cyrilzakka/clinical-trials huggingface dataset:
The Effect of Eccentric Training on Anthropometrics, Physical Fitness and Bone Strength in Overweight Children

The purpose of this study is to examine the effects of aerobic eccentric training in overweight and obese children.

recent studies have shown that similarly to regular exercise, aerobic ECcentric Contraction (ECC) exercise induces changes in the musculoskeletal system while using lower energy consumption, due to the fact that eccentric training creates greater force in the muscle.

most of the studies in this subject were done on healthy or overweight adults. therefore, the effect of aerobic eccentric training on children is still unknown. this study wants to test the impact of eccentric training on overweight and obese children.

this study will include approximately 100 overweight and obese children (boys and girls), aged 5-18 years. participants will be recruited from the population of overweight children from children sports medical center 'Meir' in Kfar Saba, Israel. participants will be randomly divided into two groups (intervention and control). Participants and their parents will sign a consent form before entering the study.

Each participant will undergo a series of tests including: anthropometrics (height, weight, bmi, body composition by BIA), fitness tests (Maximal distance achieved in a 12min outdoor run\\walk, Vertical jump, Standing long jump, 4X10 meter sprint run), quadriceps and hamstrings strength test (hand-held dynamometer MicroFet2), bone strength (bone sonometer), ankle and tibial kinematic(accelerometers+ video of foot strike).

Intervention group will then perform an 8 week (16 sessions) ECC training program on a decline treadmill, the program will include two weeks of habituation to lower as possible DOMS (delayed onset muscle soreness) and possible injuries, training length and intensity will be gradually increasing over the time of the program, maximal negative gradient will be -15% at the end of the program.

Control group will perform the same amount of training (volume, intensity and frequency) on a neutral gradient surface. After completing the training program each participant will perform again the series of tests. Once all the data is collected, statistical test will be performed in order to learn about the effect of ECC training program on overweight and obese children.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 5-18.
* Children and adolescents with overweight defined as BMI percentile over 85%.
* Children and adolescents who are able to perform moderate physical activity.
* Children and adolescents that participate in 'Meir' hospital sports and health centre.

Exclusion Criteria:

* Participant that does not wish to participate - will not be obligated to do so, and shall not participate in the study.
* Participants with orthopaedic history in the past two years.
Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)

To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in the treatment of recurrent C. difficile infection

This is a single center, randomized, parallel assignment, double-blinded, safety and efficacy study to be conducted in subjects with recurrent CDI. Approximately 300 subjects will be enrolled in the study and randomized at 1:1:1 ratio to receive lyophilized donor intestinal bacteria with various doses in capsules. All subjects will be followed for approximately 180 days following FMT for safety.

Eligibility Criteria:
Inclusion Criteria:

* Sexually active female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
* Female subjects of child-bearing potential must have a negative pregnancy test on the day of the procedure.
* Subject willing to sign an informed consent form
* Subject deemed likely to survive for ≥ 1 year after enrollment
* Able to follow study procedure and follow-ups
* Subjects' attending physician will provide non-transplant care for the subject
* Diagnosed by medical history of ≥ 3 bouts of CDI in outpatients or ≥ 2 bouts of recurrent CDI in an inpatient with ≥ 2 positive fecal tests for C. difficile toxin
* Received at least one course of adequate antibiotic therapy for CDI (≥ 10 days of vancomycin or metronidazole or fidaxomicin) since last bout of CDI
* Have a 4 degrees Celsius refrigerator at home to keep the second dose FMT for overnight

Exclusion Criteria:

* Unable to take capsules orally
* Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT
* Actively taking Saccharomyces boulardii or other probiotic at the time of FMT other than that found in fortified foods
* Need for continuing use of drugs with CDI activity: oral vancomycin, oral or IV metronidazole, fidaxomicin, rifaximin or nitazoxanide at the time of FMT and after FMT
* Severe underlying disease such that the patient is not expected to survive for one or more years or unstable medical condition requiring daily change in treatments
Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia

This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well tolerated


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with confirmed pneumonia, defined as the presence of a new progressive infiltrate(s) on chest radiograph and the presence of gram-negative organism by either culture or Gram stain of respiratory secretions. The subject must be intubated and mechanically ventilated and expected to remain so for at least 3 days after the start of study treatment. Subjects with a tracheostomy were also eligible.

Exclusion Criteria:

* Subjects with compromised or suppressed Immune systems, severe hypoxemia, neutropenia, serum creatinine \> 2mg/dl and chronic liver disease
* Had primary lung cancer or another malignancy metastatic to the lungs
* Were known or suspected to have active tuberculosis, cystic fibrosis, acquired immunodeficiency syndrome, or Pneumocystis carinii pneumonia
* Were receiving immunosuppressive therapy, defined as chronic treatment with known immunosuppressant medications
* Had a body mass index of ≥30 kg/m2
* Had burns \>40% of total body surface area
* Had known local or systemic hypersensitivity to amikacin or aminoglycosides
* Had a diagnosis of end-stage renal failure or were currently on dialysis treatment
* Had a serum albumin level \<2 g/dL at Screening
* Used amikacin by any route within 7 days before the start of study treatment
* Had a presence of any concomitant condition that, in the opinion of the investigator, would preclude completion of study evaluations or make it unlikely that the contemplated course of therapy and Follow-Up could be completed
* Had known respiratory colonization with amikacin-resistant gram-negative rods
A Drug-Drug Interaction Study to Evaluate Drug Transporter Interactions

This is an open-label, three part study to evaluate the effect of BCX7353 on drug transporters as well as the effect of an inhibitor of drug transport on BCX7353.

This is a single center, open-label, fixed-sequence, drug interaction study to evaluate the effect of BCX7353 on the pharmacokinetics of the P-gp substrate digoxin and the BCRP substrate rosuvastatin, as well as the effect of the P-gp inhibitor cyclosporine on the pharmacokinetics of BCX7353.

It is planned that 54 subjects will be enrolled into 3 cohorts of 18 subjects each. Cohort 1 will evaluate the effects of multiple doses of BCX7353 on single-dose pharmacokinetics of digoxin. Cohort 2 will evaluate the effect of multiple doses of BCX7353 on the pharmacokinetics of rosuvastatin. Cohort 3 will evaluate the effect of a single dose of cyclosporine on the pharmacokinetics of BCX7353. Cohorts may be dosed in parallel or in any order.

Eligibility Criteria:
Key Inclusion Criteria:

* written informed consent
* acceptable birth control measures for male subjects and women of childbearing potential
* creatinine clearance of at least 80 mL/min by Cockcroft-Gault equation
* complies with all required study procedures and restrictions

Key Exclusion Criteria:

* clinically significant medical history, current medical or psychiatric condition
* clinically significant ECG finding, vital sign measurement or laboratory/urinalysis abnormality at screening or baseline
* current use, or use of any prescribed or over the counter medication, vitamins or herbal products within 14 days of Day 1
* use of medication that is known to inhibit or induce metabolic enzymes or transporters within 30 days of dosing
* participation in any other investigational drug study within 90 days of screening
* recent or current history of alcohol or drug abuse
* regular recent use of tobacco or nicotine products
* positive serology for HBV, HCV, or HIV
* pregnant or nursing
* donation or loss of greater than 400 mL of blood within the previous 3 months
* history of severe hypersensitivity to any medicinal product
* for subjects enrolled in cohort 1, current use of antibiotics or probiotics, or use within 6 months prior to Day 1
This Study is Being Performed to Evaluate the Effect of Genasense on the Efficacy and the Safety of Rituximab/Fludarabine Combination Treatment in Previously Untreated Subjects With Chronic Lymphocyctic Leukemia(CLL)

To compare the efficacy and safety of combination treatment with Genasense, fludarabine, and rituximab versus combination treatment with fludarabine and rituximab in previously untreated subjects with CLL.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated subjects with intermediate-or high-risk CLL(modified Rai Stages I-IV)
* Measurable disease as primarily established by the National Cancer Institute-sponsored Working Group(NCI-WG) Guidelines for the diagnosis of CLL
* Requiring therapy for active disease, as primarily defined by the NCI-WG Guidelines
* Eastern Cooperative Oncology Group Performance Status \< 2
* Adequate organ function determined , 14 days prior to the first dose of study medication

Exclusion Criteria:

* Absolute Lymphocyte count \> 100,000/uL
* Prior chemotherapy or other therapy for CLL, including allogeneic transplant
* Less than 3 weeks from any prior major surgery at the time of informed consent
* Failure to recover from any serious adverse effect of surgery
* History of autoimmune hemolytic anemia or autoimmune thrombocytopenia
* Active serious infection requiring systemic anti-infective therapy
Bicuspid Aortic Valve Replacement: Evaluation of Transcatheter Versus Surgery-Pilot Trial

The study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (AS) in patients with a bicuspid aortic valve (BAV). Namely, the therapies to which patients will be randomized will be transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR), in patients deemed clinically suitable for both following heart team review.

The purpose of this study is to compare the safety and efficacy of Transcatheter Aortic Valve Replacement (TAVR) versus Surgical Aortic Valve Replacement (SAVR) for treating patients with severe aortic stenosis (AS) who have a congenital bicuspid aortic valve (BAV) anatomy. Patients with BAV anatomy have been under-represented in previous trials and this study might provide important information to help guide future treatment options.

The study patients will be followed with standard of care procedures for 10 years.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged \> 50 years of age
* Site-determined severe AS deemed necessary for treatment with SAVR or TAVR
* Gated contrast CT available and suitable for core laboratory analysis
* BAV anatomy confirmed by CT core laboratory analysis

Exclusion Criteria:

* Recent cardiovascular intervention within the prior 30 days.
* Presence of an existing TAVR or SAVR device
* Pregnancy or lactation
* Extreme or prohibitive TAVR or SAVR risk, determined by site or committee Active enrollment in another investigational study
* Disproportionate TAVR vs SAVR risk, as determined by treating site or committee
* Associated aortopathy (AA≥ 45 mm by maximal cross-sectional dimension, as confirmed by CT core laboratory analysis, or AA\<45 mm but site plan for surgery of the aorta in the event of randomization to surgery
* Site plan for treatment of concomitant non-coronary cardiovascular disease in the event of randomization to surgery (for instance, concomitant valve surgery, septal defect or coarctation repair, aorta or root replacement or repair)
* In the presence of coronary artery disease deemed necessary for revascularization in the event of randomization to SAVR or TAVR, Syntax score ≥ 32 or deemed unsuitable for PCI, or deemed unsuitable for coronary artery bypass grafting (CABG).
Expression of miR-204 and Consequences on Capillarization in Limb Muscles of Patients With COPD

Limb muscle dysfunction, characterized by loss of capillaries, is amongst the most troublesome systemic consequences of chronic obstructive pulmonary disease (COPD) leading to poor functional status and premature mortality.

One prevailing hypothesis stipulates that modification in the expression of miR-204 leads to change the regulation of angiogenesis in vastus lateralis of patients with COPD when compared to controls.

The investigators objective is to investigate the impact of COPD on key signaling pathways involved in the muscle angiogenesis. Mild to severe COPD patients and healthy controls will be recruited. All of the investigators patients will undergo a thorough baseline assessment in pulmonary capacity and body composition. Blood sampling and biopsy of the quadriceps will be done. Key proteins and microRNAs of signaling intramuscular pathways involved in angiogenesis will be measured in the quadriceps.

Eligibility Criteria:
Inclusion Criteria:

* COPD (FEV1/FVC \< 0.70)
* Healthy subjects: no evidence of airways obstruction (FEV1/FVC \> 0.70 and FEV1 \> 0.80 predicted)
* Smoking history \> 10 pack-years
* Ex-smoker \>6 months

Exclusion Criteria:

* Chronic hypoxemia and/or hypercapnia (PaO2 \< 60 mmHg or SpO2 \< 88% at rest and/or PaCO2 \> 45 mmHg)
* Recent exacerbation or oral corticosteroids (\< 2 months)
* Recent cancer (\< 3 years)
* Diabetes
* Myopathy, neuromuscular, neurological or articular diseases
* Kidney disease
* Other respiratory diseases
* Unstable cardiac disease
* Physical activity score \> 9 in the Voorips questionnaire
* BMI \> 30
The Consistency of Drug Screening in Vitro and Neoadjuvant Chemotherapy Results in Breast Cancer Patients

Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate. Patients with triple negative or Her2 enriched subtype who achieved pCR after neoadjuvant chemotherapy would have better survival. But the overall pCR rate of breast cancer was about 20%. And patients with luminal like subtype were less reactive for neoadjuvant chemotherapy. Improving pCR rate maybe could achieve better survival. So, different methods have tried to select effective drug before chemotherapy.Drug sensitivity screening in vitro for different chemotherapy drugs was a promising method. This study will explore whether drug screening by culturing breast cancer cells in vitro from breast cancer tissue could consistent with neoadjuvant chemotherapy in patients.40 breast cancer patients were recruited.The results of drug sensitivity in vitro and pathological evaluation after neoadjuvant chemotherapy were compared whether they were consistent.

Neoadjuvant chemotherapy for breast cancer could make unresectable breast cancer be resectable and improve breast conservation rate. Patients with triple negative or Her2 enriched subtype who achieved pCR after neoadjuvant chemotherapy would have better survival. But the overall pCR rate of breast cancer was about 20%. And patients with luminal like subtype were less reactive for neoadjuvant chemotherapy. Improving pCR rate maybe could achieve better survival. So, different methods have tried to select effective drug before chemotherapy.Drug sensitivity screening in vitro for different chemotherapy drugs was a promising method. This study will explore whether drug screening by culturing breast cancer cells in vitro from breast cancer tissue could consistent with neoadjuvant chemotherapy in patients.40 breast cancer patients who would receive neoadjuvant chemotherapy were recruited.Breast cancer tissues were obtained before chemotherapy. The breast cancer cells were cultured in unadhesive dishes. Chemotherapy drugs were put in dishes and drug sensitivity were evaluated. Patients received operation and pathological evaluationc after neoadjuvant chemotherapy. The results of drug sensitivity in vitro and pathological evaluation after neoadjuvant chemotherapy were compared whether they were consistent.

Eligibility Criteria:
Inclusion Criteria:

* invasive breast cancer candidates for neoadjuvant chemotherapy agreed to participate in this observative experiments could receive operation normal liver and renal function

Exclusion Criteria:

* inflammatory breast cancer recurrent breast cancer
Dietary Protein and Insulin Sensitivity Study

The overall objective of the Dietary Protein and Insulin Sensitivity Study is to test the hypothesis that increased protein in a diet with reduced carbohydrate (35% energy) can ameliorate insulin resistance in the absence of weight loss, and that this effect is independent of saturated fat content. Moreover, we will test whether such diets result in beneficial changes in total LDL cholesterol, small, dense LDL, and HDL cholesterol that are also independent of saturated fat intake.

Insulin resistance is a major metabolic disturbance associated with excess adiposity that contributes to atherogenic dyslipidemia and predisposes to both cardiovascular disease and type 2 diabetes mellitus. The effects on insulin resistance of changes in dietary macronutrient composition in the absence of weight loss are poorly understood. To better understand these effects, we will study men and women with insulin resistance after 4 weeks on a basal diet (15% protein, 55% carbohydrate, 30% fat) and 4 weeks after random assignment to the basal diet or one of 4 diets with 35% carbohydrate and either 20% or 30% protein, and either 7% or 15% saturated fat. At the end of each dietary period (4 weeks and 8 weeks), we will draw a blood sample for detailed metabolic measurements and measure insulin sensitivity by the frequently sampled intravenous glucose tolerance test (FSIGT) method. In addition to insulin resistance, we will assess the effect of dietary composition on parameters of atherogenic dyslipidemia.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥ 27 and ≤ 40 kg/m2
* HOMA-IR ≥ 2.5
* Non-smoking
* Total cholesterol and LDL cholesterol \<95th percentile for sex and age
* Fasting triglycerides \< 500mg/dl
* Fasting blood sugar \< 126
* Urinary microalbumin \< 30 mg/L
* Normal thyroid stimulating hormone levels
* Hematocrit ≥ 36%
* Blood pressure \< 150/90
* At least 3 months of a weight-stable state (± 5 lbs) prior to the study. During the study, subjects will be required to maintain their body weight within ± 3% (up to a maximum change of 5 lbs) of their initial weight over the course of any consecutive two weeks after the second week of baseline diet or during the last week of each diet phase

Exclusion Criteria:

* History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years
* Use of drugs known to affect lipid metabolism or insulin resistance, hormones, or the blood thinning agent, warfarin
* Use of alcohol or dietary supplements during the study
* Pregnancy
Clinical Multicenter Randomized Controlled Study of Simultaneous Cognitive Training With Transcranial Magnetic Stimulation in the Treatment of VaD-MCI Patients

A multicenter randomized controlled clinical study was conducted in the Xuanwu hospital of Capital Medical University to preliminarily explore the efficacy and safety of simultaneous cognitive training with transcranial magnetic stimulation in the treatment of VaD-MCI patients, to clarify the effective mechanism and form an effective clinical treatment plan.

This project plans to recruit 164 patients with VaD-MCI. They were randomly divided into simultaneous cognitive training with active transcranial magnetic stimulation group and simultaneous cognitive training with sham transcranial magnetic stimulation group. Patients receive treatment 3-7 days a week, and the daily treatment time is 20-40 minutes. The duration of treatment is 1-12 weeks. Before treatment, cognitive assessment, resting EEG, head MRI and PET examination were completed. Complete the overall cognitive assessment, resting EEG and MRI examination within one week after the treatment, and complete the overall cognitive assessment and PET examination at the follow-up 6 months after the treatment. Fill in the treatment side effect scale and adverse event form. Keep the original oral drug dosage unchanged during the treatment process.

Eligibility Criteria:
Inclusion Criteria:

Male or female VaD-MCI patients between the ages of 50-85; The psychological evaluation was in accordance with MMSE score of 18-26 (including 18 and 26) and CDR score of 0.5.

The inclusion criteria based on MRI examination include: ① Multiple supratentorial subcortical lacunae (3-20 mm) with or without white matter degeneration, or moderate and severe white matter degeneration (Fazekas score ≥2) with or without lacunae; ② White matter lesions such as cortical/watershed infarction, cerebral hemorrhage, hydrocephalus or other causes (such as multiple sclerosis) were excluded; ③ There was no medial atrophy of hippocampus or temporal lobe (MTA 0); Can cooperate to complete clinical research.

Exclusion Criteria:

Suffering from any cause of disturbance of consciousness. Severe aphasia or physical disability can not complete the neuropsychological examination Those who have a history of alcoholism, or drug addiction, or neurological diseases such as brain trauma, epilepsy, encephalitis, normal intracranial pressure hydrocephalus, etc. that can cause cognitive impairment.

Suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency).

Have a history of using antipsychotics for more than five years before diagnosis.

There are contraindications for head MRI examination.