cyrilzakka/clinical-trials huggingface dataset:
A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects.

An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Age 19\~45 years in healthy volunteers
2. BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
3. Subjects who agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm.
4. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator
Early Discharge After Mitral and Tricuspid Edge-to-edge Repair: an Assessment of Feasibility and Safety

Mitral regurgitation (MR) and tricuspid regurgitation (TR) are common causes of breathlessness, fluid retention and other heart failure symptoms, which lead to reduced quality of life and frequent hospitalisation. These conditions are particularly prevalent in older adults with many of these patients being at high risk for surgical intervention due to frailty and comorbidities, leaving them with few treatment alternatives.

Transcatheter edge-to-edge repair (TEER) procedures have increasingly been used to improve the severity of both MR and TR, offering patients symptomatic relief and reductions in heart failure hospitalisation at low procedural risk. There is considerable geographic variation in protocols to assess these patients prior to the procedure and also in length of hospital stay. The standard of care in the UK, and particularly in Oxford, emphasises fewer investigations before the TEER procedure and shorter length of hospital stay.

This prospective, observational cohort study will examine the safety and feasibility of this practice.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Accepted by Heart Team for TEER (mitral and/or tricuspid)
* Willing and able to give informed consent for participation in the study.
* Regurgitation (mitral and/or tricuspid) grade ≥2+ as assessed by echocardiography
* Patient is willing and able to attend all follow-up visits

Exclusion Criteria:

* Patients in whom safety or clinical concerns preclude participation
* Patient declines to be involved in the study (unwilling to consent to enrolment or deemed by the patient advocate to be unwilling to consent)
* Patient in whom a TOE is contraindicated, or screening TOE is unsuccessful
* Pregnant or planning pregnancy within next 12 months
* Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
* Patients requiring emergency TEER
Beverage Choice and Lifestyle Modification in Overweight Youth

The rise in childhood overweightness and concomitant increase in chronic disease risk warrants exploration into the effectiveness of interventions targeting the eating and activity habits of overweight youth. This research study developed and tested a "Beverage Choice and Lifestyle Modification" (BCLM) intervention for 4 to 8 year old children who are at-risk for being overweight or are overweight and who consume large amounts of sugar sweetened beverages and juice. The overall study objectives were to test the acceptability and effectiveness of the BCLM intervention for improving the weight status, energy (kcal) intake, beverage selections and beverage preferences of children in targeted age and BMI group. The investigators hypothesized that those children randomized to the BCLM group will show greater improvements in weight and Body Mass Index (BMI) status, beverage choices,and energy intake than those assigned to our Nutrition Education (NE) group.


Eligibility Criteria:
Inclusion Criteria:

* Ages 4-8 years old
* BMI≥85th percentile (based on age and sex)
* consumes large (≥16 oz.day) sugar sweetened beverages

Exclusion Criteria:

* Child has a serious medical condition
* Signs of elevated psychopathology are present, as assessed by the Child Behavior Checklist (CBCL)
* Parent demonstrates elevated psychiatric problems or eating disorders
* Failure of parent or child to meet BMI criteria
Efficacy of Favipiravir Against Severe Ebola Virus Disease

The purpose of this study is to explore the therapeutic efficacy of Favipiravir, a broad-spectrum antiviral drug against severe cases of Ebola Virus Disease (EVD), which is the most difficult aspect for clinical management of EVD due to its high fatality rate.

This is a prospective, open-label, controlled phase 2 trial of Favipiravir among severe cases (cases with hemorrhage, severe dehydration, consciousness disorders, shock, and high blood viral load with Ct value below 20) of confirmed EVD patients in the capital area of Sierra Leone. Patients with 13 years of age or older would be assigned in an 1:1 randomised manner to receive WHO-recommended therapy (mainly symptomatic and supportive therapies, control group. WHO, World Health Organization.) or oral Favipiravir (1600 mg twice on the first day, followed by a twice-daily dose of 600 mg until negative blood viral load detection or death) plus WHO-recommended therapy (treatment group). The primary efficacy end point was case fatality rate.The secondary efficacy endpoint is blood (plasma)viral load. Optimal inclusion number is 240 cases (120 for each group), but considering the actual situation of pandemic area, the front line doctors have the right to reset the inclusion number, and modify the study protocol according to the actual situation in the front.

Eligibility Criteria:
Inclusion Criteria:

* Male or famale，13 -75 years of age
* Clinical diagnosis of EVD
* Positive blood viral RNA detection
* With any one of the symptoms below:

Hemorrhage (including hematemesis, hemoptysis, hematochezia, hematuria, mucocutaneous hemorrhage), severe dehydration (including oliguria, anuria, feebleness, hypotension, tachycardia), consciousness disorders (including coma, delirium, confusion, convulsion), shock, and high blood viral load (Ct value below 20)

* Not received any therapies for EVD
* Provided written informed consent, by guardian or the patient himself
* Be able to administrate and tolerate oral administration of tablets

Exclusion Criteria:

* Severe vomiting
* Pregnancy and breast-feeding
* Received antiviral treatment against EVD
Adaptive Individualized High-Dose Radiotherapy Analysis-REctum-1 (AIDA-RE-1)

Aim of the study is to evaluate achievement of complete pathologic response (pCR) in high-risk rectal cancer treated with neoadjuvant concomitant chemotherapy plus adaptive-intensity modulated imaging-guided radiotherapy

AIDA-RE-1 is an interventional prospective trial for the treatment of locally advanced high-risk rectal cancer. In neoadjuvant setting, patients are treated with standard chemotherapy plus experimental radiotherapy. The total dose to clinical target volume (CTV, rectum and locoregional lymph nodes) is 45 Gy, with a concomitant boost of 5 Gy to gross tumor volume (GTV), delivered with IMRT-SIB (intensity modulated radiotherapy-simultaneous integrated boost) technique in 25 fractions. After 2 weeks of treatment, patients are evaluated with 18 FDG-PET and sequential boost of 5 Gy (in 2 fractions) is planned.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed diagnosis of locally advanced rectal cancer (cT3N+, cT4Nx, local relapse, cT3N0); cT2N+ is acceptable if low rectum is involved
* M0
* ECOG 0-2

Exclusion Criteria:

* M1
* familial adenomatous polyposis (FAP), non-polyposis hereditary colorectal cancer, inflammatory bowel disease
* severe cardiopathy
* previous pelvic RT
Pediatric Epidemiology of Cardiovascular Disease Risk Factors (Project Heartbeat)

To conduct a longitudinal, natural history study of cardiovascular disease risk factors in children. Growth curves were compared for levels of blood pressure, lipids, cardiac structures and function, and related to physical growth and maturation, nutrient intake, physical activity, body composition, puberty, and smoking.

BACKGROUND:

Both the pathologic precursors of atherosclerosis and the development of its major risk factors -- blood pressure, blood lipids, and cigarette smoking -- are often far advanced before age 20 or within the period from birth or conception through adolescence. In 1990, there was growing interest in understanding these aspects of human biology and in devising appropriate preventive measures.

In 1990, knowledge about the risk factors during childhood and adolescence was based mainly on cross-sectional surveys, from which very striking and consistent patterns of change with age were inferred, and from which reference values for screening and management were derived. Both growth and sexual maturation influence these patterns strongly, yet these risk factors had only recently been taken into account in 1990, only partially in screening recommendations for blood pressure and not at all for cholesterol.

DESIGN NARRATIVE:

Subjects were selected by simple random sampling. Data were collected on dependent variables including blood pressure, heart rate, echocardiography, Doppler flow, blood lipids, and smoking. Independent variables included growth, diet and nutrition, electrolytes, physical activity and fitness, personal, family, and social history, and bone age. Most observations were recorded at four month intervals. There was a six month pretest recruitment period, four years of cycled measurements and data collection, and six months of analysis and reporting. Curves for both velocity and acceleration of growth for attained levels of blood pressure, blood lipids, and smoking were determined as were longitudinal relationships between individual growth curves of blood pressure, echocardiographic measures, physical growth, sexual maturation, body composition, diet, physical activity, and social factors.

Dr. Labarthe has several R03 grants to analyze data from Project Heartbeat. See also Study 4962.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate

The dimethyl fumarate is an oral drug, indicated in the treatment of the relapsing-remitting multiple sclerosis (MS) , which efficacy and safety has been assessed and validated in two randomised, placebo phase-controlled III international studies, organized by the pharmaceutical company developing the molecule. TECFIDERA® (dimethyl-fumarate) has received European approval on January 30, 2014, for the treatment of adult patients with relapsing remitting MS.

Treatment with dimethyl fumarate is introduced as part of the usual care under supervision of a physician experienced in the treatment of the disease.

It has proved effective to reduce the number of relapses in patients with recurring-remitting MS and reduce the number of patients who have relapses during treatment.

The objective of the study is to observe, in real conditions, on the one hand the tolerance and the other evolution, clinical and radiologic disease in patients already treated by dimethyl-fumarate and collect long-term safety data.


Eligibility Criteria:
Inclusion Criteria:

* patient 18 years old and more
* with multiple sclerosis according to the criteria of Mac Donald 2010 : relapsing-remitting (RR), secondary-progressive (SP) or primary-progressive (PP)
* for which treatment with dimethyl-fumarate has been prescribed
* followed at the Rothschild Foundation in the Neurology Department
* having given written consent to participation in the study

Exclusion Criteria:

* pregnant or breastfeeding woman
* patient with a measure of legal protection
* subject unaffiliated insurance
A Follow-Up Study to WV19432, to Evaluate Long Term Post-Treatment Effects of PEGASYS (Peginterferon Alfa-2a(40KD))in Patients With HBeAg Positive Chronic Hepatitis B

This study is a long-term post-treatment follow-up to study WV19432, which evaluated the efficacy and safety of PEGASYS in patients with HBeAg positive chronic hepatitis B (CHB).Patients who received treatment with PEGASYS, and completed follow-up, are eligible to enter this post-treatment follow-up study. The anticipated time on study was 5 years, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent for Study WV19432
* Patients who have completed treatment and follow-up on study WV19432

Exclusion Criteria:

* As for Study WV19432
EYE-SYNC Concussion Classification Study

The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Men and women actively engaged in competitive athletics
* Eye tracking measurements and SCAT5 evaluations are collected within 3-day window
* Eye tracking measurements and SCAT5 evaluations are collected within 3 days of injury

Exclusion Criteria:

* Prior enrollment (subjects may only enroll once)
* POOR eye tracking data quality
* Subjects without reported injury detailing alteration of consciousness (AOC) or altered mental status (AMS) defined as self-report, witness report or the following responses to the SCAT5 SSS: "Difficulty Remembering" ≥ 4 or "Confusion" ≥ 4, or scored less than 23 on the SCAT5 Standardized Assessment of Concussion (SAC) or greater than 25 on the SCAT5 Symptom Severity Score (SSS)
* EYE-SYNC smooth pursuit standard deviation of tangential error (SDTE) variance scores \< 2.0
Dynamic Multiomics Evaluation of Anti-HER2 and Immunotherapy in HER2 Positive Gastric Cancer

Dynamic multiomics explore the efficacy and mechanism of anti-HER2 \& immunotherapy of HER2 Positive GC

The investigators will recruit 100 HER2 positive advanced gastric cancer patients.Blood and tumor tissue will be collected at treatment baseline, every time point response till disease progression. All samples will be processed by next-generation sequence , 10× genomics single-cell sequence ,whole exon sequence, proteome detection and CTC detection to explore the efficacy and mechanism of anti-HER2 \& immunotherapy of HER2 positive GC.

Eligibility Criteria:
Inclusion Criteria:

* Having signed informed consent
* Age:18-80 years old
* HER2 overexpression confirmed by IHC or ISH (IHC 3+,or IHC2+/ISH+)
* Histologically confirmed gastric adenocarcinoma
* Unresectable recurrent or metastatic gastric cancer
* Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
* Measurable disease according to the RECIST criteria
* Karnofsky performance status ≥70
* Life expectancy of ≥3 month
* No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
* ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases)
* Serum albumin level ≥3.0g/dL
* Serum AKP \< 2.5 times ULN
* Serum creatinine \<ULN, and CCr \< 60ml/min
* Bilirubin level \< 1.5 ULN
* WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl

Exclusion Criteria:

* Previous systemic therapy for metastatic gastric cancer
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
* Allergic constitution or allergic history to protium biologic product or any investigating agents.
* Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
* Pregnancy or lactation period
* Other previous malignancy within 5 year, except non-melanoma skin cancer
* Legal incapacity
Determination of Fibrin Activity in Plasma on STA-R® Prototype

The purpose of the study is to give the proof of concept of the Fibrin structure assay on STA-R® prototype. It aims to identify the parameters which discriminate the pathologic from the normal population. Secondary objectives are to determine the precision of the assay, to record the Fibrin activity, comparatively with thromboelastography on TEG®, in a coagulation activation assay and in a coagulation-lysis assay.

Background. Fibers thickness of the fibrin clot plays an important role on the clot stability and its resistance to the fibrinolysis. The innovative concept, based on the relationship between light spectrum through the fibrin clot and its fiber nanostructure (C.Dassi et al, ISTH 15ABS-3593), thanks to a multi-wavelength STA-R® prototype, was simplified by using a coag-lysis assay (An international study on the feasibility of a standardized combined plasma clot turbidity and lysis assay: SSC communication ; Pieters et al. ; JTH 2018) Preliminary results suggest that this new automated FS method provides new data on clot analysis and could be a useful tool in clinical practice in the management of hemostasis disorders. This study is extended to begining of march 2019.

Main objective. This study aims to determine the precision, the normal range of the FS method in comparison with Thromboelastography on TEG® and discriminate patients from healthy volunteers (HV).

Recruitment. 200 healthy volunteers without any known coagulation troubles, enrolled during coagulation testing or blood donation.

50 hospitalized patients or patients from consultations, without ongoing treatment (particularly anticoagulant treatment), with a normal hemostasis screening (Prothombin Time, Activated Partial Prothombine Time and Fibrinogen Level).

650 hospitalized patients for any pathology known and able to induce a increase or a decrease of the fibrinogen level, mainly from trauma patients and enrolled during coagulation testing.

The study is conducted in compliance with French regulation after ethics approval.

FS Assays. The FS determinations on STA-R® prototype and those on TEG® will be realized with fresh plasmas and whole blood samples respectively at the Hôpital d'Instruction des armées Percy. The screening tests (PT, APTT, and Fibrinogen) on STA-R® Evolution and the measurement of FS on a second STA-R® prototype will be performed with frozen plasmas at STAGO laboratory.

Statistical analysis of results. A statistical analysis will determine the most relevant parameters in the discrimination of the pathologic population from the normal population, and the quality control precision. Then, statistical analysis will compare STA-R® prototype method to the TEG® method to point out the most populations discriminating method.

Eligibility Criteria:
Inclusion Criteria:

* Patients and healthy volunteers with non-opposition to participate in the evaluation
* Healthy volunteers : from 18 years to 70 years
* Patients : minimum age limit 18 years - no maximum age limit

Exclusion Criteria:

* Healthy volonteers with ongoing treatment
* Healthy volonteers with abnormal hemostasis results
Bronchoscopic Sampling Techniques in Sarcoidosis

The development of endobronchial ultrasound (EBUS) and EBUS-guided transbronchial needle aspiration (EBUS-TBNA) has improved the safety and diagnostic accuracy of the mediastinal lymph node (MLN) sampling. Still, in some diseases routine cytological specimens are considered insufficient and histological sampling is preferred. The aim of the study is to compare the diagnostic accuracy of EBUS-TBNA and two other, more invasive procedures to obtain histological samples from MLN in patients with clinical and radiological features of sarcoidosis.

Bronchoscopy with bronchoalveolar lavage (BAL), EBUS-TBNA, EBUS guided transbronchial forceps biopsy (EBUS-TBFB), large bore (19G) histology TBNA as well as endobronchial forceps biopsy will be performed in 90 consecutive patients with mediastinal lymph node enlargement and clinical and radiological features of sarcoidosis.

Diagnostic accuracy of each sampling technique will be calculated and compared to other techniques. Diagnostic yield of different technique combinations will also be calculated and the most efficient diagnostic approach will be defined.


Eligibility Criteria:
Inclusion Criteria:

* provided informed consent
* mediastinal lymph node enlargement that requires bronchoscopy and transbronchial sampling
* clinical presentation that might be consistent with sarcoidosis

Exclusion Criteria:

* age below 18 years
* known contraindications for bronchoscopy and/or mediastinal sampling, e.g. coagulation disorders
* lung or extrapulmonary tumors with suspicion of malignant mediastinal lymph node involvement
A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids

The primary objective of this study is to determine the safety and efficacy of two oral doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.


Eligibility Criteria:
Inclusion Criteria:

* Is a pre-menopausal female, between 18 and 47 years
* Participant has a history of at least 3 regular menstrual cycles in which menorrhagia (heavy bleeding) is due to uterine fibroids
* Confirmed uterine fibroid(s) at screening
* Visit 1 historical pictorial blood loss assessment chart of \>120 milliliters (mL) of blood loss, to ensure participants have a menstrual blood loss of at least 80 mL by Alkaline Hematin Assay (during the baseline assessment period).
* A Body Mass Index (BMI) between 18 and 45 inclusive

Exclusion Criteria:

* Participant is pregnant or lactating or is attempting or expecting to become pregnant during the entire study period
* Received an investigational drug in the 30 days prior to the screening for this study
* Has an intrauterine device in place
* Observation or history of abnormal endometrial biopsy including the presence of endometrial intraepithelial neoplasia
* Participants with abnormally high liver enzymes or liver disease