Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of berberine ursodeoxycholate (htd1801) in patients with type 2 diabetes

Conditions: T2DM (Type 2 Diabetes Mellitus)

Summary: the goal of this clinical study is to evaluate the efficacy and safety of berberine ursodeoxycholate (htd1801) compared to placebo in patients with type 2 diabetes, inadequately controlled with diet and exercise alone.

this phase 3 randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of htd1801 in two phases, a 24-week double-blind phase followed by a 28-week open-label extension. to ensure stabilization of glycemic control, eligible patients will first participate in a 4-week single-blind run-in period where investigators will provide guidance on lifestyle modification, concomitant medications, and procedures for self-monitoring of blood glucose. following this period, patient eligibility will be reassessed. eligible patients will then be randomized 2:1 to receive htd1801 1000 mg twice daily (bid) or placebo for 24 weeks. patients who complete the double-blind treatment period will enter an open-label extension period where all patients will receive htd1801 1000 mg bid for an additional 28 weeks.

Eligibility criteria:
key inclusion criteria: * have been diagnosed with type 2 diabetes mellitus * have followed dietary and exercise interventions for at least 8 weeks prior to screening * if used any glucose-lowering drugs within the 8 weeks prior to screening such use was ≤7 days and was discontinued at least 4 weeks prior to screening * have hba1c ≥7.5% to ≤11.0% (screening) and ≥7.0% to ≤10.5% (pre-randomization) * have fasting plasma glucose ≤13.9 mmol/l (screening and pre-randomization) * have a body mass index ≥19.0 kg/m\^2 to ≤35.0 kg/m\^2 key exclusion criteria: * have type 1 diabetes * have had any acute diabetic complications within 12 months prior to screening * have had any grade 3 hypoglycemic event within 12 months prior to screening * have had proliferative retinopathy or macular degeneration, severe diabetic neuropathy, or diabetic foot * have been taking any weight loss medication or dietary supplement, have participated in a weight loss program, or have adhered to a special diet within 12 weeks prior to screening * have used insulin or an insulin analogue for more than 14 days within 12 months prior to screening * have used any hypoglycemic drug during the 4-week run-in period prior to randomization * have had weight gain or loss ≥5% during the 4-week run-in period prior to randomization
efficacy and safety of spinal cord stimulation in patients with chronic intractable pain

Conditions: Pain; Chronic Pain; Back Pain; Spinal Cord Stimulation; Nervous System Diseases

Summary: the purpose of this study is to evaluate the efficacy and safety of spinal cord stimulation (scs) using the pins spinal cord stimulator device for chronic and intractable pain.

adult patients with chronic intractable pain of the trunk and/or limbs who are candidates for a treatment with spinal cord stimulation will be prospectively randomized into 2 arms. spinal cord stimulation parameters are programmed and adjusted during outpatient clinic visits, within the normal clinical practice.

Eligibility criteria:
inclusion criteria: 1. have been diagnosed with chronic, intractable pain of the trunk and/or limbs which has been refractory to conservative therapy for a minimum of 3 months. 2. vas ≥ 5 3. be 18 years of age or older at the time of enrollment 4. be willing and able to comply with study-related requirements, procedures, and visits 5. be willing and capable of giving informed consent exclusion criteria: 1. pregnancy or potential for with unwillingness to use contraception 2. have a current diagnosis of a coagulation disorder, bleeding diathesis 3. have evidence of psychiatric or cognitive disorder, who are unable to cooperate with surgery and program control 4. have a life expectancy of less than 1 year 5. have a condition currently requiring or likely to require the use of diathermy 6. other inappropriate situations determined by the researcher

Keywords: pain
the effectiveness and safety for mesenchymal stem cell for alcoholic liver cirrhosis

Conditions: Alcoholic Liver Cirrhosis

Summary: background \& aim: bone marrow derived mesenchymal stem cells (bm-mscs) have capacity to differentiate into hepatocytes and anti-fibrotic effect in the experimental model. no study was done in humans with alcoholic liver cirrhosis. the researchers investigated the anti-fibrotic effect of bm-mscs in alcoholic cirrhosis as phase ii clinical study. methods: eleven alcoholic cirrhosis patients (m:f = 10:1) with child-pugh's class b and maintenance of alcohol abstinence at least 2 months were enrolled. at baseline, all patients received liver biopsy, hepatic venous pressure gradient (hvpg) measurement and serologic tests. bm-mscs were isolated from each patient's bm and amplified for one month and injected two times at 4, 8week through rt. hepatic artery. 5x106cells/ml of bm-mscs were injected in each session. follow up biopsy, hvpg and relative expression of tissue transforming growth factor-1 (tgf-β1), α smooth muscle actin (α-sma) and collagen-1 by real time rt pcr were measured after 12weeks from 2nd bm-msc injection. the primary outcome was improvement in patients' histology aim : the researchers aimed to evaluate safety and effectiveness of new therapy with bone marrow derived autologous mesenchymal stem cell for hepatic failure caused by alcoholic liver cirrhosis.

autologous bm-mscs therapy in alcoholic cirrhosis induces improvement of hepatic fibrosis in histological and quantitative measurements.

Eligibility criteria:
inclusion criteria: 1. alcoholic liver cirrhosis(child pugh class b or c, ≥ 7 scores),confirmed by clinically or biopsy. 2. stop drinking over past 6months. 3. patients agree with informed consent patients must satisfy all inclusion criteria. exclusion criteria: 1. patients who did not satisfy inclusion criteria 2. hepatocellular carcinoma 3. pregnancy or breast feeding 4. infective disease(hiv, hbv, hcv..) 5. other incurable malignancy

Keywords: autologous mesenchymal stem cell alcoholic liver cirrhosis
outreach and treatment for depression in the labor force

Conditions: Depression

Summary: this study will assess the effects of depression treatment on employee productivity. this study will also evaluate the impact of depression screening and outreach on employees' receptivity to treatment.

this study is conducted in three phases. in the first phase, employees from various companies participate in an on-line health risk assessment survey at a secure website. those who display symptoms of depression participate in a brief telephone interview to confirm the depression diagnosis. in the second phase, depressed participants are randomly assigned to receive either intervention treatment or usual care for 18 months. the intervention consists of periodic telephone contact with a mental health clinician who provides education regarding depression and its treatment. participants receiving the intervention are also provided with resources to obtain psychotherapy and/or pharmacotherapy. those who do not seek treatment are monitored and supported. participants in the usual care arm are informed of their possible depression and are encouraged to seek professional treatment. the final phase of the study involves data analysis and dissemination of aggregated results. surveys and questionnaires are used to assess participants.

Eligibility criteria:
inclusion criteria: * major depressive episode * employed
fertility after transvaginal surgery or uterine artery embolization combined with uterine curettage in patients with cesarean scar pregnancy

Conditions: Magnetic Resonance Imaging; Ovarian Function; Menstruation

Summary: to investigate the fertility in patients after treatment by transvaginal surgery or uterine artery embolization combined with uterine curettage


Eligibility criteria:
inclusion criteria: * increased levels of serum β-hcg and ultrasonography findings. the criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder(24). all patients had taken magnetic resonance imaging (mri) to clarify the diagnosis . pregnancy tissues were identified by histopathology examinations of the surgical tissues. exclusion criteria: * all enrolled patients had no contraindications for transvaginal surgery or uae, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.
comparative analysis of outcomes among patients initiating xeljanz in combination with oral mtx who withdraw mtx versus continue mtx

Conditions: Rheumatoid Arthritis

Summary: to address the objectives, a retrospective cohort design will be employed to evaluate patient characteristics, treatment patterns, medication effectiveness, and health care cost and utilization in ra patients newly initiating tofacitinib in combination with oral methotrexate (mtx)


Eligibility criteria:
inclusion criteria: * at least one claim for tofacitinib between 01 january 2014 and 31 january 2017 (the identification period). * presence of the international classification of diseases, 9th revision, clinical modification (icd-9 cm) code for ra (in any position) during the one-year pre-index period or on the index date. icd-9 = 714.0x-714.4x \& 714.81 or icd10 = m05.\* \& m06.0\*-m06.3\* or m06.8\*-m06.9\*. * at least 18 years old as of the index date. exclusion criteria: * patients with claims for other conditions for which biologics are used during the one-year pre-index period or on the index date: ankylosing spondylitis, crohn's disease, psoriasis, psoriatic arthritis, or ulcerative colitis will be excluded from the study. * patients with evidence of the index medication during the one-year pre-index period will be removed from the analysis. patients will be allowed to have been treated with other biologics approved for ra (tumor-necrosis factor-alpha inhibitors (tnfi) \[adalimumab (humira), etanercept (enbrel), certolizumab pegol (cimzia), golimumab (simponi), infliximab (remicade)\] and non-tnfi's with alternative mechanisms of action \[abatacept (orencia), and rituximab (rituxan), anakinra (kineret), tocilizumab (actemra)\]) during the one-year pre-index period.
stent placement and the risk of new-onset af in patients with ami

Conditions: Atrial Fibrillation New Onset; Acute Myocardial Infarction

Summary: the benefit of a drug-eluting stent (des) in patients with acute myocardial infarction (ami) is controversial. this study will aim to observe the effect of a des on the risk of new-onset af in patients with ami.

acute myocardial infarction (ami) is the leading cause of mortality in the world. early invasive strategy with percutaneous coronary intervention (pci) has been demonstrated to be the most effective strategy to treat ami. although drug-eluting stent (des) has not shown benefits to reduce mortality rate among ami patients compared with bare-metal stent (bms), the use of des in real-world is increasing because of reduced restenosis rates. ami patients are at higher risk to develop atrial fibrillation (af) than general population. however, whether early pci with des implantation is related to a reduced risk of af still remains unclear. the purpose of this study is to investigate the association of des implantation and the risk of af among patients with ami treated by early pci.

Eligibility criteria:
inclusion criteria: * patients were enrolled by primary diagnostic coding as acute myocardial infarction and treatment coding as receiving pci between 2007 and 2013 in taiwan national health insurance research database (nhird) exclusion criteria: 1. less than 20-years-old; unknown sex and age 2. not residents in taiwan 3. died during ami admission 4. previous history of af 5. receiving coronary artery bypass grafting (cabg), ventricular assist device (vad), extracorporeal membrane oxygenation (ecmo), and heart transplantation during observational and/or database period 6. no stent implantation during pci 7. unknown stent types

Keywords: atrial fibrillation acute myocardial infarction drug-eluting stent
a study of response-guided duration of combination therapy with gs-9451, pegasys® and copegus® with and without tegobuvir (gs-9190) in previously untreated subjects with genotype 1 chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: this phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with gs-9451 and tegobuvir and 24 weeks of a 3-drug regimen of gs-9451 without tegobuvir, all with peginterferon alfa-2a (pegasys®) and ribavirin (copegus®).


Eligibility criteria:
inclusion criteria: * adult subjects 18 to 70 years of age * chronic hcv infection for at least 6 months prior to baseline (day 1) * liver biopsy results (performed no more than 2 years prior to screening) indicating the absence of cirrhosis * monoinfection with hcv genotype 1a or 1b * hcv treatment-naïve * body mass index (bmi) between 18 and 36 kg/m2 * creatinine clearance ≥ 50 ml/min * subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male. * screening laboratory values within defined thresholds for alanine aminotransferase (alt), aspartate aminotransferase (ast), leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (tsh), potassium, magnesium exclusion criteria: * autoimmune disease * decompensated liver disease or cirrhosis * poorly controlled diabetes mellitus * severe psychiatric illness * severe chronic obstructive pulmonary disease (copd) * serological evidence of co-infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or another hcv genotype * suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers) * history of hemoglobinopathy * known retinal disease * subjects who are immunosuppressed * subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse * subjects who are on or are expected to be on a potent cytochrome p450 (cyp) 3a4 or pgp inhibitor, or a qt prolonging medication within 2 weeks of baseline (day 1) or during the study * subjects must have no history of clinically significant cardiac disease, including a family history of long qt syndrome, and no relevant electrocardiogram (ecg) abnormalities at screening

Keywords: hepatitis c hcv rapid virologic response sustained virologic response direct acting antiviral combination therapy hcv rna polymerase inhibitor protease inhibitor treatment naïve gs-9190 gs-9451
eplerenone in the management of abdominal aortic aneurysms

Conditions: Aortic Aneurysm, Abdominal

Summary: weakening and expansion of the main abdominal artery (abdominal aortic aneurysm, aaa) is a common problem in older australians. the majority of aaas are small (\<55 mm) and affect 90,000 individuals in australia and 4.5 million world-wide. currently, the only treatment available for aaa is surgery. however, surgical therapies are not effective for small aaas, and these patients undergo a program of repeat imaging and consultation to monitor the size of the aneurysm and symptoms. this proposal is aimed at addressing the urgent need to identify a medical treatment able to limit progression of aaas. the study design and rationale are based on strong preclinical evidence supporting the value of eplerenone (an agent indicated for treatment of heart failure) in limiting aaa progression. if proved effective, this medication would: 1. reduce the number of patients requiring costly surgery 2. reduce the number of surgery related deaths and complications 3. provide a therapy suitable for the rapidly expanding elderly age group who have aaas.


Eligibility criteria:
inclusion criteria: * individuals aged over 60years (inclusive); aaa measuring a maximum diameter of 30-49 mm on mri; no current indication for aaa repair according to the treating physician or expectation that this will be revised within the next year; high likelihood of compliance with treatment over 12 months; stable medication regime for the last six months; have given signed informed consent to participate in the study. exclusion criteria: * serum potassium concentration of more than 5.0 mmol/l before randomisation; evidence of renal impairment defined as serum creatinine\>133 umol/l or creatinine clearance of \ 70%) of one or both renal arteries; evidence of liver disease (i.e. cirrhosis or hepatitis) or abnormal liver function defined as aspartate aminotransferase, alanine aminotransferase or total bilirubin \>1.5x the upper limit of normal; evidence of primary aldosteronism (plasma aldosterone/renin ratio\>650 pmol/l); electrolyte imbalance; active gout; use of mr antagonists; use of potassium-sparing diuretics, or potassium supplements; individuals with claustrophobia or a history of any metallic prosthetic implant contraindicating mri.
exercise study to help patients who have type 2 diabetes and depression.

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to test an exercise treatment that includes behavioral strategies to improve blood sugar control in women with type 2 diabetes who are depressed and overweight.this research study may lead to a potentially useful treatment for diabetes management when depression is present.


Eligibility criteria:
inclusion criteria: * type 2 diabetes, depression, bmi \<44,ages between 21-65, female exclusion criteria: * bmi \>44, \>100 min. of exercise per week, type 1 diabetes, no diabetes,mi,stroke, catheterization, unstable angina in previous 6 months,pregnancy,glucocorticosteroid therapy in last 3 months,bipolar, psychotic disorder or post-traumatic disorder,moving out of area within next 6 weeks
testing adaptive physical activity in stroke

Conditions: Stroke

Summary: "testing adaptive physical activity in stroke" tests the idea that adaptive physical activity (apa) will improve fitness, balance and walking function, daily step activity, and outcomes related to quality of life in individuals with chronic stroke. adaptive physical activity is an exercise model that combines aerobic exercise with balance and gait training in a socially reinforcing group setting. individualized homework assignments encourage integration of exercise into daily life routines. our specific aims are: 1. to determine whether apa improves cardiovascular fitness and metabolic health 2. to measure the effects of apa on gait and balance, ambulatory activity, and adl function 3. to determine whether apa affects self-reported outcomes related to self-efficacy, fatigue, and stroke-specific quality of life


Eligibility criteria:
inclusion criteria: 1. ischemic stroke greater than or equal to 6 months prior in men or women ages 40- or older. hemorrhagic stroke greater than or equal to one year prior in men or women ages 40-or older. 2. residual hemiparetic gait deficits. 3. already completed all conventional inpatient and outpatient physical therapy. 4. adequate language and neurocognitive function to participate in exercise testing and training (specific screening instruments used.)

Keywords: stroke exercise balance dynamic gait cardiovascular fitness
tailored pain guide (tpg) study

Conditions: Chronic Lower Back Pain

Summary: this research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for chronic low back pain. this research will try to understand how much an electronic, self-management website like painguide can help participants. the study hypothesizes that tailored digital interventions (plus using painguide) will demonstrate greater improvement in pain interference.

there was an amendment approved by the university of michigan medical school institutional review board (ame00158411). this amendment included the following: increased enrollment numbers, updated recruitment procedures including the non-pharma program (npp) sub-study, as well as changes in time frames.

Eligibility criteria:
inclusion criteria: * chronic lower back pain (clbp) defined by the national institutes of health (nih) task force report on research standards for chronic low back pain, (i.e., low back pain present at least six months, and present more than half of those days.) * individuals must have a score of greater or equal to (≥) 60 on promis pain interference. * non-pharma sub-study: 1. must be referred and currently on the waitlist for the npp at the back \& pain center (bpc) exclusion criteria: * current cancer related pain * diagnosis of autoimmune disease * unable to speak, write or read english * visual or hearing difficulties * pregnancy or breastfeeding * any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators.

Keywords: online resources fitbit surveys
study evaluating pra-027 multiple ascending doses in cycling and postmenopausal women

Conditions: Uterine Leiomyomata (Fibroids)

Summary: this is the first multiple-dose study in humans with pra-027. this study will provide an assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed, metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is active in the body) of pra-027 after administration of 28 days of oral doses in women of childbearing potential (cycling) or postmenopausal women.


Eligibility criteria:
inclusion criteria: inclusion criteria - all women * healthy, nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day and able to abstain from tobacco throughout all times when in the clinical facility. inclusion criteria - cycling women * aged 18 to 45 years, must not be breastfeeding, pregnant, or have a recent (within 90 days before pretreatment period day 1) history of pregnancy, with a history of regular menstrual cycles (21 to 35 days in duration). inclusion criteria - postmenopausal women * aged 35 to 65 years, menopause may be natural or due to surgery, natural amenorrhea must have begun by age of 55 years and have initiated at least 6 months before study day 1. exclusion criteria: * women with hysterectomy or complex or simple ovarian cysts greater than 3 cm in diameter. * history of drug abuse (within 6 months) or alcoholism (within 12 months). * history of female infertility.