cyrilzakka/clinical-trials huggingface dataset:
Cheese Consumption and Human Microvascular Function

Increased dairy intake is associated with improved measures of blood vessel health. Dairy cheese, however, is often high in sodium. Dietary sodium can impair blood vessel function. The researchers examine if and how natural cheese may protect against impairments in blood vessel function caused by sodium. For this study, participants complete four 8-day controlled feeding periods in which they eat cheese (6 oz/day) or no cheese during a low-sodium or high-sodium base-diet. The participants complete baseline experiments while on their normal personal diet and then repeat experiments at the end of each controlled feeding period. In some of our experiments, the researchers use a technique called "microdialysis" (MD). With MD, the researchers perfuse some research drugs into the skin on the forearm through tiny tubing that mimics capillaries. These MD drugs mimic or block substances the body naturally makes to control the small blood vessels in the skin. The drugs remain in nickel-sized areas around the tubing and do not go into the rest of the body. The researchers also use a standard technique called "flow mediated dilation" (FMD) that uses blood pressure cuffs and ultrasound to look at the health of larger blood vessels in the body. FMD includes placing a small tablet of nitroglycerin under the tongue during part of the test.

Subject screening will be performed by the Penn State Clinical Translational Research Center (CTRC) medical staff and will include a physical exam by a clinician, anthropometry, and a chemical and lipid profile, liver and renal function. Participants meet with a registered dietitian to determine their caloric energy requirements and identify food preferences. The interview includes surveying the subject's physical activity over the previous 7 days.

Subjects will undergo baseline microdialysis experiments to examine the function of the blood vessels in the skin microcirculation. Subjects will also go through a baseline assessment of conduit vessel endothelial and vascular smooth muscle function with brachial artery flow-mediated vasodilation (FMD), and sublingual nitroglycerin. Following baseline experiments, subjects participate in 4 controlled feeding periods, each 8 days in duration. The controlled feeding periods are assigned in a randomized order. At the end of each 8-day controlled dietary period, subjects will repeat microdialysis experiments, brachial artery FMD, and responsiveness to sublingual nitroglycerin.

Eligibility Criteria:
Inclusion Criteria:

* Seated systolic pressure 120-140 mmHg
* Seated diastolic pressure 70-90 mmHg.
* Normoglycemic (HbA1C \<5.7%)

Exclusion Criteria:

* Taking pharmacotherapy that alters peripheral vascular control
* Pregnancy
* Breastfeeding
* Females taking contraceptives (pills, patches, shots, etc.) or hormone replacement therapy
* Taking illicit and/or recreational drugs
* Use of nicotine containing-products (e.g. smoking, chewing tobacco, etc.)
* Known allergy to latex or investigative substances
Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy

The aim of this study is to evaluate the usefulness of a newly developed multibending ultra-slim upper endoscope for the successful direct peroral cholangioscopy (POC) without assisting accessory in comparison with conventional ultra-slim endoscope. The investigators expect that multibending endoscope will show more higher successful performance than conventional endoscope.

Direct POC using an ultra-slim upper endoscope permits various diagnostic and/or therapeutic intraductal interventions under direct endoscopic visualization in selected patients who has dilated distal CBD and widened papillary orifice. Because the bile duct has anatomical position in acute angle with the duodenum, assisting accessories such as intraductal anchoring balloon, guidewire or overtube is usually required for the successful direct POC. Recently, direct peroral cholangioscopes have been developed for free-hand direct advancement of the endoscope into the bile duct from duodenum. Multibending ultra-slim endoscope may be expected to facilitate the advance into the bile duct by overcoming the acute angle between the bile duct and the duodenum. After randomization of enrolled patients into two groups, direct POC will be performed by using a conventional slim endoscope in control group and by using a multibending endoscope in study group.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatobiliary diseases that are indicated for direct POC
* The patient who aged from 20 to 80 years. Legally acceptable representative must be capable of giving written informed consent prior to participation in this study
* The woman of child-bearing age must be negative from the pregnancy test in order to participate in this study
* Dilated common bile duct (\> 8 mm)
* Having previous sphincterotomy and/or papillary balloon dilation
* The patients should not have any unacceptable conditions (e.g., physiological, familyish, social, geographical) for medical follow-up and adaptation of the study.

Exclusion Criteria:

* Contraindicated for ERCP
* Patients with stricture on papillary orifice
* Patients with periampullary malignancy
* Bleeding tendency: International normalized ratio (INR) of prothrombin time \< 1.5 or platelet count \< 60,000/mm3
* Patients with other serious disease or medical condition
* Patients with past medical history of significant neurologic or Psychiatric disorders such as dementia or seizure
* Unstable heart disease despite of treatment, recent myocardial infarction within 6 month (Even though MI was diagnosed within 6 months, if it becomes stable presently, the patient can be possible to participate).
Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population

The objective of this study is to compare asthma-related exacerbations (emergency department (ED) or inpatient (IP) visit) and related cost in pediatric patients aged 4-11 years that received either fluticasone propionate 44 mcg (FP44) or budesonide (BUD) or montelukast (MON). This retrospective observational cohort analysis utilizes a large managed care database with linked pharmacy and medical claims. Patients with ≥ 1 pharmacy claim FP44 or BUD or MON between January 1, 2000 through June 30, 2008 (4-11 years old at time of index) with ≥ 1 diagnosis for asthma (ICD-9 493.xx) in the pre-index period and continuously eligible to receive healthcare services for 1-year pre-index and at least 30 days post-index. Dose of each inhaled corticosteroid was not known in the database. Follow-up was defined for each patient as the period beginning with the index date and ending with the last date of continuous claims history, switch to another asthma controller medication, or claim for an asthma related event (ED/IP visit or OCS use) post-index, whichever occurred first.


Eligibility Criteria:
Inclusion Criteria:

* ICD-9 code for asthma
* one or more outpatient pharmacy claims for fluticasone propionate 44mg or budesonide between January 1, 2000 and June 30, 2008
* ages 4 to 11 years

Exclusion Criteria:

* diagnosis of Cystic Fibrosis
* ≥ 1 Rx claim for any asthma controller in the pre-index period
Outcome Prediction in Patients With Aortic Stenosis After TAVI

This study will investigate changes right ventricular function and functional recovery metrics after transcatheter aortic valve implantation

Aortic stenosis (AS), is a condition in which the aortic valve becomes narrowed as people get older, causing the heart pump (the left ventricle) to struggle to push blood through it, leading to breathlessness, chest pain and blackouts. If left untreated, the prognosis is bleak (similar to lung cancer). Previously the only effective treatment for AS was a valve replacement via open heart surgery, which was too high risk for many patients to undergo, meaning they were left without treatment. Over the last decade transcatheter aortic valve implantation (TAVI) has emerged as a treatment option for most patients with severe symptomatic AS. In TAVI, a new valve is inserted through a small tube, usually in the leg artery, which avoids open heart surgery.

Clinical outcomes after TAVI have significantly improved with the accumulation of operator and institution experience as well as the wide use of newer generation devices. However, a significant minority of patients undergoing TAVI derive little or no benefit from the procedure. Nearly a third describe no improvement in quality of life, or die within the first year. To combat this problem, it is essential we develop more sophisticated means of predicting adverse outcomes related to TAVI, to improve the selection of patients and identify patients where the potential benefit of the procedure is outweighed by unfavourable outcomes.

Assessment of physical recovery and improvement of symptoms and quality of life after TAVI is an important aspect of examining the outcomes of treatment. This is often a more meaningful and relevant treatment goal in the TAVI cohort than 'hard' clinical outcomes (like death and stroke) alone. Traditionally, less emphasis has been put on the assessment of the right side of the heart (the right ventricle) in evaluating physical recovery after TAVI.

We propose prospective observational study to evaluate the significance of the right side of the heart on the clinical outcomes related to functional recovery in patients undergoing TAVI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic severe aortic stenosis (AVA \<1.0 cm2/\<0.6cm2/m2 or mean gradient \>40mmHg or jet velocity \>4.0 m/s).

Exclusion Criteria:

* Extracardiac limitations of ambulatory exercise, cardiac rehab opt out, non-transfemoral TAVI, haemodynamic instability/cardiogenic shock, LVEF \<40%, poorly controlled AF, severe COPD, primary pulmonary hypertension, evidence of cardiac amyloid, more than moderate concomitant valvular heart disease other than aortic stenosis, previous sternotomy, permanent pacemaker implant, patients enrolled in another study where participation would involve deviation from either protocol.
Effect of Vitamin D on Everolimus Trough Concentrations Among Heart Transplanted Patients

Vitamin D is part of the regular treatment regimen among patients after heart transplantation. Due to potential drug-drug interaction between vitamin D and everolmus, these patients are in increased risk for increased everolimus metabolism, potentially leading to under- immunosupression.

post heart transplantation patients treated with everolimus will be screened for vitamin D levels. Patients defined as deficient will be treated with vitamin D with close and intensive monitoring everolimus levels, adjusting oral daily dose to maintain therapeutic levels.

Eligibility Criteria:
Inclusion Criteria:

Heart transplanted patients treated with everolimus

Exclusion Criteria:

-
Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women

The aim of this study is to analyze the effectiveness of a telerehabilitation program with respect to a face-to-face physiotherapy protocol in relation to the improvement of sexual function, the reduction of pain and the improvement of the quality of life, in the treatment of menopausal women with dyspareunia.

Both therapies have been proven to be effective, but since now any randomized controlled trial has been conducted to compare the results regarding the improvement in the sexual function, the reduction of pain and the improvement of quality of life in this population. The investigators hypothesize that the implementation of an asynchronous online telerehabilitation program is not inferior to the effect of the treatment carried out with a face-to-face physiotherapy protocol, in relation to the main variables obtained with the instruments Female Sexual Function Index (FSFI), the Visual Analogue Scale (VAS) and Menopause Specific Quality of Life Questionnaire (MENQOL). Secondary goals are: 1) to evaluate whether the incorporation of a telerehabilitation program to face-to-face treatment increases the effectiveness in relation to performing only the face-to-face physiotherapy protocol, 2) compare the size of the vaginal dilator inserted painlessly at the end of the treatment in all groups, 3) identify any adverse effects associated with the intervention during the study, 4) detail the degree of adherence to the treatment and 5) record satisfaction with the treatment using the Likert Scale.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age from 45 to 65 years.
* Menopausal
* Suffer dyspareunia for 3 months of evolution.
* Willing to complete study questionnaires and informed consent study.

Exclusion Criteria:

* Pacemaker or other types of electronic implant.
* Thrombophlebitis.
* Skin hypersensitivity or rejection of manual contact.
* Active or previous treatment with chemotherapy or radiotherapy in the pelvic area.
* Wounds or burns in the pelvic area.
* Allergy to nickel and chromium.
* Other pelvic floor physiotherapy treatments during the study intervention.
* Other medical and surgical treatments in the pelvic region, such as muscle infiltrations or nerve blocks during the study intervention.
* Surgical intervention in the pelvic area in the last 3 months.
* Fibromyalgia.
* Oncological processes that affect the sacrum.
* Systemic diseases (infectious, vascular, endocrine, metabolic or neoplastic conditions).
* Neuromuscular diseases (Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Myasthenia Gravis or spinal muscular atrophy).
* Myelopathy and Osteomyelitis.
* Diseases that cause alterations of the central nervous system (traumatic or vascular spinal cord injury).
* Neurological or metabolic conditions that affect the ability to respond (Diabetes, Parkinson's disease, senile dementia, etc).
* Serious mental disorder.
Colchicine After Electrocardioversion for Atrial Fibrillation

The purpose of this study is to investigate whether a 3 month treatment course of low-dose Colchicine decreases the recurrence of Atrial fibrillation (AF) after electrocardioversion (ECV) in patients with AF.

Atrial fibrillation is the most common cardiac arrhythmia worldwide and is associated with an increased risk of heart failure, stroke and death. Over the next 40 years the investigators expect another increase in the prevalence of atrial fibrillation with a risk of 1:3 in people over 65 years to develop atrial fibrillation. Electroconversion can occur in patients with atrial fibrillation reestablish sinus rhythm acutely with a controlled electrical shock. Unfortunately it is known however, that there is a short-term recurrence of atrial fibrillation in about 60%. This underlines that our current treatment options are inadequate. There is increasing evidence that inflammation is integral to initiation and maintenance of atrial fibrillation. Therefore, the researchers see inflammation as a possible therapeutic target to reduce the recurrence rate of atrial fibrillation after electroconversion. To test this hypothesis and to help patients, the investigators want to conduct the COLECTRO-AF study.

Eligibility Criteria:
Inclusion Criteria:

* Age \&gt;18 years
* ECG-documented AF prior to ECV
* Successful ECV with conversion of AF to sinus rhythm with persistent sinus rhythm ≥30 minutes after ECV
* Ability to give written informed consent

Exclusion Criteria:

* AF persistence after cardioversion or early AF recurrence within 30 minutes after ECV
* Any other rhythm than AF before cardioversion
* Pulmonary vein isolation within 3 months prior to ECV or pulmonary vein isolation planned within 3 months after ECV
* Known intolerance or hypersensitivity to Colchicine
* Any other absolute indication for Colchicine intake
* Intake of a strong inhibitor of CYP3A4 or P-Glycoprotein (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole)
* Serious gastrointestinal disease (severe gastritis or diarrhea)
* Clinically overt hepatic disease
* Severe renal disease (eGFR\&lt; 30ml/min/1.73m2)
* Clinically significant blood dyscrasia (e.g., myelodysplasia)
* Significant immunosuppression (e.g. due to transplantation or rheumatic disease)
* Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control
* Life expectancy \&lt;1 year
A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors


Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to tumor type, if such a therapy exists
* Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded
* Other active malignancy requiring concurrent intervention
* Prior organ allograft
* Active, known, or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply
Effect of Information About the Benefits and Harms of Mammography on Women's Decision Making

The aim of this study is to assess the effect of receiving information about the benefits and harms of mammography screening on informed choice, decisional conflict, intention to participate in the Early Detection of Breast Cancer Program (EDBCP), and satisfaction. The primary outcome is informed choice about breast screening (adequate knowledge, and consistency between attitudes and intentions). The sample of participants is composed by 400 women from Catalonia and the Canary Islands (Spain) who will receive their first invitation to participate in the EDBCP of the Public Health Service in a period of 2-4 months.

The selected women will receive a letter of invitation with information about the study. In the following 1-2 weeks they will receive a phone call to confirm that they have received the mailed letter and to assess the inclusion criteria. If they agree to participate in the study, they will be asked for informed consent. All the participants will receive a first questionnaire, the pre-intervention survey (10-15 minutes), via web or regular mail. Trained interviewers will collect the responses by phone for women who prefer this method. Once the pre-intervention survey is completed, women will receive the leaflet (intervention or control) via regular mail. Two weeks later, the participants will be contacted again to collect the post-intervention survey (15-20 minutes), via web or by phone. Participation in the mammographic exams of the EDBCP will be collected in the three-month period following the corresponding invitation letter.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 49-50 who - in 2-4 months - will be invited to participate for the first time in the EDBCP of the Institut Hospital del Mar d'Investigacions Mèdiques (IMIM, Barcelona), ICO-Hospitalet (Hospitalet de Llobregat), Lleida Health Region, and the Canary Islands.
* Women with low health literacy will be included

Exclusion Criteria:

* Previous history of breast cancer
* Difficulty speaking Spanish or Catalan
* Cognitive impairment to understand or complete the materials based on the interviewer judgment
TMAO and Atherosclerosis in HIV

In the present study, the investigators sought to prospectively examine the associations of plasma levels of TMAO (trimethylamine oxide), choline, betaine, dimethylglycine, and sarcosine with risk of incident carotid artery plaque, assessed by repeated B-mode carotid artery ultrasound imaging over a 7-year period, in women and men with and without HIV infection from the WIHS (Women Interagency HIV Study) and MACS (Multicenter Aids Cohort Study).


Eligibility Criteria:
Inclusion Criteria:

* participants who underwent carotid artery imaging for plaque assessment at a baseline visit (2004-2006) and at a follow-up visit (2011-2013).

Exclusion Criteria:

* a history of coronary heart disease, individuals with prevalent diabetes or prevalent carotid artery plaques at baseline
Feasibility and Acceptability of the Online JOBS Program

The aim of this study is to test the feasibility and acceptability of a web-based adaptation of the Jobs program (developed by Curran et al., 1999).

The current study is an open trial that will test the feasibility and acceptability of a web-based adaptation of the Jobs program (further be referred to as iJobs). We will use a repeated measures design: one group and three measurements (baseline, post-intervention, 3 months follow-up). iJobs consists of five sessions spread over a two-week period. The participants will learn and exercise successful job search strategies (e.g. finding job openings, creating an attractive resume, demonstrating effective interviews).

Eligibility Criteria:
Inclusion Criteria:

* Unemployed and looking for a job
* Work as volunteers and looking for a paid job
* Have a PC or laptop and basic digital competencies

Exclusion Criteria:

* They don't have internet access and are not available during the two weeks of the program
* Suffer from a chronic disease that implies special conditions for taking part in the activities
* Severe clinical depression symptoms (Cut-off=15 at PHQ9)\*
* Severe clinical anxiety symptoms (Cut-off=15 at GAD7)\*

(\*) will be included if they receive mental health treatment
Prognostic Value of Computed Tomography (CT) Scan in Hemodynamically Stable Patients With Acute Symptomatic Pulmonary Embolism

The objectives of the PROTECT study are:

* To assess the role of CT pulmonary angiography in the risk stratification of hemodynamically stable patients with acute symptomatic pulmonary embolism (PE).
* To assess the role of transthoracic echocardiography in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
* To assess the role of 2 biomarkers (troponin and brain natriuretic peptide) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
* To assess the role of the Pulmonary Embolism Severity Index (PESI) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.
* To assess the combined role of CT pulmonary angiography, transthoracic echocardiography, PESI, troponin I and brain natriuretic peptide in the risk stratification of hemodynamically stable patients with acute symptomatic PE.


Eligibility Criteria:
Inclusion Criteria:

* Acute symptomatic Pulmonary Embolism (PE) confirmed by:

  * CT pulmonary angiography positive for PE
  * Ventilation/ perfusion lung scan with high likelihood of PE (according to PIOPED criteria)
  * V/Q ventilation/ perfusion lung scan inconclusive for PE or negative CT pulmonary angiography in a patient with thoracic symptoms and a lower limb ultrasound showing a positive diagnosis for deep vein thrombosis.

Exclusion Criteria:

* Contraindication for CT pulmonary angiography (allergy to iodine contrasts or creatinin clearance \< 30 ml/min).
* Informed consent not obtained.
* Pregnancy.
* Life expectancy of less than 3 months.
* Hemodynamic unstability defined as SBP \< 90 mm Hg, need for cardiopulmonary reanimation, need for vasoactive drugs or orotracheal intubation.
* Thrombectomy, insertion of filter in the cava vein, or need for fibrinolytic treatment for PE episode.
* Participation in another clinical trial for treatment of PE.