Kornimate/medical-research-clean huggingface dataset:
a study to compare and evaluate intrahepatic cccdna reduction after administrating clevudine or entecavir in the chronic hbv patients

Conditions: Chronic Hepatitis B

Summary: this is a open, randomized, parallel study. subjects will have clevudine or entecavir therapy for 48 weeks(clevudine:entecavir = 2:1), and subjects who have complete response(hbv dna negative and alt normal) will have follow-up period for additional 48 weeks.


Eligibility criteria:
inclusion criteria: 1. patient who is older than 18. 2. patient who is hbsag positive for the previous 6 months and with hbv dna ≥ 1 x 10\^5 copies/ml 3. patient who is hbeag negative. 4. patient with alt≥1×uln. 5. patient who is able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria: 1. patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy. 2. patient is treated with interferon for the previous 6 months. 3. patient has been treated previously with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for hbv infection. 4. patient is coinfected with hcv, hdv or hiv. 5. patient has evidence of ascites, variceal hemorrhage and/or hepatic encephalopathy. 6. patient has evidence of decompensated liver cirrhosis and/or hepatocellular carcinoma. 7. patient has a history of organ transplantation. 8. patient has the treatment of nephrotoxicity drugs, competitive drugs for kidney to excrete, and/or hepatotoxicity drugs for the previous 2 months from screening. 9. patient is pregnant or breast-feeding. 10. patient has a clinically relevant history of abuse of alcohol or drugs. 11. patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic, allergic disease or medical illness that in the investigator's opinion might interfere with therapy. the patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor. 12. patient has creatinine clearance less than 60ml/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dl\]) \[note: multiply estimates by 0.85 for women\]

Keywords: hbe ag(-) chronic hepatitis b
depression amongst hiv positive patients in lilongwe

Conditions: HIV; AIDS

Summary: quantitative, validated tools of depression screening will be used to collect data to determine the prevalence of depression and its association with antiretroviral (arv) adherence amongst hiv positive patients attending art clinic at lighthouse lilongwe, malawi.

preliminary data on prevalence and associations will be collected from 200 hiv positive adult men and women attending art clinic at the lighthouse in lilongwe, malawi. quantitative, validated tools of depression screening will be used. a short structured demographic questionnaire will be used to collect demographic data. for depression, a patient health questionnaire (phq) will be used while alcohol use will be assessed by alcohol use disorders identification test (audit) screening tool. the data collected will provide baseline data planning, program development and evaluation, and to promote comprehensive care provision for the people living with aids attending art clinics in malawi.

Eligibility criteria:
inclusion criteria: * 18 years and above * hiv positive men and women accessing care at lh * both art naïve and on art * registered with lh * receiving primary care and/ or art from lh exclusion criteria: * too sick to comprehend consent or requiring admission * known mentally ill patient on psychiatric drugs * less than 18 years old

Keywords: depression aids hiv
recombinant factor viia bi (rfviia bi) treatment of acute bleeding episodes per an on-demand regimen

Conditions: Hemophilia A; Hemophilia B

Summary: the purpose of the study is to determine the efficacy and safety of rfviia bi as part of a six-month on-demand treatment regimen in hemophilia a or b subjects with inhibitors.


Eligibility criteria:
main inclusion criteria: * participant is male with hemophilia a or b with inhibitors, with a high titer (≥5 bethesda unit (bu)) or a historical high anamnestic response. * participant is 12 to 65 years old at the time of screening. * participant is currently using or has used bypassing agents for treatment of bleeding episodes. * participant has an annualized bleed rate of 5 or more bleeding episodes per year on average over the 2 years prior to the screening visit. * participant has a karnofsky performance score ≥60. * participant is hepatitis c virus negative (hcv-) either by antibody testing or polymerase chain reaction (pcr); or hepatitis c virus positive (hcv+) with stable hepatic disease. * participant is human immunodeficiency virus negative (hiv-) or hiv+ with stable disease, cd4+ count ≥200 cells/mm\^3 at screening. * participant is willing and able to comply with the requirements of the protocol. main exclusion criteria: * participant is not willing to go on an on-demand treatment scheme. * participant is positive for a fvii inhibitor at screening. * participant has clinically symptomatic liver disease. * participant has a platelet count \<100,000/µl. * the use of α-interferon with or without ribavirin is planned for an hcv-infected participant or the use of a protease inhibitor is planned for an hiv-infected participant. * participants currently taking any of these medications for ≥30 days are eligible. * participant has a known hypersensitivity to rfviia, hamster or murine proteins, or tween 80. * participant has a known history of being non-responsive to rfviia treatment of bleeding episodes. * participant has a prior history of thromboembolic event or diagnosis of other diseases that may increase the participant's risk of thromboembolic complications. * participant has participated in another clinical study involving an investigational product (ip) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an ip or investigational device during the course of this study. * participant is a family member or employee of the investigator. * participant is scheduled for surgery during the study period.

Keywords: with factor viii (fviii) or factor ix (fix) inhibitors
efficacy management and adherence evaluation of diclofenac in the treatment of knee osteoarthritis pain

Conditions: To Investigate the Effect of Diclofenac on Pain Control of Knee Osteoarthritis and the Relationship Between Pain Relief and Medicine Adherence

Summary: to investigate the effect of dichloride on pain control of knee osteoarthritis and the relationship between pain relief and medicine adherence. to evaluate the pain relief rate of patients with different initial pain.


Eligibility criteria:
inclusion criteria: * according to the oa diagnostic criteria of knee joint, the side with higher womac score is defined as observing knee joint for patients with both knees conforming to oa diagnostic criteria. 1. repeated knee pain in the past month 2. x-ray showed narrowing of articular space, subchondral sclerosis and/or cystic degeneration, and formation of osteophyte at articular margin. 3. joint fluid (\> 2 times) is cool and sticky, wbc \< 2000/ml 4. age over 40 5. morning stiffness less than 30 minutes 6. bone fricative (sensation) during exercise according to 1+2 or 1+3+5+6 or 1+4+5+6, oa of knee joint can be diagnosed. 7. the informed consent has been signed exclusion criteria: * (1) joint pain caused by other causes (infection, hip, lumbar and other diseases) (2) secondary arthritis (rheumatoid arthritis, ankylosing spondylitis, etc.) (3) severe internal medical complications and other inability to participate in the research (4) pain in other parts exceeds joint pain (5) contraindications to diclofenac use: active peptic ulcer/allergy/induced asthma (6) assessment may not complete the study

Keywords: knee osteoarthritis pain; adherence; diclofenac; follow up
a comparison of prk and lasik for correction of myopia

Conditions: Myopia

Summary: the study compares the precision and accuracy of two laser refractive techniques, prk and lasik, for correction of nearsightedness between -6 and -8 diopters.


Eligibility criteria:
inclusion criteria: * spherical equivalent subjective refraction between -6.00 and -8.00 diopters * age between 18 and 49 years * desire for having laser refractive surgery exclusion criteria: * present or past eye disease excluding myopia * pregnant or lactating woman

Keywords: excimer laser
evaluation of the product properties of individualized 3d-compression garments to treat scars

Conditions: Burn Scar

Summary: burn scars are treated with compression garments. these are produced based on manual measure data. the aim of this study is to evaluate correct fitting, wearing comfort, suitability for daily use and scar properties after using garments produced on base of measuring data from scanning in comparison to manual measured data.

in plastic and reconstructive surgery, treatment of burn scars is still challenging, because excessive and hypertrophic scarring can occur. burn garments are usually used to reduce such scarring. however, measure are taken manually by a measuring tape using interpolation. therefore, compression garments produced on base of 3d surface imaging using a scanning system are compared to compression garments based on manually measurements regarding correct fitting, wearing comfort, suitability for daily use and scar properties.

Eligibility criteria:
inclusion criteria: * burn scars on an arm after iia-iii. burn (1-30% surface area) * indication for burn garments * experience in using burn garments exclusion criteria: * consume of pain killer * medication with cortisone or immun suppressive therapy * psychiatric disease
study to evaluate safety and efficacy of precrea® on subjects with higher than normal blood sugar levels

Conditions: Diabetes Mellitus; Pre-Diabetes; Hyperglycemia; Metabolic Syndrome

Summary: the purpose of the study is to evaluate the efficacy and safety of precrea® on subjects with higher than normal blood sugar levels.

a prospective, double blind, placebo-controlled, randomized, multicentric, study to evaluate the efficacy and safety of precrea®, a twice-daily dietary supplement in people with higher than normal blood sugar levels.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years to ≤ 65 years 2. newly diagnosed male or female participants with higher than normal blood sugar levels (fpg \>100 mg/dl) on of pre-diabetes and diabetes mellitus during screening and not on any treatment 3. ability to understand and willingness to sign and date a written informed consent document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures exclusion criteria: 1. subjects with type 1 diabetes mellitus 2. participants on insulin therapy and other oral anti-diabetic agents or having uncontrolled diabetes. 3. stroke, myocardial infarction, coronary artery bypass graft (cabg) percutaneous transluminal coronary angioplasty (ptca) or angina pectoris within the last 12 months. 4. cardiac status new york heart association class iii-iv 5. uncontrolled blood pressure \> 150 mmhg systolic and \> 100 mmhg diastolic 6. impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female 7. clinically significant peripheral edema 8. clinical evidence of active liver disease or serum alenine aminotransferase (alt) or aspartate amino transferase (ast) 2.5 times the upper limit of the normal range (2.5 x uln) 9. participants on steroid 10. pregnancy or lactating women 11. known hypersensitivity to any of the study drugs 12. any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu. 13. current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years 14. subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol 15. mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study. 16. any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study.

Keywords: high blood sugar high hba1c hyperglycemia pre-diabetes natural supplement for diabetes
cytokine induced killer cells stimulated by dc immunotherapy for renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: 30% of renal cell carcinoma patients have metastases, mostly in lung, liver and bones at the time of diagnosis. because of poor response to radiation therapy or chemotherapy, several studies have been initiated to find alternative therapeutic options. cytokine induced killer cells(cik) are an unique population of cytotoxic t lymphocytes with a characteristic cd3+ cd56+ phenotype; they can be generated from cytokine cocktail-induced peripheral blood mononuclear cells (pbmc). cik cells represent strong anti-tumor cytotoxicity in vitro and in vivo. interestingly,the anti-tumor activity of cik cells can be enhanced by incubation with dendritic cells (dc), which are the most potent antigen (ag)-presenting cells. the purpose of this study was to evaluate the clinical efficacy of dc-activated cik cell treatment following regular therapy and the effects of this therapy on immune responses in patients with renal cell carcinoma after surgery.


Eligibility criteria:
inclusion criteria: 1. female or male, adult patients of 18 to 75 years of age at time of diagnosis that qualify for standard treatment including surgery. 2. histologically confirmed diagnosis of renal cell carcinoma. 3. newly diagnosed or recurrent disease. 4. karnofsky performance status 60-100. 5. life expectancy ≥ 12 weeks. 6. written informed consent of patient and/or legal guardian. 7. must be off steroid at least two weeks prior to vaccination. 8. hematologic and metabolic panel results will be within the parameters of the protocol. 9. normal renal function in the kidney. 10. adequate function of liver,lung and heart. 11. negative pregnancy test 12. fertile patients must use effective contraception 13. serologically negative for hiv,hbv,hcv. 14. syphilis serology negative 15. patient must have no prior sensitivity to the components of the dendritic cell vaccine. exclusion criteria: 1. anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the study. 2. presence of acute infection. 3. inability to obtain informed consent because of psychiatric or complicating medical problems. 4. patients with other significant illness including severe allergy, asthma, angina pectoris or congestive heart failure. 5. subjects with organ allografts. 6. known history of autoimmune disorder. 7. pregnancy or breast-feeding. 8. positive for hepatitis b, c, hiv, syphilis. 9. patients unwilling to perform a save method of birth control.
marathon runners compared to sedentary matched control subjects

Conditions: Type 2 Diabetes

Summary: the investigators wish to compare very active runners in healthy untrained control subjects on a number of parameters. the project aims to understand the underlying mechanisms by which physical inactivity causes diseases. this the investigators will study the full spectrum of physical activity, from the most inert of the most active people. the investigators have already collected muscle biopsies and established stem cells from people with type 2 diabetes, obese healthy and normal weight healthy. in this study, the investigators will establish a cohort of highly physically active marathon runners. in a case-control design, the investigators compare muscle stem cell function across the entire spectrum of physical activity / inactivity.

there has never been as much focus on running as in these days. with the knowledge the investigators have today, there is reason to believe that it is healthy to run both in a physical sense, but perhaps also in terms of brain function. however, there has not previously carried out extensive comparative studies of very active runners and healthy untrained control subjects. in this project the investigators will characterize the degree of training in subjects as the investigators will carry out various forms of physiological studies on the subjects' fitness level. the investigators will examine whether there is a linkage between training level and brain function. the investigators will also examine muscle function at the molecular level. the investigators will isolate stem cells (satellite cells) from muscles biopsy and establish primary muscle cell cultures. by electrical stimulation of these cells in vitro, the investigators can emulate a muscle contraction as during physical activity. the investigators will test the overall hypothesis that physical activity affects stem cell function. the investigators will further study whether epigenetic phenomena (methylation) of selected dna sequences are sensitive to training level.

Eligibility criteria:
inclusion criteria: * 10 marathons, 2 within the last year or 50 km/week the last 5 years exclusion criteria: * smokers, any medication, chronic diseases, digestion of performance enhancing drugs, pregnancy, alcohol abuse
quality of telemedically guided prehospital analgesia

Conditions: Analgesia; Prehospital; Telemedicine; Ambulance; Opioids; Teleconsultation; Tele-emergency Medical Services; Adverse Events; City of Aachen; Prehospital Emergency Medical Service Physician

Summary: the purpose of this retrospective study is to analyze quality and adverse events of analgesia by telemedically supported paramedics in comparison to conventional treatment by on-scene emergency medical service (ems) physicians in the ems of the city of aachen, germany.

the standard emergency medical service (ems) in germany consists of a two-tiered system with ambulances (paramedics) and prehospital ems physician units. for example, legal conditions restrict opioid-based analgesia to physicians. based on pre-defined standards regional emergency dispatch centers deploy both kinds of emergency units. in recent years telemedicine emerged as a complementary system in ems that may provide remote medical expertise and sustain or even improve quality of medical treatment on-scene. particularly, based on the results of the projects med-on-@ix and temras (telemedical rescue assistance system), emergency telemedical services were gradually implemented in daily routine of the ems of the city of aachen, germany. in this retrospective study the quality and adverse events of analgesia by telemedically supported paramedics shall be compared to conventional treatment by on-scene ems physicians in the ems of the city of aachen, germany.

Eligibility criteria:
inclusion criteria: * initial numerical rating scale ≥ 5 and * documented administration of analgesics exclusion criteria: * missing consent for telemedical consultation (in teleconsultation group) * initial nrs \< 5 * analgesia in non-st-segment elevation acute coronary syndrome (non-stemi-acs) and st-elevating myocardial infarction (stemi) * initially unconscious patient * inter-hospital transfer missions * cases involving both on-scene and telemedical-ems physicians

Keywords: analgesia prehospital telemedicine ambulance opioids teleconsultation tele-emergency medical services adverse events prehospital emergency medical service physician
trial on trabectedin in the treatment of advanced uterine and ovarian carcinosarcoma (cs)

Conditions: Carcinosarcoma, Ovarian; Carcinosarcomas Uterine

Summary: multicenter phase ii study on trabectedin in patients advanced uterine and ovarian carcinosarcoma. patients will receive trabectedin until disease progression or unacceptable toxicity. disease response evaluation will be assessed every 9 weeks.

this is a phase ii, multi-centre, single arm study aiming at evaluating efficacy and toxicity of trabectedin in a population of advanced or recurrent ovarian and uterine carcinosarcoma. trabectedin will be infused at the dose of 1.3 mg/m2 as a 3- hour iv infusion every 3 weeks via a central venous catheter.

Eligibility criteria:
inclusion criteria: * histologically documented stage i-iv or recurrent uterine or ovarian carcinosarcoma not amenable to surgery or radiotherapy * no more than 2 previous chemotherapy lines * ps 0-2 (ecog) * age\> 18 * measurable disease * life expectancy of at least 3 months * adequate organ functions: * hematopoietic; absolute neutrophil count ≥ 1,500/mm\^3; platelet count ≥ 100,000/mm\^3; hemoglobin ≥ 9 g/dl hepatic; ast and alt ≤ 1.5 times upper limit of normal (uln)\*; protocol version 1.0_05.09.2016 6 alkaline phosphatase ≤ 2.5 times uln\*; bilirubin ≤ 1.5 times uln note: \* ≤ 3 times uln if liver metastases are present renal; creatinine clearance ≥ 45 ml/min or serum creatinine ≤1.5 x uln serum albumin \>3.0 g/dl * previous brachytherapy treatment for uterine carcinosarcoma is allowed * no other invasive malignancy within the past 3 years except non-melanoma skin cancer * written informed consent exclusion criteria: * more than 2 previous chemotherapy lines * single tumor lesion inside a previous irradiated filed * pregnant (potentially fertile patients must be not in pregnancy during and for at least 3 months after study participation and must have a negative serum pregnancy test) * active infection requiring antibiotics * symptomatic peripheral neuropathy \> grade 2 according to the nci common toxicity criteria. * congestive heart failure or angina pectoris even if it is medically controlled. previous history of myocardial infarction within 1 year from study entry, uncontrolled high risk hypertension or arrhythmia. * unstable or severe intercurrent medical condition that, in the opinion of the investigator, might interfere with achievement of study objectives * psychological or sociological conditions, addictive disorders, or family problems, which would preclude compliance with the protocol
a study of the effect of supervised exercise programme in patients with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to compare the effectiveness of a supervised high-intensity exercise programme followed by an unsupervised exercise programme to an unsupervised exercise programme in patients with rheumatoid arthritis.

patients with rheumatoid arthritis are in general less fit and more at risk of comorbidities such as cardiovascular events compared with healthy age-matched controls. studies indicates that patients with rheumatoid arthritis have a lower level of physical activity than the general population and a low proportion of patients with rheumatoid arthritis exercises. regular exercise with moderate to high intensity level of intensity has proven to be effective in reducing the cardiovascular risk by improving cardiovascular fitness and to increase muscle strength. therefore, it is of interest to investigate if supervised exercise programme makes a difference making patients with rheumatoid arthritis participate in exercise.

Eligibility criteria:
inclusion criteria: * diagnosed with rheumatoid arthritis within the last three years at aarhus university hospital according to the 1987 revised acr criteria or the 2009 acr/eular criteria * must be able to sit on an exercise bike * must be able to participate in 6-weeks exercise programme with training sessions twice a week at aarhus university hospital * must be able to speak and understand danish exclusion criteria: * high disease activity assessed by das28-crp * myocardial infarction within the last six months * angina pectoris * treated with beta-blocker * severe high blood pressure * severe lung disease

Keywords: exercise programme