Kornimate/medical-research-clean huggingface dataset:
diuretics in the management of essential hypertension (dime) study

Conditions: Hypertension

Summary: the purpose of dime is to evaluate the safety (i.e. new onset of diabetes and other metabolic adverse events), efficacy and cost-effectiveness of antihypertensive treatment with low dose diuretics. the researchers' hypothesis is that use of low dose thiazide diuretics is metabolically safe when used with other appropriate antihypertensives, effective in reduction of blood pressure and cheaper than treatment without diuretics. therefore, this study is an equivalence trial.

there has been substantial evidence from clinical trials to support the rationale of use of thiazide diuretics in patients with essential hypertension. diuretics may be more effective in reduction of blood pressure in japanese patients than caucasian because of higher salt intake. moreover, given a large number of hypertensive population here, diuretics may be the most cost-effective antihypertensive agent. japanese physicians, however, tend to avoid diuretics even in elderly hypertensive patients because of much concern over metabolic adverse events including new onset diabetes, which is deemed to increase cardiovascular risk. although it is unlikely that use of low dose (12.5 mg of hctz or less) diuretics is associated with metabolic adverse events when they are given with any other appropriate antihypertensive agents (e.g. ca antagonist, ace inhibitor, arb, k sparing diuretics) other than β-blockers, the researchers have to confirm the safety of low dose diuretics in terms of new onset diabetes in japanese, who are assumed to be "diabetes prone" based upon thrifty gene hypothesis.

Eligibility criteria:
inclusion criteria: * aged 30 to 79 years * with blood pressure being \>150/\>90 if they are not on any antihypertensive treatment * with blood pressure being \>140/\>90 if they are already on antihypertensive drugs * no history of type 2 diabetes * no history of gout exclusion criteria: * with supine blood pressure being \>200/\>120 * patients already on antihypertensive treatment if duration of treatment and drugs used are not identified * patients already on thiazide diuretics * with type 2 diabetes * with gout or hyperuricaemia (\>8.0 mg/dl) * with hypokalemia（\<3.5mmol/l） * with erectile dysfunction * with renal dysfunction (s-creatinine \> 2.0 mg/dl) * with history of serious adverse reaction to thiazide diuretics * with history of stroke or myocardial infarction within 6 months * with history of percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg) within 6 months or in whom these interventions are planned * with heart failure or left ventricular dysfunction (ejection fraction\<40%) * patients who should be on thiazide diuretics * with history of malignant tumor within 5 years * pregnant, possibility of pregnancy, or during breast feeding * patients who are deemed not eligible for this study for any reason

Keywords: thiazide diuretics essential hypertension type 2 diabetes randomized clinical trial cost-effectiveness
the effectiveness of improving self-care after counseling for the diabetics mellitus foots around chiayi region

Conditions: Diabetic Foot; Type 2 Diabetes Mellitus With Established Diabetic Nephropathy

Summary: objectives: preventing diabetic foot problems (dfp) and associated consequences, such as amputation, is a critical in rural regions. the objective is to present on the association of non-invasive dfp assessment tools and physiological indicators for the early detection of dfp among rural cases of diabetes in taiwan.

1. peripheral neurological assessment was carried out using michigan neuropathy screening instrument (mnsi). the diabetes nurse educators assessed five parameters on both feet and counted the total points, ranging from 0 to10: (1) appearance of feet (normal/abnormal with 0 and 1 point); if abnormal, then inspection of lower limbs for deformities, dry skin, fissure, calluses or infection was carried out; (2) identification of foot ulceration (yes/no with 0 and 1 point); (3) vibration perception of the big toe (present/decreased/absent, with 0, 0,5 and 1 points); (4) ankle reflexes (present/reinforcement/absent, with 0, 0,5 and 1 points); (5) touch-pressure sensation test with a 10 g semmes-weinstein monofilament (normal/reduced/absent, with 0, 0,5 and 1 points). when an mnsi summative score was ≥2 points with neuropathy, patients were referred to the teaching hospitals for further evaluation. the mnsi procedures took 6-8 minutes for each participant. 2. peripheral vascular assessment: three parameters were used to assess peripheral vascular function by trained nurses. (a) the cardio-vision model ms-2000 was used to detect ankle brachial index (abi), assessed by research nurses. values of abi were classified as ≥0.9 normal and \ 2 seconds, this was taken as ischemia. assessing of all 3 parameters of peripheral vascular assessment took 10-15 minutes for each participant. 3. diabetic foot risk assessment was assessed by plastic surgeons: (a) king's college classification (kc) contained six stages of condition: not at risk, at risk, ulcer, cellulites, necrosis and amputation. (b) the texas risk classification (trc) system was divided into six categories in origin. we re-categorized three levels: low risk, at risk, and high risk. 4. the blood glucose, total cholesterol, and low density of lipoprotein cholesterol were drawn from the last 1-2 month diabetes passport record for each subject. blood pressure was measured according to standard procedures by the nurses during the study. body mass index was calculated for each participant using the standard formula (weight in kilograms divided by square of the height in meters). waist circumference in centimeter was used to measure central obesity, measuring the mid-abdominal distance between the last rib margin and the iliac crest.

Eligibility criteria:
inclusion criteria: * diabetics mellitus patients

Keywords: diabetic foot non-invasive dfp assessment tools early detection of dfp
pain types and pain severity in chronic neck pain

Conditions: Chronic Neck Pain

Summary: the aim of this study is to characterize the distribution of pain phenotypes in people with chronic neck pain and to determine the effects of pain phenotypes on pain severity, functional status and quality of life. participants will be examined to determine the type of pain and questions will be asked to assess pain severity and impact.


Eligibility criteria:
inclusion criteria: * having chronic neck pain * be over 18 years old exclusion criteria: * those under the age of 18 * those with major psychiatric illness, * those with communication problems
trama-code (two analgesics-comparative study)

Conditions: Pain

Summary: double-blind randomized study to compare the efficacy of two analgesic drugs(ixprim®, dafalgan-codeine®) in the emergency unit. the efficacy (relief of pain) would be assessed 2 hours after administration of one of the two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain assessment score).


Eligibility criteria:
inclusion criteria: * patients of 18 - 75 years of age * presented to the emergency unit of foch hospital * complaining of moderate pain (4-6 on pain assessment scale) evaluated by the reception nurse exclusion criteria: * patient already had received another type 2 analgesia or already received one of the study drugs in the last 4 hours * pregnant or lactating females * patient with one or more contraindication to one of the study drugs * patients for whom the pain assessment scale can not be performed (unconscious, confused ...) * patient cannot be included for legal reasons * patient required urgent management * patient for whom it is considered difficult to be reassessed 2 hours later * patient unable to swallow
trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults

Conditions: Pneumococcal Disease

Summary: a phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults


Eligibility criteria:
inclusion criteria: 1. male or female adults \>/= 18 years of age (from the 18th birthday) at enrollment and older. 2. adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product. 3. negative urine pregnancy test at visit1 for all subjects who are of childbearing potential. exclusion criteria: 1. previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation. 2. history of microbiologically proven invasive disease caused by s pneumoniae. 3. serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (copd) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study. 4. pregnant female subjects or breastfeeding female subjects.
instrument development of screening prediabetes patients

Conditions: Prediabetic State

Summary: it will be more effective if we can work on the primary prevention for the high risk groups of diabetes and prediabetes such as the early detection.

during the past years, many efforts were put on the diagnosis and treatment of dm and its complications. it will be more effective if we can work on the primary prevention for the high risk groups of diabetes and prediabetes such as the early detection. as a first public health step, it is worthwhile to identify prediabetes people in community by screening program. three thousand persons will be randomly selected from residents of taichung city. all the participants will fulfill a structured questionnaire and 'diabetes risk factor screening tool' which american diabetes association suggested in 2003. this project will estimate the prevalence of prediabetes in conventional hospital-base population as well as the validity of a screening questionnaire for prediabetes.

Eligibility criteria:
inclusion criteria: residents aged 40 and over of taichung city, taiwan in october, 2004. exclusion criteria: -
effects and safety of menthol on blood pressure and metabolic parameters in prehypertensive and mild hypertensive patients

Conditions: Hypertension; Prehypertension

Summary: prehypertension and mild hypertension are associated with an increased risk of atherosclerosis and coronary artery disease, and often complicated with the metabolic disorder of glucose and lipid. the comprehensive prevention of hypertension is still an important and complex clinical issue. peppermint is a popular flavoring agent, and peppermint tea help relax tension and could lower blood pressure. the effect of oral peppermint on blood pressure is not consistent, however, our previous animal study has shown that oral administration of menthol, the main component of peppermint, could reduce 24-hour mean arterial systolic and diastolic blood pressure in spontaneous hypertensive rats. furthermore, menthol increases uncoupling protein(ucp)1 dependent thermogenesis and energy expenditure through transient receptor potential melastatin(trpm)8 activation, and helps prevent obesity and metabolic disorders. in a prospective, double-blind, randomized, and parallel-group study, we will evaluate the effects of danshu capsule(menthol) on blood pressure and metabolic parameters in prehypertensive and mild hypertensive patients. this study will help develop future comprehensive prevention and treatment strategies for hypertension.


Eligibility criteria:
inclusion criteria: * blood pressure: 120mmhg≤sbp\<160mmhg, and/or 80mmhg≤dbp\<100mmhg exclusion criteria: * diabetes * hypertension: sbp≥160mmhg, or dbp≥100mmhg * known allergy to trial drugs * myocardial infarction or cerebrovascular accident in the year preceding the trial * clinical congestive heart failure * secondary hypertension * pregnancy or lactating women * malignant tumor * gastroesophageal reflux or gastroduodenal ulcer * history of hepatitis or cirrhosis * history of kidney disease * body weight﹤35kg

Keywords: hypertension menthol metabolism
exception cementless hip stem

Conditions: Osteoarthritis, Hip; Rheumatoid Arthritis; Inflammatory Arthritis; Congenital Hip Dysplasia; Avascular Necrosis of Hip; Femoral Neck Fractures

Summary: this study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study. the objectives of this study are to confirm the long-term safety, performance and clinical benefits the exception cementless femoral stem (standard and varized) when used in primary total hip arthroplasty.

six surgeons have prospectively collected clinical data for patients operated consecutively between january 2008 and september 2012. the patients have been operated based on the indications and contraindications listed in the instructions for use (ifus) of the implant. this study is an extension of the surgeons' data collection as an attempt from zimmer-biomet to fulfill its post-market surveillance obligations by recovering clinical data retrospectively and prospectively. study procedure flowchart - retrospective data collection: most patients had clinical follow-ups at pre-op, operative, immediate post-op, 3 months, 1 year, 2, 3, 5, 7 years post-surgery during which their surgeons collected clinical data. this data will therefore only be collected by zimmer-biomet after the patients specifically consent to it. study procedure flowchart - prospective data collection: the informed consent signed by the patient for this study also allow zimmer biomet to collect the data of the standard clinical follow-up that will be conducted by the investigators at least 10 years post-surgery.

Eligibility criteria:
at the time of surgery, the inclusion criteria were based on the indications presented in the ifus: * primary or secondary osteoarthritis * inflammatory impairment of the hip, rheumatoid arthritis, etc. * fracture of the neck of the femur * avascular necrosis of the femoral head * sequelae from previous operations on the hip, osteotomies, etc. * congenital hip dysplasia. * patient is older than 18 years old * patient had consented to the original data collection after his/her surgery at the time of surgery, the exclusion criteria were based on the contraindications presented in the ifus: * local or systemic infections. * serious muscular, neurological or vascular deficiencies in the limb concerned. * bone destruction or poor quality bone likely to affect the stability of the implant (paget's disease, osteoporosis, etc.) * any concomitant disorder likely to affect the function of the implant. * allergy to one of the implant components. * patients weighing more than 110 kg. * patient incapable of following the recommendations of the surgeon

Keywords: total hip arthroplasty medical device performance safety hip prosthesis clinical benefits
evaluation of the effectiveness of two marketed multi-purpose solutions for silicone hydrogel contact lenses - study 2

Conditions: Myopia; Hyperopia; Contact Lens Comfort

Summary: the purpose of this study was to evaluate the performance of opti-free® puremoist® multi-purpose disinfecting solution (mpds) compared to amo revitalens ocutec® mpds (us brand name)/complete revitalens (europe brand name) in silicone hydrogel contact lens wearers.

in this 2-period crossover study, eligible participants were randomized to either opti-free® puremoist mpds or revitalens mpds in period 1 for use with their habitual contact lenses, after which they switched to the alternate solution in period 2. each period was 30 days in length. a 2-day washout period during which participants refrained from using a multi-purpose contact lens solution preceded period 1 and period 2.

Eligibility criteria:
inclusion criteria: * wear single vision sphere silicone hydrogel contact lenses (coopervision™ biofinity®, alcon® air optix® aqua, bausch+lomb® purevision™ or acuvue® oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least 1 month prior to visit 1; * willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on 2 days during the study; * must have habitually used a biguanide preserved multi-purpose solution (other than revitalens) for at least 30 days prior to visit 1; * vision correctable to 20/30 snellen (feet) or better in each eye at distance with pre-study contact lenses at visit 1; * have access, capability and willingness to review and answer text messages; * read, sign, and date irb/iec approved informed consent and privacy document before enrollment; * willing to follow the study procedures and visit schedule; * other protocol-defined inclusion criteria may apply. exclusion criteria: * need to wear lenses on an extended wear (i.e overnight) basis during the study; * known sensitivity or intolerance to biguanide, polyquaternium-1 (polyquad), or aldox preserved lens care products; * monocular (only one eye with functional vision) or fit with only one lens; * wearing toric or multifocal contact lenses or fit with monovision; * use of additional lens care products other than a biguanide preserved multi-purpose solution such as daily or enzyme cleaners within the 1 week prior to visit 1; * use of topical ocular over-the-counter (otc) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to visit 1; * abnormal ocular condition observed during the visit 1 slit-lamp examination; * current or history of ocular infections or severe inflammation within 6 months prior to visit 1; * ocular surgery within the 12 months prior to visit 1; * participation in any other clinical trial within 30 days of enrollment; * other protocol-defined exclusion criteria may apply.

Keywords: multi-purpose solution silicone hydrogel contact lenses comfort opti-free revitalens
circulating extracellular vesicles released by human islets of langerhans

Conditions: Type1 Diabetes Mellitus; Type2 Diabetes; Islet Cell Transplantation

Summary: beta-cells release extracellular vesicles (ev) and exosomes under normal and pathophysiologic conditions. these ev contain beta-cell specific autoantigens which may trigger the immune response at the initiation of type 1 diabetes. in this study, beta-cell derived ev will be detected and characterized in human blood samples.

adult subjects will be recruited with: new onset type 1 diabetes mellitus (t1dm), type 2 diabetes mellitus (t2dm) as well as islet transplant candidates. blood samples will be collected at defined intervals to determine beta-cell specific ev and determine the utility of this biomarker as a measure of beta-cell stress or injury.

Eligibility criteria:
inclusion criteria: age 18-70 diagnosis of type 1 diabetes or type 2 diabetes or islet transplant recipient exclusion criteria: unknown diagnosis of diabetes active infection immunocompromised organ transplant recipients not including candidates for islet transplant hiv+ hepatitis c+ hepatitis b surface antigen+ known concurrent malignancy known pregnancy

Keywords: extracellular vesicles autoimmunity beta-cell injury
prehabilitation intervention to maximize early recovery (primer) in liver transplantation

Conditions: Liver Diseases; End Stage Liver Disease; Frailty

Summary: this is a single center, 2-arm, patient-randomized study evaluating the feasibility and potential efficacy of the primer intervention in improving physical function and reducing frailty in adult liver transplant candidates. the intervention will consist of a patient-tailored prehabilitation program designed to reduce frailty, improve physical function and nutritional status, and optimize pre- and post-transplant outcomes.

the investigator will pilot-test a two-arm, randomized trial of a prehabilitation intervention in 38 pre-liver transplant patients with end stage liver disease (esld). the investigator estimates an attrition rate of 20%, resulting n=30 participants; 10 participants in arm 1 (control arm) and 20 participants in arm 2 (intervention arm). to be eligible, patients must be waitlisted or "penn-ready" with a meld-na less than or equal to 25, english-speaking, able to safely participant in an exercise program, have a smartphone, and be identified as frail. the purpose of this trial is to develop and implement a program of medical optimization, physical activity, and nutrition recommendations specifically tailored to esld and designed to reduce frailty, improve physical function, and optimize pre- and post-transplant outcomes.

Eligibility criteria:
inclusion criteria: 1. participants must be wait-listed, in transplant evaluation, or "penn ready" with a meld-na score less than or equal to 25; 2. patients must be english speaking and own/use a smartphone and cognitively able to consent; 3. patient and physician feel that individual can safely participate in an exercise program; 4. meeting at least one 'at risk' criterion for impaired physical performance, frailty, or malnutrition (by sppb, abpg-sg, dynamometer measured grip strength), or physical deconditioning as determined by physical therapist, or treating clinician. exclusion criteria: 1. the patient is unable to provide informed consent; 2. the patient has been hospitalized within the last 30 days; 3. a score of 0-3 points on the sppb assessment indicating inability to participate in a physical activity program or a score of 12 in the absence of frailty or malnutrition (indicating low risk for poor physical or performance or malnutrition); 4. the patient is at risk for falling as defined by clinician assessment results or if the patient states that he/she has a history of falling (record of a fall(s) in the past 30 days); 5. the patient is already enrolled in a financial incentive-based exercise program using a wearable device; 6. any other medical conditions that would prohibit participation in a physical activity program as determined by transplant clinicians or severe vision, hearing, or mobility impairment precluding participation.

Keywords: liver transplantation malnutrition exercise prehabilitation nutrition sarcopenia
a study of patients with primary open angle glaucoma or ocular hypertension who were insufficiently responsive to monotherapy

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this is a retrospective chart review and will assess changes in iop after treatment with any fixed combination in patients who previously received monotherapy.


Eligibility criteria:
inclusion criteria: * diagnosis of glaucoma or ocular hypertension * previously treated with monotherapy followed by fixed combination therapy for at least 12 weeks exclusion criteria: * none