Kornimate/medical-research-clean huggingface dataset:
evaluation of safety and efficacy of kpg-121 plus enzalutamide, abiraterone or apalutamide in crpc patients

Conditions: Castration-Resistant Prostate Cancer

Summary: this is a phase 1, open-label, multicenter study of kpg-121 administered orally once daily (qd) in 28-day treatment cycles to adult subjects.

this phase 1 study will comprise two parts: part 1 will be a 3+3 dose escalation design to characterize the mtd and a rp2d, part 2 will be an expansion cohort at rp2d.

Eligibility criteria:
inclusion criteria: 1. signed informed consent provided prior to any study-related procedure being performed; 2. able to swallow and retain orally administered medication; 3. male aged 18 years and older; 4. diagnosis of prostate carcinoma; 5. men with either non-metastatic or metastatic crpc are eligible; 6. completed at least 4 or more weeks of prior continuous therapy with fixed stable dose enzalutamide, abiraterone or apalutamide prior to initiating study treatment (for part 1), or with fixed stable dose enzalutamide (for part 2), with no change in dose for at least 2 weeks prior to screening; 7. serum testosterone level \<50 ng/dl (\<0.5 ng/ml, \<7.0 nmol/l). 8. ecog performance status of 0 or 1; 9. adequate baseline organ function; 10. must have a qt interval corrected for heart rate according to fridericia's formula (qtcf) \<470 milliseconds (msec) or \<480 msec with bundle branch block; 11. male subject with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of screening until 3 months after the last dose of study medication; 12. willing and able to comply with all protocol required visits and assessments. exclusion criteria: 1. prior chemotherapy, radiation; 2. prior malignancy other than crpc. 3. uncontrolled hypothyroidism, or tsh \>2.0 x uln at screening. 4. current use of or anticipated requirement of prohibited medication(s); 5. any unresolved ≥grade 2 (per ctcae v5.0) toxicity from previous anti-cancer therapy; 6. previous history of difficulty swallowing capsules; 7. known active infection requiring intravenous (iv); 8. presence of hepatitis b surface antigen (hbsag), positive hepatitis c antibody test ; 9. history of seizure or any condition that may predispose subject to seizure (e.g., prior cortical stroke or significant brain trauma). history of loss of consciousness or transient ischemic attack within 12 months prior to the start of study medication; 10. poorly controlled hypertension; 11. have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs 12. history or evidence of cardiovascular risk; known cardiac metastases; 13. previous major surgery within 30 days prior to the start of study medication;

Keywords: kpg-121 enzalutamide abiraterone apalutamide non-metastatic and metastatic prostate cancer
embryoglue as an embryo transfer medium

Conditions: Infertility

Summary: in vitro fertilisation (ivf) is an increasingly common treatment for infertility. clinics which offer ivf are continuously trying to improve their success rates, measured by the numbers of ivf cycles which result in the birth of a live baby. one factor which is thought to have contributed to the success of ivf is the improvements in the embryo culture media, that is, the fluid in which the embryo resides in the laboratory before being replaced into a woman's womb. this trial seeks to identify if ivf cycles in which a particular culture media called embryoglue is used have better results when compared to ivf cycles in which a conventional embryo transfer media is used.


Eligibility criteria:
inclusion criteria: • couples having embryo transfer for fertility treatment exclusion criteria: * cycles in which elective freezing of all embryos is clinically indicated (e.g. severe risk of ohss, biopsy patients) * use of donor gametes * having endometrial scratch technique this cycle * concurrent participation in clinical trial(s) * previously randomised to this study * planned self-fund of embryoglue as transfer media
a study of xl765 (sar245409) in combination with temozolomide with and without radiation in adults with malignant gliomas

Conditions: Mixed Gliomas; Malignant Gliomas; Glioblastoma Multiforme

Summary: the purpose of this study is to determine the safety and tolerability of xl765 in combination with temozolomide in adults with anaplastic gliomas or glioblastoma on a stable temozolomide maintenance dose. xl765 is a new chemical entity that inhibits the kinases pi3k and mtor. in preclinical studies, inactivation of pi3k has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mtor has been shown to inhibit the growth of tumor cells. temozolomide (tmz, temodar®) is an orally administered alkylating agent with activity against malignant gliomas. it is approved by the food and drug administration for the following indications: 1) treatment of newly diagnosed glioblastoma multiforme (gbm) patients when given concomitantly with radiotherapy and then as maintenance treatment; 2) refractory anaplastic astrocytoma (aa), ie, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide is commonly used in the treatment of other anaplastic gliomas (ag) including oligodendroglial tumors and mixed gliomas.


Eligibility criteria:
inclusion criteria: * histologically confirmed intracranial grade 3 or 4 anaplastic glioma or glioblastoma (astrocytic tumor, anaplastic oligodendroglioma, or oligoastrocytoma) * received prior standard radiation for a grade 3 or 4 astrocytic tumor with a minimum cumulative dose of 40 gy administered * completed at least one full cycle of temozolomide of 200 mg/m2/day administered on days 1-5 of a 28-day cycle, without unacceptable toxicity or progression * karnofsky performance status of 60 or more * adequate organ and bone marrow function as defined by hematological and serum chemistry limits * at least 18 years old. * both men and women must practice adequate contraception * informed consent exclusion criteria: * progressed while on temozolomide * evidence of acute intracranial or intratumoral hemorrhage \> grade 1 * restriction of some therapies/medications within specific timeframes prior to enrollment and during the study including cytotoxic chemotherapy other than temozolomide, biologic agents, nitrosoureas or mitomycin c, small-molecule kinase inhibitors, non-cytotoxic hormonal agents, prior therapy with a pi3k inhibitors, radiation therapy, enzyme-inducing anti-convulsants, valproic acid * not recovered from the toxic effects of prior therapy * pregnant or breast feeding * history of diabetes mellitus * uncontrolled intercurrent illness * congestive heart failure, unstable angina, or a myocardial infarction within 3 months of entering the study. * hiv positive * diagnosis of another malignancy may exclude subject from study

Keywords: gbm anaplastic glioma
application of capnography monitoring on the general care nursing unit

Conditions: Postoperative Complications

Summary: the aim of this study is to increase the detection of undiagnosed obstructive sleep apnea (osa) and secondly to increase the sensitivity for detection of respiratory depression (\< 6 breaths per minute) in post operative patients on the general care nursing unit.

measures: this is an irb approved prospective trial beginning with randomization in the post anesthesia care unit (pacu) and continuing for thirty six hours post orthopedic surgical procedure. the patients are randomized into a capnography or standard of care group and the percentage of newly identified osa patients were measured in each group using the criteria set forth by 2006 american society of anesthesiologist practice guideline (anesthesiology 2006; 104:1081-93). background/changes: hospital complications are three times higher in patients with obstructive sleep apnea and the majority of these complications are related to opioid induced respiratory depression (mayo clin proc sept 2001:897-905). american society of anesthesiologist 2006 practice guideline for perioperative management of patients with obstructive sleep apnea (anesthesiology 2006; 104:1081-93) lists the criteria for identifying undiagnosed obstructive sleep apnea. one of the risk factors in the guideline lists apnea (pauses in breathing). capnography measures apnea episodes and continuously monitors respiration rate. as previously described, five percent of the general population has obstructive sleep apnea (osa) and the prevalence among patients requiring surgery is 9% (nejm 1993; 328:1230-1235). between 50-80% of osa individuals are undiagnosed when presenting for surgery.

Eligibility criteria:
inclusion criteria: * orthopedic surgical procedure * respiration rate \< 10 breaths per minute requiring supplement oxygen * one of the following: * body mass index \>30 * history of snoring * basal rate of opioid, and * one event of rr \<10 in the post anesthesia care unit. exclusion criteria: * copd * \< 18 y/o * a diagnosis of obstructive sleep apnea.

Keywords: capnography safety opioids respiratory depression postoperative orthopedic osa apnea
enterprise stent aneurysm treatment (esat) study - france

Conditions: Intracranial Aneurysm

Summary: the purpose of this study is to evaluate the morbidity, mortality, and efficacy of use of the enterprise(tm) stent for the treatment of (ruptured or non-ruptured) intracranial aneurysms.

per the opinion of the commission for the evaluation of products and services (cepp) in france, renewal is contingent upon setup of a prospective morbidity, mortality, and efficacy study. the objective is to follow the stented subjects for at least 1 year and evaluate the device and practices. this will be a multicenter study involving up to 15 interventional neuroradiologists in france. subjects presenting with ruptured or non-ruptured aneurysms for whom simple or balloon assisted endovascular treatment is considered impossible or insufficient by the interventional neuroradiologist.

Eligibility criteria:
inclusion criteria: * patient implanted with one or more codman enterprise™ stents and who present one or more ruptured or non-ruptured intracranial aneurysms assessed by angiography * agreement to take part in the study by the patient, or a representative of the patient in case of patient inability, after being informed by the investigator and have received information letter. exclusion criteria: * minors \<18 years of age * patient implanted for the same aneurysm with a codman enterprise™ stent in association with one or more stents from a different brand. * patient who does not accept to take part in the study.

Keywords: aneurysm stent intracranial aneurysm ruptured intracranial aneurysm
is there a relationship between the risk of injury and posture in wrestlers?

Conditions: Sport Injury; Posture; Wrestling; Risk Reduction

Summary: this study was planned to investigate the relationship between the risk of injury and posture in wrestlers. the study will be included male wrestlers. the spine posture and flexibility of the athletes will be measured during standing position with the idiag m360® brand spinal mouse (sm), while the overall body posture will be measured from the anterior and lateral sides using the new york posture analysis method (nypam). injury risks of the athletes will be evaluated by functional movement screen (fms) which was consisting of seven basic movement patterns.


Eligibility criteria:
inclusion criteria: * being between the ages of 18 and 40 * to be a professional wrestler who won medals in the turkey championships exclusion criteria: * had injury for in the last 6 months * had a history of surgery, or chronic and progressive disease * had any orthopaedic or neurological problems

Keywords: wrestling functional movement screen injury risk posture
prescribing interventions for chronic pain via the electronic health record study - current opioid-user population

Conditions: Opioid-use Disorder; Opioid Use; Opioid Abuse

Summary: the objective of this research is to assess the effects of electronic health record (ehr)-based decision support tools on primary care provider (pcp) decision-making around pain treatment and opioid prescribing. the decision support tools are informed by principles of "behavioral economics," whereby clinicians are "nudged," though never forced, towards guideline-concordant care.

to test the effects of these decision support tools for improving the quality of care for pain treatment, the investigators will implement a pragmatic clinic-randomized trial across the primary care clinics of fairview medical group and university of minnesota physicians. the study has two parallel components. the decision support tools to be tested will differ somewhat depending on whether a given patient is opioid-naïve, or whether a given patient is a current opioid-user. four sets of analyses will be conducted separately: one for the opioid-naïve group using ehr data, one for the current opioid-user group using ehr data, one at the pcp-level using web survey data, and one at the pcp-level using mn prescription drug monitoring program (pdmp) data.

Eligibility criteria:
inclusion criteria: - all primary care providers from all of the fairview and university of minnesota physicians study clinics exclusion criteria: - primary care providers who work less than 20% full time equivalent (fte)
gluten and amylase trypsin inhibitors (ati) free diet

Conditions: Type1diabetes

Summary: siblings of those with type 1 diabetes are at an increased risk of developing the disease themselves. through prior research, the investigators have found that siblings as well as those with type 1 diabetes have a general level of inflammation in the body. the investigators are examining the role that diet plays in this level of inflammation by asking siblings of children with type 1 diabetes to go on a gluten and amylase trypsin inhibitors (ati)-free diet for 4 weeks. blood and stool samples will be measured before the diet, after the diet is completed and again 4 weeks after participants resume their normal diet.


Eligibility criteria:
inclusion criteria: 1. males and females 2-23 years of age 2. full-sibling of an individual with a clinical diagnosis of type 1 diabetes 3. treatment naïve of any immunomodulatory agent exclusion criteria: 1. abnormal hba1c, defined as ≥ 6% 2. previous or current use of a gluten-free diet 3. current diagnosis of celiac disease 4. an elevated tissue transglutaminase iga level (\> 10 units/ml) 5. chronic (≥ 3 months duration) gastrointestinal disease or presence of gastrointestinal symptoms within the prior 6 weeks (e.g., abdominal pain, worsening constipation, diarrhea, or recurrent nausea +/- vomiting) 6. chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids 7. use of any medications that affect glucose metabolism (e.g., metformin) or the immune system (e.g., use of any glucocorticoids (inhaled, intranasal, oral, intravenous) within the previous 3 months) 8. use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics) 9. any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

Keywords: siblings
safety, tolerability, and efficacy of 24 weeks simeprevir+sofosbuvir for chronic hepatitis c genotype 1

Conditions: PT-NANBH

Summary: the goal of this pilot study is to examine both efficacy and tolerability in patients with hcv genotype 1 and mild decompensation with child-pugh-turcott score of 6 or lower. the cpt score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver transplantation. a higher cpt score denotes higher necessity of liver transplantation.

key objectives of this study include: 1. to describe efficacy (svr) in a special population of patients with chronic hepatitis c who are not willing or not candidates for ifn-based therapy. 2. to describe safety, tolerability, and treatment persistency in this patient population with advanced liver disease.

Eligibility criteria:
inclusion criteria: 1. adult 18-72 years 2. cirrhosis: defined by stage 4 on biopsy or noninvasive tests or presence of splenomegaly and platelet of 130k or lower, or presence of shrunken nodular liver on ct or mri, or presence of varices or encephalopathy or ascites. 3. hcv genotype 1 or indeterminate and later assessed at screening and confirmed as genotype 1 exclusion criteria: 1. uncontrolled ascites, uncontrolled hepatic encephalopathy, or uncontrolled esophageal/gastric varices 2. co-infection with hiv or hepatitis b (hbv) 3. cpt 7 or above, or meld \>10 4. total bilirubin 4.0 mg/dl or above 5. crcl (creatinine clearance) \< 30 ml/min 6. any unstable active medical illnesses. 7. active use of illicit substances, alcohol, or smoking. 8. any malignancy within last 5 years except for basal cell skin cancer that has been adequately treated or hcc within milan or ucsf criteria, which will be acceptable 9. any prior treatment with direct acting antivirals (approved or investigational), including hcv protease inhibitors, such as smv. patients who received prior treatment with sof, and/or ns5a inhibitors (e.g. ledipasvir or daclatasvir) can be included in this study 10. platelet \< 30 k/ul

Keywords: hepatitis c liver transplantation genotype 1
an exploratory study to look at the effect of two investigational drugs on body fat and inflammation

Conditions: Hypercholesterolemia; Dyslipidaemias; Obesity

Summary: the investigational drugs administered in this study activate proteins called ppars. data in the scientific literature on ppars, as well as animal data and early clinical data generated by gsk with these drugs, suggest that activation of ppars may cause the body to increase its use of fatty acids for energy, and lead to a reduction in body fat. there are also data to suggest a role for ppars in regulating lipid (e.g., cholesterol) levels and inflammation. these and other activities of ppars are being further explored in this clinical study.


Eligibility criteria:
inclusion criteria: * body mass index in the range of 27 - 43 kg/m2 * waist circumference \> 95cm exclusion criteria: * clinically relevant abnormalities on screening ecg/holter, labs or medical examination * use of tobacco within 6 months of the study * regular strenuous exercise * use of prescription or non-prescription medications, including vitamins and herbal/dietary supplements * ldl \ 400mg/dl

Keywords: cholesterol inflammation fat
study on examination of therapeutic efficacy and potential mechanisms of yoga treatment in schizophrenia

Conditions: Schizophrenia

Summary: the aim of this study is to examine whether yoga is efficacious as an add-on treatment for negative symptoms of schizophrenia in a randomized multi-centric trial and also to examine functional brain changes associated with self-reflection after treatment with yoga.


Eligibility criteria:
inclusion criteria: schizophrenia subject 1. icd (international classification of diseases) 10 diagnosis of schizophrenia 2. capacity to provide informed consent, as evaluated by the macarthur competence assessment tool for clinical research 3. no other current comorbid axis i diagnosis (except nicotine abuse/dependence) and no general impaired intellectual functioning healthy volunteers: 1. males and females between 18 and 45 years 2. capacity to provide informed consent 3. absence of past or present psychiatric illnesses including substance abuse 4) no general impaired intellectual functioning (mmse above24) exclusion criteria: 1. other current comorbid axis i diagnosis (except nicotine abuse/dependence) and general impaired intellectual functioning 2. history of alcohol or substance abuse or dependence in the last 12 months (with the exception of nicotine) 3. any contraindication to mri like metal implants or paramagnetic objects within the body or claustrophobia (only for patients undergoing fmri at nimhans) 4. past history of head injury resulting in loss of consciousness or neurosurgery 5. concomitant severe medical conditions 6. change in dose of antipsychotic medication or electroconvulsive therapy in the past 6weeks 7. pregnant or lactating -

Keywords: schizophrenia yoga fmri
evaluation of a local preconditioning effect in patients undergoing cardiac surgery

Conditions: Heart Disease; Coronary Artery Bypass Graft Triple Vessel

Summary: the aim of the study is to analyze the potential of pressure controlled intermittent coronary sinus occlusion (picso) to prevent/reverse the ischemic burden as well as reperfusion injury. to achieve insight into the clinical significance of this local preconditioning effect, global hemodynamics, cardiac performance and clinical outcome in the first 30 days will be related to the ability of this intervention to protect the myocardium in elective surgical procedures, ameliorating cellular decay and preserving the microcirculation therefore improving graft flow, reducing enzyme leakage and finally improving myocardial performance.

* patients undergoing elective coronary artery bypass graft (cabg) will be enrolled in this study. * a computerized randomization process is used to obtain similar distributions within each group. stratification will be done by the severity of coronary artery disease, age and sex. * routine blood sampling will be performed the day before surgery as well as a transthoracic echocardiography (tte) study to determine ventricular volumes and valvular function. * a modified minnesota quality of life questionnaire will be assessed and these data will be compared with 30 days outcome data screened in an outpatient environment. * a 12 lead electrocardiogram will be obtained. to assess eligibility and to assure grouping (stratification \& randomization) patients will be scored using the additive euroscore. pre-, intra-, and postoperative (up to 72 hrs) measurements of myocardial enzyme leakage will be performed using standard diagnostic procedures (cardiac troponin t, ck-mb, and total creatine kinase), as well as serial electrocardiograms and echocardiograms. * perioperative infarction will be assessed as the development of new persistent regional wall motion abnormalities in echocardiography together with electrocardiographic alterations and ck-mb increases and new q-wave pmi. * sequential cytokine analyses (il-1, il-6, il-8, il-10, il-17, vegf and tnf- alpha ) preoperatively, at the beginning of the operation, the beginning of ecc and 6,24 h and 30 days postop. * serial quantification of global and regional wall motion will be recorded using tee measurements during surgery.

Eligibility criteria:
inclusion criteria: * adult patients of either sex and between 18 and 85 years of age scheduled for surgery without severe confounding disease will be asked to participate in the study. * written informed consent will be obtained in eligible patients. exclusion criteria: * patients with unstable angina pectoris and/or myocardial infarction within the last 30 days, as well as persons with planned concomitant valvular interventions will be excluded. patients with malignoma, severe hepatic, renal and pulmonary disease will also be excluded