Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics and safety study of apetrol es

Conditions: Healthy

Summary: a randomized, open label, single dose, cross-over, phase i trial to investigate safety and pharmacokinetics of apetrol es and megace® in healthy male volunteers.

\[part 1\] fasting \[part 2\] fed

Eligibility criteria:
inclusion criteria: * is a healty male between 20 and 55 years old. * in a ± 20% than ideal body weight. \[ideal body weight(kg) = height(cm)-100) x 0.9 (broca's rule) * subjects who are considered to be suitable in conducting the clinical trial in serum test, hematology test, hemato-chemical test, urine test and 12-ecg result. * is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * agrees to use an adequate means of contraception during clinical trials * subject who has voluntarily decided to participate in this clinical trial and consented in writing. exclusion criteria: * is allergic against megestrol acetate or other drugs (aspirin, nsaids, antibiotics, etc.) or against foods, or has an clinically serious allergic history. * subjects who have present condition or past history of any disease involving liver, kidney, nervous system, immune system, respiratory system, or endocrine system; hematologic and oncologic disease; cardiovascular disease; or psychiatric disorder (mood disorder, obsessive-compulsive disorder, etc. that may affect adme of investigational medicinal products. * in the vital signs measured in sitting position at the screening visit, subjects who have hypertension desease(a systolic blood pressure of ≥ 150 mmhg or a diastolic blood pressure of ≥ 100 mmhg). * diabetic patients or the patients who are abnormal of impaired glucose tolerance. * the patients who have a history of arterial embolism. * the patients who have a history of adrenal insufficiency like hypotension or nausea or vertigo or asthenia or etc. * subjects who have a history of drug abuse or shown positive reaction to drugs that may be abused from a urine drug screening * subjects who took any specialized drug or an herbal medication within 2 weeks before the date of first administration or took any over the counter (otc) drug within 1 week (however, they may be included as subjects if appropriate depending on the investigator's discretion) * subjects who had whole blood donation within 2 months or component blood donation within 1 month before the clinical trial. * subjects who have abnormal diets that may affect adme of investigational medicinal products. * subjects who have been drinking extremely alcohol and caffeine (more than caffeine 5 cups/day, soju 3 cups/day, beer 3 cups/day, liquors 2 cups/day, 10 cigarettes/day) or can't refrain from drinking during the clinical trial period. * subjects who had administration a barbiturates within 1 month before the date of first drug administration * subjects who already participated in other clinical trials within 2 months before this clinical trial. * subjects who are considered to be unsuitable in conducting the clinical trial for other reason at the principal investigator's discretionary judgment

Keywords: male volunteers
subjective well being of patients receiving atypical antipsychotics as monotherapy or cotherapy with mood stabilizers

Conditions: Bipolar Disorder

Summary: cross - sectional study requiring one visit at the investigators office for the data collection. * target group: patients that suffer from bipolar disorder type 1. * ymrs - hamilton and gaf scales are going to be used to assess the clinical outcome. the findings are going to be based on the different scores reported by specialists (before the patients started to use as a therapy atypical antipsychotics / at the time that the visit actually takes place for the cause of the study.) we predefine the time period that the patient should be using atypical antipsychotics at minimum (2 months). * the first 9 consecutive patients that visit the specialist and meet the entry criteria and signs the icf will be recruited in the study.


Eligibility criteria:
inclusion criteria: * patients that are diagnosed with bipolar disorder type 1 according to diagnostic criteria dsm - iv * patients that have started therapy with atypical antipsychotics as monotherapy or cotherapy with mood stabilizers the last three months, but have completed 2 full months of therapy. * patients with anxiety disorder can be recruited in the study unless it is dominant. exclusion criteria: * patients that use antidepressant medication * patients who were treated with depot antipsychotic in the last quarter before their enrollment in the study. * patients who are addicts of toxic substances. * patients who suffer from other serious diseases.

Keywords: bipolar disorder antipsychotics social functioning mood stabilizers bipolar disorder type i atypical antipsychotics monotherapy cotherapy
early and accurate detection of prostate cancer in general practice

Conditions: Prostate Cancer; Prostate Neoplasm; Prostate Adenocarcinoma

Summary: prostate cancer (pc) is the most common malignancy (4500 new cases/year) and the second leading cause of cancer-associated mortality (1200 deaths/year) among men in denmark. pc is generally diagnosed on the basis of an elevated prostate specific antigen blood test followed by transrectal ultrasound (trus)-guided prostate biopsy. this study aims to test early detection of pc in general practice, using the sthlm3 model with superior specificity and sensitivity for clinically significant pc, combined with multiparametric magnetic resonance imaging (mpmri) of the prostate and mr guided biopsy.

while early stage pc can be cured by surgery or radiation therapy, advanced pc is incurable and associated with high morbidity and mortality. early detection is critical to save lives, but many newly diagnosed pcs are in reality non-aggressive and will not affect the patient's life or health, even if left untreated. there is an urgent need to replace current clinical practice with a more accurate diagnostic approach that can ensure early detection of aggressive pc while curable, reduce unnecessary prostate biopsies incl. risk of sepsis and reduce overdiagnosis/-treatment of indolent pc. new molecular biomarkers applied in general practice, serving as a pre-selection test for follow-up, and accurate and patient-friendly mr-imaging and mr-targeted biopsy at the hospital may help to solve these problems. in this study the investigators will assess the clinical utility of combining genetic risk testing and plasma protein markers (sthlm3 test) in general practice with mpmri and mr-guided in bore biopsy (mrgb) for early pc detection in a biopsy naïve population.

Eligibility criteria:
inclusion criteria: * aged 50-69 years * no previous pelvic cancer * no previous prostate biopsy * no previous elevated psa results * informed consent from the participant exclusion criteria: * palpable prostatae tumor by digital rectal examination * previously diagnosed with/or treated for an urogenital cancer disease * contraindications to 3 t mri * known severe renal impairment with estimated glomerular filtration rate \<30 ml / min

Keywords: sthlm3-test prostate cancer mr-imaging mr-targeted biopsy mri novel biomarkers genetic screening
human heterologous liver cells for infusion in children with urea cycle disorders

Conditions: Urea Cycle Disorders

Summary: treatment with liver cell infusion for children with urea cycle disorders (ucd).

urea cycle disorders are rare inherited diseases that generally have a poor outcome, especially with onset of the disease in the neonatal period. ucds are caused by a deficiency of one of six enzymes responsible for removing ammonia from the bloodstream. instead of being converted into urea which is removed from the body with the urine, ammonia accumulates in ucd patients leading to brain damage or death. in the light of a mortality rate of \> 50% at the age of 10 years the current pharmacological and dietary therapy is of modest success. furthermore, mental retardation, cerebral palsy and other neurological sequelae are common among surviving patients. in the last years, orthotopic liver transplantation (olt) has become the best therapeutic option for ucd with long-term survival rates of about 90%. however, in the first weeks of life olt still is technically demanding and prone to complications. with larger size of the recipient, the technical problems with olt decrease considerably. the increased body weight usually achieved at the age of more than 8 weeks is related to a major reduction in transplantation related morbidity. stabilization of metabolism until the patient can undergo olt is essential. in this study, young children with ucd will be treated by repetitive application of human liver cells. in the last consequence, the aim of this new therapy option is to supply a sufficient amount of healthy liver cells to compensate for the metabolic defect and to reduce the risk of neurological deterioration while awaiting olt.

Eligibility criteria:
inclusion criteria: * age: birth up to 5 years of age * ornithine transcarbamylase deficiency \[otcd\], carbamyl phosphate synthetase i deficiency \[cpsd\], argininosuccinate synthetase deficiency \[assd, citrullinaemia\] * written informed consent exclusion criteria: * weight ≤ 3.5 kg * presence of acute infection at the time of inclusion * severe chronic or systemic disease other than study indication * structural liver disease (eg, cirrhosis, portal hypertension) * required valproate therapy

Keywords: urea cycle disorders
postoperative analgesia after low frequency electroacupuncture

Conditions: Inguinal Hernia

Summary: the purpose of this study is to determine whether electroacupuncture is a effective tool to the postoperative analgesia

the electroacupuncture is a known therapeutic modality with particular application to pain. in this study the investigators investigate the effect of electroacupuncture in condition of surgery, which is a particularly painful situation. the investigators will verify the postoperative analgesia, as patients will receive either electroacupuncture or placebo electroacupuncture.

Eligibility criteria:
inclusion criteria: * healthy male volunteers * 18-75 years old exclusion criteria: * bilateral or recurrent hernia * significant cardiovascular, pulmonary, renal, hepatic, neurological disease * psychiatric history * use of opioids until the last month * body mass index greater than 30 * treatment with beta-blockers * aged over 75 * previous experience with acupuncture * hypersensitivity to opioids * pacemaker patient * patients being treated with monoamine oxidase inhibitors and selective serotonin reuptake inhibitors.

Keywords: electroacupuncture acupuncture pain management
coagulopathy in childhood acute lymphoblastic leukaemia

Conditions: Acute Lymphoblastic Leukemia; Thrombosis; Bleeding; Hemostatic Disorder

Summary: the goal of this study is to investigate the hemostatic balance in children with acute lymphoblastic leukaemia (all) treated according to the alltogether1 protocol with focus on the early treatment period including concomitant use of steroids and asparaginase. the investigators aim to determine if complement proteins or microparticles can be used as clinically relevant predictive or diagnostic biomarkers for thrombosis and if global hemostatic assays can predict bleeding or thrombosis. characterization of proteins connected to hemostasis before and during all treatment may provide pathophysiological insights regarding all- and treatment related coagulopathy. the ultimate goal of the study is to minimize the morbidity and mortality related to thrombosis and bleeding complications in children with all. several pediatric oncology centers in sweden will be participating in this study, which will enroll approximately 100 pediatric patients.


Eligibility criteria:
inclusion criteria: * diagnosis of acute lymphoblastic leukaemia (all) in sweden * age 1-17.99 years at diagnosis * planned/initiated treatment for all according to the alltogether1 protocol * signed informed consent from parents and patients (from 12 years - voluntary if \<15 years) exclusion criteria: * other underlying diseases which according to examiner's clinical assessment may increase the risk of bleeding or thrombosis and which are expected to lead to adaption of the therapy protocol for all (e g aps, moderate/severe v willebrand disease, haemophilia) * patient not treated according to the alltogether1 protocol (including patients with bcr::abl1, mixed phenotype acute leukaemia - mpal)
assessment of the bodyguardian remote monitoring platform in elderly healthy subjects

Conditions: Congestive Heart Failure

Summary: to adapt and refine the bodyguardian remote health monitoring system to acquire ecg, heart rate (hr), activity and breathing data, which will be integrated with weight, blood pressure and symptom data, in subjects in an independent living center, with wireless transmission of data to a central data analysis hub.

the elderly are facing an increasing prevalence of chronic disease and rapidly escalating healthcare costs threatening independent living. congestive heart failure (chf) is a growing health epidemic and is associated with significant morbidity, mortality and cost. mayo clinic and preventice have developed a non-invasive, minimally obtrusive, interactive remote monitoring platform. it enables on-body monitoring and integration of ecg, heart rate, breathing, and activity, with measures of weight and blood pressure. it is designed as a platform for physician directed patient self-management. this technology may be useful in monitoring chf patients. our overall objective is to adapt, refine, test and validate this technology in subjects in an independent living center, with wireless transmission of data to a central data analysis hub.

Eligibility criteria:
inclusion criteria: * resident at independent living facility * adequate phone service * healthy with life anticipated survival \>than one year exclusion criteria: * skin reaction/allergies to adhesives * have implantable pacemaker and/or defibrillator or have a bed partner with an implantable pacemaker
curing hcv in incarcerated patients

Conditions: Hepatitis C, Chronic

Summary: curing hcv in incarcerated patients (chip) is a 1-year demonstration project that will assess the feasibility of a hcv treatment program in the san francisco city \& county jail. the jail health services will treat 100 patients using the fda approved combination treatment, sofosbuvir/velpatasvir, epclusa® and will continue their treatment during incarceration and after their release (if applicable).

curing hcv in incarcerated patients (chip) is a 1-year demonstration project that will be conducted in the san francisco county jails. jail settings can provide an optimal opportunity to screen for hcv, initiate curative treatment, and link patients to community hcv providers to complete their treatment. this demonstration project will be funded by the gilead's investigator sponsored research. the purpose is to assess the feasibility of treating inmates with the fda approved combination oral treatment, sofosbuvir/velpatasvir, epclusa®. the san francisco department of public health's jail health services will treat 100 patients. intensive patient navigators will be an essential component for treatment to ensure medication adherence and achieve svr for those who are discharged from jail prior to hcv treatment completion. navigators will provide short-term case management services by linking patients to medical and social support services. this demonstration project will be facilitated by the jail health services' hiv \& integrated services (formerly forensic aids project).

Eligibility criteria:
inclusion criteria: * a detectable hcv viral load * no medical contraindications to treatment, including limited life expectancy of less than 12-months due to non-liver related comorbid conditions or renal failure with creatinine clearance of \< 30 ml/min. * must start hcv treatment while detained * hiv positive or negative status * hbv positive or negative status * treatment-naïve or experienced * with or without cirrhosis exclusion criteria: * a limited life expectancy of less than 12-months due to non-liver related comorbid conditions * current or history of decompensated cirrhosis, defined as presence of ascites, hepatic encephalopathy, or variceal bleeding within the past 6 months. * severe renal impairment defined as creatinine clearance of \< 30 ml/min or end stage renal disease (esrd) on hemodialysis * pregnant

Keywords: hepatitis c, chronic jail patient navigation incarcerated population hcv sofosbuvir/velpatasvir hepatitis c
lung cancer early molecular assessment trial

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the investigators hypothesize that an early molecular profiling, that includes both tissue and blood-bases analysis, for all nsclc patients, including stage i-iii, will increase diagnostic efficiency. when molecular profiles are available at an earlier stage of disease, more patients will benefit from personalized therapy once needed. this will result in both a better quality of life and outcome.

in this prospective multicentre trial tumours of all patients presenting with nsclc will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing. a minimal molecular profiling is depicted but other targets will be included in due time. the study is divided in two parts. in the first part participating centres will have a run-in period of half a year in which molecular profiling is performed as is currently standard of care. this period will be used to measure the impact of increased awareness on the diagnostic process. during the second part of the study a comprehensive upfront profiling according to local standards will take place for all nsclc patients. liquid (blood) biopsies will be included in order to increase the diagnostic yield for those patients where tissue biopsies are not adequate. patients will be treated according to standard of care, or included in clinical studies where appropriate. re-biopsies (both tissue and liquid) will be advocated at the time of establishing disease progression/disseminated disease, and personalized therapy will be initiated according to the existing data from the molecular profiling.

Eligibility criteria:
inclusion criteria: * suspicion of lung carcinoma or established nsclc but awaiting start of definitive treatment * written informed consent to undergo diagnostic procedure and molecular analysis of the disease. exclusion criteria: * not motivated to receive any treatment at any point in time. patients who consider undergoing treatment in the future are eligible.
the malmö international brother study (mibs)

Conditions: Hemophilia A With Inhibitors

Summary: existing data support the concept that a genetic predisposition for inhibitor development exists. the aim of the malmö international brother study (mibs) is to evaluate genetic factors associated with the development of inhibitory antibodies in patients with hemophilia.

inhibitory antibodies to factor viii develop in 10-15% of all patients with hemophilia a and in 25-30% of patients with the severe form of the disease after exposure to factor viii concentrates. both genetic and environmental risk factors for inhibitor development have been evaluated, but in most cases without consistent results. among the genetic factors, an association between large rearrangements of the factor viii and ix genes and a higher risk for inhibitors has been described. however, a majority of patients with null mutations, including the intron 22 inversion, do not develop inhibitory antibodies. it is obvious that other genetic markers influencing the immune response to replacement therapy in patients with hemophilia remain to be identified and the aim of malmö international brother study (mibs) is to characterize these factors.

Eligibility criteria:
inclusion criteria: -mild, moderate or severe hemophilia a or b and one or more brothers with mild, moderate or severe hemophilia a or b exclusion criteria: -absence of sufficient information to classify inhibitor status

Keywords: hemophilia a inhibitors
treatment of chronic hepatitis c with pegylated interferon and ribavirin in participants with/without substitution therapy (p05255)

Conditions: Hepatitis C, Chronic

Summary: although injection drug users represent the majority of new and existing cases of infection with hepatitis c virus (hcv), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. on the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for hcv infection successfully, the 2002 nih consensus statement on hepatitis c has recommended that substance users be treated for hcv infection on a case-by-case basis. in this study, all patients will receive pegylated interferon alfa-2b (pegifn-2b) and ribavirin according to european labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects \[methadone + buprenorphine\] or morphine).


Eligibility criteria:
inclusion criteria: * adult patients with hepatitis c exclusion criteria: * according to the products' european labeling
prediction and management of acute kidney injury with explainable artificial intelligence

Conditions: Acute Kidney Injury

Summary: the goal of this clinical trial is to compare the occurrence of acute kidney injury (aki) in inpatients when information from the 'prime solution' (aki prediction program utilizing artificial intelligence) is provided. the main questions it aims to answer are: •\[when artificial intelligence (ai) provides information regarding aki occurrence prediction within 48 hours, what would change in the physician's behavior?\] •\[if provided with ai information, what would be the incidence of aki, severe aki (stage 2 or 3), kidney replacement therapy, and changes in mortality during hospitalization?\] in the case of the intervention group that receives ai information, autonomous treatment is conducted by referring to ai prediction information. researchers will compare it with a usual-care group that does not receive ai prediction results.

the investigators designed a prospective, investigator-initiated, single-center, single-blinded, randomized controlled study with two experimental groups. a total of 1438 participants with hospitalized patients will be enrolled and randomized into two groups; intervention or usual-care groups. the investigators will apply an aki prediction model based on the patient's demographic. the investigators will collect data on vital signs, laboratory test results, medication history, and surgical records. the investigators provide information on whether aki develops within 48 hours and the top 10 explanatory factors for predicting aki to the physician. the intervention group receives the prediction results daily until the patient is discharged or up to 7 days after admission. the usual-care group does not receive analysis results.

Eligibility criteria:
inclusion criteria: * inpatients aged \> 18 years * admitted to the department of nephrology, geriatrics, urology, surgery, and orthopedics * written consent exclusion criteria: * patients with a scheduled hospital stay of 2 days or less * patients who have been hospitalized for more than 8 days since the date of hospitalization * patients scheduled to be discharged the next day * patients with last measured serum creatinine greater than 4.0 mg/dl or less than estimated glomerular filtration fate chronic kidney disease epidemiology collaboration (egfr-ckd-epi) 15 ml/min/1.73 m2 * patients undergoing dialysis (hemodialysis, peritoneal dialysis) due to end-stage renal disease * declined to participate

Keywords: acute kidney injury artificial intelligence explainable ai prediction