cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device

This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).

The purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, physiological Diagnostic (PhD)which as been implemented in the PARADYM CRT Cardiac Resynchronization System with defibrillation capabalities (PARADYM CRT System,model 8770.

Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for implantation of a CRT-D device according to current available guidelines for cardiac resynchronization therapy
* Severe HF (NYHA Class III or IV) at the time of enrollment
* At least one HF-related event (as defined for primary objective) within the last 6 months before enrolment
* Subject continues to have heart failure symptoms despite receiving optimal medical therapy consistent with current practice guidelines for the pharmacological management of heart failure
* Scheduled for implant of a PARADYM 8770
* Signed and dated informed consent

Exclusion Criteria:

* Any contraindication for standard cardiac pacing
* Any contraindication for ICD therapy
* Abdominal implantation side
* Hypertrophic or obstructive cardiomyopathy
* Acute myocarditis
* Unstable coronary symptoms (unstable angina or myocardial infarction) within the last month
* Recent (within the last month) or planned cardiac revascularization or coronary angioplasty
* Correctable valvular disease that is the primary cause of heart failure
* Mechanical tricuspid valve
* Receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intra-venous infusion) more than twice per week
* Heart transplant recipient
* Renal insufficiency requiring dialysis
* Already included in another clinical study
* Life expectancy less than 12 months
* Inability to understand the purpose of the study or refusal to cooperate
* Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization
* Unavailability for scheduled follow-up at the implanting center
* Known sensitivity to 1 mg dexamethasone sodium phosphate (DSP)
* Under guardianship
* Age of less than 18 years
* Pregnancy (Women of childbearing potential should have a negative pregnancy test prior to enrollment)
An Intelligent Cardiopulmonary Rehabilitative System on Cardiopulmonary Fitness

Contemporary cardiopulmonary rehabilitation programs often utilize cycling ergometer, involving one-on-one heart rate monitoring by physiotherapists to ensure that patients reach the target training intensity during training sessions. However, the process is frequently described as monotonous and boring, resulting in early fatigue of therapists and patients as well as poor compliance, leading to undertraining and suboptimal outcomes.

This study aims to test the feasibility of the "Intelligent Cardiopulmonary Training System (ICRS)" and a novel indicator of measuring the adherence to training intensity. The ICRS was developed with the idea to provide machine-based supervision on the user's heart rate during training. It provides moderate-intensity continuous training with a cycling ergometer. This system automatically adjusts the paddling resistance according to the user's real-time heart rate, and helps to improve the user's adherence to pre-determined training intensity without trainer's watch. The automation of intensity adjustment has its potential for conditions in which supervision is not feasible.


Eligibility Criteria:
Inclusion Criteria:

1. Sedentary healthy people

Exclusion Criteria:

* Patients whose heart rate can not be used as the indicator of training intensity (eg, ar-rhythmia, atrial fibrillation, beta-blockers users)
* With any reason that the patient is not suitable to undergo
* Patients who are unable to do cycling due to musculoskeletal problems
* Patients who can not follow the instruction of trainers due to cognitive or emotional-problems.
* Patients whose medical condition is not unstable.
Efficacy of Repeated Low-Level Red-Light Therapy in Myopia Control

The purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren.

Low level light therapy (LLLT) is an innovative and non-invasive therapeutic treatment for a variety of eye diseases. Its potential mechanisms of improving choroidal metabolic rate and circulation may improve scleral hypoxia, thus slowing down the progression of myopia. The investigator's preliminary case-series study suggested that repeated low-level red-light therapy was effective in slowing myopia progression without any clinically observable side effects. Using a randomized clinical trial design, the purpose of this study is to determine if repeated low-level red-light therapy can slow myopia progression in Chinese schoolchildren. Study subjects will be randomly assigned to either the treatment group (receive repeated low-level red-light therapy) or the control group (wearing ordinary single vision lenses). Axial length and cycloplegic refraction will be monitored over one year (1st month, 3rd month, 6th month and 12th month), after which changes in axial length and refractive errors in the two groups will be compared. An interim analysis will be performed at the 3rd month, at which the data will be reported and presented. Appropriate adjustment of the p-value and decision on the continuation of the study will be made.

Eligibility Criteria:
Inclusion Criteria:

1. Age at enrolment: 8-13 years
2. Spherical equivalent refractions (SERs): -1.00 to -5.00 diopters (D)
3. Astigmatism of 2.50 D or less
4. Anisometropia of 1.5 D or less
5. Spectacle corrected monocular logMAR visual acuity (VA): 0 or better
6. Parents' understanding and acceptance of random allocation of grouping

Exclusion Criteria:

1. Strabismus and binocular vision abnormalities in either eye
2. Ocular abnormalities in either eye or other systemic abnormalities
3. Prior treatment of myopia control, e.g. drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc in either eye
4. Other contraindications in either eye
Characterization of the Microbiome in Cutaneous T Cell Lymphoma

Investigators plan to perform a pilot study that aims to characterize the microbiome of human cutaneous T cell lymphoma patients and compare this to the microbiome of age and sex matched controls.


Eligibility Criteria:
Inclusion Criteria:

* Group 1: Patients with stage IA-IIA cutaneous T cell lymphoma
* Group 2: Patients with stage IIB and above cutaneous T cell lymphoma
* Group 3: Patients with CD30+ lymphoproliferative disorder including lymphomatoid papulosis and cutaneous anaplastic large cell lymphoma
* Group 4: Patients with plaque psoriasis with BSA\>5% on routine phototherapy per standard of care
* Group 5: Patients with moderate to severe atopic dermatitis on routine bleach bath therapy per standard of care
* Group 6: Healthy individuals without the above skin conditions, similar age and sex distribution to the patients with cutaneous T cell lymphoma
* All Groups: subjects who are age 18-89 years of age at time of enrollment
* All Groups: Subjects who are able and willing to give informed consent for this study and the Dermatology Tissue Acquisition and Biorepository (STU00009443).

Exclusion Criteria:

* All Groups: Subjects who are younger than 18 years of age or older than 90 years of age
* All Groups: Subjects who are unable to give consent
* Patients currently on systemic antibiotics or recent (within past 4 weeks) exposure to systemic antibiotics
* We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.
Standard Percutaneous Nephrolithotomy Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL

The purpose of the study is to assess and compare the efficacy and morbidity standard percutaneous nephrolithotomy with tubeless PNL. A total of approximately 60 patients will be enrolled. Patients will be randomized to one of four groups: standard percutaneous nephrostomy, double-J ureteral stent, open-ended ureteral catheter and no nephrostomy or ureteral stent/catheter. Primary Outcome Measures will include length of procedure and estimated blood loss. Post-operative analgesic use (both parenteral and oral), pain scores, time to ambulation, time to oral intake, and pain scores will also be recorded. Time to nephrostomy tube removal, external ureteral and Foley catheter removal and patient discharge from the hospital will also be recorded. Incidence and type of post-operative complications will also be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Planned single tract percutaneous nephrolithotomy
* General anesthesia for percutaneous nephrolithotomy

Exclusion Criteria:

* Age\<18 years old
* Known residual calculi at the end of the procedure
* Significant hemorrhage during procedure
* Bleeding disorder (This does not include patients taking anti-coagulants as these are stopped prior to surgery.)
* Prisoners
* Inability to give informed consent
* Pregnant females
* Solitary kidney
* Transplant kidney
* Pleural effusion during procedure requiring drainage
* Perforation of renal collecting system during procedure
* Incomplete stone clearance
* Chronic pain syndrome
Intraoperative Echocardiographic Evaluation of Pulmonary Vein Velocities and Outcomes in Lung Transplantation

This study will evaluate if an association exists between levels of blood flow through the pulmonary veins and the incidence of graft dysfunction post operatively.

Lung transplantation surgery can be fraught with a multitude of early as well as delayed complications leading to increased morbidity and mortality. During lung transplant surgery, trans-esophageal echocardiography (TEE) is routinely used to identify cardiac anatomy and measure blood flow through the pulmonary veins. This blood flow is assessed both before and after the lung has been transplanted. Blood flow through these small caliber vessels can be impacted by many variables with a resulting reduction in blood circulating to the lung, although currently there is no agreement on an acceptable level of flow. This study will look at retrospective data from lung transplant surgeries undertaken at this institution since Jan 1st 2014 until November 18th 2016 with the goal of determining if an association exists between levels of blood flow through the pulmonary veins and the incidence of graft dysfunction post operatively.

Eligibility Criteria:
Inclusion Criteria:

1. All adult patients ≥ 18 years of age
2. Having undergone single or bilateral lung transplantation surgery at Ohio State University Wexner Medical Center between January 1st 2014 and November 18th 2016

Exclusion Criteria:

1. Patients ≤ 18 years of age
Home-Based Action Observation Training for Chewing and Swallowing Function

The goal of this clinical trial is to investigate the effects of home-based Action Observation Training (AOT) applied together with Functional Chewing Training (FuCT) on chewing and swallowing functions and feeding behavior in children with Cerebral Palsy (CP) who have chewing disorders. The main questions it aims to answer are:

* Is the application of Home-Based AOT together with FuCT effective on chewing function in children with CP?
* Is the application of Home-Based AOT together with FuCT effective on swallowing function in children with CP?
* Is the application of Home-Based AOT together with FuCT effective on feeding behavior in children with CP? Within the scope of the study, children with CP will be divided into two groups as the study group and the control group. All groups will implement FuCT routines, comprising 5 sets per day, 5 days a week, for 12 weeks. Additionally, the study group will be included in an AOT program, conducted via telerehabilitation, for 1 set per day, 3 days a week, for 12 weeks, with the guidance of a physiotherapist. All children with CP will be evaluated at the beginning, after 6 weeks, and at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Cerebral Palsy,
* Age between 6 and 18,
* IQ level of 70 or above,
* Having complaints related to chewing function and inability to manage solid food intake
* Feeding orally.

Exclusion Criteria:

* Having a neurodegenerative disease other than Cerebral Palsy
* Having additional chronic illnesses such as systemic diseases, cancer, kidney diseases, gastrointestinal system diseases, etc., that may affect nutritional status,
* Experiencing visual or hearing impairment,
* Using any medication and/or oral device that may affect chewing performance,
* Having received previous chewing and/or swallowing training.
Emergency/Compassionate Use - Membranous VSD Occluder

Emergency/Compassionate use of the AMPLATZER Membranous VSD Occluder


Eligibility Criteria:
Inclusion Criteria:

* Emergency/compassionate use for patients not meeting the inclusion critera for the AMPLATZER Membranous VSD clinical trial
Effect of Vitamin D in Diets of Preterm Infants

Transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation at birth. However, few data are available related to follow-up of infants receiving these formulas who were 28-34 weeks gestation at birth.

Primary hypothesis: Provision of supplemental vitamin D to a transitional formula will lead to higher serum 25-hydroxyvitamin D (25-OHD) levels and no infant with a serum 25-OHD less than 20 ng/mL when assessed at approximately 52 weeks post-menstrual age (PMA).


Eligibility Criteria:
Inclusion Criteria:

* Born at 28 0/7 to 34 6/7 weeks PMA and 1000-2250 g birth weight.
* Currently 34 0/7 to 38 6/7 weeks post-menstrual age at time of consent.
* Born at Texas Children's (including Pavilion for Women) or Methodist campus hospitals or transferred within 48 hours of birth.
* Care expected to be provided at one of these institutions until discharge home.
* Any initial feeding will be permitted, but expected to transition to primarily (80% of feeds or up to 2 breast milk feeds per day) infant formula by 38 6/7 weeks PMA or hospital discharge, whichever comes first.
* Able to tolerate 22 kcal/oz transitional formula and receive a volume of at least 130 mL/kg/day total feeding volume.
* No longer receiving any form of mechanical ventilation or diuretics. Low flow nasal cannula (\< ¼ LPM) will be permitted if it is anticipated this will be discontinued before hospital discharge.

Exclusion Criteria:

* Bronchopulmonary dysplasia (BPD) requiring daily use of diuretics beyond 38 6/7 weeks PMA (or hospital discharge, whichever comes first) and \> 22 kcal/oz concentration formula beyond 38 6/7 weeks PMA.
* Major congenital anomalies, history of proven Stage 2 or above NEC, or severe feeding intolerance.
* Caloric density greater than 22 kcal/oz.
* Higher order multiples (However, twins are acceptable. Twins will be randomized together. Only data from 1 twin picked at random will be used in the final analyses.)
Masitinib in Severe Indolent or Smoldering Systemic Mastocytosis Unresponsive to Optimal Symptomatic Treatment

The purpose of this study is to evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients suffering from smouldering or indolent systemic mastocytosis with severe symptoms of mast cell mediator release, unresponsive to optimal symptomatic treatment.

Masitinib is a selective tyrosine kinase inhibitor that modulates mast cell activity via inhibition of c-Kit, Lyn and Fyn kinase signaling pathways. This is a multicenter, randomized, double-blind, placebo-controlled, 2-parallel-group, trial comparing oral masitinib versus placebo in the treatment of patients suffering from smouldering or indolent systemic mastocytosis with severe symptoms of mast cell mediator release (also referred to as handicaps), unresponsive to optimal symptomatic treatment. The treatment period is 24 weeks. Participants receive masitinib (3.0 mg/kg/day), given orally twice daily, with a dose escalation to 4.5 mg/kg/day after 4 weeks of treatment, followed by dose escalation to 6.0 mg/kg/day after 4 weeks of treatment. Each ascending dose titration is subjected to a safety control.

Eligibility Criteria:
Inclusion Criteria:

1. Patient with one of the following documented mastocytosis subtypes (variants): Smouldering Systemic Mastocytosis, Indolent Systemic Mastocytosis
2. An excess of mast cells or a presence of abnormal mast cells in at least two organs (among skin, bone-marrow and GI Tract).
3. Patient with documented systemic mastocytosis and evaluable disease based upon histological criteria
4. Patient with documented treatment failure of his/her symptom(s) (within the past 2 years) with at least two of the symptomatic treatments used at optimized dose: Anti H1, Anti H2, Proton pump inhibitor, Antidepressants, Cromoglycate Sodium, Antileukotriene.
5. Patient with severe symptoms of mastocytosis over the 14-day run-in period including at least one among pruritus, flushes, and depression: pruritus score ≥ 9, number of flushes per week ≥ 8, Hamilton rating scale for depression (HAMD-17) score ≥ 19.

Exclusion Criteria:

1. Patient with one of the following mastocytosis: Cutaneous Mastocytosis, Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD), Mast cell leukemia (MCL), Aggressive systemic mastocytosis (ASM)
2. Previous treatment with any Tyrosine Kinase Inhibitor
3. Treatment with any investigational agent within 8 weeks prior to screening.
Buccal Mucosal Graft for the Repair of Iatrogenic Pelviureteric Junction Obstruction or Ureteric Stricture.

Prospective study to evaluate the safety and efficacy of using buccal mucosal graft for repairing complex cases of iatrogenic pelvi ureteric junction obstruction and long segment ureteric stricture disease.

A graft of buccal mucosa will be used to augment either the narrow unhealthy pelviureteric junction or a narrow long segment of the ureter.

after freeing the narrowed part, a posterior incision will be made in the ureter or renal pelvis then the graft will be implanted on the psoas muscle using interrupted sutures in a position the allows easy anastomosis to the ureter or renal pelvis.

Alternatively a lateral incision in the renal pelvis or the ureter may be done for the graft anastomosis and then surrounded with omenal flap to ensure a good blood supply for the graft.

Eligibility Criteria:
Inclusion Criteria:

- any patient with iatrogenic pelviureteric junction obstruction or long segment ureteric stricture

Exclusion Criteria:

* elderly patients unfit for general anaesthesia.
HIV Reservoir Dynamics After Switching to Dolutegravir in Patients on a PI and 2 NRTI Based Regimen

The purpose of this study is to assess changes in viral reservoir after changing IP/r to dolutegravir in HIV-1 infected patients maintaining undetectable viral load on Antiretroviral Therapy (ART).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients infected with HIV-1
* HIV RNA \<50 copies / mL for ≥ 1 year with stable ART regimen (≥ 3 months) based on 2 NRTI and PI (Fosamprenavir, atazanavir, lopinavir or darunavir) boosted with 100 mg of ritonavir, or atazanavir (400 mg / d) not boosted with ritonavir, if the 2 NRTIs are abacavir + Lamivudine
* CD4 + lymphocytes \> 200 / mm3
* Signature of voluntary informed consent
* A woman may be eligible to enter and participate in the study if:

  1. No reproductive potential-defined as post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of getting pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy.
  2. It is in childbearing age with a negative pregnancy test on the day of screening and on Day 1 and agrees to use one of the following contraceptive methods to prevent pregnancy:

     * Complete abstinence from penis-vaginal from 2 weeks prior to administration of investigational product, throughout the study, and for at least 2 weeks after discontinuation of all study drugs;
     * Double barrier method (male / spermicidal condom, male condom / diaphragm, diaphragm / spermicide);
     * Any intrauterine device (IUD) with published data showing that the expected failure rate is \<1% per year (not all IUDs meet this criterion)
     * Male sterilization confirmed before the entry of the female subject in the study, and that this man is the only sexual partner for women
     * Approved hormonal contraception
     * Any other method with published data show that the expected failure rate is \<1% per year.

Exclusion Criteria:

* Prior virologic failure with an integrase inhibitor
* Acquired Immune Deficiency Syndrome (AIDS)-defining illness in the last 48 weeks
* Glomerular filtration rate \<50 mL / min, estimated by Chronic Kidney Disease Epidemiology (CKD-EPI) formula
* Alanine aminotransferase (ALT) ≥5 times the Upper Limit Normal (ULN) or ALT ≥3 X ULN and total bilirubin ≥1,5 ULN (with\> 35% direct bilirubin) and / or unstable liver disease (with the presence of ascites, hepatic encephalopathy, hypoalbuminemia, esophageal varices or persistent jaundice) or known biliary disorders excluded Gilbert syndrome or asymptomatic lithiasis) .
* Positive for hepatitis B (HBsAg +) or need for Hepatitis C Virus (HCV) treatment during the study .
* Subjects with severe hepatic impairment (Child Pugh Class C).
* Patients unable to understand the study protocol or any other condition that in the investigator's opinion could jeopardize compliance with the protocol
* Pregnant or breast-feeding
* History or presence of allergy to any of the study drugs or their components
The Effect of Partial and Complete Sleep Deprivation on Heat Tolerance

The purpose of the present study is to evaluate the effect of partial and complete sleep deprivation on exercise heat tolerance. Twelve healthy young male volunteers will participate in the study. They will arrive to our lab four times, in each visit the will undergo VO2 test and Heat Tolerance Test (HTT) after sleeping different amount of hours.

The volunteers will arrive to our lab fout times- During their first visit they will go through a VO2 max test in order to evaluate their aerobic fitness, and their physiological efficiency will be measured. During their second visit they will go through an exercise heat tolerance test according to our validated protocol after a full night sleep. During the third and fourth visit they will go through an exercise heat tolerance test and a measurement of their physiological efficiency after a partial and complete sleep deprivation, respectively. The physiological tests will take place in the heat chamber that is located at the Heller Institute of Medical Research. The results will be then analyzed, and a comparison between the physiological measurements during the heat tolerance tests and the physiological efficiency tests after the various sleep conditions will be performed.

Eligibility Criteria:
Inclusion Criteria:

* age 18-30
* healthy
* after medical checkup
* after signing concent form

Exclusion Criteria:

* heart disease
* respiratory disease
* baseline bp above 140/90 mmHg
* sleep disorders
* diabetes
* anhydrosis
* skin disease
* acute illness