Kornimate/medical-research-clean huggingface dataset:
atorvastatin and ldl profile in non-insulin dependent diabetes mellitus

Conditions: Hyperlipidemia; Diabetes Mellitus, Type 2; Non-Insulin Dependent Diabetes Mellitus

Summary: the study will investigate the effects of atorvastatin on the concentrations of small, dense ldl and hdl subfractions in patients with diabetes and the underlying mechanisms of these effects.

this study was terminated on october 6, 2004. the study terminated prematurely because of a higher screening failure rate than expected. there were no safety or efficacy reasons involved in the decision to terminate.

Eligibility criteria:
inclusion criteria: * male and female subjects with a diagnosis of type 2 diabetes mellitus who either have never had a major adverse cardiac event (mace) diagnosed before or who had a mace diagnosed at least 6 months ago, but who, according to the judgement of the treating general practitioner, do not receive any hyperlipidemic therapy. major adverse cardiac events (mace) include myocardial infarction, coronary angioplasty, coronary artery bypass graft or other revascularization procedures. at screening: visit 1 (week -4): 1. male patients aged \>35 and ≤75 years and postmenopausal female patients ≤75 years with a diagnosis of type 2 diabetes mellitus 2. patients have been euthyroid for at least six months 3. written informed consent obtained at visit 2 (week 0): 4. ldl cholesterol ≥130 mg/dl (3.3 mmol/l ) and \<190 mg/dl (4.9 mmol/l) 5. triglycerides \<150 mg/dl (1.69 mmol/l ) and \<600 mg/dl (11.3 mmol/l) 6. sum of ldl-5 and ldl-6 cholesterol ≥25 mg/dl (0.65 mmol/l) 7. follicle stimulating hormone (fsh) \>30 u/l in female patients aged \ 20 u/l in female patients aged ≥60 years exclusion criteria: * hba1c \> 8.0 * creatine kinase (ck) \>5 times the upper limit of normal * patients having taken lipid lowering medication within 8 weeks of the screening visit

Keywords: ldl-subfractions, hdl-subfractions, non insulin dependent diabetes mellitus (niddm), hyperlipidemia, atorvastatin
apixaban in adults with congenital heart disease and atrial arrhythmias: the protect-ar study

Conditions: Congenital Heart Disease; Atrial Arrhythmia; Thromboembolism; Anticoagulants Causing Adverse Effects in Therapeutic Use

Summary: the purpose of this study is to evaluate the safety and efficacy of apixaban for the prevention of thromboembolism in adult patients with congenital heart disease (chd) and non-valvular atrial arrhythmias (aa)

adult patients with congenital heart disease (achd) represent a rapidly growing population due to the progress of surgical techniques and optimal medical management. non-valvular atrial arrhythmias (aa) carries a significant burden for long-term morbidity and potentially mortality in achd patients. aa occur three times more frequently in achd compared to the general population. when complicating achd, aa convey a twofold increase in the risk for stroke, contributing to an up to 100-fold higher prevalence of stroke in the achd population compared to age-matched healthy controls. at present, the european society of cardiology (esc) guidelines suggest oral anticoagulation (oac) in all adult patients with aa and intracardiac repair, cyanosis, fontan palliation, or systemic right ventricle. in the remaining achd patients with aa, oac is suggested if cha2ds2-vasc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score is ≥1 (class of recommendation iia, level of evidence c). non-vitamin k oral anticoagulants (noacs) are increasingly preferred over vitamin-k antagonists (vkas) in most clinical scenarios due to improved safety (with regard to intracranial and other major bleeding) and efficacy (prevention of embolic stroke or systemic embolism) along with the convenience they offer for patients and physicians (fixed dose, no food and drug interactions, no inr monitoring). on the other hand, scarce data is available on the use of noac in achd. in order to address this gap in evidence, we propose a prospective multicenter single arm, observational cohort trial, which will provide data on the efficacy and safety of apixaban used for the prevention of thromboembolism in achd patients with aa.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged ≥18 years. 2. presence of congenital heart disease (intracardiac repair, cyanosis, fontan palliation, or systemic right ventricle or other congenital heart disease). 3. non-valvular atrial arrhythmia (including at least one electrocardiographically documented episode). 4. signed written informed consent by the patient for participation in the study and agreement to comply with the medication and the follow-up schedule. exclusion criteria: 1. moderate-to-severe mitral stenosis or mechanical valves 2. patient unwilling or unable to complete follow-up procedures

Keywords: congenital heart disease atrial fibrillation thromboembolism noac apixaban atrial arrhythmias
cohort study comparing surgeon stress, utilization of surgical instruments, surgical outcomes according to surgical approach for gastrectomy

Conditions: Gastric Cancer Patients Undergoing Gastrectomy

Summary: a new surgical instrument is supposed to allow surgeon to do surgery with better performance. however, the learning period before getting used to the new instruments is necessary. the surgeon's stress to overcome the learning effect and the surgical outcome was rarely assessed. the comparative analysis of surgical outcome, surgeon's stress, and utilization of instruments for gastrectomy will be performed in prospective cohort study

before the surgery, all the eligible patients will be explained regarding the study and informed consent will be given. during the surgery, the surgeon will wear heart rate monitoring device to monitor hear rate variability of the surgeon. the surgical procedure will be recorded. after the surgery, morbidity following surgery will be monitored and recorded. at 1 month after surgery, additional morbidity will be recorded.

Eligibility criteria:
inclusion criteria: patients with gastric cancer scheduled for gastrectomy exclusion criteria: vulnerable subject (illiterate, pregnant)

Keywords: surgeon stress instrument outcome complication
multiple doses of at-1501-a201 in adults with als

Conditions: Amyotrophic Lateral Sclerosis

Summary: this is a phase 2a, multi-center, open label, multiple dose study of at-1501, a humanized monoclonal antibody antagonist to cd40 ligand (cd40l). approximately 54 adults with amyotrophic lateral sclerosis (als) will be enrolled into the study in the united states and canada at approximately 13 als treatment sites. participants will be enrolled into one of four ascending doses.

this is a phase 2a, multi-center, open label, multiple dose study of at-1501, a humanized monoclonal antibody antagonist to cd40l. approximately 54 adults with als will be enrolled into the study in the united states and canada at approximately 13 als treatment sites. four ascending doses of at-1501 will be administered as an iv infusion to sequentially enrolling cohorts. each participant will receive 6 bi-weekly (every other week) infusions of at-1501 over an 11-week period. the study is estimated to take 19 weeks for participants.

Eligibility criteria:
inclusion criteria: 1. als diagnosed as possible, laboratory supported probable, probable, or definite as defined by revised el escorial criteria 2. als functional rating scale - revised (alsfrs-r) aggregate score of 37 or greater 3. no more than 24 months from diagnosis exclusion criteria: 1. any other central or peripheral nervous system disease that may interfere with the evaluation of als or its progression 2. presence of a tracheostomy, or use of permanent assistive ventilation (ventilatory support for 23 hours per day or more) 3. history of malignancy within the previous 5 years, except for localized non-melanoma skin cancers 4. abnormal function of the immune system resulting from: * clinical conditions affecting the immune system (e.g. hiv infection, agammaglobulinemia), * systemic administration of corticosteroids (po/iv/im) at a dose equivalent to 20 mg/day of prednisone for more than 14 consecutive days within 90 days prior to screening, * administration of anti-neoplastic and/or immunomodulating agents (e.g. tumor necrosis factor alpha (tnf α) antagonists or anti-b cell antibodies) or radiotherapy within 1 year prior to screening. 5. recipient of stem cell or gene therapy 6. positive test for hepatitis b surface antigen, hepatitis c antibody, or hiv. 7. history of deep venous thrombosis or pulmonary embolism 8. history of active substance abuse within the past 2 years 9. history of stroke, poorly controlled or significant cardiovascular disease, diabetes

Keywords: als lou gehrig's disease motor neuron disease motor neuron degeneration at-1501 humanized blocking antibody to cd40lg cd40l inhibitor monoclonal antibody
light therapy treatment in parkinson's disease patients with daytime somnolence

Conditions: Parkinson's Disease; Sleep Disorder; Excessive Somnolence

Summary: study objectives are to determine the efficacy, safety and tolerability of bright light treatment in parkinson's disease (pd) patients with daytime sleepiness. thirty pd patients will be enrolled and equally randomized to bright light or dim-red light treatment. objective (actigraphy) and subjective (sleep logs/scales) sleep measures will be collected through the baseline and intervention phases of the study. the primary outcome measure will be the change in the epworth sleepiness scale (ess) comparing the bright light treatment with dim-red light treatment. secondary outcome measures will include the multiple sleep latency test (mslt), global pittsburgh sleep quality index (psqi) score, parkinson's disease sleep scale (pdss) score, and actigraphy measures. a variety of exploratory analyses will examine the effects of bright light treatment on fatigue, depression, quality of life, cognition, and motor disability. hypothesis: bright light exposure will diminish daytime sleepiness and improve night-time sleep in pd patients with daytime sleepiness.

see above.

Eligibility criteria:
inclusion criteria: 1. diagnosis of idiopathic pd as defined by the united kingdom parkinson's disease society brain bank criteria 2. hoehn and yahr stage of 2 to 4 in the "on" state 3. excessive daytime sleepiness as defined by the epworth sleepiness scale (ess) score of greater than or equal to 12 points 4. stable pd medication regimen for at least 4 weeks prior to study screening 5. willing and able to give written informed consent exclusion criteria: 1. atypical parkinsonian syndromes 2. significant sleep disordered breathing (defined as an apnea-hypopnea index \>15 events/hr of sleep on screening psg) 3. significant periodic limb movement disorder (defined as a plm arousal index\>10 events/hr of sleep on screening psg) and rem sleep behavior disorder (based on the presence of both clinical symptomatology as well as intermittent loss of rem atonia on screening psg) 4. cognitive impairment indicated by the mini-mental status examination (mmse) score of less than 24 5. presence of depression defined as the beck depression inventory (bdi) score \>14 6. untreated hallucinations or psychosis (drug-induced or spontaneous) 7. use of hypno-sedative drugs for sleep or stimulants during the daytime 8. use of antidepressants unless the patient has been on a stable dose for at least three months 9. visual abnormalities that may interfere with light therapy, such as significant cataracts, narrow angle glaucoma or blindness 10. travel through 2 time zones within 90 days prior to study screening

Keywords: parkinson's disease daytime somnolence sleepiness light therapy
a clinical trial to compare topical agents in adults with mild to moderate atopic dermatitis (ad)

Conditions: Atopic Dermatitis

Summary: an explorative clinical trial to evaluate an intra patient comparison design of topical agents in adults with mild to moderate atopic dermatitis.

multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.

Eligibility criteria:
inclusion criteria: * subject with mild to moderate ad * four comparable tas * tss of at least 5 on all tas * difference in tss not greater than 2 between the tas * sign score erythema ≥ 2 between the tas * tas should be at least 2 cm apart exclusion criteria: * investigator's opinion * fitzpatrick skin type \>5 * topical (i.e. on the tas) treatment with prohibited medications * systemic treatment with prohibited medications * phototherapy within prohibited timeframe * use of emollients within prohibited timeframe

Keywords: atopic dermatitis eczema ad
manitoba inflammatory bowel disease cohort study

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Summary: the manitoba inflammatory bowel disease (ibd) cohort study participants were drawn from a population-based research registry. the cohort consisted of 388 adult enrollees with recent ibd onset who completed the baseline survey and interview in 2002 to 2003. participants were followed every 6 months with surveys and annually with interviews. diagnosis and disease type were verified by chart review.

the manitoba inflammatory bowel disease (ibd) cohort study, initiated in 2002, is study of adults with ibd who have been tracked prospectively through annual clinical interviews and semiannual surveys. the participants were drawn from a validated population-based research registry, which identified and recruited individuals using an administrative definition of ibd from the comprehensive health data base of manitoba health, the single insurer that provides health care to all residents in the province. the cohort consisted of 388 adult enrollees with recent ibd onset who completed the baseline survey and interview in 2002 to 2003. participants were followed every 6 months with surveys and annually with interviews. diagnosis and disease type were verified by chart review. it has been demonstrated that the cohort is representative of the provincial ibd population as a whole, with comparable age distribution, sex distribution, disease duration, and rural/urban residence.

Eligibility criteria:
inclusion criteria: * diagnosed within the previous 7 years with inflammatory bowel disease exclusion criteria: -
the effectiveness of telerehabilitation in improving upper extremity in parkinson's patients

Conditions: Parkinson Disease

Summary: parkinson's disease (pd) is a disease that affects the functional skills of the upper extremity with clinical findings such as bradykinesia, rigidity, and hypokinesia and causes limitations in the daily life activities of the patients. task-oriented training (tot) is a highly individualized, client-centered, occupational therapy, functional-based intervention compatible with motor learning and motor control principles such as intensive motor training, variable practice, and intermittent feedback. few studies have been found on the tot of the upper extremity in pd. telerehabilitation of parkinson's patients shows many strengths, such as cost-related and time-dependent ease, and the possibility of telecommunication with clinicians. in addition, the refinement of digital health solutions with the goal to offer a patient-tailored intervention remains an ongoing process. there are a limited number of studies on tot and telerehabilitation of the upper extremity in pd. in addition, no studies have been found applying tot through telerehabilitation. for this purpose, a study including tot-based telerehabilitation in upper extremity education in pd was planned.

this study is a randomized controlled study. the patients will be randomly divided into two groups as exercise and control. balance and walking exercises consisting of 3 days a week for 6 weeks will be given to both groups as a home program. in addition, the exercise group will receive tot-based telerehabilitation via video conferencing 3 days a week for 6 weeks. tot will be formed from daily life activities such as reaching out, grasping, writing, and manual skills, which are frequently used in daily life. as the outcome measures, disease severity and disability, finger and hand function, hand strength, and quality of life will be evaluated.

Eligibility criteria:
inclusion criteria: * 45- 70 years of age * having diagnosed with "parkinson's disease" by a specialist physician * having between 1-3 stages according to the hoehn and yahr scale * mini-mental test score more than or equal 24 exclusion criteria: - any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results

Keywords: parkinson disease telerehabilitation task-oriented upper extremity
a study to evaluate the safety and antitumor activity in subjects with advanced solid tumors

Conditions: Advanced Solid Tumors; Advanced Recurrent Ovarian Tumors

Summary: to determine the maximum tolerated dose or optimal biological dose, and the safety profile of medi3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies resistant to standard therapy.


Eligibility criteria:
inclusion criteria: * patients with confirmed diagnosis of advanced solid tumors (dose-escalation phase) or another solid tumor type based on antitumoral activity (dose-expansion phase) that are not responsive to standard therapy or for which no standard therapy exists * patients must be 18 years of age or older * karnofsky performance status ≥ 70 * toxicities from previous cancer therapies must have recovered to ctcae grade = or \< 2 * adequate organ and marrow function * using adequate contraceptive measures, be surgically sterile or post-menopausal exclusion criteria: * concurrently enrolled in another clinical study, except for non-interventiona observational studies, or if in a follow up period from a previous study * receipt of any investigational anticancer therapy within 30 days prior to the first dose of medi3617, or in the case of monoclonal antibodies (eg, bevacizumab), 42 days prior to the first dose of medi3617 * current or previous treatment with angiopoietin inhibitors, or inhibitors of tie1 or tie2 including, but not limited to, amg386, cvx-060, xl880, and xl820 * any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment * use of immunosuppressive medication or systemic steroids within 7 days prior to first dose of medi3617 * any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results * known bleeding diathesis * pulmonary hemorrhage or gross hemoptysis within 6 months prior to enrollment * therapeutic or palliative radiation therapy within 2 weeks prior to enrollment

Keywords: advanced solid tumors advanced recurrent ovarian tumors medi3617 ang2 ovarian cancer malignant glioma
vitamin deficiencies and suppletion in morbid obesity

Conditions: Vitamin B12 Deficiency

Summary: the purpose of this study is to evaluate the most effective treatment for patients who underwent a roux-en-y gastric bypass and developed postoperatively a vitamin b12 deficiency.

vitamin b12 deficiency accounts up to 23-64% bariatric surgery. the investigators purpose is to evaluate the most effective treatment for vitamin b12 deficiency in patients who underwent a roux-en-y gastric bypass. daily oral use of vitamin b12 tablets are may be as effective as vitamin b12 injections.

Eligibility criteria:
inclusion criteria: * vitamin b12 deficiency: \<200 pmol/l * vitamin b12 deficiency 6-12 months after surgery * all patients underwent a roux-en-y gastric bypass exclusion criteria: 1. creatin \>150micromol/l 2. liver enzymes \>2 times upper limit 3. other bariatric operations 4. intercurrent diseases 5. gastro-intestinal diseases 6. psychiatric disease 7. medicines which influences bone density 8. pregnancy
safety and efficacy of tazarotene cream 0.1% compared with adapalene gel 0.3% in the treatment of moderate to severe facial acne vulgaris

Conditions: Acne Vulgaris

Summary: comparison of the safety and efficacy of tazarotene cream 0.1% compared with adapalene gel 0.3% in treating moderate to severe facial acne vulgaris


Eligibility criteria:
inclusion criteria: * facial acne vulgaris characterized by the following: 25-100 facial inflammatory lesions (papules plus pustules); and 40 or more non-inflammatory lesions (open/closed comedones)); stable disease, non-rapidly regressing facial acne vulgaris; and, 3 or less facial nodules and/or cysts (diameter of 1cm or greater). * female subjects of childbearing potential must have a negative urine pregnancy test at baseline and practice reliable method of contraception throughout the study. exclusion criteria: * non-compliance with washout period * skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris * allergy or sensitivity to any component of the test medications * cosmetic or surgical procedure complementary to the treatment of facial acne within 14 days of the baseline visit
decreasing ed utilization by nudging patients to call their providers

Conditions: Emergency Treatment; Telephone Hotlines

Summary: in the present study, patients will be sent a message shortly after completing a medical procedure that informs or reminds them that they can reach out to geisinger, and how to do it, if they have any medical issues or concerns. researchers will assess if such messages make patients more likely to contact geisinger with post-procedure medical concerns and decrease emergency department utilization.

decreasing emergency department (ed) over-utilization is a priority for healthcare systems across the country. patients uncertain about a medical issue routinely end up in the ed when less costly and time-consuming alternatives could have addressed their concern. if patients reach out to healthcare facilities rather than heading directly to the ed, they can often be directed toward resources better suited to their concerns than the ed. geisinger is thus working to encourage patients to contact healthcare providers if any concerns arise and patients are uncertain about where to go for care. patients who have recently had a medical procedure may be particularly valuable to encourage, as they routinely have concerns related to the procedure and discharge can serve as a useful touch-point to remind the patient where they can go for questions or concerns. in the present study, patients will be sent a patient portal message shortly after completing any women's health medical procedure. the message will inform or remind patients how they can reach geisinger if they have any medical issues or concerns. the purpose of this study is to assess if such messages make patients more likely to contact geisinger with medical concerns and, in turn, decrease unnecessary ed utilization. this study will a/b test 2 messages, encouraging patients to either call their recent provider directly or to call a tele-nurse hotline, and will assess if these messages perform better than a control group that will not be sent any such message. generalized linear models will examine the primary study outcomes as a function of the study arms (between-subjects).

Eligibility criteria:
inclusion criteria: * patient had a procedure in women's health within the study period (including both surgical and in-office procedures as well as baby delivery) * patient is enrolled in mygeisinger, geisinger's patient portal exclusion criteria: * if procedure was labor that resulted in fetal demise or stillborn.

Keywords: behavioral economics patient portal