louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04571541: Endoscopic Management of Esophageal Wall Defects
Official title: Outcomes of Endoscopic Management of Esophageal Wall Defects at a Large Referral Center
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Fistula
Esophageal Perforation
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who present who our medical center with existing esophageal wall defect seeking endoscopic treatment and management

Brief summary: The study aim at comparing outcomes from the implementation of various endoscopic closure techniques including stenting and suturing on the healing and resolution of esophageal wall defects.

Detailed description: Esophageal wall defects are a rare but potentially life-threatening subset of luminal pathology which usually require timely intervention in order to reduce the known associated high morbidity and mortality. These defects can be due to surgical and endoscopic procedures, such as post-operative leaks and fistulas and perforations complicating endoscopic dilation. In addition, defects can occur spontaneously due to Boerhaave's syndrome or following chemoradiation treatments of esophageal or other chest malignancies. Surgical management was historically the mainstay of therapy for these defects with conservative management remaining an alternative in poor surgical candidates. Over the last several years however, interventional endoscopy has played an increasing role in treatment of esophageal wall defects, with endoscopic stenting quickly becoming a viable alternative. Temporary stents including the fully covered self-expandable metal stents (FC-SEMS), partially covered self-expandable metal stents (P-SEMS) and self-expandable plastic stents (SEPS) have all been successfully used and have become increasingly regarded as the new standard of care.

Indiana University is a tertiary referral center is a destination for complex thoracic surgery, oncology and esophageal disease referrals. The innovative luminal endoscopy team started employing a several modalities including flexible endoscopic suturing and stenting to close esophageal defects. To our knowledge, there is a dearth of data on outcomes associated with multi-modality esophageal defect closure techniques and little to no data comparing this approach to the current standard of care of stenting alone or surgery.

Eligibility criteria: Inclusion Criteria:

* Any patient with spontaneous or iatrogenic esophageal wall defect

Exclusion Criteria:

* None

Primary outcomes:
measure: Resolution of esophageal wall defect
timeFrame: 7/1/2014 to 7/1/2022
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
References:
Clinical trial NCT00167141: Contraception in Normal and Subnormal Men
Official title: Hormonal Male Contraception in Men With Normal and Subnormal Semen Parameters
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Healthy
Keywords: male fertility
semen parameters
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 41
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis.

Detailed description: Volunteers with normal and subnormal semen parameters receive a hormonal male contraceptive in order to investigate whether there are differences between normal and subnormal men in terms of suppressibility, rate of azoospermia and reversibility of suppression of spermatogenesis. Twenty-five men will be recruited for each group. They will be exposed to hormonal male contraception for six months.

Eligibility criteria: Inclusion Criteria:

* Volunteers with normal and subnormal semen parameters

Primary outcomes:
measure: semen parameters
timeFrame: 2005 - 2008
Secondary outcomes:
measure: hormones
timeFrame: 2005 2008
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Prof. Dr. Eberhard Nieschlag
Study officials:
affiliation: Institute of Reproductive Medicine
name: Eberhard Nieschlag, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00766441: Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan
Official title: Sitagliptin Versus Sulphonylurea Based Treatments in Muslim Patients With Type 2 Diabetes During Ramadan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Diabetes
Hypoglycemia
Keywords: diabetes
hypoglycemia
ramadan
fasting
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2008-10-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess if Sitagliptin addition to metformin or glitazone is better than current sulphonylurea based treatments during Ramadan. The rationale is that Sitagliptin offers metabolic advantages primarily with the low incidence of hypoglycemia over current sulphonylurea based treatments.

Detailed description: To define metabolic alterations during Ramadan:

1. Primary end point: Occurrence of hypoglycemia. The patients will record hypoglycaemic episodes in a self-monitoring diary together with blood glucose values.
2. Secondary endpoints: Body weight, fasting blood sugar (FBS), glycosylated haemoglobin (HbA1c)/Fructosamine, triglycerides (TG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C) and high density lipoprotein-cholesterol (HDL-C).
3. A subgroup will undergo CGMS assessment to define glycaemic excursions during and after fasting.

Eligibility criteria: Inclusion Criteria:

1. Muslim men and women with Type 2 diabetes.
2. Age 18-78 years
3. Intending to fast during the month of Ramadan
4. On oral antihyperglycemic agents (sulphonylurea based/combination therapy)

Exclusion Criteria:

1. Patient with hypersensitivity or contraindication to Sitagliptin treatment
2. Patient with CKD (creatinine clearance \<50 ml/min)
3. Patients who have participated in another intervention study in the last 2 months
4. Patients who do not give informed consent
5. Pregnant or breast feeding women.
6. Patients on insulin
7. Patients with severe liver disease

Primary outcomes:
measure: Occurrence of hypoglycemia
timeFrame: 4 weeks during Ramadan
Secondary outcomes:
measure: Body weight, fasting blood sugar, HbA1c, triglycerides, total cholesterol, LDL-C, HDL-C. CGMS to define glycaemic excursions
timeFrame: 4 weeks during Ramadan
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Wellcome Trust Clinical Research Facility
Study officials:
affiliation: University of Manchester
name: Rayaz A Malik, MBChB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00752141: Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers
Official title: Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-09-15
Enrollment: 153
Sex: ALL
Minimum age (years): 60
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to explore the possible cognitive effects of oxybutynin tablets and oxybutynin gel.


Eligibility criteria: Inclusion Criteria:

* Males and females aged 60 and over
* English as a primary language
* Given written informed consent by signing and dating an informed consent form prior to study entry

Exclusion Criteria:

* Current diseases in which the use of oxybutynin is contraindicated
* History of narrow-angle glaucoma or urinary or gastric retention
* Current use of drugs known to effect memory and cognition

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Measure of accuracy of delayed recall name-phase association test
timeFrame: one week
Secondary outcomes:
measure: Effects on other cognitive domains measured by various tests
timeFrame: one week
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: National City
country: United States
state: California
city: Maitland
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
Study officials:
References:
citation: Kay GG, Staskin DR, MacDiarmid S, McIlwain M, Dahl NV. Cognitive effects of oxybutynin chloride topical gel in older healthy subjects: a 1-week, randomized, double-blind, placebo- and active-controlled study. Clin Drug Investig. 2012 Oct 1;32(10):707-14. doi: 10.1007/BF03261924.
Clinical trial NCT02173041: Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User
Official title: Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User: Results of the Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorder
Drug Dependence,
Alcohol Dependence
Keywords: Prevention and Awareness Groups (PAG),
Substance Use Disorder,
Community based intervention
Lead sponsor: Macmillan Research Group UK
Sponsor class: INDUSTRY
Collaborators: name: NMP Medical Research Institute
name: Warwick Research Services
First posted: 2014-06-24
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Substance Use Disorder has been showing a rising trend all over the world including India. The project tested whether a Integrated community wide effort of Prevention and Awareness Groups (PAG) to manage substance use would have a greater effect on treatment attendance and drug abstinence than a de-addiction program alone.


Eligibility criteria: Inclusion Criteria:

* suburban, rural Population
* Drug and/or alcohol dependency (DSM-IV substance use disorders criteria)

Exclusion Criteria:

* Did not consent to participate
* Planning to move or relocate
* Severe mental disorder

Primary outcomes:
measure: Treatment attendance
timeFrame: Change from baseline to six month
Secondary outcomes:
measure: Drug abstinence
timeFrame: Change from baseline to six month
Other outcomes:
measure: Quality of Life assessed by General Health Questionnaire (GHQ)
timeFrame: Change from baseline to six months
Locations:
city: Bai, Nawalgarh
country: India
facility: GyanSanjeevani
state: Rajasthan
Study officials:
affiliation: Goldington Family Centre
name: Valerie Murray, MA
role: STUDY_DIRECTOR
affiliation: NMP Medical Research Institute
name: Neha Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NMP Medical Research Institute
name: Amit Punia, LLB
role: STUDY_CHAIR
References:
Clinical trial NCT06006819: Prognostic Markers of Acute Heart Failure With Chronic Kidney Disease
Official title: Plasma Proteomic Signature and the Prognosis of Acute Heart Failure With or Without Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Acute Heart Failure
Biomarker
Lead sponsor: Cheng-Hsin General Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 155
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study participants were recruited from patients admitted to Cheng Hsin General Hospital with the major diagnosis of acute heart failure. After written informed consent was obtained (in compliance with the Helsinki Declaration), patients with age more than 20 were included. Exclusion criteria were initial serum NT-proBNP level \<300ng/ml, the presence of amputation, being pregnant, and receiving regular dialysis.

Brief summary: Acute heart failure (AHF) is defined as new or worsening of symptoms and signs of heart failure and is the most frequent cause of unplanned hospital admission in elderly patients. N-terminal pro-brain natriuretic peptide (NT-pro-BNP) is one of the most developed prognostic markers for AHR patients and. NT-pro-BNP has limitations in terms of diagnostic or predictive accuracy in patients with chronic kidney disease (CKD). Plasma proteomics have the potential to examine underlying pathophysiological and prognostic roles, so we compared the plasma proteomic signature to predict outcomes of patients with or without CKD hospitalized for AHF.


Eligibility criteria: Inclusion Criteria:

* hospitalized for acute heart failure

Exclusion Criteria:

* initial serum NT-proBNP level \<300ng/ml, pregnancy, amputated, and end-stage renal disease under regular dialysis

Primary outcomes:
measure: major adverse cardiovascular events
timeFrame: 1 year
Secondary outcomes:
measure: major adverse kidney events
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
state: Baitou District
Study officials:
affiliation: Cheng-Hsin General Hospital
name: Shang Feng Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00949819: Active Surveillance for Cancer of the Prostate (ASCaP)
Official title: The UCLA ASCAP Project is an Observational, Longitudinal, and Open-ended Study Aimed at Establishing a Structured Program of Non-interventional Follow-up for Localized Prostate Cancer.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Low risk
Gleason 6
Active surveillance
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 462
Sex: MALE
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: Active Surveillance (A.S.) of prostate cancer (CaP) is the systematic monitoring of men with low-risk, localized lesions, with curative treatment of those whose tumors show substantial progression. A.S. is different from Watchful Waiting (W.W.), which is the palliative treatment of men with progressive prostate cancer.

Detailed description: This protocol is not designed as a formal clinical trial, but rather an observational protocol; no treatments and no randomization are included. Longitudinally, specimens and clinical data will be collected to provide information on the following:

* Imaging studies of the prostate
* Rates of curative intervention
* Measures of tumor recurrence/progression
* Disease specific survival
* Overall survival
* Clinical data to track Quality of Life

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of the prostate.
2. Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
3. No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
4. Patient has elected Active Surveillance as preferred management plan for prostate cancer.
5. Patient consent has been obtained according to local Institutional Review Board .
6. Patient is accessible and compliant for follow-up.

Exclusion Criteria:

1. Unwillingness or inability to undergo serial prostate biopsy.
2. Overall life expectancy less than 2 years
3. Advanced prostate cancer

Primary outcomes:
measure: Discover and confirm clinical parameters that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables.
timeFrame: Interim data analysis will be made every year
Secondary outcomes:
measure: Determine the clinical predictors of disease progression. Measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer. Determine factors that lead to active intervention
timeFrame: Interim data analysis will be done each year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Leonard S Marks, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06038019: Thresholds In Food Allergy evaluaTion And predictioN
Official title: Thresholds In Food Allergy evaluaTion And predictioN, a Prospective, Multicentre Registry Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tree Nut Allergy
Food Allergy
Keywords: Immunotherapy
Food Allergy
Diagnosis
Prognosis
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: AAAAI Foundation
name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-09-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients suspected or confirmed to be food allergic

Brief summary: Thresholds In food allergy evaluaTion And predictioN, a prospective, observational registry. The aim is to quantify food allergy thresholds in Canada and their clinical predictors.


Eligibility criteria: Inclusion Criteria:

1. Suspicion or history of food allergy based on medical history, positive skin prick test, and/or serum food-specific IgE. A suggestive history is defined as typical clinical signs and/or symptoms (urticaria, angioedema, abdominal pain, vomiting, dyspnea, wheeze) within 60 minutes of the ingestion of a food.
2. Ability to discontinue all antihistamines for 1 week before oral food challenge.

Exclusion Criteria:

1. Previous desensitization treatment to a food allergen
2. Allergies to any component of the oral challenge vehicle
3. Unstable conditions including uncontrolled asthma or chronic urticaria
4. Any clinically significant disease/chronic medical condition which may interfere with study evaluations.

Primary outcomes:
measure: Eliciting dose thresholds to food challenge
timeFrame: 1 year
Secondary outcomes:
measure: Food Allergy Quality of Life Questionnaire Child Form
timeFrame: 1 year
measure: Food Allergy Quality of Life Questionnaire Teen Form
timeFrame: 1 year
measure: Food Allergy Quality of Life Questionnaire Adult Form
timeFrame: 1 year
measure: Food Allergy Quality of Life Questionnaire Parent Form
timeFrame: 1 year
measure: Skin Prick Testing
timeFrame: 1 year
measure: Specific IgE
timeFrame: 1 year
measure: Basophil Activation Test
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences & McMaster University
name: Derek Chu, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06117319: Immersive Technology and Virtual Reality as a Health Support Tool in a Residence for the Elderly
Official title: Development and Validation of Sports Facilities in a Supportive Environment to Improve the Well-being of the Elderly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging Well
Keywords: Aging well
virtual reality
activity
learning
Lead sponsor: TOPMED
Sponsor class: OTHER
Collaborators: name: Conseil de recherches en sciences naturelles et en génie du Canada
name: SEC Fonds Immobilier Groupe Maurice
First posted: 2023-11-07
Enrollment: 48
Sex: ALL
Minimum age (years): 64
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups with different learning modalities (individual feedback compared to collective feedback)
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this clinical trial is to learn more about the potential for using virtual reality in older adults living in residences for elderly to maintain health (physical activity, cognitive activity, social behaviors). The main questions it aims to answer are:

* To what extent can virtual reality be a tool to support health in older adults?
* What are the support needs of older adults in learning to use this immersive technology?

Participants are invited to complete 5 training sessions on the use of a virtual reality headset. At the beginning and end of each session, participants will complete a questionnaire on their perception of their experience. During the sessions, the participants are asked to test games that mobilize the upper limbs. Two learning modalities are set up in two separate groups. These modalities aim to test two different support formulas in order to compare the support needs of the elderly in the use and integration of virtual reality to support the activities and health of this population.


Eligibility criteria: Inclusion Criteria:

* Independent person living in the sponsor's retirement home

Exclusion Criteria:

* Having a pacemaker
* Being at risk for epilepsy

Primary outcomes:
measure: Learning of virtual reality tasks
timeFrame: During each 45 minutes intervention session, up to 6 weeks
measure: Ease
timeFrame: Immediately after each 45 minutes intervention session, up to 6 weeks
measure: Sense of control: measurement of the participants' sense of control using a scale from 1 to 5
timeFrame: Immediately after each 45 minutes intervention session, up to 6 weeks
measure: Satisfaction with supervision
timeFrame: Immediately after each 45 minutes intervention session, up to 6 weeks
Secondary outcomes:
measure: Stress Level at the start of the session
timeFrame: Immediately before each 45 minutes intervention session, up to 6 weeks
measure: Desire to play virtual reality games
timeFrame: Immediately before and after each 45 minutes intervention session, up to 6 weeks
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Edith Martin
Study officials:
References: