cyrilzakka/clinical-trials huggingface dataset:
Confirming Permanent Lack of Blood Flow to the Brain During A-NRP DCC Organ Transplant

This study aims to evaluate the surgical technique used in Abdominal Normothermic Regional Perfusion (A-NRP) in death determination by circulatory criteria (DCC) organ donors. The proposed study will demonstrate that there is no resumption of brain blood flow or activity during the A-NRP procedure. This will be assessed using multimodal neuromonitoring protocol that enables continuous focused monitoring of brain blood flow and activity during A-NRP. This will provide evidence that brain blood flow and activity does not resume during NRP and ensure donor safety in using this technique in standard of care practice.

This will be a multi-centre prospective observational cohort study that will enroll eligible DCC donors at participating donation hospitals. Participating programs will implement the A-NRP processes and organ recovery at the donation sites. Neurocritical care teams and donation physicians at the donation site and independent of transplant teams will implement neuromonitoring using the following modalities:

1. Transcranial colour-coded Doppler (TCCD) as a measure of brain blood flow,
2. Electroencephalography (EEG), as a measure of cortical brain electrophysiologic activity, and
3. Somatosensory evoked potentials (SSEP) or brainstem auditory evoked potentials (BAEP), as a measure of brainstem electrophysiologic activity.

The neuromonitoring team will interpret observed signals in real-time during the A-NRP process. This study will confirm whether current A-NRP surgical safeguards ensure maintenance of permanent cessation of brain blood flow and/or activity during A-NRP and will guide the adoption of A-NRP in Ontario.

Eligibility Criteria:
Inclusion Criteria:

* ≤ 18 years of age
* Potential DCC donors whose families/surrogate decision makers have consented to DCC organ donation according to current criteria of the participating transplant programs. These may include patients donating a liver, kidneys, pancreas, and/or lungs; please see Appendix A for organ specific donor inclusion criteria.

Exclusion Criteria:

* \< 18 years of age
* DCC donors who proceed to donation following medical assistance in dying or those who are able to provide first-person consent at the time of donation
* Injuries that anatomically preclude the use of neurological monitoring
Continuous Registration of Bioimpedance During Hemodialysis

This studies aims at testing continuous registration of bioimpedance during hemodialysis and comparing the measurement with extracted liquid.

The purpose is to test the sensitivity and specificity of a new electronic patch in the indication of the relative change in the fluid balance. If possible, the change in hydration level should be quantified. The test is done on patients during hemodialysis. Extracted amount of fluid is used as the primary reference to the bioimpedance measurements, but other references will also be used.

The measurement is made using bioimpedance measured with four electrodes and over a large frequency spectrum. Impedance measurements are made every 20 seconds throughout the test period. The measurement is recorded in a memory (flash) on each patch. At the same time as measuring bioimpedance, the temperature in the patch is recorded.

After completion of the test, the data is transferred to a computer for analysis. As a reference, extracted amount of fluid, weight change, blood samples and clinical evaluation are used.

Eligibility Criteria:
Inclusion Criteria:

* Patients for hemodialysis

Exclusion Criteria:

* Acute in-current disease.
* Known adverse reaction to medical adhesive
Skeletal Muscle Response to Amino Acids and Load Carriage Exercise

Warfighters often experience physical overload, as the uniform and associated gear that they carry burdens them with substantial loads. The loads increase energy expenditure to levels that exceed a Warfighter's typical energy intake. The typical assault load is approximately 25 kg, although loads as high as 55 kg are often carried, which when combined with extreme energy expenditures can degrade health and performance, and increase the risk of injury. Branched-chain amino acid (leucine) supplementation may confer protection against the negative effects of operational stress by stimulating muscle protein synthesis and reducing degradation. This study will determine if leucine-enriched nutrition supplementation confers protection against the negative consequences of sustained load carriage exercise, and explore the mechanisms by which leucine might impart protection.


Eligibility Criteria:
Inclusion Criteria:

* Weight stable (±5 lbs)with a body mass index between 22-29 kg/m2 and a VO2peak of 40 - 60 ml/kg/min
* Willing to refrain from taking any NSAIDS (i.e., aspirin, Advil®, Aleve®, Naprosyn®), or any aspirin-containing products, alchohol, and nicotine
* Females must be on oral contraception

Exclusion Criteria:

* Metabolic or cardiovascular abnormalities, gastrointestinal disorders
* Disease or medication that affects macronutrient metabolism or the ability to participate in strenuous exercise
* Allergies or intolerance to foods (e.g. lactose intolerance/milk allergy), vegetarian practices, or medications (including, but not limited to, lidocaine or phenylalanine) to be used in the study
* Anemia (HCT \<38) and Sickle Cell Anemia/Trait, abnormal PT/PTT test or problems with blood clotting
* Present condition of alcoholism, use of nutritional/sports supplements, anabolic steroids, or other substance abuse issues
* Musculoskeletal injuries that compromise the ability to exercise
* Blood donation within 8 weeks of enrollment
* Pregnancy and women not on oral contraceptives
Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes in NSCLC (ECTOP-1010)

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1010. Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes (Group 11-13) in Non-small Cell Lung Cancer: a Multi-center, Prospective observational Clinical Trial

Patients would be evaluated whether meet the criteria as clinical stage T1 non-small Cell Lung Cancer. Then, he/she would receive lobectomy. Finally, the detailed anatomical location of group 11-13 would be recorded immediately after surgery and their metastasis pattern would be explored in the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Preoperative examination showed patients with clinical T1 peripheral non-small cell lung cancer (NSCLC);
2. The lesion is located in a single lung segment or between two adjacent lung segments;
3. Perform radical lobectomy;
4. The preoperative examination did not reveal unresectable lymph nodes;
5. Have not received any other tumor-related treatments (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) before surgery;
6. No malignant tumor history;
7. No contraindications to surgery (ECOG score 0-1 points);

Exclusion Criteria:

1. Pathology revealed patients with non-T1 stage non-small cell lung cancer (NSCLC);
2. Radical lobectomy is not performed;
3. Acception of any anti-tumor treatment before surgery (excluding Chinese medicine treatment);
4. Refused to enter the group or asked to leave the group.
An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms

The primary objective of the study is to evaluate vigabatrin pharmacokinetics (PK) in neonates receiving vigabatrin for infantile spasms (IS); and to determine the safety of vigabatrin.


Eligibility Criteria:
Inclusion Criteria:

* The patient's parent or legally authorized representative is able to read and understand the Patient Information Sheet and Informed Consent Form.
* The patient's legally authorized representative has signed the Informed Consent Form.
* The patient has IS, diagnosed according to the International League Against Epilepsy (ILAE) criteria.
* The patient is a full term (38 weeks gestation) male or female, aged \>=1 month to \<6 months at the time of enrollment.
* The patient's length and body weight for gestational age is \>=5th and \<=95th percentile, according to Centers for Disease Control and Prevention (CDC) Growth Charts.

Exclusion Criteria:

* The patient is currently being treated or has been previously treated with vigabatrin.
* The patient is a member of the site personnel's immediate family.
* The patient takes or has taken disallowed recent or concomitant medication or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study.
* The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to the investigational medicinal product (IMP) or the excipients (povodone/iodine) of the IMP.
* The patient has any other disorder for which the treatment takes priority over treatment of IS or is likely to interfere with study treatment or impair treatment compliance.
* The patient has been treated with any IMP within 30 days or 5 half lives (whichever is longer) prior to the Screening Visit.
* The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
* The patient has been diagnosed or is judged by the investigator to have anemia.
* The patient has been diagnosed or is judged by the investigator to have renal insufficiency.
* The patient's parent or legally authorized representative is, in the investigator's opinion, unlikely or unwilling to comply with the protocol or the patient is unsuitable for any reason.
Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

This is a randomized, open label study to investigate vasopressin versus phenylephrine as a first line pressor in cardiac surgery. All patients \>18 years of age presenting for coronary artery bypass graft (CABG), valve surgery, or combined CABG and valve surgery will be screened for inclusion. Patients with ejection fraction \< 35%, \> moderate pulmonary hypertension, \> mild right ventricular dysfunction, a planned radial arterial graft, or circulatory arrest will be excluded. Patients will be randomized to receive either vasopressin or phenylephrine as the first line vasopressor during the perioperative period to maintain mean arterial blood pressure \>65 mmhg. Primary outcome is acute kidney injury. Secondary outcomes are 30-day mortality, stroke, myocardial infarction, re-operation, sternal infection, atrial fibrillation, intensive care unit length of stay, and total vasopressor hours.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Coronary artery bypass graft (CABG), valve, or combined CABG and valve surgery

Exclusion Criteria:

* Ejection fraction \< 35%
* \> moderate pulmonary hypertension
* \> mild right ventricular dysfunction
* Radial arterial graft
* Circulatory arrest
A Study to Investigate How Respiratory Syncytial Virus (RSV) Infection Develops and Changes Over Time in Pediatric Participants

The primary purpose of this study is to observe how viral load and titer change over time in participants with RSV and how data from hospitalized participants compares with data from non-hospitalized participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant who is presenting within 5 days of onset of clinical signs at the time of informed consent.
* Participant is diagnosed with RSV within 5 days of sign onset.
* Participant's caregiver must be able to complete daily Observer Reported Outcomes (ObsROs) and collect nasal swabs

Key Exclusion Criteria:

* Participant is hospitalized for reasons other than RSV infection.
* Participant is considered by the PI to be immunocompromised, due to an underlying medical condition or medical therapy.
* Participant has or has had a confirmed respiratory infection with another clinically relevant viral/bacterial pathogen within 14 days of study enrollment.
* Participant underwent major surgery within 28 days prior to enrollment in the study or has planned major surgery within 15 days of expected study completion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Optimizing Health Among Children With Congenital Heart Defects

Quality of life and heart health are intimately connected to childhood physical activity participation (PAP). Physical activity is critical to childhood growth, development, learning, socialization, and quality of life and is an essential component of life-long heart health. Research by the investigators of this study and others has shown that low PAP levels are common among children with heart defects, and that these sedentary lifestyles are not related to exercise capacity, medical status or heart function.

Therefore, we hypothesize that psychosocial factors are important determinants of PAP in this population. Our most recent research with children who have univentricular heart indicates that gross motor skill and psychosocial factors are significant correlates of PAP. Important psychosocial factors include self-efficacy for activity, uncertainty about activity, and inaccurate perceptions of the child's PAP level, options, and abilities. This study seeks to determine whether gross motor skill and psychosocial factors influence PAP among children with a broad spectrum of cardiac defects. It will also determine the optimal changes to clinical care needed to encourage children with heart defects to develop health-related active lifestyles.

We propose a prospective, randomized, cross-over preliminary clinical trial utilizing both quantitative and qualitative assessments. Through the cross-over design, each subject will complete both interventions (information, demonstration), with the order of intervention delivery randomly determined. Quantitative assessments will document moderate-to-vigorous physical activity (MVPA), gross motor skill, and health-related fitness. Qualitative assessments will evaluate parent/child anxiety about PAP and psychosocial factors influencing PAP. All factors will be assessed at each data collection point.

Eligibility Criteria:
Inclusion Criteria:

* Successful repair of one of the following congenital heart defects: transcatheter device closure of atrial septal defect (ASD), arterial switch repair of transposition of the great arteries (TGA), surgical repair of tetralogy of Fallot (TOF), or Fontan procedure for a functionally univentricular heart (UVH).
* At least one year after most recent open heart surgery.
* 4 to 11 years of age and attending elementary school at first study visit.

Exclusion Criteria:

* Identification of exercise contraindications/limitations by the responsible cardiologist.
* Other disabilities or medical conditions that may influence PAP. Children who achieve 90 minutes of MVPA on 5 or more days per week during the baseline assessment will be excluded from the intervention phase. The study interventions are not designed to increase MVPA among children who already achieve the Health Canada guidelines for PAP.
BAROSTIM® Hope for Heart Failure Study

The purpose of this clinical investigation is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM® HOPE4HF Trial (NCT01720160).

A prospective, randomized study describing the safety and efficacy of the BAROSTIM NEO System in heart failure subjects with left ventricular ejection fraction equal to or less than 35 percent. Seventy two subjects were randomized; 32 to the medical management arm and 40 to the device arm (38 implanted, 2 withdrawn). The study closed to new enrollments on January 31, 2014. Subjects are in long-term follow-up and are required to have at least one annual visit. During the visit, there will be a physical assessment, a review of medications and serious adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Actively participating in the BAROSTIM HOPE4HF Study and currently implanted with the BAROSTIM NEO device with the device turned ON.
* Have signed a revised approved informed consent form for continued participation in this study.

Exclusion Criteria:

• Treating physician decision that the subject should not continue with therapy.
Comparison of Proportional Assist Ventilation And Neurally Adjusted Ventilator Assist

In spontaneously breathing mechanically ventilated patients, the adequacy between the patient's demand and the level of respiratory support delivered by the ventilator is a major clinical issue. Neurally adjusted ventilator assist (NAVA) and proportional assist ventilation (PAV) have been developed to adapt the level of assistance to the patient's demand. These two modes have been compared to pressure support ventilation (PSV) but have not been compared to each other.


Eligibility Criteria:
Inclusion Criteria:

* Intubated patients.
* Mechanical ventilation for a respiratory reason.
* Expected duration of Mechanical ventilation \> 48 hrs.
* Spontaneous breathing.
* Sedations stopped for more than 24 hours.

Exclusion Criteria:

* - Main contra indications to NAVA: gastro-oesophageal surgery in the previous 12 months, oesophageal obstruction, gastro-esophageal bleeding in the previous 30 days, history of esophageal varices, facial trauma or surgery, neuromuscular diseases, individuals with known or suspected phrenic nerve dysfunction.
* Main contra indications to PAV: airway leak, body weight \<25 kg, neuromuscular diseases.
* Hemodynamic instability defined as the current administration of vasopressors or inotropic drugs.
* Severe hypoxemia defined as PaO2/FiO2 ratio \<200.
* Decision to withhold life-sustaining treatment.
* Pregnant women.
* Minors \< 18 years.
Longitudinal Study of Outcomes Measures in ALS Trials

A new strength measurement device called Accurate Test of Limb Isometric Strength (ATLIS) was developed to precisely and conveniently measure static limb strength in patients with ALS. The investigators will compare ATLIS data with data from two commonly used ALS outcomes measures, the ALS Functional Rating Scale-Revised (ALSFRS-R) and slow vital capacity (SVC) in a prospective, longitudinal study. All three outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic visits during the study period.

Four sites will participate in data collection for this study and will enroll approximately 20-30 subjects per site. Subjects will be tested every 1 to 4 months for up to two years. Subjects will be tested at each visit using ATLIS, ALSFRS-R questionnaire and slow vital capacity testing.

Inclusion criteria:

* Subjects 18 years or older diagnosed with clinically possible, laboratory supported probable, probable or clinically definite ALS according to the World Federation of Neurology Revised El Escorial Criteria.
* Capable of providing informed consent and complying with trial procedures.

Exclusion criteria:

- Patients, judged by the site clinical investigator to have medical conditions that may limit their ability to safely exert maximal force using the muscles in their arms and legs will be excluded from this study (e.g. unstable hypertension, significant cardiac disease, significant musculoskeletal disorders, or other medical conditions).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* clinically possible, laboartory supported probable, probable or clinically definite ALS according to El Escorial Criteria
* capable of providing informed consent

Exclusion Criteria:

* persons with medical conditions that would limit their ability to safely exert maximal force using muscles in their arms and legs (e.g. unstable cardiac, musculoskeletal, or other medical conditions)
Natural Course of Initially Metabolic Healthy Obese Individuals (Healthy Obesity)?

The main goal of this study is to gain a thorough understanding, which specific factors drive the unhealthy sequelae of obesity. Therefore, the investigators want to understand:

1. What distinguishes obese persons without metabolic diseases from those with medical diseases in a cross-sectional comparison?
2. Which factors drive the conversions from metabolically healthy obesity into a metabolically unhealthy obesity in a longitudinal approach?

The hypothesis is, that changes in the molecular regulation of adipose tissue as well as in adipose tissue cellular composition are responsible for the development of a rather metabolic healthy or unhealthy phenotype. Knowledge of these factors will be used to generate new diagnostic concepts for personalized risk prediction and will furthermore serve as the basis to develop novel strategies to target adipose tissue to improve metabolic health.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Age between 18 and 60 years
* BMI 30-50 kg/m2
* Knowledge of German, which requires sufficient written and allow oral patient education

Inclusion criteria for initially healthy group

* Blood pressure \< 140/90 mmHg
* Normal glucose metabolism

  * HbA1c \< 6.5 %
  * Fasting Glucose \< 7.0 mmol/l
* Normal lipid metabolism

  o LDL-cholesterol \< 5.0 mmol/l
* ≤ 2 of the following metabolic syndrome criteria combined (excluding waist circumference)
* TG \> 1.7 mmol/l
* HDL-cholesterol \> 1.0 mmol/l (male) / \> 1.3 mmol/l (female)
* Fasting glucose ≥ 5.6 mmol/l
* BP ≥ 130/85 mmHg

Exclusion Criteria:

* Pregnancy
* Medication and / or pathologies that prevent a safe execution of the fat tissue biopsies
* History of or planned bariatric operation
* Medical conditions that prevent examinations and testing (e.g. symptomatic cardiovascular diseases)
* Active Malignant tumor (\<2a remission)
Safety and Efficacy Study of BMS-823778 to Treat Uncontrolled High Blood Pressure in Overweight and Obese Patients

The purpose of this study is to determine whether BMS-823778 is safe and effective in the treatment of hypertension in overweight and obese patients.


Eligibility Criteria:
Inclusion Criteria:

* Qualifying seated blood pressure between ≥90 and ≤105 mmHg diastolic AND ≤155 mmHg systolic
* Mean 24-hour diastolic blood pressure ≥85 mmHg
* Body mass index (BMI) ≥27 kg/m2
* If receiving an oral anti-hyperglycemic medication or a cholesterol lowering medication, receiving a stable dose for at least 6 weeks

Exclusion Criteria:

* History of Cushing's disease or syndrome, or Addison's disease
* Glycosylated hemoglobin (HbA1c) ≥10%
* Cerebrovascular insult, unstable angina, or myocardial infarction (MI) within 6 months
* History of impaired renal or hepatic function
* BMI ≥50 kg/m2
* Any injectable antihyperglycemic agent (such as insulin) within 16 weeks
* Currently receiving more than one class of antihypertensive agents within 4 weeks
* Daily use of nonsteroidal anti-inflammatory agents within 1 week
* Use of androgen medications, including topical preparations, within 6 weeks
* Diagnosis or history of breast cancer