Kornimate/medical-research-clean huggingface dataset:
study of transdermal testosterone patches in surgically menopausal women with low libido

Conditions: Hypoactive Sexual Desire Disorder

Summary: this study is designed to evaluate efficacy and safety of a testosterone patch as treatment for low libido in surgically menopausal women who are taking estrogen therapy.

women with hypoactive sexual desire disorder (hsdd) who had undergone bilateral salpingo-oophorectomy and hysterectomy were randomized into a 24-week, multicenter, multinational, double-blind (db), parallel-group, placebo-controlled study. patients were stratified based on their use of oral or transdermal et and randomized to receive placebo or testosterone transdermal system. patients had to maintain a stable dose of estrogen throughout the study. patients who completed the first 24 weeks of the study were given the opportunity to participate in a 3.5 year open-label (active treatment) study extension which was added to the protocol by amendment. safety was assessed by adverse events, lipids, serum chemistry with hepatic, renal and carbohydrate metabolism evaluation, and hematology. physical exam including clinical assessments of facial hair and acne were monitored.

Eligibility criteria:
inclusion criteria: eligible women must: 1. be 20-70 years old and in generally good health 2. have undergone hysterectomy and removal of both ovaries at least 6 months prior to screening 3. be receiving a stable dose of estrogen replacement therapy for at least 3 months prior to screening with the intention of maintaining that regimen. 4. be, in her own judgment, in a stable monogamous sexual relationship that is perceived to be secure and communicative, for at least one year prior to study entry. 5. meet the criteria for having hypoactive sexual desire disorder. exclusion criteria: eligible women must not: 1. have received androgen therapy at any time during the past 3 months (during the past 7 months if therapy was an investigational implantable product) 2. be experiencing any chronic or acute life stress relating to any major life change 3. be experiencing depression and/or receiving medication for such illness or disorder 4. have current severe skin problems (such as severe or cystic acne) or allergy to adhesives (like the ones in bandages) 5. have had a major illness, active gall bladder disease, or gynecological or breast surgery within the last 6 months 6. have a history of breast, endometrial, or other gynecological cancer at any time before study participation or other cancer within the last 5 years 7. have diabetes, a history of cerebrovascular disease, thromboembolic disorders, heart attack, or angina at any time before study participation or thrombophlebitis within the last 5 years 8. have abnormal laboratory test results upon initial screening for this study 9. have previously participated in p\&gp study 1999068 or 1999092 10. have previously participated in a clinical trial within 30 days or received an investigation medication within 30 days.

Keywords: surgical menopause hsdd
the impact of food on blood sugar in people with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study will record the impact of food on blood glucose levels using continuous glucose monitoring (cgm). the investigators think the impact will improve as medication doses are adjusted. the investigators also think that the impact will differ depending on the type of medication taken.


Eligibility criteria:
inclusion criteria: * study participants who are consented for the primary study and have not yet done the baseline cgm data collection at week -2-0. exclusion criteria: * study participants who are unable to complete the baseline cgm data collection at week -2-0. * study participants who are allergic to or have a food intolerance to any of the foods in the fixed meal

Keywords: type 2 diabetes metformin glargine exenatide glycemic impact of food continuous glucose monitoring
sta-4783/paclitaxel or paclitaxel alone in melanoma

Conditions: Melanoma

Summary: this study is designed to assess the efficacy of a weekly treatment regimen of sta-4783 and paclitaxel in comparison to paclitaxel alone on tumor response in metastatic melanoma patients.

sta-4783 is a taxane potentiator, enhancing the effect of antitumor response of paclitaxel. in an attempt to improve efficacy, paclitaxel is sometimes used in combination with other anticancer agents. when paclitaxel is combined with other anticancer agents, although response rate is usually increased, side effects are usually increased as well. there is an urgent need for agents that can enhance the antitumor effects of paclitaxel without further increasing undesirable side effects.

Eligibility criteria:
inclusion criteria: * m or f 18 or older with histologically confirmed metastatic (stage iv) melanoma of cutaneous origin * ecog performance status of greater than or equal to 2 * measurable disease per recist criteria * received no more than 1 regimen of prior chemotherapy (unlimited immunotherapy regimens are allowed) * at least 4 weeks have passed since last chemotherapy or immunotherapy * at least 2 weeks have passed since last radiotherapy. * life expectancy of greater than 12 weeks * clinical lab values within protocol parameters exclusion criteria: * female patients pregnant or lactating * female patients of childbearing potential not using or not willing to use effective contraception * presence of a second malignancy other than nonmelanoma skin cancer * presence of a clinically significant and uncontrolled infection * presence of clinically significant arrythmias * presence of serious concurrent illness or other conditions that do not permit adequate follow-up and compliance with protocol * history of severe hypersensitivity reactions to taxanes * use of any investigational agents within 4 weeks prior to the first dose of study drug

Keywords: metastatic increased antitumor effect
modified radical prostatectomy for prostate cancer patients with enlarged prostate and severe lower urinary tract symptoms: a single-center, retrospective study

Conditions: Prostate Cancer

Summary: the goal of this retrospective, observational study is to preliminarily learn about the safety and efficacy of two-step radical prostatectomy in the treatment of low- to intermediate-risk prostate cancer patients with enlarged prostate and severe benign prostatic hyperplasia. the main questions it aims to answer are: 1. whether two-step prostatectomy is safe enough to decrease the surgical difficulty of these patients? 2. whether the oncologic control is promising?


Eligibility criteria:
inclusion criteria: diagnosed as prostate cancer pathologically by prostate biopsy evaluated as localized prostate cancer by imaging studies prostate volume\>70ml evaluated by transrectal ultrasonography or multi-parametric magnetic resonance imaging gleason score≤ 4+3=7 preoperative psa\ 10 years； informed consent is obtained from the patient exclusion criteria: the patient has received other therapy including radical radiotherapy, transurethral resection of the prostate, cryoablation, hifu, etc. any contraindication of surgery or anaesthesia
validity and reliability of the egyptian-arabic version of abilhand-kids

Conditions: Cerebral Palsy

Summary: hypotheses it is hypothesized that the egyptian-arabic abilhand-kids 21-item will be psychometrically appropriate to be used with egyptian children with cerebral palsy.

background upper extremity functional impairment is a common problem in children with cerebral palsy. this has a significant impact on the children's manual ability which leads to activity limitation and participation restriction. the abilhand-kids is a parent-reported outcome measure that quantifies the manual ability of children with cp. abilhand-kids measures a child's ability to manage 21 daily activities that require the use of the upper limbs. the abilhand-kids demonstrated very good measurement properties and is currently available in english, french, dutch, sweden, and polish. it was also translated and adapted into the classic arabic language in saudi arabia; in their study removal of two items resulted in a 19-item, valid, and reliable unidimensional scale meeting the requirement of the rasch model without establishing measurement invariance between cultures. a linguistic adaptation is not sufficient to prove cross-cultural validity as item difficulties may vary across countries due to translation errors or cultural differences.

Eligibility criteria:
inclusion criteria: - parents of 100 children with cp will be recruited. exclusion criteria: * mental retardation

Keywords: hand function
clinical assessment of spatial neglect following stroke

Conditions: Stroke

Summary: spatial neglect (sn) is a common heterogeneous cognitive affliction that predicts poor recovery after a stroke. it is important to identify sn so alliviating actions can be initated. results of this cross-country study between iceland and lithuania should provide information on how to best identify sn in clinical care.

spatial neglect (sn) is a common disorder following stroke, adversely affecting recovery. sn often involves associated symptoms, including anosognosia, extinction, difficulties with sustained attention and problems with emotional processing. correct identification of sn and associated problems is essential for initiating alleviating strategies and for measuring progress. several assessment tools exist, but psychometric testing has mostly been conducted in non-dynamic environments; a single country or culture. thus non-transferable to a wider context and ward-based care. to optimize identification of sn and develop procedures for diverse healthcare settings, this cross-country study includes patients from iceland and lithuania. we will seek to maximize the clinical utility by avoiding exclusion of patients, e.g., with psycholinguistic difficulties and multiple strokes. we will: a) use behavioral sn assessment and visuo-graphic tests to validate a newly developed sn tool that incorporates many aspects of sn that are currently not addressed in conventional tests, b) validate integration of an additional component into the national institute of health stroke scale as a screening tool to identify sn, and c) evaluate differences in clinical characteristics between patients with left- and right-sided sn, and patients with and without sn.

Eligibility criteria:
inclusion criteria: * stroke diagnosis confirmed by results of ct/mri. * lives in iceland or lithuania. * 18 year or older. * informed consent provided by patient or proxy. exclusion criteria: • patients receiving end-of-life care

Keywords: spatial neglect perceptual disorders diagnostic techniques and procedures symptom assessment rehabilitation acute care
hybrid ablation of atrial fibrillation

Conditions: Persistent Atrial Fibrillation; Atrial Fibrillation, Persistent; Atrial Arrhythmia; Atrial Fibrillation

Summary: a randomised controlled trial to assess the efficacy of staged hybrid ablation when compared with standard catheter ablation in patients with non-paroxysmal atrial fibrillation (af)

the objective of this randomized study is to evaluate the safety and efficacy of convergent hybrid ablation when compared to standard catheter ablation in patients with non-paroxysmal af. patients will be randomised in a 1:1 ratio. the primary efficacy endpoint will be freedom from persistent atrial arrhythmia (measured from the end of a 3-month blanking period up to 24 months (12 and 24 months).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * persistent or long-standing persistent af * dilated left atrium * suitable for either procedure exclusion criteria: * unable to provide written consent * previous open-heart surgery * active infection, oesophageal ulcer stricture or oesophageal varices * prior catheter ablation of atrial fibrillation (prior ablation for atrial flutter / supraventricular tachycardia or ventricular arrhythmia acceptable) * contraindication to anticoagulation, or active thrombus in left atrium despite therapeutic anticoagulation * severe valvular heart disease * unstable coronary artery disease * uncontrolled ventricular arrhythmia * heart attack or stroke within the last 90 days * pregnant, breast-feeding, or women of childbearing age who plan to get pregnant within six months * severe concomitant condition or presence of an implanted device that would preclude the patient from undergoing trial procedures
walking aids in the management of hip osteoarthritis

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine whether or not the use of a nonpharmacologic intervention (single point cane) is effective in the treatment of knee osteoarthritis.

osteoarthritis (oa), the most common joint disease in humans, is a significant cause of pain and disability. non-pharmacological treatments for hip oa include education, exercise, appliances (walking sticks or insoles), and weight reduction if obese or overweight. canes are often recommended to reduce adverse forces across joints although there is currently no research evidence regarding the efficacy of walking sticks for hip oa. little information is available regarding the impact of walking aids on psychosocial function and quality of life in individuals with hip oa. this study will evaluate the effects of walking aids in hip oa by examining gait biomechanics, quality of life, pain, and opinions regarding using a cane. comparisons: compare gait biomechanics in people with symptomatic unilateral hip oa while walking with and without a cane at baseline and after 4 weeks of cane use. compare gait biomechanics in people with symptomatic unilateral hip oa with and without a cane to those of healthy, age-matched controls. compare pain and health-related quality of life in people with symptomatic unilateral hip oa following 4 weeks of cane use. determine the association between changes in gait biomechanics, pain, and health-related quality of life in people with symptomatic unilateral hip oa following 4 weeks of cane use.

Eligibility criteria:
inclusion criteria: 1. hip oa (grades ii-iv) of the kellgren/lawrence classification 2. with pain in one hip for most days of the prior month 3. ability to walk 30 feet without postural sway 4. ability to stand unaided 5. ability to understand verbal instructions 6. ability to give informed consent exclusion criteria: 1. history of hip or knee trauma or surgery including arthroscopic surgery in the past six months 2. severe obesity (\> 300 pounds) 3. neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy, vestibular dysfunction or poor vision 4. injury or amputation to the lower extremity joints 5. history of other types of arthritis or fibromyalgia 6. pain from spine, knee, ankle, or foot disease that would interfere with assessment of the hip 7. poor health that would impair compliance or assessment such as shortness of breath with exertion, chest pain 8. foot deformities such as hallux rigidus, valgus deformity of the midfoot, previous ankle arthrodesis 9. greater trochanteric pain syndrome

Keywords: osteoarthritis walking sticks canes
partial synovectomy in articular side of quadriceps tendon verified to reduce crepitus in retrospective study

Conditions: Osteoarthritis, Knee; Rheumatoid Arthritis, Knee; Spontaneous Osteonecrosis of Knee

Summary: crepitus causing unsatisfied result to patients after posterior stabilized total knee arthroplasty. recent retrospective study demonstrated removal of hyperplastic synovium in distal quadriceps caused reduce of crepitus. however, this study has limitation of time gap exist between arms, different in observation time and bias caused by retrospective review. thus aim of this study is that by randomized trial, verified hyperplastic synovium in distal quadriceps causing crepitus. target enrolled patients in this study are scheduled to perform both total knee arthroplasty. experimental group is randomized side (right or left) of knee, and control group is other side of knee. both arms decided by randomized number table. crepitus measured after 3mo, 6mo, 1year after surgical treatment

surgical treatment of tka with synovium removal in distal quadriceps tendon performed classifed as experimental arm and tka wiout synovium removal classified as control arm. before surgical treatment, radiologic and physiological evaluation performed to check too much variance shown in either arm. radiologic parameter include hip knee ankle angle, femoral tibial angle, level of joint line, insall-salvati ratio, posterior tibial slope, posterior femoral condylar offset, patellar thickness, patellar tilt, patellar displacement. during surgical treatment patella resurfacing in either group excluded this study. indication of patella resufacing is icrs grade iv in lateral surface of patella. after surgical procedure done check grade of crepitus (0-no crepitation, 1-fine crepitation, 2-coarse crepitation) with womac, knee society score, eq-5d (european quality of life -5 dimensions), forgotten joint score after 3month, 6month and 1year after surgical procedure. other collecting variance age, gender, bmi, range of motion of knee, fmoeral/tibial component size, pe thickness

Eligibility criteria:
inclusion criteria: 1.patients who scheduled to perform both total knee arthroplasty(tka) using posteiror crucitate sustain type (ps) exclusion criteria: 1. lost follow up (including death of patient) 2. unexpected complication (e.g) infection, periprosthetic fracture) 3. patella resurfacing 4. canceled surgical treatment 5. refused to enrolled study 6. too much radiological or physicological variance shown between either knee
analgesic effect of ibuprofen, paracetamol (acetaminophen), and paracetamol (acetaminophen) plus codeine on acute pain

Conditions: Surgery

Summary: the purpose of this placebo controlled clinical trial is to evaluate the dose response relationship of ibuprofen in doses from 400 mg to 800 mg and paracetamol (acetaminophen)in doses from 500 mg to 1000 mg compared with paracetamol (acetaminophen)1000 mg plus codeine 60 mg on acute postoperative pain after surgical removal of impacted third molars.

acetaminophen (paracetamol) and related aspirin-like drugs have traditionally been used for pain control of minor to moderate postoperative pain. gradually traditional non-steroidal anti-inflammatory drugs (nsaids) have become more popular as analgesics due to assumed superior therapeutic effects and aggressive marketing campaigns orchestrated by the pharmaceutical industry. ibuprofen is a widely used analgesic both in non-prescription and prescription doses. a dose-response relationship for low ibuprofen doses is shown. evidence of a progressing dose response relationship for moderate (i.e. 400 mg) to higher doses is scarce. a possible analgesic ceiling effect has been suggested for doses above 400 mg, although a correlation between given ibuprofen doses above 400 mg and patient serum levels is shown. however, it may be questioned if the plasma concentration of ibuprofen is an important determinator of analgesic drug efficacy. a higher dose is more likely to influence the duration of analgesic effect rather than the peak analgesic effect. there are few clinical trials investigating the dose-response relationship of increasing ibuprofen doses and paracetamol doses. to our knowledge no published study has investigated the dose-response relationship of ibuprofen and paracetamol in the same trial with a negative (i.e. placebo) and a positive (i.e. best standard analgesic treatment) control group.

Eligibility criteria:
inclusion criteria: * patients of both sexes referred for surgical removal of impacted third molars, due to symptoms or after being advised to do so by their dentist. * persons of both sexes (asa type i). * females who are not pregnant or plan conception. * persons who have not used analgesics for 3 days prior to the day of surgery. * persons without known active ulcus or gastrointestinal bleeding. * persons without any known hypersensitivity for nsaids. * persons under no other continuous drug treatment than contraceptives. * caucasian origin. * persons with at least moderate postoperative pain as defined by subjective score on a verbal rating scale after surgical removal of third molars. exclusion criteria: * patients with surgery time exceeding 60 minutes * peroperative complications such as profuse bleeding or perforation to the maxillary sinus requiring additional drug treatment during or after the surgical removal of the third molar. * postoperative complications such as extended bleeding, nausea and regurgitation during the observation period. * smoking before taking the test-drug or during the observation period.

Keywords: pain analgesics molar third acetaminophen paracetamol ibuprofen codeine placebo
metabolomics for identifying biomarkers of dietary intake and kidney disease progression

Conditions: Dietary Modification; Kidney Diseases, Chronic

Summary: the present record represents a secondary data analysis of the modification of diet in renal disease (mdrd) study. for this analysis, the mdrd study data and specimens were retrieved from the national institute of diabetes and digestive and kidney diseases (niddk) central repository. a global, untargeted, metabolomic profile was used to investigate biomarkers of dietary intake as well as biomarkers of kidney disease progression.

the present study was conducted in order to: 1) quantify the metabolomic expression of dietary intake; and 2) examine the relationship between metabolites that reflect dietary intake and kidney disease progression. this secondary data analysis leverages the completed modification of diet in renal disease (mdrd) study, a randomized clinical trial of dietary protein restriction (n=840).

Eligibility criteria:
inclusion criteria: * age 18-70 * evidence of chronic renal disease with increased serum creatinine (men: 1.4-7.0 mg/dl, women: 1.2-7.0 mg/dl) * mean arterial blood pressure less than or equal to 125 mmhg exclusion criteria: * insulin-dependent diabetes * kidney transplant recipient
efficacy of 5-fluorouracil and low molecular weight heparin in high-risk pediatric retinal detachment

Conditions: Retinal Detachment; Proliferative Vitreoretinopathy

Summary: evaluation of 5-flourouracil and low molecular weight heparin intraoperative infusion in preventing proliferative vitreoretinopathy in high risk pediatric rhegmatogenous retinal detachment

after informed consent, children under 14 years of age with high-risk prrd underwent pars plana vitrectomy and silicone oil injection with scleral buckle divided into 2 groups in prospective randomized trial. group a received intraoperative infusion of 5-fu (200 µg/ml) and lmwh (5 iu/ml), group b received infusion of normal saline. primary outcome was occurrence of recurrent prrd within 12 weeks, secondary outcomes were occurrence of pvr, best corrected visual acuity (bcva), number and timing of secondary procedures within 12 weeks.

Eligibility criteria:
inclusion criteria: children under 14 years of age with rrd undergoing primary repair preoperative pvr grade b or higher high risk rrd: uveitis; large, giant, or multiple tears; vitreous hemorrhage; preoperative choroidal detachments; aphakia; and large detachments involving greater than two quadrants of the eye exclusion criteria: children with rrd related to penetrating ocular trauma involving the posterior segment previous rd repair surgery uncontrolled glaucoma or other concomitant ocular morbidities patients with bleeding diathesis, hepatic and renal failure corneal opacity sufficient to impair surgical view no light perception vision inability to complete follow-up

Keywords: pediatric retinal detachment proliferative vitreoretinopathy 5-fluorouracil low molecular weight heparin