louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02499640: The Effects of Cold Water Immersion With Different Dosages (Duration and Temperature Variations) on Heart Rate Variability Post-exercise Recovery
Official title: The Effects of Cold Water Immersion With Different Dosages (Duration and Temperature Variations) on Heart Rate Variability Post-exercise Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryotherapy Effect
Keywords: Recovery of function
Autonomic nervous system
Heart rate variability
Cryotherapy
Immersion
Lead sponsor: Paulista University
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the present study was to investigate the effects of cold water immersion (CWI) during post-exercise recovery with different durations and temperatures on heart rate variability (HRV) indices. 100 participants performed a protocol of jumps and a Wingate test, and immediately afterwards were immersed in cold water, according to the characteristics of each group (CG: control; G1: 5' at 9±1°C; G2: 5' at 14±1°C; G3: 15' at 9±1°C; G4: 15' at 14±1°C). Analyses were performed at baseline, during the recuperative technique (TRec) by CWI and 20, 30, 40, 50 and 60 minutes post-exercise. The HRV indices average of all RR intervals in each analysis period (Mean RR), standard deviation of normal R-R intervals (SDNN), square root of the mean of the sum of the squares of differences between adjacent R-R intervals (RMSSD), spectral components of very low frequency (VLF), low frequency (LF) and high frequency (HF), scatter of points perpendicular to the line of identity of the Poincaré Plot (SD1) and scatter points along the line of identity (SD2) were assessed. Comparisons between groups and moments were performed using the technique of analysis of variance for repeated measures in two scheme factors. A significance level of p\<0.05 was considered.


Eligibility criteria: Inclusion Criteria:

* male sex
* healthy
* aged between 18 and 30 years
* classified as physically active through the International Physical Activity Questionnaire

Exclusion Criteria:

* smokers
* alcoholics
* use drugs that influenced cardiac autonomic activity
* cardiovascular, metabolic or endocrine diseases.

Primary outcomes:
measure: Change from Baseline in indices of heart rate variability at 60 minutes
timeFrame: 20, 30, 40, 50 and 60 minutes post-exercise
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04978740: Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)
Official title: Ocular and Palpebral Manifestations of Mastocytosis (MOOMA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mast Cell Activation Disease
Mast Cell Activation Syndrome
Mast Cell Disease
Urticaria Pigmentosa
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Mastocytosis is a rare condition characterized by an accumulation of mast cell cells in one or more organs such as the liver, bone marrow, spleen and intestines. Its prevalence in the general population is 1 in 10,000.

This pathology is due to the proliferation of a mast cell clone and the excessive release of inflammatory mediators which lead to abnormal tissue infiltration.

To date, there are only a few cases reporting ocular and orbital manifestations of mastocytosis.

Our prospective, interventional and single-center study consist in describing the ocular functional manifestations and ocular surface abnormalities of patients with systemic and cutaneous mastocytosis.

Detailed description: Patient with systemic or cutaneous mastocytosis will be included in the study. Data about organ involvement of mastocytosis will be collected. Participants will be screened with a medical and eye disease history. They will also have an eye exam.

Participants will provide a tears sample.

Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of mastocytosis
* Male or female, 18 years of age and over
* Ability to understand and provide written informed consent.

Exclusion Criteria:

* Disorders that do not allow good visualization of the posterior pole (cataract, intravitreal hemorrhage)
* Patients with another ocular pathology that may bias the results (corneal dystrophy, dysthyroid orbitopathy, retinal pathologies)
* History of refractive surgery

Primary outcomes:
measure: Proportion of Subjects with mastocytosis presenting eye abnormalities
timeFrame: up to 2 hours
Secondary outcomes:
measure: Nature and Frequency of eye abnormalities
timeFrame: up to 2 hours
measure: Risk factor of eye abnormalities
timeFrame: up to 2 hours
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Masson Regnault
state: Nouvelle Aquitaine
Study officials:
References:
Clinical trial NCT03170440: Non-invasive Nerve Stimulation for PTSD and Sleep
Official title: Non-invasive Vagal Nerve Stimulation and Sleep
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Traumatic Brain Injury
Keywords: Nerve stimulation
sleep deprivation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: US Department of Veterans Affairs
name: North Florida/South Georgia Veterans Health System
First posted: 2017-05-31
Enrollment: 221
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: In this study, our objective is to determine the effect of two different nerve stimulation types in changing sleep architecture.

Detailed description: Persons suffering from PTSD or mild TBI may suffer from sleep deprivation. The purpose of this study is to explore options to improve sleep quality.

Eligibility criteria: Inclusion Criteria:

* veterans with history of PTSD with and without history of mild TBI

Exclusion Criteria with:

* history of severe psychiatric illness unrelated to PTSD or TBI
* other medical conditions of severity that may impair cognition
* current illicit or prescription drug abuse
* breathing disorder requiring constant use of oxygen

Primary outcomes:
measure: Physiological sleep architectural quality
timeFrame: up to 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Jacksonville
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
Study officials:
affiliation: University of Florida
name: John Williamson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00783640: Dermacyd Femina (Lactic Acid) Pocket BR - Photo Evaluation
Official title: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Pocket BR.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Femina (Lactic Acid) Pocket BR.


Eligibility criteria: Inclusion criteria:

* Age between 18 and 60 years old;
* Phototype Skin I,II, III e IV
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs one month before the study;
* Personnel history of atopy;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs or cosmetics during the study;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: Throughout the study
measure: The sensibility will be evaluated according to the skin type.
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT03436940: Comparison Between Two Strategies of Discharge Planning for the Reduction of Short Term Hospital Readmissions
Official title: Comparison Between Two Strategies of Discharge Planning for the Reduction of Short Term Hospital Readmissions: A Cluster Randomized Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Discharge
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 802
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: cluster randomized cross-over trial
Primary purpose: OTHER

Brief summary: The purpose of this study is to improve discharge planning effectiveness by comparing two strategies \[on-Demand Discharge Planning (DDP) vs. Routine Discharge Planning (RDP)\], in terms of reduction of hospital readmissions for inpatients classified at intermediate risk of complex discharge using the simplified Blaylock Risk Assessment Screening Score (BRASS).

Detailed description: The purpose of this study is to improve discharge planning effectiveness by comparing two strategies \[on-Demand Discharge Planning (DDP) vs. Routine Discharge Planning (RDP)\], in terms of reduction of hospital readmissions for inpatients classified at intermediate risk of complex discharge using the simplified Blaylock Risk Assessment Screening Score (BRASS).

Five Internal Medicine Unit and four Units of Neurology will be randomized to the two different strategies of discharge planning (RDP or DDP), based on two different alternating sequences of four periods (each period comprising three months). The randomization will be stratified by type of unit.

Patients at risk of complex discharge, according to the simplified BRASS score, are assigned to the Hospital Unit of Continuity of Care (NOCC) team, using the hospital telematics system. Afterwards, the NOCC team proposes an appropriate discharge planning, considering clinical and social needs.

Eligibility criteria: Inclusion Criteria:

* Adults patients (age ≥ 18 years);
* Residents in Piedmont, Italy;
* Patients admitted to General Internal Medicine or Neurology Units of Molinette Hospital (Turin)
* Patients with a score in the simplified BRASS between 4 and 6 at admission

No specific exclusion criteria were applied.

Primary outcomes:
measure: Unexpected hospital readmission within 90 days from discharge
timeFrame: 90 days
Secondary outcomes:
measure: Proportion of Long Length of Stay (LLOS)
timeFrame: 150 days
measure: Death within 90 days from discharge
timeFrame: 90 days
measure: Proportion of patients reported to the NOCC team during the DDP-experimental phase
timeFrame: 150 days
measure: Healthcare costs until 90 days from the discharge
timeFrame: 90 days
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute
Study officials:
affiliation: A.O.U. Città della Salute e della Scienza
name: Daniela Corsi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05126940: Bedside Lung Ultrasonography by Nurses in Acute Dyspnea.
Official title: Bedside Lung Ultrasonography by Emergency Department Nurses as an Aid for Identifying Heart Failure in Patients With Acute Dyspnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea; Cardiac
Keywords: Lung ultrasound
heart failure
diagnosis
accuracy
nurses
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A convenience sampling approach, including all patients admitted to the ED for acute dyspnea as chief complaint, was used.

Brief summary: This study assesses the potential of lung ultrasonography to diagnose heart failure.

Detailed description: Dyspnea is one of the most distressing situations for the patient . Emergency cases do not always present in conditions that are ideal for immediate diagnosis, which sometimes compromises outcome. Physical examination, laboratory findings and radiography are imperfect, resulting in a need for sophisticated test results that delay management.

Lung ultrasonography is becoming a standard tool in critical cases in the ED.

the investigators aim to perform ultrasonography on consecutive patients admitted to the ICU with dyspnea, comparing lung ultrasonography results on initial presentation with the final diagnosis by the nurses.

Three items were assessed: artifacts (horizontal A lines or vertical B lines indicating interstitial syndrome), lung sliding, and alveolar consolidation and/or pleural effusion, these items were grouped to assess ultrasound profiles.

the study aimed to evaluate the accuracy and reproducibility of B-lines testing assessed by emergency nurses after 12-h training in the diagnosis of HF in patients admitted to the emergency department with acute dyspnea.

Eligibility criteria: Inclusion Criteria:

* non traumatic dyspnea with the final diagnosis of heart failure

Exclusion Criteria:

* age less than 18 years
* impossibility to give consent to participate in the study
* post-traumatic dyspnea
* pregnant women
* need for endotracheal intubation or inotropic drugs
* patients who were deemed too unstable for sonography by the treating team

Primary outcomes:
measure: the accuracy of LUS performed by nurses in the diagnosis of heart failure
timeFrame: 0 days
measure: the Specificity of LUS by nurses in the diagnosis of heart failure
timeFrame: 0 days
measure: the reproducibility of LUS in by nurses the diagnosis of heart failure
timeFrame: 0 days
measure: Agreement between nurses and expert's
timeFrame: 0 days
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Nouira Semir
Study officials:
References:
Clinical trial NCT04950140: Randomized Clinical Trial Comparing Conventional Laparoscopic Surgery and Robot-Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
Official title: Randomized Clinical Trial Comparing Conventional Laparoscopic Surgery and Robot-Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parastomal Hernia
Oncology
Lead sponsor: Instituto do Cancer do Estado de São Paulo
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective randomized prospective interventional study with 40 consecutive patients for whom surgical treatment for PH was indicated and who are in postoperative follow-up with the Oncology Surgery group of the Department of Digestive Tract Surgery and Coloproctology, Faculty of Medicine, University of São Paulo .

The free and informed consent form will be applied to the patient by the researchers in two copies of equal content and after any doubts related to the research are resolved, the patient will sign the copies together with the researcher. At any time, the patient may opt out of the study. The contacts of the researchers and the institution will be fully available to the research subject to resolve doubts and for any eventuality that may occur.


Eligibility criteria: Inclusion Criteria:

* Patients with PH in permanent ostomy, aged between 18 and 75 years, undergoing surgery for cancer treatment at ICESP, with stable cancer disease (recurrence or metastasis without evolution) or in follow-up after treatment with curative intent, who have computed tomography with a diagnosis of HP, and who agree to participate in the study.

Exclusion Criteria:

* Patient with progressive cancer disease. Presence of disease that prevents the performance of videolaparoscopic surgical procedure such as severe heart failure, severe lung disease, etc. Clinical criteria according to the research team that may indicate the application of another specific technique that is not covered in this study.

Primary outcomes:
measure: To study the return time of ostomy functioning of patients approached by laparoscopic assisted robot using the Sugarbaker technique using a semi-absorbable biosynthetic mesh.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03570840: Pediatric Metabolic Syndrome Study
Official title: Pediatric Metabolic Syndrome Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Overweight and Obesity
Cardiovascular Risk Factor
Keywords: pediatric metabolic syndrome
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 477
Sex: ALL
Minimum age (years): 4
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: obese 4 to 21 yo subjects

Brief summary: The Pediatric Metabolic Syndrome Study is an observational study being conducted at the Medical University of South Carolina to investigate cardiometabolic risk parameters in obese subjects ages 4 to 21. A detailed assessment is performed on eligible subjects including fasting labwork, anthropometrics, nutrition analysis, body composition testing, echocardiography, and carotid IMT measurements.


Eligibility criteria: Inclusion Criteria:

age 4 to 21 years history of obesity (BMI at or over the 95th% for age/gender)

Exclusion Criteria:

age below 4 or above 21 years no history of obesity current pregnancy current chronic oral steroid use current insulin use

Primary outcomes:
measure: fasting insulin
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: MUSC
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Melissa H Henshaw, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06907940: Upper Extremity Stability and Balance in Youth Basketball Players
Official title: Upper Extremity Stability and Balance in Youth Basketball Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Balanced
Keywords: basketball
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 73
Sex: MALE
Minimum age (years): 14
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: basketball player

Brief summary: Ball games require extensive skill, including physical, technical, mental and tactical abilities. Among them, the physical abilities of the players show obvious effects on the players' own skills and the tactics of the team. It involves skillful moves that include shooting, defending, and dribbling. It requires repeated maximum effort, such as a.

Detailed description: Endurance is defined as the strength of the physical and physiological characteristics of a basketball player to cope with fatigue. Flexibility is the ability of the athlete to use the range of motion he uses while demonstrating the movements, in every possible direction in the joint range.

Eligibility criteria: Inclusion Criteria:

* Being a basketball player
* Regular attendance at training sessions

Exclusion Criteria:

* Known neurological disorder
* Serious orthopedic disorders that prevent exercise
* cognitive impairment

Primary outcomes:
measure: Star Excursion Balance Test
timeFrame: day 1
measure: Medicine Ball Throwing
timeFrame: day 1
measure: Upper extremity Y Test
timeFrame: day 1
measure: Closed Kinetic Chain Upper Extremity Stability Test (TEST)
timeFrame: day 1
measure: Push Up Test.
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahceşehir University Health Center
Study officials:
References:
citation: Xu HR, Zhang YH, Mao Y, Ngo TL, Zhang Q, He G, Feng Z, Sun W, Wang XQ. Validity and reliability of upper extremity star excursion balance test in adolescent swimmers. J Exerc Sci Fit. 2023 Apr;21(2):210-217. doi: 10.1016/j.jesf.2023.02.003. Epub 2023 Feb 27.