Kornimate/medical-research-clean huggingface dataset:
modified atkins diet and type 2 diabetic patients

Conditions: Obese Type 2 Diabetic Patients

Summary: this randomized control trial compared the influence of an atkins diet to that of the ada recommended diet on type 2 diabetic obese patients during a one-year follow-up period


Eligibility criteria:
inclusion criteria: * type 2 diabetic patients age 35-75 years * bmi 30-39.9kg/m * hba1c\>7% * not receiving insulin * micro-albumin excretion\<60 mg/day exclusion criteria: * serum creatinine level \> 1.4 mg per deciliter * diastolic blood pressure \> 100 mmhg or systolic blood pressure \> 180mmhg * liver disease * ldl cholesterol \> 160 mg per deciliter despite lipid-lowering treatment * use of psychiatric medications * osteoporosis * cancer * food allergies, and * low carbohydrate diet in the past 6 months.

Keywords: obesity atkins weight reduction kidney function
auricular acupuncture for exam anxiety in medical students

Conditions: Anxiety

Summary: title of the study: auricular acupuncture (aa) for pre-exam anxiety: a blinded randomized crossover study on healthy volunteers study period: 04/2012 - 07/2012 institution: department of anesthesiology and intensive care medicine university medicine of greifswald aim of the study: to investigate the anxiolytic effect of auricular acupuncture (aa) in comparison to placebo acupuncture and no intervention during oral exams in anatomy at the university of greifswald design: prospective blinded randomized crossover trial intervention: 1. aa using indwelling fixed needles, retained 24 h in situ 2. aa using placebo needles number of volunteers: n = 40 outcome measures: anxiety level, heart rate, blood pressure.


Eligibility criteria:
inclusion criteria: 1. medical students at the university of greifswald 2. going to take part in oral exams of human anatomy 3. participants without previous anxiolytic medication 4. participants without any experiences with acupuncture 5. patients who have given written informed consent exclusion criteria: 1. local auricular skin infection 2. pregnant or lactating women 3. participants with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolapse (risk of bacterial endocarditis according to guidelines of aha) 4. participants who are unable to understand the consent form 5. history of psychiatric disease, alcohol and drug abuse
a telenovela intervention for caregivers of african-american and hispanic hospice patients

Conditions: Hospice; Caregivers

Summary: this randomized clinical trial (rct) intends to look at the preliminary efficacy of novela (intervention group) in changing anxiety and self-efficacy compared to usual hospice care (control group). in the novela intervention, hospice care will be enhanced with the telenovela videos for hospice family caregivers (hfcg) education during twice weekly hospice telehealth visits to prepare caregivers for proper use of hospice support and healthcare services.

telenovela is a television drama or soap opera that can be used to lead viewers to contemplate and discuss critical issues through video storytelling. prior work showed informational telenovelas had a positive effect on latino family caregivers' attitudes toward end-of-life (eol) care services. the role of videos in hospice and palliative care shows significant promise, underscoring the videos as a mode of education for family caregivers that could potentially enhance caregiver's self-efficacy, decrease caregiver's anxiety, and reduce burnout. despite the value of video education, many programs have failed to provide engaging material. based on input from hfcg, the investigators have produced a bilingual (spanish and english version) four chapter telenovela video series (to care/ el privilegio de cuidar) as part of nci funded diversity supplement study. founded upon extensive preliminary work, to care portrays the journey of one hospice family as the family struggle with the hospice decision, pain management, decision-making, and finally the dying process. averaging only 4:65 minutes, each chapter addresses one of these problems, validating family experiences and identifying potential solutions. in a follow-up study, the investigators developed an interventionist-led conversation guide as a companion for the telenovela. the intervention, which includes the video series and the conversation guide, is named novela (short for telenovela). the investigators preliminary single-arm trial found novela feasible and acceptable in the hospice setting, with promising improvements in caregiver anxiety symptoms. thus, storytelling and culturally tailored videos can be powerful tools to educate family caregivers of hospice patients. the overall expectation is that novela will improve self-efficacy thus lowering anxiety in hospice family caregivers. this proposal has the following aims: * specific aim 1: investigate the preliminary efficacy of delivering novela to african american (aa) and hispanic hfcgs of cancer patients. * specific aim 2: evaluate the benefits of novela as perceived by hospice staff.

Eligibility criteria:
inclusion criteria: * identified family caregiver of patients enrolled in hospice * caregivers must be over the age of 18 * without cognitive impairment * with access to wireless device and internet. exclusion criteria: * hfcg of patients that are actively dying * caregivers younger than 18 years * with cognitive impairment * without internet access.

Keywords: videos hospice family caregivers education telenovelas self-efficacy anxiety feasibility
clinical study between two 1% clindamycin/5% benzoyl peroxide topical gel formulations

Conditions: Acne Vulgaris

Summary: a randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% clindamycin/5% benzoyl peroxide topical gel formulations.


Eligibility criteria:
inclusion criteria: * healthy men or women, 12 years of age and older * willing to participate and sign a copy of the informed consent form * moderate to severe facial acne exclusion criteria: * history of allergy or hypersensitivity to clindamycin or benzoyl peroxide * pregnant or lactating women * evidence of a clinically significant disorder * receipt of any drugs as part of a research study within 30 days prior to study dosing * use of systemic, topical or facial products which may interfere with study * significant facial hair, tattoos, excessive facial scarring, active facial sunburn, or peeling due to sunburn

Keywords: acne vulgaris bioequivalency clindamycin benzoyl peroxide
trial of dasatinib in patients with advanced cancers harboring ddr2 mutation or inactivating b-raf mutation

Conditions: Carcinoma, Non-small Cell Lung

Summary: the purpose of this study is to establish whether patients with malignancy harboring a discoidin domain receptor 2 mutation or an inactivating b-raf mutation will respond to dasatinib.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria * diagnosis of advanced malignancy, nonsmall-cell lung cancer (nsclc) only during stage 1 of accrual. * nonsynonymous mutation of b-raf or ddr2, defined as follows:. i) nsclc with inactivating b-raf mutation. ii) nsclc with discoidin domain receptor 2 (ddr2) mutation. iii) malignancy of other histology with ddr2 mutation or inactivating b-raf mutation, or nsclc having a b-raf mutation that is not functionally characterized. * at least 1 target lesion per response evaluation criteria in solid tumors, vol 1.1, on baseline staging evaluation. * disease progression after ≥ 1 prior treatment regimen. exclusion criteria * pleural or pericardial effusion, grade \>1. * qtcf \>470 msec (grade ≥2) or diagnosed congenital long qt syndrome. * absolute granulocyte count \<1500/mm\^3. * hemoglobin level \<10 g/dl. * platelet count \< 75,000/mm\^3. * serum calcium level \<institutional lower limit of normal. * hypokalemia, hypophosphatemia, or hypomagnesemia, grade \>1, despite supplementation. * creatinine \>3\*institutional upper limit of normal (uln). * total bilirubin level \>1.5\*uln. * alanine transaminase level \>3\*uln. * other protocol-defined inclusion/exclusion criteria apply.
neoadjuvant study of pyrotinib in patients with her2 positive breast cancer

Conditions: Breast Cancer; Neoplasm, Breast; Breast Diseases

Summary: this is a randomized, double-blind multicenter phase iii study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and carboplatin versus placebo and trastuzumab plus docetaxel and carboplatin given as neoadjuvant treatment in her2 positive early stage or locally advanced breast cancer.

the investigators hypothesized that the experimental group (pyrotinib+trastuzumab+docetaxel+ carboplatin) could have a higher pathological complete response (pcr) rate than the control group (placebo +trastuzumab+docetaxel+ carboplatin) in neoadjuvant chemotherapy. it is proposed that 100 participants will be enrolled in this study. the target population is women with early breast cancer (stage of t1-4n0-3m0) who are eligible for primary systemic therapy. the primary objective of the trial is to determine the pcr rate. the secondary objective of the trial is to determine the event-free survival(efs), disease-free survival (dfs), distance disease-free survival (ddfs), objective response rate (orr) rate.

Eligibility criteria:
inclusion criteria: 1. female patients, 18 years ≤ age ≤ 80 years； 2. performance status- eastern cooperative oncology group (ecog) 0-1 3. histologically confirmed invasive breast cancer（early stage or locally advanced） 4. her2 positive (her2+++ by ihc or fish+) 5. known hormone receptor status. 6. cardiovascular: baseline left ventricular ejection fraction (lvef)≥55% measured by echo 7. signed informed consent form (icf) exclusion criteria: 1. metastatic disease (stage iv) or inflammatory breast cancer 2. previous or current history of malignant neoplasms, except for curatively treated: basal and squamous cell carcinoma of the skin, carcinoma in situ of the cervix. 3. clinically relevant cardiovascular disease: known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); 4. unable or unwilling to swallow tablets.
incidence rate of heart failure after acute myocardial infarction with optimal treatment

Conditions: Acute Myocardial Infarction; Heart Failure

Summary: the main purpose of this study is to build a multi-center, prospective and regionally representative acute myocardial infarction(ami) cohort，and build a study platform for heart failure caused by ami; to explore the 1 year incidence rate of heart failure after ami given the optimized treatment and the treatment model affecting the incidence rate of heart failure, and finally to reduce the incidence rate of heart failure by 5%.

the study aim to enroll 12000 acute myocardial infartion (ami) patients, including st-segment elevation myocardial infarction (stemi) and non st-segment elevation myocardial infarction (nsetmi), patients were divided into two groups(optimized group and un-optimized group) according to treatment models they accepted in 20 reginally representative hosptials of china. whether optimizaed or not is judged by 4 four aspects,including emergency treatment procedure, pre-infusion medication, reperfusion strategy selection, and early rehabilitation after reperfusion.patients were followed at 1 month, 6 months and 12 months. the physical condition and clinical events(heart failure, death, re-infarction, revascularization, apoplexy, malignant arrhythmias, bleeding events, other adverse events)were collected at follow up.

Eligibility criteria:
inclusion criteria: * age≥18 years * diagnosed acute myocardial infarction * signed the informed consent form exclusion criteria: * ami is caused by surgery, trauma, gastrointestinal bleeding or complications of pci; * ami occurred in patients who have been hospitalized for other reasons; * patients with previous history of chronic heart failure; * researchers judging that patient's compliance was poor and could not complete the study according to the requirements. * life expectancy is less than 12 months; * heart transplant patients; * patients with tumors;

Keywords: acute myocardial infarction heart failure optimized treatment
cardiovascular patient outcomes and research team primary pci registry

Conditions: ST Elevation Myocardial Infarction

Summary: the proposed study is a registry of patients treated with primary angioplasty for acute myocardial infarction. the aim of this registry is to define the outcomes of patients treated for acute, st-segment myocardial infarction (stemi) at community hospitals without on-site cardiac surgery programs that have completed the cardiovascular patient outcomes and research team (c-port) primary angioplasty development program. the primary medical outcome for the registry is the combined incidence of death, recurrent non-fatal myocardial infarction and stroke.

the primary study endpoint is the composite incidence of death, non-fatal reinfarction and stroke 6 weeks after index myocardial infarction. secondary endpoints include: 1. composite of death, recurrent non-fatal mi and stroke at hospital discharge and at 6 months 2. specific subgroup analyses are planned based on history of diabetes age anterior versus other infarct locations race gender 3. incidence of complications including significant bleeding, need for coronary artery bypass surgery, cardiac arrest

Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. ability to give informed consent 3. acute myocardial infarction with 1. \> 30 mins ongoing ischemic cardiac pain at presentation and \> 0.1 mv st-segment elevation in 2 or more contiguous ecg leads or 2. new or suspected new left bundle branch block (lbbb) or 3. \> 0.1 mv st-segment depression in v1 and v2 consistent with true posterior infarction 4. rescue pci for failed thrombolytics 5. cardiogenic shock - (defined as systolic blood pressure \ 80 mmhg) exclusion criteria 1. inability to obtain informed consent (surrogate consent may be obtained if approved by your irb)

Keywords: myocardial infarction angioplasty stent
tdcs for treatment of depression in parkinson's disease

Conditions: Idiopathic Parkinson Disease; Depression

Summary: investigation of possible benefits of transcranial direct current stimulation (tdcs) as a treatment of depression in patients with parkinson's disease, through a randomized placebo-controlled clinical trial.

we aim to investigate the effects of transcranial direct current stimulation (tdcs) as treatment for depression in patients with parkinson's disease. we have designed a clinical trial in which volunteers that fulfill inclusion criteria will receive 15 sessions of tdcs during 1 week (3 sessions a day, with 30 minutes interval in between). subjects will be randomly allocated into two groups, one that will receive the real intervention (active) and the other that will receive the placebo intervention (sham). the collaborator in charge of administering the session will not participate in the evaluations, keeping both subjects and evaluators blinded to the nature of the sessions. subjects will be evaluated at baseline, and after the end of sessions, 1 week, 4 weeks and 8 weeks, the latter being the main outcome. we aim to enroll 50 subjects, 25 for each arm. the sample size calculation took into consideration previous clinical trials using tdcs for depression in different settings.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease * geriatric depression scale - 15 higher that 5 * major depression disorder exclusion criteria: * cns disease other than parkinson's disease (i.e. epilepsy, stroke) * mental disorder other than depression on anxiety disorder (i.e. bipolar disorder, schizophrenia) * previous neurosurgical intervention (i.e. dbs) * current use of antidepressant drug * high suicidality risk * limited capacity of understanding written and spoken portuguese

Keywords: parkinson disease depression transcranial direct current stimulation neuromodulation
immunogenicity and safety of quadrivalent influenza vaccine in children and adolescents

Conditions: Influenza, Human

Summary: this study is a multi-center, randomized, double-blind phase iii clinical trial. the aim of the study is to describe the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

subjects are randomly assigned in a 4:1 ratio to nbp607-qiv versus agrippal s1. to assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(hi) assay from sera obtained at pre-vaccination and 28 days post-vaccination. to assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. the serious adverse events are collected during 6 months post-vaccination.

Eligibility criteria:
inclusion criteria: * children and adolescents aged 6 months to 18 years. * those who was born after normal pregnancy period(37 weeks) for aged 6 months to \< 1 year * those whose legally acceptable representative have given written consent to participate in the study and comply with all study requirements. exclusion criteria: * subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products. * subjects with immune deficiency disorder or malignant cancer. * history of guillain-barre syndrome. * thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. * subjects who experienced fever within 72 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day. * subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening. * subjects who had received blood products or immunoglobulin within 3 months before screening. * subjects who had received influenza vaccination within 6 months prior to the screening. * subjects who had received other vaccination within a month before. screening, or those who had another vaccination scheduled within a month after study vaccination. * subjects who had participated in other clinical trial within 4 weeks prior to study vaccination. * subjects with clinically significant chronic disease. * pregnant women, breast-feeding women. * any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
safety and pharmacokinetic profile of udenafil in healthy mexican adults

Conditions: Erectile Dysfunction; Phosphodiesterase 5 Inhibitor

Summary: the purpose of this study is to evaluate the safety and tolerability of udenafil 150 mg compared to placebo.

the drug being tested in this study is called udenafil. udenafil is being tested to determine a safe and well-tolerated dose. this study will look at vital signs, laboratory tests and side effects in people who take udenafil. the study will enroll approximately 84 patients. participants will be randomly assigned (by chance) and by blocks to assure balanced groups (i.e. same number of participants) to one of the four treatment schemes-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * a) udenafil-udenafil * b) udenafil- placebo * c) placebo-udenafil * d) placebo-placebo all participants will be asked to take one tablet on day 1 and one tablet on day 3. this single-centre trial will be conducted in mexico. the overall time to participate in this study is up to 7 days. participants will make 3 visits to the clinic, including 5 days confinement to the clinic, and will be contacted by telephone 15 days after last visit to the clinic for a follow-up assessment.

Eligibility criteria:
inclusion criteria: 1. sign a letter of informed consent prior to performing any procedure. 2. male 3. clinically healthy 4. age between 18 and 55 years old. 5. body mass index (bmi) between 18.5 and 24.9. 6. capability and disposition to attend clinical intervention period exclusion criteria: 1. current use of any allopathic, over the counter (otc) (e.g. nutritional supplements) or alternative (e.g. herbal) medication within two weeks prior to trial initiation. 2. history of psychiatric diseases. 3. history of drug abuse (alcohol, tobacco or any other). 4. chronic consumption of caffeine (coffee, cola, green tea, st. johns wort). 5. laboratory tests with clinically significant alterations. 6. intestinal disorders that may modify absorption. 7. history of allergy to the drug or related drugs. 8. blood donation within 45 days prior to study initiation. 9. participation in a clinical trial within 2 months prior to study initiation. 10. history of orthostatic alterations or presyncope. 11. vegetarian diet or other peculiar dietary habits which would interfere the participant's acceptance to standardized meals. 12. inability to communicate or social vulnerability.

Keywords: drug therapy
comparison of hybrid and bismuth quadruple therapies for helicobacter pylori eradication

Conditions: Helicobacter Pylori Infection

Summary: according the maastricht iv consensus report publish in the gut 2012, bismuth containing quadruple therapy was suggested to be the first choice for eradication therapy of helicobacter pylori in the area with high clarithromycin resistance. whether hybrid therapy or 14-day bismuth containing quadruple therapy can replace standard triple therapy as the recommended first-line treatment is unknown. the investigators compared the efficacy of 14-day hybrid therapy and 14-day bismuth containing quadruple therapy in first-line treatment.

for this randomly assigned to receive either a 14-day hybrid therapy (a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days) or a 14-day bismuth containing quadruple therapies (pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days).at a 1:1 ratio. our primary outcomes was the eradication rate by intention-to-treat and per- protocol analyses

Eligibility criteria:
inclusion criteria: * consecutive h pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis exclusion criteria: * previous h pylori-eradication therapy * ingestion of antibiotics or bismuth within the prior 4 weeks * patients with allergic history to the medications used * patients with previous gastric surgery * the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia) * pregnant women

Keywords: helicobacter pylori hybrid therapy bismuth containing quadruple therapy eradication