cyrilzakka/clinical-trials huggingface dataset:
Factors Determining Quality of Life Related to Respiratory Status According to Gender of Chronic Obstructive Pulmonary Disease (COPD) Patients

The purpose of this study is to evaluate with sufficient precision and according to gender the determining independent factors of quality of life related to respiratory status of patient with moderate to severe COPD.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient who has a clinical visit for their usual follow-up.
* patient with COPD with at least a three month follow up

Exclusion Criteria:

* Current or history of asthma
* Current participation in an interventional clinical study
Estimated Physical Activity of Congestive Heart Failure Patients by a Physical Activity Questionnaire

The treatment and follow-up of congestive heart failure (CHF) represents a major part of France's health expenses. The beneficial effects of cardiac rehabilitation is well established, especially regarding the reduction of dyspnea, exercise limitation and fatigue and leads ultimately to a better quality of life. Maintaining these benefits in secondary prevention requires an improvement in daily physical activity, which is challenging and supposes a close follow-up difficult to perform on a daily living basis. However, a better knowledge of the type and dose of daily physical activity of this population would be very beneficial for the practitioner to prescribe or advise individually the type and the dose of physical activity required to maintain the benefits of cardiac rehabilitation. To date, only a physical activity questionnaire adapted to CHF could provide information regarding both the type and dose of daily physical activity. Such a questionnaire has been developed by our research team and allows an estimation of daily energy expenditure as well as the daily energy expended in its physical activity dimensions (rest, activities \< 3 MET, activities between 3 and 5 MET, and activities \> 5 MET). During its first step of validation, daily and physical activity energy expenditure estimated by this questionnaire was correlated to various factors of physical condition and notably, to peak V'O2 (R=0.71), prognostic factor largely recognized in CHF. A second step of validation was a pilot study comparing the estimation of daily energy expenditure by the questionnaire with a measurement of free-living daily energy expenditure with the doubly labelled water (DLW) method in 11 middle-aged males patients suffering CHF (NYHA I to III). Daily energy expenditure estimated from the questionnaire was very close to daily energy expenditure measured from the DLW method (R2 = 0.81; individual relative error \< 7%). However, the high cost of the DLW method reduced the population studied to a small sample, which is a major limitation of this study since the sample was somewhat different to general CHF population in France.

Therefore, the aim of the present study was to assess the validity of the questionnaire against the DLW method in a larger population of 30 patients with CHF more representative of the general population with CHF, including men and women, NYHA I to IV, with a larger age panel. Along with this concordance study, a measurement of the energy cost of specific physical activities of daily life is performed with an ambulatory gaz analyzer method to further validate the calculation method of daily energy expenditure from the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Congestive Heart Failure
* Stade II, III of NYHA
* Between 20 to 80 years old
* EF \< 45%
* Written informed consent
* French language

Exclusion Criteria:

* Corticotherapy
* Thyroid dysfunction
* Cachectic status
Monitor Patients With Sleep Apnea

The primary objective of the study is to gather data to correlate physiological signals measured by the AVIVO™ Mobile Patient Management System with the patient's respiratory status, including apnea and hypopnea events, during polysomnography

Patients with suspected sleep disordered breathing will be monitored during polysomnography and the collected information will be used to assess patient's respiratory status.

Eligibility Criteria:
Inclusion Criteria:

* Is female or male, 18 years of age or older
* Undergoing polysomnography for suspected sleep apnea
* Is willing to provide written informed consent and comply with study guidelines
Safety and Efficacy Study of LymphoStat-B (Belimumab) in Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.

The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with active SLE disease. Patients were randomly assigned, following stratification by the screening SELENA SLEDAI score (4 to 7 versus ≥ 8), to 1 of the 4 study arms (3 active arms and 1 placebo arm plus standard therapy for SLE). All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 52 weeks. Patients completing the 52-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.

Eligibility Criteria:
Primary Inclusion Criteria

* Clinical diagnosis of SLE
* "Active" SLE disease
* On a stable SLE treatment regimen
* History of measurable autoantibodies

Primary Exclusion Criteria

* Received a non-FDA approved investigational agent within last 28 days
* Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days
* Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (\> 100 mg/day) within last 90 days
* Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days
* History of renal transplant
* History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days
* History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency
* Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C
Effects of IAP-EOGBSD on Offspring's Gut Microbiome and Immunity.

This study is planned to be recruited in two hospitals in South China, Zhujiang Hospital of Southern Medical University and Zhongshan Boai Hospital Recruit participants, plan to recruit obstetrics and child health departments in study hospitals, meet inclusion and discharge criteria 1\~3 infants, a total of 360, recruited by Pearl River Hospital of Southern Medical University and Zhongshan Boai Hospital 180 people each.

This is a case-control study. By collecting fecal samples of infants and young children in the observation group and control group at different time points (0\~1 years old, 1\~2 years old, 2\~3 years old), the intestinal flora of infants and young children was detected by 16S rDNA sequencing, and fecal calprotectin (CP) and secretory IgA (SIgA) were detected by ELISA. To study the effects of exposure factors on intestinal flora and immunity in offspring.

Eligibility Criteria:
Inclusion Criteria:

* Infants:37-41 weeks of age, born through vaginal delivery, 2500g\<= birth weight \< 4000g,0-3 years of age;
* The mother: birth ranging in age from 18 to 40 years old, the single pregnancy, pregnancy 35 -41 weeks to complete the GBS screening;
* The guardian agrees to participate in the study voluntarily.

Exclusion Criteria:

* Infants and children with serious congenital abnormalities, infections or clinical diseases;
* Antibiotics should be used in infants within 2 weeks, probiotics, prebiotics and biostime should be supplemented, or long-term drug treatment should be given for digestive, immune, blood and other diseases;
* Infant mothers: childbirth after long-term drug treatment due to digestive, immune, blood and chronic diseases during pregnancy; Or infants who were breastfed within 12 hours of antibiotic use after delivery;
* Any medical or non-medical condition that the investigator deems inappropriate to participate in.
Adjuvant Whole Breast Irradiation in Five Fractions Versus Fifteen Fractions in Early Breast Cancer

the study aiming for compairing results of hypofractionaton radiotherapy treatment in patient with early breast cancer between two arms the first arm recieving five fractions and the other arm recieving fifteen fraction


Eligibility Criteria:
Inclusion Criteria:

* age group ( 18-80) years
* breast conservation surgery
* Stages (pT1-3, pN0-1, M0) breast cancer.
* Any histological type of invasive breast cancer.
* All grades of breast cancer (I,II,III)

Exclusion Criteria:

* Stage (III or IV) breast cancer.
* Metastatic breast cancer (MBC)
* Recurrent breast cancer.
* Patients' co-morbidities that contraindicate radiotherapy
Crossover Trials Which Assessed Consumption of Slowly Digestible Carbohydrates for 21 Days on Gastric Emptying Rates

To gain a better understanding about the conditioning effect of consumption of slowly digestible carbohydrate on gastric emptying rate, respiratory quotient and metabolic flexibility, this study will focus on monitoring change in gastric emptying with consumption of a single source of slowly digestible carbohydrate (30 g of raw corn starch) for 21 days and compared to a control (21 days of continious consumption of rapidly digesting carbohydrate maltodextrin).

Corn starch, a commonly consumed food ingredient, considered GRAS (generally recognized as safe) CFR 182.70- 182.90 will be used as the test meal treatment fed to non-responding subjects (rapid gastric emptying rate after consumption of slowly digestible carbohydrate) for 1 month. Corn starch will be mixed with applesauce (200 g) and a small amount of xanthan gum (amount to be determined) (GRAS # 121) for palatability and viscosity, respectively.

In order to determine whether potential changes in gastric emptying time are induced by consumption of slowly digestible carbohydrates, a control group will be used. The control group will consume a meal composed applesauce (200 g) and xanthan gum with a fast digesting carbohydrate (30 g DE -1 maltodextrinpregelatinized starch). The product is commercially available and will be provided by Tate and Lyle under the brand name of Star-Dri 1. The general term "maltodextrin" is a non-sweet nutritive polymer that consists of D-glucose units linked primarily by \[alpha\]-1-4 bonds and that has a dextrose equivalent (D.E.) of less than 20. It is regarded as Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration for direct use as a food ingredient (GRAS, 21CFR184.1444).DE-1 Maltodextrin is commercially available and will be provided by Tate and Lyle under the brand name of Star-Dri 1. Maltodextrin is a non-sweet nutritive saccharide polymer that consists of D-glucose units linked primarily by \[alpha\]-1-4 bonds and that has a dextrose equivalent (D.E.) of less than 20. It is regarded as Generally Recognized as Safe (GRAS) by the Food and Drug Administration for direct use as a food ingredient (GRAS, 21CFR184.1444). Ultimately, this study will help elucidate attributes of carbohydrate-based foods that can promote slow digestion and create a satiety feeling and promote weight management, which can then be implemented to develop foods with superior health benefits.

Eligibility Criteria:
Inclusion Criteria:

* normal body mass index (18.5 kg/m² \< BMI \< 25)
* healthy eating index score (\<65)

Exclusion Criteria:

* gastrointestinal and cardiovascular disease
* food allergies or intolerances
* pregnancy
* smokers
RaFIST: A Radiomics-Based Tool for Intratumoral Fibrosis Stratification in Non-Small Cell Lung Cancer

Patients with suspected Lung cancer who underwent contrast-enhanced CT and pathological examinations at Center 1 between January 2011 and January 2020 and Center 2 between September 2017 and Januray 2020 were eligible for inclusion in this study.The Clinical data, preoperative clinical information, laboratory results, CT images and pathological sections were collected. The investigators also collected the disease-free survival and overall survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and PyRadiomics was used to extract the radiomic features. Fibrosis quantification was performed on picrosirius red (PSR)-stained tissue sections using color deconvolution and binarized collagen signal analysis in ImageJ software. The investigators developed RaFIST, a radiomics-based stratification tool, to noninvasively quantify intratumoral fibrosis in non-small cell lung cancer (NSCLC) using contrast-enhanced CT imaging. And it was further tested on the held-out external test cohort. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC).


Eligibility Criteria:
Inclusion Criteria:

* Solid pulmonary nodule detected on CECT within 3 weeks pre-resection
* No history of previous treatment such as chemotherapy, or radiotherapy

Exclusion Criteria:

* Unavailable pathological sections
* Missing CT images or hard-to-annotate CT images
* Undergone anticancer therapy before CT
* Loss to follow-up
* Concurrent other malignant tumors
Cholestasis Reversal: Efficacy of IV Fish Oil

The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).

The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven), when used in lieu of the conventional soy-based fat emulsion (Intralipid), is effective in the treatment of parenteral nutrition associated liver disease (PNALD).

Eligibility Criteria:
Inclusion Criteria:

1. Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
2. Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of \> 2 mg/dl or currently on Omegaven through another protocol. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
3. Direct bilirubin \> 2.0 mg/dl or already on Omegaven through another protocol
4. Signed patient informed consent.
5. The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and the use of ursodiol (i..e., Actigall®).

Exclusion Criteria:

1. Pregnancy
2. Other causes of chronic liver disease (Hepatitis C, biliary atresia, and alpha 1 anti-trypsin deficiency).
3. Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
4. The parent or guardian or child unwilling to provide consent or assent

In rare instances, patients diagnosed with PNALD may later be found to have liver disease due to other causes in addition to the use of PN (i.e., inborn errors of metabolism, viral infections ). Such causes may not be known at the time of enrollment and will not preclude them from continuing in the study. For the sake of statistical analysis, however, these patients will be excluded although all data will be collected and reviewed.
Can the Prophylactic Administration of Tranexamic Acid Reduce Blood Loss After Robotic-assisted Radical Prostatectomy?

The prophylactic administration of tranexamic acid reduces blood loss during procedures at high risk of perioperative bleeding. Several studies in neurosurgery, cardiac surgery, and orthopedics confirm this finding. The aim of this study is to evaluate the effect of tranexamic acid on peri-and postoperative blood loss and incidence and severity of postoperative complications. A prospective, double-blind, randomized study is conducted to evaluate the effect on several parameters.

Based on pilot study data the investigators decided to include 200 patients in the period from February 2020 to March 2022. The patients will be randomly assigned to study and control groups of 100 patients each. The minimum follow-up will be 3 months.

Prostate adenocarcinoma is the second most common malignancy and the second most common cause of death due to malignancy in men. Standard treatment includes radical prostatectomy or radiotherapy in patients with life expectancy for more than 10 years. In recent years, a general tendency toward minimally invasive surgical procedures has been seen. Despite tremendous development in the technology and technique of robotic-assisted radical prostatectomy for more than 25 years, there is still need to look for ways to improve oncological and functional outcomes. Decreasing peri- and postoperative blood loss may lead to faster recovery after the procedure.

Tranexamic acid is an antifibrinolytic used to relieve bleeding. The mechanism of action lies in binding to plasma free plasminogen with higher affinity than tissue plasminogen activator. It prevents its conversion to plasmin, which is responsible for the degradation of fibrin polymers. It results in greater stability of the fibrin clot at the site of bleeding and, therefore, lower blood loss. The use of tranexamic acid during or after the operation does not improve results, unlike administration prior to surgery and the dorsal complex vein is sutured in the beginning of the procedure.

This study is designed to answer the question of whether it might lower the drop in hemoglobin level after the procedure or increase the rate and severity of complications.

This trial was approved by the independent ethics committee at the University Hospital Hradec Kralove (registration number 201903 I90P).

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for robotic-assisted radical prostatectomy without pelvic lymph node dissection
* Signed informed consent provided
* Body mass index ≤ 35
* Age of the patient ≤ 75 years
* Operating surgeon with experience \> 100 cases

Exclusion Criteria:

* Body mass index \> 35
* Age of the patient \> 75 years
* Coagulation disorder (congenital or iatrogenic due to the chronic use of anticoagulants)
* Thromboembolic, cerebral, or an acute coronary event within the 6 months prior to prostatectomy
* Chronic renal insufficiency (arbitrary cut-off level of creatinine 200 μmol/l)
* Allergic reaction to tranexamic acid
* Operating surgeon with experience \< 100 cases
* Participation in other study
Myotonic Dystrophy - Vascular and Cognition

The cognitive disorders of adult forms of myotonic dystrophies type 1 are heterogeneous (impairment of executive functions, visio construction and theory of the mind, which can progress to the stage of dementia). Nevertheless, patients have very different degrees of cognitive impairment. Expansion of CTG triplets disrupts the alternative splicing of mRNAs of various proteins, including the insulin receptor and Tau protein. Type 2 diabetes, associated with peripheral insulin resistance, is therefore common in this pathology.

Type 2 diabetes,could to explain the cognitive impairment of patients, through the accelerated development of brain lesions (especially tauopathy and cerebral atrophy).


Eligibility Criteria:
Inclusion Criteria:

* Molecularly proven type 1 myotonic dystrophy
* Voluntary, having given informed consent
* Socially insured patient
* Patient willing to comply with all study procedures and duration (3 hours + MRI 35 minutes)
* Patient insured under the French social security system
* Signed consent form

Exclusion Criteria:

* Neurological history other than neuropathy: epilepsy, stroke, dementia
* Pregnancy or breastfeeding or woman of childbearing age without effective contraception (a pregnancy test will be done)
* Contra indication to MRI
* Person under guardianship or curators
* Persons of full age deprived of their liberties by a judicial or administrative decision
* Major comorbidity considered as a contraindication by the investigator (cancer, unstable angina, etc.).
Percutaneous Endocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy

This prospective, multicenter, single-arm objective performance criteria trial is designed to assess the efficacy and safety of the Percutaneous Endocardial Septal Radiofrequency Ablation (PESA) procedure in the treatment of obstructive hypertrophic cardiomyopathy (oHCM). The primary objectives include investigating:

1. the treatment efficacy and safety of PESA treatment in oHCM patients with either left ventricular outflow tract obstruction (LVOTO) or midventricular obstruction;
2. the impact of PESA treatment on the functional capacity, quality of life and long-term prognosis of oHCM patients with either LVOTO or midventricular obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of hypertrophic cardiomyopathy;
* At least 18 years old;
* The presence of a resting or maximum provoked LVOT/midventricular gradient of ≥50 mmHg with symptoms, despite maximum tolerated medical therapy;
* Willing to receive PESA treatment;
* LVEF≥55%;
* Signed and dated written informed consent and willing to return for clinical follow-up.

Exclusion Criteria:

* Midventricular obstruction rendered by isolated papillary muscle hypertrophy;
* Complete right bundle branch block;
* Acute decompensation heart failure with NYHA IV;
* Previous septal reduction therapy including surgical and interventional procedures;
* Combination of other diseases requiring surgical treatment (including but not limited to coronary artery bypass grafting and apical aneurysm);
* Contraindications of radiofrequency ablation procedure;
* Women who are pregnant or lactating, or who plan to become pregnant while in the trial;
* Currently enrolled in another investigational device or drug trial;
* Combining any other clinical condition with a life expectancy less than 1 year.
Aquatic_Training in Obese Women

This study aims to assess the effects of 10-week water-based aerobic training (thrice a week) on anthropometrics, biochemicals, cardiovascular parameters, and explosive strength in young overweight and obese women. The findings indicate that water-based aerobic training could be a useful program to enhance body composition, biochemical, cardiovascular, and explosive strength parameters in young overweight and obese women compared to inactive persons

This study is based on a randomized controlled trial with a pre-to-post testing design, twenty-seven young overweight and obese women were assigned to training group (a water-based aerobic training) or control group (maintaining their usual activities during the studying period. For each training session, water activities were implemented for 50 min which included warm-up (10 min), main activities (30 min), and cool-down (10 min). The swimming pool where the intervention took part was 1.50 m deep of water. The pre- and post-intervention participants were assessed for their anthropometrics, biochemicals (fasting glycemia, total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol and triglyceride (TG)), resting blood pressure, and resting heart rate, and explosive strength of upper (countermovement jump and squat jump) and lower limbs (a seated medicine ball throw test).

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 35 years
* Sedentary lifestyle within six month
* Not using drugs or other therapy for obesity.

Exclusion Criteria:

* BMI below 25.0 and over 34.9 kg.m-2
* having any infectious or skin diseases
Clinical Test for Armed-used Blood Pressure Monitor With Preformed Cuff(Monitor When Being Inflated)

The purpose of this study is to monitor the blood pressure level of the patient using a blood pressure monitor which test the blood pressure level in inflating state . The cuff range in the study is 22cm-48cm


Eligibility Criteria:
Inclusion Criteria:

* cuff circumference:22cm-48cm

Exclusion Criteria:

* None