cyrilzakka/clinical-trials huggingface dataset:
Empowering Health: Acute Psychological Effects of an Electromyostimulation-Whole-Body-Workout

The study investigates the acute psychological effects of a whole-body-workout using Electromyostimulation (EMS) in participants with depression and healthy individuals.

EMS-whole-body-workouts are less time-consuming and effort-intensive but generate physical effects which are comparable to conventional strength training. Therefore EMS could lower the barrier to physical activity. The present study focusses on acute psychological effects of an EMS workout - especially with regard to the reduction of depressive symptoms. Physical activity is notably important for patients with depression and shows multiple positive psychological and physical effects. But due to disease-related factors like lethargy, physical activity is far too rarely implemented. Therefore EMS-whole-body-workouts could provide an opportunity to generate positive psychological effects through a less (subjective) cost-intense strength training.

Eligibility Criteria:
Inclusion Criteria:

* Subject familiarized with experimental procedure and had given written informed consent
* Depression, according to ICD-10
* BDI-II Score ≥ 14
* Able to understand German
* Reachability of participant for the two training sessions

Exclusion Criteria:

* Contraindications for physical exercise
* Contraindications for EMS-use
* Current EMS-use
* Pregnancy
* Borderline personality disorder
* Bipolar Disorder
* Schizophrenia
* Anorexia Nervosa, Bulimia Nervosa
* Dementia
* Acute suicidality
* Substance dependencies with actual consumption (except nicotine)
Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain

Use huawei wristwatch to record maternal rhythm status and record the VAS score after cesarean section under combined spinal-epidural anesthesia. Based on this study the investigators intend to explore the correlation between maternal circadian rhythm status and postoperative pain after cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 45
* ASA(American society of anesthesiologists) status II-III
* 37-42 weeks gestation
* undergo elective cesarean section with subarachnoid anesthesia
* participate in this study and sign informed consent

Exclusion Criteria:

* Patients with contraindications of combined spinal and epidural anesthesia
* Patients with severe systemic disease
* Alcoholism and long-term use of anti-inflammatory and analgesic drugs
* Patients who were unable to cooperate or refused to participate in the trial
* with psychiatric disorder
* researchers considered unsuitable to participate in or unable to cooperate with the study
Ventilation Weaning Strategies and Correlation to Outcomes in Tracheostomized Patients in the Lausanne ICU

This retrospective study aims to study characteristics of patients tracheotomized in the Lausanne ICU, both overall and by primary reasons of intubation. Ventilation data both before and after tracheotomy, weaning technique and timing are studied in this retrospective study.


Eligibility Criteria:
Inclusion Criteria:

* All patients hospitalized in the Lausanne ICU between May 1st 2017 and November 31st 2018 with a tracheotomy and mechanically ventilated more than 72 hours.

Exclusion Criteria:

* Presence of a know opposition to participation to research projects
* Patient tracheostomized specifically for ENT (ear-nose-throat) reason
* Burn victim
* Patient tracheostomized before his/her admission to the Lausanne ICU
Evaluation Safety and Explore Efficacy Long-term Follow-up Study on Subjects Receiving SMUP-IA-01 or Active Control

This is a follow-up study to investigate the long-term safety and explore efficacy of SMUP-IA-01, for the treatment of Knee Osteoarthritis. Subjects who participated in and completed the initial stage of the Phase II trial (NCT05182034) will be followed-up until 60 months.

The subjects will be followed up at 12-month, 24-month, 36-month, 48-month and 60-month after the initial administration of SMUP-IA-01.

Eligibility Criteria:
Inclusion Criteria:

1. Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase II clinical trial.
2. Subject who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.

Exclusion Criteria:

1. Subject who were not enrolled in phase II clinical trial of SMUP-IA-01 for assessing safety and explore efficacy.
2. Other subjects, excluding those listed above, who were deemed unsuitable by the PI
Intra-abdominal Hypertension in Critically Ill Patients

The aim of the proposed study is to determine the incidence and prevalence of intra-abdominal hypertension and abdominal compartment syndrome in consecutive intensive care admissions using broad inclusion criteria.

Increased pressure within the abdominal cavity is particularly common in intensive care patients and has been shown to be an independent risk-factor for mortality in this patient population. The quoted rates of intra-abdominal hypertension of range anywhere from 20-60% are dependent on the population of patient studied. The prospective observational studies performed to date have been underpowered, used strict inclusion/exclusion criteria or were performed prior to consensus guidelines on the definition and measurement of intra-abdominal pressure and hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Foley catheter in-situ on admission

Exclusion Criteria:

* Contra-indication to bladder pressure measurement
* Home service asked that patient is not included
* Death within 24 priors of admission before bladder pressure measured
* No bladder pressure performed within 24 hours of admission
* Consent refused or unable to be obtained (lack of SDM, patient unable to provide)
Effect of Aprepitant on Cyclophosphamide Pharmacokinetics in Patients With Breast Cancer

RATIONALE: Antiemetic drugs, such as aprepitant, may help lessen or prevent nausea and vomiting in patients undergoing chemotherapy.

PURPOSE: This randomized clinical trial is studying aprepitant to see how well it works compared to placebo in preventing nausea and vomiting in patients undergoing chemotherapy for breast cancer.

OBJECTIVES:

Primary

* To evaluate the effect of aprepitant on cyclophosphamide and 4-hydroxycyclophosphamide pharmacokinetics as measured by plasma AUC in patients with breast cancer.

Secondary

* To evaluate total control of nausea and vomiting, as defined by no vomiting episodes and no use of rescue medication, 72 hours after courses 1 and 2 of chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive aprepitant 125 mg orally once daily on day 1 and 80 mg orally once daily on days 2 and 3. Beginning 1 hour after receiving aprepitant, patients receive an infusion of cyclophosphamide on day 1. During course 2, patients crossover and receive treatment (placebo) as in arm II.
* Arm II: Patients receive a placebo 125 mg orally once daily on day 1 and 80 mg orally once daily on days 2 and 3. Beginning 1 hour after receiving the placebo, patients will receive an infusion of cyclophosphamide infusion on day 1. During course 2, patients crossover and receive treatment (aprepitant) as in arm I.

Patients complete a diary documenting nausea and vomiting on days 1, 2, and 3 of both courses. Patients also complete The Functional Living Index-Emesis (FLIE) questionnaire documenting compliance, rescue antiemetic therapy, and any adverse effects and record them in the diary for each course. Information in the patient's diary is obtained by the coordinator via telephone on day 4 of each course.

Patients undergo blood sample collection periodically for pharmacokinetic studies via high performance liquid chromatography.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Planning to receive cyclophosphamide 600 mg/m²-1,000 mg/m² IV infusion

  * No cyclophosphamide dose change between courses 1 and 2

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 2 months
* ANC ≥ 1,500/μL
* Platelet count ≥ 100 x 10\^9/L
* Hemoglobin ≥ 9.0 g/dL
* Serum creatinine ≤ 1.5 mg/dL
* AST/ALT ≤ 2 times upper limit of normal
* Not pregnant or nursing
* No contraindication to aprepitant

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent medications that are CYP3A4 substrates, inhibitors, and/or inducers, with the exception of the dexamethasone contained as part of the standard antiemetic regimen
Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA)

Obstructive sleep apnea (OSA) is a common clinical condition, involving the development of arterial hypertension. A Meta analysis study have shown that isometric hand grip training promotes blood pressure reduction. It is going to be conducted a clinical trail to determine the effects of hand grip training in OSA patients to change the arterial hypertension.

Background: obstructive sleep apnea (OSA) is a common clinical condition, involving the development of arterial hypertension. Meta analysis study have shown that isometric hand grip strength promotes blood pressure reduction, and its reduction is higher than that observed after aerobic training. Objective: to analyze the effects of the isometric hand grip on blood pressure changes of patients with uncontrolled arterial hypertension with OSA. Methods: a randomized controlled trial involving 18 adults with OSA and uncontrolled arterial hypertension of both sexes, randomized between control group (receive general guidelines) and hand grip group. 12 weeks of training with load equivalent to 30% of maximum voluntary capacity was performed. All participants will be submitted for evaluation of blood pressure (BP) central and brachial, pulse wave velocity, full polysomnography,before and after the study protocol (the change from the baseline at 12 weeks). Expected results: the authors believe that hand grip training can change (reduce) blood pressure in patient with OSA.

Eligibility Criteria:
Inclusion Criteria:

* OSA diagnose based on polysomnography,
* Apnea-Hypopnea Index (AHI) \> 5,
* arterial hypertension (systolic arterial pressure \> 140 mmHg or diastolic arterial pressure \> 90 mmHg)

Exclusion Criteria:

* other heart disease
Epidemiology and Risk Factors of Uterine Fibroids in China

Uterine fibroids are the most common form of benign uterine tumors in the uterine muscle layer, which had a certain rate of malignancy, but it is rare. The prevalence of uterine fibroids estimates range from 4.5% to 68.6% depending on study population and diagnostic methodology. The prevalence of fibroids has been historically underestimated by epidemiologic studies which focused mainly on symptomatic women, leaving behind a large population of asymptomatic women and women who underreport their symptoms. What investigators don't know was which women who have fibroids will develop clinical symptoms and which women who have an operation of myomectomy will relapse. The purpose of this study is to investigate the prevalence, incidence and risk factors for the development of uterine fibroids in Chinese women.


Eligibility Criteria:
Inclusion Criteria:

* Current place of residence≥ 6 months;
* No serious mental illness or mental abnormality;
* Those who agree to participate in this survey and cooperate in completing the questionnaire.

Exclusion Criteria:

-
Switching to Potential Reduced Exposure Products in Adult Smokers

This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 30 non-treatment seeking adult smokers to investigate within-person changes in smoking behavior as a result of switching to different concentrations of oral nicotine pouch products (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to oral nicotine pouches.


Eligibility Criteria:
Inclusion Criteria:

1. 21-77 years old(in line with NIH guidelines for 18+ being the age of consent in adults) (2008 PHS Guideline Update Panel)
2. English literate
3. Smoke at least 1 cigarette per day
4. Expired breath carbon monoxide level ≥ 6ppm at baseline
5. Not currently actively pursuing smoking cessation services or planning to use evidence-based cessation tools to quit in the next month
6. Not interested in the use of existing FDA-approved tobacco pharmacotherapies (i.e., NRT, wellbutrin, varenicline).

Exclusion Criteria:

1. Currently using any stop smoking treatments (2008 PHS Guideline Update Panel)
2. History of serious psychiatric condition (i.e., bipolar disorder, schizophrenia)
3. Current uncontrolled medical condition
4. Cardiac conditions that required a hospitalization or intensive treatment on an outpatient basis in the past year including: myocardial infarction, coronary artery disease, unstable angina, congestive heart failure, or tachyarrhythmias (including rapid atrial fibrillation, ventricular tachycardia, or ventricular fibrillation)
5. Female participants of child-bearing age will be excluded if they are currently pregnant or breastfeeding or report an unwillingness to use effective birth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier method such as condoms) for the duration of the study
6. Severe lung disease that requires supplemental oxygen
7. Uncontrolled asthma (\<20 on the Asthma Control Test (ACT) or requiring steroids more than 1x per year)
8. Unstable COPD: defined as GOLD category C or D (more than 2 exacerbations or 1 exacerbation leading to hospitalization in the past year)
9. Planning to quit smoking with a set goal or time for quit attempt
10. Known hypersensitivity to propylene glycol
11. Patients with an FEV1 \< 40%
Vestipitant 28-day Tolerance Study

This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant 15mg/day for treatment of Primary Insomnia in adults outpatients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female aged 18-64 years inclusively with Diagnosis of Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders -Text Revision (DSM-IV-TR) criteria 307.42
* PSG variables collected during 2consecutive PSG screening nights falling as follows: TST between 240-420 mins inclusive (both nights) - LPS (Latency to Persistent Sleep): mean not less than 20mins, each night not less than 15 mins - WASO (Wake After Sleep Onset): mean not less than 60mins, each night not less than 45mins
* Women: non child bearing potential or if child bearing potential agree on Contraceptive Methods listed in Protocol

Exclusion Criteria:

* clinically significant Psychiatric and neurological disorders (sleep disorders other than Primary Insomnia, history of alcohol orother substance abuse or dependnce);
* nightshift or rotating shift-work;
* Lifestyle habits in agreement with Protocol requirement: caffeine - alcohol intake and smoke
* healthy according to GSK criteria - laboratory and ECG limits set in the Protocol
A Study of the Effectiveness of Risk Minimization Measures Related to Depakine® (Sodium Valproate) in Saudi Arabia

A cross-sectional, national, multicenter, survey-based study to assess the effectiveness of Risk Minimization Measures related to Depakine® (sodium valproate) in Saudi Arabia. The study duration will be 7 months from 30 November 2024 to 30 May 2025. The end of study is defined as the end of the data collection period. No intervention will be administered, and no study related visits are required.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare professionals working only in Saudi Arabia AND
* Prescribers of Depakine® (sodium valiporate) at least once in the six months leading up to survey completion OR
* Obstetricians/Gynecologists who consulted at least one women of childbearing potential treated with Depakine® (sodium valproate) in the six months leading up to survey completion OR
* Pharmacists who have dispensed Depakine® (sodium valproate) in the six months leading up to survey completion

Exclusion Criteria:

* Healthcare professionals who may have conflicts of interest with the survey (i.e. employed by regulatory bodies or pharmaceutical companies)
* Healthcare professionals (or with a relative) involved in valproate-related lawsuits or associations for victims of valproate syndrome
* Healthcare professionals who are not prescribing Depakine® (sodium valproate), except for obstetricians/gynecologists (who do not prescribe Depakine® \[sodium valproate\])
* Healthcare professionals having started to prescribe or dispense Depakine® (sodium valproate) earlier than six months before survey completion

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Intervention With Lupin Kernel Fibre in Hypercholesterolemic Subjects

The objective of the conducted study was to determine the efficacy of lupin kernel fibre-enriched food (Lupinus angustifolius Boregine) on prevention of risk factors for gastrointestinal or cardiovascular diseases.

Dietary fibre is suspected to effect the faecal concentration and excretion of bile acids by binding the bile acids and by increasing the faecal mass. Bile acids, especially the secondary bile acids, are potential risk factors for colorectal cancer. A high bile acid-binding ability of fibre could lead to lower blood cholesterol concentrations by interrupting the enterohepatic circulation. There is evidence that the consumption of lupin kernel fibre, containing both soluble and insoluble fibre fractions, may beneficially modify bowel health.

A total of 133 subjects were recruited for this study. Sixty moderate hypercholesterolemic volunteers (total cholesterol \> 5.2 mmol/L) fulfilled the selection criteria and were randomly assigned three groups. Forty-five subjects (mean age of 47 years, 34 women and 20 men) completed the double-blind, randomized crossover trial.

The subjects consumed a high-fibre diet containing 25 g fibre (citrus- or lupin fibre) per day and a low-fibre diet (placebo) for four weeks each. After baseline, each volunteer had to pass all three periods in different order with a two-week wash-out period between each.

At the end of each intervention period, subjects consumed a standardized diet for three days. Furthermore, a quantitative stool collection took place and fasting blood samples were drawn.

Eligibility Criteria:
Inclusion Criteria:

* moderate Hypercholesterolemia (total cholesterol \> 5.2 mmol/L)
* age 20-75 years

Exclusion Criteria:

* intake of lipid-lowering pharmaceuticals
* intake of nutritional supplements
* allergy against legumes
* intolerance against milk protein
* pregnancy, lactation
* chronic bowel diseases
Effects of Green Light Therapy on Body Contouring and Cellulite

A double-blind, placebo-controlled randomized evaluation of the effect of Cellulize, a green light low level laser system for aesthetic use for the non-invasive reduction in fat layer for body contouring and reduction of cellulite.

This clinical trial will provide objective evidence showing effectiveness of the Cellulize 532nm green light therapy for the non-invasive reduction in fat layer for body contouring, and for the non-invasive treatment for the appearance of cellulite.

Eligibility Criteria:
Inclusion Criteria:

* Study participant between the ages of 18 and older.
* Female only
* Subject is willing and able to abstain from partaking in any treatment other than the study procedures (existing or new) to promote body contouring/circumference reduction/weight loss during the course of study participation.
* Subject is willing and able to maintain his or her regular (typical pre-study) diet and exercise regimen without effecting significant change in either direction during study participation.

Exclusion Criteria:

* No photo-therapy (red or green) within 3 weeks of treatment.
* Known cardiovascular disease such as cardiac arrhythmias, congestive heart failure.
* Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
* Prior surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc.
* Medical, physical, or other contraindications for body sculpting/weight loss.
* Current use of medication(s) known to affect weight levels/cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent.
* Any medical condition known to affect weight levels and/or to cause bloating or swelling.
* Active infection, open wound (e.g. sores, cuts, ulcers, burns, etc.) or other external trauma to the areas to be treated with the laser/lymphatic drainage system devices.
* Photosensitive condition or medication.
* Active cancer within the past year.
* Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation.
* Diminished ability to void waste (liver or kidneys).
* Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
Risk Factors of POCD in General Anesthesia Patients Underwent Noncardiac and Non Neurological Procedures.

The study was a prospective cohort study to assess the effect of age, duration of anesthesia, repeated surgery, and type of surgery on cognitive impairment in 108 geriatric patients (≥60 years) who underwent general anesthesia for non-neurologic noncardiac surgery.

The study was a prospective cohort study, assessing the effect of age, duration of anesthesia, repeated surgery, and type of surgery on cognitive impairment in 108 geriatric patients (≥60 years) who underwent general anesthesia for non-neurologic noncardiac surgery. The study used cognitive tests such as RAVLT, TMT, and Digit span tests. POCD definition is reduction in postoperative cognitive function by as much as 20% at a minimum of 2 cognitive tests.

Eligibility Criteria:
Inclusion Criteria:

* geriatric patient (age over 60) underwent noncardiac non-neurological procedure under general anesthesia
* patient can do reading and writing
* patient can speak in Bahasa
* signing informed consent

Exclusion Criteria:

* patient with cognitive impairment or psychiatric disorder such as delirium, amnesia, anxiety disorder, or depression.
* patient under psychotropic drugs or narcotics.
* patient with history of brain tumor, head injury or motoric disturbance and disability that can disturbed neurocognitive test