Kornimate/medical-research-clean huggingface dataset:
sofosbuvir, daclatasvir, ribavirin for hepatitis c virus (hcv) cirrhotics

Conditions: Hepatitis C; Cirrhosis

Summary: the investigators will treat 100 patients with cirrhosis due to hepatitis c with sofosbuvir 400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if \ 75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.

cirrhosis due to hepatitis c presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of treatment. the new direct acting antivirals have provided these patients with a new hope. one such combination is sofosbuvir (sof) 400 mg and daclatasvir (dcv) 60 mg given once daily with or without weight-based ribavirin (rbv) for 12 or 24 weeks. the current recommendation for cirrhotics is sof/dcv/rbv for 24 weeks but that recommendation is based on the lack of data for shorter periods. in order to evaluate the response rate to the combination of sof/dcv/rbv the investigators decided to treat 100 hcv cirrhotics with this combination for 12 weeks. subjects include genotype 1 and 3 patients, the prevalent genotypes in iran. patients with model for end stage liver disease (meld) \> 20 are excluded. the investigators will calculate the sustained viral response rate at 12 weeks (svr12).

Eligibility criteria:
inclusion criteria: * positive qualitative hcv rna test on two occasions at least 6 months apart * cirrhosis proven by either of: 1. liver biopsy, 2. liver elasticity \> 12 kilopascal (kpa), 3. clinical certainty (ascites, splenomegaly, small liver, low albumin, low platelet) exclusion criteria: * renal failure (egfr \< 30 cc/min), * meld score \> 20, * child's c (ctp score \> 12), * heart rate \< 50/min, * taking amiodarone

Keywords: hepatitis c cirrhosis sofosbuvir daclatasvir ribavirin
a phase 3 study of vx-121 combination therapy in participants with cystic fibrosis (cf) heterozygous for f508del and a minimal function mutation (f/mf)

Conditions: Cystic Fibrosis

Summary: the purpose of this study evaluates the efficacy and safety of vx-121/tezacaftor/deutivacaftor (vx-121/tez/d-iva) in cf participants who were heterozygous for f508del and a minimal function mutation (f/mf participants).


Eligibility criteria:
key inclusion criteria: * heterozygous for f508del and a minimal function mutation (f/mf genotype) * forced expiratory volume in 1 second (fev1) value \>=40% and \ =40% and \<=80% for participants not currently receiving elx/tez/iva key exclusion criteria: * history of solid organ or hematological transplantation * hepatic cirrhosis with portal hypertension, moderate hepatic impairment (child pugh score 7 to 9), or severe hepatic impairment (child pugh score 10 to 15) * lung infection with organisms associated with a more rapid decline in pulmonary status * pregnant or breast-feeding females other protocol defined inclusion/exclusion criteria may apply
study of genetic alzheimer's disease mutation carriers in preclinical stages of the disease 18f-florbetaben positron emission tomography study

Conditions: Alzheimer Disease

Summary: the main purpose of the study is to assess safety of a single dose of fbb followed by pet scan in individuals at risk of genetic alzheimer's disease.


Eligibility criteria:
inclusion criteria: * adult children (\> 18 yo) of genetic alzheimer?s disease patients with a known mutation in psen1, app o psen2 genes and who are either cognitively normal (cdr=0) or have mild symptoms of cognitive decline (cdr 0.5 or 1) * according to the principal investigator, participants must be committed to participate and complete all study procedures. * has signed the informed consent form voluntarily to participate in the study exclusion criteria: * subjects that are not able to complete the study. * any major disease or history of a major disease, especially hepatobilliar disease (ast /alt ? 5 x uln) or advanced renal insufficiency (creatinine ? 2 x uln) * current or previous history of alcohol abuse or epilepsy * allergic to florbetaben or any of its constituents * multiple drug allergies and/or previous history of contrast allergy. * pregnancy or breast feeding or planned pregnancy during the study period * any disease or history of disease which, in the opinion of the investigator, can cause disturbance of brain function (e.g. vitamin b12 or folic acid deficiency, disturbed thyroid function) * evidence for any other neurological or psychiatric disease
effect of healing touch on the experience of women undergoing treatment for breast cancer

Conditions: Breast Cancer

Summary: to learn what effect, if any, healing touch (a gentle, non-invasive form of energy work that promotes relaxation and can help manage the side effects of chemotherapy and radiation), has on physical symptoms, mood, and qualify of life for women undergoing treatment for breast cancer.


Eligibility criteria:
inclusion criteria:- patients undergoing treatment for breast cancer. * age 18 or over. * participants in healing partners program. exclusion criteria:- patients not under the care of a physician. * patients not able to come to regular healing touch sessions.
effect of gemigliptin on metabolic endotoxemia and lipemia

Conditions: Type 2 Diabetes Mellitus

Summary: this is an exploratory study on the metabolic endotoxemia associated with type 2 diabetes. the investigators will measure systemic endotoxin level and lipid level after ingestion of high fat diet to evaluate the effect of gemigliptin, a dpp-4 inhibitor, on metabolic endotoxemia and lipemia induced by high fat diet.

study subjects will be allocated to either gemigliptin or placebo. after 4 weeks of treatment and 2 weeks of wash out period, all subjects will be switched to the opposite arm. the subjects will be tested oral fat tolerance test and adipose tissue needle biopsy(only for the subjects who agreed to participate donate adipose tissue) at 3 time points: the start of 1st treatment, end of 1st treatment and end of 2nd treatment.

Eligibility criteria:
inclusion criteria: * age from 20 to 75 * at least 6 months from the diagnosis of type 2 diabetes * current diabetes treatment: life style modification and/or metformin and/or sulfornylurea * no change of the diabetes treatment (drug number and dossage) in recent 3 months * hba1c 6.5% to 10% exclusion criteria: * recent cardiovascular event in 6 months * concurrent use of statin or fibrate or ezetimibe * renal failure, chronic liver disease * pregnancy or lactation * use of other dpp-4 inhibitor or glp-1 analogue in recent 3 months

Keywords: diabetes mellitus metabolic endotoxemia gemigliptin dpp-4 inhibitor
improving women's health by using an electronic pelvic floor questionnaire

Conditions: Urinary Incontinence; Fecal Incontinence; Pelvic Floor Disorders

Summary: the overall goal of this study is to test whether an electronic pelvic floor questionnaire (e-paq-pf) will increase discussion rates of incontinence in a primary care setting.


Eligibility criteria:
inclusion criteria: * woman * aged 40 and older * scheduled for a well visit at the women's health internal medicine west clinic exclusion criteria: * unable to speak english * unable to fill out questionnaire * excluded by patient's clinician prior to recruitment

Keywords: urinary incontinence fecal incontinence communication
study comparing the efficacy and safety of abt-874 to etanercept and placebo in subjects with moderate to severe chronic plaque psoriasis

Conditions: Moderate to Severe Plaque Psoriasis

Summary: compare the efficacy of abt-874 versus etanercept in subjects with moderate to severe plaque psoriasis


Eligibility criteria:
inclusion criteria: * diagnosis of psoriasis for 6 mo * bsa 10% * pasi 12 or above * pga 3 or above exclusion criteria: * previous exposure to either etanercept or abt-874
investigating the structural and functional changes to the retina following prp in diabetic retinopathy patients

Conditions: Diabetic Retinopathy

Summary: laser therapy is an established method to stabilize and control proliferative diabetic eye disease. questions on the long-term effect on the retina from these treatments remain to be answered. the purpose of the study was to evaluate changes in the retina following panretinal photocoagulation (prp) over time, using structural and functional diagnostic tests.

diabetic retinopathy is the most common cause of adult-acquired retinal vascular disease. diabetic retinopathy is estimated to affect more than 100 million adults, and is the leading cause of blindness worldwide. over the past 30 years, epidemiological studies and clinical trials have shown that early detection through annual eye exams, intensive glucose and blood pressure control, and timely laser photocoagulation could prevent visual loss. more recently, a variety of newer ocular treatments and medications have been introduced, such as the use of the pascal photocoagulation laser system, and various anti-vascular endothelial growth factor therapies. while these treatments have revolutionized how diabetic retinopathy patients are managed clinically, questions on appropriate patient selection and the long-term efficacy and safety of these treatments remain to be answered. the purpose of this study is to focus on studying the nature and the time course over 2 years of structural and functional changes to the retina following pascal photocoagulation in severe preproliferative or proliferative diabetic retinopathy patients.

Eligibility criteria:
inclusion criteria: * male or female patient's greater than 18 years of age who have signed an informed consent. * patients with type 1 or type 2 diabetes mellitus (according to ada or who guidelines) that have severe preproliferative or proliferative diabetic retinopathy and require prp surgery in at least one eye. * adequate pupil dilation and clear media to perform laser photocoagulation, hrt, oct and visual field testing. exclusion criteria: * advanced lens opacity (lens opacity that excludes the ability to capture data) * prior prp within the past year * focal laser within one year of study entry

Keywords: panretinal photocoagulation
pharmacodynamics of omiganan (cls001) in patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: to assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients with mild to moderate atopic dermatitis (ad).


Eligibility criteria:
inclusion criteria: 1. male and female subjects with mild to moderate ad 18 to 65 years of age, inclusive. 2. ad diagnosed by physician / medical specialist and that has been (intermittently) present for at least 1 year 3. able to participate and willing to give written informed consent and to comply with the study restrictions. exclusion criteria: 1. have any current and / or recurrent clinically significant skin condition in the treatment area other than ad. 2. any confirmed, active significant allergic reactions (urticaria or anaphylaxis) including allergic reactions against any drug, multiple drug allergies or (ingredients of) emollients. 3. participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
comparative study between patellar denervation and non-patellar denervation in total knee arthroplasty with patellar resurfacing

Conditions: Patellar Denervation; Non-patellar Denervation; Patellar Resurfacing

Summary: the purpose of this study is to compare the post-operative anterior knee pain (akp) between patellar denervation and non-patellar denervation in total knee arthroplasty with patellar resurfacing


Eligibility criteria:
inclusion criteria: * primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty exclusion criteria: * valgus deformity * history of inflammatory arthroplathy * previous fracture or open surgery on the same knee * history of patellar instability
clinical effectiveness of first trimester pre-eclampsia screening program.

Conditions: Pre-eclampsia

Summary: to evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.

the incidence of pre-eclampsia is about 2-8%, it is a leading cause of maternal and perinatal mortality and morbidity. both acog (american congress of obstetricians and gynecologists) and nice (national institute for health and clinical excellence) guideline advocate the use of traditional screening method, which uses demographic characters and medical history to identify high risk women. this method detects only 35-40% of pre-eclampsia women. study has shown that combination of maternal factors and biomarkers (uterine artery pulsatility index, placenta growth factor, plgf; pregnancy associated plasma protein-a, papp-a) improves the detection rate. in taiwan, the prevalence of pre-eclampsia is about 1.21%. the incidence of pre-eclampsia is correlated with maternal age, with a relative risk of 5.13-fold in women aged 40 and above. marrying late predisposes these women at high risk of developing pre-eclampsia. our institution will be implementing first-trimester screening program starting from april 2019, this study aims to evaluate the clinical effectiveness of this screening program in preventing pre-eclampsia.

Eligibility criteria:
inclusion criteria: - women who are 20 years of age or older with singleton pregnancy between 11 to 13 + 6 weeks and received first trimester pre-eclampsia screening test in this institution. exclusion criteria: * women who are not regularly inspected or not receiving prenatal care in this institution. * women who received first trimester pre-eclampsia screening test at other institution
a pharmacokinetic, safety, and pharmacodynamic study of teduglutide in pediatric subjects with short bowel syndrome

Conditions: Short Bowel Syndrome

Summary: this will be an open label, 4-cohort study. non-randomized subjects will receive teduglutide in each of the 3 active cohorts. an attempt will be made to enroll additional subjects into an observational cohort who will receive standard of care. three doses of teduglutide are to be investigated for 12 weeks. all subjects will be screened prior to the start of treatment (sot) to establish baseline characteristics including safety, eligibility and nutritional support parameters.


Eligibility criteria:
key inclusion criteria: * current history of sbs as a result of major intestinal resection, (eg, due to necrotizing enterocolitis, midgut volvulus, intestinal atresia, or gastroschisis) for at least 12 months prior to screening * short bowel syndrome that requires parenteral nutrition/intravenous (pn/iv) support * stable pn/iv support for at least 3 months prior to enrollment based upon the opinion of the investigator key exclusion criteria: * serial transverse enteroplasty or any other bowel lengthening procedure performed within the past 3 months * unstable absorption due to cystic fibrosis, untreated hirschsprung's disease or known dna abnormalities (ie, familial adenomatous polyposis, fanconi syndrome) * evidence of obstruction on upper gastrointestinal (gi) series done within 6 months prior to screening * major gastrointestinal surgical intervention within 3 months prior to screening (insertion of feeding tube or endoscopic procedure is allowed)

Keywords: sbs pediatric sbs short bowel syndrome
efficacy and safety of oral regimens for the treatment of chronic hcv infection

Conditions: Chronic Hepatitis C

Summary: this study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis c virus (hcv) infection.


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent * chronic hcv infection * cirrhosis determination (liver biopsy may be required) * screening laboratory values within specified limits * males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception * specific genotype, prior medical history, or concurrent disease as required by the specific study group key exclusion criteria: * history of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol * pregnant or nursing female, or male with pregnant female partner * clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) * use of any prohibited concomitant medications note: other protocol defined inclusion/exclusion criteria may apply.
lower extremity muscle and function in the elderly: study 2

Conditions: Mobility Limitation

Summary: this research study is looking to compare the effects of two uniquely different power training interventions (high force, lower velocity versus low force, high velocity) on changes in mobility status among older individuals at risk for mobility disability.


Eligibility criteria:
inclusion criteria: * male and female 70-85 yrs * community dwelling * short performance battery score \>9 * bmi range 19-32 kg/m2 * willingness to be randomized and come the laboratory for 20 weeks. exclusion criteria: * acute or terminal illness * mi in previous 6 months, symptomatic coronary artery disease or congestive heart failure. * upper or lower extremity fracture in previous 6 months * uncontrolled hypertension (150/90mmhg) * neuromuscular diseases and drugs that affect neuromuscular function * hormone replacement therapy * participation in any regular endurance or resistance training exercise during previous 3 months

Keywords: resistance exercise physical activity mobility disability physical function muscle strength older adults mobility-limited peak power and strength
coronary artery disease in patients suffering from schizophrenia

Conditions: Schizophrenia; Cardiovascular Disease

Summary: schizophrenia is a severe mental illness associated with excess mortality and affecting nearly 1% of the population. the average life expectancy for patients diagnosed with schizophrenia has been 55-60 years through the last generations in denmark, while the general population has over the same period of time experienced an increase in life expectancy. as a result, the standardized mortality rate for patients with schizophrenia has increased markedly over the last three decades and is currently a major public health concern. causes of death are mainly cardiovascular disease and patients diagnosed with schizophrenia has a relative risk of cardiovascular disease that is about 2-fold higher than the general population.

little is known about severe progression of premature coronary arteriosclerosis in patients suffering from schizophrenia. coronary artery calcium score is a well-defined measure to predict cardiovascular disease events, however there has not yet been any attempt to investigate whether there is an association between coronary artery calcium score and premature morbidity and mortality in patients diagnosed with schizophrenia. the objective of this study is to investigate the progression of arteriosclerosis in patients with schizophrenia at different stages of the disease, and to offer and implement adequate treatment for these patients according to their somatic condition. this study will identify risk factors of somatic diseases in these patients, with specific focus on early diagnoses, prevention, intervention and treatment of arteriosclerosis in schizophrenic patients. the investigation is about the possibility of detecting any differences between developing arteriosclerosis in schizophrenia patients versus the general population, and how common risk factors are contributing to this process. the results of this study should provide important modifications in the clinical guidelines for treatment of patients diagnosed with schizophrenia.

Eligibility criteria:
inclusion criteria: * participants with a diagnosis of f20 schizophrenia. * informed statement of consent * age \> 18 exclusion criteria: * incompetency to create stabile relation or make agreements * pregnancy and also breastfeeding women * participants with severe claustrophobia * participants with lack of ability to cooperate with the planned study program.

Keywords: schizophrenia cardiovascular disease premature mortality arteriosclerosis risk factor intervention treatment somatic morbidity
tocotrienol as a nutritional supplement in patients with advanced ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to to investigate the effect of tocotrienol as a nutritional supplement in combination with bevacizumab in patients with advanced ovarian cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. * prior treatment with at least two different cytostatic regimens including platinum. * progression on previous treatment. * measurable disease by recist 1.1 or evaluable by gcig ca-125 criteria. * age ≥ 18 years. * performance stage 0-2. * adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion): * wbc ≥ 3.0 \* 10\^9/l or neutrophils (anc) ≥ 1.5 \* 109/l * platelet count ≥ 100 \* 10\^9/l * hemoglobin ≥ 6 mmol/l * serum bilirubin \< 2.0 \* uln * serum transaminase ≤ 2.5 \* uln * serum creatinine ≤ 1.5 uln * urine dipstick for protein \<2+. if the dipstick shows protein ≥2+ 24 hour urine testing must be made with protein contents \< 1 g. * written informed consent. exclusion criteria: * other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence. * other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation. * underlying medical disease not adequately treated (diabetes, cardiac disease). * uncontrolled hypertension (bt \>150/100 despite antihypertensive treatment). * surgery, incl. open biopsy, within 4 weeks prior to first dose of bevacizumab. * non-healing wounds or fractures. * cerebral vascular attack, transient ischemic attack or subarachnoidal hemorhage within 6 months before start of treatment. * clinically significant cardiovascular disease, including: * myocardial infarction or unstable angina within 6 months before start of treatment * new york heart association (nyha) class ≥ 2 * poorly controlled cardiac arrhythmia despite medication * periferal vascular disease grade ≥ 3 * allergy to the active substance or any of the auxiliary agents * bleeding tumor * pregnant or breast-feeding patients. for fertile women a negative pregnancy test at screening is mandatory. * fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment

Keywords: platinum resistant
one-stage exchange arthroplasty for chronic prosthetic joint infections

Conditions: Exchange of Prosthetic Joint; Prosthetic Joint Infection; One-step Exchange

Summary: the results found in the literature do not allow to define objectively the indications respective for a one-step or a two-step exchange of prosthetic joint. some criteria could help to decide for one-step exchange or two-step exchange: bacteria is/are identified, profile of the bacteria, anesthetic difficulties,.. a puncture could allow to identify the bacteria involved in the prosthetic joint infection (pji) and an antibiotherapy for a few days can be given to the patient in order to decrease the inoculum. then, a one-step exchange can be performed. the purpose of this study is to describe the management of patients who had a pre-treatment before a one-step exchange of their prosthetic joint.


Eligibility criteria:
inclusion criteria: * patient with prosthetic joint infection and having had a pre-treatment, managed at the croix-rousse hospital * \> 18 years old exclusion criteria: -

Keywords: pre-treatment antibiotherapy prosthetic joint infection treatment failure