Kornimate/medical-research-clean huggingface dataset:
male circumcision and hiv rates in kenya

Conditions: HIV Infections

Summary: the luo tribe of kisumu, kenya, does not traditionally practice male circumcision (mc). this study will work with the luo tribe to test the effectiveness of mc on reducing the risk of hiv infections in young men.

since 1989, numerous epidemiological studies have reported a significant association between lack of male circumcision (mc) and risk for hiv infection through heterosexual intercourse. these results have led to calls for male circumcision to be considered as an additional hiv prevention strategy. however, there is a consensus among the international health community that a randomized controlled trial of mc is needed to control for possible confounding factors. additionally, known risks associated with mc need further investigation. this study will assess the effectiveness of male circumcision in reducing hiv incidence and will evaluate complications of the mc procedure, changes in sexual behavior following circumcision, and the biological mechanisms by which the foreskin may increase hiv susceptibility. the study will be conducted in kisumu, kenya, where the luo tribe is the main ethnic group and less than 10% of adult men are circumcised. uncircumcised men aged 18 to 24 years old will be offered voluntary hiv counseling and testing. hiv negative men will be asked to enroll in the study. all study participants will be interviewed to obtain socio-demographic information and assess behavioral risk factors. participants will be examined for significant medical conditions. all men will be counseled in strategies to reduce their risk for hiv infection. consenting men will be randomly assigned to either the treatment (circumcised) arm or the control (uncircumcised) arm of the study. after circumcision, men will be monitored for complications. they will be counseled to abstain from sex until healing is complete. follow-up visits will occur every 6 months for 2 years. uncircumcised men will be offered circumcision at the end of follow-up. the primary study endpoints will be hiv incidence and surgical complications. additional outcomes will be the incidence of other sexually transmitted diseases and behavioral risks. additional laboratory studies of foreskin tissue will evaluate the number and density of specialized cells rich in hiv receptors in order to illuminate the biological mechanisms by which presence of foreskin may increase hiv susceptibility.

Eligibility criteria:
inclusion criteria * hiv uninfected and willing to be tested * live in kisumu district, kenya * uncircumcised but willing to be circumcised * at least one sexual partner in the 12 months prior to study entry

Keywords: male circumcision hiv acquisition sexually transmitted infection hiv seronegativity
fibrin clot properties and blood loss following coronary artery by-pass grafting

Conditions: Coronary Artery Disease; Internal Mammary-Coronary Artery Anastomosis; Coronary Artery Bypass; Blood Loss, Postoperative; Fibrinolysis

Summary: up to 15% of operations in cardio-pulmonary by-pass are complicated by excessive postoperative blood loss, which negatively affects the outcomes. recently, it has been demonstrated that fibrin clot susceptibility to lysis is a modulator of postoperative blood loss after cardiac surgery for aortic stenosis. earlier, a preliminary study showed a negative association of postoperative blood loss after coronary artery by-pass grafting (cabg) with fibrin clot lysis time, reflecting susceptibility to fibrinolysis. in cabg, postoperative blood loss may depend on the operative technique with respect to left internal mammary artery (lima) harvesting. lima is taken down in virtually all cabg procedures, but harvesting technical details remain at surgeons discretion (skeletonization without opening the pleural cavity vs. pedicled graft with pleura wide open). the investigators decided to test the hypothesis that fibrin clot properties modulate the postoperative drainage following cabg strongly enough to attenuate the influence of surgical technique by randomizing the patients undergoing cabg with regard to lima harvesting technique.


Eligibility criteria:
inclusion criteria: * angiographically confirmed coronary artery disease * heart team qualification for first time elective coronary artery by-pass grafting * no significant valvular disease or congenital heart disease * normal sinus rhythm on ecg * continued aspirin in perioperative period exclusion criteria: * need for any concomitant cardiac procedure * st. p. percutaneous coronary intervention within preceding 3 months * any previous cardiac surgery * known bleeding diathesis * acute cardiovascular incident within preceding 3 months * heart failure with left ventricular ejection fraction \<30% * any autoimmune disease * any acute infection * known neoplasm * any thyroid disease * treatment with any thienopyridine, oral anticoagulant, heparin or any non-steroid anti-inflammatory agent other than aspirin * mental disorder * severe comorbidities (liver failure, renal failure on hemodialysis) * lacking consent

Keywords: coronary artery by-pass grafting cabg fibrin clot lysis time clt bleeding drainage rethoracotomy
study comparing conversion from calcineurin inhibitors to rapamune versus standard therapy in established renal allograft recipients

Conditions: Graft Rejection; Kidney Failure; Kidney Transplantation

Summary: the purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to rapamune based therapy in patients with mild to moderate renal insufficiency.


Eligibility criteria:
inclusion criteria: * age over 18 * treatment with a calcineurin inhibitor * patients with mild to moderate renal insufficiency exclusion criteria: * patients with acute rejection * patients who received a transplant more than 10 years ago

Keywords: kidney transplant
study of the pharmacokinetics and safety of recombinant factor viia fusion protein (rviia-fp, csl689) in patients with congenital factor vii deficiency

Conditions: Congenital Coagulation Factor VII Deficiency

Summary: the purpose of this study is to investigate the pharmacokinetics (pk) and safety of rviia-fp (csl689) in a total of 10 to 16 male or female adults with inherited coagulation factor vii (fvii) deficiency. subjects will receive a single dose of their routine fvii replacement product (ie, either recombinant activated coagulation fvii \[rfviia, eptacog alfa (activated)\] or plasma-derived fvii \[pdfvii\]) as a comparator, and will then be randomly assigned to a single low dose or a single high dose of the study product csl689 (8 subjects per csl689 dose level). serial blood samples for pk analysis will be taken up to 24 hours after the eptacog alfa (activated) or pdfvii injection, and up to 48 hours after the csl689 injection. subject safety will be routinely monitored throughout the study.


Eligibility criteria:
inclusion criteria: * proven congenital fvii deficiency. * age ≥ 18 years. * fvii level \< 2% of normal levels. * minimum of 50 previous exposure days to pdfvii (including prothrombin complex concentrates \[pccs\]) or rfviia. exclusion criteria: * history of, or risk factors for, thromboembolic events, including known deep vein thrombosis. * inhibitor to fvii or rfviia, current or historic. * known or suspected hypersensitivity to hamster protein, to csl689, or to any excipient of csl689. * known or suspected allergy to rfviia or hamster protein. * major surgery within 1 month before screening. * advanced atherosclerotic disease (ie, known history of ischemic heart disease, or ischemic stroke). * human immunodeficiency virus (hiv)-positive subjects with cluster of differentiation 4 (cd4)+ lymphocyte count of \< 200/µl at screening. * use of an investigational agent within 30 days before the study. * use of concomitant therapy not permitted during the study (ie, other platelet inhibitors, desmopressin, fibrinolysis inhibitors, except if used as local treatment \[eg, for oral bleeds\])
nifedipine or nifedipine plus indomethacin for treatment of acute preterm labor

Conditions: Preterm Labor

Summary: tocolytic agents are used for the treatment of preterm labor. it is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

the investigators current treatment for preterm labor has not been shown to be effective in prolonging pregnancy sufficiently to improve neonatal outcomes and other treatment strategies are needed. multiple examples demonstrate that multi-agent treatments are routine clinical practice in other fields of medicine including chemotherapeutics for cancer, multi-therapeutics for myocardial infarction and broad spectrum antibiotics for pneumonia. at this time, it is unclear if a combination of tocolytic medications for preterm labor is more advantageous for women. if pregnancy is prolonged with combined tocolytic therapy, this could directly influence the treatment of preterm labor and potentially improve neonatal outcomes. there currently are no trials of combination regimens using widely used tocolytic agents, such as nifedipine and indomethacin. thus, we propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

Eligibility criteria:
inclusion criteria: * we will include pregnant women between 22 0/7 to 31 6/7 weeks gestation who present with regular uterine contractions defined as at least one contraction every 10 minutes for 30 minutes with at least one of the following: * cervical change of at least 1 cm or * cervical dilation of 2 cm at the time of initial exam or * positive fetal fibronectin and transvaginal cervical length \<2.5 cm exclusion criteria: * we will exclude pregnant women with any contraindication to tocolysis: * clinical chorioamnionitis (defined as a temperature of \>100.4 f and any of the following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent vaginal discharge) * non reassuring fetal heart tones * suspected placental abruption * preterm premature rupture of membranes * prior tocolytic treatment during the past 48 hours * known adverse effect to indomethacin or nifedipine * already receiving nifedipine for chronic hypertension

Keywords: pregnancy preterm labor tocolysis
the clinical effect of intensive statin therapy in stemi patients before emergency pci

Conditions: ST-elevation Myocardial Infarction; (STEMI)

Summary: the purpose of this study is to evaluate the clinical effect of intensive statin therapy before emergency pci in patients with stemi.

150 stemi patients planned for emergency pci were randomized to three groups, group 1:received atorvastatin 80-mg loading dose before pci then followed by 40-mg daily for one month and a maintenance dose of 20-mg qd thereafter(n=50); group 2:received atorvastatin 40-mg qd after pci for one month and a maintenance dose of 20-mg qd thereafter(n=50); group 3: received atorvastatin 20-mg qd after pci (n=50).before pci,all subjects received oral administration of aspirin 300mg and clopidogrel 300mg.levels of creatine kinase,ck-mb(creatine kinase-mb),were measured to estimate myocardial damage degree.hs-crp(high sensitivity c -reactive protein),no(no synthase),saa(serum amyloid a) were measured at preoperation 1 hour,postoperative 24 and 72 hours,7days after pci. to compare echocardiography changes among three groups.patients enrolled in the study need to receive follow-up survey which was carried out by clinical doctors.hence,maces were analyzed during 6-month follow-up.so, the aim of our study is to evaluate the clinical significance of loading dosage of atorvastatin therapy and analyze the mechanism underlying it.

Eligibility criteria:
inclusion criteria: * 1.clinical diagnosis of stemi less than 12 hours 2.eligible for emergency pci exclusion criteria: * 1.contradiction to atorvastatin 2.contradiction to aspirin, clopidogrel and contrast medium 3.life expectancy less than 3 months 4.tumor or inflammatory diseases

Keywords: st-elevation myocardial infarction(stemi) emergency percutaneous coronary intervention(pci) lipitor or atorvastatin
influence of tobacco use on cannabis use

Conditions: Cannabis Use; Tobacco Use

Summary: cannabis smokers who also smoke tobacco cigarettes have markedly higher rates of cannabis relapse relative to those who do not use tobacco. there is a clear need to develop and evaluate interventions for dual tobacco and cannabis users. the investigators of this study have previously shown that the co-use of tobacco cigarettes contributes to the maintenance of daily cannabis use, and that age of cigarette onset is a critical predictor of treatment outcome. short-term tobacco cessation may suffice in altering cannabis relapse rates in later-onset cigarette smokers, while a longer period of tobacco cessation may be needed for earlier-onset smokers. in the current study, a human laboratory model will be utilized to determine whether cannabis relapse varies as a function of tobacco cessation duration and age of tobacco use onset.


Eligibility criteria:
inclusion criteria: * males and non-pregnant females aged 18-60 years old * use cannabis * smoke tobacco cigarettes * medically and psychologically healthy exclusion criteria: * regular drug use other than cannabis * current pregnancy/lactation
to compare the pharmacokinetic characteristics of the fixed-dose combination compared to the loose combination

Conditions: FDC; Diabetes Mellitus, Type 2

Summary: to compare the safety and pharmacokinetic properties between the administration of dwp16001 and dwc202213 as an individual drug, and the administration of dwj1563 as a combination drug.


Eligibility criteria:
inclusion criteria: 1. before participating in the clinical trial, a person who fully explained the purpose, content, and characteristics of the clinical trial drug and signed a written consent form approved by the irb of chungbuk university hospital to participate in this study according to his free will. 2. healthy adults aged 19 or older at the time of screening. 3. those who weigh more than 50.0 kg in men and women, and have a body mass index (bmi) of 18.0 kg/m2 or more and less than 30.0 kg/m2 or less in women. * body mass index (bmi) = weight (kg) / \[height (m)\] 2. exclusion criteria: 1. a person with a clinically significant history in liver, kidney, neuropsychiatric system, respiratory system, endocrine system, blood and tumor system, cardiovascular system (including orthostatic hypotension), digestive system, musculoskeletal system, etc. 2. a history of gastrointestinal diseases (e.g., esophageal diseases such as crohn's disease, esophageal achalasia, or esophageal stenosis) or surgery (except appendectomy, hernia). 3. those who are hypersensitive to other drugs (dpp-4 inhibitors, etc.) or have a history of clinically significant hypersensitivity reactions, including dwp16001, dwc202213 and homogeneous (sglt2 inhibitors) 4. a person who shows the following results in the inspection items conducted during screening. * blood alt, ast, total bilirubin \> twice the upper limit of the normal range. * the glomerular filtration rate (e-gfr) \<90 ml/min/1.73 m2 (using the ckd-epi method) 5. after more than 3 minutes of rest, systolic blood pressure \> 150 mmhg or \ 100 mmhg or \<60 mmhg, or pulse ≤ 40 bpm or ≥ 100 bpm in vital signs measured at the seat
glucose metabolism after partial pancreatectomy

Conditions: Pancreatectomy; Hyperglycemia; Diabete Mellitus

Summary: this is a single center observational study to assess alteration of glucose metabolism after pancreatectomy.

biochemical markers of glucose metabolism including oral glucose tolerance tests, fasting blood glucose, insulin, glucagon and hba1c were performed on patients receiving pancreatectomy (pancreaticoduodenectomy and distal pancreatectomy). tests were done preoperatively, postoperatively at 3 months, and at 1 year. the primary endpoints were the incidence and risk factors of new-onset and worsened dm after each type of pancreatectomy.

Eligibility criteria:
inclusion criteria: * partial pancreatectomy exclusion criteria: * total pancreatectomy * incomplete testing * follow-up loss * death within 1 year

Keywords: pancreatectomy diabetes mellitus pancreaticoduodenectomy
effectiveness of acceptance and commitment therapy self-help for carers of people with multiple sclerosis

Conditions: Carer Stress Syndrome

Summary: this is a feasibility study to evaluate whether it is possible to conduct a larger study to evaluate whether providing psychological support to carers of people with ms is effective in reducing carer strain. whilst not all carers experience distress as a result of their caring duties, some do. this study is testing the use of acceptance and commitment therapy (act) in a self-help format. participants will learn about and use act by reading a book provided to them by the study. one group will receive the act book, another will receive the same book alongside weekly telephone support to use the book, and a third group will act as a control group and therefore will not have extra support. participants are allocated to the groups based on chance (a computer will decide group allocation). participants will complete questionnaires before group allocation, and then again 3 months after they were allocated to a group, and one final time 6 months after group allocation. those who receive the self-help book will get sent chapters each week for 8 weeks. the groups will be compared on scores from the questionnaires and complete feedback interviews with a subgroup of those who receive the book, to gain feedback about their experiences of the study.


Eligibility criteria:
inclusion criteria: * primary carer for a person with ms, * english speaking (intervention and assessments are in english), * able to give informed consent. * score at least 21 on the zarit burden interview (demonstrating a minimum of mild distress) exclusion criteria: * diagnosis of ms themselves * psychiatric diagnosis * inability to commit to the intervention

Keywords: carers of people with multiple sclerosis carer strain acceptance and commitment therapy
long-term effects of aat in patients with abi

Conditions: Acquired Brain Injury

Summary: the aim of this study is to investigate weather patients treated with animal-assisted therapy show better socioemotional skills compared to treatment as usual. 70 patients will be allocated randomly to one of two groups (control group and intervention group). during 6 weeks, all patients get two therapy sessions (aat vs. tau) per week. the 35 patients in the control group will get treatment as usual (tau) in speech therapy, occupational therapy or physiotherapy twice a week whereas the 35 patients in the intervention group will get the same therapies but there will be an animal included in the therapy sessions. the main outcome is the amount of expressed emotion and interaction in a standardized social situation measured via behavioral video coding. measurements will be done before the first therapy session (pre-measurement, t0) and after the last therapy session (post-measurement, t1) of the 6 weeks of intervention. the follow-up measurement will be done 6 weeks (follow-up i, t2) and 12 weeks later (follow-up ii, t3).


Eligibility criteria:
inclusion criteria: * informed consent as documented signed by the patient or his/her legal representative * inpatients of rehab basel with acquired brain injury and fim-score over 60 (funktionale selbstständigkeitsmessung, internationale vereinigung für assessment in der rehabilitation, 1997) * minimum age of 18 years exclusion criteria: * enrolment of the investigator, his/her family members, employees and other dependent persons * medical contraindications for contact with animals as allergy, phobia etc.
study of bc3195 monotherapy in patients with advanced solid tumors

Conditions: Locally Advanced or Metastatic Solid Tumors

Summary: this is a phase i study to evaluate the safety, tolerability, pharmacokinetics (pk), and preliminary efficacy of bc3195 in patients with locally advanced or metastatic solid tumors.

this is a phase i study to evaluate the safety, tolerability, pharmacokinetics (pk), and preliminary efficacy of bc3195 in patients with locally advanced or metastatic solid tumors. the patients in whom standard treatment has failed (either due to disease progression or intolerance), who meet the criteria will receive bc3195 via intravenous (iv) in 21-day treatment cycles. a safety monitoring committee (smc) will be established to decide the dose levels to be administered and dose regimen during dose escalation based on a thorough review of all the safety, pk (if applicable), and other relevant data from the previous dose cohort, and to determine the mtd and the putative rp2d for dose expansion.

Eligibility criteria:
inclusion criteria: 1. patients voluntarily participate in the study and should provide a written informed consent. 2. male or female patients ≥ 18 years of age. 3. eastern cooperative oncology group (ecog) performance status of 0-1. 4. subjects with locally advanced or metastatic solid tumors failed to prior socs and no appropriate soc to treat the current disease per investigator's judgement. 5. life expectancy ≥ 3 months. 6. subjects with adequate organ function. 7. men or women of childbearing potential (which refer to men or women who have not been surgically sterilized and pre-menopausal women) must use a highly effective method of contraception during the study and continue to take contraception measures for 6 months after the last dose of the study drug. exclusion criteria: 1. pregnant or lactating women. 2. prior systemic anticancer treatment within 5 half-lives or 4 weeks before the first dose (whichever is shorter). 3. active viral infection requiring systemic therapy during the screening period. 4. hypertension that cannot be well-controlled with medical treatment. 5. cardiovascular disease of clinical significance. 6. subjects with any active infection that requires anti-infective therapy judged by the investigators. 7. subjects are not suitable for participating the study judged by the investigators. 8. subjects with poor compliance, who are unwilling to or unable to follow study procedures.

Keywords: solid tumors