louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06458166: Associations Between Low Frequency Fatigue, Jump Height and Perceptual Measures of Muscle Soreness, Fatigue and Recovery
Official title: Associations Between Low Frequency Fatigue, Jump Height and Perceptual Measures of Muscle Soreness, Fatigue and Recovery in Youth Elite Soccer Players
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fatigue
Physical Exercise
Keywords: sports
soccer
low frequency fatigue
Lead sponsor: University of Maia
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 40
Sex: MALE
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Players at the highest division of the portuguese national championships in their respective age group.

Brief summary: Over the recent years, the increased competitive demands in elite competitive athletes has sparked a heightened interest in monitoring fatigue. Given the nature of the soccer game, athletes may experience low-frequency fatigue. Until recently, this assessment was restricted to in-lab. However, the emergence of new instruments aiming to allow low-frequency assessment to be carried out on a daily basis, in the context of professional teams. This study aimed to analyze the recovery of low-frequency fatigue, jump height and perceptual responses following competition and investigate possible associations between the objective and subjective parameters.


Eligibility criteria: Inclusion Criteria:

* Elite level youth soccer players, competing in the highest portuguese division

Exclusion Criteria:

* Older adults
* none elite soccer player
* Play less than 70 minutes of match

Primary outcomes:
measure: Differences in Low frequency fatigue measured using Myocene (eletrical stimulus and force measurement)
timeFrame: 2 hours before the match; 30 minutes following the match, 24 hours following the match; 48 hours following the match
Secondary outcomes:
Other outcomes:
Locations:
city: Maia
country: Portugal
facility: University of Maia
state: Porto
Study officials:
References:
Clinical trial NCT03243266: DxH520 Pediatric Reference Interval Verification
Official title: DxH520 Pediatric Reference Interval Verification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 290
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric specimens from apparently healthy children

Brief summary: Results from this study will be used to verify that the published pediatric reference intervals are met on the DxH 520 Hematology Analyzer for the pediatric age ranges.

Detailed description: Pediatric specimens from each age range will be tested from apparently healthy children. Ten male and Ten female are required for each age range. The values will be assessed against published reference ranges to verify that the values obtained fall within the expected reference interval for the age ranges listed below:

1. Neonate: 0 to 30 days
2. Infant: \> 30 days to 2 years
3. Child: 3 years to 12 years
4. Adolescent: 13 years to 21 years

Eligibility criteria: Inclusion Criteria:

* All subject genders, race and ethnicity will be included in the study. Pediatric samples will be targeted for this study within the specified age ranges.
* Specimens should be from apparently healthy individuals.
* Samples from inpatient and ED visits maybe included if they are confirmed to be the final CBC before discharge and the patient had a non-hematological diagnosis

Exclusion Criteria:

* Samples originating from a hematology/oncology clinic (both inpatient and outpatient)
* Samples originating from a patient with a hematological disorder or diagnosis
* Samples from the Neonatal Intensive Care Unit that are not the last specimens collected prior to discharge

Primary outcomes:
measure: Pediatric Reference Interval Verification of Hematology CBC/Diff parameters
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Khosrow Adeli, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Children's Hospital
name: Meer-Taher Shabani-Rad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02373826: Novel Method for Real Time Co-Registration of IVUS and Coronary Angiography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intravascular Ultrasound (IVUS) Angiography Co-registration
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing routine coronary angioplasty

Brief summary: During coronary angiography, the lumen of the arteries is imaged but intravascular ultrasound (IVUS) is necessary to determine the plaque extension and its composition, lesion length and luminal reference diameter. We aimed to investigate the accuracy, feasibility, safety and value of a novel method for co-registration of IVUS and coronary angiographic images.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing routine coronary angioplasty

Exclusion Criteria:

* Cardiogenic shock
* Acute myocardial infarction

Primary outcomes:
measure: Accuracy of Co-Registration of IVUS and Coronary Angiography
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT03065426: Microbiome and Bariatric Surgery
Official title: Mechanisms That Predict Weight Trajectory After Bariatric Surgery: The Interactive Roles of Behavior and Biology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Weight Change, Body
Lead sponsor: North Dakota State University
Sponsor class: OTHER
Collaborators: name: Neuropsychiatric Research Institute
name: The Cleveland Clinic
First posted: 2017-02-27
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants planning to undergo Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.

Brief summary: This is a prospective, 24-month, longitudinal study of patients planning to undergo bariatric surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) in which we aim to identify correlates and predictors of observed weight loss trajectories following bariatric surgery. This approach will expand current knowledge by examining the combined impact of empirically supported behavioral and biological data in a large sample over time. Intensive measurement of problematic eating behaviors, mood, and compliance with diet and exercise regimens post-surgery will be analyzed in the context of lterations in parallel with, or in response to, changes observed in the gut microbiota. Identifying these post-surgical predictors of weight loss and comorbidity resolution will allow for the development of individualized interventions to optimize surgery-related outcomes.


Eligibility criteria: Inclusion Criteria:

1. In evaluation for Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.
2. Age 18-65, inclusive

Exclusion Criteria:

1. Alcohol or substance use disorder in past year
2. Severe psychiatric disorder that may affect ability to complete the protocol
3. Regular tobacco use during the last year
4. Current medication taken routinely and known to impact factors that may affect the gut microbiome
5. Use of any oral or injectable antibiotic in the past month
6. Use of commercially available pre/pro biotic in the past month
7. History of significant disease/disorder that would be expected to impact the microbiome of the gut
8. Inability to engage in physical activity or dietary monitoring
9. Nonprescribed/illicit drug use
10. Pregnant or breastfeeding

Primary outcomes:
measure: Weight trajectory
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Neuropsychiatric Research Institute
state: North Dakota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT02473926: Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes
Official title: Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Activity
Health Behavior
Diabetes Mellitus, Type 2
Keywords: Physical Activity
Physical Function
Physical Impairment
Sedentary Lifestyle
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2015-06-17
Enrollment: 55
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study plans to learn more about physical activity and physical function in sedentary older adults with type 2 diabetes.

Detailed description: The purpose of this study is to conduct a randomized controlled trial with 1:1 patient-level randomization to an evidence-based physical activity program intervention versus usual care in sedentary older adults with type 2 diabetes in two primary care clinic sites.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes
* Sedentary individual, performing \<20 minutes of physical activity on \<3 days/week

Exclusion Criteria:

* Dementia (Folstein Mini-Mental Status Exam \<24) or clinical diagnosis
* Excessive fall risk: Can not hold semi-tandem stance for \>10 seconds
* Type 2 diabetes-related safety concerns: Prior diabetic foot ulcer, Charcot foot, asymptomatic hypoglycemia
* Severely uncontrolled hypertension (BP \>180/100)
* Excessive hearing or visual impairment for counseling
* Limited life expectancy: Active treatment for malignancy
* Performs regular physical activity \>20 minutes on \>3 days/week

Primary outcomes:
measure: Change From Baseline in Objective Physical Activity at 4 Months
timeFrame: Baseline, 4 Months
Secondary outcomes:
measure: Change From Baseline in Physical Function at 4 Months
timeFrame: Baseline, 4 Months
measure: Change From Baseline in Physical Function at 4 Months
timeFrame: Baseline, 4 Months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver | Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Amy Huebschmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huebschmann AG, Glasgow RE, Leavitt IM, Chapman K, Rice JD, Lockhart S, Stevens-Lapsley JE, Reusch JEB, Dunn AL, Regensteiner JG. Integrating a physical activity coaching intervention into diabetes care: a mixed-methods evaluation of a pilot pragmatic trial. Transl Behav Med. 2022 May 25;12(4):601-610. doi: 10.1093/tbm/ibac014.
Clinical trial NCT04319926: Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects
Official title: An Open Label, Randomized, Two-treatment, Two-period, Single-dose Study Evaluating the Product Adhesion in Healthy, Adult Subjects Using ZTlido 1.8% Topical System and a Generic Lidocaine Patch 5%.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Scilex Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: An open label, randomized, two-treatment, two-period, single-dose study evaluating the product adhesion in healthy, adult subjects using ZTlido 1.8% Topical System and a generic Lidocaine Patch 5%


Eligibility criteria: Key Inclusion Criteria:

* Must be healthy based on by medical history, laboratory work, ECG, and physical exam with BMI range between 18.00 and 30.00 kg/m2 inclusive.
* Be at least 18 years of age
* If childbearing potential, use of acceptable form of birth control
* In the case of females of childbearing potential, have a negative serum pregnancy test

Key Exclusion Criteria:

* Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation
* Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness
* Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
* History of addiction, abuse, and misuse of any drug
* Use of local anesthetics of antiarrhythmic drugs (such as tocainide or mexiletine) within 14 days prior to product application

Primary outcomes:
measure: Mean Percent Adhesion
timeFrame: 12 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Dilworth
country: United States
facility: AXIS Clinicals
state: Minnesota
Study officials:
affiliation: AXIS Clinicals
name: Patrick Luger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gudin J, Webster LR, Greuber E, Vought K, Patel K, Kuritzky L. Open-Label Adhesion Performance Studies of a New Lidocaine Topical System 1.8% versus Lidocaine Patches 5% and Lidocaine Medicated Plaster 5% in Healthy Subjects. J Pain Res. 2021 Feb 23;14:513-526. doi: 10.2147/JPR.S287153. eCollection 2021.
Clinical trial NCT01219426: A Transversal Study for the French Validation of Two Assessment Tools of Gambling Related Cognitions.
Official title: A Transversal Study for the French Validation of Two Assessment Tools of Gambling Related Cognitions.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gambling
Keywords: Gambling
cognitive distortions
assessment tool
validation
French
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-10-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To be more than 18 years old (the legal age to gamble in France)

Brief summary: This study is divided into two stages. In the first stage, students from the University of Nantes completed the two assessment tools of gambling related cognitions (GABS : Gambling Attitudes and Beliefs Survey ; GRCS : Gambling Related Cognitions Scale), and a reference tool for gambling problem severity (SOGS : South Oaks Gambling Screen). In the second stage, consecutive pathological gamblers seeking treatment at the University Hospital of Nantes completed the three questionnaires. Only questionnaires from participants who reported gambling at least one time in the past year were kept for analyses.Responses of students gamblers and pathological gamblers presenting for treatment have been compiled for analysis.The main objective of the study is to validate the French adaptations of the GABS and the GRCS, and to explore their psychometric properties and structures.

Detailed description: This study is divided into two stages. In the first stage, students from the University of Nantes completed the two assessment tools of gambling related cognitions (GABS : Gambling Attitudes and Beliefs Survey ; GRCS : Gambling Related Cognitions Scale), and a reference tool for gambling problem severity (SOGS : South Oaks Gambling Screen).

In the second stage, consecutive pathological gamblers seeking treatment at the University Hospital of Nantes completed the three questionnaires.

Only questionnaires from participants who reported gambling at least one time in the past year were kept for analyses.

Responses of students gamblers and pathological gamblers presenting for treatment have been compiled for analysis.

The main objective of the study is to validate the French adaptations of the GABS and the GRCS, and to explore their psychometric properties and structures.

The recruitment period for the first stage is comprised between March 2008 and August 2008.

The recruitment period for the second stage started in September 2008.

Eligibility criteria: Inclusion Criteria:

* To be more than 18 years old (the legal age to gamble in France)

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Marie Grall-Bronnec, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06372626: Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.
Official title: A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neuroendocrine Carcinoma
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-04-18
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment.


Eligibility criteria: Inclusion Criteria:

* Fully understand the study and voluntarily sign the informed consent form.
* Male or female 18-70 years of age.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
* Histologically confirmed recurrent or metastatic neuroendocrine carcinoma
* Life expectancy ≥ 3 months.

Exclusion Criteria:

* Medical history, computed tomography or magnetic resonance imaging results indicate that existence of the central nervous system metastases;
* Any other malignancy within 5 years.
* participants were deemed unsuitable for participating in the study by the investigator for any reasons.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)
timeFrame: Up to 2 years
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 years
measure: Adverse Event (AE)
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
name: Jason Wu
role: STUDY_CHAIR
References:
Clinical trial NCT04291326: Cerebral Blood Flow Velocity Changes During Laparoscopic Surgery
Official title: A Study on Cerebral Blood Flow Velocity Changes During Laparoscopic Surgery in Pediatric Patients: Observational Study Using Transfontanelle Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Blood Flow
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 30
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients undergoing general anesthesia for laparoscopic surgery

Brief summary: Little is known about how implementation of pneumoperitoneum contributes to cerebral blood flow in pediatrics. We investigated this question in patients undergoing laparoscopic surgery, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion.


Eligibility criteria: Inclusion Criteria:

* pediatric patients undergoing laparoscopic surgery

Exclusion Criteria:

-

Primary outcomes:
measure: Cerebral blood flow
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
References:
Clinical trial NCT02892526: Wound Vitality Markers in Forensic Pathology
Official title: Wound Vitality Markers in Forensic Pathology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wound
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated in Plastic and Reconstructive Surgery and Maxillofacial Surgery departments at CHRU Nancy for therapeutic abdominoplasty.

Deceased patients, whose medico-scientific autopsies are performed for diagnosis in Anatomy and Pathological Cytology or Legal Medicine departments.

Brief summary: The purpose is to determine intrinsic properties of various immunohistochemical markers (FVIIIra, CD15, CD30, tryptase, TNFα, IL-1β, TGFα et TGFβ1) for diagnosis of vital wound, alone and in association (evaluation of sensibility with surgery wounds and evaluation of specificity with post-mortem wounds).

Secondary purposes are to measure the minimum time to obtain a positive labeling in vital wounds, and to evaluate inter-observer reproducibility of vitality diagnosis with different markers. Expression of microRNA miR 9, miR 21 et miR 198 will be also studied.


Eligibility criteria: Inclusion Criteria:

Alive persons:

- Abdominoplasty

Deceased persons:

- Medico-scientific autopsy for diagnosis

Exclusion Criteria:

Alive persons:

* Fragmented sample with non-visible banks
* Cutaneous pathology

Deceased persons:

* Persons under protection
* Medico-legal obstacle
* Cutaneous pathology

Primary outcomes:
measure: Sensibility of markers for vitality diagnosis
timeFrame: baseline
measure: Specificity of markers for vitality diagnosis
timeFrame: baseline
Secondary outcomes:
measure: Minimum time to obtain a labeling (between incision and devascularization)
timeFrame: baseline
measure: Coefficient of inter-observer correlation of vitality diagnosis (for reproducibility analysis)
timeFrame: baseline
measure: Expression level of miR 9 by qRT-PCR
timeFrame: baseline
measure: Expression level of miR 21 by qRT-PCR
timeFrame: baseline
measure: Expression level of miR 198 by qRT-PCR
timeFrame: baseline
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: Service de Médecine Légale - CHRU de Nancy
name: Laurent MARTRILLE
role: PRINCIPAL_INVESTIGATOR
References: