circuits responsible for emotion processing and reward processing during hormone withdrawal than low-risk control women. The expected outcome of this research is the identification of neural circuits underlying both the susceptibility to and mediation of hormone-related affective dysfunction. Understanding these neurobiological mechanisms will subsequently improve the ability to identify those at risk for PPD, which may strengthen prevention efforts and ultimately prevent the deleterious effects of maternal depression on offspring.
#Intervention
- DRUG : Leuprolide Acetate
- All subjects will receive one IM injection (3.75 mg) each month for four months.
- Other Names :
- Lupron
- DRUG : Micronized estradiol
- All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.
- Other Names :
- Estrace
- DRUG : Progesterone
- All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day.
- Other Names :
- Micronized progesterone
|
#Eligibility Criteria:
Inclusion Criteria:
Group 1: Women with a history of PPD
* A history of a major depression episode that occurred within two months of childbirth (as determined by a SCID interview) and remitted at least one year prior to enrollment in the study;
* has been well for a minimum of one year;
* a regular menstrual cycle for at least three months;
* age 22 <= age <= 50;
* not pregnant, not lactating and in good medical health;
* medication free (not including birth control pills; participants may opt to temporarily discontinue birth control pills to participate);
* no history of puerperal suicide attempts or psychotic episodes requiring hospitalization.
Group 2: Healthy Controls
1) Controls will meet all inclusion criteria specified above except they must not have any past or present Axis I diagnosis or evidence of menstrually related mood disorders.
A structured clinical interview (SCID) will be administered to all women prior to study entry. Any woman with a current axis I psychiatric diagnosis will be excluded from participating in this protocol.
Exclusion Criteria:
Patients will not be permitted to enter this protocol if they have important clinical or laboratory abnormalities including any of the following:
* current axis I psychiatric diagnosis
* endometriosis;
* undiagnosed enlargement of the ovaries;
* liver disease;
* breast cancer;
* a history of blood clots in the legs or lungs;
* undiagnosed vaginal bleeding;
* porphyria;
* diabetes mellitus;
* malignant melanoma;
* gallbladder or pancreatic disease;
* heart or kidney disease;
* cerebrovascular disease (stroke);
* cigarette smoking;
* a history of suicide attempts or psychotic episodes requiring hospitalization;
* recurrent migraine headaches;
* pregnancy (patients will be warned not to become pregnant during the study and will be required to agree to employ barrier contraceptive methods);
* pregnancy-related medical conditions such as hyperemesis, pre-toxemia and toxemia, deep vein thrombosis (DVT) and bleeding diathesis;
Any woman with a first degree relative (immediate family) with either ovarian cancer, premenopausal breast cancer or breast cancer presenting in both breasts or any woman who has multiple family members (greater than three relatives) with postmenopausal breast cancer will also be excluded from participating in this protocol;
Any woman meeting the Stages of Reproductive Aging Workshop Criteria (STRAW) for perimenopause will be excluded from participation. Specifically, we will exclude any woman with an elevated plasma follicle stimulating hormone (FSH) level (> 14 IU/L) and with menstrual cycle variability of > 7 days different from their normal cycle length.
Sex :
FEMALE
Ages :
- Minimum Age : 22 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01762943
|
{
"brief_title": "Neurophysiology of Postpartum Depression in an Experimental Model of Pregnancy and Parturition",
"conditions": [
"Postpartum Depression"
],
"interventions": [
"Drug: Progesterone",
"Drug: Leuprolide Acetate",
"Drug: Micronized estradiol"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01762943",
"official_title": "Neurophysiology of Postpartum Depression in an Experimental Model of Pregnancy and Parturition",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2016-10-13",
"study_completion_date(actual)": "2016-10-13",
"study_start_date(actual)": "2013-08"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"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)": "2017-11-20",
"last_updated_that_met_qc_criteria": "2013-01-07",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-01-08",
"first_submitted": "2012-11-13",
"first_submitted_that_met_qc_criteria": "2017-09-18"
}
}
}
|
#Study Description
Brief Summary
Scientific literature supports that teachers are at greater risk for voice disorders than the general population. In the classroom, the teacher's voice represents the main communication tool. Optimal voice use is indispensable to ensure effective teaching and preserve the teacher's vocal health.
This project investigates how virtual reality (VR) facilitates the learning of effective vocal skills and their application in real-world contexts. Based on acoustic analyses and self-assessment scales, the investigators compare 100 future teachers randomly assigned in two groups. The experimental group (n=50) receives a voice training by VR simulations and voice information. The control group (n=50) only receives voice information.
Detailed Description
Experimental group participants receive direct method (three 1-hour sessions of voice training by virtual reality simulations over a course of 3 weeks) and indirect method (one 1-hour session of information on voice function and voice hygiene). Control group participants receive indirect method (one 1-hour session of information on voice function and voice hygiene).
#Intervention
- BEHAVIORAL : Direct Method
- Learning effective vocal skills using speech therapy exercises and virtual reality simulations.
- BEHAVIORAL : Indirect Method
- Information on voice function and voice hygiene.
|
#Eligibility Criteria:
Inclusion Criteria:
* future teacher having completed at least one internship as a schoolteacher
* speaking French fluently
Exclusion Criteria:
* hearing impairment
* voice pathology at the time of the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT04096352
|
{
"brief_title": "Virtual Reality in Teachers' Vocal Motor Behavior Acquisition (VirtuVox)",
"conditions": [
"Voice Disorders",
"Virtual Reality Therapy"
],
"interventions": [
"Behavioral: Direct Method",
"Behavioral: Indirect Method"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT04096352",
"official_title": "Virtual Reality in Teachers' Vocal Motor Behavior Acquisition (VirtuVox): Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02-20",
"study_completion_date(actual)": "2020-02-20",
"study_start_date(actual)": "2019-09-29"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2020-04-07",
"last_updated_that_met_qc_criteria": "2019-09-17",
"last_verified": "2020-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-09-19",
"first_submitted": "2019-09-06",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a 2 centres, randomised, double blind, three-treatment, three-period cross-over trial in subjects with type 1 diabetes mellitus.
Each subject will be administered individualised single subcutaneous doses of BioChaperone Human Insulin (HinsBet®), insulin lispro (Humalog®) and regular human insulin (Huminsulin® Normal) immediately before ingesting a standardised mixed meal.
Following trial drug administration, PK and PD assessments will be carried until 6 hours after start of the standardized test meal.
The total trial duration for an individual subject will be up to 11 weeks.
#Intervention
- DRUG : BioChaperone Human Insulin (HinsBet®)
- BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake
- DRUG : Insulin Lispro (Humalog®)
- Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake
- DRUG : Regular human insulin (Huminsulin® Normal)
- Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake
|
#Eligibility Criteria:
Inclusion Criteria:
* Male or female subject aged 18 <= age <= 64 years (both inclusive).
* Type 1 diabetes mellitus (as diagnosed clinically) >= 12 months.
* Treated with multiple daily insulin injections or CSII >= 12 months.
* Current total daily insulin treatment < 1.2 (I)U/kg/day.
* Current total daily bolus insulin treatment < 0.7 (I)U/kg/day.
* BMI 18.5 <= age <= 28.0 kg/m^2 (both inclusive).
* HbA1c <= 9.0 % by local laboratory analysis
* Fasting C-peptide <= 0.30 nmol/L.
Exclusion Criteria:
* Known or suspected hypersensitivity to IMPs or related products.
* Type 2 diabetes mellitus.
* Previous participation in this trial. Participation is defined as randomised.
* Participation in any clinical trial within 3 months prior to this trial.
* Clinically significant abnormal haematology, coagulation, biochemistry, lipids, or urinalysis screening tests, as judged by the Investigator considering the underlying disease.
* Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea), as judged by the Investigator.
* Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the Investigator might change gastrointestinal motility and food absorption.
* Unusual meal habits and special diet requirements or unwillingness to eat the food provided in the trial.
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT02739906
|
{
"brief_title": "A Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With T1DM",
"conditions": [
"Type 1 Diabetes Mellitus"
],
"interventions": [
"Drug: BioChaperone Human Insulin (HinsBet®)",
"Drug: Insulin Lispro (Humalog®)",
"Drug: Regular human insulin (Huminsulin® Normal)"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT02739906",
"official_title": "A Randomised, Double Blind, Three-period Cross-over Trial to Investigate Post Prandial Blood Glucose Control With Fast-acting Human Insulin HinsBet® Compared to Insulin Lispro (Humalog®) and Regular Human Insulin (Huminsulin® Normal) After Ingestion of a Standardized Meal in Subjects With Type 1 Diabetes Mellitus (T1DM)",
"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)": "2016-04"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "TRIPLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-08-18",
"last_updated_that_met_qc_criteria": "2016-04-14",
"last_verified": "2016-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-15",
"first_submitted": "2016-04-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This research is being done to study the effects of the drug omalizumab (Xolair) in people with cat allergies. The investigators will use omalizumab to study changes in the cells in the nose, cells in the blood and cells in the skin that cause allergies. The investigators will compare the changes in the nose to changes in the skin and blood cells.
Objective: To test the hypothesis that treatment with omalizumab will decrease the nasal allergen challenge late-phase eosinophil count in nasal brushings at the time when blood basophils have become hypo-responsive to in vitro allergen exposure.
Detailed Description
This is a randomized, placebo-controlled, double-blind, parallel group design study that includes 3.5 months of treatment with omalizumab or placebo and a 3 month follow-up. All subjects will be cat allergic.
Twenty four subjects (1:1 randomization) will undergo a cat allergen nasal challenge prior to treatment and another challenge after 2 months of treatment or when their blood basophils become hyporesponsive to cat allergen in vitro. A second group of 10 subjects (1:1 active:placebo), will not undergo nasal challenges. This group will participate in an ancillary study in which the effects of omalizumab on gene expression profiles in peripheral blood cells will be studied.
#Intervention
- DRUG : Omalizumab
- Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.
- Other Names :
- Xolair, Anti-IgE
- DRUG : Placebo
- Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.
|
#Eligibility Criteria:
Inclusion criteria:
* Male or female, ages 18 <= age <= 50
* Females must be surgically sterile or postmenopausal or using a specified acceptable form of birth control throughout the duration of the study. Females in certain categories (not sexually active, vasectomized partner) will be admitted at the discretion of the investigator on a case-by-case basis.
* Females must have a negative urine pregnancy test at Visit A and other visits specified in this protocol.
* Clinical history of perennial allergic rhinitis for at least two years, with or without seasonal allergic rhinitis, and with or without mild persistent asthma as define by the 2007 NAEPP guidelines.
* Allergic cat sensitization defined by a positive puncture skin test (mean wheal diameter 3 mm or more greater than diluent control), and a positive CAP-RAST to cat > 0.35 kU/L.
* Positive intranasal cat allergen challenge defined by the induction of a total of >= 5 sneezes at screening(criterion not applicable in the ancillary study).
* Baseline in vitro histamine release of peripheral blood basophils to cat allergen >=7%.
* Peripheral blood basophils > two million per 100 ml of blood (criterion only applicable in the ancillary study)
Exclusion Criteria:
* Asthma with baseline FEV1 < 80% predicted, and/or moderate to severe asthma classification per the 2007 NAEPP guidelines.
* Individuals with total serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment.
* Individuals with reduced hematocrit (< 32%), WBC count (2400/microliter), platelet count (< 75000/microliter), and increased creatinine (> 141.4 micromolar/L), or AST (> 100 IU/L).
* Individuals with body weight less than 30 kg or greater than 150 kg.
* Pregnant females or females with plans to become pregnant or breastfeed during the duration of the study.
* Individuals with perforated nasal septum, structural nasal defects, large nasal polyps causing obstruction, evidence of acute or chronic sinusitis.
* History of malignancy, anaphylaxis or bleeding disorder.
* Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
* Use of any investigational drugs within 8 weeks of participation.
* Contraindications to omalizumab including patients with a previous hypersensitivity to omalizumab.
* Recent recipient of any licensed or investigational live attenuated vaccine(s) within two months of study initiation such as flu mist.
* Any prior use of omalizumab.
* Frequent episodes of acute sinusitis (>2 documented episodes per year) or active sinusitis within 2 weeks prior to enrollment
* Use of aeroallergen immunotherapy within 5 years prior to enrollment
* Current or within 4 weeks prior to enrollment use of nasal steroids, nasal cromolyn or oral steroids
* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may compromise the quality
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
|
NCT01003301
|
{
"brief_title": "The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge",
"conditions": [
"Cat Allergy"
],
"interventions": [
"Drug: Omalizumab",
"Drug: Placebo"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01003301",
"official_title": "The Effects of Omalizumab on the Late-phase Response to Nasal Allergen Challenge",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-12",
"study_completion_date(actual)": "2013-09",
"study_start_date(actual)": "2009-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-04-07",
"last_updated_that_met_qc_criteria": "2009-10-27",
"last_verified": "2014-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-10-28",
"first_submitted": "2009-10-27",
"first_submitted_that_met_qc_criteria": "2014-02-24"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to conduct a randomized pilot trial of a mobile intervention that targets obesity and binge eating.
#Intervention
- BEHAVIORAL : Behavioral weight loss
- Participants will receive behavioral weight loss intervention
- BEHAVIORAL : Intervention component: Decrease overvaluation of weight and shape
- Participants will receive an intervention component to decrease overvaluation of weight and shape
- BEHAVIORAL : Intervention component: Decrease unhealthy weight control practices
- Participants will receive an intervention component to decrease unhealthy weight control practices
- BEHAVIORAL : Intervention component: Decrease negative affect
- Participants will receive an intervention component to decrease negative affect
|
#Eligibility Criteria:
Inclusion Criteria:
* Adults age >= 18 years
* Obesity (BMI >=30)
* Recurrent binge eating (>=12 episodes in the past 3 months)
* Interested in losing weight and reducing binge eating
* Willing to use a mobile application
* Has a smartphone with Internet access and capacity for calls and text messaging
* Has a valid email address
* Has access to a scale
* Not pregnant
* English-speaking
Exclusion Criteria:
* Diagnosis for which the study/intervention is not clinically indicated
* Not currently receiving clinical services for weight management or binge eating
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
|
NCT04771455
|
{
"brief_title": "Testing Intervention Strategies for Addressing Obesity and Binge Eating",
"conditions": [
"Obesity",
"Binge Eating"
],
"interventions": [
"Behavioral: Intervention component: Decrease unhealthy weight control practices",
"Behavioral: Behavioral weight loss",
"Behavioral: Intervention component: Decrease overvaluation of weight and shape",
"Behavioral: Intervention component: Decrease negative affect"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04771455",
"official_title": "Testing Intervention Strategies for Addressing Obesity and Binge Eating",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-30",
"study_completion_date(actual)": "2022-11-30",
"study_start_date(actual)": "2021-02-16"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "SINGLE",
"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": "2021-02-24",
"last_verified": "2024-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2021-02-25",
"first_submitted": "2021-02-16",
"first_submitted_that_met_qc_criteria": "2024-09-16"
}
}
}
|
#Study Description
Brief Summary
Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensification.
#Intervention
- DRUG : Insulin degludec/insulin aspart
- Administered subcutaneously (s.c. under the skin) once daily.
- DRUG : Insulin glargine
- Administered subcutaneously (s.c. under the skin) once daily.
- DRUG : Insulin aspart
- Administered subcutaneously (s.c. under the skin) once daily.
|
#Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, age at least 18 years at the time of signing informed consent Algeria: Male or female, age at least 19 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus
* Treated with any basal insulin for at least 90 days prior to the day of screening
* Subject not on any OAD(s) prior to trial participation OR subjects on stable daily dose(s) of OAD(s) for at least 90 days prior to screening visit (V1). The OAD(s) include any of the following anti-diabetic drug s)/regimen: a. Biguanides (metformin at least 1500 mg or maximum tolerated dose documented in the subject medical record) b. Other OADs (at least half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record): i. Insulin secretagogues (SU and glinides) ii. Di-peptidyl-peptidase IV (DPP-4) inhibitors iii. α-glucosidase inhibitors iv. Sodium/glucose co-transporter 2 (SGLT-2) inhibitors v. Oral combination products (of the allowed individual OADs above)
* HbA1c 7.0 <= age <= 10.0% (53 <= age <= 86 mmol/mol) (both inclusive) by central laboratory analysis
* Body mass index (BMI) equal to or below 45.0 kg/m^2
Exclusion Criteria:
* Participation in any clinical trial of an approved or non-approved investigational medicinal product within four weeks prior to the day of screening (V1)
* Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
* Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) equal or below 90 days prior to the day of the screening and between screening and randomisation
* Any of the following: myocardial infarction, stroke or hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and between screening and randomisation
* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening
* Impaired liver function, defined as alanine aminotransferase (ALT) equal to or above 2.5 times upper normal limit (UNL) at screening.
* Subjects presently classified as being in New York Heart Association (NYHA) Class IV
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening
* Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids)
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
|
NCT02906917
|
{
"brief_title": "A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification",
"conditions": [
"Diabetes",
"Diabetes Mellitus, Type 2"
],
"interventions": [
"Drug: Insulin aspart",
"Drug: Insulin glargine",
"Drug: Insulin degludec/insulin aspart"
],
"location_countries": [
"India",
"Algeria",
"United States",
"Serbia",
"Russian Federation",
"Turkey",
"Czechia"
],
"nct_id": "NCT02906917",
"official_title": "This Trial is Conducted Globally. The Aim of This Trial is to Compare the Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-08-31",
"study_completion_date(actual)": "2017-12-24",
"study_start_date(actual)": "2016-09-20"
},
"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)": "2019-11-13",
"last_updated_that_met_qc_criteria": "2016-09-15",
"last_verified": "2019-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-09-20",
"first_submitted": "2016-09-15",
"first_submitted_that_met_qc_criteria": "2018-08-28"
}
}
}
|
#Study Description
Brief Summary
Recently, IgE-type autoantibodies against self proteins have been detected in the serum of the atopic dermatitis patients. The role of this IgE autoantibodies involved in the pathogenesis of atopic dermatitis is not known, yet. But, there may be a correlation between the severity of the disease and the serum levels of this autoantibodies. The autologous serum skin testing is applied to both atopic dermatitis patients and healthy control and the results are estimated in this study.The investigators detected 70% positive autologous serum skin testing in atopic dermatitis patients and test positivity was higher in patients with atopy history, moderately severe disease calculated by SCORAD index and high serum IgE levels.
|
#Eligibility Criteria:
Inclusion Criteria:
* Sixty AD patients and 30 healthy individuals
Exclusion Criteria:
* . The patients showing evidence of any other disease are not included to our study. No drug was allowed fourteen days prior to the test, including antihistamines and steroids.
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01238263
|
{
"brief_title": "Autologous Serum Skin Testing in Patients With Atopic Dermatitis Autologous Serum Skin Testing in Patients With Atopic Dermatitis",
"conditions": [
"Atopic Dermatitis, Serum Skin Test"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT01238263",
"official_title": null,
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-06",
"study_completion_date(actual)": "2010-08",
"study_start_date(actual)": "2009-04"
},
"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)": "2010-11-10",
"last_updated_that_met_qc_criteria": "2010-11-09",
"last_verified": "2009-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2010-11-10",
"first_submitted": "2010-11-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Taiwan.
#Intervention
- BIOLOGICAL : 13-valent pneumococcal conjugate vaccine (13vPnC)
- 13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
- BIOLOGICAL : 7-valent pneumococcal conjugate vaccine (7vPnC)
- 7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy 2-month-old infants (42 to 98 days)
* Available for the entire study period (14 months)
Exclusion Criteria:
* Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
Sex :
ALL
Ages :
- Minimum Age : 42 Days
- Maximum Age : 98 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
|
NCT00688870
|
{
"brief_title": "Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan",
"conditions": [
"Vaccines",
"Pneumococcal Conjugate Vaccine"
],
"interventions": [
"Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)",
"Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)"
],
"location_countries": [
"Taiwan"
],
"nct_id": "NCT00688870",
"official_title": "A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, DOUBLE-BLIND TRIAL EVALUATING THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS GIVEN WITH ROUTINE PEDIATRIC VACCINATION IN TAIWAN",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-01-13",
"study_completion_date(actual)": "2010-01-13",
"study_start_date(actual)": "2008-06-05"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE3"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-10-07",
"last_updated_that_met_qc_criteria": "2008-06-02",
"last_verified": "2022-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-06-03",
"first_submitted": "2008-05-29",
"first_submitted_that_met_qc_criteria": "2011-04-18"
}
}
}
|
#Study Description
Brief Summary
The main aim of this project is to analyze and compare the effects of an adapted taekwondo program with respect to multi-component training and walking program on health status in independent older women. The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach. The sample will be 64 women without health problems, between 60 and 65 years old and who decide to participate voluntarily. The participants will be randomized and distributed into four groups: experimental group 1 (adapted taekwondo), experimental group 2 (multi-component training), experimental group 3 (walking program) and a control group (no intervention). Assessments will consist of: systolic and diastolic blood pressure with automatic blood pressure monitor; lipid profile with the Cardiochek meter; frequency of food consumption with the modified dietary habits survey for older people; body composition by direct anthropometry and bioimpedance; cognitive status with the survey of memory, phonetic fluency and temporal-spatial orientation (in Spanish, MEFO); brain activity by means of surface electromyography; quality of life perception with the Health Survey Short Form (SF-36) version 2; physical-functional fitness with the Senior Fitness Test; handgrip strength with a hydraulic dynamometer; and postural balance with a force platform. Assessments will be performed before the 16-week intervention and after the intervention. To analyze the pre-and post-intervention results, repeated measures ANOVA will be applied for group factors (EG1 vs. EG2 vs. EG3 vs. CG) and time (pre-and post-intervention) with the Bonferroni post-hoc test; the reliability of the evaluations will be verified by means of the coefficient of intraclass correlation, and the inter-individual variability to the intervention (responders vs. non-responders) will be calculated using the technical error of measurement. The expected results indicate that adapted taekwondo produces significantly greater effects and a more favorable inter-individual response in cognitive status, brain activity, quality of life perception and postural balance compared to a multi-component training and walking program, in addition to producing similar effects at the group and inter-individual level for blood pressure, lipid profile, frequency of food consumption, body composition and physical-functional fitness in independent older women.
Detailed Description
Design The study includes an experimental design (randomized controlled trial), double-blind, with repeated measures, parallel groups and a quantitative approach. Sixty-four women over 60 years of age will be invited to participate in the study voluntarily and then be electronically randomized (https://www.randomizer.org/) and assigned to either experimental group 1 (EG1, n = 16; adapted taekwondo), experimental group 2 (EG2, n = 16; multi-component training), experimental group 3 (EG3, n = 16, walking program) or the control group (CG, n = 16; no intervention).
Sample The sample calculation indicates that the ideal number of participants per group is 16. According to previous research, for this calculation, an average difference of 3.46 repetitions (chair stand test) was used as the minimum difference required for substantial clinical relevance, with a standard deviation of 3.38 repetitions, considering an alpha level of 0.05 with 90% power and an expected loss of 15%. The inclusion criteria for the sample will be: i) older women aged between 60 and 65 years old; ii) presenting the ability to understand and follow instructions in a contextualized way through simple commands; iii) independent, that is, have a score equal to or greater than 43 points in the Preventive Medicine Exam for the Older People (in Spanish, EMPAM) of the Ministry of Health (31); and iv) complying with at least 85% attendance at the sessions scheduled for interventions. Regarding the exclusion criteria, the following will be considered: i) having any disabling disease; ii) those women who have musculoskeletal injuries or who are undergoing physical rehabilitation treatment that prevents their normal physical performance; and iii) those who have permanent or temporary contraindications to perform PA.
All participants will be informed of the scope of the research and will sign an informed consent that authorizes the use of the information for scientific purposes. In addition, the research protocol will follow the CONSORT guidelines, will be reviewed by the Scientific Ethics Committee of the Universidad Católica del Maule and will be developed following what is stated in the Declaration of Helsinki for work with human beings.
Before starting the intervention, during the last week of July 2022 (for one week), older women will be evaluated in the variables considered for the research, later, from the first week of August to the last week of November 2022 (16 weeks) will participate in designated training programs. After the intervention (first week of December 2022), for one week, the older women will undergo the same initial assessments.
#Intervention
- OTHER : Physical activity
- Combat sports and exercise
- Other Names :
- Physical fitness
|
#Eligibility Criteria:
Inclusion Criteria:
* Older women aged between 60 and 65 years.
* Presenting the ability to understand and follow instructions in a contextualized way through simple commands.
* Independent, that is, have a score equal to or greater than 43 points in the Preventive Medicine Exam for the Older People (in Spanish, EMPAM) of the Ministry of Health (31).
* Complying with at least 85% attendance at the sessions scheduled for interventions.
Exclusion Criteria:
* Having any disabling disease.
* Those women who have musculoskeletal injuries or who are undergoing physical rehabilitation treatment that prevents their normal physical performance.
* Those who have permanent or temporary contraindications to perform physical activity.
Sex :
FEMALE
Ages :
- Minimum Age : 60 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT05275140
|
{
"brief_title": "Adapted Taekwondo on Health Status in Older Women",
"conditions": [
"Healthy People Programs"
],
"interventions": [
"Other: Physical activity"
],
"location_countries": [
"Chile"
],
"nct_id": "NCT05275140",
"official_title": "Effectiveness of Adapted Taekwondo, Multi-component Training and Walking on Health Status in Independent Older Women: a Randomized Controlled Trial With Group and Inter-individual Analysis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2023-12-30",
"study_completion_date(actual)": "2024-01-30",
"study_start_date(actual)": "2023-05-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-03-08",
"last_updated_that_met_qc_criteria": "2022-03-01",
"last_verified": "2024-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-11",
"first_submitted": "2022-01-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The goal of this clinical trial is to compare different Coronavirus Disease 2019 (COVID-19) vaccination schedules in healthy adults that have not yet been exposed to SARS-CoV-2, the virus causing COVID-19. The main questions it aims to answer are:
1. Is it possible to adapt COVID-19 vaccination schedules while maintaining an adequate humoral immune response?
2. Is it possible to adapt COVID-19 vaccination schedules while maintaining an acceptable safety profile?
Participants will be vaccinated twice with a COVID-19 vaccine (on day 0, and on day 28 or 84). After each vaccination, they will collect information about adverse events in a diary for 14 days. Information about the occurrence of events such as hospitalizations and infections with SARS-CoV-2 will be collected by the investigator for up to 364 days after the first vaccination. Blood samples will be taken on different timepoints and used to assess immunity against SARS-CoV-2.
Researchers will compare 8 vaccination schedules to see if the immune response and safety profile is similar. Each participant will receive 1 of the following 8 vaccine schedules:
* BNT162b2 (30µg) on day 0, followed by BNT162b2 (30µg) on day 28
* BNT162b2 (20µg) on day 0, followed by BNT162b2 (20µg) on day 28
* BNT162b2 (30µg) on day 0, followed by BNT162b2 (30µg) on day 84
* BNT162b2 (30µg) on day 0, followed by mRNA-1273 (100µg) on day 28
* BNT162b2 (30µg) on day 0, followed by ChAdOx1-S \[recombinant\] on day 28
* BNT162b2 (6µg, intradermal administration) on day 0, followed by BNT162b2 (6µg, intradermal administration) on day 28
* mRNA-1273 (100µg) on day 0, followed by mRNA-1273 (100µg) on day 28
* mRNA-1273 (50µg) on day 0, followed by mRNA-1273 (50µg) on day 28
#Intervention
- DRUG : BNT162b2 30µg
- intramuscular administration of 30µg
- DRUG : BNT162b2 20µg
- intramuscular administration of 20µg
- DRUG : BNT162b2 6µg
- intradermal administration of 6µg
- DRUG : mRNA-1273 100µg
- intramuscular administration of 100µg
- DRUG : mRNA-1273 50µg
- intramuscular administration of 50µg
- DRUG : ChAdOx1-S [Recombinant]
- intramuscular administration of not less than 2.5 x 10\^8 infectious units
|
#Eligibility Criteria:
Inclusion Criteria:
* Male, female, or X (non-binary gender) subjects, 18 <= age <= 55y inclusive on the day of signing of the ICF
* Provision of signed and dated informed consent form
* Available at all provided timepoints of the study and is not planning to move abroad for the whole duration of the study
* In good general health as evidenced by medical history and/or physical examination or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
* Willing and able to comply with all study procedures
* Participants born female must be either:
* of childbearing potential and using effective contraception for at least 1 month prior to screening and agree to use such a method during study participation until 1 months following the last study dose administration.
* of non-childbearing potential.
Exclusion Criteria:
* Previous clinical or microbiological confirmed diagnosis of COVID-19.
* Febrile illness within 72hours before first vaccination (this is a temporary exclusion criterion).
* Unstable, severe, progressive disease in the past 3 months.
* History of malignancy during the past 5 years.
* History of severe adverse reaction associated and/or anaphylaxis with a vaccine.
* Known allergic reactions of any severity to polyethylene glycol [PEG] or to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG).
* Primary or secondary immunodeficiency disorders (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection...).
* Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 20 mg/day, or equivalent. Inhaled, nasal, opthalmic and topical steroids are allowed.
* Pregnancy or lactation.
* History of drug or alcohol abuse.
* Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk, including relevant psychiatric diagnosis.
* Previous vaccination or planned to accept other vaccination during this study with any coronavirus vaccine outside this study.
* Previous vaccination or planned to accept other vaccination during this study with any coronavirus vaccine outside this study, with the exception of a third COVID-19 vaccine during fall/winter '21-'22.
* Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
* Participation in another clinical trial with an IMP or a new medical device within 28 days prior to study entry and/or during study participation.
* Participant is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as first degree family members and household members of the employees or the investigator, or an employee of the sponsor.
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
|
NCT06189040
|
{
"brief_title": "Immunogenicity After COVID-19 Vaccines in Adapted Schedules",
"conditions": [
"Coronavirus Disease 2019",
"COVID-19"
],
"interventions": [
"Drug: BNT162b2 6µg",
"Drug: BNT162b2 20µg",
"Drug: mRNA-1273 100µg",
"Drug: ChAdOx1-S [Recombinant]",
"Drug: BNT162b2 30µg",
"Drug: mRNA-1273 50µg"
],
"location_countries": [
"Belgium"
],
"nct_id": "NCT06189040",
"official_title": "Assessment of the Immunogenicity and Safety of Marketed Vaccines for COVID-19 After Regular Schedule and Adapted Vaccine Schedules and Routes: BNT162b2, mRNA-1273 Vaccine and ChAdOx1-S [Recombinant]",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-11-03",
"study_completion_date(actual)": "2022-07-08",
"study_start_date(actual)": "2021-05-26"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-03",
"last_updated_that_met_qc_criteria": "2024-01-02",
"last_verified": "2024-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-01-03",
"first_submitted": "2023-12-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to determine whether mesalazine or budesonide is more active in the treatment of active Crohn's disease.
Detailed Description
Crohn's disease is often treated with glucocorticoids or mesalazine. Both drugs are indicated for active Crohn's disease. Treatment with mesalazine is indicated for the treatment of mildly to moderately active Crohn's disease. Budesonide 9 mg/day or mesalazine 4.5 g/day are better than lower doses.
So far only one trial compares the efficacy and safety of budesonide and 5-ASA. The result of this trial is that budesonide is more effective in inducing remission than mesalazine. The primary objective of this trial is to confirm this result for other presentations of budesonide and mesalazine; i.e. Budenofalk® capsules (9 mg/day) and Salofalk® tablets (Eudragit-L-coated oral mesalazine; 4.5 g/day) in moderately active Crohn's disease. Mesalazine is used in this trial as a comparator.
#Intervention
- DRUG : budesonide
- 9 mg
- DRUG : mesalazine
- 4.5 g
|
#Eligibility Criteria:
Inclusion Criteria (main):
* Symptoms of Crohn's disease since at least 3 months; diagnosis confirmed by endoscopic and histological, or endoscopic and radiological criteria [endoscopy not older than 12 months or if older, then clinical signs (e.g. pain localization, pain intensity, blood in stool) and behaviour (according to Vienna classification) should be unchanged compared to former episodes]
* Localisation of CD either in terminal ileum, ascending colon or ileocolitis
* Active phase of disease (200 < CDAI < 400)
Exclusion Criteria (main):
* Known Crohn's lesion in the upper GI-tract (up to and including the jejunum) with present symptoms
* CD in the rectum currently present
* Short bowel syndrome
* Septic complications
* Baseline stool positive for germs causing bowel disease
* Abscess, perforation or active fistulas
* Ileostomy or colostomy
* Resection of more than 50 cm of the ileum
* Bowel surgery within the last 3 months
* Immediate surgery required
* Clinical signs of stricturing disease
* Subileus within the last 6 months
* Suspicion of ileus, subileus or corresponding symptomatology
* Contra-indications, special warnings and precautions mentioned in SmPC
* Treatment with immunosuppressants, cytostatics, 6-TG, methotrexate, or cyclosporine within the last 3 months; in case of treatment with azathioprine or 6-MP the drugs have to be used for maintenance of remission only and dosage has to be unchanged within the last 3 months before baseline visit and during the study
* Treatment with ketoconazole, ciprofloxacin or other CYP3A inhibitors within the last month before baseline visit
* Treatment with anti-TNF-a therapy within 6 months before baseline visit
* Conventional steroids (iv, po, rectal) within 2 weeks before the study
* > 6 mg/d budesonide po or > 3 g/d mesalazine po within 2 weeks before the study
* Patients known to be steroid-refractory or steroid-dependent from former CD episodes
* Treatment of study disease with oral antibiotics (e.g., metronidazole) within the last 2 weeks
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
|
NCT00300118
|
{
"brief_title": "Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)",
"conditions": [
"Crohn's Disease"
],
"interventions": [
"Drug: mesalazine",
"Drug: budesonide"
],
"location_countries": [
"Germany"
],
"nct_id": "NCT00300118",
"official_title": "Double-blind, Double-dummy, Randomized, Multicentre Study to Compare the Efficacy and Safety of Oral Budesonide (9 mg) and Oral Mesalazine (4.5 g) in Moderately Active Crohn's Disease Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-05",
"study_completion_date(actual)": "2008-05",
"study_start_date(actual)": "2004-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2014-05-19",
"last_updated_that_met_qc_criteria": "2006-03-07",
"last_verified": "2014-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2006-03-08",
"first_submitted": "2006-03-07",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This project will evaluate the effectiveness of the Take TIME health promotion campaign. The Take TIME (Tobacco free, Injury free, Moving daily, Eating healthy) campaign will target parents and caregivers of children up to 8 years of age.
The study will help answer the following research questions
1. Are community organizations able and willing to deliver a health-promotion campaign targeting young children?
2. What impact does the Take TIME campaign have on the readiness of the community to support healthy childhoods?
3. What impact does the Take TIME campaign have on awareness and achievement of healthier lifestyles for young children?
4. Can health promotion initiatives be 'institutionalized' within the Municipality and community organizations so that the campaign will continue beyond the study period?
5. Are changes in awareness and/or behaviour related to exposure to the Take TIME campaign?
Detailed Description
The Take TIME initiative will be developed and delivered in conjunction with the Township of Uxbridge and the Heart and Stroke Foundation of Ontario. The Durham Region Health Department, the Ministry of Health Promotion and Sport, and 35 schools and community organizations have also agreed to collaborate on project activities. The health promotion campaign will occur from October 15, 2010 until May 31, 2011. The campaign activities were developed from the input of parents and programme/care providers gathered during the planning phase of this research.
The impact of the Take TIME campaign will be evaluated in two ways. The overall readiness of the community to support healthy childhoods will be evaluated using the Community Readiness Model, which relies on a series of interviews with key individuals in leadership positions. Awareness and current behaviour among community members will be assessed through the completion of telephone surveys of randomly selected households. Each of these evaluations will be completed twice, before and after delivery of the Take TIME campaign. The pre-campaign evaluations will be completed in September 2010. The post-campaign evaluations, using the same procedures, will be completed in June 2011.
#Intervention
- BEHAVIORAL : Take TIME Health Campaign
- 1. Provision of free, family-based events, at least twice per month, that offer opportunities for physical activity and/or healthy eating in a safe, tobacco-free environment.
2. Information dissemination, via project web site, media and other formats, on how to achieve a healthier lifestyle with the already hectic family schedules.
3. Adoption of guidelines by community organizations and the Township of Uxbridge that will reduce tobacco exposure, increase safety and promote physical activity and healthy eating for young children.
|
#Eligibility Criteria:
Inclusion Criteria:
* Parent(s) or caregiver(s) of young children (8 years and younger) will be eligible for the pre- and post- intervention telephone surveys.
* Intervention activities will target parents and caregivers of young children and children 8 years and younger, although the events, information and policies may also influence other residents of the community.
Exclusion Criteria:
* Children and adults who are not parents or caregivers for young children 8 years or younger are not eligible to complete the random telephone survey.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
|
NCT01290848
|
{
"brief_title": "A Health Promotion Campaign Targeting Caregivers of Young Children",
"conditions": [
"Childhood Obesity"
],
"interventions": [
"Behavioral: Take TIME Health Campaign"
],
"location_countries": [
"Canada"
],
"nct_id": "NCT01290848",
"official_title": "Take TIME for Your Child's Health: A Health Promotion Campaign Targeting Caregivers of Young Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2011-07",
"study_completion_date(actual)": "2012-04",
"study_start_date(actual)": "2010-09"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-08-27",
"last_updated_that_met_qc_criteria": "2011-02-04",
"last_verified": "2013-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-02-07",
"first_submitted": "2011-02-03",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Charcot Leyden crystals (CLC) are sometime reported in pathological reports of airway or sinonasal samples but their clinical significance remain elusive. The investigators organized a retrospective analysis of all consecutive patients with CLC seen at our institution between 1986 and 2019
Detailed Description
In recent years, improved knowledge of eosinophilic inflammation has led to the approval of biologics aimed at inhibiting the pathways of eosinophilic activation, notably via the interleukin 5 pathway in eosinophilic asthmatic patients uncontrolled despite receiving maximum doses of standard drugs. These treatments showed efficacy in asthmatic patients with a high level of eosinophils in their induced sputum (\> 3%) and the criteria were extended to those with circulating eosinophilia (\> 300 / mm3). Eosinophils are therefore an important biomarker for phenotyping asthmatic patients. The Charcot-Leyden crystals are a reflection of the presence of eosinophils, and are sometimes found in some pathological samples. It is hypothesized that the presence of Charcot-Leyden crystals, a reflection of tissue eosinophilia, is a predictive factor for the efficacy of anti-IL5 biotherapies in patients with severe eosinophilic asthma.
|
#Eligibility Criteria:
Inclusion Criteria:
* Having Charcot Leyden Crystals in a pathological sample
Exclusion Criteria:
* Having Charcot Leyden Crystals in a pathological sample taken outside the airways the nose and the sinus
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT03999242
|
{
"brief_title": "Charcot Leyden Crystals in Pathology",
"conditions": [
"Asthma"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT03999242",
"official_title": "Clinical Significance of Charcot-Leyden Crystals in Bronchial and Sinonasal Pathological Samples",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-05-01",
"study_completion_date(actual)": "2019-05-15",
"study_start_date(actual)": "2019-04-01"
},
"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)": "2019-06-26",
"last_updated_that_met_qc_criteria": "2019-06-25",
"last_verified": "2019-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-06-26",
"first_submitted": "2019-05-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The occurrence of sudden disruption of abdominal wall laparotomy wound is a major disaster and a major psychological trauma to the patient . Acute wound dehiscence is defined as postoperative separation of the abdominal musculoaponeurotic layers within 30 days after operation.
Many risk factors were incriminated in causation of burst abdomen including malnutrition, anemia, hypo-proteinemia, pre and post-operative prolonged steroid therapy, peritonitis, malignancy, jaundice, uremia and post-operative abdominal distension or cough.
Wound dehiscence may be related to the technique of closure of abdomen and the sutures used. Numerous studies have been conducted evaluating many closure techniques and suture materials.
There is a number of studies evaluating various closure techniques and suture materials to prevent wound dehiscence following emergency midline laparotomy. In developing countries such as India, most patients operated as an emergency develop wound dehiscence such as they have prolonged intraperitoneal sepsis and malnutrition.
The current opinion for closure of a midline incision is mass closure with non-absorbable or slowly absorbable suture . Tension is distributed evenly along the length of the wound.
The standard technique for abdominal closure is 'mass closure' (closing all layers of the abdominal wall, excluding the skin), usually with nonabsorbable sutures, although 'slow-resorbing' sutures such as polydioxanone (PDS) are also widely used .
In Smead-Jones method of closure tension between two loops is distributed in such a way that the fascial edges are well approximated. Originally described method was interrupted. Continuous method has advantage of being faster and has less risk of wound dehiscence due to dynamic distribution of increased tension in postoperative period due to see-saw effect. We proposed modification of original Smead-Jones technique by doing it in continuous manner to increase the benefits and found this method to be fast, cost-effective, equally effective in controlling wound infection and better than interrupted technique to prevent wound dehiscence.
#Intervention
- PROCEDURE : Midline abdominal closure
- Abdominal Closure in Emergency Midline Laparotomy
|
#Eligibility Criteria:
Inclusion Criteria:
* Any patient has risk factor for weak scar who underwent emergency laparotomy through midline incision .
Exclusion Criteria:
* Patients who had previous laparotomy.
* patients who underwent laparotomy through incisions other than midline incisions.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT05199974
|
{
"brief_title": "Comparison Between Conventional and Modified Smead Jones Method for Mass Closure in Emergency Midline Laparotomy",
"conditions": [
"Midline Laparotomy"
],
"interventions": [
"Procedure: Midline abdominal closure"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT05199974",
"official_title": "( Comparison Between ) Conventional and Modified Smead Jones Method for Abdominal Mass Closure in Emergency Midline Laparotomy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-05-30",
"study_completion_date(actual)": "2022-05-30",
"study_start_date(actual)": "2021-11-01"
},
"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)": "2022-06-07",
"last_updated_that_met_qc_criteria": "2022-01-19",
"last_verified": "2022-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-01-20",
"first_submitted": "2021-12-13",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Endoscopic submucosal dissection is commonly performed under light to moderate sedation, and minimizing patient movement is of key importance for successful outcome. Propofol has widely replaced benzodiazepines as sedative drug of choice, and has been reported to enhance the quality of procedure in our past study. However, despite higher satisfaction scores of the endoscopists and faster post-procedural recovery, patient satisfaction scores were found to be higher in patients that received midazolam and meperidine instead of propofol and remifentanil. This seems to be due to the anterograde amnestic effects of midazolam rather than the quality of sedation itself. Investigator hypothesized that by premedicating the patient with low lose midazolam before receiving sedation for ESD with propofol and fentanyl, patient satisfaction would be enhanced without affecting endoscopic performance.
#Intervention
- DRUG : midazolam 0.02mg/kg
- Other Names :
- Premedication of midazolam 0.02mg/kg before sedation for endoscopic submucosal dissection
- DRUG : No premedication
- No premedication before sedation for endoscopic submucosal dissection
|
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients over the age of 19 diagnosed with early gastric cancer or gastric adenoma that are scheduled for endoscopic submucosal dissection
* American society of anesthesiologist physical status 1~3
Exclusion Criteria:
* Patient refusal
* Patients that received sedatives within 24 hours prior to endoscopic submucosal dissection
* History of gastrectomy or previous endoscopic submucosal dissection at same site
* Allergies to propofol or its ingredients, soybeans or peanuts
* Pregnant or breastfeeding patients
* Patients with severe debilitating underlying medical conditions
* Patients with altered mental status
* Illiterate patients or foreigners
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02504164
|
{
"brief_title": "Effect of Midazolam Premedication on the Satisfaction Levels of Patients After Endoscopic Submucosal Dissection",
"conditions": [
"Early Gastric Cancer",
"Gastric Adenoma"
],
"interventions": [
"Drug: midazolam 0.02mg/kg",
"Drug: No premedication"
],
"location_countries": [
"Korea, Republic of"
],
"nct_id": "NCT02504164",
"official_title": null,
"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)": "2014-09"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"NA"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2016-03-07",
"last_updated_that_met_qc_criteria": "2015-07-19",
"last_verified": "2016-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-07-21",
"first_submitted": "2015-07-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese population.
Primary objectives:
* To describe the safety profile of all subjects who receive at least 1 injection
* To describe the immunogenicity to toxin A and toxin B in all subjects from serum samples obtained on Days 0, 14, 30, and 60.
Detailed Description
Participants will be randomly assigned to receive the vaccine or placebo on the selected schedule. Safety parameters, solicited injection site and systemic reactions will be collected for 6 days after each injection; unsolicited adverse events including serious adverse events will be collected up to Day 60 post-vaccination.
#Intervention
- BIOLOGICAL : Clostridium difficile Toxoid Vaccine
- 0.5 mL, intramuscular
- BIOLOGICAL : 0.9% normal saline
- 0.5 mL, intramuscular
- Other Names :
- NaCl
|
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adult subjects aged 40 <= age <= 75 on the day of inclusion
* Informed consent form has been signed and dated
* Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
* Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination)
* Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccine.
* Planned receipt of any vaccine between study vaccinations and in the 4 weeks following the last trial vaccination, except for influenza (seasonal or pandemic) and pneumococcal vaccines
* Previous vaccination against C. difficile with either the trial vaccine another vaccine, or monoclonal antibodies
* Self-reported current or prior Clostridium difficile infection (CDI) episode
* Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* Known systemic hypersensitivity to any of the vaccine components (including aluminum hydroxide, sodium citrate,sucrose, formaldehyde, sodium chloride), or history of a life-threatening reaction to a vaccine containing any of the same substances
* Known medical history or concomitant disease of thrombocytopenia
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
* Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
* Subjects who have any history of intestinal diverticular bleeding
* Subjects who have had surgery within the past three months for Gastro-Intestinal malignancy
* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 37.5°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
* Subject who has concomitant disease that, according to investigator's/sub-investigator's judgment, would adversely affect the safety of the subject in the study, e.g., cardiovascular disease, renal disease, hepatic disease, hematologic disease, and/or growth impairment
* Subject with a past history of convulsions
* Subject ineligible for participation in the study according to the investigator's/sub-investigator's judgment.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT01896830
|
{
"brief_title": "Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan",
"conditions": [
"Clostridium Difficile Infection"
],
"interventions": [
"Biological: Clostridium difficile Toxoid Vaccine",
"Biological: 0.9% normal saline"
],
"location_countries": [
"Japan"
],
"nct_id": "NCT01896830",
"official_title": "Safety and Immunogenicity of a Clostridium Difficile Toxoid Vaccine Administered to Healthy Adult Subjects Aged 40 to 75 Years in Japan",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-10",
"study_completion_date(actual)": "2014-06",
"study_start_date(actual)": "2013-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-07-18",
"last_updated_that_met_qc_criteria": "2013-07-08",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-07-11",
"first_submitted": "2013-07-08",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Total knee replacement is associated with severe post-operative pain. The purpose of this study is to compare two methods of treatment for pain control following Total Knee Replacement with an accelerated physical therapy protocol to aid the achievement of rehab milestones.
Detailed Description
A total of 106 patients undergoing total knee arthroplasty will be randomized into two groups: one to receive only Periarticular injections and the other periarticular injections AND adductor canal block.
Patients will be asked their numeric pain scores before surgery as baseline and at 24 and 48 hours post-operation. Patients also will be asked questions from painOUT questionnaire at 24 and 48 hours.
Time to reach discharge criteria based on physical therapy assessments will also be measured.
#Intervention
- DRUG : Bupivacaine
- DRUG : Morphine
- DRUG : Methylprednisolone
- DRUG : Cefazolin
- DRUG : Normal saline
- DRUG : Midazolam
- DRUG : Propofol
- DRUG : Dexamethasone
- DEVICE : 8 MHz. Chiba needle, 22 G / 4 inches
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
* Age 18 <= age <= 80
* Planned use of regional anesthesia
* Ability to follow study protocol
* English speaking (secondary outcomes include questionnaires validated in English only)
Exclusion Criteria:
Hepatic or renal insufficiency Patients younger than 18 years and older than 80 Patients intending to receive general anesthesia Patients planning to go to rehab post operatively Patients scheduled to go into the OR after 1 pm Allergy or intolerance to one of the study medications Patients with an ASA of IV Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months) Diabetes Patients on workers compensation or disability
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
|
NCT02292082
|
{
"brief_title": "The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)",
"conditions": [
"Osteoarthritis"
],
"interventions": [
"Drug: Methylprednisolone",
"Drug: Midazolam",
"Drug: Dexamethasone",
"Device: 8 MHz. Chiba needle, 22 G / 4 inches",
"Drug: Cefazolin",
"Drug: Bupivacaine",
"Drug: Morphine",
"Drug: Normal saline",
"Drug: Propofol"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02292082",
"official_title": "The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)",
"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)": "2014-11"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-01-11",
"last_updated_that_met_qc_criteria": "2014-11-12",
"last_verified": "2019-01"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-11-17",
"first_submitted": "2014-11-10",
"first_submitted_that_met_qc_criteria": "2019-01-10"
}
}
}
|
#Study Description
Brief Summary
Evaluation of the pharmacokinetics and safety of raltegravir and ezetimibe when co-administered to male and female healthy volunteers.
#Intervention
- DRUG : Raltegravir and ezetimibe
- Group 1: raltegravir 400 mg orally twice daily for 10 days followed by 10 days of raltegravir 400 mg twice daily and ezetimibe 10 mg orally once daily for 10 days followed by a 10 days wash out period and ezetimibe 10 mg once daily for 10 days
- DRUG : Ezetimibe and raltegravir
- Group2: ezetimibe 10 mg orally once daily for 10 days followed by ezetimibe 10 mg and raltegravir 400 mg orally twice daily for 10 days followed by a 10 days wash out period and raltegravir 400 mg twice daily for 10 days
|
#Eligibility Criteria:
Inclusion Criteria:
* The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements
* Male or non-pregnant, non-lactating females
* Between 18 <= age <= 65, inclusive
* Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive.
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month after the study
Exclusion Criteria:
* Any significant acute or chronic medical illness
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
* Positive blood screen for hepatitis B and/or C antibodies
* Positive blood screen for HIV-1 and 2 antibodies
* Current or recent (within 3 months) gastrointestinal disease
* Clinically relevant alcohol or drug use (positive urine drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study
* Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug
* Consumption of grapefruit, or Seville oranges or any grapefruit or Seville orange containing product within one week of first dose of study drug and for the duration of the study
* Use of any other drugs, including over-the-counter medications and herbal preparations, within two weeks prior to first dose of study drug, unless approved/prescribed by the Principal Investigator as known not to interact with study drugs.
* Females of childbearing potential without the use of effective non-hormonal birth control methods, or not willing to continue practising these birth control methods for at least 30 days after the end of the treatment period
* Previous allergy to any of the constituents of the pharmaceuticals administered in this trial
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
|
NCT00772551
|
{
"brief_title": "Raltegravir and Ezetimibe PK Study",
"conditions": [
"HIV"
],
"interventions": [
"Drug: Raltegravir and ezetimibe",
"Drug: Ezetimibe and raltegravir"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00772551",
"official_title": "Evaluation of the Pharmacokinetics and Safety of Raltegravir and Ezetimibe When Co-administered to Male and Female Healthy Volunteers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-08",
"study_completion_date(actual)": "2008-08",
"study_start_date(actual)": "2008-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "CROSSOVER",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-08-16",
"last_updated_that_met_qc_criteria": "2008-10-14",
"last_verified": "2010-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-10-15",
"first_submitted": "2008-10-10",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study will provide data on the switch from a protease inhibitor or efavirenz to the new formulation of raltegravir (RAL) dosed once daily. The study group consists of patients with metabolic risk factors and co-morbidities, in need of optimization of their current ART to minimize the drug-related metabolic side effects as standard of care.
The primary objective of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir once daily reduces liver fat in patients who are overweight or obese and have at least one metabolic syndrome component. For this purpose, the liver fat content will be analyzed using the proton magnetic resonance spectroscopy.
In addition, the aim is to clarify the change in the body composition and metabolism in this study group. For this purpose the visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) volumes will be measured and subcutaneous tissue samples will be collected for future analyses of adipose tissue function.
Detailed Description
The prevalences of overweight (body-mass-index, BMI 25-30 kg/m2) and obesity (BMI\>30 kg/m2) are steadily increasing among HIV-infected patients globally. In parallel, the risk of non-alcoholic fatty liver disease (NAFLD) increases. Clinically alarming are the data which suggest that HIV infected have higher rates of progressive form of NAFLD than non-HIV infected age, gender and BMI matched controls.
As the treatment for HIV is life-long, it is crucial to understand the effects of different antiretroviral therapy (ART) regimens on metabolism. Some antiretroviral agents appear to promote unfavourable changes in metabolism (e.g. in blood lipids) and predispose to trunk fat redistribution and liver fat accumulation.
Raltegravir has been demonstrated to have beneficial impact on some metabolic parameters compared to the protease inhibitor class or efavirenz. In this study, the aim is to investigate whether switching a protease inhibitor or efavirenz to raltegravir reduces liver fat in patients who are overweight or obese and have at least one metabolic syndrome component. For this purpose, the proton magnetic resonance spectroscopy will be used.
In addition, the aim is to clarify the change in the body composition in this study group. For this purpose, the visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) volumes will be measured using MRI.
To acquire more knowledge on metabolic effects in adipose tissue level, subcutaneous adipose tissue biopsies will be collected together with blood, saliva and feces samples.
#Intervention
- DRUG : Raltegravir
- The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
- Other Names :
- Isentress
|
#Eligibility Criteria:
Inclusion Criteria:
* Written informed consent (IC) obtained.
* HIV-positive adult (age over 18) subjects currently on stable ART, with no changes in the ART regimens during the past 6 months.
* Current ART includes either a protease inhibitor or efavirenz.
* No documented or suspected resistance to integrase inhibitors or to NRTIs.
* No prior history of virologic failure. Failure is defined as a confirmed plasma viral load > 200 cop/ml measured no less than six months after initiation or modification of therapy.
* Virological blips accepted only if a single viral load measurement has been between 50 <= age <= 200 cop/ml followed by viral load < 50 cop/ml without the need to initiate a change in ART and no blip within 12 month window period prior to screening.
* Documented evidence of at least two HIV viral load < 50 cop/ml measurements during the past 12 months prior to inclusion: one within 6 months prior to screening.
* HIV viral load < 50 cop/ml at screening.
* BMI>25 kg/m2 and one metabolic syndrome condition, which are
* BP >= 130/>= 85 mmHg or hypertension medication currently in use or
* fasting glucose >= 5.6 mmol/l or B-HbA1C > 42 mmol/mol or diabetes medication currently in use or
* HDL < 1.0 mmol/l in men and < 1.3 mmol/l in women or triglycerides >= 1.7 mmol/l or a cholesterol-lowering regimen currently in use or
* waist circumference > 94 cm in men and >80 cm in women (or respective cut off values for non-European ethnic groups as defined by International Diabetes Federation). OR
* ultrasound or biopsy proven hepatosteatosis.
Exclusion Criteria:
* Within 12 month window period prior to screening, HIV viral load measurement of >50 cop/ml.
* More than one consecutive HIV viral load measurements of > 50 cop/ml in the treatment history after initial viral suppression with ART.
* Chronic hepatitis B or C.
* Daily alcohol consumption >= 30 g for men and >= 20 g for women.
* Pregnancy or planned pregnancy during the study period.
* Lipid or glucose lowering regimen or hormonal supplement started within 3 months before the planned study start.
* Psychiatric disorder, which prevents a study subject to understand the study protocol.
* Other serious disease, which prevents a study subject to participate in the study.
* For MRI/spectroscopy imaging: metal objects in the body or claustrophobia.
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
|
NCT03374358
|
{
"brief_title": "Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir",
"conditions": [
"HIV Seropositivity",
"Metabolic Syndrome",
"Fatty Liver"
],
"interventions": [
"Drug: Raltegravir"
],
"location_countries": [
"Finland"
],
"nct_id": "NCT03374358",
"official_title": "Effect on Liver Fat, Adipose Tissue and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Once Daily Raltegravir in HIV+ Patients With Body Mass Index Over 25 kg/m2 and With at Least One Metabolic Syndrome Component",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-11-02",
"study_completion_date(actual)": "2019-11-30",
"study_start_date(actual)": "2018-01-10"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-09-05",
"last_updated_that_met_qc_criteria": "2017-12-13",
"last_verified": "2021-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2017-12-15",
"first_submitted": "2017-12-02",
"first_submitted_that_met_qc_criteria": "2021-06-15"
}
}
}
|
#Study Description
Brief Summary
Current cesarean section often chooses spinal anesthesia. And in order to avoid the impact of drugs on the fetus, before the delivery, anesthesiologist generally don't use sedative or analgesic drugs. However, the majority of puerperas would appear nervous, anxiety, fear and other psychological reactions in cesarean section. Although the placental transfer and the foetal metabolism of dexmedetomidine have been reported and the result show no adverse effects on neonates, but the placental transfer of dexmedetomidine in intravertebral anesthesia area was lack of systematical research. This study intends to use of dexmedetomidine in the cesarean section under epidural anesthesia and investigate its effects on the parturients' haemodynamics and the neonates' placental transfer and metabolism.
Detailed Description
Current cesarean section in domestic and overseas often chooses spinal anesthesia. And in order to avoid the impact of drugs on the fetus, before the delivery, anesthesiologist generally don't use sedative or analgesic drugs. However, the majority of puerperas would appear nervous, anxiety, fear and other psychological reactions in cesarean section, and thus produced a series of stress reactions that not only cause the hemodynamic fluctuating in anesthesia and operation, but also lead to different degrees of personality and behavior changed. It causes serious injury to physical and mental health of patients. Dexmedetomidine is a highly selective α2 receptors agonist (α2-AR) ，it has sedation, analgesia, antisympathetic pharmacological effects and unique 'conscious sedation' without respiratory depression. At present, dexmedetomidine has been widely used in patients in clinics and clinical anesthesia, it has been hailed as an'dvocate medicine in modern comfortable anesthesia.'Experiments in animals have shown that dexmedetomidine had no adverse effects on pregnant rats. In addition, Dexmedetomidine has successful application in preterm infants, infants and children anesthesia, also has a few for caesarean patients sedation reports. Although the placental transfer and the foetal metabolism of dexmedetomidine have been reported and the result show no adverse effects on neonates, but the placental transfer of dexmedetomidine in intravertebral anesthesia area was lack of systematical research.
The safety of the use of dexmedetomidine on neonatal outcome is a very important issue. Experimental study on acute exposure of rats to dexmedetomidine at the anticipated delivery time recorded absence of any adverse effects on perinatal morphology of pups, their birth weight, crown-rump length, physical growth and postnatal behavioural performances. Others studied the transfer of clonidine and dexmedetomidine across the isolated perfused human placenta. Dexmedetomidine disappeared faster than clonidine from the maternal circulation, while even less dexmedetomidine was transported into the fetal circulation. This was due to its greater placental tissue retention, the basis for which probably is the higher lipophilicity of dexmedetomidine.
Umbilical cord blood gas analysis of umbilical vein and umbilical artery in this study was similar to the results of previous studies . The partial oxygen pressure (PO2) of the arterial blood gas in the umbilical vein was not significantly affected to the oxygen supply of the newborn infants. On the other hand, the umbilical arterial blood gas was the most reliable indicator of the oxygenation index and acid-base status of the fetus. Previous studies have indicated that the relationship between hydrogen ion concentration(PH), base excess（BE） and neonatal asphyxia was relatively large, and it was positively related to growth.
Previous research of in vitro placental perfusion indicated that the transfer rate of dexmedetomidine through the placenta to foetus was 0.77, and the other study indicated that the rate of placental transfer of dexmedetomidine in cesarean section operation under general anesthesia was 0.76. It's indicated that dexmedetomidine can also easily pass through the placental barrier like other anaesthetic drugs. However, the placental transfer rate of dexmedetomidine is much lower than that of clonidine(0.85) and that of remifentanil(0.88), which may be caused by dexmedetomidine being more fat-soluble and easier to be retained in the placenta.
Recently, there is a published interested case report about the successful use of dexmedetomidine 1 µg/kg followed with 1 µg/kg/h for 10 minutes before cesarean delivery to facilitate awake fiberoptic endotracheal intubation patient with spinal muscular atrophy type III with provided adequate sedation, without respiratory compromise. Although pharmacokinetic data cannot be determined, this case confirms existing in vitro data that dexmedetomidine has significant placental transfer. Nevertheless, serious neonatal effects were not detected. Similarly, others used, i.v. dexmedetomidine successfully as an adjunct to opioid-based PCA and general anesthesia for the respective provision of labor analgesia and cesarean delivery anesthesia in a parturient with a tethered spinal cord, with favourable maternal and neonatal outcome.
Project Objectives:
The investigators hypothesize that application of dexmedetomidine in cesarean section under epidural anesthesia was conducive to maintaining the stability of hemodynamics of the patients, reducing patients' anxiety and pain stress during the operations, which also had no adverse effects on newborns.
The aims of the present study are:
Our research efforts will focus on identifying the effects of 0.5 µg/kg/h dexmedetomidine for uncomplicated cesarean delivery on the followings.
Hemodynamic \[heart rate, systolic and mean blood pressure\] changes. The rate of placental transfer of dexmedetomidine . Apgar score (1 and 5 minute) after delivery. The umbilical cord venous and arterial blood gases analyses. The sedation of Dexmedetomidine. The incidence of the major complications (respiratory, cardiovascular events, nausea, vomiting and other adverse reactions).
Project Design:
Study Design:
The study was approved by the first affiliated hospital ethics committee of Nanjing Medical University, and the puerperas and their families signed informed consent.
Sampling Site:
I. Patient Selection: patients aged 23-41 years (ASA physical status I-II) scheduled for elective in about 40 women (American Society of Anesthesiologists \[ASA\] I and II), with uncomplicated, singleton pregnancies, who will receive epidural anesthesia. The investigators will exclude women with a history of cardiac, liver, or kidney diseases; allergy to amide local anesthetics; epilepsy; those taking cardiovascular medications; and those with pregnancy-induced hypertension, evidence of intrauterine growth restriction, or fetal compromise.
II. Anesthesia method
Routine monitoring such as electrocardiogram(ECG), heart rate(HR), saturation of pulse oxygen(SpO2) were monitored after patient arrived at the operation room. Selected the forearm vein to open venous access, infused sodium lactate Ringer's solution before anaesthesia. Then began to epidural anesthesia: The patients were at left side lying position, the L2,3 gap was chosen for puncture. After determined the success of puncture, inserted the epidural catheter into the head side, the length of the epidural space is 4cm. By intraductal injection of 2% lidocaine 3ml, signs of spinal anesthesia were excluded. Additional 0.75% ropivacaine 10 \~ 20ml was injected to control the level of pain disappear on thoracic4(T4) or thoracic6(T6) to satisfy the operation needs. After the level of anesthesia completed, Dex group: dexmedetomidine was continuously infused by 0.5 μg/kg in 10 min, followed with 0.5 μg/kg/hr continuous infusion until the closure of the abdominal. normal saline(NS)group: Pumped in the same volume of normal saline. In the operation, if the blood pressure was lower than 70% before anesthesia given ephedrine 10 \~ 15mg, and 0.5mg atropine was used when the heart rate was lower than 60 beats per minute. All operations were performed by the same group of maieutologists.
III. The Investigators who will be involved with subsequent postoperative patient assessment will be blinded of the patient group.
IV. Observational information
Systolic pressure(SBP) and diastolic blood pressure(DBP), heart rate(HR) were recorded at four time points: before anesthesia(T0), infused 10 min(T1), at the delivery of the baby(T2), at the end of the operation(T3). Ramsay sedation scales were evaluated at three time points: before anesthesia (T0), skin incision (T1) and 10min after delivery (T2). (Ramsay standard for evaluation: 1 point: anxious or restless or both; 2 point: cooperative, orientated and tranquil; 3 point: responding to commands; 4 point: brisk response to stimulus; 5 point: sluggish response to stimulus; 6 point: no response to stimulus. The Apgar scores were evaluated at 1 and 5 minute after the delivery. The urinary volume, the bleeding volume and the infusion volume during the operation were measured. Adverse effects such as nausea and vomiting in 24 hour after the operation were recorded. Postoperative analgesic formula: 12mg butorphanol tartrate, 9mg granisetron hydrochloride, diluted with normal saline to 100ml. Background dose: 2 milliliter per hour, patient controlled analgesia (PCA): 0.5 milliliter, locking time:15 minutes.
V. Samples Collection and Analysis For blood gas analysis and the plasma dexmedetomidine concentrations:
Maternal venous blood samples (MV), umbilical artery(UA) and umbilical vein(UV) will be collected for blood gas analysis, plasma dexmedetomidine concentrations. concentrations at points: When the baby was born.
1. Type of samples: centrifuged 3500 revolutions per minute for 5 minutes and separated of plasma to -20℃ frozen preservation.
2. Laboratory Analysis:
High-performance liquid chromatography-mass spectrometry(HPLC-MS/MS) was then used for measuring the plasma dexmedetomidine concentrations \[concentration of umbilical vein(CUV), concentration of umbilical artery(CUA) and concentration of maternal vein(CMV)\]..
VI. Statistical Analysis: The statistical analysis was performed with SPSS 22.0. The measurement data are shown as mean ± standard deviation (x±s), the t-test was used for comparison between the groups, and repeated measures analysis of variance was performed for comparison within the group; chi-square test was used for comparison of the count data, and rank-sum test was used for comparison of the level information. p \< 0.05 was considered as statistically significant.
VII. Report Writing: 2 months
#Intervention
- DRUG : Dexmedetomidine
- The dexmedetomidine groups (n = 20 ) will receive i.v. infusion of 0.5 μg/kg of solution containing 5 µg/mL of dexmedetomidine, at 10 min after the level of anesthesia completed. Followed with 0.1ml/kg/hr continuous infusion until the closure of the abdominal.The placebo and the dexmedetomidine solutions will be looked identical and their infusions will be continued until skin closure.
- Other Names :
- Dexmedetomidine Hydrochloride Injection
- DRUG : Placebo
- The placebo group (n = 20) will pumped in the same volume of saline 0.9% as calculated by patients' weight in 10 min, then will receive an i.v. infusion of 0.1 mL/kg/h saline 0.9%, until the closure of the abdominal. The placebo and the dexmedetomidine solutions will be looked identical and their infusions will be continued until skin closure.
|
#Eligibility Criteria:
Inclusion Criteria:
* 40 cases of full-term puerperas with single baby ASA I or II, aged 23 <= age <= 41 old, weighing 61 <= age <= 92 kg, without spinal canal puncture contraindication and scheduled for caesarean section under epidural anesthesia were selected for this study.
Exclusion Criteria:
* women with a history of cardiac, liver, or kidney diseases;
* women with allergy to amide local anesthetics;
* women with epilepsy;
* those taking cardiovascular medications;
* those with pregnancy-induced hypertension;
* women with evidence of intrauterine growth restriction or fetal compromise.
Sex :
FEMALE
Ages :
- Minimum Age : 23 Years
- Maximum Age : 41 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT02715154
|
{
"brief_title": "Dexmedetomidine for Cesarean Section",
"conditions": [
"Cesarean Section, Affecting Fetus or Newborn"
],
"interventions": [
"Drug: Placebo",
"Drug: Dexmedetomidine"
],
"location_countries": [
"China"
],
"nct_id": "NCT02715154",
"official_title": "Effect and Placental Transfer of Dexmedetomidine During Caesarean Section Under Epidural Anaesthesia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-11",
"study_completion_date(actual)": "2015-11",
"study_start_date(actual)": "2015-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-03-28",
"last_updated_that_met_qc_criteria": "2016-03-21",
"last_verified": "2017-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-03-22",
"first_submitted": "2016-03-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Chronic obstructive pulmonary disease (COPD) is characterized by increased oxidative stress which aggravates airway and systemic inflammation. Previous studies suggested that dietary factors such as ample consumption of antioxidants might have beneficial effects in lung function in COPD patients.
The investigators' primary aim is therefore to investigate prospectively whether a nutritional intervention consisted of diet rich in antioxidants such as fresh fruits and vegetables, would significantly affect lung function decline in COPD patients compared to a free diet.
Methods: This is a 3-year prospective study, incorporating a run-in period of six months and outpatient clinic visits, scheduled every 6 months. Consecutive sampling was used to recruit 120 patients with COPD. At baseline and at each visit all patients were evaluated for respiratory symptoms, dietary habits, medication used and pulmonary function. Patients will be randomized either to a diet based on increased consumption of foods containing antioxidants (fresh fruits and vegetables), intervention group (IG) or, to a free diet, control group (CG).
The investigators hypothesize that the results from the study will suggest that a diet rich in antioxidants may be associated with improvement in lung function in COPD patients. In this respect dietary interventions should be considered in the management of COPD.
#Intervention
- DIETARY_SUPPLEMENT : Diet rich in antioxidants
- Dietary intervention based on diet with increased consumption of foods containing antioxidants such as fresh fruits, fruit juices and vegetables. Patients are advised by a physician and a specialist nurse during regular scheduled outpatient clinic visits to increase fresh fruit /fruit juices/vegetable consumption of at least one portion per day compared to baseline and to maintain this regime throughout the study period.
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of COPD according to the GOLD definition*
* Ability to perform spirometry.
(*Pauwels RA, Buist AS, Calverley PM, et al. Global strategy for the diagnosis, management and prevention of Chronic Obstructive Pulmonary disease. NHLBI/WHO Global initiative for Chronic Obstructive Lung Disease (GOLD). Workshop summary. Am J Respir Crit Care Med 2001; 163(5):1256 <= age <= 1276.)
Exclusion Criteria:
* A history of lung cancer, bronchial asthma or other respiratory disease
* Continuous use of systemic steroids more than 30 days prior was used as exclusion criteria
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:
No
|
NCT00884299
|
{
"brief_title": "Nutritional Enhancement in Chronic Obstructive Pulmonary Disease (COPD)",
"conditions": [
"Chronic Obstructive Pulmonary Disease"
],
"interventions": [
"Dietary Supplement: Diet rich in antioxidants"
],
"location_countries": [
"Greece"
],
"nct_id": "NCT00884299",
"official_title": "Nutritional Enhancement in COPD: Randomized, Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-03",
"study_completion_date(actual)": "2009-04",
"study_start_date(actual)": "2004-01"
},
"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)": "2009-04-21",
"last_updated_that_met_qc_criteria": "2009-04-17",
"last_verified": "2009-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-04-20",
"first_submitted": "2009-04-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Patients with diabetes have dysfunction of the lining of the arteries which lead to impaired circulation in the small blood vessels. This is thought to be secondary to reduced chemicals in the blood viz: nitric oxide. This chemical is derived from an amino acid (protein) L-arginine. Therefore, the researchers investigated whether giving patients L-arginine (versus dummy powder) would improve the blood flow in the small blood vessels in the lower limbs of patients with damage to their nerves (neuropathy).
Detailed Description
Peripheral neuropathy is one of the most common complications of diabetes mellitus (DM) with a prevalence of around 30 - 45%. In addition, diabetic patients are at increased risk of macrovascular disease, as well as other complications such as retinopathy and nephropathy.
The majority of patients will have developed peripheral neuropathy 10-20 years after the onset of diabetes, which is an important cause of foot ulceration, Charcot joints, amputation and increased morbidity and mortality. In view of this the cost to the National Health Service in 1987 was a staggering £13.5 million. Therefore there is an urgent need for prevention of diabetic neuropathy and its sequelae.
The exact pathogenesis of diabetic neuropathy is unclear, with both metabolic and vascular factors having been implicated. Microvascular disease is possibly the initial event in the development of diabetic complications. Microvascular disease may play an important role in the causation and exacerbation of diabetic neuropathy. Histopathological studies have shown thickening of vessel walls, hyperplasia of capillary endothelial cells and increased plugging of vessels in neuropathic patients. Endothelial dysfunction is thought to be an important initiating factor for the development of these complications. Endothelial dysfunction is thought to develop as a consequence of changes in nitric oxide and cell adhesion molecules in the plasma of diabetic patients. L-arginine is an amino acid, which is the only source of NO in the body.
We therefore propose to study the efficacy of arginine supplementation ( this is available over the counter as a food supplement) on endothelial function and other biomarkers of impaired endothelial function. We hope with this study to demonstrate that L-arginine supplementation will enhance nitric oxide availability, thereby improve the microcirculation and subsequently improve peripheral nerve function. We will use surrogate markers to assess the efficacy of L-arginine supplementation to show an improvement in diabetic complications such as microalbuminuria in the urine, and TcPO2 in the skin of the lower limbs. In addition microcirculation will be assessed using the Moor Laser Doppler flow machine and the Radiometer TcPO2 device. Endothelial function will also be assessed indirectly by measuring the cell adhesion molecules ICAM-1, VCAM-1, P-selectin and E-selectin. This will be performed using standard ELISA techniques.
A total of 40 patients will be recruited for the study. Half will be randomised to taking the food supplement L-arginine and half to placebo. At baseline all patient will have a clinical assessment of their neuropathy status in the lower limb, blood pressure and BMI. Fasting bloods for glucose, lipids profile, U\&E's, FBC, CRP, cell adhesion molecules and nitric oxide will be done at baseline and three months later at the end of the study. The TcPO2 and micro-circulation will be assessed at baseline and also at three month.
Each of the twenty patients that is randomised to L-arginine will be given a tin containing 1 kilogram of the food supplement L-arginine. They are to take a spoonful (three grams) of the L-arginine and dissolve it in a glass of sugar free cold drink of their choice such as orange or lemon squash. They are to take it before food three times a day. The twenty patient randomised to placebo will receive a tin containing one kilogram of placebo and the instruction is as for the L-arginine group.
20 patients will receive L-arginine powder (3G TDS) and 20 patients will receive placebo, lactose powder (3G TDS)
Clinical examination as part of routine care:
1. BMI, BMI will be calculated by weight/height (kg/m2).
2. Lying and standing blood pressure will be measured twice, in the right arm using Dinamap™ (Critikon, UK), after resting for 10 minutes. Hypertension will be defined according to WHO criteria (systolic blood pressure (sBP) \>140 mm Hg and/or diastolic blood pressure (dBP) \>90 mm Hg or if the patient is on current antihypertensive treatment.
3. Overnight microalbumin excretion rate.
4. Neuropathic Disability Score and Vibration Perception threshold.
Additional examination:
1. TcPO2 of the right foot.
2. Micro-circulation of the right foot using Moore Laser Doppler iontophoresis.
Blood from an antecubital vein will be collected after an overnight fast and after resting for fifteen minutes in the supine position for:
1. as part of routine care - FBC, U\&E's, fasting glucose, glycated haemoglobin, fasting lipid profile
2. additional blood test - CRP, cell adhesion molecules, nitric oxide
#Intervention
- DIETARY_SUPPLEMENT : L-arginine
- 3gm TDS for three months
- DIETARY_SUPPLEMENT : Placebo Lactose powder
- 3gm TDS for 3 months
|
#Eligibility Criteria:
Inclusion Criteria:
* Males and females diabetic patients with peripheral neuropathy, aged 30 <= age <= 65 years
* Type 2 diabetes (NIDDM) judged by WHO criteria:
* onset of diabetes mellitus after the age of 30 years
* not requiring insulin for control of diabetes or insulin treatment initiated after one year diagnosis of diabetes
* no history of diabetic ketoacidosis
* All patients will have detailed history and physical examination
Exclusion Criteria:
* Patients with ischaemic heart disease
* Previous stroke and severe peripheral vascular disease)
* Previous amputation
* Renal failure (defined as serum creatinine > 120 mmol/l)
* Uncontrolled hypertension (BP > 160/90)
* Patients on nitrates
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT00902616
|
{
"brief_title": "Effect of Arginine on Microcirculation in Patients With Diabetes",
"conditions": [
"Type 2 Diabetes"
],
"interventions": [
"Dietary Supplement: Placebo Lactose powder",
"Dietary Supplement: L-arginine"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00902616",
"official_title": "L-Arginine and Endothelial Dysfunction in Type 2 Diabetic Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2006-06",
"study_completion_date(actual)": "2006-06",
"study_start_date(actual)": "2003-06"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "DOUBLE",
"phase": [
"PHASE4"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2013-11-27",
"last_updated_that_met_qc_criteria": "2009-05-13",
"last_verified": "2009-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-05-15",
"first_submitted": "2009-05-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Background: With regard to patients with thoracic outlet syndrome (GBS), it is important to improve inspiratory muscle strength and endurance, and pain perception in patients with TOS, so that patients are able to regain pulmonary function and endurance. Objective: To investigate the impact of osteopathic interventions on respiratory parameters and pain levels in individuals diagnosed with thoracic outlet syndrome (TOS). Subjects and methods: forty adults after the onset of TOS will be assigned randomly into two equal groups. In Group A will be allocated to traditional physical therapy program, three sessions/week in addition to 60-minute sessions of Osteopathic technique, one session/week for 3 months, group B will receive traditional physical therapy program, three sessions/week for 3 months. Selected respiratory parameters by spirometer, maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) and a visual analogue scale of pain severity, measured at baseline and after 3 months.
Detailed Description
Method Design This parallel, two-group, randomized controlled trial will use concealed allocation, blinding of outcome assessors and intention-to- treat analysis. People with TOS will enroll to 3-month, osteopathic technique (Group A) or traditional physical therapy program (Group B). The allocation order will be concealed by placing each random allocation in a sealed opaque envelope, which will be opened after the participant enrolled in the study. Thus, researchers and therapists will not know or decide which enrolling participant would receive which therapy. After an envelope was opened, the participant and the therapists who administered the interventions will became aware of that participant's allocated intervention. Outcomes were measured at baseline and after 3 months. In addition to ethics approval \*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*\*.
Participants The study was conducted in Outpatient clinics of Faculty of physical therapy, Horus University. The study population will be consisted of patients diagnosed, by physicians or neurologists, as previous cases of 'definite' TOS. To be eligible to participate, patients with TOS were required to be aged 30-35 years, be in a stable clinical condition and have a physical disability based on assessment. The exclusion criteria were Patients with surgery plan for TOS, those who underwent TOS surgeries, those with smoking history, traumatic cervical injuries, diabetes mellitus and/or malignancies.
Measurement procedures:
1. Spirometer:
2. Micro Respiratory Pressure Meter:
3. Visual Analogue Scale:
Interventions Group A In addition to usual care from the treating physician or neurologist, participants will be prescribed a 3 months program. It will consist a 60 minute of traditional physical therapy program, three sessions/week in addition to 60-minute of Osteopathic technique, once per week.
The program included:
I- Postural correction through correction of:
* Forward head
* Protracted shoulders
* Depressed shoulder.
II- Strengthen ex to:
* Shoulder girdle elevators and retractors.
* Cervical and dorsal extensors
* raising arms to reach full flexion and elevation.
III- Restoration of normal mobility o Inhibition of muscle spasm especially scaleni and pectoral ms. by source of heat\& slow, sustain and self-stretching ex.
IV- Breathing ex: diaphragmatic breathing.
The Osteopathic technique included:
Patients will be positioned in a supine position. Osteopathic technique will consist of supoccibital release, soft tissue release of thoracic outlet, mobilization of cervical facet joints, stretching of scalene anterior, scalene medius, upper trapezius, and levator scapula, pectorals major and minor. Subsequently, cost vertebral and cost transverse joint mobilizations will be applied using rib elevation. Then, manipulation of the vertebrae the levels between C6 and T1 will be applied using thrust mobilization technique. Afterwards, mobilization of the first rib will be applied. Finally, mobilization of the upper cervical spine will be performed.
Group B In addition to usual care from the treating physician or neurologist, participants were prescribed a 60 minute, three times per week of traditional physical therapy program.
The program included:
I- Postural correction through correction of:
* Forward head
* Protracted shoulders
* Depressed shoulder.
II- Strengthen ex to:
* Shoulder girdle elevators and retractors.
* Cervical and dorsal extensors
* raising arms to reach full flexion and elevation. III- Restoration of normal mobility o Inhibition of muscle spasm especially scaleni and pectoral ms. by source of heat\& slow, sustain and self-stretching ex.
IV- Breathing ex: diaphragmatic breathing,.
#Intervention
- OTHER : Osteopathic technique
- Patients will be positioned in a supine position. Osteopathic technique will consist of supoccibital release, soft tissue release of thoracic outlet, mobilization of cervical facet joints, stretching of scalene anterior, scalene medius, upper trapezius, and levator scapula, pectorals major and minor. Subsequently, cost vertebral and cost transverse joint mobilizations will be applied using rib elevation. Then, manipulation of the vertebrae the levels between C6 and T1 will be applied using thrust mobilization technique. Afterwards, mobilization of the first rib will be applied. Finally, mobilization of the upper cervical spine will be performed.
|
#Eligibility Criteria:
Inclusion Criteria:
* The study population consisted of patients diagnosed, by physicians or neurologists, as previous cases of 'definite' TOS.
* To be eligible to participate, patients with TOS were required to be aged 30 <= age <= 35 years, be in a stable clinical condition and have a physical disability based on assessment.
Exclusion Criteria:
* Patients with surgery plan for TOS, those who underwent TOS surgeries, those with smoking history, traumatic cervical injuries, diabetes mellitus and/or malignancies.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
|
NCT06446141
|
{
"brief_title": "Effect of Osteopathic Technique on Respiratory Parameters and Pain in Thoracic Outlet Syndrome",
"conditions": [
"Thoracic Outlet Syndrome"
],
"interventions": [
"Other: Osteopathic technique"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT06446141",
"official_title": "Effect of Osteopathic Technique on Respiratory Parameters and Pain in Thoracic Outlet Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2024-05-31",
"study_completion_date(actual)": "2024-05-31",
"study_start_date(actual)": "2024-05-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"NA"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-06-06",
"last_updated_that_met_qc_criteria": "2024-06-01",
"last_verified": "2024-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-06-06",
"first_submitted": "2024-06-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This is a pilot study to establish an arterial venous methodology to measure the activity of the TCA cycle or flux directly in tissues of human beings. It will also perform correlative studies to study the proteome, metabolome, oxygen consumption, carbon dioxide production and exosomes derived from the arterial venous supply of tissues with correlation to the TCA cycle activity.
Detailed Description
The tricarboxylic (TCA) or Krebs cycle is the 'central hub of cellular metabolism' that takes place within the mitochondria. It is a series of sequential chemical reactions that generate cellular energy in the form of ATP. In addition, the cycle provides intermediate metabolites that are utilized in the biosynthesis of amino acids and fatty acids as well as reducing agents such as nicotinamide adenine dinucleotide (NADH) and flavin adenine dinucleotide (FADH2) that are used in numerous biochemical reactions. The dysfunction of the TCA cycle is recognized for its association in neurodegenerative and cardiovascular diseases, metabolic syndromes, tumorigenesis and aging. Hence, being able to measure the activity or flux of the TCA cycle either in vitro or in vivo holds significant clinical significance. Almost all studies are based on in vitro approaches except NMRS based studies that involve multiple non-validated assumptions.
Various stable isotope labeling studies have been used to estimate the TCA cycle flux by measuring one or more labelled intermediate metabolites within the cycle. Unfortunately, these labelled intermediates are often present through only partial segments of the cycle due to exchange, anaplerosis (entrance into the cycle), cataplerosis (export out of the cycle) or incomplete cycling. Though these previous isotope labeling studies of the TCA cycle flux were qualitatively informative, many were quantitatively inaccurate due to unexpected dilutions of the TCA cycle intermediates arising from unlabeled precursors.
This is a pilot study to establish a novel methodology using mass-isotopomer flux analysis after infusions of 2-13C-Acetate, 2-15N-Glutamine and D5-phenylalanine to measure the in vivo TCA cycle flux in tissues of human beings. This study will simultaneously determine the validity of measuring the TCA cycle flux in tissue indirectly through dynamic differences in enrichment of labelled TCA cycle intermediates between arterial and venous blood supplies of that particular tissue bed (i.e. arteriovenous model or A-V balance technique). We propose to measure the rates of the different metabolic reactions within the TCA cycle by tracing the position-specific 13C and 15N transfer between the intermediate metabolites in order to characterize the oxidative, anaplerotic, cataplerotic and exchange rates across the TCA cycle. The use of 2-15N-Glutamine will specifically allow us to determine the rate of glutamine entry into the cycle via its conversion to glutamate, thus providing a more accurate quantification of the TCA flux.
This methodology will be validated in the setting of controlled physiologic perturbations in human study participants such as low endogenous insulin levels alone or in combination with high glucagon levels.
Finally, correlative studies evaluating the mitochondrial activity in the skeletal muscle tissue, the oxygen consumption in the skeletal and splanchnic tissue beds, the role of circulating exosomes derived from the arteriovenous circulation of the skeletal and splanchnic tissue beds and the changes in the whole body metabolome will also be performed:
* First, mitochondrial respiration will be measured by high resolution respirometry (Oxygraph, Oroboros Instruments, Innsbruck, Austria) using a stepwise protocol to evaluate various components of the electron transport system. Protein content of the mitochondrial suspension will be measured using a colorimetric assay (Pierce 660-nm Protein Assay). Oxygen flux rates will be expressed per tissue-wet weight and per milligram of mitochondrial protein.
* Secondly, reactive oxygen species (ROS) emissions will also be evaluated on all skeletal muscle tissue samples. Briefly, a Fluorolog 3 (Horiba Jobin Yvon) spectrofluorometer with temperature control and continuous stirring will be used to monitor Amplex Red (Invitrogen) oxidation in freshly isolated mitochondrial suspensions obtained from the skeletal muscle biopsies. Amplex Red oxidation will be measured in the presence of glutamate (10 mmol/L), malate (2 mmol/L), and succinate (10 mmol/L). The fluorescent signal will be corrected for background auto-oxidation and calibrated to a standard curve. The H2O2 production rates will be expressed relative to mitochondrial protein.
* Third, simultaneous assessments of the oxygen consumption and carbon dioxide production will be determined through blood gas measurements from the arteriovenous samples obtained from the splanchnic and skeletal muscle tissue beds. These assessments will be performed at all three time points of blood sample assessments and correlated with the measured TCA cycle flux in their respective tissue beds.
* Circulating exosomes will also be derived from the arteriovenous samples of the splanchnic and skeletal muscle tissue beds to determine its intra-exosome proteome and metabolome and its relationship with the TCA cycle flux in their respective tissue beds. Incorporation of D5-phenylalanine will help trace the protein formation in the exosomes.
* Finally, changes in the whole body metabolome and proteome determined via the arteriovenous samples obtained from the splanchnic and skeletal muscle tissue beds will also be performed and correlated with the TCA cycle flux in their respective tissue beds.
#Intervention
- DRUG : Somatostatin
- Somatostatin infusion to create a low insulin state.
- Other Names :
- growth hormone-inhibiting hormone
- DRUG : Glucagon
- Glucagon infusion in the setting of ongoing somatostatin.
- Other Names :
- Glucagen
|
#Eligibility Criteria:
INCLUSION CRITERIA:
* Ages 18 <= age <= 45
* Able to provide written consent
EXCLUSION CRITERIA:
* Diabetes mellitus or impaired fasting glucose levels (fasting blood glucose >110mg/dl).
* Renal Failure
* Pregnancy
* Steroid use
* Muscle Disease
* Liver Disease
* Major Depression
* Anemia
* H/O alcohol use
* Medications other than OCPs
* BMI of 30 or greater
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02748369
|
{
"brief_title": "In Vivo Assessment of Cellular Metabolism in Humans",
"conditions": [
"Normal Cellular Metabolism"
],
"interventions": [
"Drug: Somatostatin",
"Drug: Glucagon"
],
"location_countries": [
"United States"
],
"nct_id": "NCT02748369",
"official_title": "In Vivo Assessment of the Tricarboxylic Acid Cycle Flux in the Muscle and Splanchnic Bed of Humans: A Pilot Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-03-02",
"study_completion_date(actual)": "2017-03-02",
"study_start_date(actual)": "2016-07"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2022-08-03",
"last_updated_that_met_qc_criteria": "2016-04-19",
"last_verified": "2022-08"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-22",
"first_submitted": "2016-04-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The objective of the prospective multicenter observational study consists in defining a difficult intravenous access score in adult, during the preoperative period.
The main objective: the outcome of interest is defined as failure of cannulation on first attempt.
The risk factors of failure of cannulation on first attempt will be described. Adjusted multivariate models will be constructed. A prediction model will be proposed according to the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD)
Detailed Description
Objectives:
To define a difficult intravenous access score in adult during the preoperative period Methods Multicenter, Observational prospective study
Patients:
patients \>18 years old, undergoing peripheral IV placement just before a surgery in operating room excision criteria: pregnant woman, induction of anesthesia with sevoflurane, Predictor variables include: history of patient (age,BMI, Fitzpatrick skin type, cancer, ICU stay, burn, diabetes, kidney disease, anxiety of patient...) , operator experience characteristics( years since graduation, years of anesthesiology experience, IVs started per month), type of catheter and place of catheterization),and postcatheterization data (success on fist attempt yes or no, number of total attempts until success...)
#Intervention
- PROCEDURE : peripheral intravenous catheterization
- success or failure intravenous placement on first attempt and factors associated with failed intravenous catheterization
|
#Eligibility Criteria:
Inclusion Criteria:
* patients >18 years, undergoing peripheral IV placement just before a surgery in operating room
Exclusion Criteria:
* patients who refused IV placement; pregnant woman; induction of anesthesia with sevoflurane without venous access in place
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
|
NCT02789046
|
{
"brief_title": "DIFFICULT INTRAVENOUS ACCESS IN ADULTS (VENSCORE)",
"conditions": [
"Peripheral Venous Catheterization"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT02789046",
"official_title": "DIFFICULT PERIPHERAL INTRAVENOUS ACCESS IN ADULT DURING THE PREOPERATIVE PERIOD",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-06",
"study_completion_date(actual)": "2018-06",
"study_start_date(actual)": "2016-06"
},
"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)": "2019-04-04",
"last_updated_that_met_qc_criteria": "2016-05-26",
"last_verified": "2019-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-06-02",
"first_submitted": "2016-05-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This retrospective study aimed at assessment of different patterns (morphological and pathological) of tumor recurrence found at first evaluation after BCG induction therapy (3 months cystoscopy) for intermediate and high-risk NMIBC and its prognostic implications at a tertiary referral center.
Detailed Description
Bladder cancer (BCa) is the second most common genitourinary malignancy with approximately 75-85% of all patients with BCa present at diagnosis a non-muscle invasive bladder cancer (NMIBC) (Ta, T1 and Tis). Although NMIBC usually carries a favorable prognosis, there is a high risk of disease recurrence and a 10% to 20% risk of progression to muscle-invasive disease.
The common treatment for intermediate- and high-risk patients is a transurethral resection followed by intravesical therapy with bacillus Calmette-Guerin (BCG), a non-specific immunotherapy that has remained the gold standard for 40 years. Over the last decades, several studies have confirmed the superiority of BCG over the combination of epirubicin and interferon, mitomycin C or epirubicin alone for prevention of tumor recurrence, in intermediate- and high-risk tumors.
Despite wide acceptance of BCG intravesical therapy in intermediate and high risk NMIBC, there is still a controversy regarding the optimal protocol of administration. However, most of the guidelines have recommended an induction regimen of six weekly BCG instillations followed by maintenance instillation for at least 1 year.
Complete response (CR) rates after an induction course of BCG for intermediate and high risk NMIBC are high and range from 50-70%. Tumor recurrence at first evaluation (3-months cystoscopy) after BCG induction therapy has been defined as a poor prognostic indicator in those groups of patients with an increased potential risk of disease recurrence and /or progression.
Different patterns of tumor recurrence may be encountered at 3-mo cystoscopy during first evaluation after induction therapy either morphological (single tumor vs. multiple, \<3 cm or more, site (? bladder neck involvement), papillary or non papillary) or histopathological (Ta vs. T1, concurrent CIS or not, tumor grade). To determine how to optimally manage those heterogeneous groups of patients, studying of the specific impact of different tumor characteristics on oncological outcomes is warranted.
#Intervention
- DRUG : induction regimen of intravesical BCG
- intravesical instillation of 6 weekly doses of BCG
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients for who complete TURBT, was carried out
* Intermediate and high risk NMIBC.
* Patients who received full induction BCG regimen (6 weekly doses).
* Patients completed at least 12 months follow up after 3 months cystoscopy.
Exclusion Criteria:
* Patients who received incomplete induction BCG regimen (less than 6 weekly doses)
* Patients with incomplete (less than 12 months) follow up.
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
|
NCT04319263
|
{
"brief_title": "Oncological Outcomes of Different Patterns of Tumor Recurrence at First Evaluation After Bacillus Calmette-Guérin Induction Therapy for Intermediate and High Risk Non Muscle Invasive Bladder Cancer",
"conditions": [
"Bladder Cancer"
],
"interventions": [
"Drug: induction regimen of intravesical BCG"
],
"location_countries": [
"Egypt"
],
"nct_id": "NCT04319263",
"official_title": "Oncological Outcomes of Different Patterns of Tumor Recurrence at First Evaluation After Bacillus Calmette-Guérin Induction Therapy for Intermediate and High Risk Non Muscle Invasive Bladder Cancer",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-03-18",
"study_completion_date(actual)": "2020-03-18",
"study_start_date(actual)": "2020-03-01"
},
"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)": "2020-03-26",
"last_updated_that_met_qc_criteria": "2020-03-23",
"last_verified": "2020-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-03-24",
"first_submitted": "2020-03-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of inflammatory erosive osteoarthritis of the hand.
#Intervention
- DRUG : Placebo
- Solution for subcutaneous injection
- DRUG : gevokizumab
- Solution for subcutaneous injection
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of hand osteoarthritis
* Joint tenderness and/or redness
* At least one erosion by X-ray (as determined by the central reader)
* Contraceptive measures adequate to prevent pregnancy during the study
Exclusion Criteria:
* History of inflammatory disease other than hand EOA including: secondary post-traumatic OA; rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia
* History of gout, pseudogout, or hemochromatosis
* History of allergic or anaphylactic reactions to monoclonal antibodies
* History of recurrent or chronic systemic infections
* Known allergy to acetaminophen
* Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding
Other protocol-defined inclusion/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
|
NCT01882491
|
{
"brief_title": "Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand",
"conditions": [
"Osteoarthritis"
],
"interventions": [
"Drug: Placebo",
"Drug: gevokizumab"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01882491",
"official_title": "A Phase 2 Proof-of-concept Study of Gevokizumab in Subjects With Inflammatory Erosive Osteoarthritis of the Hand",
"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)": "2013-05"
},
"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)": "2014-03-04",
"last_updated_that_met_qc_criteria": "2013-06-17",
"last_verified": "2014-03"
},
"study_registration_dates": {
"first_posted(estimated)": "2013-06-20",
"first_submitted": "2013-06-17",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The third space robotic and endoscopic cooperative surgery (TS-RECS) combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view. TS-RECS takes full advantage of the methodology of the third space, making it possible to dissect gastric GISTs (gastrointestinal stromal tumors) entirely without the damage of mucosal layer. Here, this study preliminarily assessed the feasibility, safety and effectivity of the novel hybrid operation.
#Intervention
- PROCEDURE : the third space robotic and endoscopic cooperative surgery
- This technique combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view, and take full advantage of the methodology of the third space to dissect gastric submucosal tumors.
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with gastric GISTs originating from muscularis propria diagnosed by EUS (endoscopic ultrasound)；
* The maximal cross-sectional diameter of tumor ranging from 2cm to 5cm, or the maximal cross-sectional diameter of tumor <2cm but with malignant potential ( irregular shape, cystic space, heterogeneity and rapid growth during follow-ups ) ；
* No evidence of tumor metastasis on all per-operative evaluations；
Exclusion Criteria:
* 1. Patients with serious systemic comorbidities, such as severe heart failure, respiratory failure, uncontrolled hypertension;
* 2. Patients with advanced malignant tumor;
* 3. Patients were required the emergency operation by complete intestinal obstruction, perforation and hemorrhage caused by the tumor;
* 4.Patients with ulcer penetration into tumors;
* 5. Patients with the contraindications for general anesthesia;
* 6. Patients were pregnant or younger than 18 years；
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
|
NCT03804762
|
{
"brief_title": "A New Method: the Third Space Robotic and Endoscopic Cooperative Surgery (TS-RECS)",
"conditions": [
"Gastric Soft Tissue Neoplasm"
],
"interventions": [
"Procedure: the third space robotic and endoscopic cooperative surgery"
],
"location_countries": [
"China"
],
"nct_id": "NCT03804762",
"official_title": "Feasibility of the Third Space Robotic and Endoscopic Cooperative Surgery(TS-RECS) for Treating Gastric Stromal Tumor",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-12-15",
"study_completion_date(actual)": "2018-12-20",
"study_start_date(actual)": "2018-04-05"
},
"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)": "2019-01-15",
"last_updated_that_met_qc_criteria": "2019-01-11",
"last_verified": "2018-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2019-01-15",
"first_submitted": "2018-12-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Background: A total of 25-50% of patients with stable coronary atherosclerosis treated with metallic stent implantation remain with effort angina despite optimal medical treatment and absence of stent restenosis at 1 year. The most plausible cause of persistent effort angina after stent implantation is microcirculatory dysfunction. Coronary circulation matches the myocardial blood supply and oxygen consumption. Metallic stent implantation has been related with endothelial dysfunction and impaired coronary blood flow reserve (relation between coronary blood flow at rest and maximal hyperemia) of the treated vessel at 1 year.
Bioresorbable Vascular Scaffold (BVS) has been shown to improve the endothelial function and to improve the angina symptoms at 1 year. However, the coronary blood flow of BVS has never been tested.
Main objective: To determine differences in the blood average peak velocity at maximal hyperemia with adenosine infusion between patients treated with bioresorbable and metallic coronary stents at 1 year after stent implantation.
Methodology: A total of 70 patients are 1:1 randomized to everolimus-eluting metallic stent (EES) versus everolimus-eluting BVS implantation in patients with stable coronary disease. At 1 year, patients undergo to invasive coronary angiography prior cessation of vasomotor drugs. A pressure/Doppler wire is advanced distally to the 'treated segment' and the endothelial (acetylcholine) and non-endothelial (adenosine and nitroglycerine) vasomotor function is assessed with quantitative coronary angiography and pressure and Doppler measurements. Angina test questionnaires are obtained at different time-points of the study.
Expected results: A difference between patients treated with BVS and EES of 12.0 cm/sc in the maximal average peak velocity (APV) under maximal hyperemia (with adenosine administration) is expected, as assessed by Doppler measurements, at 1 year after stent implantation. The study is powered to assess superiority in terms of maximal APV favoring patients treated with BVS.
#Intervention
- DEVICE : Bioresorbable vascular scaffold
- Other Names :
- Bioresorbable stents
- DEVICE : Everolimus-eluting stent
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients with stable angina or silent angina with myocardial ischemia detected by non-invasive tests or patients with acute coronary syndromes with no increase of > 5 times the upper value of normality of cardiac biomarkers (troponin).
* Patients with coronary artery disease with angiographic stenosis >
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
|
NCT02738658
|
{
"brief_title": "Comparison of the Vasomotor Function and Myocardial Flow in Patients Treated With Bioresorbable and Metallic Stents at 1 Year",
"conditions": [
"Stable Angina"
],
"interventions": [
"Device: Bioresorbable vascular scaffold",
"Device: Everolimus-eluting stent"
],
"location_countries": [
"Spain"
],
"nct_id": "NCT02738658",
"official_title": "Comparison of the Vasomotor Function and Myocardial Flow in Patients Treated",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2018-07-02",
"study_completion_date(actual)": "2018-07-02",
"study_start_date(actual)": "2015-03-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE4"
],
"primary_purpose": "OTHER",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2018-07-03",
"last_updated_that_met_qc_criteria": "2016-04-13",
"last_verified": "2018-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-14",
"first_submitted": "2016-04-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This research study is evaluating a drug called avastin in combination with standard radiation as a possible treatment for treatment for recurrent pelvic-confined gynecological cancer (i.e. endometrial, cervical, vulvar, ovarian or vaginal cancers).
Detailed Description
The purpose of this research study is to learn the effects (good and bad) of an antiangiogenic therapy drug (drugs that stop new blood vessel growth and starve a tumor by cutting off its blood supply) called avastin. Avastin is an antibody directed against vascular endothelial growth factor, or VEGF. VEGF is a potent, specific growth factor with a well-defined role in normal and abnormal blood vessel formation. It is present in a wide variety of normal tissues, but is produced in excess by most solid cancers (tumors). In the setting of cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells. In laboratory studies, avastin has been shown to inhibit the growth of several different types of human cancer cells.
This drug has been studied in at least 3500 people with breast, colorectal, renal, ovarian and lung cancer. It has not been studied in combination radiation therapy in people with recurrent gynecological cancer.
Previous clinical trials involving the use of avastin in combination with standard radiation in colorectal and pancreatic cancer show no significant increase in toxicity as compared to standard radiation therapy toxicity.
The primary objective of this study is to assess the toxicity of administering avastin with radiation for recurrent gynecological cancer. The secondary endpoint will be to assess the time to progression of the disease. This means we hope this treatment program will delay any regrowth of your cancer as compared to standard therapy with radiotherapy alone. In addition, how well you respond to the treatment, patterns of remission or recurrence will be measured.
#Intervention
- DRUG : Avastin
- Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.
- Other Names :
- Bevacizumab
|
#Eligibility Criteria:
Inclusion Criteria:
* All patients (> 18 yearsyears) will have locally recurrent gynecological cancer with a component of disease that will fit within a standard RT portal at the time of presentation
* ECOG performance status score 0 <= age <= 1
* All patients will have had a prior hysterectomy
* Histological confirmation of recurrent gynecological cancer, including adenocarcinoma, papillary serous carcinoma, clear cell carcinoma, or carcinosarcoma
* Age > 18 years
* Radiologic work-up computer tomography of the chest and abdomen, and computer tomography or MR of the pelvis confirming pelvis-confined recurrence
* Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL
* Adequate hepatic function as evidenced by:
Serum total bilirubin < 1.5 mg/dL SGOT/SGPT < 3X the ULN for the reference lab
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Patients with a prior history of full course external beam radiation therapy to the pelvis (patients with prior vaginal brachytherapy may be included)
* Inability to comply with study and/or follow-up procedures
* Life expectancy of less than 12 weeks
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored avastin cancer study
* Known CNS disease (including history of encephalitis, multiple sclerosis or seizure disorder), except for treated brain metastasis
* Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
* Any prior history of hypertensive crisis or hypertensive encephalopathy
* New York Heart Association (NYHA) Grade II or greater congestive heart failure
* History of myocardial infarction or unstable angina within 6 months prior to study enrollment
* History of stroke or transient ischemic attack within 6 months prior to study enrollment
* Known CNS disease (including history of encephalitis, multiple sclerosis or seizure disorder)
* Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
* Symptomatic peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Any surgical procedure requiring an incision, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for any surgical procedure requiring an incision during the course of the study (excluding vascular access device placement or procedures that do not require an incision)
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
* Serious, non-healing wound, ulcer, or bone fracture
* Proteinuria at screening as demonstrated by either Urine protein:creatinine (UPC) ratio >= 1.0 at screening OR Urine dipstick for proteinuria >= 2+ (patients discovered to have >=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate <= 1g of protein in 24 hours to be eligible).
* Known hypersensitivity to any component of avastin
* Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to give informed consent or cooperate and participate in the study or to interfere with the investigator's ability to interpret the results
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
|
NCT00545792
|
{
"brief_title": "Safety Study Of Avastin And Pelvic Radiation In Women With Recurrent Gynecological Cancers",
"conditions": [
"Cervical Cancer",
"Endometrial Cancer",
"Ovarian Cancer",
"Vaginal Cancer",
"Carcinoma of the Vulva"
],
"interventions": [
"Drug: Avastin"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00545792",
"official_title": "A Pilot Study Evaluating The Safety Of Avastin And Pelvic Radiation In Women With Pelvic-Confined Recurrence of Gynecological Cancers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2010-11",
"study_completion_date(actual)": "2013-10",
"study_start_date(actual)": "2007-05"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2017-03-15",
"last_updated_that_met_qc_criteria": "2007-10-15",
"last_verified": "2017-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2007-10-17",
"first_submitted": "2007-10-15",
"first_submitted_that_met_qc_criteria": "2014-05-30"
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to establish the efficacy profile of rectally administered budesonide foam, as compared to an equivalent volume of rectally administered placebo foam over the same dosing schedule, in participants who present with a diagnosis of active, mild to moderate, ulcerative proctitis (UP) or ulcerative proctosigmoiditis (UPS). During the study, eligible participants will be allowed to maintain previously established oral 5-aminosalicylic acid (5-ASA) treatment at doses up to 4.8 grams/day (g/day).
#Intervention
- DRUG : Budesonide
- Budesonide will be administered as per the dose and schedule specified in the respective arm.
- DRUG : Placebo
- Placebo matching to budesonide will be administered as per the dose and schedule specified in the respective arm.
|
#Eligibility Criteria:
Inclusion Criteria:
* Voluntarily sign written informed consent.
* Male or non-pregnant and non-lactating females.
* Confirmed diagnosis (by endoscopy procedure) of active, mild to moderate UP or UPS, with disease extending at least 5 centimeters (cm) but no further than 40 cm from the anal verge.
* Must possess a baseline MMDAI score between 5 and 10.
Exclusion Criteria:
* History or current diagnosis of Crohn's disease and indeterminate colitis.
* Prior gastrointestinal surgery except appendectomy and hernia.
* Concomitant active gastrointestinal disease or distortion of intestinal anatomy.
* History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
* Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus.
* Uncontrolled abnormal thyroid function.
* Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
* Hemoglobin levels less than (<) 7.5 grams /deciliter (g/dL).
* History of sclerosing cholangitis, cirrhosis, or hepatic impairment.
* Renal disease manifested by greater than (>) 2.0 mg/dL serum creatinine.
* History of avascular hip necrosis, active tuberculosis, ocular herpes simplex or ocular varicella zoster, malignant disease, and HIV or hepatitis B or C.
* Adrenal insufficiency.
* Active systemic or cutaneous infection or toxic megacolon, fistula, perforation or abscess.
* History of uncontrolled psychiatric disorders or seizure disorders.
* History of asthma requiring ongoing use of inhaled steroids.
* Recent history of drug or alcohol abuse.
* Positive stool test for bacterial pathogens, Clostridium difficile toxin, or ovum and parasites.
* Vaccination within 28 days prior to randomization.
* Allergies to budesonide or to any other items used in its preparation.
* Participation in another clinical trial in the past 30 days.
* Pregnant or at risk of pregnancy.
* Taking a prohibited medication. Some medications to treat UP/UPS are prohibited during participation in the study, including laxatives and anti-diarrhea medications; however, oral 5-ASA agents at doses up to 4.8 g/day and daily fiber supplements are allowed. Other medications (e.g., antibiotics, anti-seizure and anti-coagulant medicines) are also prohibited.
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
|
NCT01008423
|
{
"brief_title": "Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis",
"conditions": [
"Proctitis",
"Proctosigmoiditis"
],
"interventions": [
"Drug: Placebo",
"Drug: Budesonide"
],
"location_countries": [
"United States"
],
"nct_id": "NCT01008423",
"official_title": "A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Budesonide Foam (2 mg/25 mL BID for 2 Weeks, Followed by 2 mg/25 mL QD for 4 Weeks) Versus Placebo in Subjects With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2013-03-18",
"study_completion_date(actual)": "2013-03-18",
"study_start_date(actual)": "2009-11-20"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"PHASE3"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2019-08-14",
"last_updated_that_met_qc_criteria": "2009-11-04",
"last_verified": "2019-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-11-05",
"first_submitted": "2009-11-04",
"first_submitted_that_met_qc_criteria": "2019-07-19"
}
}
}
|
#Study Description
Brief Summary
The aim of this study is to identify the effect of a school-based food fortification intervention with multi-micronutrients with or without deworming to improve anemia, micronutrient status, cognitive function, health (morbidity and reinfestation rate) and growth (ponderal) in Vietnamese primary schoolchildren.
Detailed Description
Concurrent micronutrient deficiencies are prevalent in schoolchildren in Vietnam. These deficiencies not only lead to anemia, impair growth, increase susceptibility to infection, impair work capacity, but also impair cognitive development and impair learning ability. The risk of micronutrient deficiencies and anemia increases when individuals are exposed to intestinal helminth infections. Schoolchildren are a neglected group with regard to micronutrient interventions, and school programs afford an excellent opportunity to improve health of these groups. Food fortification with multi-micronutrients is a cost-effective and sustainable strategy, but is not yet implemented on a large scale in Vietnam. Furthermore, little is known about whether high prevalence of intestinal helminthic infection in schoolchildren limits the effect of fortification when this is not combined with regular de-worming.
#Intervention
- DIETARY_SUPPLEMENT : worm treatment and multiple micronutrient fortified biscuits
- A single dose of intestinal anthelminthic treatment as orange-flavored chewable tablets containing 400 mg Albendazole (Vidoca, Thephaco, Vietnam) was given. Deworming was repeated with Albendazole for all children at the end of the study (after 4 months).
The composition and amount of nutrients in each serving of fortified biscuit were 6 mg iron, 5.6 mg zinc, 35µg iodine, 300 µg RAE vitamin A, 1.0 mg thiamin, 0.9 mg riboflavin, 1.1 mg vitamin B6, 10.5 mg NE niacin, 1.5 µg vitamin B12, 120 µg folic acid, 28 mg vitamin C, 150 mg calcium, 74 IU vitamin D, 40 mg magnesium, 6.8 µg selenium, 378 mg potassium, 70 mg phosphorus, 3.0 mg pantothenic acid, 2.8 µg vitamin E, 10 µg vitamin K and 18 µg biotin.
- Other Names :
- Vidoca (Thephaco, Vietnam)
|
#Eligibility Criteria:
Inclusion Criteria:
* school children aged 6 <= age <= 8 years with written informed consent from parents/caregivers
Exclusion Criteria:
* hemoglobin concentrations < 80g/L
* chronic disease
* congenital abnormalities
* mental or severe physical handicap
* severe malnutrition
* obesity
* receiving deworming within the previous 6 mo
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 8 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT00728273
|
{
"brief_title": "Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming in Vietnamese School Children",
"conditions": [
"Healthy"
],
"interventions": [
"Dietary Supplement: worm treatment and multiple micronutrient fortified biscuits"
],
"location_countries": [
"Thailand"
],
"nct_id": "NCT00728273",
"official_title": "Efficacy of Multiple Micronutrient Fortified Biscuits and Deworming on Reducing Anemia Prevalence, and Improving Micronutrient Status, Cognitive Function, and Growth in Vietnamese School Children",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2007-01",
"study_completion_date(actual)": "2007-06",
"study_start_date(actual)": "2007-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "FACTORIAL",
"masking": "QUADRUPLE",
"phase": [
"PHASE2"
],
"primary_purpose": "BASIC_SCIENCE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2008-12-04",
"last_updated_that_met_qc_criteria": "2008-07-31",
"last_verified": "2008-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-08-05",
"first_submitted": "2008-07-30",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This trial studies how well fludeoxyglucose F-18 - positron emission tomography (PET) works in planning radiation therapy in participants with early non-small cell lung cancer, early stage lung cancer, or cancer that has spread to lungs from other parts of the body. Using PET in addition to the standard computed tomography to plan radiation therapy for cancer may help doctors to maximize the dose to the cancer and minimize the dose to normal tissues.
Detailed Description
PRIMARY OBJECTIVE:
To determine the maximum inter-fraction variability of fludeoxyglucose F-18 (18-F FDG)-PET activity of thoracic tumor treatment volumes through a 5-fraction stereotactic body radiation therapy (SBRT) course as it relates to the planning feasibility of emission-guided radiation therapy, or biologically-guided radiation therapy (BgRT).
SECONDARY OBJECTIVES:
I. To compare similar inter-fraction variability of FDG-PET activity for non-thoracic SBRT target volumes for the purpose of determining the feasibility of BgRT.
II. To compare dosimetric endpoints for primary tumor coverage and dose to organs at risk between conventional SBRT planning and simulated BgRT, or emission-guided radiation therapy planning for thoracic and non-thoracic targets.
III. To compare dosimetry for primary tumor coverage and dose to organs at risk between adaptive cone beam computed tomography (CT) planning, and simulated adaptive emission-guided radiation therapy (BgRT) planning for thoracic and non-thoracic targets.
IV. To compare variability of 18-F FDG-PET in patients undergoing immunotherapy simultaneously during SBRT, or within 4 weeks of SBRT treatment with patients undergoing SBRT but not receiving immunotherapy.
OUTLINE:
Participants receive fludeoxyglucose F-18 intravenously (IV) and after 60 minutes undergo PET within 4 weeks of the first planned SBRT fraction, prior to the second planned fraction, and prior to the fifth planned fraction.
#Intervention
- DRUG : Fludeoxyglucose F-18
- Given IV
- Other Names :
- 18FDG, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
- PROCEDURE : Positron Emission Tomography (PET)
- Undergo FDG-PET
- Other Names :
- Medical imaging, positron emission tomography, PET scan, Positron emission tomography scan, Proton magnetic resonance spectroscopic imaging
- RADIATION : Stereotactic Body Radiation Therapy (SBRT)
- Undergo SBRT
- Other Names :
- SABR, Stereotactic ablative body radiation therapy
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who are offered radiotherapy using a 5-fraction stereotactic body radiation therapy course, at the recommendation of the treating radiation oncologist
* Patients with early non-small cell lung carcinoma, or clinically-diagnosed early stage lung cancer, or pulmonary metastases
* Patients with a limited (1 <= age <= 5) number of metastatic foci outside of the thorax who are candidates for consolidative treatment with SBRT
* Patient with either a single focus or multiple foci (multi-isocentric planning) of disease in the thorax amenable to SBRT with at least one focus with at least 1.5 cm or larger in its largest diameter
* Patients who are planned to receive either chemotherapy, targeted therapy, immunotherapy, or no additional cancer-directed drug therapy
Exclusion Criteria:
* Prior radiation therapy which would provide significant dose overlap with the planned target volume(s) delivered within 30 days of enrollment or registration
* Major invasive surgical procedure occurring between the first treatment-eligible PET/CT examination and end of radiotherapy that would affect the treatment target region
* Patients with minimal FDG-avidity localized to the planned treatment target (e.g. maximum standardized uptake value [SUV] < 4.0)
* Pregnancy
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
|
NCT03493789
|
{
"brief_title": "Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy",
"conditions": [
"Stage I Lung Cancer",
"Stage I Non-Small Cell Lung Cancer AJCC v7",
"Stage IA Non-Small Cell Lung Carcinoma AJCC v7",
"Stage IB Non-Small Cell Lung Carcinoma AJCC v7",
"Stage II Lung Cancer",
"Stage II Non-Small Cell Lung Cancer AJCC v7",
"Stage IIA Non-Small Cell Lung Carcinoma AJCC v7",
"Stage IIB Non-Small Cell Lung Carcinoma AJCC v7"
],
"interventions": [
"Procedure: Positron Emission Tomography (PET)",
"Radiation: Stereotactic Body Radiation Therapy (SBRT)",
"Drug: Fludeoxyglucose F-18"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03493789",
"official_title": "A Pilot Study of FDG-PET Variability to Establish Biology-Guided Treatment Planning Feasibility for Stereotactic Body Radiation Therapy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2019-03-19",
"study_completion_date(actual)": "2019-03-19",
"study_start_date(actual)": "2018-04-13"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": "DIAGNOSTIC",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2023-10-18",
"last_updated_that_met_qc_criteria": "2018-04-03",
"last_verified": "2023-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-04-11",
"first_submitted": "2018-03-20",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In this study we will be monitoring for patient events (emergency department admission, hospital admission, admission to an observation unit, or death) and evaluating the feasibility and utility of using pinpointIQ in the management of patients with COVID-19. Vital sign (physiology data) is collected to build a Covid Decompensation Index and contribute data to a Covid Digital Hub supported by the National Institutes of Health.
Detailed Description
This is a prospective, non-randomized, open-label, two-phase design. The primary focus for the study is data collection for index development. This will be done in two phases: the first phase allows for determination of predictor variables that establish the COVID-19 Decompensation Index (CDI) and the second phase establishes performance of the CDI. A participant is considered to have completed the study if he or she completes all phases of the study including the last day of monitoring (day 28).
#Intervention
- DEVICE : Use of the pinpointIQ solution (physIQ, Inc.)
- Patients are monitored for 28 days post COVID19 diagnosis or COVID19 post-hospitalization discharge using the pinpointIQ solution.
|
#Eligibility Criteria:
Inclusion Criteria:
Obtained signed and dated informed consent form Patient in the University of Illinois Health System Patient agrees to comply with all study procedures and availability for the duration of the study Male or female, aged > 18 years Patient diagnosed with COVID-19 (positive SARS CoV2 test) Patient agrees to refrain from swimming or taking baths (any activity that submerges the biosensor in water for any period). Showering is okay.
Exclusion Criteria:
Known allergic reactions to components of the hydrocolloid gel adhesives Subject has cognitive or physical limitations that, in the opinion of the investigator, limits the subject's ability to fully follow study procedures Cognitive ability, in the opinion of the investigator, that limits the patient's ability to use the biosensor and smartphone consistent with study requirements.
Does not speak or read English or Spanish
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT04575532
|
{
"brief_title": "Detection of COVID-19 Decompensation",
"conditions": [
"Covid19"
],
"interventions": null,
"location_countries": [
"United States"
],
"nct_id": "NCT04575532",
"official_title": "Personalized Analytics and Wearable Biosensor Platform for Early Detection of COVID-19 Decompensation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2021-09-09",
"study_completion_date(actual)": "2021-09-09",
"study_start_date(actual)": "2020-10-05"
},
"study_design": {
"allocation": null,
"interventional_model": null,
"masking": null,
"phase": null,
"primary_purpose": null,
"study_type": "OBSERVATIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2021-09-13",
"last_updated_that_met_qc_criteria": "2020-10-01",
"last_verified": "2021-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-10-05",
"first_submitted": "2020-10-01",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Interval (missed) cancers and lower than expected mortality reduction of proximal colon cancers in the United States and elsewhere after screening colonoscopy drew attention to quality indicators. Missed adenomas which are more likely to be in the proximal colon may be contributing factors. An independent predictor of the risk of interval cancers is adenoma detection rate. In pilot observations, the investigators showed that water exchange enhanced adenoma detection in the right colon (cecum to hepatic flexure). This prospective, randomized controlled trial will compare water exchange with water immersion and traditional air insufflation in patients undergoing colonoscopy. The investigators test the hypothesis that compared with air insufflation and water immersion, water exchange produces a significantly higher adenoma detection rate in the right colon
Detailed Description
All of the procedures will be recorded and stored as digital files.
#Intervention
- PROCEDURE : Air insufflation
- Insufflation during colonoscopy including insertion phase
- PROCEDURE : water immersion
- Water will infused during insertion phase and removed during withdrawal phase of colonoscopy
- PROCEDURE : water exchange
- Water will infused and removed during insertion phase of colonoscopy
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing colonoscopy performed by the participating endoscopists
Exclusion Criteria:
* obstructive lesions of the colon known before colonoscopy
* massive ascites
* past history of partial colectomy
* refusal to provide written informed consent
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT02737514
|
{
"brief_title": "Comparing the ADR With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy",
"conditions": [
"Adenoma"
],
"interventions": [
"Procedure: water exchange",
"Procedure: water immersion",
"Procedure: Air insufflation"
],
"location_countries": [
"Taiwan",
"United States"
],
"nct_id": "NCT02737514",
"official_title": "A Randomized, Controlled Trial Comparing the Adenoma Detection Rate With Air Insufflation, Water Immersion and Water Exchange During Two-endoscopist Colonoscopy",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-02",
"study_completion_date(actual)": "2020-02",
"study_start_date(actual)": "2015-12"
},
"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)": "2020-05-29",
"last_updated_that_met_qc_criteria": "2016-04-08",
"last_verified": "2020-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2016-04-14",
"first_submitted": "2015-08-25",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The investigators seek to develop a clinical prediction rule (CPR) to identify patients with a primary complaint of shoulder pain who are likely to benefit from manual therapy to the neck and upper back regions. Manual therapy will include mobilizations (therapist moves the joints in an oscillating fashion) and manipulations (therapist performs a high velocity low amplitude movement) The investigators hypothesize that a cluster of signs and symptoms from the subject history and physical examination will exist that maximize the accuracy of identifying patients with a primary complaint of shoulder pain likely to benefit from this manual therapy treatment based on a reference standard of patient-reported improvement.
The investigators also seek to investigate the psychometric properties (how good a test is), including test retest reliability of a modified version of the Fear Avoidance Beliefs Questionnaire (FABQ) and the shortened Tampa Scale for Kinesiophobia (TSK-11) in patients with shoulder pain. The investigators will also look at the convergent validity (determine if measures that should be related are in reality related) and discriminant validity (show that measures that should not be related are in reality not related) of the modified FABQ and the TSK-11 in patients with shoulder pain.
Detailed Description
The point prevalence of shoulder symptoms has been reported to range from 20-33% and the incidence of shoulder complaints in the general population is increasing. Furthermore, several authors have reported low rates of perceived recovery (patient reports of 'being cured') for patients with a new episode of shoulder or neck pain.3-6 According to Bot et al, less than 25% of patients with a first episode of shoulder pain reported recovery after 3 months, and only 32% stated they had recovered (no longer had symptoms) after 1 year. Other studies have investigated the prognosis of shoulder pain in general practice. Croft et al reported recovery rates of only 21% after 6 months and 49% after 18 months. Van der Windt et al and Winters et al reported recovery rates of 51% and 59% after 12 to 18 months, respectively. Finally, Rekola et al reported that 25% of patients with shoulder or neck pain experienced at least one episode of recurrence within 12 months. These findings suggest that shoulder pain can be recurrent and frequently progresses to the chronic stage.
The Guide to Physical Therapist Practice describes 5 components of patient management; examination, evaluation, diagnosis, prognosis, interventions and outcomes. Information collected during the examination is evaluated in an attempt to improve decision making regarding the most appropriate treatment strategy for the individual patient. Contrary to the medical model which attempts to identify pathology to arrive at a diagnosis, the diagnostic process in physical therapy involves classifying or labeling patients based on functional limitations (restrictions in activities caused by a certain condition) and impairments (loss or abnormality in function such as decreased strength or motion) in an attempt to specifically direct treatment. Clinical decision making regarding treatment involves a certain degree of uncertainty as to which interventions will maximize individual patient outcomes. While the amount of quality evidence supporting physical therapy interventions is increasing, this uncertainty can make it difficult to decide on an appropriate treatment strategy. The American Physical Therapy Association has stated that identifying subgroups of patients who are likely to benefit from specific treatments is a research priority. (APTA) The Guide to Physical Therapist Practice indicates that interventions such as mobilization/manipulation are utilized by physical therapists to manage patients who have shoulder pain. There is growing evidence that impairments in the cervicothoracic spine may contribute to shoulder pain, and that patients with shoulder pain may benefit from manipulation in this region. Manipulation is defined as a manual therapy technique comprising a continuum of skilled passive movements, including small-amplitude/high velocity movements (thrust) and oscillations (non-thrust), that is targeted at joints and soft tissues.
While it is not likely that all patients who have with shoulder pain will benefit from manipulation (thrust and non-thrust) of the cervicothoracic spine, it is possible that a subgroup exists that will experience rapid and dramatic improvement with the use of these manual physical therapy techniques. It is our specific aim to develop a clinical prediction rule (CPR) to identify patients with a primary complaint of shoulder pain who are likely to benefit from cervicothoracic manipulation. The purpose of a CPR is to improve the clinician's accuracy in predicting a diagnosis or an expected outcome. For example, CPRs exist to improve the accuracy of diagnosing ankle fractures in individuals with acute injuries,predict the likelihood of death within four years for individuals with coronary disease, or determine when cervical radiographs are required for patients who have experienced neck trauma. The process of developing and testing a CPR has been described in detail elsewhere. Although CPRs can be developed to improve the accuracy of making a certain diagnosis, the focus of this project is to develop a CPR to predict a certain treatment outcome. The development of a CPR utilizes diagnostic properties of sensitivity, specificity, and positive and negative likelihood ratios, which are based on the individual patient. Thus their interpretation can be readily applied to an individual patient. Development of a CPR to accurately predict which patients with shoulder pain will likely experience a clinically meaningful improvement in pain and function with cervicothoracic spine manipulation before treatment would be immensely helpful for clinicians in the decision-making process. Thus the purpose of this project is to develop a CPR to identify patients with shoulder pain likely to benefit from cervicothoracic spine thrust and non-thrust manipulation.
#Intervention
- PROCEDURE : Cervicothoracic manipulation
- Thrust and non-thrust manipulation to the cervical and thoracic spine
- Other Names :
- Mobilization
|
#Eligibility Criteria:
Inclusion Criteria:
* Primary complaint of shoulder pain (defined as pain between the neck and the elbow at rest or during movement of the upper arm, see diagram at right)
* Age between 18 <= age <= 65 years
* Shoulder Pain and Disability Index (SPADI) score greater than 20 points (full description of this measure provided in self report measures section)
Exclusion criteria:
* Medical red flags noted in the patient's Medical Screening Questionnaire(i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, weight loss, fever, prolonged history of steroid use, etc.)
* Acute fractures in the shoulder region.
* Acute severe trauma to the cervical (neck) or thoracic (upper back) regions in the last 6 weeks.
* Contraindications to manipulative therapy (for example osteoporosis of the cervicothoracic spine).
* Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
* Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms
* Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
Muscle weakness involving a major muscle group of the upper extremity Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps brachii reflexes) Diminished or absent sensation to pinprick in any upper extremity dermatome
* Prior surgery to the neck or thoracic spine involving fusion or open reduction internal fixation.
* Insufficient English language skills to complete all questionnaires as they have only been validated in English.
* Inability to comply with treatment and follow-up schedule
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
|
NCT00835302
|
{
"brief_title": "Development of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation",
"conditions": [
"Shoulder Pain"
],
"interventions": [
"Procedure: Cervicothoracic manipulation"
],
"location_countries": [
"United States"
],
"nct_id": "NCT00835302",
"official_title": "Development of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2008-12",
"study_completion_date(actual)": "2009-03",
"study_start_date(actual)": "2006-10"
},
"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)": "2013-01-30",
"last_updated_that_met_qc_criteria": "2009-02-02",
"last_verified": "2009-02"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-02-03",
"first_submitted": "2009-02-02",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The main objective of the study is to evaluate the safety and tolerability of six escalating doses of SCIO-469 in RA patients. SCIO-469 belongs to a new class of treatments that inhibit p38 kinase, a stimulatory modulator of pro-inflammatory factors including tumor necrosis factor-alpha (TNF-alpha), interleukin-1 (IL-1), and cyclooxygenase-2 (COX-2), all of which are known to contribute to both symptoms and disease progression in patients with Rheumatoid Arthritis.
Detailed Description
This multicenter, randomized, double-blind, placebo-controlled, dose-escalating study will assess the safety, tolerability, efficacy, PK and pharmacodynamics of SCIO-469 in patients with active RA who also are receiving methotrexate. A total of 120 subjects will be randomly assigned and treated in one of seven dose groups with the total daily dose of SCIO-469 ranging from 0 to 180 mg. Dose groups will be staggered over four Treatment Periods. Safety and available PK data from a Treatment Period with lower dose groups will be reviewed prior to initiating higher dose groups in the next Treatment Period. Placebo subjects will be randomized in all Treatment Periods. Study drug will be taken for 30 days. Each subject will be followed for approximately 4 weeks after completing the 30-day Treatment Period. Safety will be assessed by way of physical examination, medical history, vital signs, orthostatic vital signs, chest radiograph, 12-lead electrocardiogram (ECG), clinical laboratory evaluations (including serum chemistry, hematology, qualitative urinalysis, and liver function tests), purified protein derivative test for tuberculosis, neurological tests, adverse events, and concomitant medications through out the study. Study drug will be administered for 30 days at one of the following dosage strengths; 30 mg, 60 mg, 90 mg. One group of subjects will get 60 mg for one week followed by 120 for one week followed by 180 mg for two weeks.
#Intervention
- DRUG : SCIO-469
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients who have active rheumatoid arthritis and are receiving methotrexate
* meet the revised 1987 American Rheumatism Association (ARA) criteria for rheumatoid arthritis
* has active RA as demonstrated by 9 tender and 6 swollen joints and one of the following: C-reactive protein 1.0 mg/dL, Erythrocyte sedimentation rate (ESR) 28 mm/hour, or Morning stiffness = 45 minutes. .
Exclusion Criteria:
* Patient used etanercept, infliximab, anakinra, or an experimental biologic agent within past 3 months
* Had elevation of liver enzymes within past 6 months
* Has a history of Tuberculosis
* Vertigo, inner ear, or vestibular abnormalities
* Cancer
* HIV-positive
* Abnormal electrocardiogram
* patient has chronic or acute infection
* Multiple sclerosis, neuropathy or encephalopathy
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
|
NCT00043732
|
{
"brief_title": "Safety Study of SCIO-469 to Treat Patients With Active Rheumatoid Arthritis Receiving Methotrexate",
"conditions": [
"Rheumatoid Arthritis"
],
"interventions": null,
"location_countries": null,
"nct_id": "NCT00043732",
"official_title": "A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study of SCIO-469 in Patients in Active Rheumatoid Arthritis Receiving Methotrexate",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": null,
"study_completion_date(actual)": "2003-09",
"study_start_date(actual)": null
},
"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)": "2010-04-27",
"last_updated_that_met_qc_criteria": "2002-08-13",
"last_verified": "2010-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2002-08-14",
"first_submitted": "2002-08-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
The purpose of this study is to evaluate the extent of moxidectin transfer into the breast milk of lactating women and to provide the initial pharmacokinetic and safety profile of moxidectin in lactating women.
#Intervention
- DRUG : Moxidectin
|
#Eligibility Criteria:
Inclusion criteria:
Healthy lactating women aged 21 <= age <= 45 inclusive at screening. Women should:
* Be at least 12-weeks postpartum after uncomplicated delivery with a full milk supply established.
* Be willing to discontinue breastfeeding permanently and should be in the process of weaning their infant. Care should be taken to ensure that subjects have not discontinued breastfeeding an infant in order to participate in the study.
* Not plan to breastfeed within 9 months of study drug administration.
* Be willing to fully express breast milk from both breasts during the duration of the milk collection portion of the study. Subjects must be able to express milk from each breast at each pumping session using a breast pump.
* Body mass index in the range of 18 to 35 kg/m2.
Exclusion criteria:
* Presence or history of any disorder that may prevent the successful completion of the study.
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Sex :
FEMALE
Ages :
- Minimum Age : 21 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
|
NCT00751764
|
{
"brief_title": "Study Evaluating The Excretion Of Moxidectin Into The Breast Milk Of Lactating, Non-Breastfeeding Women",
"conditions": [
"Infection"
],
"interventions": [
"Drug: Moxidectin"
],
"location_countries": [
"United Kingdom"
],
"nct_id": "NCT00751764",
"official_title": "An Open-Label, Single-Dose Study to Evaluate the Excretion of Moxidectin Into the Breast Milk of Lactating, Non-breastfeeding Women.",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-09",
"study_completion_date(actual)": "2009-09",
"study_start_date(actual)": "2008-11"
},
"study_design": {
"allocation": "NON_RANDOMIZED",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"PHASE1"
],
"primary_purpose": null,
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2010-09-16",
"last_updated_that_met_qc_criteria": "2008-09-11",
"last_verified": "2010-09"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-12",
"first_submitted": "2008-09-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Pediatric spinal fusion (PSF) surgery is a painful procedure that can treat adolescent idiopathic scoliosis (AIS). One technique that can potentially reduce patients' pain levels and need for opioid medication is the ultrasound-guided Erector Spinae Plane Block (ESPB). The ESP block is a technique that involves injecting an anesthetic medication into the muscles of the lower back on both sides of the spine. Previous studies have shown that ESPB application led to a reduction in opioid use, and there is one pediatric case report of ESPB use in two patients undergoing PSF. However, there is still lack of evidence that the ESPB technique is feasible and effective in the pediatric patient population.
The present study is designed to be the first randomized controlled trial to evaluate the role of ESPB in pediatric spinal fusion surgery and the role of ESPB within an enhanced recovery pathway.
#Intervention
- PROCEDURE : Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone
- Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation.
- OTHER : No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)
- Patients who are randomized to this group will not receive a bilateral erector spinae plane block
|
#Eligibility Criteria:
Inclusion Criteria:
* Age 10 <= age <= 19 years
* Patients undergoing multilevel posterior spinal instrumentation and fusion
* Undergoing surgery for correction of adolescent idiopathic scoliosis
* Patients under the care of participating surgeons
* English Speaking
Exclusion Criteria:
* Patients younger than 10 years or older than 19 years
* Neuromuscular scoliosis
* Patient under the care of non-participating surgeon performing the procedure
* History of chronic opioid therapy (longer than 4 weeks) to treat back pain attributed to scoliosis tolerance, as defined by Centers for Disease Control (CDC) criteria (more than 60 oral morphine equivalents (OME) daily for over 2 weeks)
* Chronic pain conditions necessitating neuromodulating medications (gabapentin, pregabalin)
* Allergy, intolerance, or contraindication to any protocol component/study medication/technique
* Patient or parent refusal
* Non-english speaking
Sex :
ALL
Ages :
- Minimum Age : 10 Years
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
|
NCT04500613
|
{
"brief_title": "Erector Spinae Plane Blocks for Adolescent Idiopathic Scoliosis",
"conditions": [
"Pain, Postoperative",
"Opioid Use",
"Recruitment"
],
"interventions": [
"Procedure: Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone",
"Other: No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)"
],
"location_countries": [
"United States"
],
"nct_id": "NCT04500613",
"official_title": "Utilization of Erector Spinae Plane Blocks in a Multimodal Analgesic Pathway for Instrumentation and Fusion of Adolescent Idiopathic Scoliosis: A Feasibility Study",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-28",
"study_completion_date(actual)": "2022-12-02",
"study_start_date(actual)": "2021-02-22"
},
"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)": "2024-12-27",
"last_updated_that_met_qc_criteria": "2020-08-03",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2020-08-05",
"first_submitted": "2020-07-27",
"first_submitted_that_met_qc_criteria": "2024-11-25"
}
}
}
|
#Study Description
Brief Summary
The purpose of the registry is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms.
Detailed Description
The purpose of the study is to compare the surgical and endovascular approaches to the treatment of thoracoabdominal aortic aneurysms. In particular, the study aims at comparing the short- and mid-term mortality, morbidity and reintervention rate after open surgery or endovascular repair of thoracoabdominal aortic aneurysms in comparable cohorts of patients according to preoperative characteristics and evaluating the cost-effectiveness of both techniques, according to the EUnetHTA core model.
The study results will contribute to the creation of a HTA Report regarding endovascular technology to treat thoracoabdominal aortic aneurysms which will be evaluated by the appropriate Health Authorities.
#Intervention
- PROCEDURE : Surgical repair
- Patients affected by a thoracoabdominal aortic aneurysm who received an open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft
- PROCEDURE : Endovascular repair
- Patients affected by a thoracoabdominal aortic aneurysm who received endovascular repair (with off-the-shelf or custom-made Fenestrated/Branched-Endovascular Aortic Repair - F/BEVAR)
|
#Eligibility Criteria:
Inclusion Criteria:
* Patients affected by a thoracoabdominal aortic aneurysm who received an open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft) or endovascular repair (with off-the-shelf or custom-made Fenestrated/Branched-Endovascular Aortic Repair - F/BEVAR) between January 2013 and June 2021 at San Raffaele Hospital (Vascular Surgery Unit)
* Adult patients >=18 years
* The patient is able to understand and sign the informed consent approved by the Ethics Committee of the San Raffaele Hospital
Exclusion Criteria:
* Patients treated with a hybrid approach (open surgical retrograde revascularization of renovisceral arteries followed by aneurysm exclusion with endograft)
* Patients treated with other endovascular techniques besides fenestrated or branched technology (e.g., physician-modified endografts, parallel grafts).
* Patients with a juxtarenal or pararenal aortic aneurysm
* Patients treated with F/BEVAR for a visceral artery patch aneurysm after open thoracoabdominal repair
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
|
NCT05266781
|
{
"brief_title": "A PROpensity Score Matching Analysis on ENDovascular vs Open Thoraco-Abdominal Aortic Aneurysm Repair (PRO-ENDO TAAA Study)",
"conditions": [
"Thoracoabdominal Aortic Aneurysms"
],
"interventions": [
"Procedure: Surgical repair",
"Procedure: Endovascular repair"
],
"location_countries": [
"Italy"
],
"nct_id": "NCT05266781",
"official_title": "A PROpensity Score Matching Analysis on ENDovascular vs Open Thoraco-Abdominal Aortic Aneurysm Repair . A Single-center, Retrospective-prospective, Observational Study/ EUnetHTA Core Model",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-10-31",
"study_completion_date(actual)": "2022-10-31",
"study_start_date(actual)": "2022-04-01"
},
"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)": "2022-11-14",
"last_updated_that_met_qc_criteria": "2022-02-23",
"last_verified": "2022-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-04",
"first_submitted": "2022-02-23",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Several surgical techniques are used for the treatment of acute acromioclavicular joint dislocations. The investigators investigate a new method using arthroscopic repair using the Tightrope fixation device.
Detailed Description
The Tightrope consists of a suspension system with a strong suture thread intertwined between an oval button and a round button, which is inserted through drilling holes in the clavicula and the coracoid. The investigators want to prospectively evaluate the results in a series of 25 patients.
#Intervention
- PROCEDURE : Tightrope fixation
- Arthroscopic repair
- Other Names :
- Tightrope (R) (Arthrex, Naples, Florida)
|
#Eligibility Criteria:
Inclusion Criteria:
* Acute acromioclavicular joint dislocation
* >= 18 years
Exclusion Criteria:
* Unable to sign 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
|
NCT01274884
|
{
"brief_title": "Tightrope Fixation of Acromioclavicular Joint Dislocation - a Prospective Series",
"conditions": [
"Acromioclavicular Joint Dislocation"
],
"interventions": [
"Procedure: Tightrope fixation"
],
"location_countries": [
"Norway"
],
"nct_id": "NCT01274884",
"official_title": "Prospective Series of Acute Acromioclavicular Dislocations Grade III+. Arthroscopic Fixation With Tightrope (R).",
"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)": "2010-03"
},
"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)": "2014-11-19",
"last_updated_that_met_qc_criteria": "2011-01-11",
"last_verified": "2014-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-01-12",
"first_submitted": "2011-01-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Diabetic foot ulcers (DFU) develop because of the interaction of predisposing factors like neuropathy, angiopathy and infection. Likewise, environmental factors like lesion hygiene, diet and life style.
DFU results as a complication in diabetic patients and it is the most common cause of non-traumatic foot amputation in people older than 50 years. Foot amputation decreases patients´ quality of life since only 33% of them will continue walking with the use of a prothesis.
However, 30% of patients subjected to amputation will die in the first year after surgery and by the 5th year, post-surgery 50% of them will need the amputation of the remaining body extremity.
According to the World Foundation for Diabetes, in Latin America there are 18 million people with Diabetes Mellitus Type 2 (DM2). This number will increase in the next 20 years to 30 million.
Medical expenses for diabetic patients are calculated to be around 8,000 million dollars, annually. In Mexico, according to the Mexican Federation for Diabetes there are 6.5-10 millions of diabetic patients.
Amputation due to DFU complications has many social and economic implications. In Mexico in 2011 diabetes mellitus complications were the principal cause of death in the institute of mexican social security (IMSS) population.
On the other hand, 5-methyl-1-phenyl-2-(1h)-pyridone (PFD) is considered an anti-inflammatory drug that promotes re-epithelization due to fibroblast stimulation, angiogenesis and vasculogenesis during tissue remodeling.
According to this, the investigators believe that PFD could play an important role in DFU resolution and for this reason, the investigators consider necessary to analyze the efficacy of 5-methyl-1-phenyl-2-(1h)-pyridone for the treatment of DFU since it has showed improvement in chronic skin ulcers in pilot studies.
Nowadays, DFU treatment includes management of metabolism, angiopathy and neuropathy along with broad-spectrum antibiotic therapy. However, several reports indicate it is insufficient for and adequate control of diabetic patients.
Then, it is important to develop efficient therapies for the treatment of DFU. In this context, Ketanserin (Sufrexal™) is a drug to induce scar formation. It has been demonstrated to decrease peripheral vascular resistance, platelet aggregation and improves hemorheologic parameters.
Topical administration of ketanserin has showed beneficial effects in inflammation, granulation and epithelization.
Since these two drugs have showed beneficial effects in tissue regeneration, the investigators believe it is important to compare their safety and efficacy for the treatment of DFU
Detailed Description
Subjects will be randomized using a random number table to distribute in the control (ketanserin) and the experimental group (PFD+MODD). Demographics data and medical history will be registered on a monthly basis, relative ulcer volume will be calculated by measuring the longest, widest and deepest ulcer side with sterile flexible graduated ruler. The ulcer will be classified according to Wagner scale and photographs will be taken. Ulcer area will be washed with aseptic solution (accua aseptic solution™) and a biopsy of around 10-15 mm3 will be taken from the middle of the ulcer using a scalpel blade. Patients in the experimental group will receive topical PFD+MODD (8% gel) three times a day and patients in control group will receive ketanserin (2% cream) twice a day. Both groups will apply the medicament for six months previous cleansing of the area. Biopsies will be taken at the beginning, at month one and month two. After this time, only photographs will be performed, and relative ulcer volume will be measured. 5 ml of blood will be taken at the beginning and the end of the study to measure general clinical parameters.
#Intervention
- DRUG : Pirfenidone with MODD
- Patients with diabetic foot ulcer will be treated three times a day with a smooth layer (standar finger tip unit 0.5g for an area of 100 to 120 square centimeters) of KitosCell Q (Pirfenidone with MODD) in form of gel and the wound will be covered with a bandage.
- Other Names :
- KitosCell Q, 5-methyl-1-phenyl-2(1H)-pyridone with MODD
- DRUG : Ketanserin
- Patients will be administered ketanserin twice a day usign the standar finger tip unit (0.5g for an area of 100 to 120 square centimeters) and the wound will be covered with a bandage. This arm is a control for evolution of diabetic foot ulcer.
- Other Names :
- sufrexal
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnostic for diabetic foot ulcer grade I to II according to Wagner scale
* Volunteer patients that accept to sign an informed consent letter
* Patients that agree to fill a clinical history, access to physical exploration and biochemical analysis samples, ulcer biopsy and photodocumentation of ulcer progress.
* Patients willing to sign a compliance letter to apply treatment as indicated by the principal investigator.
Exclusion Criteria:
* Patients with another chronic disease like venous insufficiency or cardiopathy.
* Patients with severe arteriopathy that do not have possibility to direct revascularization like the ones subject to graft tissue, plastics or stents positioning.
* Patients with severe arteriopathy that do not have possibility to indirect vascularization like the ones subject to sympathectomy .
Elimination criteria:
* Patients without adherence to treatment
* Patients that miss medical appointments
* Patients that show allergy to the 8% 5-methyl-1-phenyl-2-(1h pyridone gel and MODD or any of its components.
* Patients allergic to the 2% ketanserin gel or any of its components.
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
|
NCT02632877
|
{
"brief_title": "Efficacy of Pirfenidone Plus MODD in Diabetic Foot Ulcers",
"conditions": [
"Diabetic Foot Ulcer"
],
"interventions": [
"Drug: Ketanserin",
"Drug: Pirfenidone with MODD"
],
"location_countries": [
"Mexico"
],
"nct_id": "NCT02632877",
"official_title": "Efficacy of Pirfenidone Gel Combined With Modified Oxide Diallyl Disulfide (MODD) Versus Ketanserin for the Treatment of Diabetic Foot Ulcers",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-11",
"study_completion_date(actual)": "2015-12",
"study_start_date(actual)": "2014-01"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "SINGLE",
"phase": [
"PHASE1",
"PHASE2"
],
"primary_purpose": "TREATMENT",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-12-17",
"last_updated_that_met_qc_criteria": "2015-12-14",
"last_verified": "2015-12"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-17",
"first_submitted": "2015-12-09",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study aimed to evaluate the effects of different nasal irrigation (NI) methods for relieving nasal obstruction on pain, crying and procedure times, and physiologic parameters in infants with acute upper respiratory tract infection.
Detailed Description
Acute upper respiratory tract infections (URTIs) are the leading cause of acute disease incidence worldwide. Nasal saline irrigation (NSI) is a recommended approach to relieve nasal symptoms and maintain upper airway patency in children, offering a safe, inexpensive, and well-tolerated symptomatic treatment for children with URTIs. Nasal irrigation (NI) relieves URTI symptoms by clearing mucus, reducing congestion, and improving breathing. NI techniques and irrigation solutions used to relieve nasal obstruction in infants are effective in providing procedural comfort. Considering the effectiveness of NI in relieving nasal congestion, which negatively influences the quality of life of children, filling the gap in the literature on NSI is crucial. This study was conducted to determine the effects of various NI methods (NI/NI + nontraumatic nasopharyngeal aspiration) using different irrigation solutions on pain, crying and procedure times, and physiologic parameters in infants with URTIs aged 6 months to 2 years.
#Intervention
- PROCEDURE : Nasal irrigation with isotonic saline
- Infants were placed on the examination stretcher in the right or left lateral position. Then, 10 mL of isotonic saline solution was administered over 5 s into the upper nasal cavity of the infant. The secretion and irrigation solution from the lower nasal cavity were cleaned using gauze. The infant was placed on the other side, and the same procedure was repeated for the other nasal cavity. The infant was then placed in the prone position, and the tapotement technique was applied. The infant's mouth and nose were cleaned with gauze, completing the procedure.
- PROCEDURE : Nasal irrigation with hypertonic saline
- Infants were placed on the examination stretcher in the right or left lateral position. Then, 10 mL of hypertonic saline solution was administered over 5 s into the upper nasal cavity of the infant. The secretion and irrigation solution from the lower nasal cavity were cleaned using gauze. The infant was placed on the other side, and the same procedure was repeated for the other nasal cavity. The infant was then placed in the prone position, and the tapotement technique was applied. The infant's mouth and nose were cleaned with gauze, completing the procedure.
- PROCEDURE : Nontraumatic nasopharyngeal aspiration
- After nasal irrigation, the secretions and saline solution from the underlying nasal cavity were nontraumatically aspirated from the entrance of the nasal cavity after the irrigation. The infant was positioned on the other side, and the same procedure was repeated for the other nasal cavity. The infant was then placed in the prone position, and the tapotement technique was applied. The infant's mouth and nose were cleaned with gauze, completing the procedure.
|
#Eligibility Criteria:
Inclusion Criteria:
* infants aged between 6 months and 24 months, born at term, and recommended NSI for nasal cleansing by the physician due to a diagnosis of URTI.
Exclusion Criteria:
* infants with chronic diseases, nasal congestion due to reasons other than URTI, congenital anomalies related to the respiratory system, allergic rhinitis, unconsciousness, use of analgesics, antibiotics, and corticosteroids before admission to the hospital, and developmental retardation.
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 24 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
|
NCT06691620
|
{
"brief_title": "Effects of Different Nasal Irrigation Methods on Pain Level, Crying and Procedure Times in Nasal Congestion in Infants",
"conditions": [
"Nasal Congestion",
"Nursing"
],
"interventions": [
"Procedure: Nontraumatic nasopharyngeal aspiration",
"Procedure: Nasal irrigation with isotonic saline",
"Procedure: Nasal irrigation with hypertonic saline"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT06691620",
"official_title": "Effects of Different Nasal Irrigation Methods on Pain Level, Crying and Procedure Times, and Physiologic Parameters in Nasal Congestion in Infants: a Randomized Controlled Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-11-08",
"study_completion_date(actual)": "2022-11-08",
"study_start_date(actual)": "2022-01-03"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "TRIPLE",
"phase": [
"NA"
],
"primary_purpose": "SUPPORTIVE_CARE",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-11-15",
"last_updated_that_met_qc_criteria": "2024-11-14",
"last_verified": "2024-11"
},
"study_registration_dates": {
"first_posted(estimated)": "2024-11-15",
"first_submitted": "2024-11-14",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This study was planned to investigate whether the wetness of surgical drapes (disposable and resusable drapes) used in the intraoperative period causes hypothermia.
Detailed Description
After being informed about the study and potential risk all patients giving written informed consent then the study started. Patients who will undergo elective, gastrointestinal and other major abdominal surgery were included in the study. After patients were randomized by the investigator, patients were covered with disposable or reusable surgical drapes in accordance with hospital procedure. The body temperatures of the patients were followed for 2-6 hours as tympanic and esophageal. In addition, pre- and postoperative surgical drapes, sponges, compresses were measured with precision scales.
#Intervention
- OTHER : Disposable Drape
- Disposable surgical drapes, consisting of 6 pieces, were used as a set during surgery
- OTHER : Reusable Drape
- Reusable surgical drapes, consisting of 6 pieces, were used as a set during surgery
|
#Eligibility Criteria:
Inclusion Criteria:
* ASA 1 <= age <= 2-3
* Patients with abdominal surgery
* Patients receiving general anesthesia
Exclusion Criteria:
* Unwanted to participate in the study
* Patients > 70 years
* Presence of central (high) fever originating from the central nervous system resulting from conditions such as cerebrovascular disease, cerebral trauma, intracranial surgery, epilepsy or acute hydrocephalus
* Abnormalities of thermoregulation such as hypothyroidism, hyperthyroidism, history of malignant hyperthermia, or neuroleptic malignant syndrome
* Presence of infectious fever
* ASA 4 and above
* Emergency surgery
* Patients receiving pre-operative chemotherapy
* Having problems such as tearing and perforation of the covers during the work.
* Patients being hyperthermic in the intraoperative process
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 69 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
|
NCT05302323
|
{
"brief_title": "Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia",
"conditions": [
"Hypothermia"
],
"interventions": [
"Other: Reusable Drape",
"Other: Disposable Drape"
],
"location_countries": [
"Turkey"
],
"nct_id": "NCT05302323",
"official_title": "Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-11-30",
"study_completion_date(actual)": "2021-06-30",
"study_start_date(actual)": "2019-04-01"
},
"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)": "2022-04-14",
"last_updated_that_met_qc_criteria": "2022-03-21",
"last_verified": "2022-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2022-03-31",
"first_submitted": "2022-03-21",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
This phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy. Blossom Smart Expander Technology allows for slow and continuous injection of small amounts of saline, from an external pouch and based on precise pressure and volume measurements, into breast expander implants. It may help in achieving the same reconstructive goals as conventional tissue expansion in a shorter period of time and while avoiding frequent injections through the skin, which cause patient discomfort and require many clinic visits.
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the clinical effectiveness of the application of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction.
SECONDARY OBJECTIVES:
I. Patient satisfaction. II. Patient self-reported pain. III. Incidence of complications.
OUTLINE:
After mastectomy, participants undergo 2-staged implant-based breast reconstruction (IBR) with the Blossom Smart Expander Technology comprising of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant.
After completion of study treatment, participants are followed up at 1 week and then every week or every month thereafter for up to 12 months
#Intervention
- DEVICE : Blossom
- Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology
- Other Names :
- Blossom Smart Expander Technology (Syringe Assist Device)
- OTHER : Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire
- Ancillary studies
|
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of breast cancer or reason for prophylactic mastectomy (e.g., BRCA mutation and/or strong family history of breast cancer), both unilateral or bilateral mastectomy
* No prior breast surgery (excluding biopsy and lumpectomy) or breast radiation
* Ability to understand and the willingness to sign a written informed consent document
* No life expectancy restrictions
* Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed
* No requirements for organ and marrow function
Exclusion Criteria:
* Recent steroid use
* No major medical comorbidities (defined as American Society of Anesthesiologists [ASA] III or greater)
* No connective tissue disorder
* Prior breast surgery, excluding biopsy and lumpectomy
* History of or plan for breast radiation
* Pregnancy and nursing patients will be excluded from the study
* No restrictions regarding use of other investigational agents
* No exclusion criteria related to history of allergic reactions
* No exclusion criteria relating to concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study agent
* No other agent-specific exclusion criteria
* No exclusion of cancer survivors or those who are human immunodeficiency virus (HIV)-positive
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
|
NCT03657069
|
{
"brief_title": "Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy",
"conditions": [
"Breast Carcinoma",
"Breast Disorder"
],
"interventions": [
"Device: Blossom",
"Other: Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire"
],
"location_countries": [
"United States"
],
"nct_id": "NCT03657069",
"official_title": "A Pilot Study of Applying New Device Technologies for Tissue Expander/Implant-Based Breast Reconstruction (Blossom Syringe Assist Device)",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2020-08-19",
"study_completion_date(actual)": "2020-08-19",
"study_start_date(actual)": "2018-08-01"
},
"study_design": {
"allocation": "NA",
"interventional_model": "SINGLE_GROUP",
"masking": "NONE",
"phase": [
"NA"
],
"primary_purpose": "DEVICE_FEASIBILITY",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2024-01-22",
"last_updated_that_met_qc_criteria": "2018-08-30",
"last_verified": "2023-04"
},
"study_registration_dates": {
"first_posted(estimated)": "2018-09-04",
"first_submitted": "2018-08-30",
"first_submitted_that_met_qc_criteria": "2023-04-18"
}
}
}
|
#Study Description
Brief Summary
To describe treatment reality of patients with colorectal cancer treated by office-based and clinic-based medical oncologists in Germany.
Detailed Description
The TKK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of colorectal cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.
The impact of nutrition (CoNut) and physical activity (CoNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (CoTox) and the final phase of the palliative process (CoLife). Based on the available data a prognostic score will be developed.
|
#Eligibility Criteria:
Inclusion Criteria:
* Colorectal cancer
* 18 years and older
* Antineoplastic treatment
Exclusion Criteria:
* No colorectal cancer
* Below 18 years
* No antineoplastic treatment
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
|
NCT00910819
|
{
"brief_title": "Tumour Registry Colorectal Cancer",
"conditions": [
"Colorectal Cancer"
],
"interventions": null,
"location_countries": [
"Germany"
],
"nct_id": "NCT00910819",
"official_title": "Prospective and Retrospective Observation of the Adjuvant and Palliative Treatment Strategies in the Therapy of Colorectal Cancer in Germany",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2022-03",
"study_completion_date(actual)": "2022-03",
"study_start_date(actual)": "2006-09"
},
"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)": "2022-05-18",
"last_updated_that_met_qc_criteria": "2009-05-29",
"last_verified": "2022-05"
},
"study_registration_dates": {
"first_posted(estimated)": "2009-06-01",
"first_submitted": "2009-05-28",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Several preliminary studies have shown that diet can have beneficial effects on cognitive decline. Among food shown to have such effects are some polyphenols from selected botanicals.
Preclinical studies have concluded that polyphenols play a role in moderation of oxidative stress and inflammation, increased neuronal signaling, and improved metabolic function among other effects. Noteworthy, a positive and statistically significant association between the midlife level of polyphenol intake and cognitive function assessed 13 years later was found in a cohort of 2574 adults.
Several mechanisms may be involved in these positive effects of food polyphenols on cognitive function in older adults: experimental studies suggest that polyphenols display neuroprotective effects, enhancement of the neuronal function, stimulation of brain flow and inducing neurogenesis, and might prevent age-related damage to the central nervous system through their antioxidant and anti-inflammatory activities.
Based on these promising results, a food supplement from botanicals offering complementary polyphenol profile was developed. This food supplement is aimed to aid at maintenance of cognitive function in older adults.
Detailed Description
This project aims to investigate the effects of 6 months supplementation with a polyphenol-rich supplement vs. placebo to consume daily on human cognitive function. Polyphenol-rich supplement and placebo will be provided as capsules matched for appearance.
The study will be conducted as a randomized, double-blind, parallel-groups (2 arms) placebo-controlled, multicentre interventional design. Two groups, each of 102 volunteers, are studied. One group of volunteers will consume the polyphenol-rich product while the other one will consume the placebo product.
Each volunteer will be seen for 3 visits at the investigational site, will have 2 follow-up calls and mid-term dietary survey. Baseline and follow-up visit will include cognitive assessment with the CANTAB battery. CANTAB tests will cover several aspects of memory: visio-spatial learning and episodic memory, verbal recognition memory and visio-spatial working memory. Moreover, psychological and mood components will be evaluated (mnesic complaint, depression, fatigue). Physical activity and food habits will also be recorded. Finally, biological parameters will be assessed (lipid profile, glycemia, insulinemia, CRPus, thyroid stimulating hormone, transthyretin, plasma level of phenolic compounds).
#Intervention
- DIETARY_SUPPLEMENT : Polyphenol-rich extract
- Two groups, each of 102 volunteers, are studied. For 24 weeks, one group of volunteers will consume the active product (polyphenol-rich extract) while the other one will consume the placebo product.
- DIETARY_SUPPLEMENT : Placebo
- The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component.
Two groups, each of 102 volunteers, are studied. For 24 weeks, one group of volunteers will consume the active product (polyphenol-rich extract) while the other one will consume the placebo product.
|
#Eligibility Criteria:
Inclusion Criteria:
* Independent subjects, living at home;
* Body Mass Index (BMI) 20 <= age <= 30 kg/m2 (limits included);
* 26 < MMSE score <= 29
* Logical memory subtest of the Wechsler Memory Scale (16 <= age <= 69 years battery) sub-scores complying with the following:
* Immediate recall score < 29;
* Delayed recall score < 16;
Exclusion Criteria:
* Evidence of actual major depressive disorder according to the module A of the Mini International Neuropsychiatric Interview (MINI);
* Subject consuming food supplements likely to have an effect on memory;
* High physical activity practice;
* Restrictive or unbalanced diet (hypocaloric, vegetarian, vegan, ...) self-declared at V0;
* Diabetes;
* Cardiovascular disease diagnosed within less than 2 years, with the following exceptions: subjects with controlled (medicated) high blood pressure and/ or controlled (medicated) can be included;
* Personal history of Cerebrovascular Accident (CVA);
* Unbalanced thyroid disease;
* Anti-depressant treatment stopped since less than 3 months or still ongoing;
* Personal history of schizophrenia or other psychiatric disorders;
* Ongoing neuroleptic treatment;
* Uncorrected visual or auditory dysfunction (according to the volunteer's self-declaration);
* History of moderate to severe traumatic brain injury and / or intracranial surgery;
* Life threatening pathology (such as cancer) in remission for less than 1 year or still ongoing;
* General anesthesia in the last 6 months or planned in the next 6 months;
* Documented food allergy(ies), namely to one of the components of the study product;
* Psychological or linguistic incapability to sign the informed consent.
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
|
NCT02063646
|
{
"brief_title": "Effect of a Polyphenol-rich Food Supplement on Cognitive Function in Healthy Aging Adults",
"conditions": [
"Healthy Elderly"
],
"interventions": [
"Dietary Supplement: Placebo",
"Dietary Supplement: Polyphenol-rich extract"
],
"location_countries": [
"France",
"Canada"
],
"nct_id": "NCT02063646",
"official_title": "Effect of a Polyphenol-rich Food Supplement on Cognitive Function in Healthy Aging Adults: Randomized, Placebo-controlled, Double-blind Clinical Trial",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2015-03",
"study_completion_date(actual)": "2015-03",
"study_start_date(actual)": "2014-02"
},
"study_design": {
"allocation": "RANDOMIZED",
"interventional_model": "PARALLEL",
"masking": "QUADRUPLE",
"phase": [
"NA"
],
"primary_purpose": "PREVENTION",
"study_type": "INTERVENTIONAL"
},
"study_record_dates": {
"study_record_updates": {
"last_update_posted(estimated)": "2015-05-27",
"last_updated_that_met_qc_criteria": "2014-02-12",
"last_verified": "2014-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2014-02-14",
"first_submitted": "2014-02-12",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In patients where fluid is withdrawn from the bloodstream by Continuous Venovenous Hemofiltration (CVVH), the ultrafiltration rate will be calculated for a zero balance. From there, the ultrafiltration steps are performed, after increasing the ultrafiltration rate, the sublingual microcirculation is assessed by sidestream dark field (SDF). The images are subsequently randomly analyzed, and the sublingual microcirculation is expressed as a number, the microvascular flow index (MFI).
Detailed Description
Before deciding to threat a patient actively with CVVH, a target balance will be agreed for the next 12 hours. Then the ultrafiltration rate for the zero balance is calculated. From there, the ultrafiltration rate progressively increased to 50 ml per hour, up to a maximum ultrafiltration rate of 300 ml per hour.
After each increase of the ultrafiltration rate, the sublingual microcirculation is assessed by SDF.
After obtaining the desired ultrafiltration rate, the microcirculation will again be assessed before and after the patient is temporarily placed in Trendelenburg position. This could possibly show that underfill has the greatest influence on the microcirculation, and not other factors like a rising hematocrit.
|
#Eligibility Criteria:
Inclusion Criteria:
* > 18 yearsjaar
* informed consent
Exclusion Criteria:
* age < 18 jaar
* oral surgery
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
|
NCT01362088
|
{
"brief_title": "Microcirculation in Continuous Venovenous Hemofiltration Patients on the Intensive Care Unit",
"conditions": [
"Continuous Venovenous Hemofiltration"
],
"interventions": null,
"location_countries": [
"Netherlands"
],
"nct_id": "NCT01362088",
"official_title": "Evaluation of Sublingual Microcirculation by Means of SDF Imaging by Stepwise Ultrafiltration in CVVH Patients on the ICU",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2012-10",
"study_completion_date(actual)": "2012-10",
"study_start_date(actual)": "2011-09"
},
"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)": "2012-11-01",
"last_updated_that_met_qc_criteria": "2011-05-26",
"last_verified": "2012-10"
},
"study_registration_dates": {
"first_posted(estimated)": "2011-05-27",
"first_submitted": "2011-05-11",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
Assessment of right ventricular (RV) function in patients with acute respiratory syndrome (ARDS) is warranted because RV failure is frequent and associated with worse outcome. Transthoracic echocardiography is the cornerstone of RV assessment but it remains challenging. Quantification of RV deformation by speckle-tracking imaging echocardiography (STE) is a widely available and reproducible technique that readily provides an integrated analysis of all segments of the RV. This study aims to investigate the accuracy of STE-derived strain parameters in assessing RV function during ARDS.
|
#Eligibility Criteria:
Inclusion Criteria:
* patients with moderate or severe ARDS (Berlin definition)
* receiving mechanical ventilation (>48h estimated length)
* Transthoracic echocardiography performed during the first 36h after ICU admission
Exclusion Criteria:
* pregnancy
* protected or deprived of Liberty major
* chronic respiratory disease
* history of clinical right heart failure
* chronic heart failure with LVEF < 35%
* severe valvular heart disease
* under 18 or protected-adults
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
|
NCT02638844
|
{
"brief_title": "Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome",
"conditions": [
"ARDS"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT02638844",
"official_title": "ARDStrain : Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2017-07",
"study_completion_date(actual)": "2017-08",
"study_start_date(actual)": "2015-12"
},
"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)": "2018-02-05",
"last_updated_that_met_qc_criteria": "2015-12-21",
"last_verified": "2017-07"
},
"study_registration_dates": {
"first_posted(estimated)": "2015-12-23",
"first_submitted": "2015-12-16",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
#Study Description
Brief Summary
In secondary prevention, the beneficial role of cardiac rehabilitation programs after myocardial infarction, percutaneous coronary intervention or coronary artery bypass is now well established. The large majority of patients don't benefit from cardiac rehabilitation but for those who do, they usually follow an inhospital short health educational program with a sensibilisation to different coronary risk factors like smoking, overweight and inactivity. The impact of these inhospital short health educational programs combined to cardiac rehabilitation has never been totally evaluated, especially the impact on smoking cessation, weight loss and daily physical activity.
Therefore, the present study aims to evaluate the impact at one year on 400 consecutive patients' coronary risk profile of:
* an inhospital short health educational program alone
* an inhospital short health educational program combined to cardiac rehabilitation
* a cardiac rehabilitation program alone
Detailed Description
Classical CV risk factors, quality of life, daily physical activity and energy expenditure, smoking dependency and a daily quantification of fat intake are assessed with previously validated self-administrated questionnaires. Further factors like the lipid profile and glycaemia (with HbA1c in case of diabetes) will also be assessed. These evaluation will take place once at the of the hospitalization for acute coronary events in all patients, once at the end of any of the three rehabilitation programs for the concerned patients and, finally, one year after the hospitalization or the end of the rehabilitation program (mailed questionnaires and biological check-up). At this time, smoking dependency, medication, body mass index, any coronary event or need of coronary revascularization along with the professional ongoing situation (return to work) will be investigated.
As this study aims to evaluate the efficiency of France's clinical practice in spotting most relevant risk factors, the results of the present study could help us to focus the medical and paramedical resources on the modification of specific relevant risk factors.
|
#Eligibility Criteria:
Inclusion Criteria:
* acute coronary syndrome or myocardial infarcts
Exclusion Criteria:
* misunderstand the questionnaires
* living in institution
* severe morbidity
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
|
NCT00758810
|
{
"brief_title": "Impact at One Year of a Secondary Prevention Educational Program on Cardiovascular Risk Factors",
"conditions": [
"Myocardial Infarction",
"Acute Coronary Syndrome"
],
"interventions": null,
"location_countries": [
"France"
],
"nct_id": "NCT00758810",
"official_title": "Impact at One Year of a Secondary Prevention Educational Program on Cardiovascular Risk Factors, Daily Physical Activity, Dietary Habits and Blood Glucose and Fatty Acids in Coronary Syndromes Patients",
"recruitment_information": {
"primary_completion_date(actual)(final_data_collection_date_for_primary_outcome_measure)": "2009-06",
"study_completion_date(actual)": "2009-06",
"study_start_date(actual)": "2006-10"
},
"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)": "2009-06-17",
"last_updated_that_met_qc_criteria": "2008-09-24",
"last_verified": "2009-06"
},
"study_registration_dates": {
"first_posted(estimated)": "2008-09-25",
"first_submitted": "2008-09-24",
"first_submitted_that_met_qc_criteria": null
}
}
}
|
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