Kornimate/medical-research-clean huggingface dataset:
collaborative italian-american clinical trial of nutritional supplements and age-related cataract (ctns)

Conditions: Cataract

Summary: the collaborative italian-american clinical trial of nutritional supplements and age-related cataract (ctns) is a 13-year study designed primarily to evaluate the safety and efficacy of a vitamin-mineral supplement (centrum) containing recommended daily-allowance dosage (rda) in preventing age-related cataract or delaying its progression in participants with early or no cataract at baseline.

despite dramatic increase in the rates of cataract surgery during the last decades, age-related cataract is still responsible for about 50% of cases of severe visual impairment in developing countries, and for high and growing health care costs in western countries. ctns was designed to complement the u.s. age-related eye disease study (areds) by evaluating a much broader spectrum of nutrients at rda dosages. whereas about 60% of the areds control group was taking rda dose multivitamin supplements, none of the participants in ctns had taken any type of nutritional supplement for at least one year before the qualification visit. therefore, the ctns will be able to evaluate the effect of rda doses versus no supplementation at all. ctns and areds will use similar procedures, including those for grading the presence and severity of lens changes. ctns is a randomized,parallel group, placebo controlled, double blinded, single center, intervention trial. primary outcomes: photographic evaluation of a prespecified increase from baseline in nuclear, cortical, or posterior subcapsular cataract (psc) opacity grades or cataract surgery. secondary outcomes: increase in type-specific opacity grade, cataract surgery, and visual acuity loss from baseline \> or = 15 letters. patients will be followed for a maximum of 10 years.

Eligibility criteria:
inclusion criteria: * clinical and photographic diagnosis of early or no age-related cataract * participants with early cataract must have at least one eligible eye with va score 20/32 or better * participants with no cataract must have va score 20/32 or better in both eyes. exclusion criteria: * advanced cataract * bilateral aphakia or pseudophakia * any ocular disease or condition that might complicate the future evaluation of cataract * regular use of nutritional supplements * failure to take at least 75% of run-in medication * cancer with evidence of recurrence in the past 5 years * major cerebral or cardiovascular events in past 12 months * current participation to other clinical trials * any condition likely to prevent adherence to ctns follow-up schedule

Keywords: cataract nutritional supplements
pioglitazone on heart failure in type-2 diabetes mellitus participants

Conditions: Type 2 Diabetes Mellitus in Obese; Heart Failure With Preserved Ejection Fraction

Summary: our goal of the study is to learn the effects of the diabetes medication named pioglitazone, in type-2 diabetic obese participants with heart failure. the main question it aims to answer are: 1. to demonstrate that impaired mitochondrial function leading to reduced atp generation plays a key pathophysiologic role in the development of heart failure with preserved ejection fraction (hfpef) in obese type 2 diabetic (t2d) individuals. 2. to demonstrate that pioglitazone, improves diastolic (as well as systolic) function by improving myocardial insulin sensitivity and by reducing both myocardial and epicardial fat content.

either pioglitazone or placebo pioglitazone will be administered during this study in this type 2 diabetic population with heart failure to examine if there are any beneficial effects on diastolic and systolic function. myocardial blood flow (mbf) is measured using a pet scan, then participants will be randomized to pioglitazone or a placebo to examine the effects of the study drug on the effects on the systolic and diastolic function of the heart. in addition, myocardial insulin sensitivity change will be measured as well as myocardial fat content. the ratio of atp: pcr will also be measured.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 30-70 years 4. body mass index (bmi) of 27.5-40kg/m² 5. hba1c of 6.5 to 10% 6. blood pressure of less than or equal to 145/65mmhg 7. egfr greater than 45 ml/min/1.73m² 8. subject must have hfpef (ef \> 50% by echo screening) 9. nyha class ii-iii heart failure 10. only t2d patients treated with diet/exercise, metformin, sulfonylurea, metformin/su, dpp4i or insulin will be studied. 11. for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional \[4 weeks\] after the end of study participation. 12. for males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner. exclusion criteria: 1. subjects with history of osteoporosis or proliferative diabetic retinopathy 2. subjects with heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, etc. will be excluded 3. patients with symptomatic coronary artery disease. 4. subjects with significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose, or addition of another hf medication). 5. subjects treated with a glp-1 ra or thiazolidinedione. 6. subjects treated with a sglt2i 7. pregnancy or lactation 8. known allergic reactions to components of the study interventions. 9. any metal plates, parts, screws, shrapnel, pins in body, or cardiac (heart) pacemaker
effect of cystocele repair with trans obturator tape vs. trans obturator tape alone on stress urinary incontinence.

Conditions: Stress Urinary Incontinence

Summary: the goal of this interventional study is to compare the effect of concurrent cystocele repair and trans obturator tape (tot) and tot alone in a sample of iraqi female participants with diagnosed stress urinary incontinence and cystocele. the main questions to answer are: 1-what are the effects of the tested interventions on the outcomes measured by the pelvic organ prolapse quantification (pop-q) system? 1. what are the effects of the tested interventions on the degree of pelvic organ prolapse? 2. what are the effects of the tested interventions on the frequency, severity, and effect of stress urinary incontinence on the quality of life of the patients? 3. what are the effects of the tested interventions on the impact of lower urinary tract symptoms on the quality of the patient's life? female patients diagnosed with sui indicated for intervention were divided into 2 groups group i: (n=49) offered tot alone group ii: (n=49) offered concurrent tot and cystocele repair patients were then followed up and evaluated using the pelvic organ prolapse quantification (pop-q) system, the international consultation on incontinence questionnaire-short form (iciq-sf), and the king health questionnaire (khq). the efficacy of both procedures and their impact on sui and quality of life was measured.


Eligibility criteria:
inclusion criteria: * female patients. * pure stress and/or stress-predominant mixed urinary incontinence (mui) associated with cystocele. * had not undergone a previous sui surgery. * bmi less than 35 kg/m2 exclusion criteria: * patients out of the age limit. * patients refused to participate in the study. * severe comorbid disease (heart failure hyha class ii and above, etc.). * patients with a previous surgical history of transvaginal mesh. * patients suffering detrusor overactivity. * patients diagnosed with the female genital system or urinary bladder malignancies. * patients diagnosed with the presence of neurological disorders that caused voiding dysfunction.

Keywords: urinary incontinence, stress cystocele trans obturator tape pelvic organ prolapse
prostate artery embolization compared to holmium laser enucleation of the prostate for benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of this study is to evaluate improvement of symptoms from benign prostatic hyperplasia (bph) as assessed by the international prostate symptom score (ipss) for prostate artery embolization (pae) with microspheres (embozene™, 400µm) compared to conventional holmium laser enucleation of the prostate (holep).

this is a prospective randomized controlled study that collects data of patients with benign prostatic hyperplasia that are treated with prostatic artery embolization (pae) or with holmium laser enucleation of the prostate (holep). for pae a catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate. the injected microspheres will slow the blood flow to the prostate. for holep a holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra. clinical follow-up include clinical visit after 1, 6 and 12 months. acute as well as long term complications will be recorded. the patients fill in the questionnaires for urologic disease. urodynamic examination will record functional outcome.

Eligibility criteria:
inclusion criteria: * patients evaluated in the urology department and candidates to surgical treatment * age \> 45 years * ipss ≥ 10 * maximum urinary flow \< 12 milliliters (ml)/second (s) * post-void residual urinary volume \< 300ml * prostatic volume between 20ml and 250ml assessed by ultrasound * signed informed consent exclusion criteria: * psa \> 10 (if not negative prostate biopsy) * life expectancy below 1 year * renal insufficiency defined as glomerular filtration rate \< 30 ml/min/1,73m2 * known severe reactions to iodine-based contrast or gadolinium-based contrast * ct examination reveals no access to the prostate arteries.
temperature manipulating gloves for the treatment of insomnia

Conditions: Insomnia

Summary: the investigators plan to test the effectiveness of warm gel gloves in reducing the time it takes individuals to fall asleep (sleep latency). the investigators will have subjects track their sleep for two-weeks using both sleep logs and a small wristwatch-like monitor called an actigraph to measure the degree of the persons' difficulty falling asleep. it must take at least 30-minutes to fall asleep 3-days per week to qualify for the study. if a subject qualifies, they will wear the heated gel gloves or a placebo non-heated gel glove during sleep for two-weeks and sleep will be measured again using sleep logs and actigraphy. the baseline sleep latency data will be compared to the treatment period using a independent t-test. the investigators believe that wearing the warm gel gloves will reduce sleep latency.

insomnia affects anywhere from six percent to 33% of the u.s. population depending on the precision of the definition being used. therefore, represents one of the most prevalent health concerns for americans. individuals with insomnia frequently report problems such as (but not limited to) difficulty focusing and concentrating, memory difficulties, impaired motor coordination, irritability and impaired social interactions. moreover, chronic insomnia has also been associated with reduced quality of life, higher absenteeism, impaired job performance, and higher healthcare utilization.

Eligibility criteria:
inclusion criteria: * inclusion criteria for each participant are as follows: must be between 18 and 65 years old * have difficulty initiating sleep for at least two-weeks, including a sleep latency of at least 30-minutes, three days per week (as measured by wrist actigraphy and/or sleep logs) * no history of a dermatological disorders or chronic pain conditions * not currently using narcotics, psychotropic or hypnotic medications and willing to refrain from using these medications during the course of the study * limits caffeine consumption to less than or equal to 2 coffee servings, or equivalent per day * limits alcohol intake to 7-drinks per week and less than or equal to 1 drinks on any one night, must adjust alcohol consumption to 7-drinks per week and less than or equal to 1 drink on any one night for at least two weeks before study begins, and must not consume alcohol later than 8pm * naps less than or equal to 1-hour per week according to subjective report * must have a body mass index less than 30 * shift workers will not be accepted. exclusion criteria: * history of a dermatological disorder * using narcotics, psychotropic or hypnotic medications * caffeine consumption greater than 2 coffee servings, or equivalent per day * alcohol intake greater than 7 drinks per week and greater than 1 drink on any one night, consume alcohol later than 8pm * naps greater than 1-hour per week according to subjective report * body mass index greater than 30; shift worker.
appropriate strategy of surgical treatment in ischemic diabetic foot

Conditions: Diabetic Foot; Ischemic Diabetic Foot Ulcer; Popliteal Artery Stenosis

Summary: this cohort study aims to evaluate the outcomes of appropriate surgical treatment strategies in diabetic foot ulcers with different rate of popliteal artery stenosis(\<50% or ≥50%). in this study, patients with texas university grade 2-4(stage c-d) ischemic diabetic foot ulcers will be included. data of patients who underwent surgical treatment in the past will be retrospectively collected. the patients with follow-up time less than 12 months will continue to follow up. also the postoperative patients will be prospectively collected. effects of different surgical strategies, including wound healing therapy, interventional therapy and tibial transverse bone transport therapy will be measured by several indexes.


Eligibility criteria:
inclusion criteria: * patients with diabetic foot, according to "chinese guidelines for diagnosis and treatment of diabetic foot (2017)". * texas university grade 2-4(stage c-d) ischemic diabetic foot ulcers. * have clear consciousness, not suffer from mental illness, can cooperate in research and treatment. * patients who are informed, participate in the research voluntarily, and have signed the informed consent. * have complete clinical data. exclusion criteria: * patients with severe systemic infection, who need to be amputated immediately to save lives. * patients with mental illness, who cannot cooperate to complete the adjustment and nursing of the external fixator. * patients with severe cardiovascular and cerebrovascular diseases (such as severe cardiac insufficiency, severe sequelae of cerebrovascular disease), or with acute infectious diseases. * have used or using glucocorticoids systemically within 3 months before admission. * have participated in other medical clinical trials within 3 months before admission. * patients with severe liver or kidney function abnormalities * pregnant or lactating women. * patients who lost follow-up.

Keywords: ischemic diabetic foot ulcer surgical strategy cohort study
retroprospective real life observatory of eribulin

Conditions: Metastatic Breast Cancer

Summary: the objective of this observatory is to evaluate the effecacy of eribulin in patients with metastatic breast cancer on a recent prescription period. part of the data collection will be retrospective and the other part will be prospective for patients started treatment by eribulin between november 2014 and september 2015. it will allow a better assessment on the safety profile of this drug.

approximately one third of patients treated for localized breast cancer will present a metastatic evolution and 5% of patients are metastatic immediately. at this stage, the malignancy is incurable with a median survival from 2 to 3 years. metastatic breast cancer treatment is part of a multidisciplinary approach. these two objectives are to prolong survival and improve quality of life. at present, there is no standard after the first line of chemotherapy, with fe strategy studies eribulin is now a new therapeutic option to consider. many patients have benefited from this treatment option and it seems interesting to evaluate in real life the effecacy and tolerance of chemotherapy.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. patient with breast cancer, histologically proven, metastatic or locally advanced 3. patient treated by eribulin between january and october 2014 (for the retrospective part) or between november 2014 and september 2015 (for the prospective part). 4. patient with at least an assessment of the response to eribulin exclusion criteria: 1. presence of other neoplasia 2. man
study of difluprednate ophthalmic emulsion in the treatment of uveitis

Conditions: Anterior Uveitis; Panuveitis

Summary: the purpose of this phase 3 confirmatory study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of treatment of uveitis.

the objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion (dfba) in patients with endogenous anterior uveitis, in comparison with 0.1% betamethasone sodium phosphate ophthalmic solution (bp).

Eligibility criteria:
inclusion criteria: * patients diagnosed with endogenous anterior uveitis or panuveitis * patients with 10 - 49 anterior chamber cells within one field of the anterior chamber as observed by slit lamp microscopy (criterion for rating of signs 2 or 3) * patients aged ‰1425 years (on the day of obtaining informed consent) who were able to accurately express their own symptoms * patients provided written informed consent prior to initiation of the study exclusion criteria: * patients who did not meet all of the above inclusion criteria * patients received systemic administration of any corticosteroid or immunosuppressive drug within the past 1 week prior to instillation of the investigational product * patients received topical injection of any corticosteroid in eyes prior to instillation of the investigational product (solution formulation: within the past 1 week, depot: within the past 2 weeks) * patients received systemic administration of any non-steroidal anti-inflammatory drug or antiphlogistic enzyme within the past 3 days prior to instillation of the investigational product * patients received instillation of any corticosteroid, non-steroidal anti-inflammatory drug or antiphlogistic enzyme within 12 hours prior to instillation of the investigational product * patients with glaucoma or ocular hypertension * patients with corneal abrasion or ulcer * patients with any confirmed or suspected viral, bacterial or fungal keratoconjunctival disease * patients with allergy to similar drugs such as other corticosteroids * patients requiring use of contact lens during the study period * women who are or might be pregnant, or lactating women * patients participating in another clinical study within the past 3 months before initiation of the present study
lifestyle modification to improve diet in women with gdm

Conditions: Gestational Diabetes; Diabetes; Childhood Obesity; Diabetes Mellitus

Summary: the study aims to adapt a lifestyle modification program to engage gdm women early in the postnatal period to evaluate its effectiveness in reducing adiposity and metabolic parameters in the mother. women will be randomized to receive a structured intervention or standard care.

a complex intervention based on a proven lifestyle modification program (lmp) will be delivered to participants randomized to the intervention arm, starting in the early postnatal period. the intervention will consist of individualized face-to-face counseling on diet and weight management, meeting with exercise instructor, followed by telephone contact. control will receive standard postnatal education materials and usual care provided by government health service.

Eligibility criteria:
inclusion criteria: 1. women who developed gestational diabetes in their most recent pregnancy 2. gdm is diagnosed according to the who 2013 criteria of fbg ≥ 5.1mmol/l, or 1 hour glucose ≥10.0mmol/l, or 2 hour glucose ≥ 8.5mmol/l during 75g ogtt performed at 24-28 weeks of pregnancy 3. singleton pregnancy 4. reside normally in hong kong 5. able to communicate in chinese 6. willing to give consent and follow study procedures exclusion criteria: 1. subjects with pre-existing diabetes (t1d or t2d) 2. subjects with life-threatening conditions including malignancy that is not in remission 3. subjects with known psychiatric conditions including depression 4. substance abuse or use of illicit substances 5. subjects with significant renal impairment (egfr\<60ml/min at baseline) or non-diabetic renal disease (e.g. biopsy-proven glomerulonephritis or obstructive uropathy) 6. subjects on chronic corticosteroids treatment 7. subjects with known myocardial infarction within the preceding 3 months 8. major physical disability 9. participation in other intervention trials 10. surgical or medical interventions to treat obesity 11. pregnancy at any point during the intervention period

Keywords: gestational diabetes diabetes lifestyle diet modification childhood obesity diabetes mellitus
light therapy in cardiopulmonary bypass surgery

Conditions: Acute Kidney Injury; Inflammation

Summary: the goal of this study is to determine whether or not exposure to blue spectrum light reduces acute kidney injury and systemic inflammation in subjects undergoing cardiopulmonary bypass. subjects scheduled to undergo cardiopulmonary bypass surgery will be exposed to either bright (1000 lux) blue spectrum (480nm) light or to ambient, white fluorescent light for a 24 hour photoperiod the day prior to surgery and for a 24 hour photoperiod in the immediate postoperative period.

light modifies the biology and physiology of mammals, including humans. the cellular biology of both the immune system, as well as, the cells comprising tissues and organs (e.g., kidney, liver) are under the regulation of light and exhibit circadian rhythms. studies show that the severity of organ injury varies with the time of the day, the duration of the day, and the season. this variation is due to the biology of circadian rhythms, and light is the principle environmental cue entraining circadian biology. more recent data suggest that modulating the spectrum of light to which an organism is exposed may therapeutically modulate the cellular response to stress or injury. specifically, exposure to a short (24 hour) photoperiod of high illuminance, blue spectrum light attenuated liver and kidney injury when animals were subjected to ischemia/reperfusion (i/r), a model in which the blood flow to an organ is temporarily reduced and then restored. a predominant cause of organ injury in this model is the misdirected and exacerbated inflammation of a type of immune cell called the neutrophil. however, blue light inhibited neutrophil infiltration into the ischemic kidney and liver, and thereby reduced inflammation and neutrophil-mediated organ injury. cardiopulmonary bypass (cpb) surgery is an operation characterized by excessive inflammation and a high risk of organ injury, particularly acute kidney injury (aki). thus, we hypothesize that exposure to blue light, by comparison to standard environmental, white fluorescent light, will reduce inflammation, organ injury and improve the outcome of patients undergoing cpb.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * undergoing cardiopulmonary bypass surgery exclusion criteria: * blindness * immunocompromised or immunosuppressed state * anticipated survival \< 24 hours