cyrilzakka/clinical-trials huggingface dataset:
Home Blood Pressure Monitoring to Improve Hypertension

The goal of this single group pre-post-study is to test the possibility of self-monitoring with shared medical appointments program for lifestyle education in improving blood pressure (BP) of patients with uncontrolled hypertension.

The main questions it aims to address is:

1. To assess if patients with uncontrolled hypertension and their physicians will be interested in trying a program that includes self-monitoring with 6-week support for lifestyle changes and coping skills to improve BP and hypertension control.
2. To assess if patients with uncontrolled hypertension can safely participate in a program that includes self-monitoring with 6-week support for lifestyle changes and coping skills to improve their BP and ability to self-manage hypertension

Participants will:

* Send self-reports of their home BPs, diet, physical activity and emotions
* Attend 6-week education program of lifestyle changes and coping skills delivered by physicians, holistic psychotherapists and yoga therapists.

Participants will be taught the proper use of Home BP machines using a teach-back technique. Patients will be loaned valid home BP machines.

Participants will be taught how to send self-reports of their home BP, diet, physical activity and emotions using an app on their phone.

Participants will be signed up for a 6-week educational program of lifestyle changes and coping skills delivered by physicians, holistic psychotherapists and yoga therapists.

Participants will receive summary reports of their Home BP, lifestyle and emotions.

Researchers will monitor home BP levels and any adverse effects. Primary care physicians of the patients with persisting high BP levels will be notified of their average home BPs. Patients will complete surveys that assess their ability to self-manage their hypertension, emotions, and social connections. Change in average home BP from before, during, and after 6-week educational program participation will be evaluated. Final average home BP and clinic BP notifications will be sent to the primary care physicians of all patients.

Eligibility Criteria:
Inclusion Criteria:

* Uncontrolled hypertension based on Clinic BP measurement of systolic BP\>140 or diastolic BP \>90 mm Hg (as the cutoff in the current common hypertension performance measures and ACO metrics)
* PCP recommends or patient desires a trial of self-monitoring and lifestyle modifications
* Patient owns a smart phone and be willing to complete self-reports of BP during study participation.

Exclusion Criteria:

* On dialysis
* Pregnant
* Have a terminal illness,
* Clinic BP \> systolic\>180, diastolic\>110
* Arm circumference that exceeds the limit for the largest home BP monitor cuff
* Severe cognitive impairment
* Major cardiovascular or cerebrovascular event in the past 6 months (Coronary artery disease, heart valve problems, arrhythmias, heart failure, stroke)
* Any physical or mental impairment that would affect patients' ability to participate(Ability to participate will be assessed by demonstrated ability to use available home BP machine and complete self-report during recruitment).
Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse

The aim of this study is to investigate the inflammatory and maturation processes of immature myeloid cells (IMC) in the vaginal tissue in women with advanced pelvic organ prolapse (POP) (stage III-IV) and in normal non-POP controls.

We hypothesize that the processes contributing to POP may be related to immune response and changes in myeloid cell populations and the cytokine environment.


Eligibility Criteria:
Inclusion Criteria:

* Women with POP undergoing colporrhaphy
* Women undergoing hysterectomy

Exclusion Criteria:

* Autoimmune and connective tissue disorders
* Cancer in genital tract
EPIdemiological Approaches to the Cardiovascular Consequences of COVID-19

The COVID-19 pandemic highlights the importance of the prognosis of co-morbidities, such as coronary artery disease, which significantly increase the risk of mortality in patients infected with SARS-CoV2. Investigators have recently studied the complex links between respiratory infections, particularly pneumonia, and type 2 myocardial infarction (MI) in many respects. The etiology of type 2 MI is based on an imbalance of myocardial oxygen supply/need in the absence of rupture/erosion of atheromatous plaques. Based on the RICO survey data, the investigators investigated whether COVID-19-related sepsis and/or respiratory failure could be an underlying mechanism of MI2.


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized for a type 2 MI in CCU from CHU Dijon Bourgogne With or without pneumonia
* patients hospitalized for a type 2 MI in CCU from CHU Dijon Bourgogne With or without COVID 19

Exclusion Criteria:

* None
Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair

The purpose of this study is to collect additional safety data and demonstrate the performance of Integra Gentrix® Surgical Matrix for reinforcement of ventral hernia repairs.

Retrospective data will be collected and assessed for early post-operative surgical site events and complications in the immediate post-operative period of 90 days.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between 22 years and 80 years old (inclusive) at time they underwent abdominal wall reconstruction utilizing Gentrix® Surgical Matrix as a reinforcement graft during the time period between November 1, 2017, and present (90 days prior to the start of the data collection)..
2. Subject underwent abdominal wall reconstruction for a hernia(s) using Integra® Gentrix® Surgical Matrix.

Exclusion Criteria:

1. Subject has known allergy to porcine-derived products.
2. Subject required use of Gentrix® device and a second non-Gentrix surgical mesh in the same plane or in different planes for single hernia e.g., Gentrix sublay and a synthetic device in the onlay position.
3. Subject had active necrotizing fasciitis or any current known uncontrolled systemic infection.
4. Subject had uncontrolled diabetes, defined as Hb1AC value \>7% within 12 weeks prior to index procedure.
5. Subject has been diagnosed with cirrhosis and/or ascites.
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections

This is pilot study of the immunologic effects of intradermal Bacille Calmette-Guerin (BCG) vaccination of adults with cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and healthy volunteers.

This single-site, open-label clinical trial to investigate the immune effects of BCG vaccination in adults with cystic fibrosis, non-cystic fibrosis bronchiectasis and healthy volunteers by measuring pre and post vaccination immune responses, BCG uptake and protection against infections, including nontuberculous mycobacteria (NTM). This study will also gather data on study feasibility, tolerability, and safety.

Eligibility Criteria:
Inclusion Criteria (CF and non-CF bronchiectasis):

* Confirmed diagnosis of either CF or non-CF bronchiectasis
* Forced expiratory volume over one second (FEV1) \> 40%
* Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.
* Available for the study duration, including all planned follow-up visits

Inclusion Criteria (Healthy Volunteers):

* Negative HIV enzyme-linked immunosorbent assay (ELISA) and confirmatory test at screening.
* Willingness to participate in the study after all aspects of the protocol have been explained and written informed obtained.
* Available for the study duration, including all planned follow-up visits

Exclusion Criteria (All arms):

* Current or prior history of active or latent tuberculosis (TB) (per report, not formally tested) or NTM infection
* Prior BCG vaccination
* Previous vaccine in the past 4 weeks
* History of severe anaphylaxis to any vaccine or vaccine components
* History of organ/bone marrow transplantation or other immunosuppressing condition, including HIV
* Immunosuppressing drugs (including oral corticosteroids equivalent to \>10mg of prednisone for 5 days) in the 30 days prior to study enrollment
* Cirrhosis or portal hypertension
* Pregnant or breastfeeding
* Receipt of another investigational product in the last 28 days or planned receipt during this study
* Has any other condition that, in the opinion of the principal investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
A Prospective Cohort Study of MR Abnormalities and Back Pain Risk

Low back pain is a frequent cause of disability and a common reason for outpatient care in veterans. Magnetic resonance imaging (MRI) of the lower back often reveals abnormalities,which may be used to justify expensive and invasive therapy, such as surgery. Yet the link between MRI abnormalities and the risk of developing clinically significant back pain is far from clear. This longitudinal study will determine the prevalence and incidence of MRI abnormalities among veterans and determine the extent to which specific MRI abnormalities predict future development of back pain. The result should help clinicians use MR imaging more efficiently, and they may ultimately help reduce the frequency of unnecessary back surgery.

Primary Objective:

Low back pain is a frequent cause of disability and a common reason for outpatient care in veterans. Magnetic resonance imaging (MRI) of the lower back often reveals abnormalities, which may be used to justify expensive and invasive therapy, such as surgery. Yet the link between MRI abnormalities and the risk of developing clinically significant back pain is far from clear. This longitudinal study will determine the prevalence and incidence of MRI abnormalities among veterans and determine the extent to which specific MRI abnormalities predict future development of back pain. The results should help clinicians use MR imaging more efficiently, and they may ultimately help reduce the frequency of unnecessary back surgery.

Study Abstract:

Low back pain is the second most common symptomatic reason for physician visits in the U.S. resulting in over $24 billion annually in direct health care costs. A survey of primary care patients a the Seattle VA revealed that more than one-quarter experienced back pain severe enough to require a visit to a health care practitioner. Imaging plays a vital role in the valuation of patients with back pain. However, a causal relationship between imaging abnormalities and back pain has yet to be clearly established. Abnormalities of the lumbar spine on magnetic resonance (MR) imaging are common and increase with age to the point that they are nearly ubiquitous over the age of 50. Despite this, imaging abnormalities are often used to justify various therapies for low back pain, including expensive and invasive therapy, such as surgery. Prior studies have examined the prevalence of imaging abnormalities, but no study has investigate either the degree of risk that imaging abnormalities impart for the development of low back pain or the incidence of imaging abnormalities. The goal is to examine the natural history of magnetic resonance imaging of the lumbar spine in asymptomatic subjects. We want to determine the relationship of imaging abnormalities to the development of low back pain by comparing patients with normal imaging to those with abnormal imaging

Eligibility Criteria:
VA patients who did not have low back pain within the past four months of recruitment, never had spine surgery, and had no serious systematic medical problem.
Evaluation of Fluid Retention Due to Superpotent Topical Corticosteroid

Clinical observation frequently shows a paradoxical effect of topical corticosteroids in charge of a sudden melting of edema in the first days of treatment, which could be due to mobilization of extracellular. No study has shown the value of this measure in patients treated with topical steroids. This uncertainty, coupled with the observation of the paradoxical effects of topical steroids on edema are some patients that despite the systemic absorption of clobetasol propionate, a salt-free diet is not currently recommended practice.

The main objective of the study is to evaluate whether there is fluid retention after introduction of clobetasol propionate treatment from 10 g/day dosage to 40 g / day in patients with bullous pemphigoid. Bio-impedance is a noninvasive device for measuring with an electric current of low intensity the different volumes of the human body. A preliminary experiment of impedance measurements in some patients with bullous pemphigoid (examination requested as part of a nutritional assessment) showed that these patients had mostly a total water loss without dehydration, corresponding to a significant undernutrition during 1 month of treatment, possibly related to muscle wasting and protein loss by skin erosions without obvious argument for fluid retention, justifying reproduce these measures on a larger number of patients and the other to accurately assess the evolution of nutritional parameters during the first month of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patient with age higher than 18
* Patient with bullous pemphigoid,
* Patient treated by local corticosteroid therapy (clobetasol propionate cream) but not yet processed or for less than 48 hours,
* Signed informed consent.
* Patient affiliated to Social Security Regimen
* Effective contraception in women of childbearing age (for postmenopausal women, confirmatory diagnosis of menopause will be collected)

Exclusion Criteria:

* Concomitant treatment with corticosteroids
* Recent introduction or recent (\<6 weeks) treatment with diuretics, angiotensin-converting enzyme, receptor antagonist or anti-angiotensin renin (aliskiren)
* contraindication to the use of Clobetasol propionate (DERMOVAL and CLARELUX)
* Patient on salt diet (\<or = to 5 g / d)
* Patients carry a defibrillator or a pace maker
* Amputated Patient
* Pregnant and lactating
* Patient with Urinary Incontinency
* Recent heart decompensation in the last 6 weeks
* known Nephrotic Syndrome
* known or Severe hepatic impairment
* Hypoalbuminaemia less than 20 g / l
Textbook Outcome in Colon Carcinoma

BACKGROUND:

Textbook outcome (TO) is a multidimensional quality management tool that uses a set of traditional surgical measures to reflect an "ideal" surgical result for a particular pathology. The aim of the present study is to record the rate of TO in patients undergoing elective surgery for colon cancer.

MATERIAL AND METHODS:

Retrospective study of all patients undergoing scheduled colon cancer surgery at a Spanish university hospital from September 2012 to August 2016. Patients with rectal cancer were excluded. The variables included in the definition of TO were: R0 resection, number of isolated nodes ≥12, no Clavien-Dindo ≥IIIa complications, no prolonged stay, no readmissions, and no mortality in the first 30 days.

The main objective of this study is to analyse the achievement of TO in a series of patients undergoing scheduled colon cancer resection at the Doctor Balmis General University Hospital in Alicante, Spain. The investigators assess the relationship between TO and overall and disease-free survival, and analyse the indicators included in the definition of TO in colon cancer surgery in order to establish recommendations for its standardization.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective colon cancer resection with confirmed histological diagnosis were eligible for the study

Exclusion Criteria:

* Age under 18 years
* Emergency surgery
* Resections of the rectum or resections for pathologies other than cancer
* Follow-up of less than two years (with the exception of patients who died)
Effect of Vitamin D on Morbidity and Mortality of the COVID-19

Patients diagnosed of COVID-19 disease are randomized to receive a single dose of 100.000 IU of Cholecalciferol (Vitamin D arm) or no vitamin D (on top of the current medication used to treat COVID 19).

Clinical, radiological and biochemical outcomes of COVID 19 disease as well as mortality are evaluated.

Efficacy parameters to compare both groups (vitamin D and No vitamin D).

Time to reach undetectable levels of SARS COV2 Infection.

Time of normalization of symptoms and clinical parameters.

Time of normalization of radiological images.

Time of normalization of biochemical markers.

Time of normalization of molecular inflammatory markers.

Transfer to the Intensive care Unit.

Mortality rate.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 year
* Diagnosis of COVID-19
* Accept to participate in the study ( consent)

Exclusion Criteria:

* Pregnancy
* Allergy to vitamin D
* Consumption of any form of vitamin D during the last 3 months
* Expected fatal outcome in the next 24 hours
* Cognitive deterioration
Short Duration Versus Fourteen Days Antibiotic in Common Bile Duct Cholangitis

Common bile duct stone cholangitis is a potentially fatal condition, characterized by an obstruction and bacterial infection of biliary system. The principles of management are appropriate biliary drainage and systemic antibiotics. There has been limited data about appropriate time of antibiotics in patient with successful endoscopic drainage.

The aim is comparing the efficacy and safety between short duration and standard fourteen days antibiotic treatment in patients with acute common bile duct stone (CBDS) cholangitis after successful endoscopic biliary drainage as regards recurrence rate of acute cholangitis, complete stone clearance rate, morbidity and mortality associated acute cholangitis, and complications related ERCP procedure.

The study will be divided patients with acute CBDS cholangitis with complete stone clearance into 2 groups, group (A) will be received intravenous antibiotic until the temperature is less than 37.8 c for 72 hours and group (B) will be received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old
* diagnosis of acute mild to moderate severity of ascending common bile duct stone cholangitis
* endoscopic retrograde cholangiopancreatography (ERCP) with biliary drainage within 72 hours after admission

Exclusion Criteria:

* pregnant woman
* the cause of obstruction other than common bile duct stone
* severe co-morbid diseases such as cardiovascular/pulmonary/kidney disease
* active concomitant infections of other organs
* history of allergy to cephalosporin group
Interest of Self-compression Technique on Tolerance of Mammography

Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local cancer breast.

It is sometimes poorly tolerated by some patients who complain of an uncomfortable examination or pain.

Breast compression by the manipulator aims to reduce the thickness of the breast during mammography; This act is an important factor of pain or discomfort felt by the patient. But, it is also an image quality factor.

This study aimed to compare self-breast compression by the patient to the compression standard technique carried out by the manipulator.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 years and ≤ 75 years of age
* ECOG performance \<2
* Mammography planned as part of a breast cancer screening or a monitoring following treatment of a breast lesion
* Ability to provide written informed consent
* Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study.

Exclusion Criteria:

* Eastern Cooperative Oncology Group performance status ≥ 2
* Treatment for benign lesion with surgery for less than 3 years
* Treatment for cancer with surgery and / or radiotherapy for less than 3 years
* Biopsy for less than 1 year
* Breast prosthesis
* Mastectomy
* Assessment motivated by a clinical breast abnormality
TREND-HD - A Trial of Ethyl-EPA (Miraxion™) in Treating Mild to Moderate Huntington's Disease

This study is designed to determine the effect of 2 gram/day of ethyl-EPA on motor (movement) signs and symptoms of Huntington disease.

Multi-center, double blind, placebo-controlled study with parallel groups of outpatients with early, symptomatic Huntington's disease. Participants will be randomized to receive 1 gram twice daily (2 gram/day total daily dose) of active study drug or placebo. The 6-month placebo-controlled phased will be followed by a subsequent 6-month open-label extension phase with all subjects receiving 1 gram twice daily (2 grams/day total daily dose) of active study drug.

Eligibility Criteria:
Inclusion Criteria:

* Clinical features of Huntington's disease (HD) and confirmatory family history of HD, and/or CAG repeat expansion greater than or equal to 36
* Ambulatory, not requiring skilled nursing care (total functional capacity \[TFC\] greater than or equal to 7)
* Chorea score of at least 2 in one extremity (UHDRS)
* Maximal dystonia less than or equal to 2 and maximal bradykinesia less than or equal to 2
* 35 years of age or older of either gender
* Must be on stable dosages of non-competitive NMDA receptor antagonists, and/or antiepileptic medications for 60 days prior to baseline
* Females of child-bearing potential must use adequate birth control

Exclusion Criteria:

* History of established diagnosis of tardive dyskinesia
* Clinical evidence of unstable medical or psychiatric illness
* Clinically significant active and unstable psychotic disease (hallucinations or delusions)
* Major depression (Beck Depression Inventory \[BDI\]-II Score greater than 20) at Screening Visit
* Suicidal ideation (BDI-II item 9 greater than or equal to 2) at Screening Visit
* History of clinically significant substance abuse within 12 months of Baseline Visit
* Pregnant/lactating women
* Participation in other drug studies within 60 days prior to Baseline Visit
* Previous participation in any investigational study of ethyl-EPA (Miraxion™)
* Use of aspirin at daily dosage greater than 325 mg/day
* Exclusionary Drugs (within 6 months Baseline Visit): Depot neuroleptics
* Exclusionary Drugs (within 60 days Baseline Visit): Omega-3 supplementation, tetrabenazine or reserpine, high dose and/or variable dose oral anti-psychotic medications, steroid (other than topical), selenium supplements greater than 55 mcg/day, lithium, benzodiazepines (except for low dose), anticoagulants