louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05161273: Risk Factors for Lower Extremity Overuse Injuries in Jump-landing Athletes
Official title: Biomechanical (Fatigue-related) Risk Factors for the Development of Lower Extremity Overuse Injuries in Jump-landing Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Landing Biomechanics
Fatigue
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy jump-landing athletes

Brief summary: In this prospective study, male jump-landing athletes (volleyball and basketball) will be screened pre-season and followed for one consecutive season. Pre-season screening consists of 3D biomechanical analysis of standardized (such as drop vertical jump) and sports-specific jumps (such as stop-jump) before and after a high-intensity, intermittent exercise protocol and clinical field tests (such as force measurements).


Eligibility criteria: Inclusion Criteria:

* volleyball and basketball players
* elite and non-elite
* male
* healthy

Exclusion Criteria:

* symptoms or complaints of lower extremity acute of overuse injuries in the past 3 months
* history or surgery of the lower extremities
* history of fractures of the lower extremities

Primary outcomes:
measure: Jump-landing biomechanics
timeFrame: 1 year
measure: Jump-landing biomechanics after fatigue
timeFrame: 1 year
Secondary outcomes:
measure: Clinical tests - force
timeFrame: 1 year
measure: Clinical tests - mobility
timeFrame: 1 year
measure: Clinical tests - foot posture
timeFrame: 1 year
measure: Clinical tests - force endurance
timeFrame: 1 year
measure: Clinical tests - endurance
timeFrame: 1 year
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Vakgroep Revalidatiewetenschappen
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Roosen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02422173: Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke
Official title: Effects of Different Montages of Transcranial Direct Current Stimulation on the Risk of Falls and Lower Limb Function for Acute Stroke Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stroke
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2015-04-21
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: Transcranial direct current stimulation (tDCS) has shown promising results in the modulation of cortical excitability and the promotion of neuronal plasticity after stroke. The purpose of this study was to compare the effectiveness of three different montages of tDCS (anodal, cathodal and bilateral) in reducing the risk of falls and recovery of lower limb function in acute stroke patients.

Detailed description: This is a randomized sham-controlled trial reported following the 2010 CONSORT guidelines. The subjects were randomly allocated into 1 of 4 groups in a double-blinded parallel study design. Each patient received 10 sessions (5 consecutive days for 2 weeks) of real or sham stimulation at 2 mA intensity and current density equivalent to 0.05 A/m2.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute stroke
* Able to walk 10m independently
* High risk of falling

Exclusion Criteria:

* Severe functional limitations
* Cognitive impairment

Primary outcomes:
measure: Four Square Step Test
timeFrame: Change from Baseline in Risk of Falls at 3 months
Secondary outcomes:
measure: Occurrence of Falling Index
timeFrame: Baseline, Week 2, Week 4 and Week 12
measure: Overall Stability Index
timeFrame: Baseline, Week 2, Week 4 and Week 12
measure: Falls Efficacy Scale - International
timeFrame: Baseline, Week 2, Week 4 and Week 12
measure: Berg Balance Scale
timeFrame: Baseline, Week 2, Week 4 and Week 12
measure: Six-minute walk test
timeFrame: Baseline, Week 2, Week 4 and Week 12
measure: Sit to Stand Test
timeFrame: Baseline, Week 2, Week 4 and Week 12
Other outcomes:
Locations:
Study officials:
References:
citation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Clinical trial NCT00057473: A Phase II Study of Carboplatin Plus Irinotecan Versus Irinotecan in Children With Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms
Keywords: unspecified childhood solid tumor, protocol specific
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2003-04-03
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This clinical research study is being conducted to investigate the effectiveness of combining carboplatin and irinotecan, versus irinotecan alone, in treating children who have refractory solid tumors.


Eligibility criteria: * children 1-21 years of age
* confirmed diagnosis of measurable solid tumor, including brain tumor, which has progressed on or after standard therapy, or for which no effective standard therapy is known
* at least 4 weeks since last dose of immunotherapy, radiotherapy, or chemotherapy
* no more than 3 prior chemotherapies
* no symptomatic brain metastases

Primary outcomes:
measure: estimate response rate
Secondary outcomes:
measure: evaluate safety
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Local Institution
state: Florida
city: Houston
country: United States
facility: Local Institution
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05159973: Patients With Non-ST-segment Elevation Acute Coronary Syndrome
Official title: Frequency of Serious Rhythmic Complications in Patients With Non-ST-segment Elevation Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: Acute Coronary Syndrome
ACS
ST segment elevation
Myocardial infarction
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient whose main diagnosis retained at the end of hospitalization is a non-ST + ACS

Brief summary: There are two types of acute coronary syndrome (ACS): ACS with persistent ST segment elevation (ACS ST +) and ACS without ST segment elevation (non-ST + ACS). The incidence of non-ST + ACS is increasing and currently accounts for the majority of myocardial infarction (MI) hospitalizations, while that of ST + ACS is declining. Complications of MI, which include rhythm and conduction disturbances, are mainly associated with ACS ST +. It is recognized that these complications can occur during non-ST + ACS, but with less frequency. This frequency is not clearly established, and has been the subject of few studies. Recent studies in this direction suggest that the frequency of rhythmic complications is low during non-ST + ACS. However, the data collected concerns inter-hospital transport.

The aim of the study is to estimate the frequency of occurrence of potentially fatal rhythmic complications in patients admitted to the emergency room and to the cardiology department for non-ST + ACS.


Eligibility criteria: Inclusion criteria:

* Adult patient (≥ 18 years old)
* Man or woman
* Patient admitted to the Emergency Department (SU) or to the Cardiology Department at the NHC between January 1, 2019 and December 31, 2020
* Patient whose main diagnosis retained at the end of hospitalization is a non-ST + ACS
* Patient who did not express his opposition to the reuse of his data for scientific research purposes.

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship, curatorship or safeguard of justice

Primary outcomes:
measure: Evaluation of the frequency of occurrence of potentially fatal rhythmic complications in patients with non-ST segment elevation acute coronary syndrome
timeFrame: Files analysed retrospectively from January 01, 2019 to December 31, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service des Urgences Médico-Chirurgicales Adultes - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service des Urgences Médico-Chirurgicales Adultes - Hôpitaux Universitaires de Strasbourg
name: Sébastien HARSCOAT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00602173: Bioequivalency Study of 100 mg Cilostazol Tablets Under Fasting Conditions
Official title: A Single Dose, Randomized, Three-Period, Three-Treatment, Crossover Bioequivalency Study of Cilostazol 100 mg Tablets Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Claudication
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 100 mg, to PLETAL® Tablets, 100 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 3-treatment, 3-period, crossover design.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Cilostazol or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Seven day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research, LLC
name: Daniel V Freeland, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04075773: Brief Religious Alcohol Intervention
Official title: Brief Religious Alcohol Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy Drinking
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either an intervention condition, where they will write about how their drinking relates to their religious identity, or to a control condition, where they will write about how their drinking relates to their age.
Primary purpose: TREATMENT

Brief summary: This study is a trial of a brief alcohol intervention, a brief expressive writing intervention that incorporates religious identity.


Eligibility criteria: Inclusion Criteria:

* 18 to 29 years old
* Have had a binge episode (4/5 drinks on one occasion for women/men) at least once in the past month
* UH students

Exclusion Criteria:

* Participants who are currently enrolled in treatment for alcohol or other substances
* Participants who have been diagnosed with and/or treated for verbal learning disabilities

Primary outcomes:
measure: Change in the Timeline Follow-Back one month following the intervention
timeFrame: It will be assessed before the intervention and one month following the intervention.
Secondary outcomes:
measure: Chang in the Young Adult Alcohol Consequences Questionnaire one month following the intervention
timeFrame: It will be assessed before the intervention and one month following the intervention.
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston Psychology Department
state: Texas
Study officials:
affiliation: University of Houston
name: Mary M Tomkins, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06925373: Housing, Environment, And Living Conditions for Transformed Health
Official title: Housing, Environment, And Living Conditions for Transformed Health (HEALTHe Birmingham)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Diseases
Chronic Disease
Keywords: Lung Health
Chronic Disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2025-04-13
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project will compare the health effects of public housing renovation, neighborhood built and social environment improvements, and indoor air purification, alone and in combination, as well as the cost effectiveness of each approach.

STUDY 1: The study will assess the effects of public housing and neighborhood environment (built and social) improvements on health-related behaviors, psychosocial and physiologic stress, and self-reported and physiological markers of lung health and chronic disease.

STUDY 2: The study will determine whether indoor air purification can positively impact lung health in public housing sites not undergoing housing renovation, comparing a site near industrial pollution vs one less contaminated.

Detailed description: Participants will complete surveys, physical exam, lung function tests, and blood draw. An indoor air purifier with a usage tracker and an indoor air quality monitor will be provided, and used filters will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Adults age 18 years and older
* English speaking
* Residents of one of 4 public housing site in Birmingham, Alabama

Exclusion Criteria:

* Individuals who are not 18 years or older
* Do not speak English
* Do not meet the residency criteria

Primary outcomes:
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health
timeFrame: Baseline, 12 months, 24 months
measure: Change in Allostatic load
timeFrame: Baseline, 12 months
measure: Change in Indoor Air Quality
timeFrame: Baseline, 6 months, 12 months (Study 2 only)
Secondary outcomes:
measure: The percentage change in FEV1/FVC
timeFrame: Baseline, 6 months, 12 months (Study 2 only)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Lung Health Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham (UAB)
name: Gabriela R Oates, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06444373: Artificial Intelligence in Lung Cancer Screening
Official title: Development of an Artificial Intelligence Model in Lung Cancer Screening for the Diagnosis of Lung Nodules and Risk Stratification in Subjects With Occupational and/or Smoking Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer Screening
Asbestos
Keywords: Artificial Intelligence
Asbestos
Lung Cancer Screening
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 728
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age \&gt; 50 years; smokers for at least 20 pack-years (20 cigarettes a day for 20 years) or former heavy smokers if they quit less than 15 years ago; and/or previous professional exposure to asbestos.

All subjects were enrolled in lung cancer screening program.

Brief summary: Single-center, non-profit, observational, retrospective study of collection of clinical and amnestic data and images to create, implement and develop a pilot model of an integrated virtual platform.

Detailed description: The project we propose is a study whose objective was to develop an artificial intelligence program integrated into a web-based platform for the optimization of the performance of lung cancer screening for the diagnosis of lung nodules and risk stratification in subjects exposed to environmental carcinogens and/or cigarette smoke.

Inclusion criteria:

Age \&gt; 50; smokers for at least 20 pack-years (20 cigarillos a day for 20 years) or former heavy smokers if they quit less than 15 years ago; and/or previous professional exposure to asbestos; absence of lung cancer symptoms; who performed lung cancer screening after the year 2000 upon approval of the study by the relevant EC.

Eligibility criteria: Inclusion Criteria:

* Age \&gt; 50 years;
* smokers for at least 20 pack-years (20 cigarettes a day for 20 years) or former heavy smokers if they quit less than 15 years ago;
* and/or previous professional exposure to asbestos;
* absence of lung cancer symptoms;
* who performed lung cancer screening after the year 2000 upon approval of the study by the relevant Etical Committee

Exclusion Criteria:

* Age \&lt; 50 years
* never smokers
* lung cancer symptoms

Primary outcomes:
measure: AIM 1 Pilot deep learning model
timeFrame: from enrollment to the end of treatment at 2 years
Secondary outcomes:
measure: AIM 2 Clinical database
timeFrame: from enrollment to the end of treatment at 2 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
References:
Clinical trial NCT00568373: Gastric Pacemaker Implantation for Gastroparesis
Official title: Gastric Electric Stimulation-Enterra Therapy for the Treatment of Chronic Intractable (Drug Refractory) Nausea and Vomiting Secondary to Gastroparesis of Diabetic or Idiopathic Etiology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastroparesis
Keywords: Gastroparesis
Gastric electrical stimulator
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients who have severe symptoms and have been identified by the PI and Sub I to qualify for the treatment will be under one single group
Primary purpose: TREATMENT

Brief summary: Gastric pacemakers and/or temporary gastric stimulators will be implanted in eligible patients.

Detailed description: Due to HUD status, this protocol is for implant only. This is NOT a clinical trial.

Eligibility criteria: Inclusion Criteria:

* Used only if patients have tried and failed conventional treatment ( drug therapy and dietary modification)due to intractable nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03280173: A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood
Official title: A Phase 1, Open-label, Randomized, Four-period, Four-sequence, Single-dose, Crossover Study In Healthy Volunteers, To Determine The Relative Bioavailability Of Pf-06291826 61 Mga Tafamidis Free Acid Soft Gelatin Capsules Compared To Commercial 4 × 20 Mg Tafamidis Meglumine Soft Gelatin Capsules Administered Under Fasted And Fed Conditions And The Effect Of Food On The Oral Bioavailability Of Pf-06291826 61 Mga Tafamidis Free Acid Soft Gelatin Capsules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-09-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 2 different formulations of tafamidis will be compared under both fed and fasted conditions. Subjects will be fasted overnight or fed. After swallowing one of the tafamidis formulations, tafamidis blood concentrations will be measured periodically for 8 days. After 16 days, subjects will take a different formulation in the fed or fasted state or take the same formulation in the opposite feeding condition. This will be repeated, 16 days apart, until all subjects have taken each formulation both fed and fasted.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females of non-child bearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria:

* Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
* Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
* Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.

Primary outcomes:
measure: Area under the concentration-time curve 0-72 hours (AUC72)
timeFrame: 72 hrs
measure: maximum observed plasma concentration (Cmax)
timeFrame: 168 hrs
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 168 hrs
measure: Mean residence time (MRT)
timeFrame: 168 hrs
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 168 hrs
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 168 hrs
measure: Area under the curve from zero to infinity (AUCinf)
timeFrame: 168 hrs
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: