cyrilzakka/clinical-trials huggingface dataset:
A Trial to Evaluate the Safety and Efficacy of a Fully Degradable Ventricular Septal Defect (VSD) Closure

The purpose of this clinical trial is to verify the safety and effectiveness of the Fully Absorbable VSD Occlusion System and VSD Occlusion System produced by Shanghai shape memory alloy materials co., LTD. Clinical trials are designed as prospective, multicenter, randomized controlled, noninferiority clinical trials. Prospective randomized multicenter trial involving about 108 subjects will be enrolled in 4 centers. Patients will be randomized to two groups in equal proportion (54 in each). The success rate of occlusion at 6 months after operation is the main evaluation index in this clinical trial.

1. This is a prospective, multicenter, randomized and noninferiority clinical trial, which is designed to compare the effectiveness and safety with the fully absorbable ventricular septal defect (VSD) occlusion system and VSD occlusion system produced by Shanghai shape memory alloy materials co., LTD.
2. This trial will recruit about 108 subjects from 4 centers. Patients will be randomized to two groups in equal proportion (54 in each). The proposal recruiting period is 12 months and the follow-up will be performed at 1 month, 3 months and 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects and/or their legal guardians will be informed of the nature of this study and agree to participate in this clinical trial in accordance with all terms of this study.Signed the informed consent approved by the ethics committee, agreed to accept the postoperative treatment program, and completed the follow-up and related examinations as required by the follow-up;
2. Aged from 1 to 60 years old, weight more than 10 kg, male or non-pregnant women;
3. VSD effective shunt ≥3mm, ≤14mm;
4. Distance between the edge of defect and the right aortic valve is more than 3mm, no aortic valve prolapse or moderate aortic regurgitation.

Exclusion Criteria:

1. Irreversible pulmonary vascular disease;Severe pulmonary hypertension with bidirectional shunt;
2. Bleeding disorders or known clotting disorders (including heparin-induced thrombocytopenia),contraindications to antiplatelet therapy, or rejection of transfusions;
3. Sepsis or severe infection within 1 month prior to occlusion;
4. Patients with thrombosis at the occluder placement and venous thrombosis at the catheter insertion site;
5. Cardiac malformation dependent on ventricular septal defect (VSD);
6. Not suitable for treatment with this product.
Evaluating The Efficacy Of A Mind-Body Intervention In Overcoming Opioid Addiction

This study demonstrates the feasibility, acceptability of SKY program as an adjuvant therapy for American population suffering with OUD through a pilot program in Columbus, Ohio. The aim of this study is to evaluate the SKY program as an adjuvant therapy to treat opioid addiction.

This research proposal aims to test the feasibility, acceptability and efficacy of SKY (Sudarshan Kriya Yoga) program, a mind-body intervention, as an adjuvant therapy for people suffering with opioid use disorder (OUD), in Columbus, Ohio. Previous research carried out in India in 2015, has demonstrated that SKY significantly improved the quality of life among people with OUD, however, the suitability, acceptability of SKY program has not been tested among American population. SKY differs from mindfulness and other meditation processes in that, it is a more physiological, rather than cognitive process. It involves controlled breathing techniques that can be easily mastered, and do not require mental effort. The investigator's goals are to a) DEMONSTRATE the feasibility, acceptability and efficacy of SKY program as an adjuvant therapy for American population suffering with OUD. Studies will be carried out in OUD subjects at Mary Haven clinic in Columbus. The efficacy of SKY will be measured using psychometric questionnaires. Feasibility and acceptability will be measured by attendance and attrition.

Eligibility Criteria:
Inclusion Criteria:

* The proposed participants are currently residents of Mary Haven
* Are currently undergoing addiction treatment which may include medication assisted treatment as well as counseling.
* The intervention is designed for adults, therefore, only individuals 18 and above will be included in the study.

Exclusion Criteria:

* Pregnant women who are beyond their first trimester are excluded from the study as the program requires breathing techniques that are not recommended for pregnant women.
* Also, patients diagnosed with schizophrenia and bipolar disorder will also be excluded from the study, as SKY program is not suitable for people with these conditions.
Development and Improvement of an Acceptance and Commitment-based Treatment for the Prevention of Chronic Pain After Total Knee Arthroplasty

Reducing the incidence of chronic post-surgical pain after Total Knee Arthroplasty (TKA) is paramount. NOPAIN, a technology-enhanced Acceptance and Commitment-based treatment, will be developed, tested and improved for this purpose. The feasibility of NOPAIN will be evaluated in a small sample of patients listed for TKA at the IRCCS Istituto Auxologico Italiano. Potential pre-surgical and post-surgical predictors of non-response to treatment will be measured and tested using a machine learning algorithm. The results of this study will be employed to improve the content of NOPAIN or for identification of criteria for patient selection. Finally, a randomized controlled clinical trial will be performed. Patients listed for TKA will be randomized to Treatment As Usual (TAU) or to NOPAIN+TAU. Primary outcome will be time to complete pain relief, secondary outcomes will include subjective and objective measurements of quality of life and functional recovery.


Eligibility Criteria:
Inclusion Criteria:

* having an age between 18 and 80 years
* having a diagnosis of OA as determined by medical record review
* having undergone a Total Knee Arthroplasty

Exclusion Criteria:

* Inability to provide informed consent
Efficacy/Safety Pilot Study to Investigate Iberogast N's Efficacy in Mild to Moderate Colitis Ulcerosa Patients

The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in patients with mild to moderate ulcerative colitis in an acute flare.


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild to moderate active ulcerative colitis (UC), i.e. Clinical Activity Index (CAI) ≥ 5 up to 10 points (including)
* Patients in whom the active UC is treated independent from any participation in the current study with oral mesalazine at least 14 days up to maximal 28 days before Visit 2
* Age between 18 to 80 years (including)
* UC may reach from left-sided colitis to pancolitis

Exclusion Criteria:

* Severe forms of UC (CAI \> 10)
* Crohn's disease, infectious colitis or undetermined colitis
* Steroid dependence and steroid resistance
* Concomitant medication with oral steroids, oral or topic budesonide, biologicals, immune modifiers, immunosuppressants
* Antibiotics at screening visit, during the course of the study a short-term use in non-colitic afflictions is allowed, and is documented
* Prior medication with biologicals, immune modifiers and immunosuppressants \< 3 month wash-out
* Total colectomy
* Known allergies to components of STW5-II
* Severe allergic diathesis
* Topical mesalazine application
* Known intolerance to azo dyes E110 and E151
Yoga Poses and Breath Control Cardiovascular Changes in Hypertensive Post-Menopause Women

Autonomic and endothelial imbalance in post menopause women raise the need to manage cardiovascular risk. Yoga poses and breathing control present controversial results on prevention and treatment of hypertension.. The aim of this study is to compare the effect of 12 week intervention based on yoga poses and their muscle contractions known as bandhas (pelvic floor, core and throat/neck) and ujjayi pranayama (victorious breath) on autonomic modulation, endothelial function, arterial stiffness, aerobic capacity and cognitive function of hypertensive post-menopausal women.

Abstract: Increased hypertension prevalence in post-menopausal women, along with cardiovascular damages such as autonomic and endothelial imbalance raise the need to include non-pharmacological interventions, such as yoga in the management of cardiovascular risk. Yoga practices are composed by several variations of techniques including physical postures (yoga poses and specific muscles contractions), breathing control (pranayamas), relaxation and meditation, beside others.The effects of each of these compounds has not been elucidated up to date and can be considered confounding effects for commonly named "yoga programs". Existing yoga based data are controversial about its effect on prevention and treatment of hypertension and point to poor methodological standards of most studies. Considering the effects of comparable interventions such as slow breathing on improving autonomic modulation, resistive and isometric exercise on endothelial function, and associations of flexibility with arterial stiffness, it´s licit to search for specific effects of yoga compounds. Thus, the aim of this study is to compare the effect of 12 week intervention based on yoga poses including their muscle contractions known as bandhas (pelvic floor, core and throat/neck), ujjayi pranayama (victorious breath) and stretching/ flexibility on autonomic modulation, endothelial function, arterial stiffness, aerobic capacity and cognitive function of hypertensive post-menopausal women.

Eligibility Criteria:
Inclusion Criteria:

* FSH\>35mui/ml
* minimum 12 months amenorrhea
* sedentary life style (less than 150 minutes per week of exercise)
* never been in yoga -practicing (self declaration)
* Blood pressure \> 140/90 or in continuous use of medication (diuretics,Ca+ channel inhibitors, ACE inhibitors)

Exclusion Criteria:

* Use of Betablockers
* recent cardiovascular events or surgery
* renal alterations
* respiratory and/or motor pathologies
* smoking
* BMI\>34,9
Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

A phase 2a, multicenter, randomized, double-blind, placebo-controlled study in adults with stable angina to evaluate the effect of erenumab (AMG 334) compared to placebo on exercise time during an exercise treadmill test.


Eligibility Criteria:
Inclusion Criteria

* History of chronic stable angina or at least 3 months prior to screening, with at least 1 angina episode per month
* Ischemic heart disease documented by myocardial infarction, coronary angiography or a revascularization procedure
* Receiving stable doses of cardiac medication
* Completes 2 exercise treadmill tests during screening meeting protocol requirements

Exclusion Criteria:

* Participating in another investigational study
* Current or prior malignancy within 5 years of randomization
* Known sensitivity to any components of the investigational product
* Not able to complete all protocol required study visits
* Having the following within 3 months prior to or during screening: Unstable angina or acute coronary syndrome, transient Ischemic attack (TIA) or stroke, revascularization procedure, or instability in ST-segment depression between screening exercise treadmill tests, as assessed by the core electrocardiograph (ECG) laboratory
Extension Study of Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

To assess the safety and tolerability of long-term pimavanserin treatment in subjects with major depressive disorder and inadequate response to antidepressant treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Completed the antecedent study, Study ACP-103-054 or Study ACP-103-059
2. May benefit from longer term therapy with open-label pimavanserin treatment
3. If the subject is female, she must not be pregnant or breastfeeding. She must also be of nonchildbearing potential OR must agree to use acceptable methods of contraception

Exclusion Criteria:

1. Is determined to be inappropriate for the study
2. Has developed neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that would affect the patient's ability to participate in the program

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
GIRH Chronic Obstructive Pulmonary Disease Observational Study

The purpose of this study is to establish the large COPD cohort and biological database in China, aiming for precision medicine to optimize diagnosis and treatment choices.


Eligibility Criteria:
Inclusion Criteria:

-Aged 40-70 years COPD group: baseline post-bronchodilator FEV1/FVC \< 0.7 Signed informed consent obtained prior to participations with the ability to comply with protocol and be available for study visits over 5 years

Exclusion Criteria:

* Acute exacerbation in the past 3 months Having other respiratory diseases with massive lung tissue destruction such as severe bronchiectasis and tuberculosis, etc The usual criteria of serious uncontrolled diseases thoracic or abdominal surgery in the last 3 months eye surgery in the last three months retinal detachment myocardial infarction in the last 3 months admission to hospital for any cardiac condition in the last month heart rate over 120 beats per minute antibacterial chemotherapy for tuberculosis pregnant or breast feeding
Spa Therapy for Upper or Lower Limb Lymphoedema

THERMOEDEME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial.

The aim of this study is to evaluate effects of spa therapy in phlebology with a therapeutic education program in daily life of patients suffering lymphoedema.

Lymphoedema is a chronic disease related to an insufficiency of the lymphatic system, which most often affects the limbs. Secondary forms are the most common, particularly those following surgical and radiotherapy treatments for cancer, the most classic being the post-therapeutic large arm of breast cancer.

The lymphoedema is a traditional phlebology indication in spa therapy. The spa therapy linked with therapeutic education could constitute a favorable environment for the treatment of lymphoedema.

The primary endpoint is the comparison of the rate of patients improved from baseline to 6 months on LMS27 (upper limb lymphoedema) or LYMQOL-LEG (lower limb lymphoedema) (Improvement is defined as 7 points between baseline and 6-month follow-up).

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and older
* available for a spa treatment (phlebology indication) during 18 days and a follow up period of 15 months
* with permanent lymphoedema of the upper or lower limb (2 ou 3 stade of International Society for Lymphology scale)
* voluntary to participate to the study, informed consent form signed after appropriate information
* affiliation to the social security system or equivalent

Exclusion Criteria:

* cancer undergoing chemotherapy and radiotherapy treatment in primary phase
* the baseline score of LMS27 or LYMQOL-LEG \> 79
* pain of upper limb linked with a radical plexitis
* contra-indication of spa treatment (cancer in progress, psychiatrics disorders, immunodeficiency)
* Erysipelas case history in the last 6 months or pachyderma and lymphangiectasia
* no previous spa treatment for upper limb lymphoedema during the spa year
* risk of intensive treatment in the next 6 months
* subject participating to an other clinical study interventional
* pregnancy, parturient or breast feeding
ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors

This is an open-label dose escalation study designed to evaluate the safety and pharmacokinetics of ABBV-085 and determine the recommended Phase 2 dose (as monotherapy or in combination with standard therapies) in subjects with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
3. Participants must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens:

   - Participants with non-evaluable or non-measurable cancer are eligible if they have a confirmed increase in tumor antigens \>=2 x upper limit of normal (ULN).
4. All participants must consent to provide archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue and on study biopsies.
5. Participant has adequate bone marrow, renal, hepatic and cardiac function.
6. Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment.

Exclusion Criteria:

1. Participant has received anticancer therapy or any investigational therapy within a period of 21 days prior to the first dose of ABBV-085.
2. Uncontrolled metastases to the central nervous system (CNS). Participants with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 4 weeks after definitive therapy and have not used steroids for at least 4 weeks prior to first dose of ABBV-085.
3. Unresolved adverse events \>= Grade 2 from prior anticancer therapy, except for alopecia.
4. Participant has ongoing hemolysis.
5. Major surgery within \<=28 days prior to the first dose of ABBV-085.
6. Clinically significant uncontrolled condition(s).
7. Participant has history of major immunologic reaction to any auristatin-based and /or Immunoglobulin G (IgG) containing agent.
Effect of Maraviroc on Metabolic Function in Obese Subjects (Phase I)

The purpose of this study is to determine the effect of maraviroc therapy in obese insulin resistant subjects on:

1. Plasma triglyceride concentration
2. Plasma HDL-cholesterol and LDL-cholesterol concentrations
3. Plasma markers of cardiometabolic risk and inflammation

The purpose of this study is to determine, in obese insulin resistant subjects, the effect of maraviroc therapy, a selective antagonist of the human chemokine receptor CCR5, on:

1. Plasma triglyceride concentration
2. Plasma HDL-cholesterol and LDL-cholesterol concentrations
3. Plasma markers of cardiometabolic risk and inflammation

Eligibility Criteria:
Inclusion Criteria:

* obese (body mass index (BMI) between 30 and 45.9)
* increased plasma triglyceride concentrations (150-400 mg/dL)

Exclusion Criteria:

* active or previous infection with hepatitis B or C
* history of alcohol abuse
* current alcohol consumption (\>20g/day)
* severe hypertriglyceridemia (\>400 mg/dL)
* active peptic ulcer disease
* diabetes
* pregnant or lactating
* take statins, fibrates, niacin, moderate to strong Cyp3A4 inhibitors or inducers, or any other medication that might confound interpretation of the study results will be excluded.
Study of Effects of Low Level Laser Therapy in the Physical Training and the Muscle Responses in Humans.

The hypothesis of this study is that a chronic program of physical strength

training, associates to effects of low level laser therapy (LLLT) can,

possibly, provide changes in genic expression of muscle and to promote an

enhancement of anaerobic muscle performance in humans.


Eligibility Criteria:
Inclusion Criteria:

* healthy young male volunteers;
* non-athletic physical activity;
* Body Mass Index (BMI) under 26;
* no prescription medicine or dietary supplement use (such as muscle mass builders.

Exclusion Criteria:

* metabolic disease;
* joint, bone and muscles of lower limbs with any disease
Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases

This study is being done to determine the mechanism(s) contributing to the onset of symptoms (i.e. shortness of breath and/or palpitations) as well as changes in heart structure in patients with congenital heart disease (CHD)


Eligibility Criteria:
Inclusion Criteria:

* Moderate (or greater) PR based on quantitative Doppler echocardiography.
* Repaired TOF
* Congenital Heart Disease diagnosis including but not limited to Ebstein's anomaly, coarctation of the aorta (COA), Fontan palliation, transposition of the great arteries, congenitally corrected transposition of the great arteries.

Exclusion Criteria:

* Pregnant Women
* Unable to undergo CMRI
Investigation of the Suburothelial Myofibroblast Network and of Smooth Muscle Function and Control in the Human Urinary Outflow Tract

The aim is to find out if adreno-muscarinic synergy is present also in human tissues of the urinary outflow tract that have a dual adrenergic-muscarinic receptor fitting. To further characterise morphology and function of the suburothelial myofibroblast network in the human bladder outlet.


Eligibility Criteria:
Inclusion Criteria:

Tissue will be collected from the operation theatre only after having obtained the patient´s consent and in strictest accordance with histopathological requirements, i.e. after assessment of resection margins. It might be necessary to retrieve the tissue from the pathologist after first pathological assessment is completed. Tissue will be placed in Tyrode´s solution, gassed with 95 % O2 and 5 % CO2, for functional and RT-PCR or Western blot experiments, or in OCT (optimal cutting temperature) compound, snap-frozen in liquid nitrogen, and stored in a -80°C freezer until cutting for immunohistochemical experiments.

Exclusion Criteria:

None.
Molecular Determinants of Acquired Clinical Resistance to Crizotinib in Non-small Cell Lung Cancer Harboring a Translocation or Inversion Event Involving the ALK Gene Locus

The purpose of this study is to try to learn more about how small molecule kinase inhibitor medications work in treating lung cancer. Crizotinib (PF-02341066) is a drug that has been shown to shrink tumors in some patients with lung cancer. While the investigators know how this drug works to stop the growth of tumors that depend on change in the gene named ALK (also called EML4-ALK), the investigators do not know why the drug stops working. The investigators would like to examine the tumor to help us better understand why crizotinib has stopped working as well as it once did. The tumor will be examined with multiple tests to look for the reason that crizotinib stopped working.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Histologically proven diagnosis of NSCLC at MSKCC Tumor positive for a translocation or inversion event involving the ALK gene locus
* Clinical response to treatment with crizotinib as defined by either:

Radiographic partial or complete response defined by RECIST or WHO

OR:

Radiographic stable disease for at least 8 weeks

* Radiographic progression of disease amenable to biopsy while on treatment with crizotinib as defined by RECIST or WHO
* Signed informed consent

Exclusion Criteria:

* Deemed by their treating physician to be medically unfit for biopsy
* Women who are pregnant or breast-feeding