Kornimate/medical-research-clean huggingface dataset:
a study of different doses of atevirdine mesylate plus zidovudine in hiv-positive patients

Conditions: HIV Infections

Summary: to determine the tolerance and antiviral response of two different doses of atevirdine mesylate (u-87201e) in symptomatic hiv-positive patients with cd4 counts of 50-350 cells/mm3, who also take zidovudine (azt).

patients are randomized to 1 of 3 treatment groups: u-87201e at 1 of 2 doses or placebo administered every 8 hours. patients must have taken azt for at least 3 months prior to randomization.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * primary or secondary prophylaxis for opportunistic infections. patients must have: * hiv infection. * symptoms (currently or prior to enrollment) included in category b or c of cdc classification, although the following current acute medical conditions are not allowed: * cryptococcosis * pneumocystis carinii pneumonia * herpes zoster * histoplasmosis * cmv * hepatic or renal disease * lymphoma. * cd4 count 50 - 350 cells/mm3 within 14 days prior to study entry. * ongoing therapy with azt at 500 - 600 mg total daily dose for at least 3 months prior to study entry. * consent of parent, guardian, or person with power of attorney if less than 18 years of age. exclusion criteria co-existing condition: patients with the following conditions are excluded: * intolerance to azt. * current diagnosis of malignancy for which systemic therapy will be required during the study. concurrent medication: excluded: * any other investigational drugs. prior medication: excluded: * cytotoxic chemotherapy within 1 month prior to study entry. * prior u-87201e or any other non-nucleoside antiretroviral medications, including but not limited to nevirapine, tibo r-82150 or tibo r-82913, l-697639 or l-696229, u-90152s, or any protease inhibitors. * antiretroviral agents other than azt within 3 months prior to study entry. required: * azt for at least 3 months prior to study entry. present use of excessive alcohol or illicit drugs.

Keywords: drug therapy, combination acquired immunodeficiency syndrome aids-related complex antiviral agents
efficacy and safety of diabetes-specific formula in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: hypothesis: the diabetes-specific formula nutren diabetes provides better postprandial glucose control in patients with type 2 diabetes when compared to the isocaloric diet.

this study is an open label, randomized controlled cross-over study research objectives: 1. to study the efficacy of diabetes-specific formula (nutren diabetes) in comparison with an isocaloric diet in the aspect of postprandial blood glucose and insulin response (baseline, 30, 60 and 120 minute). 2. to study the safety and tolerance of a diabetes-specific formula compared with an isocaloric diet in patients with type 2 diabetes mellitus statistical analysis method 1. descriptive statistics: categorical data will be summarized as number and percentage, continuous data with normal distribution will be presented as means and standard deviations, and continuous data with non-normal distribution will be summarized as median, minimum and maximum. 2. inferential statistics: repeated measure anova from analyzing the difference of means from measuring fasting glucose and insulin more than two times. 3. inferential statistics: paired t-test or wilcoxon matched pairs signed rank test derived by analyzing the comparison between the means of two dependent groups. 4. report of the difference between two categories by the difference of means with 95% confidence interval 5. number of participant (subjects) and criteria for participation 30 participants by calculation formula of frison and pocock (1992) with stata program.

Eligibility criteria:
inclusion criteria: * dm type 2, hba1c \< 9% fpg \< 180 mg/dl * aged between 18- 70 years. * participants must have stable body weight (+/- not over 5%) for the past six months. * participants must control their diabetes by diet control or taking diabetes medicine without medicine dose adjustment during the period of the research. * participants are willing to participate in the research and sign written consent form. exclusion criteria: * participants receive insulin hormone and gpl-1 agonist injection. * gfr \< 30 ml/min/1.73 m2 * participants have decompensated liver cirrhosis or alcoholism or drug abuse record. * participants have record of allergy to any ingredients in diabetes-specific formula,soybean milk or bologna and mayonnaise sandwich. * participants decline to participate

Keywords: diabetes-specific formula
1 week versus 6 weeks of levetiracetam in surgical brain tumor patients

Conditions: Brain Neoplasms; Brain Cancer; Brain Tumors; Cancer of the Brain; Cancer of Brain; Seizure

Summary: the purpose of this study is to see if there are any differences in patient reported neurotoxicity between patients who receive levetiracetam tablets for one week after surgery to remove a brain tumor versus those who receive levetiracetam tablets for six weeks after surgery. specifically, we will see if one group has less side effects than the other, and whether or not one group has more seizures than the other.

because seizures are one of the leading neurologic complications in brain tumor patients, neurosurgeons prescribe antiepileptic drugs (aeds) to help prevent them. although the american academy of neurology (aan) guidelines recommend that aeds be stopped after the first post-operative week in patients without seizures, there is no standard length of treatment and some patients may stay on aeds indefinitely. in an attempt to develop clinical guidelines for aed use in post-operative brain tumor patients, we will try to determine if taking levetiracetam for 1 week results in less neurotoxicity than taking it for 6 weeks.

Eligibility criteria:
inclusion criteria: * adult (\>18 years of age and older) patients who have or will have undergone surgical resection or biopsy of a supratentorial brain tumor and are able to consent for themselves. * able to be randomized prior to or up to 48 hours after surgery. exclusion criteria: * no known history of seizure activity. * pregnant or breastfeeding. * renal dysfunction (crcl \< 30ml/min). * beck's depression inventory (bdi) ≥14 * allergy to levetiracetam.
validity of laboratory biomarkers in diagnosis of nonalcoholic fatty liver disease (nafld) and it's consequences

Conditions: Non-alcoholic Fatty Liver Disease

Summary: the validity of laboratory biomarkers in the diagnosis of nafld is still not established, and adherence to a healthy dietary lifestyle for those patients in our community is not well studied.

non-alcoholic fatty liver disease (nafld) is characterized by excessive hepatic fat accumulation, associated with insulin resistance, and defined as the histological presence of steatosis in \>5% hepatocytes. nafld is an umbrella terminology incorporating a spectrum of liver diseases ranging from simple steatosis (nonalcoholic fatty liver), steatohepatitis (nonalcoholic steatohepatitis, nash), and cirrhosis. nafld is also the leading cause of liver cirrhosis, hepatocellular carcinoma, and death. early diagnosis and assessment of nafld and liver fibrosis are essential for monitoring disease progression and selecting the best treatment options for affected individuals. given that liver biopsy had considerable disadvantages, there was a dire need for genuine noninvasive methods for nafld detection and risk assessment. the serum markers and other indicators is valuable for screening diseases due to their convenience, low cost, and accuracy of diagnosis unhealthy dietary composition is an important factor in the progression of non- alcoholic fatty liver disease. many studies surround the benefits of a mediterranean diet in conditions such as metabolic syndrome, t2dm, and cardiovascular disease; such conditions often coexist and have a pathophysiological link with nafld. the mediterranean diet (med) is defined as a plant-based diet characterized by a high intake of fruits and vegetables, legumes, whole grains, and a high ratio of monounsaturated fatty acids (mufa), which is associated with a lower risk of many chronic diseases

Eligibility criteria:
inclusion criteria: * all adult patients attending outpatient clinics characterized by an age over 18 years. * patients diagnosed as nafld. exclusion criteria: * patients younger than 18 years old. * patients diagnosed with viral hepatitis to avoid other causes of liver fibrosis. . * patients with alcoholic fatty liver (more than three standard drinks per day for men or more than two standard drinks per day for women). * patients receiving treatment with drugs known to promote liver steatosis (for example, tamoxifen, amiodarone, estrogen, or corticosteroids). * patients with malignant tumors or other severe organ dysfunction diseases.
post-marketing safety and efficacy surveillance of motherwort injection

Conditions: Bleeding; Real-world Study; Adverse Events

Summary: this study aims to provide evidence concerning the safety and efficacy of motherwort injection in real-world settings.


Eligibility criteria:
inclusion criteria: * meet the clinical indications for the use of motherwort injection * voluntarily participate in this study * fulfill ethical requirements. exclusion criteria: * none

Keywords: adverse events motherwort injection bleeding real-world study post-abortion hemorrhage uterine retraction
effect of ketosteril on sarcopenia in patients with chronic kidney disease

Conditions: Chronic Kidney Disease; Sarcopenia

Summary: the investigators hypothesize that ketosteril can improve sarcopenia in patients with renal disease without increasing the burden on the kidneys and causing deterioration of renal function. therefore, this study intends to take patients with ckd stage 3-4 and sarcopenia as the research object, give ketosteril intervention or not to patients on the base of low-protein diet, and clarify the clinical benefits of ketosteril prescription for improving sarcopenia in patients with ckd.


Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for ckd stage 3-4 (15 ≤egfr\<60 ml/(min\*1.73m2)) in the 2012 kidney disease improving global outcomes (kdigo) guideline. 2. sarcopenia should be diagnosed according to the 2019 asian working group for sarcopenia (awgs) diagnostic criteria for sarcopenia: ① muscle strength: grip strength (\< 28 kg for males, \< 18 kg for females); ② physical function: is assessed by walking speed over 6 m (\< 1.0 m/s) or five-repetition sit-to-stand test (5sts) (≥ 12 s) or recommended short physical performance battery (sppb) (≤ 9); ③ artificial skeletal muscle (asm) of extremities: bioelectrical impedance analyzer (bia) (\< 7.0 kg/m2 for males and \< 5.7 kg/m2 for females). on the basis of meeting criteria ③, sarcopenia can be diagnosed if at least one of the first two items is met. 3. patient can walk normally. 4. provide the written informed consent. exclusion criteria: 1. patients with diabetes. 2. obese/overweight patients (body mass index\>25 kg/m2) 3. had previously received renal replacement therapy (including kidney transplantation, hemodialysis, peritoneal dialysis). 4. patients with new cardiovascular events, uncontrolled acute or chronic cardiac failure within 3 months. 5. patients with acute infection (c-reactive protein\>10 mg/l) or acute exacerbation of chronic diseases that is not under control within 3 months. 6. patients with cerebrovascular events, severe liver disease, malignant tumor and multiple organ failure. 7. patients with osteoarthritis, metabolic bone disease, osteonecrosis of the femoral head, hemiplegia and cognitive dysfunction. 8. patients with hypercalcemia and amino acid metabolism disorder. 9. those who are allergic to the active ingredients or other excipients of the ketosteril. 10. patients with poor compliance, unable to follow the study requirements for diet control. 11. participated in other interventional clinical trials within 30 days before this study.

Keywords: ckd sarcopenia
study of the 2.25mm sirolimus-eluting stent in the treatment of patients with coronary artery lesions

Conditions: Coronary Artery Disease

Summary: the main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting bx velocitytm stent in reducing in-lesion restenosis in patients with de novo native coronary artery lesions.

this is a multicenter (approximately 10 - 14 sites), prospective, non-randomized study. the study is designed to evaluate the safety and effectiveness of the sirolimus-eluting bx velocitytm stent in patients with de novo native coronary artery lesions. a total of 100 patients will be entered in the study. patients who meet the eligibility criteria will be enrolled into the study. patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4 and 5 years post-procedure, with all patients undergoing repeat angiography at 6 months. approximately 50 patients will be required to have an intravascular ultrasound (ivus) procedure at baseline and at the 6-month angiographic follow-up.

Eligibility criteria:
inclusion criteria: 1. male or non-pregnant female patients minimum 18 years of age 2. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b\&c, i-ii) or patients with documented silent ischemia; 3. target lesion is 20mm in length (visual estimate); 4. target lesion stenosis is \>50% and \<100% (visual estimate); exclusion criteria: 1. patient has experienced a q-wave or non-q-wave myocardial infarction with documented total ck \>2 times normal within the preceding 24 hours and the ck and ck-mb enzymes remains above normal at the time of treatment; 2. has unstable angina classified as braunwald iii b or c, or is having a peri infarction; 3. documented left ventricular ejection fraction 25%; 4. impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
type of exercise and education in patients with subacromial pain syndrome

Conditions: Shoulder Pain

Summary: patients seeking care for shoulder pain will be recruited to enroll will be randomized to one of four combined treatment groups; eccentric or traditional strengthening alone and eccentric or traditional strengthening with pain neuroscience education. patients will be followed for 1 year.

patients seeking care for their shoulder in a primary care setting will be recruited to participate in a trial investigating the value of different exercise and education regimens. patients that choose to participate will be randomized to 1 of 4 different treatment groups focused on strengthening of the rotator cuff and shoulder girdle muscles: eccentric strengthening alone; traditional strengthening alone; eccentric strengthening plus education focused on pain neuroscience, traditional strengthening plus education focused on pain neuroscience. all patients will be seen in the clinic for 4-6 sessions over a 4-week period, as well receive a home exercise program that aligns with the exercise group there were randomized to. one-year outcomes will be compared across all 4 groups.

Eligibility criteria:
inclusion criteria: 1. age 18 to 65 2. read and speak english well enough to provide informed consent, follow study instructions, and independently answer the questionnaires/surveys 3. tricare beneficiary (eligible for medical benefits in the military health system) 4. primary complaint of new episode of unilateral shoulder pain; defined as not having sought care for shoulder condition in 6 months prior 5. meets criteria for saps, as determined upon physical exam 6. at least 20% on either pain or disability subscales of the spadi outcome measure 7. available and willing to come in for treatment up to 8 sessions over a 4-week period exclusion criteria: 1. history of shoulder dislocation, subluxation, fracture, adhesive capsulitis of the glenohumeral joint, or cervical/shoulder/upper back surgery, or shoulder injury as the result of trauma (e.g. fall, mva) 2. presence of cervical radiculopathy, radiculitis, or referral from cervical spine (reproduces shoulder symptoms) 3. patient reports their condition is "acceptable" on patient acceptable symptom state (pass) at baseline 4. anyone pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury 5. unable to give informed consent to participate in the study.

Keywords: exercise pain neuroscience education physical therapy subacromial pain rotator cuff
a study on efficacy and safety of topiramate in the treatment of patients with obesity

Conditions: Obesity

Summary: the purpose of this study is to compare the efficacy and safety of topiramate (96, 192, and 256mg daily) with placebo in long-term treatment of obesity.

topiramate is not approved for the treatment of obesity. this double-blind, placebo-controlled study assesses long-term effectiveness and safety of topiramate in patients with obesity. after completing 6 weeks of run-in phase (a single-blind placebo-treatment phase during which patients begin non-pharmacological therapy), patients will be randomized to receive either topiramate or placebo. topiramate group will receive 16mg of topiramate and the dose will be titrated over 8 weeks. patients will then receive two years of treatment. effectiveness will be evaluated by body weight, body mass index (bmi), anthropometric measurements (waist circumference, hip circumference, waist/hip ratio), fasting lipid profile, fasting plasma glucose, hba1c, fasting uric acid, fasting insulin, blood pressures, body fat compositions, mass of left ventricle of the heart (as measured by echocardiography), and health related quality of life scores. safety evaluation (incidence of adverse events, laboratory tests, electrocardiogram, vital signs) will be performed throughout the study. the study hypothesis is that topiramate will be effective in achieving and maintaining weight reduction in obese patients. during the initial 8 weeks, the doses of topiramate or placebo will be gradually increased to the target dose (either 96mg, 192mg, or 256mg daily by mouth) and the doses will be maintained for 2 years.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) \>= 30 and \< 50 * bmi \>= 27 and \< 50 if patient has controlled hypertension or abnormal blood lipids * stable weight * female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test) exclusion criteria: * known contraindication, or hypersensitivity to topiramate * a diagnosis of diabetes (except those diagnosed during the enrollment if no medications are needed) * history or evidence of clinically significant liver, disease, cardiovascular disease, uncontrolled hypertension or high thyroid levels * history of obesity with known cause * history of weight loss surgery or liposuction * history of malignancy within last 5 years

Keywords: obesity hypertension hyperlipidemia type 2 diabetes mellitus body mass index
effect of epa and dha in the inflammation and metabolic disorders in dmd/dmb patients

Conditions: Muscular Dystrophy, Duchenne

Summary: the purpose of this study is to evaluate the effect of docosahexaenoic fatty acid and eicosapentaenoic fatty acid supplementation for six months on the inflammation state as well as the process of muscular regeneration and the metabolic disorders like obesity and insulin resistance in patients with duchenne muscular dystrophy (dmd) and becker muscular dystrophy (dmb) compared to those receiving placebo.

dmd and dmb are x-linked diseases caused by mutations in the dmd gene, these mutations have important functional and structural consequences in skeletal muscle. in muscle fiber is observed inflammation and necrosis as a result of lost regenerative capacity. the muscle fibers can be replaced by connective and adipose tissue. in a previous study the investigators identified that 50% of duchenne and becker patients in the range of thirteen years old have obesity. in addition, these patients (n=66) have hyperinsulinemia (53.7%) and insulin resistance (48.5%). it is well known that obesity, hyperinsulinemia and insulin resistance have a inflammatory background. it has been demonstrated that eicosapentaenoic fatty acid (epa) and docosahexaenoic fatty acid (dha) exhibit anti-inflammatory properties and have beneficial effects on obesity, hyperinsulinemia and insulin resistance in children and adolescents. objective: determine the effect of epa and dha on inflammation, obesity and insulin resistance in patients with dmd/dmb compared to those receiving placebo.

Eligibility criteria:
inclusion criteria: * written informed consent and assent by the patient and both parents or guardian. * patients with clinical diagnosis of duchenne muscular dystrophy (dmd) or becker muscular dystrophy (dmb) * patients were not under treatment with corticosteroids exclusion criteria: * patients decided to withdraw from the study * consumption of dietary supplements containing polyunsaturated fatty acids omega 3. * with hypersensitivity to fish oil. * patients with respiratory and gastrointestinal problems. medical responsible assessment the presence of respiratory and gastrointestinal problems. * patients with difficulty swallowing food, including those who have the difficulty ingesting oil capsules. * gastrostomy fed patients.

Keywords: muscular dystrophy duchenne muscular dystrophy becker muscular dystrophy omega 3 eicosapentaenoic fatty acid docosahexaenoic fatty acid
focus (nifedipine gits's effect on central pressure assessed by applanation tonometry)

Conditions: Hypertension

Summary: to determine whether the combination of nifedipine gits and valsartan is more effective in reducing central blood pressure than nifedipine gits or valsartan alone, and to determine whether nifedipine gits is comparable to valsartan


Eligibility criteria:
inclusion criteria: * untreated grade 2 or grade 3 hypertension defined by mean diastolic blood pressure (bp) \>/= 100 and/or mean systolic bp \>/= 160mmhg without anti-hypertensive treatment or treated grade 2 hypertension defined by mean diastolic bp \>/= 100 and/or mean systolic bp \>/=160mmhg with current diuretics and/or beta-blockers use for \>/= 4 weeks exclusion criteria: * secondary form of hypertension * mean systolic bp \>/= 200mmhg and or mean diastolic bp \>/= 120mmhg * treated with other antihypertensive medication except diuretics or beta-blockers * type 1 diabetes mellitus * known cardiovascular disease including history of angina pectoris, heart failure, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and transient ischaemic attack) within the previous 12 months * renal insufficiency defined as a serum creatinine: \>/= 1.7 mg/dl * pregnancy or not using contraceptive in childbearing aged women * breast feeding women * any disease or condition that in the opinion of the investigator may interfere with completion of the study

Keywords: central blood pressure nifedipine valsartan