cyrilzakka/clinical-trials huggingface dataset:
Bile Acids and Gut Microbiota as Potent Coronary Atheroma Risk Factors: a Prospective Study in Human

The purpose of this study is to describe the composition of bile acids and the gut microbiota comparing two populations: patients with coronary atheroma and the healthy subjects.

Our hypothesis is based on the demonstration of the anti atherogenic and anti inflammatory effect of certain bile acids, and the role of the gut microbiota in the metabolic regulation.

Atherosclerosis is the main cause of cardiovascular diseases which remain the first cause of death worldwide. The prevention of risk factors can reduce the development of cardiovascular diseases. The final goal of our study is to find new protective or new risk factors that can be modulated to reduce the incidence of cardiovascular events.

Gut microbiota and its main metabolite, the bile acids, are implicated in the metabolic regulation. Some bile acids, especially the secondary bile acids, transformed from the primary bile acids by the bacteria of the gut microbiota, are now demonstrated in murine experimental atherosclerosis models, to be anti inflammatory and anti atherogenic molecules.

We want to compare the pool of bile acids and the composition of gut microbiota between the coronary patients and the healthy subjects to identify the potential protective or deleterious bacteria / bile acids.

All patients admitted for a scheduled coronary angiogram will be included, then divided into two groups: coronary or healthy, based on the presence or the absence of atheroma during the coronary angiogram.

Feces and blood samples, and clinical and biological data, will be collected during the patient's hospitalisation. No additional exam will be performed. The blood sample will be collected during the coronary angiogram or during a routine blood test.

Eligibility Criteria:
Inclusion Criteria:

- All patients admitted for a coronary angiogram

Exclusion Criteria:

* Statins, hypolipemic drugs, corticoids, anti HIV drugs
* Antibiotics adminisitration in the last 3 months
* Past of cholecystectomy
* Hepatic disorders
* Acute coronary syndrome
* No agreement, Insufficiency in comprehension
* Non fasting for at least 8 hours
A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height

Estrogens are responsible for the disappearance of growth cartilage in the long bones at the end of the pubertal growth spurt both in boys and in girls. It is therefore hypothesized that stopping pubertal development and hence estrogen production, will prolong and increase the pubertal growth spurt, especially when growth hormone is given concommitantly.

Boys in early puberty, with a bone age between 11 and 13 years and a predicted adult height below 163 cm or girls in early puberty with a bone age between 10 and 12 years and a predicted height under 151 cm will be treated with triptorelin 3.75 mg and Zomacton growth hormone for 4 years.


Eligibility Criteria:
Inclusion Criteria:

* Adult height prediction below -2.5 SD : 151 cm for girls and 164 cm for boys based on the vlaamse groeicurve 2004 (vub.ac.be/groeicurven)
* Pubertal: breast development at least M2 for girls and at least 4 ml of testicular volume for boys
* Bone age \>10 years but \< 12 years for girls and \> 11 but \< 13 years for boys
* Signed informed consent

Exclusion Criteria:

* Adopted children ( different genetic background, lack of data on birth parameters and parents)
* Bone dysplasia or sitting height/ total height \> 2 SDS on standards by Gerver et al (see appendix)
* Chronic use of glucocorticoids
* Previous growth promoting therapy such as GH, sex steroids, oxandrolone,
* Known GH deficiency
* Chronic infectious disease
* Active rheumatic disease
* Previously diagnosed or currently suspected malignancy
* Sex steroid therapy
* Diabetes mellitus
* Renal insufficiency (serum creatinine \> 1.5 mg/dl)
* Hepatic disease ( liver test \> 4 fold upper limit of normality)
* Current congestive heart failure
* Inability to follow the study protocol
* Treatment with a non registered drug during the last 30 days before the moment of inclusion.
A Single and Multiple Ascending Dose Study of BMS-986318 in Healthy Participants

A study to evaluate single and multiple ascending doses of experimental medicine BMS-986318 in healthy participants.

A Phase 1, Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986318 Administration in Healthy Participants

Eligibility Criteria:
Inclusion Criteria:

* Healthy Participants as determined by no clinically significant deviations from normal in medical history, physical examination, ECG and clinical laboratory results as determined by the investigator
* Male participants who are sexually active with Women of Child Bearing Potential (WOCBP) must agree to follow instructions for methods of contraception for duration of treatment plus 92 days.
* Female participants must have documented proof that they are not of childbearing potential and a negative pregnancy test at screening and within 24 hours before the first dose of study treatment.

Exclusion Criteria:

* Use of any prescription drugs within 4 weeks or use of over-the-counter (OTC) medications or herbal preparations within 2 weeks prior to study treatment administration (except acid controllers, which are not allowed within 4 weeks prior to study treatment administration
* Women of Child Bearing Potential (WOCBP) or women who are breastfeeding.
* Any major surgery within 12 weeks of study administration Or any history of GI surgeries as listed.(eg, gastric bypass, gastric banding, Roux-en-Y) or gastric- emptying issues that could impact upon the absorption of nutrients.
BIOFLOW-china Post-marketing Study (BIOTRONIK)

This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods.

The goal of this study is to assess the safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in the Chinese patient population after marketing in China.

This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods. A total of 2,000 subjects will be enrolled from up to 15 research sites in China. Suitable subjects will be selected according to the inclusion and exclusion criteria, and those who meet the inclusion and exclusion criteria will accept follow-up after signing the informed consent form from the site ethics committee until 5 years after surgery. It is aimed to further assess the safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in the Chinese patient population after marketing in China by observing the data collected in this trial.

Eligibility Criteria:
Inclusion Criteria:

* The subject should be 18 years or older when undergoing the procedure.
* The subject has signed the Informed Consent.
* The subject signed Informed Consent dated back within 12 months and was implanted with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.

Exclusion Criteria:

* The subject has or had a life expectancy less then 12 month after treatment with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.
* The subject has any known allergies to the following substances: aspirin, heparin/divalerythromycin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), bivalirudin, rapamycin, L-605 cobalt-chromium (Co-Cr) alloy or its main elements (cobalt, chromium, tungsten and nickel), acrylic acid, fluoropolymer, silicon carbide, PLLA allergy or contraindications.
* The investigator judges that the subject has poor compliance and cannot complete the study as required, or other circumstances that are not suitable for participation in this study .
Synchronous Telerehabilitation vs Face to Face Method for Upper Extremity Functions in Children With Hemiparetic CP

The aim of this study is to investigate the effectiveness of synchronous telerehabilitation on improving upper extremity function in children with hemiparetic cerebral palsy.

46 children with hemiparetic cerebral palsy who meet the inclusion criteria and agree to participate in the study will be included. The participants will be randomly divided into two groups. The groups are: a) the synchronous telerehabilitation group; b) face to face rehabilitation group. Both groups will receive physiotherapy 2 days a week (1 session of 45 minutes) for 12 weels, for a total of 24 sessions. Evaluations will be made at baseline and the end of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Presence of confirmed hemiparetic cerebral palsy
* Manual Ability Classification System ≤ 3
* Age between 6 and 18
* Absence of major visual and/or auditory deficits
* Sufficient cooperation to comprehend and complete the test procedure and participate in treatment
* Family members being active mobile phone or computer and internet users

Exclusion Criteria:

* Seizures uncontrolled by therapy
* Surgery and/or botulinum toxin-A injections in the upper limb within 6 months prior to the baseline assessment
* Having a disabling behavioral disorder to treatment
* Family's discontinuation of treatment
Family Routines - Healthy Families

The purpose of the proposed study, Family Routines - Healthy Families, is to examine the feasibility and acceptability of a parenting/family routine intervention program for parents of young children, ages 2-5, with type 1 diabetes.

The intervention in Family Routines - Healthy Families contains an established and effective parent skills training curriculum called "The Incredible Years," uniquely integrated with a newly developed family evening routine component e.g., family dinner time and evening routine, to promote improved metabolic control. The investigator will assess outcomes during and at one week post intervention. Outcome measures will include family routine, specifically the time between the dinner and bedtime glucose check, parent bedtime decision making, and child overnight glucose control. In addition, parental quality of life and receptiveness to the intervention will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. Self identification as primary care giver of child that fits following criteria:

   1. Age 2 - 5 years
   2. Diagnosis of Type 1 diabetes
   3. Most recent Hemoglobin A1c (HbA1c) \> 8.0
   4. Child a patient of Pediatric Endocrinology, Beaumont Children's Hospital
2. English fluency

Exclusion Criteria:

1. Cognitively impaired
2. Does not meet inclusion criteria
European Stop Tyrosine Kinase Inhibitor Study

The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response (MMR) or better after stopping TKI therapy.

Secondary goals include:

* Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of Complete molecular remission (CMR), risk score, duration of TKI treatment, type of TKI pretreatment)
* Evaluation of quality of life (QoL) in patients stopping TKI
* Evaluation of medico-economic impact of stopping TKI
* Estimating the number of patients in CMR who are eligible for stopping TKI therapy by setting up a screening log
* Time to recovery of CMR There will be no randomised comparison. Based on the experience of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month molecular-relapse-free survival probability of at least 40%. An interim analysis will be performed after a pilot phase where 200 patients have been observed for at least six months. Formally, it is planned to test the null hypothesis H0: Six-month molecular relapse-free survival probability P ≤ 40% against the alternative hypothesis H1: Six-month molecular-relapse-free survival probability P \> 40%. Eligible are adult CML patients in chronic phase on TKI treatment in CMR for at least one year (\> 4 log reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by a PCR within a standardized CMR laboratory). Clinical and biological monitoring will be performed during 3 years: Associated scientific projects are performed. Recruitment period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500


Eligibility Criteria:
Inclusion Criteria:

* CML in CP under treatment with TKI in first line or in second line because of toxicity to first line TKI or with TKI in combination
* Duration of TKI treatment before enrolment at least 3 years
* At least complete molecular remission MR4
* Before inclusion confirmation of CMR4 through a EUTOS-CMR laboratory
* Baseline data and documentation on treatment before study entry available
* Both sexes but fertile women only if using effective contraceptive
* Health insurance coverage
* 18 years or older

Exclusion Criteria:

* Under 18 years old
* Hospitalized patients without ability to give informed consent
* Adults under law protection or without ability to consent
* Previous or planned allogeneic stem cell transplantation
Effect of Novel Antidiabetic Drug Combined With Angiotensin Receptor/Neprilysin Inhibitor on Urinary Protein

The purpose of this study is to determine whether the combination of SGLT2i and ARNI in type 2 diabetic patients with combined albuminuria could reduce urinary protein more significantly than single agent.

This project is a single-center retrospective cohort study to obtain the biochemical index levels of urinary albumin creatinine ratio, urinary protein creatinine ratio, blood renal function, blood lipids, and blood glucose at the immediate, 3rd, 6th, and 12th month of cohort inclusion in each group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Clinical diagnosis of type 2 diabetes mellitus
* Immediate urine albumin creatinine ratio greater than 30mg/g
* Signed informed consent and available for follow-up

Exclusion Criteria:

* severe renal insufficiency, i.e. eGFR ≤ 30ml/min/1.75m2
* clinical diagnosis of various acute and chronic urinary tract infections
* combined with various serious infectious diseases
* combined with acute complications of diabetes mellitus
* end-stage malignancy
* pregnancy and lactation
Resistance and Aerobic Exercise With Nutritional Supplementation in Men and Women

The purpose of this study is to identify the influence of resistance and aerobic exercise with different nutritional supplements in middle-aged men and women on various physiological measures. Throughout the study, the investigators examine body composition, body weight, food intake, fitness level, metabolism, and blood hormones.


Eligibility Criteria:
Inclusion Criteria:

* men and women age 35-65 yr
* body weight \<300 lbs (136 kg)
* body mass index between 28 kg/m2 and 35 kg/m2
* fasting glucose \<110 mg/dL
* blood pressure \<160/100 mm Hg
* plasma total cholesterol \<260 mg/dL
* LDL-cholesterol \<160 mg/dL
* triacylglycerol \<400 mg/dL
* not currently or previously following a weight loss diet or other special/non-balanced diet (in the past 6 months)
* \<1 hour/week of habitual aerobic exercise training and no resistance
* exercise training (in the past 6 months)

Exclusion Criteria:

* men and women age \< 35 yr or \>65 yr
* body weight \>300 lbs (136 kg)
* body mass index between \<28 kg/m2 or \>35 kg/m2
* fasting glucose \>110 mg/dL
* blood pressure \>160/100 mm Hg
* plasma total cholesterol \>260 mg/dL
* LDL-cholesterol \>160 mg/dL
* triacylglycerol \>400 mg/dL
* currently or previously following a weight loss diet or other special/non- balanced diet (in the past 6 months)
Prevalence Study of the Etiology of Pregnancy Anemia

Anemia during pregnancy occurs in 41% of women. The most common etiology is iron deficiency, but studies to determine prevalence of other causes of anemia in pregnancy are still lacking. However, anemia in pregnancy lead to adverse pregnancy outcomes and increase risk of maternal and fœtal morbidity and mortality. Specific management of anemia is so needed.


Eligibility Criteria:
Inclusion Criteria:

* woman 18-years or older
* woman with a normal pregnancy
* anemia with accidental or symptomatic discovery, whatever the term of pregnancy
* non opposition collected

Exclusion Criteria:

* Refuse to participate
* Stopped pregnancy whatever the term
* Medical abortion of pregnancy
the Association of Intestinal Microbial Metabolites and Cardiac Function in Acute Myocardial Infarction

Recently, more and more studies have confirmed that intestinal flora is closely related to the occurrence and development of cardiovascular diseases.Bile acids (BAS), short chain fatty acids (SCFA) and trimethylamine oxide (TMAO), the main metabolites of intestinal flora, are the key mediators of the interaction between gut and host. We aim to explore the association of BAs and SCFA with cardiac function in patients with AMI.

Cardiovascular disease is the leading cause of death in China, and acute myocardial infarction (AMI) is the main cause of death of cardiovascular disease. In recent years, clinical epidemiological studies have confirmed that intestinal flora is closely related to the occurrence and development of cardiovascular diseases such as diabetes, hyperlipidemia, hypertension, atherosclerosis, coronary heart disease, heart failure and so on. Bile acids (BAS), short chain fatty acids (SCFA) and trimethylamine oxide (TMAO), the main metabolites of intestinal flora, are the key mediators of the interaction between gut and host. It is suggested that intestinal flora and its metabolites participate in the pathophysiological process of cardiovascular disease through inflammation, oxidative stress and programmed death, and have the potential to be intervention targets. Basic and clinical studies have shown that TMAO is associated with the onset and poor prognosis of AMI by promoting the development of atherosclerosis and thrombosis, but there are few reports on the relationship between BAs or SCFA and AMI. We aim to explore the association of BAs and SCFA with cardiac function in patients with AMI.

Eligibility Criteria:
Inclusion Criteria:

The patient, aged 18-85 years, had undergone coronary angiography and agreed to be enrolled and signed the informed consent.

AMI : according to ST segment elevation myocardial infarction diagnostic criteria.

UAP:

1. typical chest pain symptoms;
2. negative in markers of myocardial injury;
3. The stenosis of main coronary artery or its main branches is more than 50%

Control:

1. atypical chest pain symptoms
2. negative in markers of myocardial injury;
3. The stenosis of main coronary artery and its main branches is less than 50%

Exclusion Criteria:

1. Acute infection or application of antibiotics in the past 3 months;
2. Chronic heart failure;
3. History of inflammatory or absorptive bowel disease and bowel resection;
4. Acute, chronic liver disease or other reasons lead to abnormal liver function (transaminase is more than 5 times of normal value);
5. Renal insufficiency (serum creatinine \> 220μml/L or creatinine clearance rate \< 30 ml/min);
6. Malignant tumor;
7. Autoimmune diseases;
8. Uninformed patients
ANGIOCOMB Antiangiogenic Therapy for Pediatric Patients With Diffuse Brain Stem and Thalamic Tumors

The purpose of this study is to determine whether initial local irradiation with topotecan and following oral antiangiogenic drugs, thalidomide, celecoxib and etoposide are effective in the treatment of pediatric diffuse brainstem tumor.

All pediatric patients (aged 1-16 yrs) with newly diagnosed diffuse brain stem tumor or inoperable thalamic tumor which infiltrate brain stem from the pediatric oncology units in Denmark, Finland, Iceland, Norway and Sweden will be eligible. A possible tumor biopsy with histologic findings is not taken into account. The diagnosis is based on MRI. The patients are given a conventional local radiotherapy of 54 Gy, during which the patient also receives topotecan as radiosensitizer. Within four weeks after completed radiotherapy, the investigational drugs are started. If the family for some reason refuses radiotherapy, the investigational therapy may still be considered. The guardians and age-appropriate patients are asked for written informed consent. If the family is not willing to participate in the trial, the patient is treated according to the currently best available therapy (meaning RT without topotecan as palliative therapy). The family has the right to withdraw from the study, whenever they so wish.

Brain MRI at initial diagnosis, before the start of triple medication, and q 3 mo after initiation of triple medication, if not otherwise clinically indicated. In case it is decided to continue medication with progression in MRI, repeat MRIs are recommended every month. MRI should also be registered, if feasible, at the discontinuation of the medication.

The clinical follow-up, as well as MRI follow-up, on clinical indications will continue also after discontinuation of therapy.

PET-CT and/or MRI spectroscopy should be considered at diagnosis and at 3 mo after the start of triple medication.

Eligibility Criteria:
Inclusion Criteria:

-pediatric diffuse brainstem tumor

Exclusion Criteria:

* wish of the family
* need for strong painrelievers
* decreased level of consciousness
* inability to swallow.
ADJUNCTIVE EFFECT OF LIGHT EMITTING DIODE ON HAND GRIP STRENGTH IN BURN PATIENTS

This study will be done to evaluate effect of applying LED before hand exercise on hand grip strength. Sixty male patients with subacute partial thickness burn of hand will be randomly allocated into two equal groups of 30 patients. The following equipment and tools will be used

Measurement equipments:

* For total active motion of fingers (TAM): Goniometer.
* For hand grip strength: Hand grip dynamometer.

Therapeutic equipment:

Light emitting diode therapy (LED) device.


Eligibility Criteria:
Inclusion Criteria:

The subject selection will be according to the following criteria:

* Burn caused by thermal injury (flame or scald) with involvement of the wrist and hand and other parts of the body not including shoulder and elbow.
* Age range between 20-35 years.
* Male gender.
* Subacute Partial-thickness burn " From 3rd day of burn".
* Recent discharge of in patient acute care, spontaneous healing.
* All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria:

* Cardiac diseases.
* Perception of persistent respiratory problem related to a previous inhalation injury
* Signs of burn infection (i.e., unclear fluid oozing from the wound, increased pain, expanded redness and swelling)
* Exposed tendons.
* Nerve, muscle injury.
* Scar contracture of hand.
* Cognitive disorders.
* Presence of fractures.
* Patients who suffer from skin diseases, diabetes, varicose veins, and peripheral vascular diseases.
* Patients with life threatening disorders as renal failure, myocardial infarction or other similar diseases will be excluded from the study.