cyrilzakka/clinical-trials huggingface dataset:
Screen Free Time With Friends Feasibility Trial

The Screen Free Time with Friends Feasibility Trial is a study designed to inform development of a definitive trial. The feasibility trial aims to 1) examine the feasibility of an intervention aimed to limit recreational screen media use and promote more time with peers after school and during weekends among 10-11 year old children, 2) examine participant recruitment and retention rates, 3) examine the feasibility of the data collection plan and completeness of the compliance and outcome assessment, and 4) obtain baseline and follow-up data on the planned full trial primary outcome. The Screen Free Time with Friends Feasibility Trial will be conducted as a non-randomized single group feasibility trial including children, their parents and school and afterschool personal from 3rd grade school classes from different schools in the Region of Southern Denmark. The goal is to include a representative sample of children and parents in the participating 3rd grades, and thus there will be no individual level inclusion and exclusion criteria. A process evaluation and outcome measurements will be conducted to evaluate the feasibility and acceptability of the intervention, the data collection plan, and compliance. A baseline- and follow-up assessment will be carried out for some measurements, while others will be collected continuously during the intervention period.


Eligibility Criteria:
Inclusion Criteria:

* the distance between the school and the related afterschool club is in walking and cycling distance
* the afterschool club must have potential for improvement (assessed by the municipality)
* the afterschool club personal must have a wish to develop the afterschool club
COVID-19 Associated Coagulopathy in Egypt

Coagulopathy is one of the most significant prognostic factors in patients with COVID-19 and is associated with increased mortality and admission to critical care. Most commonly observed coagulopathy in patients hospitalized with COVID-19 (COVID-19-associated coagulopathy) is characterized by increased D-dimer and fibrinogen levels. 71% of patients who did not survive hospitalization reported to have developed disseminated intravascular coagulation (DIC) compared to 0.6% of survivors.

studying the detailed coagulation screen and second line coagulation parameters including both thrombophilia screen and other acute phase coagulation factors.

Eligibility Criteria:
Inclusion Criteria:

* patients with COVID 19 positive by RT- PCR

Exclusion Criteria:

* no exclusions
Prospective Study on Plasma Pro-endothelin-1 in Predicting Bronchopulmonary Dysplasia

Serial quantitative measurements of plasma pro-endothelin-1 concentrations in very preterm infants. Comparing pro-endothelin-1 with established clinical indices of bronchopulmonary dysplasia (BPD). Hypothesis: Pulmonary-vascular remodeling in infants developing BPD is directly related to circulating pro-endothelin-1, which therefore serves as surrogate marker of BPD.


Eligibility Criteria:
Inclusion criteria:

* Very preterm infants born before 32 weeks gestational age

Exclusion criteria:

* Severe fetal malformation, congenital heart defect, inborn syndrome, cardiomyopathy, fetal hydrops
Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause

evaluate the efficacy of paroxetine in the management of vasomotor symptoms in patients with surgical menopause, in order to seek an alternative therapy to hormone therapy, which is associated with proinflammatory and procoagulant effects that increase the risk of thrombosis and is therefore contraindicated in people with diabetes mellitus, chronic arterial hypertension and patients with a history of thromboembolism

Vasomotor symptoms that occur in the peri-menopausal and postmenopausal period are experienced by 80% of women and can greatly affect the quality of life by temporarily interrupting daily activities. These symptoms are experienced early in our study population who are induced to early menopause by undergoing surgical procedures such as total abdominal hysterectomy plus bilateral salpingo-oophorectomy.

Due to the controversy that exists about the use of hormone replacement therapy, in recent years different alternative therapies have been proposed for the management of these symptoms, mainly for those patients who have contraindications for hormone therapy. For this reason, the use of non-hormonal therapy has been investigated.

Since there are women who have contraindications to conventional therapy such as patients with cardiovascular and thrombosis risks, there is a need to search for new alternative therapies such as selective serotonin reuptake inhibitors, specifically paroxetine, so with our study we seek to evaluate how effective paroxetine is in reducing vasomotor symptoms and thus provide an alternative to this type of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with surgical menopause attending IHSS outpatient clinic.
* Patients with surgical menopause with presence of hot flashes and night sweats.
* Surgical menopausal patients with episodes of anxiety and palpitations.
* Patients with surgical menopause who receive treatment for 6 months with Paroxetine.
* Patients who after reading and explanation of the Informed Consent agree to participate voluntarily.

Exclusion Criteria:

* Patients medicated with psychotropic drugs, including all sedatives and hypnotics.
* Patients under treatment with Menopausal Hormone Therapy.
* Patients with impaired hepatic or renal function.
* Patients with unstable heart disease.
* Patients with a history of self-destructive behaviors.
* Patients with a history of clinical diagnosis or treatment for depression or any other psychiatric disorder (including substance abuse or alcohol disorders) and any other ongoing medical condition.
The Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)

The purpose of the study is to test whether the health care provider access and training in CERTAIN (Checklist for Early Recognition and Treatment of Acute Illness), would facilitate timely and error free best-practice delivery and minimize preventable death and costly complications in critically ill patients.


Eligibility Criteria:
Inclusion:

All adult (≥ 18 years) patients admitted for the first time to the participating ICUs will be included.

Exclusion:

Not critically Ill, admitted for low risk monitoring, planned ICU admissions for routine postoperative surveillance for less than 24 hours after uncomplicated surgery, readmission and transferred from outside ICU.
A Proof of Concept and Dose-finding Study of XXB750 in Patients With Heart Failure

This is a multicenter, randomized, placebo- and active-controlled, parallel-group, 24-week trial to investigate the efficacy, safety, and tolerability of XXB750 in participants with HFrEF/HFmrEF.

Eligible participants will be randomized to receive either subcutaneous (s.c.) XXB750 or placebo; or sacubitril/valsartan for 16 weeks, and then followed-up for 8 weeks

Eligibility Criteria:
Inclusion Criteria:

* Current symptom(s) of HF NYHA class II-III and LVEF \< 50%
* Elevated NT-proBNP levels at screening.
* Receiving standard of care background HF therapy.

Exclusion Criteria:

* Current acute decompensated HF or hospitalization for HF within 3 months prior to screening.
* Current symptomatic hypotension (for example dizziness/presyncope).
* K+ \> 5.4 mmol/L at screening
* eGFR \< 30 mL/min/1.73m2 at screening

Other protocol-specific criteria may apply.
Comparison of Acoustic Attenuation Parameter Using FibroTouch With Liver Biopsy for Diagnosis of Hepatic Steatosis

This will be a multi-center, prospective, controlled study. It is expected that about 240 subjects from 10 study centers will be enrolled, and 224 effective subjects will be statistically analyzed in the end, in which 56 effective subjects with stage F0 (25%), 56 effective subjects with stage F1 (25%), 56 effective subjects with stage F2 (25%), 56 effective subjects with stage F3 (25%). By comparison of the result of FibroTouch examination with that of liver biopsy, their specificities, sensitivities and accuracies for diagnosis of liver steatosis will be identified.

The patients with liver diseases who need to have a liver biopsy in hospital and meet all of the inclusion criteria and none of the exclusion criteria, may participate in this study. Within two weeks of FibroTouch examination, subjects are required to have qualified histological specimens of liver biopsy for comparation.


Eligibility Criteria:
Inclusion Criteria:

* Subject at the age of 18 to 65 years, non-limited gender.
* Within two weeks of FibroTouch examination, qualified histological specimens of liver biopsy are required. Using the liver biopsy needle of 16G or 14CT, puncture and remove more than 2.0 centimeters long liver tissue (including at least 11 portal areas, no less than 6 complete portal areas and the minimum length of specimen should be more than 1.0 centimeter).
* Willing and able to abide by all principles and complete all study procedures.
* Willing and can provide written informed consent form by patient or patient's legal guardian.

Exclusion Criteria:

* Subject with active or suspected cancer or history of malignant tumor by evidence within 5 years before enrolling. And the subject who has the liver malignant tumors injury cannot participate in this study.
* There is evidence that the subject has a history of alcohol overdoses\* or drug abuse. Definition of alcohol overdoses: 40 gram (g)/day for male and 40 g/day for female. Alcohol intake (g) = the volume of drinking (ml) × alcohol percentage (%, v/v) × 0.8 (g/ml); 1g alcohol is the equal of 25-40 ml of beer, 8-10ml of Chinese rice wine, 5-12ml of (grape) wine, 3-7ml of health care liquor or Chinese spirits.
* Subject with alcoholic liver disease and hepatitis C.
* Pregnant or nursing woman, and subject with a pregnant plan and is unwilling to take contraceptive measures during this study.
* Subject with history of organ transplantation or has functional grafts (except for the cornea or hair graft).
* Subject with non-healing wound on the right upper abdomen at this moment.
* In the investigator's opinion, the subject is unsuitable to participate in the study as he or she has a history of serious illness, or other evidence shown that the subject has any other serious illness.
* Subject who participates in other clinical trial at the same time.
A Novel Noninvasive Thermoregulatory Device for Postural Tachycardia Syndrome

The investigators hope to learn the feasibility and preliminary efficacy of the Embr device for improving thermal comfort in individuals with POTS and impaired thermoregulation. Feasibility will be assessed via usage of the Embr device and participant feedback. Preliminary efficacy measures will include temperature-related symptoms and temperature- related quality of life in individuals with POTS and impaired thermoregulation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of POTS
* Participant self-report of heat or cold intolerance
* Willingness to wear the Embr device for 3 weeks, charging the device daily, and
* Have a working smartphone (iPhone 6 or greater; or Android 8.0 or greater
* Comfortable downloading and using the companion app on their phone
* Able to provide informed written consent
* Able to complete written questionnaires

Exclusion Criteria:

* Prior or current use of the study device
* Hypohidrosis, hyperhidrosis, or anhidrosis, as determined by sudomotor testing; peripheral neuropathy; perimenopausal, menopausal, postmenopausal state; temperature intolerance due to other medical disorders (i.e. malignancy, systemic autoimmune disease)
* Medications known to affect sweat function
* Non-English speaking
A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease

This project is the stage of dose escalation, is was divided into single and multiple dose clinical study, This is a multi-center, randomized, double-blind, placebo-controlled , study to the safety, tolerability and pharmacokinetic characteristics of TQC3927 powder for inhalation in Chronic Obstructive Pulmonary Disease


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 45 years (inclusive)，both male and female
* The subjects were able to undergo reproducible FEV1 lung function testing according to the American Thoracic Society/European Respiratory Society (ATS/ERS) 2005 standard during screening
* Subject should weigh at least 45kg. And body mass index (BMI) within 18\~30 kg/m2
* Have no pregnancy plan and voluntarily take effective contraception measures from time of screening to at least 90 days after the last dose (subjects and their partners)

Exclusion Criteria:

* Patients with a history of glaucoma, functional constipation, prostate hyperplasia, urinary tract obstruction, etc
* Individuals with a history of illegal drug abuse or who have tested positive for drug abuse screening during the screening period (including benzodiazepines, methamphetamine, cocaine, morphine, ketamine, tetrahydrocannabinol)
* Participated in other clinical trials and received research interventions in the 3 months prior to participating in this trial
* Screening for individuals who have used biologics within the past 3 months
* Individuals who have lost blood or donated more than 400 mL of blood within 3 months prior to the experiment, or who have received blood transfusions or used blood products
* Any clear history of drug or food allergies, especially those who are allergic to ingredients similar to the investigational drug
* Screening for individuals who have frequently consumed alcohol within the previous 6 months (i.e. females consume more than 14 standard units of alcohol per week, males consume more than 21 standard units of alcohol per week (1 standard unit contains 14g of alcohol, such as 360 mL beer or 45 mL of 40% alcohol strong liquor or 150 mL wine) or are unable to abstain from alcohol during the trial period; Or those who test positive for alcohol breath test
* History of any malignant tumors in organs or systems within the past 5 years, regardless of whether they have received treatment or not, except for local basal cell carcinoma of the skin
* When screening, the sitting systolic blood pressure should be ≥ 160 mmHg, and the sitting diastolic blood pressure should be ≥ 100 mmHg; Pulse rate\<50 bpm or\>100 bpm
* Clinically significant apnea patients requiring continuous positive airway pressure (CPAP) or non-invasive positive airway pressure (NIPPV) devices
* Those who require long-term oxygen therapy (oxygen therapy time\>15 hours/day)
* Individuals who have undergone lobectomy or lung volume reduction surgery within the 12 months prior to the start of the study
Calorie Restricted Diet and Exercise

Calorie-restricted(CR) diet and exercise were effective to reduce Metabolic syndrome(MetS), however, its effect on knee functions for MetS patients with degenerate meniscus lesions(DMLs) was still poorly investigated.

The CR diet and exercise group received a balanced diet with an energy consists carbohydrates 45-65%; fat 20-35%; and protein 10- 35% and a deficit of 600 kcal/day from their daily energy requirement. Total daily energy intake of 1200-2000 kcal/day were based on baseline weight, and for safety, no woman was provided with less than 1100 kcals/d and no man less than 1300 kcals/d. The energy of the intake calorie restricted diet per day was calculated based on the detailed composition of meals, such as rice, vegetables, eggs, pork, and beef, using the Chinese food composition tables. Our diets were cooked with traditional Chinese cooking methods such as boiling, stir-frying, and stewing. During the intervention, other lipid-lowering drugs were not allowed to intake supplement as it alters the outcome. Participants receive education or counseling by a dietitian for modulations of their caloric intake weekly.

The exercise intervention included aerobic exercises and resistance exercise, flexibility exercises about 150 minutes for ≥2 d/week for 6 months. The aerobic exercises included walking on a treadmill, stationary cycling for at least 30 minutes for≥2 d/week. Resistance exercises included nine upper-extremity and lower-extremity exercise with weighting lift machines for ≥2 d/week, while, flexibility exercise including the major muscle-tendon groups (a total of 60 s per exercise) for ≥2 d/week. Participants performed 1 or 2 sets with 8-12 repetitions of each exercise. The exercise sessions were monitored by telephone video. Patients who complete at least 80% of diet restriction and exercise were included in analysis. Calorie restricted diet and exercise group contain both the above intervention.

Eligibility Criteria:
Inclusion Criteria:

* • Must be age between 35 and 70 years old;

  * Clinical diagnosis of metabolic syndrome;

Exclusion Criteria:

* • Must be able to have no acute knee injury such as car crash or acute sports injury;

  * Must be able to have no knee surgeries history;
  * Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity;
  * Must be able to have no contraindications to MRI;
  * Must be able to have no severe cardiopulmonary disease;
  * Must be able to have no musculoskeletal or neuromuscular impairments ;
  * Must be able to have good visual, hearing, or cognitive;
Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)

This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
* PANSS total score of at least 70 at enrolment and at assignment Day 1
* CGI Severity of Illness score of at least 4 (moderately ill) at enrolment and at assignment Day 1 and with worsening of the patient's condition during the 3 weeks

Exclusion Criteria:

* Known intolerance or lack of response to quetiapine fumarate
* Administration of a depot antipsychotic injection within one dosing interval (for the depot) before assignment
* Substance or alcohol dependence at enrolment
* Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR)

This is a randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant users. The study will consist of an outpatient Screening Visit, an in clinic Qualification Phase, an in-clinic Treatment Phase, and an outpatient Follow-Up visit.

VAL-104 is a phase 1, randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant users. The study objectives include assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of manipulated ADAIR 30mg when compared to crushed d-amphetamine sulfate and placebo. The primary PD endpoint is mean maximum drug liking (Emax) on a bipolar 100mm visual analog scale.

A total of 64 subjects demonstrating a confirmed positive response to stimulants will enter the treatment phase. Safety will be assess via adverse events, vital signs, ECGs, clinical laboratory tests and Columbia Suicide Severity Rating Scale (C-SSRS).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers, 18 to 55 years of age inclusive
* Recreational drug abuse experience (\>/= 10 times lifetime abuse of a CNS stimulant, \>/= 1 abuse of CNS stimulant in the previous 3 months)
* Prior intranasal recreational drug abuse experience
* Body mass index (BMI) 18 to 33 kg/m2 inclusive

Exclusion Criteria:

* History of any significant disease or disorder
* History or current diagnosis of substance dependence (excluding caffeine and nicotine)
* Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator
* Positive for hepatitis B, hepatitis C or HIV infection
* Pregnant or lactating women
* Participation in an investigational drug or device study within the last 30 days prior to Day 1 of the study
* Confirmed positive drug screening
* Positive alcohol breath test at screening / any Day -1
* Heavy smoker (\> 20 cigarettes, \> 8 pipefuls or \> 8 cigars per day)
Comparing TR Band to Statseal in Conjunction With TR Band

The primary objectives of this study are to evaluate the performance of StatSeal Advanced used in conjunction with the TR Band (SSA) as compared to the TR Band without SSA (TRB) relative to: the incidence of peri-procedural radial artery occlusion (RAO) at discharge or 24 hours, whichever occurs first, and the Time to Hemostasis (TTH).

This study is a physician initiated, prospective, observational, two arm, randomized study to be performed at up to four experienced 'Radial First' centers (UCSD, UCLA. Arkansas Heart Hospital and LBVA). A maximum of 180 patients having undergone successful radial catheterization will be enrolled in the study, 60 in each arm. 60 patients will be enrolled at the LBVA. Enrollment will continue at each site on discretion of the investigators until each center enrolls a minimum of 30 patients, or a maximum of 180 patients are enrolled. Clinicians will perform the catheterization in accordance with local standard practice, with a minimum of 5,000 units of unfractionated heparin for anticoagulation. At the start of the TRA procedure, prior to radial artery cannulation, a baseline Pleth-ox exam will be performed for all patients and recorded on the CRF. Ulnar compression will be applied to confirm that the radial artery is patent. Patients with a type D pattern exam will be excluded from the study. At the conclusion of a successful transradial procedure, the patient will be randomized to either SSA or TRB, each device applied per protocol \& IFU. It is hypothesized that if radial artery compression time can be shortened to 40 minutes or less, the following could result: improved catheterization lab efficiency, greater patient satisfaction and lower complication rates, including RAO, may be improved.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing diagnostic angiography or PCI via the radial artery
* Patients with a Barbeau test prior to the procedure showing pattern A,B,or

Exclusion Criteria:

* Use of a radial sheath larger than 6 Fr (a 7Fr-in-6 Glidesheath Slender ® is allowed).
* Use of an anticoagulant other than unfractionated heparin or bivalirudin.
* Any anticipated need for continued anticoagulation post-catheterization. Glycoprotein inhibitors are acceptable.
* Any active treatment with oral anticoagulants continued during course of procedure.
* Presence of arteriovenous dialysis fistula in the ipsilateral arm.
* Any physical deformity or trauma / injury of either wrist that would prevent proper placement or function of the hemostasis band.
* Raynaud's syndrome or known peripheral vascular disease of the forearm.
* Mental incompetence or inability to follow the instructions to complete the study.
* History or presence of Radial Artery Occlusion.
* Barbeau test showing Pattern D.
* Patients undergoing catheterization from the femoral or ulnar artery approach.
* Cardiogenic shock or any clinical instability as assessed by the physician performing the procedure.