cyrilzakka/clinical-trials huggingface dataset:
Physical Activity, Hypertension, Diabetes, and Coronary Heart Disease

To study the influences of physical activity on the incidence of hypertension, non-insulin-dependent diabetes (NIDDM), and coronary heart disease (CHD), taking into account the influences of other life-style elements such as body size, cigarette habit, alcohol consumption habits, and parental history of disease on these same chronic diseases.

BACKGROUND:

Epidemiologic investigations of the influence of physical activity on the incidence of specific chronic diseases encounter problems of confounding or interaction with eating behavior, tobacco use, other social habits, and a host of personal characteristics. These influences of life styles on chronic diseases are not mutually exclusive, nor do they operate independently. Rather, they blend, amplifying or diminishing the effects of one another.

DESIGN NARRATIVE:

The study used data collected since 1960 as part of the College Alumni Health Study -- a cohort of 50,000 former students who attended Harvard College, 1916-1950, or the University of Pennsylvania, 1931-1940, and who reported by questionnaire on their health habits and health status in post-college years through 1988. Over 17,000 Harvard alumni have been followed from 1962 through 1988 for both non-fatal and fatal chronic diseases. These predictor (risk factors) and outcome (specific diseases) data were analyzed to test the hypothesis that different kinds and amounts (frequencies, intensities, durations, and constancies) of physical activity affect differently the incidence rates of hypertension, NIDDM, and CHD. Continuities and changes in specific life styles and chronic diseases have been measured continually through return-mail questionnaires in 1962, 1966, 1972, I977, and 1988. Cause-specific mortality has been monitored continuously over this span of time, 1962-1988. Using the data, the investigators computed relative and attributable risks of developing hypertension, NIDDM, and CHD that related to alumni patterns of physical activity, body size, alcohol consumption, cigarette use, and other personal characteristics and ways-of-living. In this discrete population, they searched for the relative importance of physical activity and other potential predictors in influencing the occurrence of these hypertensive-metabolic-atherosclerotic diseases.

Eligibility Criteria:
No eligibility criteria
A Trial of a Home Based Walking Program as an Alternate Program for Non Attenders at Cardiac Rehabilitation

The purpose of this study is to investigate if a home-based walking program is an acceptable alternative for those who choose not to attend formal cardiac rehabilitation programs and if such a program has an effect on coronary risk or physical fitness.

Coronary heart disease (CHD) is the most important cause of life years lost in Northern Ireland (NI). A recently updated Cochrane review (Joliffe et al, 2003) confirmed the findings of earlier meta-analyses (O'Connor et al, 1989; Oldridge et al, 1988) which indicated that participation in cardiac rehabilitation (CR) reduces mortality after MI. The earlier work demonstrated a reduction of 20-25% in all-cause and cardiac mortality. The recent work allowed analysis of an increased number of patients (8440 in 32 trials) and reported a reduction in total cardiac mortality of up to 31%. Participation in CR after MI also improves well-being and reduces disability (NHS, 1998). However, informal reports suggest that only approximately 50% of patients actually attend a hospital based program.

The hypothesis to be tested is that for those who chose not to attend formal CR, a home-based walking program is an acceptable alternative.

This programme of work entails two separate study designs. To evaluate the home-based walking program, we plan a randomised controlled trial (RCT). Randomisation of subjects to study groups will follow determination of eligibility to participate. Participants randomised to the experimental group will be asked to walk for up to 30 minutes, 5-days per week. They will be requested to record aspects of their walking in a diary, including time, intensity and number of steps taken (recorded using a pedometer).

Qualitative methodology using semi-structured interviews will be used to explore the experiences of those allocated to the intervention group. The attitudes and experiences of other non-attenders of CR who declined to participate in the trial will be explored in focus groups. Three focus groups each containing 8 participants are planned.

Focus group transcripts will be analysed independently by two observers using a computer program (NUDIST) to identify themes and develop questions for the semi-structured interviews. Analysis of the semi-structured interviews will be descriptive, responses being categorised into themes as appropriate.

RCT results will be analysed by intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* Justification of diagnosis of myocardial infarction by report of cardiac bio-markers or electrocardiogram changes

Exclusion Criteria - planned for RCT - applied to small pilot:

* Heart failure/ Cardiogenic shock
* Complex ventricular arrhythmias
* Mental/physical impairment (exclude if housebound/dementia)
* Valve disorder-severe stenotic or regurgitant lesion
* Hypertrophic cardiomyopathy
* Exercise Stress Test result- exclude if ST depression\>=2 mm or angina at \<5 Metabolic Equivalent of Tasks (METS) (e.g. 3 minutes of a Bruce protocol). (Also exclude if report of ST segment depression \>=1 mm on resting ECG )
This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.


Eligibility Criteria:
Inclusion Criteria:

* Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings;
* Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;

Exclusion Criteria:

* Subject had significant PVR volume (\> 150 mL);
* Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
* Subject had an indwelling catheter or practices intermittent self catheterization.
* Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
* Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
* Subject had moderate to severe hepatic impairment
* Subject had severe renal impairment
* Subject had a clinically significant abnormal ECG
* Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening.
* Subject had an average QTcF interval \> 450 ms for males or \> 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia).
* Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.
Comparative Effectiveness of Cystine Versus Nicotine Replacement Therapy

A pragmatic, single blinded, randomized, controlled non-inferiority trial of Cytisine versus Nicotine Replacement Therapy for continuous abstinence is conducted in the government run primary health hospitals in Mongolia.

Rationale: In Mongolia, smoking cessation assistance in the governmental health sector consists of behavioral counseling and a 3-week regimen of the NRT patch that costs 175 USD. This cost for low income adults limits effectiveness. A 2014 study documented the superiority and lower cost (\<20 USD) of Cytisine versus NRT for continuous abstinence. Trial investigators are testing the comparative effectiveness of Cytisine in the "real life setting" of their national health care system and, if proven effective, will include coverage for Cytisine in the national health plan.

Research Question/Objective: To determine whether a 25 day course of Cytisine tablets is at least as effective as 25 days of NRT in helping smokers remain abstinent for at least one month.

Design: A pragmatic, single blinded, randomized, controlled non-inferiority trial.

Setting: Six governmental primary care centers in Ulaanbaatar, Mongolia, and outskirts.

Participants: Mongolian adult smokers referred to government-run addiction units.

Intervention and procedures: Participants are randomized to 5 weeks of treatment (n=654) or usual care (n=653) and a 6-month follow-up. The treatment consists of a 25-day course of Cytisine tablets and behavioral counseling. Usual care consists of 25 days of NRT and behavioral counseling.

Measurements: The primary outcome is continuous abstinence (\< 5 cigarettes smoked since quit date) at 1 month. Secondary outcomes include 7-day point prevalence abstinence rates and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Seeking smoking cessation treatment
* Ages 18 years or older
* Currently smoking \> 5 cigarettes per day
* Willingness to make quit attempt with pharmacotherapy
* Able to provide verbal and written informed consent
* Have telephone access

Exclusion Criteria:

* Pregnancy or currently breastfeeding
* Current users of NRT (patch, gum, lozenge)
* Current users of non_NRT smoking cessation pharmacotherapy
* Enrolled in another smoking cessation program (non-governmental)
* Clinical disorder that contraindicates use of NRT or Cytisine (heart attack, stroke, severe angina within the past 2 weeks, uncontrolled hypertension, phaeochromocytoma, severe mental illness)
Medico-economical Assessment of Telemedicine During Chronic Diabetes-related Foot Wound Management

The aim of the study is to assess the cost-effectiveness of telemedicine in the care of chronic diabetic foot ulcers.

Patients will be randomized into 2 groups: 1/conventional care group with iterative visits to diabetes specialist or 2/innovative care (telemedicine group).

the health insurance system perspective is adopted.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 or 2 diabetes, at least 18 years old
* Patient with a diabetic foot wound :

  * Acute or chronic (evolving for at least 30 days)
  * size ≤ to 3 cm²
  * Level I, II or III, stage A or B, excluding stages C and D from the University of Texas Wound Classification Systems
* Person affiliated to French Health insurance or equivalent
* Person having signed freely the consent form after receiving sufficient information
* Treatment compliance and 6 months follow-up feasible

Exclusion Criteria:

* Patient with a ischemic wound: Ankle-Brachial Index (ABI) \<0.9 or Transcutaneous oxygen pressure (TcpO2) \< 30 mmHg (stage C and D from the University of Texas Wound Classification Systems)
* Patient with emergency hospitalization indication whatever the reasons.
* Person deprived of liberty by a legal or administrative decision, patients in emergency and people hospitalised without consent and who are not protected by law.
* Pregnant or breastfeeding women
* Patient currently participating in another telemedicine research protocol (such as : Study on the impact of Telemedicine on the management of patients with type 1 diabetes (TELEDIAB-3))
The Effect of Two Weeks of Voluntary Reduced Physical Activity in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease (COPD) is the most common pulmonary disease, responsible for considerable morbidity and mortality and is the third leading cause of death worldwide. As well as its consequences in the lungs, COPD is well recognized to be associated with a range of important systemic consequences and co-morbidities. Interestingly, skeletal muscle dysfunction is noted in both early and advanced disease, suggesting its origins may not be wholly pulmonary.

Treatment strategies targeting lung function are, unfortunately, of limited value. Given the burden of disease, it is becoming increasingly important that investigative and therapeutic work now focuses on other systemic characteristics and sequelae which define the disease phenotype.

This is a randomized controlled trial of the effect of 14 days of voluntary reduced activity on muscle mass, muscle strength, body composition, and atrophy signalling in patients with COPD and age-matched controls.

The primary hypothesis upon which this study is based is that a short reduction in ambulation will induce a transient reduction in quadriceps muscle mass, quadriceps strength and physical performance in patients with COPD compared to matched COPD patients whose mobility has not been restricted.

The secondary hypothesis is that the magnitude of the above changes will be greater in physically inactive COPD patients compared to physically inactive age-matched controls.

The overall aim of this research is to use an in vivo human model of 14 days of voluntary reduced physical activity to test the above hypotheses. If the model proves feasible, this will allow for earlier proof of concept studies of novel therapeutic agents.

This is a non-commercial randomized controlled trial. 15 patients with COPD and 15 age-matched controls will voluntarily reduce their daily step-count to no more than 1500 steps/day, from a baseline of \> 3500 steps/day.

Before and after 14 days of reduced daily step-count, these 30 participants will undergo measures of appendicular mass, quadriceps strength, exercise tolerance and blood and urinary biomarkers. Quadriceps muscle biopsies will also be taken before and after the 14-day intervention.

15 patients with COPD will be studied 14 days apart but will not undergo the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoking adult patients with COPD (GOLD stage II-IV)
* Non-smoking, healthy, age-matched controls
* Baseline step count \> 3500 steps/day
* Baseline 6 minute walk distance \> 140m

Exclusion Criteria:

* Inability to provide written, informed consent
* Significant co-morbidity limiting exercise tolerance
* Within 1 month of acute exacerbation of COPD
* Within 1 month of pulmonary rehabilitation
* History of venous thrombo-embolism or known increased risk of thrombotic disease
Comparison of Outcome of Three Days Bowel Preparation vs No Bowel Preparation in Patients of Colostomy Reversal

The goal of this trial is to compare the outcomes of colostomy reversal with three days bowel preparation with no bowel preparation in terms of anastomotic leakage, surgical site infection and hospital stay.

The important question this trial aims to answer is:

1. is there any difference in outcomes after colostomy reversal with three days gut preparation pre-operatively vs no gut preparation?

This prospective Randomized Controlled trial will include children with colostomy divided into two groups:

Group A: No Mechanical Bowel Preparation Group B: 3 Days Mechanical Bowel Preparation Participants of Group A will be admitted 1 day prior to surgery date as they require no special preparation before surgery. They will be made Nil per oral 6 hours prior to surgery. Group B participants will be admitted 3 days prior to surgery. These participants will be restricted to fiber rich diet and milk 72 hours prior to surgery. They will be shifted to clear liquids 24 hours prior to surgery. Normal saline enema will be given 8 hourly through the stoma as well as per rectally by the trained person.

Comparative outcomes will be:

1. Anastomotic leakage
2. Hospital Stay
3. Wound infection


Eligibility Criteria:
Inclusion Criteria:

* Children with colostomy between 1-15 years of age

Exclusion Criteria:

* Malnourished
* Previous history of colostomy site anastomotic leakage
Hair Up Prospective Study

The objective of this study is to assess the performance of Hair Up on female pattern hair shedding and regrowth. 58 adult female patients suffering from hair loss will be evaluated in a single center prospective study


Eligibility Criteria:
Inclusion Criteria:

* Women who report hair loss during the past 3 months prior to the study

Exclusion Criteria:

* Disorders and medications affecting hair loss/growth, pregnancy, scarring alopecia
Middle Meningeal Artery Embolization for Patients with Chronic Subdural Hematoma

COMPLEMENT study (ChrOnic subdural hematoMa Patients suppLemented with Embolization of Middle mENingeal artery Trial) is a prospective, open label, blinded endpoint (PROBE), Japanese, two-arm, randomized, controlled, post-market study to assess the efficacy and safety of middle meningeal artery embolization for chronic subdural hematoma.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>=18
2. pre-mRS 0-3
3. Hematoma thickness \>=10mm
4. Having at least one risk factor Risk factor: Age \>=75, Antithrombotic therapy, DM, Bilateral hematoma, Markwalder grading score \>3, Preoperative volume \>=130ml, Preoperative midline shift \>=8mm, CT appearance (Homogeneous, laminar or separated)

Exclusion Criteria:

1. Cr \>=1.8
2. Plt \<50,000, PT-INR \>2
3. Life expectancy \<6 months
Effects of Miglitol on Daily Plasma Glucose in type2 Diabetes Treated With Insulin

In this study, the effect of miglitol on daily plasma glucose will be evaluated in type 2 diabetic patients treated with insulin.


Eligibility Criteria:
Inclusion Criteria:

* type2 diabetes
* postprandial plasma glucose levels ≧180mg/dl

Exclusion Criteria:

* type1 diabetes
* AST(GOT) or ALT(GPT) ≧100IU/l
* creatinine ≧2.0mg/dl
Clinical Trial ES 900 - 2019

The primary objective of this clinical trial is to assess the clinical performance of the investigational device. To that end, the Limits of Agreement with respect to comparator devices are analyzed. The Limits of Agreement allow estimating the expected measurement deviation per measurand, which is compared to the "maximum acceptable measurement error", as defined by the Risk Analysis of the investigational device, to assess the risk involved in measurements of the investigational device. Furthermore, the in-vivo repeatability will be quantified for each measurand, as well as the confidence intervals for mean deviation with respect to the current gold standard device.

As a secondary objective of the study, raw measurement data will be collected to allow for improvement of existing algorithms, development of additional measurands and for retrospective analysis.

The EYESTAR900 (the investigational device) is a new device by HAAG-STREIT AG, for measurement of optical biometry and advanced corneal topography by swept-source optical coherence tomography (OCT).

Eligibility Criteria:
Inclusion Criteria:

At least one eye of each subject needs to fulfill one of the following inclusion criteria:

* volunteers with normal phakic eye;
* patients seeking cataract surgery;
* patients with pseudophakic eye;
* patients with oil-filled eye;
* patients with aphakic eye.

Exclusion Criteria:

* Exclusion criteria per subject:

  * underage patients (younger than 18 years);
  * vulnerable patients;
  * inability to give informed consent;
* Exclusion criteria per eye:

  * inability to maintain stable fixation;
  * corneal lesions or scarring;
  * previous corneal surgery (except: pseudophakic eyes, oil-filled eyes, aphakic eyes);
  * previous intraocular surgery (except: pseudophakic eyes, oil-filled eyes, aphakic eyes);
  * active inflammation of the eye;
  * active infection of the eye;
  * tear film break up time of less than 5 sec.
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of at least 23 years of age and not more than 79 years of age at the time of signing informed consent
* Human growth hormone (hGH) treatment naïve or no exposure to hGH or growth hormone (GH) secretagogues for at least 180 days prior to randomisation with any registered or investigational hGH or GH secretagogue product (if only used in connection with stimulation tests for diagnosis of growth hormone deficiency (GHD), subjects can be included)
* If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator
* FOR ALL COUNTRIES EXCEPT JAPAN:

Confirmed diagnosis of adult growth hormone deficiency (Subjects must satisfy one of the following criterion and documentation of test results must be available before randomisation (either from subjects' file or new test):

1. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L)
2. Growth hormone releasing hormone (GHRH) + arginine test according to body mass index (BMI): i) BMI less than 25 kg/m\^2, a peak GH less than 11 ng/mL (11 mcg/L), ii) BMI 25-30 kg/m\^2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m\^2, a peak GH less than 4 ng/mL (4 mcg/L)
3. Three or more pituitary hormone deficiencies and insulin like growth factor - I standard deviation score (IGF-I SDS) less than -2.0 - FOR JAPAN ONLY: Confirmed diagnosis of adult growth hormone deficiency (subjects with adult onset adult growth hormone deficiency (AGHD) need to satisfy at least one of the following criteria, subjects with a history of childhood GHD need to satisfy at least 2 of the following criteria):

a. ITT test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) b. glucagon test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) c. growth hormone releasing peptide 2 (GHRP-2) tolerance test: a peak GH of less than or equal to 9 ng/mL (assay using recombinant GH standard)

Exclusion Criteria:

* Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of squamous cell or basal cell carcinoma of the skin
* Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's file