cyrilzakka/clinical-trials huggingface dataset:
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life.

1. Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care?
2. Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?

REHAB Fontan Failure is a a multi-center, non-blinded, randomized clinical trial evaluating the effect of cardiac rehabilitation compared to usual care on exercise tolerance among adults with Fontan failure. Eligible study subjects will be identified from clinical chart review and study informational fliers will be sent to Adult Congenital Heart Disease (ACHD) cardiologists at all centers. Fontan failure patients being evaluated for outpatient care at ACHD centers and meeting eligibility criteria will be enrolled and randomly assigned to either cardiac rehabilitation or usual clinical care.

Eligibility Criteria:
Inclusion Criteria:

* Fontan failure, defined as history of a Fontan procedure and at least one of the following: systemic ventricular EF \<50% (by echocardiography, cardiac magnetic resonance imaging, or computer tomography), protein losing enteropathy, plastic bronchitis, chronic loop diuretics prescribed by ACHD Cardiologist, and/or peak VO2 \< 50% predicted (by FRIEND equation)
* Age \>= 18 years old

Exclusion Criteria:

* Inotrope-dependence
* Symptomatic, uncontrolled arrhythmias
* Pregnancy
* Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation
* Inability to comply with the protocol
* Recent (\<3 months) planned Fontan pathway percutaneous or surgical intervention
* Resting hypoxemia with baseline oxygen saturation \<80%
The Effects of Music Therapy on Women's Anxiety Before and During Cesarean Delivery

The purpose of the study is to determine if listening to your choice of music with a portable mp3 player before and after a cesarean section for delivery of a baby will decrease the patient's anxiety level.

Music has been suggested and evaluated as a therapeutic intervention to reduce preoperative anxiety for surgical patients. Music intervention in the immediate preoperative period may be effective in lowering anxiety levels during Cesarean delivery. If this investigation shows that music intervention before and after Cesarean delivery reduces anxiety levels, this intervention can be integrated into future operative care for women having scheduled or emergency Cesarean deliveries. Music therapy could be expanded to included patients undergoing other surgical procedures under regional anesthesia. The effect of reducing anxiety levels could aid in lactation initiation and improve infant bonding in new mothers, but it could also shorten postoperative recovery time for all surgical patients.

Eligibility Criteria:
Inclusion Criteria:Women age 18 and older with a history of one prior Cesarean delivery that are scheduled for a repeat Cesarean delivery under regional anesthesia, or women who are undergoing a primary cesarean section will be eligible to participate.

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Exclusion Criteria:Women with cardiovascular disease, chronic hypertension, insulin dependent diabetes mellitus, multiple gestation pregnancies, psychiatric disorders, and fetal anomaly.

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Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis

Background: Both endoscopic variceal ligation (EVL) and propranolol are valuable methods for secondary prophylaxis of variceal bleeding. Addition of ISMN to propranolol improves the efficacy of drug therapy. It is hypothesized that a combination of EVL and portal pressure reducing drugs should significantly be better than EVL alone.

Patients and Methods: Patients with history of variceal bleed were randomized to EVL plus drugs (propranolol and ISMN) or EVL alone. EVL was repeated every 3-4 weeks until variceal eradication. Propranolol dose was adjusted to reduce the resting heart rate to 55 bpm. Dose of ISMN was 40 mg/d. Primary end points were rebleed or death. Secondary end points included complications of portal hypertension and the development of serious adverse effects to therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to G B Pant Hospital, New Delhi, with history of hematemesis and/or melena and proven to have esophageal varices as the bleeding source on upper GI endoscopy were included in the study.

Exclusion Criteria:

* A history of undergoing endoscopic sclerotherapy (EST), EVL, or cyanoacrylate injection;
* A history of surgery for portal hypertension;
* Coexisting malignancy;
* Severe cardiopulmonary or renal disease;
* A history of severe side-effects or contraindications to beta-blockers like bronchial asthma, uncontrolled diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, arterial hypotension (systolic blood pressure \< 100 mm Hg), bradycardia (basal heart rate \<55 beats per minute), or complete heart block; and
* Refusal to give consent to participate in the trial.
Predicting Responses to Exhausting, Prolonged, and Repeated Exercise Demands (PREPARED) for Heat

The overall goal of this project is to identify a work/rest cycle that allows for faster mission completion needed in emergency situations, compared to current Army heat guidance, while mitigating heat strain and neuromuscular fatigue. This project will determine the trade-off between faster mission completion and risk of heat strain and physical performance decrements. Completion of this project will allow military leaders to make informed decisions by understanding the impact of their choices on the magnitude of physical performance decrements and expected heat casualties, setting up hot weather missions for success.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Physically active

Exclusion Criteria:

* History of cardiovascular, metabolic (such as clinical thyroid disease), respiratory, neural, or renal disease
* Hypertensive (systolic blood pressure \> 139 mmHg, diastolic blood pressure \> 89 mmHg) or tachycardic (heart rate \> 100 bpm) during the screening visit
* Taking medications or supplements known to effect physiologic responses to exercise or thermoregulation (e.g., beta blockers, omega-3 fatty acids, statins, aspirin)
* Tobacco or nicotine use currently or in the past six months
* Musculoskeletal injury expected to impact exercise in the protocol
* A positive pregnancy test at any point in the study
* Study physician discretion based on any other medical condition or medication
* Inability to understand or follow instructions or the protocol
* Gastrointestinal disease or previous surgery prohibiting core temperature capsule use. Participants with a contraindication can opt to insert the pill rectally as a suppository.
The Effect of Deep Breathing and Transcutaneus Electrical Nerve Stimulation on Heart Rate Variability

This interventional study aims to investigate the effect of deep breathing (DB) and transcutaneous electrical vagus nerve stimulation (tVNS) on heart rate variability (HRV) in healthy participants and patients with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). HRV is used as a surrogate measure of vagal nerve tone.

The study consists of three sub-projects:

Sub-project 1: To compare the effect of one session of DB and one session of non-invasive auricular tVNS on vagal nerve tone measured by HRV in healthy participants and in patients with RA and SLE. The hypotheses is that DB has a similar effect on HRV as non-invasive electrical tVNS.

Sub-project 2: A dose-response study in healthy participants comparing the effect of 5, 15 and 30 minutes of DB on HRV. The hypothesis was that HRV increases as a function of the number of minutes the DB is performed in healthy participants.

Sub-project 3: To investigate the effect of the optimal dose found in sub-project 2 in patients with RA and SLE measured by HRV, and to investigate its reproducibility by doing it twice.The hypothesis was that HRV increases after DB in patients with RA and SLE, and the effect is reproducible.

In all three sub-projects the washout period will be investigated by measuring HRV three times after the intervention. We hypothesise that the effect of DB and tVNS on HRV decreases over time.


Eligibility Criteria:
Inclusion Criteria:

* Men and women in the age range from 18 years to 85 years old.
* For subproject 1 and 3 the participants must be diagnosed with either rheumatoid arthritis or systemic lupus erythematosus.
* Must sign and date informed consent.

Exclusion Criteria:

* Lacking ability to make or understand informed consent.
* Medical history with psychiatric or psychological conditions which the person in charge of the research estimates will affect the participants ability to participate in the study.
* Furthermore participants with severe mental illness will be excluded due to the fact that severe mental illness cause decreased heart rate variability.
* Pregnancy.
* Addict or prior addict defined as abuse of hash, opioids or other euphoriant drugs.
* Known atrial fibrillation or atrial flutter.
* Known chronic lung disease.
Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.

Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Hepatic Cirrhosis.

To investigate the effects of hUC-MSC treatment for Hepatic Cirrhosis, 20 patients with Hepatic Cirrhosis will be enrolled and receive 4 times of hUC-MSC transplantation.

Eligibility Criteria:
Inclusion Criteria:

* The patient who have signed the informed consent document;
* Clinical, radiological, or biochemical evidence of liver cirrhosis.

Exclusion Criteria:

* Pregnant women or lactating mothers;
* Patients who have received any anti-inflammatory drugs including herb-drug within 14 days;
* Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment;
* Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection;
* Abnormal blood coagulation, combine other tumor or special condition;
* Patients who had participated in other clinical trials within three months prior to this study.
Improving Uptake of Early Infant Diagnosis of HIV for the Prevention of Mother-to-child Transmission of HIV

Early accurate diagnosis is one of the first crucial steps in care for infants born to HIV-infected mothers. Early initiation of antiretroviral therapy (ART) relies upon early diagnosis and results in significant reductions in infant morbidity and mortality. There is little information on evidence-based interventions that specifically target improved attendance of postpartum clinic visits and subsequent infant HIV testing in the context of prevention of mother-to-child transmission of HIV (PMTCT) programs. The investigators propose a randomized controlled trial to examine the effect of text messages sent to women enrolled in PMTCT programs on adherence to postpartum clinic visits and uptake of early infant diagnosis by DNA polymerase chain reaction (PCR). This study seeks to test the hypotheses that (a) text messages sent to women enrolled in PMTCT will improve their attendance at the postnatal clinic within the first 6-8 weeks after childbirth; and (b) text messages sent to women enrolled in PMTCT programs will increase uptake of DNA PCR HIV testing at 6-8 weeks among infants exposed to HIV. This study will evaluate a novel strategy to improve adherence to postnatal clinic visits and increase the uptake of infant HIV testing. If proven superior to standard care, the proposed intervention can be easily scaled-up and integrated into existing healthcare systems in resource-limited settings. Findings from this study will provide randomized trial evidence to inform HIV prevention program planners and implementers. This study will also provide further information on the feasibility of using mobile phone-based technology for public health interventions in resource-limited settings.


Eligibility Criteria:
Inclusion Criteria:

* age at least 18 years
* report ability to read SMS
* ≥ 28 weeks gestation or delivery at study clinic on day of enrollment
* HIV positive women enrolled in the PMTCT program
* have access to a mobile phone (personal or partner's if HIV serostatus disclosed to partner)
* willing to receive SMS messages from the study
* planning to remain in the study area (Nyanza province) for the duration of the study

Exclusion Criteria:

* age less than 18 years old
* women who share phones with partners but HIV status not disclosed to partners
* intention to deliver at a non-study hospital
CD34+ Cell Enriched and T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Mismatched Related Donors or Borderline Organ Function

The purpose of this protocol is to provide access to the CliniMACS® System to hematopoietic cell transplant (HSCT) patients who do not have a matched related donor. The CliniMACS system is currently approved for use in patients who have AML, and a genetically matched sibling donor. Through this protocol, the investigators will be able to offer potentially life-saving transplants to patients who have genetically mis-matched donor, who have no other options for treatment.


Eligibility Criteria:
Inclusion Criteria:

* Participant age is 0 (newborn) to 35 years-old.
* Participant has a disorder affecting the hematopoietic system that are inherited, acquired, or a result from the myeloablative treatment that can benefit from alternative stem cell transplantation according to standard practice guidelines for including patients for transplant.
* Participant's medical screening clears s/he for allogeneic transplantation as per current institutional SOP based on standards of foundation for accreditation of cellular therapy and stem cell transplantation (FACT);
* Participant must lack a healthy, HLA-identical related or unrelated donor unless s/he has a borderline organ function that will preclude the recipient from receiving a curative therapy due to the need of post-HSCT immunosuppressive therapy.
* Participant must have a matched or mismatched-related donor who is:
* Able to receive granulocyte colony-stimulating factor (G-CSF) and undergo apheresis either through placement of catheters in antecubital veins or a temporary central venous catheter OR agrees on a bone marrow harvest;
* Healthy as per donor selection screening (following current SOP based on standards of foundation for accreditation of cellular therapy and stem cell transplantation - FACT);
* Willing to participate and sign consent.
* Participant or Legal Authorized Representative is able to sign informed consent (and signed assent, if applicable) for transplant.

Exclusion Criteria:

* Participant does not qualify for an allogeneic transplant due to medical screening, underlying disease, or lack of alternative donors.
* Any condition that compromises compliance with the procedures of this protocol, as judged by the principal investigator.
the Effect Between Platelet Reactivation and Antiplatelet Drugs

Different antiplatelet drugs played various role in coronary artery disease. The mechanisms were unclear. Platelet reactivation maybe was one of major causes. Compared with clopidogrel, Ticagrelor is more powerful antiplatelet drug. However, because of increased bleeding and dyspnea risk, both loading double dose and following second dose time had potential risk and inconvenient in routine clinical work, especially in elective PCI of comparable stable patients in Chinese. The benefit and risk should be balanced in such patients. The investigators supposed loading single dose and followed by second routine time dose was superior to clopidogrel and safer than ticagrelor previously prescribed.

All admission patients were divided into two groups, the first group were prescribed loading dose (180 mg) ticagrelor, the second group were prescribed with 90 mg ticagrelor. We measured both platelet activity and platelet reactivity using the LTA at baseline, pre-operation and post-operation. All bleeding or dyspnea events were recorded in hospital period.

Primary endpoints: platelet activity, platelet reactivity using the LTA and safety events were recorded in hospital period.

Eligibility Criteria:
Inclusion Criteria:

coronary artery disease, percutaneous coronary intervention

Exclusion Criteria:

high risk bleeding patient, allergic to the drugs
Impact of Branched-chain Amino Acids in the Development of Insulin Resistance

The purpose of this study is to clarify the role of the branched-chain amino acids in the development of Insulin resistance in patients with diabetes

The proposed project aims to elucidate the role of the BCAA in the development of insulin resistance and type 2 diabetes. The project tests the hypothesis that a diet induced decrease of BCAAs concentrations alter the metabolic mechanisms involved in the control insulin resistance and diabetes progression.

The specific aims are to elucidate the effect of the diet induced decrease of BCAAs concentrations on (I) peripheral and hepatic insulin sensitivity (II) ectopic fat distribution (III) energy metabolism (IV) metabolic and inflammatory status

Eligibility Criteria:
Inclusion Criteria:

* Diabetes type 2
* Non smokers
* Untrained
* Willingness to adhere to a diet intervention

Exclusion Criteria:

* Chronic disease
* Pregnancy
* Cancer
* Antibiotic therapy
* Drug/alcohol abuse
* Competitive athletes
Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With Insomnia

The purpose of this study is to evaluate the efficacy and safety of three doses of Hipnos medication in adults with insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 50 years or more;
* Diagnosis of insomnia disorder according to criteria defined by the DSM-V;
* Sleep latency ≥ 20 minutes obtained through polysomnography performed prior to the randomization visit.

Exclusion Criteria:

* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Known hypersensitivity to the formula components used during the clinical trial;
* Decompensated diabetes mellitus, hypothyroidism or hyperthyroidism;
* History of hepatic impairment;
* Current smoking;
* Pregnancy or risk of pregnancy and lactating patients;
* History of sleep-disordered breathing, sleep disorders associated with changes in circadian rhythm and severe neurological and psychiatric disorders;
* Diagnosis of clinical diseases that interfere with sleep;
* Participants who have used psychostimulant medications, antidepressants and/ or antipsychotic with sedative effects and/or antiepileptic;
* Participation in clinical trial in the year prior to this study.
A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes

The main purpose of this study is to evaluate the safety and tolerability of a study drug called nasal glucagon (Baqsimi) in pediatric participants with type 1 diabetes (T1D) aged 1 to less than 4 years. Blood tests will be performed to check how much nasal glucagon gets into the bloodstream. Blood sugar will also be measured to understand the effect of the drug on blood sugar levels. The study consists of a screening period up to 35 days before dosing, 1 day when a dose of nasal glucagon will be given and then 2 telephone follow up calls; first follow-up call on the day after the nasal glucagon was given and second call about one week after nasal glucagon was given. The study will last up to 9 days, not including the screening period.


Eligibility Criteria:
Inclusion Criteria:

* Have a Type 1 Diabetes diagnosis for at least 6 months
* Have been receiving insulin therapy via multiple daily injections or using an insulin pump and have been stable for at least 3 months prior to screening
* Have a HbA1c level of ≤ 9.5% at screening
* Have sufficient venous access for collection of blood samples
* Have good general health, apart from their Type 1 diabetes, with no prior history of choanal atresia, nasal/pharyngeal blockage or nasal anomaly

Exclusion Criteria:

* Have a presence or history of glucagon hypersensitivity
* Have a history of pheochromocytoma
* Have a history of epilepsy or seizure disorder
* Have 1 or more congenital anomalies to the anatomy of the nose, or require changes to the anatomy of the nose
* Are using closed-loop insulin therapy, unless such a device is set to 'open loop/manual' mode on the day of the dosing visit
* Have an episode of severe hypoglycemia or have had glucagon administered , during the 3 months prior to the screening visit and no severe hypoglycemia between the screening and dosing visit
Myocardial Function of the Setonis Aortic Valve Before and Beyond Valve Replacement

Study the consequences on heart muscle of the stenosis aortic valve before and after the replacement procedure, the repercussion on heart. Study the impact on the heart of "sick" valve can affect on "well-being" and prognosis in the year following the surgery.


Eligibility Criteria:
Inclusion Criteria:

* major patient freely accepting to participate in the study
* non-opposition signed
* aortic surface \<1cm² or \<0.6cm² / m² of indication surgical restraint
* oriented to short interventional management surgical term
* LVEF Left ventricular ejection fraction\> 50%
* In the subgroup "MRI-fibrosis", absence of indication for performing MRI

Exclusion Criteria:

* patient under guardianship, curatorship or safeguard of justice
* minor patient
* pregnant woman
* patient with significant polyvalvulopathy for which it is from the start programmed more than aortic valve replacement
* patient with severe coronary artery disease requiring revascularization
* allergy to the contrast product
Representation of the Bladder Innervation Using Diffusion Tensor Imaging Fiber Tracking With MRI - a Pilot Study

The exact innervation of the bladder and the changes after a spinal cord injury have been not yet been illustrated.

Diffusion tensor imaging with magnetic resonance imaging is a new technique which can be used to visualize single nerve fibers, and thus represent the neural supply of a region in vivo. There are studies in which both the sacral plexus and the lumbar nerve roots have been represented using diffusion tensor imaging. However, there is no study concerning the innervation of the bladder.

The investigators are therefore using diffusion tensor imaging with magnetic resonance imaging to represent the bladder innervation of individuals with neurogenic lower urinary tract dysfunction and individuals with normal bladder function.


Eligibility Criteria:
Inclusion Criteria:

* neurogenic lower urinary trat dysfunction
* normal bladder function

Exclusion Criteria:

* no signed informed consent
* contraindications for MRI (pace maker, implanted metal, claustrophobia)
* upper or lower urinary tract surgeries
* pregnancy (anamnestic)