louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05180539: A Multi-Component Alcohol and Sex Risk Intervention for College Students
Official title: A Multi-Component Alcohol and Sex Risk Intervention for College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: College Drinking
Lead sponsor: Lehigh University
Sponsor class: OTHER
Collaborators: name: Brown University
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-01-06
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hazardous alcohol use, sexually transmitted infections, and sexual violence are interrelated and highly prevalent public health concerns in college student populations. The current study seeks to develop a tri-pronged sex-positive intervention that addresses risky alcohol use, unsafe sex, and sexual violence for college men and women (ages 18-24). The study involves a small randomized pilot trial to demonstrate the feasibility and acceptability of the recruitment methods and research design. Preliminary evidence of intervention efficacy will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Must be student at the site university

Exclusion Criteria:

* Students who have participated in relevant site specific studies will be excluded

Primary outcomes:
measure: Primary Outcome: Program Satisfaction as Assessed by the Acceptance Questionnaire After First Intervention Session
timeFrame: Immediate post intervention (same day as intervention), after first session on day 1
measure: Program Satisfaction as Assessed by the Acceptance Questionnaire After Second Session
timeFrame: Immediate post intervention (same day as intervention), after second session on ~Day 14
measure: Heavy Alcohol Use
timeFrame: Change from baseline to 6 month follow-up
measure: Alcohol Use Before or During Sex
timeFrame: Change from baseline to 6 month follow-up
measure: Bystander Behaviors Willingness Questionnaire
timeFrame: Change from baseline to 6 month follow-up
measure: Bystander Behaviors Self-efficacy Questionnaire
timeFrame: Change from baseline to 6 month follow-up
Secondary outcomes:
measure: Alcohol and Sex Related Protective Behavioral Strategies Use
timeFrame: Change from baseline to 6 month follow-up
measure: Perceived Student Drinking Norms as Assessed by the Drinking Norms Rating Form
timeFrame: Change from baseline to 6 month follow-up
measure: Perceived Student Sex Norms as Assessed by a Sex Norms Questionnaire
timeFrame: Change from baseline to 6 month follow-up
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Lehigh University
state: Pennsylvania
Study officials:
affiliation: Lehigh University
name: Lucy Napper, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Shannon Kenney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02077439: Interactive Intention-Driven Upper-Limb Training Robotic System
Official title: Trial: Interactive Intention-Driven Upper-Limb Training Robotic System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Hand
Upper Extremity
Robotics
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine robotic hand system is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in subjects after stroke.

Detailed description: This study will investigate the recovery in hand and upper limb functions when the physical training is assisted by an exoskeleton robotic hand system.

Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.

During the training, you will be asked to do the hand open and hand grasp by Electromyography-driven robotic control strategy.

There will be evaluations on the upper limb motor functions before and after the 20-session of training and follow up session by clinical assessments on functional recovery.

Eligibility criteria: Inclusion Criteria:

* Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.

Exclusion Criteria:

* Excessive spasticity of the affected arm
* Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months
measure: Action Research Arm Test
timeFrame: Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months
Secondary outcomes:
measure: Wolf Motor Function Test
timeFrame: Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months
measure: modified Ashworth Scale
timeFrame: Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Raymond KY Tong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05066139: Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)
Official title: Monocentric Randomized Study Evaluating the Impact of an Early Multidisciplinary Program in Elderly Subjects Starting a Chemotherapy for Digestive Cancer: Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Digestive System Disease
Neoplasms
Keywords: Digestive cancer
supportive care
gastrointestinal cancer
Lead sponsor: Institut de cancérologie Strasbourg Europe
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 144
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a monocentric, comparative, open-label, randomized parallel group study enrolling elderly subjects hospitalized in Strasbourg Europe Cancerology Institute (ICANS), starting chemotherapy or targeted therapy for the treatment of digestive cancer.

Detailed description: At the ICANS an EPODIG-G program, consisting in a coordination of supportive care that are existing in the Institute, is proposed to elderly patients with digestive cancer. The purpose of this study is to evaluate the impact of this early multidisciplinary geriatric program (EPODIG-G), when it is initiated before therapeutic treatment.

Eligibility criteria: Inclusion Criteria:

* Patients must be ≥ 75 years old
* Performance status 0, 1 or 2
* Diagnostic of digestive cancer, all stages (adjuvant or metastatic), with an indication for chemotherapy treatment or targeted therapy
* Patients previously treated with one or several lines of chemotherapy for this digestive cancer are eligible
* Estimated life expectancy ≥ 3 months
* Patients able to speak, read and understand French
* Signed informed consent from the patient
* Patients must have a social security coverage

Exclusion Criteria:

* History of differentiated neuroendocrine tumors grade 1 or 2 (pancreas, small intestine)
* History of another treated cancer during the last five years
* History of major surgery and/or curative radiation therapy during the last 4 weeks before inclusion
* Patients unable to submit to medical follow-up for geographical, social or psychological reasons
* Patients placed under guardianship

Primary outcomes:
measure: Impact of EPODIG-G program on treatment.
timeFrame: 24 weeks after treatment initiation
Secondary outcomes:
measure: Dose-intensity evaluation. Cumulative doses and theoretical doses of chemotherapy or targeted therapy.
timeFrame: 24 weeks after treatment initiation
measure: Number of adverse events and serious adverse events according to CTCAE v5.0.
timeFrame: throughout treatment, at 8, 16 and 24 weeks after treatment initiation
measure: Progression free survival
timeFrame: 3 years after last inclusion
measure: Overall survival
timeFrame: 3 years after last inclusion
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe
Study officials:
References:
Clinical trial NCT04247139: Kefir Cholesterol Lowering Pilot Study
Official title: Effect of Traditionally and Commercially Prepared Kefir on Cholesterol Levels in Adult Males With Borderline High Cholesterol Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: high cholesterol, kefir
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: High cholesterol (a type of fat in humans blood) may be one factor that can lead to heart disease. If people have higher cholesterol, it is possible that kefir (a food similar to yogurt) may help to control blood cholesterol levels.

Detailed description: New research shows that kefir (which contains bacteria also known as microbes), similar to yogurt, may improve health by lowering cholesterol levels. Much of this research however, focuses on traditional types of kefir, which differ significantly from commercially prepared kefir with regards to the types of microbes in each kefir. Additionally, there is a lack of research looking at how commercial kefir compares to traditional kefir in its ability to improve health. This has led to the consumer being confused about the health benefits they believe they are receiving, such as reduced weight gain, and improved cholesterol levels, when they purchase and consume commercial kefir. The researchers have produced a commercially usable kefir that has the health benefits of traditional grain fermented kefir. This was accomplished with only a small subset of microbes present in the traditional kefir, leading to a much easier product to commercialize and produce. Thus, this study aims to look at whether kefir, produced in the researchers laboratory and commercially available kefir, given to males for in two separate months, results in any cholesterol lowering effects. Successful completion of this project could potentially result in the development of a new commercial kefir with health benefits that are supported by scientific research and testing. In addition, if positive results are seen, a larger study will be carried out to ensure that results of the current study are consistent for the Canadian population.

Eligibility criteria: Inclusion Criteria:

1. Males, aged 18-65y
2. Moderately hypercholesterolemic adults: LDL-C between 3.2 and 4.9 mM, but otherwise healthy
3. No history of CVD, type 2 diabetes, monogenic dyslipidemia or use of medications for hyperlipidemia (including statins).
4. No dairy allergy

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Blood Lipids following provision of each type of Kefir
timeFrame: 4 weeks
Secondary outcomes:
measure: Fecal microbiota composition changes following the provision of each type Kefir
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References:
Clinical trial NCT06964139: Hydrus Learning Curve Study
Official title: Learning Curve Associated With Hydrus Microstent Implantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Surgery
Surgical Procedures, Minimally Invasive
Training
Training Effectiveness
Learning Curve
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2025-05-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma fellow at the Moran Eye Center, Washington University or Baylor University

Brief summary: The goal of this observational study is to better understand the learning curve among novice glaucoma surgeons performing Hydrus microstent insertion. The main question it aims to answer is what is the average number of cases does it take new glaucoma surgical fellows to become competent in Hydrus insertion. Researchers will review and grade videos of surgical cases. Participating fellows will complete a survey reporting the number of cases they had completed before beginning their glaucoma surgical fellowship and how many Hydrus cases they performed during their fellowship before they felt comfortable performing Hydrus cases without an attending surgeon overseeing their work.


Eligibility criteria: Inclusion Criteria:

* Current glaucoma fellow at the Moran Eye Center, Washington University or Baylor University

Exclusion Criteria:

* None

Primary outcomes:
measure: Mean number of cases across all fellows needed to achieve and maintain at least an 80% competence score
timeFrame: through study completion, an average of 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah John A. Moran Eye Center
state: Utah
Study officials:
affiliation: University of Utah John A. Moran Eye Center
name: Craig Chaya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03819439: Microbiome and Mycobiome Registry of Volunteers With and Without Autism Spectrum Disorder
Official title: Microbiome and Mycobiome Registry of Volunteers With and Without Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Keywords: autism
microbiome
mycobiome
bacteria
fungi
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 74
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers will or will not have a diagnosis of Autism Spectrum Disorder (ASD). Volunteers will be both local and national. There will be no limit to the number of volunteers who participate; however, we anticipate being able to enroll at least 50 volunteers within the first year.

Brief summary: Analyze, describe, and understand how the human gut microbiome (i.e. bacteriome and mycobiome) and Autism Spectrum Disorder (ASD) are related.


Eligibility criteria: Inclusion Criteria:

* Volunteers \> 2 years of age
* Able to list all medical conditions and medications when applicable.
* Have already donated a stool sample to BIOHM™.

Exclusion Criteria:

* Volunteers \< 2 years of age

Primary outcomes:
measure: Characterize the microbiome [bacteria and fungal community]
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT01327339: REQUIP RLS Post Marketing Surveillance
Official title: An Open-label, Multi-centre, Observational, Post-marketing Surveillance to Monitor the Safety of REQUIP(Ropinirole) Administered in Korean Restless Leg Syndrome Patients According to the Prescribing Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Restless Legs Syndrome
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-01
Enrollment: 755
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects are patients prescribed for ropinirole by the investigators at the sites based on prescription information in normal clinical practices.

Brief summary: post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS

Detailed description: This study is a post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS(restless leg syndrome) and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of ropinirole in real clinical practices after marketing. The subjects are patients prescribed for ropinirole by the investigators at the sites based on prescription information in normal clinical practices.

Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with RLS by the investigator
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol

  * To be contactable over the phone
  * To follow the administration regimen.
* A male or female aged 18 years and more at the time of the first prescription.
* Subjects with no experience of RLS treatment using ropinirole

Exclusion Criteria:

Considering the nature of this non-interventional PMS study, there is no strict exclusion criteria set up. GSK Korea encourage the doctors participating this study to enrol the subjects prescribed with Ropinirole following the locally approved Prescribing Information (Appendix ) The following criteria should be checked at the time of study entry.

* Subjects with hypersensitivity to ropinirole and any excipients
* Female who is during the period of the pregnancy or who are lactating

Primary outcomes:
measure: Number of Participants With Any Adverse Event
timeFrame: one month
Secondary outcomes:
measure: Number of Participants With Any Serious Adverse Event
timeFrame: one month
measure: Number of Participants With the Indicated Unexpected Adverse Events
timeFrame: one month
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Ji-Yun Kim BA, Shin-Young Oh MS, Han-Kyu Lee MD, MS and Dr. Yil-Seob Lee MD, PhD. A Post-marketing Surveillance to Monitor the Safety of Ropinirole (Requip) in Korean Patients with Restless Legs Syndrome. [JPERM]. 2012;5:25-30.
Clinical trial NCT06995339: Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostat on Gouty Obese Non-Diabetic Patients
Official title: Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostate on Gouty Obese Non-Diabetic Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Gout
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Dalia Naser Abdel-Sadek Safa , Faculty of Pharmacy, Tanta University
name: Sahar Mohamed Elhaggar, Faculty of Pharmacy, Tanta University
name: Tarek Mohamed Abd-Elazez Nasr-Allah, Faculty of Medicine - Al-Azhar University
First posted: 2025-05-29
Enrollment: 60
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: Gout is a systemic disease that results from the deposition of monosodium urate crystals (MSU) in tissues. Increased serum uric acid (SUA) above a specific threshold (\>6.8 mg/dl) is a requirement for the formation of uric acid crystals. MSU crystals can be deposited in all tissues mainly in and around the joints forming tophi. Early presentation of gout is an acute joint inflammation that is quickly relieved by non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine. Lowering SUA levels below deposition threshold either by dietary modification or using serum uric acid lowering drugs is the main goal in management of gout. This results in dissolution of MSU crystals preventing further attacks


Eligibility criteria: Inclusion Criteria:

* Males or females aged \< 18 years.
* All patients are diagnosed to have gout with serum uric acid \< 7 mg/dl.
* All patients are diagnosed to have obesity with body mass index (BMI) ≥ 30 kg/m2.

Exclusion Criteria:

* The presence of any type of diabetes mellitus.
* Patients with drug-induced hyperuriceamia (those taking anti-TB agents, low dose aspirin, cytotoxic chemotherapy, diuretics, immunosuppressants, fructose, lactate infusion, testosterone or xylitol).
* Non-obese patients with BMI \>30 kg/m2.
* Pregnant or lactating women.

Primary outcomes:
measure: Change in serum uric acid level
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Mostafa Bahaa
state: New Damietta
Study officials:
References:
Clinical trial NCT02398539: Silver Nitrate Application and Topical Corticosteroids for Hypergranulation Tissue
Official title: Randomized Clinical Trial Comparing Silver Nitrate Application With Topical Corticosteroids for Hypergranulation Tissue at Gastrostomy Sites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypergranulation Tissue; Gastrostomy Tube Site
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This protocol describes a randomized, two arm clinical trial comparing two topical treatments in patients with hypergranulation tissue at gastrostomy tube sites. The subjects are randomized to either group 1or group 2 treatments:

Maximum duration of therapy is 4 weeks. However, the therapy may be discontinued anytime at the discretion of the investigator or if there is resolution of the of the hypergranulation tissue.


Eligibility criteria: Inclusion Criteria:

1. Pediatric patients \<18
2. Evaluated for hypergranulation at the G-tube site
3. Inpatient and out-patient

Exclusion Criteria:

Children not meeting the above criteia

Primary outcomes:
measure: Maximal reduction in granulation tissue
timeFrame: During maximum of 4 weeks of therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
Study officials:
References: