louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06992817: The Impact of Brief One-time Education and Coach Encouragement on Hydration Status in Child Judo Athletes
Official title: Çocuk Judocuların Antrenör Yönlendirmesi ve Eğitim Müdahalelerinin Hidrasyon Durumlarına Etkisi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration in Children
Dehydration
Keywords: hypohydration
health
athletic population
combat sports
Lead sponsor: Kastamonu University
Sponsor class: OTHER
Collaborators: name: Selcuk University
name: Duzce University
name: Harran University
name: Mustafa Kemal University
name: Bartın Unıversity
First posted: 2025-05-28
Enrollment: 74
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Due to the lack of any comparative study related to effect of different hydration processes, this study aimed to compare the effectiveness of coach encouragement and hydration education in maintaining hydration status in child judo athletes

Detailed description: Forty-seven athletes participated in a four-day training camp, during which hydration status was assessed before and after training sessions under three different conditions: no intervention (control), coach-guided fluid intake encouragement, and pre-training brief one-time hydration education. Athletes were unaware of the intervention conditions assigned to each day, and the educational session was delivered without emphasizing its experimental nature. To minimize potential carryover effects, the sequence of interventions was fixed. Hydration status was objectively monitored using urine specific gravity (USG) and urine color (UC) measurements.

Eligibility criteria: Inclusion Criteria:

* having at least three years of judo experience
* having at least a green belt
* being healthy enough to attend all training sessions during the camp.

Exclusion Criteria:

* having less than three years of judo experience
* having orange belt or lower
* not being healthy enough to attend all training sessions during the camp.

Primary outcomes:
measure: hydration status (i.e., urine specific gravity and urine colour)
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bartın
country: Turkey
facility: Bartın Judo Hall
Study officials:
affiliation: Selçuk University
name: Şükrü Serdar Balcı, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06813417: CAR T Therapy With GCAR1 for Relapsed Alveolar Soft Part Sarcoma
Official title: An Open Label Individual Patient Dose Escalation Study Investigating the Safety and Efficacy of Retreatment With GCAR1 in a Patient With Multiply Relapsed Alveolar Soft Part Sarcoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Sarcoma
Alveolar Soft Part Sarcoma (ASPS)
Keywords: CAR T
GCAR1
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Alberta Health Services, Calgary
name: Alberta Precision Laboratories
First posted: 2025-02-07
Enrollment: 1
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single patient study to determine whether GCAR1 is safe and effective for re-treatment of alveolar soft part sarcoma (ASPS) with GPNMB surface expression that has relapsed and is not responding to usual treatment.

Detailed description: CLIC-YYC-GPNMB-04 is an Open Label Individual Patient (OLIP)/Single Patient Study (SPS) developed according to the Health Canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. The patient under consideration for CLIC-YYC-GPNMB-04 has refractory, progressive metastatic alveolar soft part sarcoma (ASPS). There are no standard therapies for relapsed ASPS known to provide potential for cure, and there are no clinical trials available in Canada for consideration. We propose to re-treat the patient with GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB). The patient was previously treated with GCAR1 under CLIC-YYC-GPNMB-01 (c#276646).

Eligibility criteria: Inclusion Criteria:

* The patient must provide informed consent
* Adequate organ function, defined as creatinine clearance \>30 ml/min and LVEF \>45%

Exclusion Criteria:

* Any active uncontrolled infection
* Pregnancy or nursing
* Anti-cancer therapy within 21 calendar days prior to the first dose of lymphodepleting chemotherapy. If subject has received anti-cancer therapy, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy as per the discretion of the Qualified Investigator/Co-Investigator

Primary outcomes:
measure: Treatment Response
timeFrame: Diagnostic imaging (CT and/or MRI) will be performed at baseline (pre-treatment) and then subsequently at 4-6 weeks after GCAR1 infusion, and at 3 months, 6 months, 9 months and 1 year after last infusion to evaluate response to therapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Centre
state: Alberta
Study officials:
References:
Clinical trial NCT00815841: Methylphenidate in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Healthy
Keywords: Determine the effect of MPH on a diagnostic continuous performance task that assesses attention and on a decision making test in young healthy adults
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2008-12-31
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Background: There is a paucity of data as to the effect of methylphenidate (MPH) on young adults who do not have attention deficit hyperactivity disorder (ADHD). The existing data is equivocal and focuses on neuropsychological functions that are not always relevant to the clinical aspects of attention. Objective: To determine the effect of MPH on a diagnostic continuous performance task that assesses attention per se (TOVA) and on a decision making test (Modified Gamble Decision Test) in young, healthy adults. Methods: Fifty young adults, men and women ages 20-30, without ADHD, learning disabilities, history of past or present use of MPH or other psychotropic drugs, will be eligible to participate. Design: The experiment will be conducted in 2 sessions, the first lasting 3.5 hours and the second 2.5 hours in a randomized, double-blind prospective design. In the first session, the subjects will be screened for ADHD past and present, major psychiatric diagnosis (depression, anxiety, etc), use of MPH in the past, psychotropic medications or recreational drugs and any other chronic illness; urine will be tested for beta-hCG to rule out pregnancy. Blood pressure and heart rate will be measured. The participants will then be given either placebo or MPH (15-20 mg) and after 90 minutes will proceed to complete the TOVA (that lasts 22 minutes) and Modified Gamble-Decision Test (15 minutes). Before taking the pill and prior to the testing, the subjects will complete the Visual Analogue Scale (VAS) which quantifies their subjective feelings regarding present mental and emotional state. In the second session, 2 weeks later, blood pressure and heart will be measured and the VAS completed prior to and 90 minutes after taking the tablet. The subjects then undergo the TOVA and Modified Gamble-Decision Test. Data Analysis: will be performed using the paired t-tests for parametric variables and one way ANOVA with repeated measurements. Significance: Results of this study are important since MPH is used and abused by healthy students as a "study aid" although its objective effects in normal young adults are not well delineated


Eligibility criteria: Inclusion Criteria:

* ages 20-30

Exclusion Criteria:

* ADHD
* learning disabilities
* history of past or present use of MPH or other psychotropic drugs
* pregnancy
* chronic illness

Primary outcomes:
measure: The TOVA score
timeFrame: January - December 2009
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01723241: Phase 1 Study of XAF5 Gel Applied to Skin of Healthy Volunteers
Official title: A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose Study to Assess the Safety and Tolerability of XAF5 Gel Applied to the Skin of Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: volunteers
Lead sponsor: Topokine Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-07
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when applied to the skin of healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Must understand and provide informed consent
* Skin upon which a reaction would be visible
* Body weight \>= 70 kg

Exclusion Criteria:

* Any active skin disease
* History of skin hypersensitivity
* Clinically significant abnormality on physical exam, ECG, or laboratory tests
* Positive test for HIV, Hepatitis B, or Hepatitis C

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Topokine Therapeutics
name: Michael S. Singer, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02215941: Study to Characterize the Pharmacokinetics and Safety of TV-45070 Ointment in Healthy Volunteers
Official title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study to Characterize the Pharmacokinetics and Safety of 8% TV-45070 Ointment Following 7.5 Days of Twice Daily Topical Application in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary objective of this study is to characterize the pharmacokinetics of TV-45070 in plasma following single and multiple-dose topical application of 8% TV-45070 ointment.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects aged 18 to 50 years
* Body Mass Index (BMI) ≥18.0 and ≤32.0 kg/m2.
* Able and willing to provide written informed consent.
* Able and willing to comply with all study procedures and restrictions.

Exclusion Criteria:

* History or evidence of clinically significant illness or surgery
* Presence of open wounds, sunburn, tattoo, major scarring, non-intact or damaged in the proposed application area that would interfere with the application of the study drug treatments or biopsies.
* History of significant drug or alcohol abuse
* Use of prescription drugs within 30 days or 5 half-lives (whichever is longer) prior to Day 1.
* Use of topical application of an OTC medicated or prescription medication or other skin creams/ointments (eg, moisturizers, balms) in the areas intended for study drug administration within 7 days prior to Day 1. Use of topical capsaicin within 6 months prior to Day 1.
* Pregnant or nursing females
* Shaving or waxing the planned study treatment application area within 7 days prior Day 1.
* Laser hair removal of the planned study treatment application area within 2 months prior to Day 1.

  * other criteria apply, please contact the investigator for more information

Primary outcomes:
measure: Plasma concentrations
timeFrame: Day 8
Secondary outcomes:
measure: Drug level in skin
timeFrame: Days 1, 8, 15, 22, 29
measure: Excretion of drug in urine
timeFrame: Day 8
measure: Identification of metabolites in blood
timeFrame: Days 8, 10
measure: Identification of metabolites in urine
timeFrame: Day 8
measure: Identification of metabolites in skin
timeFrame: Days 1, 8, 15, 22, 29
measure: Intraepidermal nerve fiber density in skin
timeFrame: Days 1, 8, 15, 29
measure: Percentage of Participants with Adverse Events
timeFrame: 10 Weeks
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Teva Investigational Site 12961
state: Kansas
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01825941: Diphenhydramine for Acute Migraine
Official title: Diphenhydramine as Adjuvant Therapy for Acute Migraine. A Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Keywords: migraine
headache
metoclopramide
diphenhydramine
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 208
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parenteral diphenhydramine is commonly used as adjuvant therapy for acute migraine despite the fact that data supporting this practice do not exist. The investigators propose a randomized double blind study to test the hypothesis that 50mg of intravenous diphenhydramine, when added to standard migraine therapy, will result in a greater rate of sustained headache relief than standard migraine therapy alone. For this study, standard migraine therapy will be 10mg of intravenous metoclopramide. Sustained headache relief is defined as achieving a headache level of "mild" or "none" within two hours and maintaining a level of "mild" or "none" for 48 hours. Patients who present to the Montefiore emergency room (Bronx, NY) with an acute migraine will be approached for participation. They will be screened for medication contra-indications and non-migraine etiologies of headache. The study will be randomized. Assignment will be concealed. Participants and researchers will be blinded. Efficacy outcomes and adverse events will be assessed every half hour for two hours in the Emergency Department and by telephone 48 hours after medication administration. A sample size calculation, based on pilot data, revealed the need for 374 participants. An interim analysis will be performed after 200 participants have been enrolled with the goal of assessing for lack of conditional power.


Eligibility criteria: Inclusion Criteria:

* Acute migraine headache
* Present to our emergency room in the Bronx, NY for treatment of migraine headache

Exclusion Criteria:

* Temperature \> 100.3 F
* Pheochromocytoma
* Seizure disorder
* Parkinson's disease
* Use of monoamine oxidase (MAO) inhibitors
* Use of anti-rejection transplant medications
* Use of potassium supplements
* Use of pramlintide

Primary outcomes:
measure: Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
timeFrame: up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin W Friedman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Friedman BW, Cabral L, Adewunmi V, Solorzano C, Esses D, Bijur PE, Gallagher EJ. Diphenhydramine as Adjuvant Therapy for Acute Migraine: An Emergency Department-Based Randomized Clinical Trial. Ann Emerg Med. 2016 Jan;67(1):32-39.e3. doi: 10.1016/j.annemergmed.2015.07.495. Epub 2015 Aug 29.
Clinical trial NCT01958541: A Brief Behavioral Sleep Intervention for Depression Among Military Veterans
Official title: A Brief Behavioral Sleep Intervention for Depression Among Military Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Depression
Suicidal Ideation
Keywords: Sleep
Insomnia
Suicidal Symptoms
Suicidal Ideation
Military Veteran
Service Member
Depression
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: VA Palo Alto Health Care System
First posted: 2013-10-09
Enrollment: 77
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: This study investigates the impact of brief behavioral insomnia treatment on depressive symptoms among military veterans.


Eligibility criteria: * Age 18 or older
* Veteran
* Insomnia Symptoms
* Depression

Primary outcomes:
measure: Suicidal Ideation
timeFrame: Change from Baseline in Suicidal Ideation at 7 weeks
Secondary outcomes:
measure: Insomnia Symptoms
timeFrame: Change from Baseline in Insomnia Symptoms at 7 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Healthcare System
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Rebecca A Bernert, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01448941: Arthrodesis Versus Extra-articular Plate Fixation in Lisfranc Injury
Official title: Arthrodesis Versus Extra-articular Bridge Plating of the First Tarsometatarsal Joint After Acute Lisfranc Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lisfranc Injuries
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 48
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: The purpose of this study is to compare arthrodesis of the first TMT-joint to extraarticular bridge plate fixation of the same joint in acute Lisfranc injuries.

Detailed description: We want to compare arthrodesis of TMT 1 to temporary bridge plating of TMT 1 in acute Lisfranc injuries where at least tarsometatarsal joints 1-3 are involved.

We preform arthrodesis of TMT 2 and 3 in both groups.

Eligibility criteria: Inclusion Criteria:

* Lisfranc injuries with instability off TMT1, and fracture/instability of TMT 2 and 3. No major fracture in relation to TMT1.
* Age 18-65

Exclusion Criteria:

* Feet with other major foot/ankle injuries
* Previous foot infection or foot pathology on affected side
* Previous surgery to the TMT joints
* Sequelae after previous foot injuries
* Diabetes mellitus, neuropathy and peripheral vascular disease

Primary outcomes:
measure: AOFAS Midfoot scale
timeFrame: 2 years postoperative
Secondary outcomes:
measure: SF-36
timeFrame: 2 years postoperative
Other outcomes:
measure: ROM TMT 1 after temporary plate fixation
timeFrame: 1 year post operative
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Are H Stødle, cand. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04665141: Similarities and Differences of Biological Therapies for Severe Asthma.
Official title: Similarities and Differences of Biological Therapies for Severe Asthma.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Hospital Regional de Malaga
First posted: 2020-12-11
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients, adults and children, with a diagnosis of severe asthma in the participating centers.

Brief summary: This is an ambispective multicenter longitudinal observational study to evaluate the efficacy and safety profile of biological therapies in patients diagnosed with severe asthma in real life conditions.

Detailed description: The use of biologicals to treat severe asthma has been implemented in a regular basis while information on long term effectiveness and safety is lacking. It is necessary to establish strategies to closely monitor the possible occurrence of reactions, adverse effects of innovative biological medicines used to treat severe asthma.

In this study the investigators want to evaluate the comparative effectiveness, utilization patterns, long-term safety, and use in special groups in real-life conditions in severe asthma.

Eligibility criteria: Inclusion Criteria:

* Individuals of any age: adults and children.
* Diagnosis of severe asthma as given by the treating physician, and defined as an asthma that remains uncontrolled in despite adherence with maximal optimized therapy and treatment of contributed factors, or asthma that worsens when high dose treatment is decreased.
* Being treated or not (control group) with biological drugs.
* Signed Informed Consent.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Treatment dose scheduling and changes of dose throughout the study.
timeFrame: 2 years after inclusion
measure: Number of treatment discontinuations and causes of interruption throughout the study.
timeFrame: 2 years after inclusion
measure: Incidence of Relevant Treatment-Related Adverse Events recorded throughout the study.
timeFrame: 2 years after inclusion
measure: Severity of Treatment-Related Adverse Events recorded throughout the study.
timeFrame: 2 years after inclusion
measure: Change of asthma control during the treatment.
timeFrame: 2 years after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Civil-Hospital Regional Universitario de Málaga
Study officials:
References:
Clinical trial NCT00848341: Canadian Registry of ICD Implant Testing Procedures
Official title: Canadian Registry of ICD Implant Testing Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Fibrillation
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
First posted: 2009-02-20
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who are indicated for a market approved ICD

Brief summary: To document practices in Canadian ICD implant centres around defibrillation therapy efficacy testing.

Detailed description: To document types of defibrillation testing (DFT) procedures are in current use in Canada, rates of use an dno use of DFT testing, medical indications for non use of DFT testing, rate of successful testing of first lead configuration, rates and types of complications from DFT testing, costs of implant procedures and the costs associated with DFT testing, short term outcomes of patients with different types of implant procedures.

Eligibility criteria: Inclusion Criteria:

* Receiving a Guidant ICD system, including replacements

Exclusion Criteria:

* New epicardial lead(s) implanted, included in another cardiovascular trial (may be in the ELECTION Study)

Primary outcomes:
measure: to systematically collect and quanitfy characteristics of ICD implant procedures in Canadian Hospitals
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hamilton Health Sciences Center
name: Stuart Connolly, MD
role: PRINCIPAL_INVESTIGATOR
References: