cyrilzakka/clinical-trials huggingface dataset:
vibroX-training in Endurance Trained Men

In endurance sports competitions such as cycling, an athlete's capacity to sustain submaximum power (i.e. endurance capacity) strongly influences overall race performance. Endurance capacity can be increased by both long, continuous endurance exercise at moderate oxygen consumption, and high-intensity (at or above peak oxygen consumption) interval training. However, it has also been shown that resistance exercise, if performed in addition to endurance exercise, can further enhance endurance capacity. The investigators have recently described a novel training method, which is based on combined vibration and resistance training and superimposed vascular occlusion. Based on the investigators previous results showing that this type of training leads to marked increases in endurance capacity in previously untrained young women, the investigators aim at investigating whether the method is also effective in increasing endurance capacity in highly endurance-trained young men, and whether the method leads to bigger improvements relative to resistance exercise alone. Besides the functional outcomes the investigators are also interested in the specificity of the cellular adaptations with respect to the two trainings methods.


Eligibility Criteria:
Inclusion criteria:

* male
* no fever / no common cold at the beginning of the study
* at least 4 endurance training sessions prior to beginning of study
* age 18-35y
* non-smoker
* no cardiological / orthopedic problems
* no pacemaker
* fulfills health questionnaire's requirements

Exclusion criteria: female

* fever / common cold at beginning of study
* untrained condition (less than 4 endurance training sessions prior to the
* beginning of the study)
* age under 18 oder above 35y
* smoker
* cardiovascular or orthopedic problems
* cardiac pacemaker
* does not fulfill health questionnaire's requirements
Folic Acid Supplementation in Calcific Aortic Valve Disease

This is a prospective, randomized, comparative, clinical trial conducted by Wuhan Union Hospital that aims to evaluate the efficacy and safety of folic acid compared to placebo in patients with calcific aortic valve disease with mild aortic valve stenosis.

Folic acid is involved in important physiological activities in the body such as DNA synthesis, cell division and growth and development. Recent studies have shown that folic acid may also have a positive effect on cardiovascular system health. Aortic valve calcification is a cardiovascular disease whose incidence increases progressively with age. Early studies suggest that folic acid may slow the progression of aortic valve calcification by inhibiting cell calcification and promoting calcium deposition. Participants were randomized into two groups: one group was given oral folic acid treatment and the other group was given placebo control. Patients in both groups were observed for aortic valve calcification during the follow-up period, and changes in aortic valve thickness, degree of calcification, and flow were recorded by cardiac ultrasonography, while the incidence of cardiovascular events and adverse effects were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult ≥ 35 years of age at the time of recruiting.
* Subject has calcific aortic valve disease with mild to moderate aortic valve stenosis as defined by Doppler echocardiography results: Aortic Valve mean pressure gradient between 10-30 mmHg and Aortic Valve Area ≥ 1.2 and ≤ 2.0 cm2 on transthoracic echocardiography within 2 weeks prior to randomization and Cardiac Compute Tomography (CT) test results: aortic valve calcium score (Agatston score) ≥ 200 AU at baseline cardiac CT within 1 month prior to randomization
* Subject provides written informed consent prior to initiation of any study procedures.
* Subject understands and agrees to comply with planned study procedures.

Exclusion Criteria:

* Subject has concomitant moderate or severe mitral or tricuspid valve disease.
* Subject has left ventricular ejection fraction \< 50%.
* Subject previous history of aortic valve surgery, pancreatitis, malignant tumor, drug or alcohol abuse.
* Subjects whose alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2.5 times the upper limit of normal range.
* Subjects who cannot undergo Cardiac CT.
* Pregnant or lactating women.
* Consideration by the investigator, for safety reasons, that the subject is an unsuitable candidate to receive study treatment.
Effect of Pericapsular Nerve Group (PENG) Block for Perioperative Analgesia in Geriatric Patients With Hip Fractures

the goal of this clinical trial is to evaluate the analgesic effect of pericapsular nerve group (PENG) block in elderly patients with hip fractures undergoing hip surgery .

and to evaluate its effect in reducing post operative complications .

all patients meeting the inclusion criteria will be informed about the study goal , methods and procedure in clear language. a written informed consent will be taken.

All patients ,once arrived to the OR, monitor will be attached, spinal anesthesia will be performed as follows, after sterilization of the back with bovidon iodine, local anesthesia 3cc of lidocaine 20% will be injected at the level of L3-L4 spine , then injection of 17 mg bupivacaine 0.5% through a 25 spinal needle.

At the end of surgery,all patients will receive PENG block through ultrasound. The regional block was performed with the patient in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 20 mL bupivacaine 0.25%.

Eligibility Criteria:
Inclusion Criteria:

* patients must age 60 years or more .
* patients must belong to american society of anesthesiologists (ASA) classification class II or III

Exclusion Criteria:

* age \< 60 years
* ASA IIII
* refusal of peripheral nerve block
* infection at the site of injection
* coagulopathy INR \> 1.8
* platelets count \< 50,000
* known allergy to used medications.
Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)

The project comprises two research lines. In the line 1, human monoclonal antibodies toward SARS-CoV-2 will be generate and characterized by in vitro functional tests. In the line 2, in vitro tests will be performed to evaluate the efficency of immune response mediated by antibodies direct to specific tumor molecules.


Eligibility Criteria:
Inclusion Criteria:

Line 1: - Age \>18 at time of signing informed consent form

* Signed informed consent form Line 2: - Primery liver tumor
* Age \>18 at time of signing informed consent form
* Signed informed consent form

Exclusion Criteria:

Line 1: - Active or history of neoplastic malignancy

* Active autoimmune disease ongoing treatment with immunosuppressive therapy
* Evidence of positive HIV, HCV, HBV test
* Diabetes
* Failure to sign informed consent form Line 2: - Concomitant diseases with life expectancy of less than 12 months
* Chronic autoimmune or inflammatory diseases
* Treatment with atezolizumab, bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, checkpoint inhibitors and tyrosine kinase inhibitors or anti-VEGF therapies
* Other extrahepatic neoplasms occurring or in the last 3 years except for tumors resected with curative intent and without evidence of relapse for \>3 years prior to signing informed consent and considered low risk of relapse
* HIV infection
* Failure to sign informed consent form
Mirror Trial - Follow-Up Management of Peripheral Arterial Intervention With Clopidogrel

The Mirror Study is a randomized, double-blinded mono-centre trial the access the periinterventinal and postinterventional administration of clopidogrel in patients with peripheral vascular disease.

Clopidogrel is approved for secondary prevention of atherosclerosis in patients with peripheral vascular disease. Currently there are no data about the amount of platelet activation during peripheral arterial intervention, the effect of clopidogrel on platelet adhesion and its clinical impact.

Patients with chronic peripheral arterial disease receive placebo or clopidogrel before the intervention and for 6 months in follow-up. Platelet activation, the effect on macro-and microcirculation will be assessed as well as clinical endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Peripheral arterial disease which requires intervention

Exclusion Criteria:

* Patient already on coumadin or clopidogrel
* Acute onset of PVD symptoms
* Patient requiring an operation
* Contraindication to aspirin and clopidogrel
Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure

Babies born with hypoplastic left heart syndrome (HLHS) have three separate, complex heart surgeries before they turn three years of age. The first surgery typically happens in the first two weeks of life. After this operation, babies come back to the intensive care unit with their chests open. Babies who have heart surgery retain body water after surgery and this extra water slows recovery. Surgeons cannot close the chest until the baby gets rid of the extra water. As a result, babies have to stay in the intensive care unit and on a breathing machine for longer.

Peritoneal dialysis, also known as PD, involves placing a small catheter into the belly cavity at the time of surgery. PD helps the kidney to get rid of extra body water. PD involves putting small amounts of special fluid into the belly through the catheter. This special fluid attracts water and is drained hourly. By allowing the belly cavity to drain, this helps both the heart and the lungs. This allows the chest to be closed and the breathing tube to be removed. The investigators are looking to see how quickly the babies, with and without PD, get rid of the extra water in turn shortening their stay in the intensive care unit and in the hospital. PD is not permanent, and only used for the first few days after the operation.


Eligibility Criteria:
Inclusion Criteria:

* Infants with HLHS or its variants who have a Norwood procedure
* Parental consent

Exclusion Criteria:

* Premature neonates less than 37 weeks gestation
* Weight less than 2 kg
* Urine output less than 0.5ml/kg/hr over 24 hours in the 48 hours prior to the Norwood
* Pre-operative renal replacement therapy
* Abdominal defects precluding placement of a PD catheter
* Known chromosomal abnormality
* Pre-operative cardiopulmonary resuscitation (CPR)
* Pre-operative extra-corporeal life support (ECLS)
Intravitreal Bevacizumab in Recalcitrant Inflammatory Ocular Neovascularization

One complication of uveitis which is driven by an increase in VEGF is the formation of inflammatory ocular neovascularization (ION). Here, we analyze the therapeutic role of intravitreal bevacizumab in ION not responding to standard therapy (systemic and ocular corticosteroids and systemic immunosuppressants) in a multicenter retrospective study.The natural history of subfoveal choroidal new vessels histoplasmosis, multifocal choroiditis, Harada and other inflammatory chorioretinal disorders has been very guarded, but with this new approach, we hope to stop the visual loss in these relatively young patients.

Members of the American Society of Retinal specialists, the American Uveitis Society and the International Uveitis Society were invited to contribute their consecutive cases of ION not responding to standard therapy (corticosteroids (CST) 4 or immunosuppression) and treated with intravitreal anti-VEGF agents. Cases with concomitant or prior cystoid macular edema, diabetes mellitus, or age-related macular degeneration were excluded. Most of the patients had initially been treated in a stepwise fashion with high doses of oral CST, with or without intraocular or subtenon CST or immunosuppressive therapy (as monitored by a rheumatologist). All patients opted to intravitreal anti-VEGF treatment after detailed information about the limited experience, potential side effects and the off-label character of the drug. The risks and benefits of intravitreal therapy were discussed with the patients (or their guardians) who signed an informed consent. Primary outcome measure: Best corrected visual acuity measured as logMAR. Secondary outcome measures:macular thickness on OCT, and stoppage of leakage by IVFA.

Eligibility Criteria:
Inclusion Criteria:

* Inflammatory ocular neovascularization (INO)

Exclusion Criteria:

* Eyes with age-related macular degeneration
* Diabetes mellitus
* Prior cystoid macular edema
* Uncontrolled systemic hypertension
* Cardiovascular disease
Transverses Abdominis Plane Block Versus Local Wound Infiltration in Total Abdominal Hysterectomy

To compare the transverses abdominis plane block outcome versus local wound infiltration for postoperative analgesia in patients undergoing total abdominal hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age range 18 to 50 years
* Female
* ASA I \& II
* Undergoing Abdominal Hysterectomy under General anaesthesia

Exclusion Criteria:

* Hepatic failure (assessed on clinical signs and symptoms, elevated liver enzymes and ultrasound findings showing loss of normal texture of liver) or renal failure (a GFR of 15 or less)
* Allergy or contraindication to study drugs on history
* Drug abuse or addiction
* Bleeding tendency
Survivorship Care Planning in Improving the Quality of Life in Breast Cancer Survivors

This randomized pilot clinical trial studies survivorship care planning in improving the quality of life in breast cancer survivors. Survivorship care planning may reduce stress and improve the well-being and quality of life of cancer survivors.

PRIMARY OBJECTIVES:

I. Test the effectiveness of the navigation intervention and survivorship care plan (SCP)-breast cancer survivors (BCS) template booklet on accessing and adhering to SCP-BCS guidelines compared to the control group receiving usual care and the SCP-BCS template booklet.

SECONDARY OBJECTIVES:

I. Develop a clinically and psychosocially responsive SCP-breast cancer survivors (SCP-BCS) template in English and English-Spanish adopted from American Society of Clinical Oncology (ASCO)-SCP.

II. Assess the acceptability, utility and format preference (electronic vs paper) of the SCP-BCS template.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive SCP-BCS template booklet and receive counseling sessions with a patient navigator for 40 minutes twice weekly for 4 sessions.

ARM II: Participants receive SCP-BCS template booklet and receive standard follow-up care.

After completion so study treatment, participants are followed up at 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* In early survivorship phase, defined as being post-surgery to ending of active treatment to 18 months post active treatment for stage 0-3 breast cancer (BCA)
* Reside in Southern California
* BCS treated at Kaiser, an health maintenance organization (HMO) provider, will be excluded since their SCP implementation project is underway
* BCS will not be excluded based on cancer treatments received or a history of diagnosis of mild depression, anxiety, and hypertension and diabetes
Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Pneumonia

The purpose of the study is to compare the clinical efficacy of amoxicillin given twice or three times a day to children with non-severe community-acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Children aged between 2 and 59 months
* Report of respiratory complaints
* Presence of pulmonary infiltrate on chest x-ray taken on admission and read by the pediatrician on duty

Exclusion Criteria:

* lower chest indrawing
* danger signs (inability to drink, convulsions, somnolence, central cyanosis, grunting in a calm child)
* diagnosed underlying chronic diseases (anatomic abnormalities of the respiratory tract, chronic pulmonary illness besides asthma, immunological defects, progressing neurological disorders, psychomotor retardation, heart disease with clinical repercussion, hemoglobinopathy, liver or kidney disease)
* severe malnutrition
* other concurrent infection
* hospitalization during the previous 7 days
* amoxicillin or similar antibiotic use during the last 48 hours
* allergy to amoxicillin
* history of aspiration
GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma

This study is designed to investigate:

* the interest of a new monoclonal antibody (GA101)versus rituximab
* the interest of PET to identify early responders

Patients will receive either rituximab (standard treatment), either GA101 (study treatment), according to the randomization arm.

The monoclonal antibody will be associated to a chemotherapy: CHOP or ACVBP according to site's choice.A PET scan will be done before inclusion, after 2 chemotherapy cycles, and after 4 chemotherapy cycles, to identify early patients responders, for who consolidation with ASCT is not required.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification)
* Baseline PET scan available with at least one hypermetabolic lesion
* Aged ≥ 18 years and ≤ 60 years
* Eligible for autologous stem cell transplant
* Patient not previously treated
* Age adjusted International Prognostic Index (aa-IPI) equal to 1, 2 or 3
* Life expectancy ≥ 3 months
* Negative HIV, HBV (anti-HBc negativity) and HCV serologies before inclusion
* Having signed a written informed consent
* Having ability and willingness to comply with study protocol procedures
* Men must agree to use a barrier method of contraception during the treatment period and until 3 months after the last dose of GA101 or rituximab, or ACVBP14 or CHOP14 chemotherapy, whichever is longer
* Women of childbearing potential must agree to use an adequate method of contraception, such as oral contraceptives, intrauterine device, or barrier method of contraception during the treatment period and until 12 months after the last dose of GA101, Rituximab, ACVBP14, or CHOP14 chemotherapy, whichever is longer

Exclusion Criteria:

* Any other histological type of lymphoma
* Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included
* Central nervous system or meningeal involvement by lymphoma
* Contra-indication to any drug contained in the chemotherapy regimens
* Poor cardiac function (LVEF \< 50%) on echocardiogram or MUGA scan
* Poor renal function (creatinine level \> 150\*mol/l or clearance \< 30ml/min), poor hepatic function (total bilirubin level \> 30µmol/l, transaminases \> 2.5 X maximum normal level) unless these abnormalities are related to the lymphoma
* Poor bone marrow reserve as defined by neutrophils \< 1.5 G/L or platelets \< 100 G/L, unless related to bone marrow infiltration
* Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
* Any serious active disease (according to the investigator's decision)
* Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy
* Pregnant or lactating women
* Adult patient under tutelage
* Prior history of Progressive Multifocal Leukoencephalopathy (PML)
Complicated Skin and Skin Structure Infections

The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are hospitalized males and females, aged 13 years or older, with clinical evidence of complicated skin and skin structure bacterial infection with material suitable for culture from 1 primary site of infections
* Within 72 hours before enrollment or at the time of enrollment, all subjects must provide an appropriate specimen for culture and susceptibility testing
* Subjects who have been given prior antibacterial therapy within 14 days of trial entry may be entered only if a culture is obtained showing persistence of a pathogen in blood or at the site of infection

Exclusion Criteria:

* Subjects with a known or suspected hypersensitivity to cephalosporins, penicillins, or carbapenems
* Subjects with a history of seizure disorders or subjects currently receiving antiepileptic medication
* Subjects with underlying infections or conditions which would interfere with evaluation of this study
Zenith TX2® Post-market Approval Study

The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or
* Descending thoracic aortic aneurysm with a history of growth greater than or equal to 0.5 cm within the previous 12 months; or
* Descending thoracic aortic degenerative or atherosclerotic ulcers greater than or equal to 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

* Age less than 18 years
* Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years)
* Pregnant, breast-feeding, or planning on becoming pregnant within 24 months
* Unwilling or unable to comply with the follow-up schedule
* Inability or refusal to give informed consent
* Simultaneously participating in another investigative device or drug study