cyrilzakka/clinical-trials huggingface dataset:
Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus

Type 2 diabetes mellitus (T2DM) is a major public health problem .Prevalence of vitamin D deficiency is also high i.e. 78-96% in different groups of population in north India. Observational studies find association between low Vitamin D status and type 2 diabetes mellitus. Prediabetes is a condition that progress to diabetes at a rate of 6-10% per year .There is mechanistic support that vitamin D may influence both insulin secretion and insulin sensitivity and subsequently T2DM incidence. In general, cross-sectional and prospective studies support the role of vitamin D in the prevention of T2DM. This study will be a single blind randomized placebo controlled trial to study the effect of oral cholecalciferol in insulin sensitivity and secretion in adults with prediabetes who are also vitamin D insufficient.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 20 years
* Impaired fasting glucose (IFG) - FPG 100-125 mg/dl
* Impaired glucose tolerance((IGT)- 2hr PPG 140-199mg/dl

OR

* both ( IFG +IGT)
* with or without Hb A1c -5.7-6.4 %

WITH

* Asymptomatic Vitamin D deficiency(\< 20ng/ml) or vitamin D in sufficiency(\< 32ng/ml)

Exclusion Criteria:

* Diabetes mellitus,
* Base line 25(OH)D3 \> 32 ng/ml,
* Symptomatic vitamin D deficiency,
* Any medication within last month that could affect insulin secretion, insulin sensitivity , vitamin D and calcium metabolism
* Chronic renal , hepatic ,malignant, intestinal or endocrine diseases
* Febrile illness or infective morbidity in last 2 weeks,
* Grossly deranged liver and kidney function
Workplace Based Rehabilitation for Low Back Disorders

The purpose of this study is to examine the effect of back supports plus education upon recovery from a work-related low back disorder. The study tests the hypothesis: the use of back supports plus health education is not different from health education alone in promoting recovery from a work-related low back disorder in consideration of personal, health, and job factors. Significant improvements in physical health, neurogenic symptoms, back pain disability, and low back pain were observed over the twelve months of study follow-up. No statistically significant difference between the study groups was found with respect to these measures.

BACKGROUND Low back pain remains a common major source of morbidity and disability. Few studies consider the effectiveness of interventions for low back pain while simultaneously considering personal, health, and job characteristics.

METHODS This is a randomized clinical trial in which 433 active employees with low back disorders were randomly assigned to one of two study groups: 1) back support plus education on back health; or 2) education on back health only. Demographic, health, medical, and job factors were recorded. Outcomes were evaluated over a twelve month period and included self-reported measures of back pain, back pain disability level, physical health, mental health, back pain recurrence and administrative measures.

RESULTS Significant improvements in physical health, neurogenic symptoms, back pain disability, and low back pain were observed over time in both study groups. However, there was no significant difference between the study groups with respect to these outcome measures. The adjusted hazard ratio of recurrence rate was suggestive of an incremental protective effect due to back supports over education alone (adjusted hazard ratio \[AHR\]=0.711, 95% CI 0.50, 1.04, p=.085). There was also a marginal effect of back supports and education on decreasing low back pain over time (AHR=0.0015, p=0.091).

CONCLUSIONS Back supports may have some value in promoting recovery from low back pain, but this effect is only observed in individuals who are actively employed in jobs with medium risk of low back disorders.

Eligibility Criteria:
Inclusion Criteria:

work-related low back disorder, 18-64 years of age,active hourly worker, enrollment into study within eight weeks of diagnosis, signed informed consent

Exclusion Criteria:

no other concurrent work-related condition not pregnant
Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation

The purpose of this multi-center randomized trial is to identify any differences in the complication rates of patients undergoing Hartmann's (end colostomy) versus Primary Anastomosis (with defunctioning ileostomy) for left-sided colonic performation (including the stoma reversal operation).

Hartmann's operation: the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy.

End colostomy: A stoma is created from one end of the bowel while the other portion of the bowel is either removed or sewn shut (Hartmann's pouch).

The second operation (reversal) requires a colo-rectal anastomosis.

Primary anastomosis: colonic resection with primary anastomosis and defunctioning ileostomy. The second operation (stoma reversal) requires an entero-enteral anastomosis.

Anastomosis: is to join together two bowel ends to restore continuity after resection or stoma formation.

Colostomy: is a reversible surgical procedure in which a stoma is formed by drawing the healthy end of the colon through an incision in the anterior abdominal wall and suturing it into place. This opening, in conjunction with the attached stoma appliance, provides an alternative channel for feces to leave the body.

Ileostomy is a surgical opening constructed by bringing the loop of small intestine (the ileum) out onto the surface of the skin.

Eligibility Criteria:
Inclusion Criteria:

* Patient age \> 18 years
* Left-sided colon perforation
* German language speakers

Exclusion Criteria:

* Patient age \< 18 years
* Perforation outside of the left-colon
* Bowel obstruction/disease without perforation
* Evidence of metastasis
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.

The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal anti-inflammatory drugs (NSAIDs) and/ or colchicine are contraindicated, not tolerated, or ineffective. The efficacy of canakinumab was compared to the corticosteroid triamcinolone acetonide.

The purpose of the first 12 week extension study was to collect additional safety, tolerability and efficacy data in patients who have completed the core study CACZ885H2357.

The purpose of the second one year open-label extension study was to confirm the long-term safety and tolerability of canakinumab in patients who had completed the first extension study.


Eligibility Criteria:
Core Study:

Inclusion criteria:

* Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout
* Onset of current acute gout flare within 5 days prior to study entry
* Baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (VAS)
* History of ≥ 3 gout flares within the 12 months prior to study entry
* Contraindication, or intolerance, or lack of efficacy for non-steroidal anti-inflammatory drugs (NSAID) and/or colchicine

Exclusion criteria:

* Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
* Presence of severe renal function impairment
* Use of specified pain relief medications or biologics (corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, IL-blocker, and tumor necrosis factor inhibitor within specified periods prior to study entry
* Live vaccinations within 3 months prior to randomization
* Requirement for administration of antibiotics against latent tuberculosis (TB)
* Refractory heart failure (Stage D)
* Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
* Any active or recurrent bacterial, fungal, or viral infection

Extension Study 1:

Inclusion:

- Completion of the Core study. A patient was defined as completing the core study if they completed the study up to and including visit 7.

Exclusion:

- Continuation in this extension study was considered inappropriate by the treating physician.

Extension Study 2:

Inclusion Criteria:

* Completion of the first extension study CACZ885H2357E1. A patient was defined as completing the first extension study if they completed the study up to and including Visit 10).

Exclusion Criteria:

-Continuation in this second extension study was considered inappropriate by the treating physician.

Other protocol-defined inclusion-exclusion criteria applied to the core and extension studies.
A Study to Evaluate The Effects Of a Multivitamin/Mineral With Ginko In Subjects With Age Associated Memory Impairment

A Study to evaluate the cognitive effects and tolerance of a Multi-Vitamin/Mineral Preperation containing Gingko in elderly subjects with age associated memory impairment.


Eligibility Criteria:
Inclusion Criteria:

* Subject is generally healthy (includes subjects presenting with mild chronic diseases where the disease and/or the pharmacological treatment does not result in psychomotor impairment or improvement).
* Subject is of either gender, and 60+ years of age, inclusive.
* Subject demonstrates Age Associated Memory Impairment after completion of the CDR test battery and comparison to normative data.
* Female subject who is post-menopausal.
* Subject is able to understand the study instructions and has given written informed consent prior to study participation.
* Subject admitted to this study is oriented to person, place and time and has the ability to communicate with the study staff.
* Subject is, in the opinion of the study staff, motivated to participate and complete the study as instructed.
* Subject is willing to be attend visits in a well-rested state.

Exclusion Criteria:

* Subject has participated in an interventional study within the one month prior to screening.
* Intake within three months prior to screening, or intended intake during the study, of one of the following: Ginkgo biloba, St John's Wort, Ginseng, Gotu Kola (Indian Pennywort), or daily doses of vitamin E (-tocopherol) above 30 mg, folic acid above 400 g, vitamins B-1 (thiamine), B-2 (riboflavin), B-6 (pyridoxine) above 2 mg, or other cognition enhancers.
* Subject has a history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
* Subject has a history of Alzheimers disease, dementia, mental retardation, Morbus Parkinson, or any other mental disorders.
* Subject has not been diagnosed with AAMI after completion of the CDR test battery and comparison to normative data.
* Subject has a history of any bleeding/coagulation disorder (e.g., haemophilia, Protein C or S deficiency).
* Subject is taking/being treated with a concomitant medication which may affect/inhibit blood coagulation (e.g., warfarin, aspirin, heparin).
* Subject has history of relevant vascular disorders (e.g., carotid stenosis, stroke, PRIND, coronary artery disease, peripheral vascular disease, thrombosis).
* Subject has Body Mass Index (BMI) above 40 kg/m2 (severely obese).
* Subject smokes more than 15 cigarettes, or equivalent daily.
* Subject has moderate-to-severe hepatic impairment.
* Subject has history of alcohol or drug abuse.
* Subject has known allergies or intolerance to any ingredients in the study preparations.
* Subject is intending to undergo surgery during or immediately upon completion (within two weeks) of study participation.
Effects of Movement Pattern Training Versus Proprioceptive Neuromuscular Training in Footballers With Groin Pain

Effects Of Movement Pattern Training Versus Proprioceptive Neuromuscular Facilitation On Pain Range Of Motion Flexibility and Kick Distance Among Footballers With Groin Pain.

According to the literature, due to the small number of PT studies on elite athletes (compared with the number of studies on general athletes), it is necessary to further understand whether PT can also benefit this group and accurately test the sports science equipment to facilitate the planning of accurate training courses.There is limited number of studies that have investigated comparative effects of pattern training and propiocetive neuro muscular facilitation..Also, there was no study found that Effects Of Movement Pattern Training Versus Proprioceptive Neuromuscular Facilitation On Pain Range Of Motion Flexibility and Kick Distance Among Footballers With Groin Pain.

Eligibility Criteria:
Inclusion Criteria:

* History of groin or adductor strain Patient Neurological involvement that influenced coordination or balance
* Male players,groin pain during or after the game
* groin pain \> 8 weeks.
* Tenderness on palpation.
* pain during hip adduction with resistance
* Willingness to participate in the research

Exclusion Criteria:

* Subjects with urinary tract infection
* Lower limb fractures,
* metastasis
* Spinal pathology,
* hip joint osteoarthritis
* Inguinal pain(2).
Effects of Exercise Training with Blood Flow Restriction

In this study, it was aimed to compare the effects of low load blood flow restriction exercise (LL-BFRE) training versus high load resistance exercise (HL-RE) training in healthy young individuals on the parameters of lower extremity muscle strength, dynamic and static postural balance, functional performance and cognitive performance.

In this randomized controlled study, there will be two study group. Study group 1 will recieve low load blood flow restriction exercise training and Study group 2 will recieve high load resistance exercise training for 6 weeks, 2 exercise sessions weekly.

At baseline assessment, individuals who met the inclusion criteria, informed by the researcher and accept the participate in the study, researcher will record the participants' sociodemographic and physical informations and then, asess the lower extremity muscle strength with Hand-held digital dynamometer, dynamic postural balance with Y-Balance Test-Lower Quarter, static postural balance with Single Leg Stance Test (Eyes open/closed condition), functional performance with 6-Minute Walking Test and cognitive performance with Stroop Word and Colour Test and Trail Making Test.

At the end of the 6 week exercise training all participants will undergo the same assessments.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study,
* Being between the ages of 18-30.

Exclusion Criteria:

* Presence of any painful condition or pathology involving the lower extremity and lumbar spine and the presence of a surgical history,
* Presence of serious malalignment and deformity affecting the lower extremity,
* Presence of neuromuscular and metabolic disease,
* Presence of any disease affecting lower extremity circulation,
* Having a history of deep vein thrombosis and the presence of peripheral vascular disease,
* Presence of endothelial dysfunction (ED) and any disease that may cause ED,
* Presence of active infection, cancer and having received radiotherapy / chemotherapy,
* Continuous use of anticoagulant medication,
* Having had COVID-19 in the last 3 months or having long COVID syndrome,
* Presence of a cognitive or mental disorder that would disability to participate in the study,
* Disruption of exercise program 3 times in a row
Investigation of Analgesic and Anti-hyperalgesic Effect of Opioids in Experimental Pain

To compare the analgesic and anti-hyperalgesic effect of Buprenorphine and Fentanyl against experimental pain in skin, muscle and bone. The study will be performed with healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* men \> 18 years

Exclusion Criteria:

* women
* known allergy against the investigated drugs
* ongoing participation in other experiments or participation in other experiments 14 days before screening
* previously pain or psychiatric conditions
* simultaneously use of pain killers
* alcohol
* previously drug-addict or member of family with drug-addicts
* chronic constipation
* ileus
* inflammatory bowel syndrome
* abdominal surgery within the last three months
The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects

The purpose of this study is to determine the effect of theobromine on blood lipid parameters in healthy subjects. Secondary objectives are to determine the effect of cocoa and an interaction effect of cocoa and theobromine on blood lipid parameters.

Hypothesis: theobromine has a positive effect on blood lipid parameters.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy men and post-menopausal women: no medical conditions which might affect study measurements (judged by study physician)
* Willing and able to participate in the study protocol
* Written informed consent
* Age 40-70 years
* 10-year risk of developing CHD \<10%, based on data from the Framingham Heart Study
* BMI \> 18 and \< 30 kg/m2
* Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by research physician
* Willing to comply with the dietary restrictions of the study.
* Accessible veins on arm(s) as determined by examination at screening

Exclusion Criteria:

* Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
* Diabetes mellitus
* Reported alcohol consumption \> 14 units/week (female) or \> 21 units/week (male)
* Currently on a medically prescribed diet, or slimming diet
* Reported weight loss or gain of 10% body weight or more during a period of 6 months before pre-study examination
* Reported intense sporting activities \> 10 h/w
* Use of prescribed medication which may interfere with study measurements, as judged by the physician
* Use of antibiotics in the three months before screening or during the study.
* Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months preceding the study and during the study itself
* Reported intolerance to test products or other food products provided during the study
* Blood donation 1 month (males) or 2 months (females) prior to screening and during the study
* Reported participation in another nutritional or biomedical trial 3 months before screening or during the study.
* Extreme coffee consumption
Early Detection of Renal Abnormalities in Metabolically Healthy and Unhealthy Weight Excess"

Overweight and obesity are increasingly prevalent worldwide. Weight excess increases the risk of in developing the metabolic syndrome, which is composed by a set of cardiometabolic risk factors such as abdominal adiposity, dyslipidemia, high blood pressure and elevated fasting glucose levels. Obesity and the metabolic syndrome are known to be risk factors for the development of chronic kidney disease. It is not clear however, whether they can be considered independent risk factors for impaired renal function and renal damage. Whereas obesity may represent an independent risk factor for renal damage, it is not clear yet if the contemporaneous presence of obesity and metabolic alterations is associated with an additional increase in the risk.

It may be important to understand the relationship between obesity, metabolic syndrome and renal health, as treatment strategies may be different for the two metabolic phenotypes of obesity, i.e., metabolically healthy obese (MHO) and metabolically unhealthy obese (MUO) patients.

The primary objective of this multicentre observational prospective study is to assess the relationship between metabolic phenotype and reduced renal function (glomerular filtration rate \<90 ml/min/1.73m2 or microalbuminuria 30-300 mg/24h) in a population of 1000 patients with overweight or obesity.

The secondary aim is to study the association between diet quality, consumption of ultra-processed foods and indicators of reduced renal function and renal damage.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years
* BMI at least 25 kg/m2

Exclusion Criteria:

* Pregnancy or breastfeeding
* Diabetes mellitus
* Renal disease
* Systemic autoimmune diseases with possible renal involvement
* Agonistic physical activity
* Heart failure
* Pharmacologcal treatment with RAAS-inhibitors, sartans, thiazide diuretics, loop diuretics
* Urinary tract infection
Efficacy of Topical Cyclosporine Versus Tears for Improving Visual Outcomes Following Multifocal IOL Implantation

The purpose of this study is to evaluate the efficacy on quality of vision and dry eye signs and symptoms in patients undergoing cataract surgery using the ReZoom® multifocal IOL.


Eligibility Criteria:
Inclusion Criteria:

* · Males or females \> 50 years old

  * Scheduled to undergo bilateral phacoemulsification with implantation of a multifocal IOL.
  * Likely to complete all study visits and able to provide informed consent
  * Visual potential of 20/25 or better

Exclusion Criteria:

* · Prior use of topical cyclosporine

  * Known contraindications to any study medication or ingredients
  * Active ocular diseases or uncontrolled systemic disease
  * Active ocular allergies
Cannabidiol Treatment in Patients With Early Psychosis

Cannabidiol (CBD) is a component of herbal cannabis that is present in varying concentrations in cannabis extracts. CBD has been shown to produce central effects including hypnotic, anticonvulsive, anxiolytic and neuroprotective effects.The investigators hypothesize that treatment with CBD will result in: 1) Improvement evidenced by a reduction in scores on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), 2) Improvement evidenced by a reduction in the Clinical Global Impression of Severity scale (CGI); Secondary Hypothesis: 1) Greater improvement in functioning as measured on the "Patient Assessment of Own Functioning Inventory: (PAOFI) and the Quality of Life Scale (QLS) In this 2 period cross over design, subjects will be randomized in a 1:1 ratio to receive either: Order 1: CBD (Period 1) followed by placebo (Period 2) or Order 2: Placebo (Period 1) followed by CBD (Period 2) under double-blind conditions. The 2 study periods will be separated by a washout of at least 2 weeks. During each period subjects will receive study medications (CBD \[total 800mg/day\] or placebo) for a period of 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Primary psychotic disorder
* Ages 18-65 (inclusive)

Exclusion Criteria:

* Current significant medical condition or other comorbidities
* Current substance depdendence
* Women who are pregnant or breastfeeding