louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02918799: Pilot of Mpowerment for Young Men Who Have Sex With Men (YMSM) in Beirut
Official title: Pilot of Culturally Tailored Mpowerment for HIV Prevention Among YMSM in Beirut
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Lebanese AIDS Society
name: Arab Foundation for Freedom and Equality
name: University of California, San Francisco
name: AIDS Project Los Angeles
First posted: 2016-09-29
Enrollment: 226
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention will be evaluated with community cohort and use of pre- post-intervention analysis plan
Primary purpose: PREVENTION

Brief summary: This project will adapt and pilot a multi-level, community-based intervention to promote HIV prevention and sexual health among young men who have sex with men in Beirut.

Detailed description: Mpowerment (MP) is an evidence-based community-level, structural, social and behavioral intervention for HIV prevention developed for YMSM that targets individual and community empowerment and mobilization, self-affirmation, sexual self-knowledge, and creation of a supportive social environment. MP has been widely used in the U.S., but not in a mostly Muslim setting. This project will adapt and pilot MP for the sociocultural issues facing YMSM (age 18-29) in Beirut. There will be a 2-year pilot implementation of MP, with longitudinal cohorts of YMSM in Beirut and Jounieh, the latter being the control community. Primary outcomes will be unprotected anal sex and HIV testing, with secondary outcomes being engagement in peer outreach, and perceived peer norms related to condom use and HIV testing.

Eligibility criteria: Inclusion Criteria:

* men aged 18-29, who have had anal sex with men in the past 6 months

Exclusion Criteria:

* not residing in Lebanon

Primary outcomes:
measure: condomless anal sex
timeFrame: past 3 months
measure: HIV testing
timeFrame: past 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: RAND
name: Glenn Wagner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05755399: Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor
Official title: Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cranial Neurosurgery
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Transcranial focused ultrasound (tFUS) offers a platform for non-invasive imaging and treatment of the brain and pathology of the brain -- allowing high resolution imaging in both spatial and temporal dimensions. Compared with the gold- standard for brain imaging, magnetic resonance imaging (MRI), ultrasound offers reduced contrast while providing improved sampling in time through a significantly more cost-effective approach. In addition, while MRI is used to guide invasive treatments, only ultrasound can offer treatments through three primary mechanisms: 1) neuromodulation, 2) blood brain barrier modulation, and thermal/mechanical ablation through high intensity focused ultrasound (HIFU). All three treatment options require targeting therapy through the skull, which remains a barrier to clinical translation. This proposal is to test the feasibility of acquiring noninvasive targeting imaging intraoperatively prior to clinically indicated cranial neurosurgery. By acquiring volumetric ultrasound images while coregistered to previously obtained stereotactic magnetic resonance imaging, the study will be able to compare the ability of tFUS to identify and focus on brain pathology.


Eligibility criteria: Inclusion Criteria:

* Able to undergo informed consent
* Scheduled and present for brain surgery
* General Anesthesia planned
* Neuronavigation used for surgery
* Thin cut post-contrast imaging available for coregistration
* At least 18 years of age

Exclusion Criteria:

* Awake craniotomy planned
* Unhealed wounds or infection of scalp
* Diseases and conditions that would increase the morbidity and mortality of craniotomy and tumor resection (e.g. cardiopulmonary issues) in the opinion of the PI.
* Pregnancy (also generally required for surgery)

Primary outcomes:
measure: Test feasibility
timeFrame: baseline
Secondary outcomes:
measure: Volume assessment
timeFrame: Baseline
measure: Morphology assessment
timeFrame: Baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: David Darrow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05736042: Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery
Official title: Microinterventional Endocapsular Nuclear Fragmentation Assisted Cataract Surgery Versus Conventional Phacoemulsification Using Divide-and-conquer: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nuclear Cataract
Keywords: LOCS III grade 5 or more
Lead sponsor: Oogziekenhuis Rotterdam
Sponsor class: OTHER
Collaborators: name: Stichting Wetenschappelijk Onderzoek Het Oogziekenhuis Prof.dr H.J. Flieringa
name: Carl Zeiss Meditec AG
First posted: 2023-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rationale: In cataract surgery, fragmentation of a hard nucleus requires relatively much ultrasound energy. It is suspected that the level of energy used is associated with the degree of corneal endothelial loss. Recently, it was demonstrated that with miLOOP (Zeiss Meditec) assisted nuclear fragmentation ultrasound energy can be substantially reduced.

Objective: To compare miLOOP assisted cataract surgery and conventional surgery with respect to the energy needed for phacoemulsification and loss of corneal endothelial cells.

Study design: Randomized, controlled trial. Study population: Patients with nuclear cataract of a grade ≥ 5. Intervention: Microinterventional endocapsular nuclear fragmentation. Main study parameters: Cumulative dispersed ultrasound energy (CDE) and endothelial cell loss.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Informed consent.
* Advanced visually significant nuclear sclerosis grade ≥ 5 (LOCS III).

Exclusion Criteria:

* Endothelial cell density (ECD) \< 1500 mm-2.
* Corneal opacification (any cause).
* Corneal surgery or trauma.
* Implant lens.
* Refraction surgery.
* Prior glaucoma surgery.
* Pseudoexfoliation.

Primary outcomes:
measure: Ultrasound cumulative dispersed energy (CDE)
timeFrame: During surgery
measure: Change of corneal endothelial cell density (ECD)
timeFrame: Preoperative and at 3 months
Secondary outcomes:
measure: Procedure time
timeFrame: During surgery
measure: Peri-operative complications
timeFrame: During surgery
measure: Postoperative complications
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Oogziekenhuis Rotterdam
Study officials:
References:
Clinical trial NCT00840242: Smoking Reduction or Cessation With Nicotine Replacement Therapy
Official title: Smoking Reduction or Cessation With Nicotine Replacement Therapy. A Placebo Controlled Double Blind Trial With Nicotine Gum or Inhaler.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2009-02-10
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the success rate of smoking reduction or cessation with different nicotine products.

Detailed description: To test if smoking reduction or cessation is induced with different nicotine products and to investigate the possible health benefits of smoking reduction

Eligibility criteria: Inclusion Criteria:

* Age above 18
* Smoking \>/= 15 cigarettes/day
* Having smoked for 3 years or more
* CO \>/= 10ppm at inclusion
* Want to reduce smoking
* Prepared to adhere to the protocol
* Willing to provide signed informed consent
* Having made at least one serious attempt to quit smoking

Exclusion Criteria:

* Unstable angina pectoris, myocardial infarction within the last three months
* Use of other nicotine-containing products such as cigars, pipes, snuff
* Current use of NRT or involved in behavioral or pharmacological smoking cessation/reduction program
* Pregnancy/lactation or intended pregnancy
* Under psychiatric care or medication that might interfere with the trial
* Abuse of alcohol or any other drug

Primary outcomes:
measure: Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels
timeFrame: Baseline to 6 weeks, 3 and 4 months
Secondary outcomes:
measure: Changes in laboratory values of cardiovascular risk factors
timeFrame: Baseline up to 12 months
measure: Changes in clinical and laboratory exposure parameters
timeFrame: Baseline up to 12 months
Other outcomes:
Locations:
city: Kutna Hora
country: Czech Republic
facility: Smoking Cessation Clinic
city: Prague
country: Czech Republic
facility: Institute of Hygiene and Epidemiology
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT07006142: Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists
Official title: Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Endoscopy
GLP1-R-related Disease
Keywords: GLP1 receptor agonists
upper endoscopy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study has 3 arms, but two of them are historical cohorts (i.e. previous patients who have already been taken care of). One group will consist of patients who are not on GLP1 medications who underwent upper endoscopy, and another group will consist of patients who are on GLP1 medications who underwent upper endoscopy. The third group is the prospective group who are being enrolled and recruited - this group will consist of patients who are on GLP1 medications who abide by a modified fasting guideline consisting of a full-liquid diet 48 hours prior to procedure, clear liquid diet 24 hours prior to procedure, and no liquids or solids after midnight on the day of upper endoscopy.
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine whether a modified fasting protocol can reduce the potential risk of aspiration for patients currently prescribed GLP1-RAs.

Detailed description: The overall objective of this project is to identify a reasonable means by which patients on GLP1-RAs can be safely cared for in the perioperative period that can be agreed upon by all groups involved in perioperative patient care. This will be assessed in patients undergoing upper endoscopy specifically since assessment of gastric contents would be minimally invasive for this patient population receiving anesthetic care.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective upper endoscopy with gastroenterology team

Exclusion Criteria:

* Urgent or emergent procedure
* Inclusion of colonoscopy or antegrade small bowel enteroscopy in planned procedure
* Upper GI barium study performed in past 24 hours.
* Gastroparesis
* Achalasia
* Pancreatitis
* Use of outpatient pro-motility medications
* Patient refusal
* Inability for patient to provide own consent

Primary outcomes:
measure: Gastric contents
timeFrame: Baseline
Secondary outcomes:
measure: Diagnosis of aspiration within 72 hours of procedure
timeFrame: From the time of upper endoscopy until 72 hours post-procedure.
measure: Aspiration pneumonitis diagnosis postoperatively
timeFrame: 72 hours after completion of upper endoscopy
measure: Postprocedural ICU admission
timeFrame: Immediately after upper endoscopy
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
References:
Clinical trial NCT02362542: Effect of Transcranial Direct Current Stimulation (tDCS) on Appetite Control Related Brain Regions
Official title: Effect of Transcranial Direct Current Stimulation (tDCS) on Appetite Control Related Brain Regions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Chungbuk National University
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of Transcranial Direct Current Stimulation (tDCS) on appetite control related brain regions.

Detailed description: Transcranial direct current stimulation (tDCS) is emerging tool for brain modulation in a variety of clinical conditions. In addition, recent neuroimaging studies suggest that modifying the activity of brain circuits involved in eating behavior could provide therapeutic benefits in obesity.

The investigators aim to assess whether modulation of the dorsolateral prefrontal cortex (DLFPC) using tDCS, modifies behavioral response and brain activity while watching visually presented food cues in obese subjects.

Subjects will receive tDCS two times, one is active stimulation and the other is sham stimulation. Both stimulations will be separated at least one week and the order of sham and active tDCS will be counterbalanced across subjects.

Subjects will perform functional MRI experiments with visual food cues. Questionnaire with behavior measures, body compositions, blood tests will be performed.

Eligibility criteria: Inclusion Criteria:

* BMI \> 28 kg/m2

Exclusion Criteria:

* history of brain trauma, epilepsy, or other neurological problems

Primary outcomes:
measure: Regional brain activity measured by blood-oxygen-level dependent (BOLD) signal of functional MRI
timeFrame: Immediately after intervention
Secondary outcomes:
measure: Behavior outcomes on the visual analog scale
timeFrame: Immediately after intervention
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University
state: Chungcheongbuk-Do
Study officials:
References:
Clinical trial NCT00677742: The Impact of Pack Supply on Birth Control Pill Continuation
Official title: Impact of Pack Supply on Oral Contraception Continuation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Contraception
Keywords: oral contraception
hormonal contraception
contraceptive behavior
patient compliance
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2008-05-14
Enrollment: 700
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether getting more packs of birth control pills leads to improved continuation, when compared with getting the traditional supply.

Detailed description: Discontinuation of oral contraceptive use in the initial months is common; successful early continuation is predictive of long term continuation and prevention of unintended pregnancy. The conventional approach to initiation of hormonal contraceptives in publicly funded clinics across the United States is to give the patient a limited supply of OCs, or a prescription with a limited number of refills, and then have her return to the clinic for a refill. This approach requires the patient to make frequent visits to the clinic, a barrier to method continuation.

This randomized trial will evaluate a simple but potentially powerful change in family planning clinic practice, i.e., the effect of dispensing more versus fewer cycles of oral contraception (OC). The study will be carried out in an urban, publicly funded family planning clinic that serves a population that is poor, young and primarily Hispanic or AfricanAmerican. This population was targeted as its members are at increased risk of discontinuing contraception in the ﬁrst year of use.

Eligibility criteria: Inclusion Criteria:

* English or Spanish speaker
* age less than or equal to 35 years requesting OC as their primary method of contraception
* currently sexually active or anticipating sexual activity within the next 30 days

Exclusion Criteria:

* contraindications to oral contraceptives per clinic protocol (e.g., hypertension and pregnancy)
* currently using OCs (that is, current users requesting a routine refill)
* desiring pregnancy within the next 6 months
* leaving the clinic catchment area within 6 months
* previous participation in this study

Primary outcomes:
measure: oral contraception continuation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center, Family Planning Clinic
state: New York
Study officials:
affiliation: Columbia University
name: Katharine O'Connell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: White KO, Westhoff C. The effect of pack supply on oral contraceptive pill continuation: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):615-622. doi: 10.1097/AOG.0b013e3182289eab.
Clinical trial NCT01884142: Effects of Exercise Training on Mechanoreflex and Metaboreflex Control in Heart Failure Patients
Official title: Effects of Exercise Training on Mechanoreflex and Metaboreflex Control of Muscle Sympathetic Nerve Activity in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2013-06-21
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that exercise training would improve the mechanoreflex and metaboreflex control in heart failure patients.


Eligibility criteria: Inclusion Criteria:

* Patients with systolic heart failure;
* New York Heart Association (NYHA) class II-III;
* Left ventricular ejection fraction less than 40%;
* Peak Oxygen Consumption less than 20 ml/Kg/min;
* Stable Clinical Status.

Exclusion Criteria:

* Chronic Obstructive Pulmonary Disease;
* Neuromuscular Diseases;
* Orthopedic Diseases;
* Neurologic Diseases;
* Neoplastic Diseases;
* Recent myocardial infarction or cardiac surgery (less than 6 months);
* Unstable angina pectoris;
* Atrial Fibrillation;
* Pacemakers users;
* Changing medication or hospital admission.

Primary outcomes:
measure: Autonomic Control
timeFrame: 4 months
measure: Muscular Evaluation
timeFrame: 4 months
Secondary outcomes:
measure: Functional Capacity
timeFrame: 4 months
measure: Muscle Blood Flow
timeFrame: 4 months
measure: Blood Pressure
timeFrame: 4 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor), University of Sao Paulo Medical School
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Carlos E Negrão, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Unable to connect to PubMed to validate , last attempt on June 19, 2013 at 12:03 PM EDT
Clinical trial NCT00248742: Psychobiology in Inflammatory Bowel Disease(IBD)
Official title: The Impact of Psychobiological Factors in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease
Keywords: IBD, psychological, stress management
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Aker
name: Haukeland University Hospital
name: University of Bergen
name: Lübeck University Clinic
name: University Hospital, Akershus
First posted: 2005-11-04
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with ulcerous colitis and Crohn's disease, age 18-60, with a relapse within the last 18 months and an activity index ≥4, with a long time stress level ≥60 on the perceived stress questionnaire (PSQ) were randomized to a stress management intervention program or treatment as usual and followed up for 18 months.

Detailed description: The study includes distressed patients with ulcerous colitis and Crohn's disease with relapse or enduring activity last 18 months and an simple activity index ≥4, on stable medication last 4 weeks. All patients were followed by a gastroenterologist at baseline, 3, 6, 12 and 18 months follow up and a psychiatrist or clinical psychologist at 18 months. Half of the patients received additional psychosocial intervention (education, relaxation, supportive psychotherapy with stress management). Assessments include gastrointestinal assessments; blood tests; psychiatric evaluations and psychometric evaluations.

Eligibility criteria: Ulcerous colitis and Crohn's disease verified by histology and endoscope Relapse last 18 months or enduring activity Activity index≥4 PSQ≥60

Primary outcomes:
measure: Improvement in activity index.
timeFrame: 18 months
Secondary outcomes:
measure: Reduction of inflammatory parameters.
timeFrame: 18 months
measure: Reduction in number of relapses.
timeFrame: 18 months
measure: Quality of life improvement
timeFrame: 18 months
measure: Psychobiological factors related to improvement
timeFrame: 18 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: RRHF
Study officials:
affiliation: Psychological behavioral intervention based on cognitive behavioral methods
name: Georg Høyer, MD
role: STUDY_DIRECTOR
References: