cyrilzakka/clinical-trials huggingface dataset:
Reducing Sedentary Time in Patients With Cardiovascular Disease

The purpose of this study is to develop and test a 12-week sedentary behavior reduction intervention ("Sit Less" program) for patients with cardiovascular disease. The program aims to reduce and break sitting times among this population using an objective activity monitor and mHealth. The investigators will test the program to help cardiovascular disease patients break up sitting time, reduce daily sitting time, and move more. The investigators will also study whether the program leads to improvements in heart disease risk factors, and whether cardiovascular disease patients like the program and can follow it.

The investigators propose to develop and conduct a pilot 2-arm RCT to test a wearable technology-based sedentary behavior reduction intervention in cardiovascular disease patients. Participants will be randomized to either the control group or the sedentary behavior reduction intervention group. The intervention group will target a 120 minute per day reduction in sedentary behavior using an objective activity monitor and mHealth.

Specifically, the study aims to: determine the feasibility and acceptability of the sedentary behavior reduction intervention in cardiovascular patients by evaluating reach, retention, satisfaction, and compliance with the intervention; evaluate the preliminary efficacy of the sedentary behavior reduction intervention on changes in sedentary time; and explore preliminary effects of the sedentary reduction intervention on physical activity, cardiometabolic markers and patient-centered outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 and above
* Have at least one of the following conditions including history of heart attack or peripheral artery disease or a stent placed in heart or leg
* Self-report of sitting ≥ 8 hr/day
* Ability to stand and walk
* Ownership of a smartphone

Exclusion Criteria:

* Currently using an activity tracker
* Currently participating in exercise of cardiac rehabilitation programs
* Non-English speaking
* Patients who are classified as unstable (e.g. heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake, or any other conditions contradictory to standing or walking and
* Currently pregnant
Study of Weight-Reducing Effect and Safety of Rimonabant In Obesity in ASIA (RIO-ASIA)

Primary : effect on weight loss and weight maintenance over 9 months when prescribed with a hypocaloric diet in obese patients.

Secondary : effect on HDL-Cholesterol, triglycerides, fasting-insulin, fasting glucose, waist circumference - safety and tolerability


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI)\> 25 kg/m²

Exclusion Criteria:

* Absence of stable weight (variation \< 5 kg) within three months prior to screening visit),
* Absence of effective contraceptive method for females of childbearing potential,
* Presence of treated or untreated type 1 or type 2 diabetes,
* Systolic blood pressure \> 165 mm Hg and/or diastolic blood pressure \> 105 mm Hg on 2 consecutive visits from the screening to the inclusion visit,
* Presence of secondary hypertension,
* Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint (presence of any clinically significant endocrine disease according to the Investigator, obesity of known endocrine origin...)
* Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study,
* Presence of any clinically significant abnormality according to the Investigator on the ECG performed on the inclusion visit.
* Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.
* Related to previous or concomitant medications :

  * Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc).
  * Antidiabetic drugs.
* Related to laboratory findings:

  * Positive test for hepatitis B surface antigen and/or hepatitis C antibody.
  * Abnormal TSH level (TSH \> ULN or \< LLN).
  * Positive urine pregnancy test.
Dartmouth-Hitchcock GreenCare Registry for Total Knee Replacement

Evolving reimbursement policies are driving health systems to improve quality and efficiency. Transitioning to an electronic health record (EHR) provided Dartmouth-Hitchcock Medical Center (DHMC) an opportunity to redesign staff roles and care path for Total Knee Replacement (TKR). The organization implemented a coordinated team-based care delivery model that integrated real-time measurement of: (1) compliance with trusted guidelines, (2) process of Shared Decision-Making (SdM), and (3) use of Patient-Reported Outcomes (PROs). The investigators present the implementation protocol and data.

Patient-reported outcome measures were completed 1 month preceding TKR and also at 1 and 12 months following surgery. The primary outcome was change in physical function from baseline to 1-year following surgery in the Physical Component Summary (PCS) of the Veterans-Rand (VR-12) Survey. Preoperative measures were: (1) general demographics (patient age, sex, height, weight, body mass index (BMI); (2) treatments tried before surgery; (3) health habits (tobacco use, alcohol use); (4) pre-existing medical conditions (Charlson score); (5) physical exam findings (knee range of motion, knee laxity); (7) lab tests (hemoglobin); and (7) radiographic measures (severity of osteoarthritis on standing x-rays). Secondary outcomes included Physical Score (PS) of the Patient Reported Outcome Measurement Information System Global Survey (PROMIS-10), knee function (Knee Osteoarthritis Outcome Score, KOOS), safety (reoperations, readmissions, emergency visits, and infection) and measures of patient experience (Clinician Group and Hospital Consumer Assessment of Healthcare Providers and Systems).

Eligibility Criteria:
Inclusion Criteria:

* Scheduled TKR
* Osteoarthritis of the knee

Exclusion Criteria:

* previous TKR on the affected knee
* diagnosis other than osteoarthritis
* age less than 18 years
* declined consent
Pulmonary Hypertension in Haemodialysis Patients :Frequency and Risk Factors

High mortality rates due to cardiovascular disease in end-stage renal disease patients been described by epidemiological and clinical studies. It accounts for approximately 50 percent of deaths in dialysis patients. Although controversial, this may be due to the presence of excess vascular calcification particularly in the form of extensive coronary artery calcification which can be observed even in very young dialysis patients. It was suggested that abnormalities of the right ventricular function in patients with end-stage renal disease were largely due to pulmonary hypertension which usually develops secondary to pulmonary artery calcifications.

Primary whose mechanisms are incompletely known, is another vascular disease entity recently described in chronic kidney disease particularly in patients undergoing haemodialysis. It corresponds to 5th subtype of World Symposium on Pulmonary Hypertension classification established in 2008 in Dana Point and updated in 2013 in Nice. Pulmonary hypertension is defined by Pulmonary arterial pressure mean ≥25 mm Hg at rest measured by right heart catheterization. Its pathophysiological mechanism is controversy maybe explained by vascular calcification, blood flow in arteriovenous fistula and fluid overload. Primary pulmonary hypertension is a major problem of haemodialysis patients because of its high prevalence, sometimes reaching 68% and by its significant morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* 80 haemodialsis patients aged from 18 to 60 years old
* 80 haemodialysis patients are on regular haemodialysis for more than one year

Exclusion Criteria:

* All patients with a high probability of secondary pulmonary hypertension, those with the following history: chronic obstructive pulmonary disease, pulmonary embolism congenital heart disease, heart failure, Bilharziasis plus active HIV infection.
The Purpose of This Study is to Determine if Eplerenone is Effective in Treatment of Mild to Moderate Heart Failure

The purpose of this study is to determine if eplerenone is effective in the treatment of mild to moderate heart failure


Eligibility Criteria:
Inclusion Criteria:

* Current symptoms consistent with mild to moderate heart failure (NYHA functional class II and III)
* LVEF (left ventricular ejection fraction) of \<35% by equilibrium-gated RVG at screening
* Therapy with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) and beta-blocker (BB) (unless documented intolerance) for at least 3 months duration and at dose that has not been adjusted within the previous 4 weeks

Exclusion Criteria:

* Current decompensated heart failure or heart failure hospitalization or severe heart failure (NYHA functional class IV) within 6 months of screening
* Use of eplerenone or spironolactone within 30 days of randomization or for more than 7 days within the previous 6 months
A Study to Compare How Effective is Encorafenib Plus Binimetinib in Real-world and Clinical Trial Settings

Brief summary The purpose of this study is to compare how effective, encorafenib plus binimetinib is in the real-world and clinical trial settings. And produce results to show that combining data on encorafenib plus binimetinib from both the real-world and clinical trial settings is possible for future research studies.

This study group is identified from the database who:

* Have taken at least 1 order or administration of encorafenib plus binimetinib treatment after the confirmation of having metastatic melanoma after 27 June 2018.
* Are at least 18 years of age at the time of first encorafenib plus binimetinib initiation (index date).
* Had never received encorafenib plus binimetinib or had received first-line immunotherapy at the start of the study.
* Have ECOG status of 0 or 1 at the index date.
* have available data on the number of deaths in an area or group of people.

Patients will be followed from the date that the patient started the first encorafenib plus binimetinib treatment (treatment initiation) up to their last date of data availability. Last date of data availability could be the date of following events: patient lost to follow up at the clinic, death, or end of the database (January 2020). The database timeframe is June 2018 to January 2020.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of melanoma (International Classification of Diseases 9th or 10th Revision Clinical Modification - ICD-9-CM: 172.X; ICD-10-CM: C43.x) and secondary malignancy or metastasis (ICD-9-CM: 196.x, 197.x, 198.x; ICD-10-CM: C77.x, C78.x, C79.x).
* Confirmed BRAF V600E/V600K activating mutation reported in the data based on laboratory or genetic analysis results.
* At least 1 order or administration of ENCO+BINI treatment

Exclusion criteria:

* Patients without information on mortality
* Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron Electronic Health Record)
* Patients with a history of or concurrent uveal or mucosal melanoma, basal cell or squamous cell carcinoma (as per trial inclusion criteria); this exclusion will also be applied to RWD patients
Congenital Cytomegalovirus: Prevalence in Buenos Aires City (cCMV Prevalence)

The goal of this observational study is to recognise the prevalnce of congenital cytomegalovirus (cCMV) and to follow up positive babies until 12 months The main questions it aims to answer are: pevalence of cCMV, cCMV clinicals outcomes during the first year of life.

Participants will be screened with a salive swab for CMV DNA. Babies with positive results will be follow up for one year.

Cytomegalovirus (CMV) is a frequent cause of congenital infection and a leading nongenetic cause of sensorineural hearing loss. In most infants with congenital CMV infection, clinical abnormalities do not manifest at birth; rather, the infection is asymptomatic. However, sensorineural hearing loss eventually develops in approximately 10 to 15% of CMV positive children.

The prevalence of congenital cytomegalovirus has been reported as 0·2% to 2·0% (average of 0·64%). There is not any publication of the prevalence of cCMV in Buenos Aires City. We aim the study to find the prevalence in this population Screening of newborns for CMV infection permit early identification of at-risk congenitally infected infants for purposes of targeted monitoring and intervention during critical stages of speech and language development.

Testing saliva via DNA detection of the virus through polymerase chain reaction testing (PCR) or rapid culture is shown to have a high sensitivity (\>97%) and specificity (99%) for detecting congenital CMV infection.

Our objective is to describe the prevalence of cCMV using saliva specimens for PCR detection.

Secondary objectives includes describing prevalence of neurosensorial hearing loss and visual impairments during 1 year follow up.

Eligibility Criteria:
Inclusion Criteria:

* Newborns between 1 and 21 days
* informed consent

Exclusion Criteria:

* Lethal malformation
Five-Plus Year Follow-Up of SMART Randomized Controlled Trial

The objective of this study is to evaluate long-term ongoing effectiveness of the Intracept Intraosseous Nerve Ablation System for the treatment of chronic low back pain.

This is a prospective multi-center, nonintervention, observational, single arm post market data collection of the 5+ year effectiveness and satisfaction outcome for the SMART trial population.

Eligibility Criteria:
Inclusion Criteria:

* LBP at least 6 months from original SMART Trial
* RF Ablation Arm from SMART Trial

Exclusion Criteria:

-Control Arm Subjects from SMART Trial
Role of Prohepcidin in Uremic Patients

The investigators aimed to study the effect of prohepcidin levels on hematologic parameters and inflammatory markers in non-diabetic uremic patients. The investigators selected three groups of patients: Hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. A control group was formed from healthy volunteers also. Each group has been planned to be formed of about 25 patients. Diabetic patients were excluded. Prohepcidin, hsCRP, IL-6, fibrinogen have been planned to be studied besides other routine biochemical analysis including hematological ones.


Eligibility Criteria:
Inclusion Criteria:

* hemodialysis and peritoneal dialysis patients who had been on dialysis therapy for more than 3 months,
* age between 18-80 years,
* patients with creatinine clearance between 15-30 ml/min.

Exclusion Criteria:

* age less than 18 or more than 80,
* diabetic patients,
* current active infectious or inflammatory disease.
Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults

The purpose of the study is to extend the intended use of two BGMSs to include testing of arterial blood by Health Care Professionals (HCP) in a clinical setting.

This trial will evaluate the performance of both Contour Next BGMS and Contour Plus Elite BGMS using arterial blood from adult patients hospitalized in a Critical Care Unit (medical and surgical intensive care units (ICUs)). The investigational BGMS will be tested by a Point-of-Care (POC) operator in a clinical setting using residual arterial blood samples from adults who underwent prescribed arterial blood tests that were deemed necessary due to their medical conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 18 years old.
* Residual Arterial blood samples collected from subjects hospitalized in a Critical Care Unit (medical and surgical intensive care units (ICUs)).
* Sample blood volume must be sufficient to complete investigational testing procedures clinical laboratory testing.

Exclusion Criteria:

- Residual arterial blood samples collected from subjects previously enrolled. and evaluated for this study.
Placebo-Controlled Therapeutic Trial for the Prevention of Lymphedema

This randomized clinical trial studies an investigational drug in preventing lymphedema in patients at high risk after undergoing axillary lymph node dissection. The study drug may prevent lymphedema in patients undergoing axillary lymph node dissection.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of study drug in improving chronic lymphedema while further elucidating the role of inflammatory and lymphangiogenic processes in the pathogenesis of this disease.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive study drug orally (PO) thrice daily (TID) for up to 1 year in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Axillary lymph node dissection within the preceding 12 months

Exclusion Criteria:

* Patients with active cancer
* Patients with lymphedema
* Infection or bleeding tendency
* Patients with medical contraindications to nonsteroidal anti-inflammatory drugs (NSAIDs), including history of allergies, know gastrointestinal intolerance
* Other serious systemic illness (e.g., renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would impair the patients' ability to participate
* Persons not competent to consent
* Patients on aspirin therapy
* Minors (\< 18 years of age)
* Pregnant and/or lactating women
* Males
Study of First Line Treatment of Chronic Graft Versus Host Disease With the Association of Ciclosporine, Corticosteroids and Rituximab (Protocol R-GVHD)

The main objective of the study is to improve the response rate (complete and partial remission) at 12 months after diagnosis of chronic Chronic Graft Versus Host Disease (GVHD) and treatment with the combination of ciclosporine, prednisone and Rituximab as first line treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years) who have received a first allogeneic stem cell transplantation for a hematological disease
* Confirmed diagnosis of first episode of chronic GVHD requiring systemic immunosuppressive therapy. Chronic GVHD diagnosis is defined according to the NIH Working Group Consensus. Chronic GVHD diagnosis will be based on the evaluation of the severity of the different clinical manifestations including :

  1. Ocular, oral and mucosal symptoms,
  2. Performance status evaluation,
  3. Pulmonary function evaluation,
  4. Cutaneous evaluation measured by the percentage of extension of manifestations of liche-noid or sclerodermatous aspects, eventually confirmed with a biopsy whenever possible,
  5. Evaluation of the musculoskeletal manifestations, especially the amplitude of the rele-vant articulations,
  6. Evaluation of liver involvement (Total bilirubin, Transaminases, Phosphatase alcalines and Gamma GT).
* Any source of hematopoietic stem cells is authorized.
* Any category of conditioning regimen prior to allo-SCT is authorized.
* Any type of stem cell donors is authorized.
* Signed informed consent.
* Any prior GVHD prophylaxis previously used is accepted.
* Absence of contra-indications to the use of Rituximab.
* Subjects affiliated with an appropriate social security system.
* Women who are of childbearing potential must have a negative serum pregnancy test and agree to use a medically acceptable method of contraception throughout the study and for 3 months following the end of the study.

Exclusion Criteria:

* Patient developing acute GVHD (whether early or "late onset" form)
* A "limited" form of chronic GVHD not requiring systemic immunosuppressive therapy
* Treatment with prednisone (or equivalent) at doses higher than 1 mg/kg/day at the time of enrollment.
* GVHD occurring following donor lymphocytes infusion (DLI)
* Not the first episode of chronic GVHD needing systemic immunosuppressive therapy
* Neutropenia \<500/µL
* Second allogeneic stem cell transplant
* Uncontrolled systemic infection which in the opinion of the investigator is associated with an increased risk of the patient's death within 1 month after the start of therapy
* Severe neurological or psychiatric disorders
* Denied informed consent
* Pregnancy
The Effect Of Nebulizied Nitroglycerin As An Adjuvant Therapy For Persistent Pulmonary Hypertension Of Newborns

This aim of the study is to evaluate the effect of nebulized nitroglycerin on echocardiographic (biventricular function, pulmonary artery pressure, PDA and PFO shunting and tissue doppler imaging) and clinical parameters (Oxygen saturation index, heart rate, blood pressure, mean airway pressure, ventilation setting) in patients with PPHN.


Eligibility Criteria:
Inclusion Criteria:

* Infants ≤72 hours' old, ≥37 weeks of gestation, ≥50% FiO2 need despite lung recruitment, abnormal oxygen saturation index or echocardiographic signs of PPHN will be enrolled in the trial.

Exclusion Criteria:

* • Diagnosis of PPHN discovered after more than 72 hours.

  * Failure of used medications and need to administrate milrinone