Kornimate/medical-research-clean huggingface dataset:
post-marketing registration study of nifekalant hydrochloride (nif) injection

Conditions: Ventricular Tachycardia; Ventricular Fibrillation

Summary: retrospective and prospective single arm, observational study to evaluate efficacy and safety of nif in the treatment of ventricular tachycardia and ventricular fibrillation. the information registration of the target population will be collected with the hospital his system or lis system.

subjects enrolled in the retrospective study may be enrolled in a prospective study if the study drug is re-used, but in the end only the most-registered case of the subject would be collected. the recommended treatment plan for this study is from the usage and dosage of nif. the clinician can make appropriate adjustments to the specific usage and dosage according to the patient's condition. load dose: adults usually use 0.3mg/kg each time, under continuous ecg monitoring, the injection should be completed within 5 minutes, and the maximum dose should not exceed 0.5 mg/kg. maintenance dose: after load injection, the adult routine dose is 0.4 mg/kg/h under continuous ecg monitoring. the dosage could be appropriately increased or decreased according to the patient's reaction, but the maximum dose should not exceed 0.8 mg/kg/h.

Eligibility criteria:
inclusion criteria: * patients with life-threatening ventricular tachycardia or ventricular fibrillation in cases where other drugs are ineffective or inoperable. * patients who have received or are about to receive nifekalant hydrochloride for treatment according to the instructions. exclusion criteria: -

Keywords: ventricular tachycardia ventricular fibrillation
impact of a printed decision aid on patients' intent to undertake prostate cancer screening

Conditions: Prostate Cancer

Summary: although the number of recommendations against systematic screening of prostate cancer, 70% of patients still request testing because they overestimate the benefits and are unaware of the limitations. the investigators aim is to assess the impact of a short printed decision aid presenting benefits and limits of screening, on patients' intent to undergo prostate cancer screening.

a cochrane systematic review of 5 randomized controlled trials showed that screening for prostate cancer, using digital rectal examination and dosage of prostate specific antigen (psa), did not significantly decrease prostate cancer specific mortality. rather, screening for prostate cancer often led to over-diagnosis by detecting tumors that would not otherwise have become symptomatic or by producing false positive results. it could therefore result in unnecessary supplementary testing (including prostate biopsies), inadequate and/or harmful treatment, and negative psychological outcomes among patients. although the growing number of recommendations against psa testing for screening of prostate cancer, 70% of patients still request testing prior to any information because they overestimate the benefits and are unaware of the limitations. as a result, about 55% of patients between 50 and 74 years old, undergo prostate cancer screening in the usa every year, despite recommendations against it. to help patients understand the complexities about psa testing for prostate cancer screening, professional organizations encourage physicians and patients to use decision aids to make informed decisions. the aim of this study was to evaluate the impact of a decision aid, usable in daily practice by general practitioners, presenting harms and benefits of prostate cancer screening on patients' intent to undergo screening.

Eligibility criteria:
inclusion criteria: * male patients from 50 to 75 years old exclusion criteria: * personal history of prostate cancer * any urinary tract symptoms * history of prostate cancer in a first degree relative * known exposition to chlordecone

Keywords: prostate cancer screening decision aids
supine percutaneous nephrolithotomy

Conditions: Renal Stone

Summary: there is an increased incidence of renal stones, especially in the pediatric age group. the percutaneous approach in the pediatric age took a long time till it again accepted among surgeons worldwide. the prone position is the preferred approach to perform percutaneous nephrolithotomy in the pediatric age group. this study aims to compare supine versus prone position percutaneous nephrolithotomy in the pediatric age group.

the incidence of renal stones in the pediatric age group increased from 18.4 to 57.0% per100,000 children in the period from 1999 to 2008. the acceptance of pcnl in pediatrics was slow at first due to concerns of the small kidney size compared to relatively large instruments percutaneous nephrolithotomy in pediatric patients was conventionally performed in the prone position for historical reasons, being more familiar to surgeons and it was considered safer to avoid colonic injury. supine pcnl has several valuable advantages to pediatric patients in particular better irrigation shorter operative time with a comparable outcome with the prone position. our study aims to assess the efficacy and the safety of percutaneous nephrolithotomy in the supine position in comparison to the prone position in the pediatric age group.

Eligibility criteria:
inclusion criteria: * patients aged from two to sixteen years old with single or multiple renal stones indicated for percutaneous nephrolithotomy exclusion criteria: * patients with renal anomalies, bleeding tendency, elevated kidney function tests for age, previous renal surgical intervention on the same site of intervention. * patients with skeletal abnormalities and spine deformities were also excluded * patients with a single kidney were also excluded
extension at 10 years of the: "observational study evaluating efficacy and costs of secondary prophylaxis vs on-demand therapy with kogenate bayer in patients with severe haemophilia a."

Conditions: Hemophilia A

Summary: following the performance of the potter observational study, whose primary objective was to collect data on the benefits of secondary prophylaxis versus on demand treatment in terms of prevention of bleeding episodes, the present study aims to extend the observation time up to 10 years, of the same population involved in the previous study. the present study has been designed to allow a focus on long term disease-related damage at joint level in subjects with severe haemophilia a, as well as on the pharmacoeconomics impact of the two different treatment regimens.


Eligibility criteria:
inclusion criteria: * completion of follow-up in the original potter study without having being excluded from the intention to treat efficacy analysis of the primary endpoint; * written informed consent specifically issued for the 5-year extension. exclusion criteria: * switching of treatment to a factor viii concentrate different from kogenate bayer/helixate nexgen after the end of the previous follow-up period.

Keywords: hemophilia a, congenital
tax + carboplatin or cisplatin 1st line post-surgery ovarian

Conditions: Ovarian Neoplasms

Summary: evaluate response rate of docetaxel in combination with carboplatin or cisplatin as first line chemotherapy in epithelial ovarian cancer. assess the progression free survival, tolerance, duration of response and survival in the same patient population.


Eligibility criteria:
inclusion criteria: * histologically confirmed epithelial ovarian carcinoma. patients with peritoneal carcinomatosis are also eligible, without necessarily having histological proof of a primary source in the ovary, provided that the tumour is not mucin-secreting, and that there is no evidence of a primary fallopian tube cancer (see exclusion criteria). * female, aged 18 or over- figo stages ic-iv with or without successful cytoreductive surgery at staging laparotomy. stage ic patients will be limited to those with malignant cells in ascitic fluid, peritoneal washings or with tumour on the surface of the ovary * patients with ruptured capsule as the only evidence of stage ic will not be eligible for entry into the study. exclusion criteria: * ecog performance status \> 2 * prior treatment with chemotherapy or radiotherapy. * patients with, pre-existing fluid retention such as pleural effusion, pericardial effusion and ascites are not excluded from the study, but should be monitored closely for any deterioration. efforts should be made to determine by cytological analysis whether any significant pre-existing fluid collections are due to ovarian cancer, and subsequent drainage is recommended before initiating chemotherapy. * inadequate bone marrow function defined as neutrophils \< 1.5 x 109/l or platelets \< 100 x 109/l. * inadequate renal function as defined by serum creatinine \> 1.25 x upper limit of normal. * inadequate liver function as defined by bilirubin \> upper limit of normal or ast/alt \> 1.5 x upper limit of normal or alp \> 3 x upper limit of normal. * concurrent severe and/or uncontrolled co-morbid medical condition (i.e. uncontrolled infection, hypertension, ischaemic heart disease, myocardial infarction within previous 6 months, congestive heart failure) * patients with mixed mesodermal tumours. * patients with borderline ovarian tumours or tumours termed 'possibly malignant'. * adenocarcinoma of unknown origin, if histologically shown to be mucin-secreting cancer or thought to be possible primary fallopian tube carcinoma. * history of previous malignancy within the previous 5 years (except curatively treated carcinoma in situ of the uterine cervix, or basal cell carcinoma of the skin), or concurrent malignancy (e.g. coexisting endometrial cancer) . * history of prior serious allergic reactions (e.g. anaphylactic shock). * history of other relative contraindications to corticosteroid administration * pregnant or lactating women (or potentially fertile women not using adequate contraception). * symptomatic peripheral neuropathy \> ncic-ctc grade ii. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
fsh treatment for non-obstructive azoospermic patients

Conditions: Azoospermia

Summary: aim of the study is to evaluate the effect of highly purified human follicle-stimulating hormone treatment on the chance of retrieving testicular sperm (sperm retrieval rate) from infertile male patients with non-obstructive azoospermia of unknown origin.

preliminary reports showed that hormonal treatment may improve the chance of retrieving viable testicular sperm from men with noa, but no rct are available in the field. this randomized placebo-controlled clinical trial sought to evaluate whether the testicular sperm retrieval rate could result higher in noa patients treated with follicle-stimulating hormone compared to placebo-treated noa subjects.

Eligibility criteria:
inclusion criteria: * azoospermia; * testis longitudinal axis less than 4.5 cm; * serum follicle-stimulating hormone greater than 7.6 iu/l exclusion criteria: * history of testicular biopsy, * malignancy, * varicocele, * hyperprolactinemia, * thyroid disfunction, * chemotherapy, * radiotherapy

Keywords: follicle stimulating hormone treatment azoospermia nonobstructive male infertility follicle stimulating hormone
brief delirium assessments in non-intensive care unit (icu) patients

Conditions: Delirium

Summary: delirium is an acute confusional state characterized by fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. this form of organ dysfunction occurs in up to 50% of hospitalized patients and is associated with worsening mortality, prolonged hospital length of stay, higher health care costs, and accelerated functional and cognitive decline. despite the negative consequences of delirium, the majority of cases are unrecognized by hospital physicians because it is not routinely screened for. in an effort to facilitate delirium screening, we sought to validate two brief delirium assessments (\<2 minutes) in the hospital setting.

delirium is often missed because physicians do not routinely screen for this diagnosis. most delirium assessments can take up to 10 minutes to perform making them less likely to be incorporated into the routine physician assessment. using brief (\<2 minutes) and easy to use delirium assessments may ameliorate this quality of care issue. the confusion assessment method for the intensive care unit (cam-icu) possesses these characteristics, but has only been validated in mechanically and non-mechanically ventilated intensive care unit patients. as a result, it still requires validation in the non-icu hospitalized patients. recently, we also developed the brief confusion assessment method (b-cam) which is a modification of the cam-icu. the benefit is that it takes even less time than the cam-icu. however, it also requires validation in hospitalized patients. as result, we propose the following and the following specific aims: aim #1: to validate the b-cam in non-icu hospitalized patients. the b-cam will be performed by a clinical trials associate (cta) and principal investigator in 150 non-icu hospitalized patients that are \> 65 years old. this instrument will be validated against a psychiatrist's diagnostic and statistical manual of mental disorders, 4th. edition text revision assessment as the reference standard. aim #2: to validate the cam-icu in non-icu hospitalized patients. the cam-icu will be performed by a clinical trials associate (cta) and principal investigator in approximately 150 non-icu hospitalized patients that are \> 65 years old. this instrument will be validated against a psychiatrist's diagnostic and statistical manual of mental disorders, 4th. edition text revision assessment as the reference standard.

Eligibility criteria:
inclusion criteria: * 65 years of age or greater * in the non-icu inpatient setting * consulted and evaluated by psychiatry exclusion criteria: * severe mental retardation or dementia * baseline communication barriers such aphasia, deafness, blindness, or who are unable to speak english * refusal of consent * previous enrollment * comatose * out of hospital before the assessments are completed

Keywords: delirium, diagnosis, elderly, hospitalization
glucocorticoids for acute drug induced liver injury with hyperbilirubinemia

Conditions: Drug Induced Liver Injury

Summary: drug-induced liver injury (dili) can lead to potentially fatal complications, such as acute liver failure and even death. in clinical practice, glucocorticoids have been considered in some cases of dili, especially patients with hyperbilirubinemia. however, the available evidence remains controversial and its quality is also very limited. herein, a multicenter randomized controlled trial (rct) has been designed to explore the efficacy and safety of glucocorticoids in patients with acute dili and hyperbilirubinemia.

overall, 232 patients with acute dili with hyperbilirubinemia will be enrolled. they will be randomly assigned at a ratio of 1:1 to the conventional treatment alone or combined with glucocorticoids groups. the primary endpoint is the improvement of dili after treatment on second week. secondary endpoints include the improvement of dili on fourth week, rates of progressive liver injury, liver failure, liver transplantation, survival, and adverse events. exploratory endpoints will assess the beneficial population and changes of inflammatory factors following glucocorticoid treatment.

Eligibility criteria:
inclusion criteria: * a definite diagnosis of acute dili; * 5×uln ≤ tbil level at baseline ≤ 20×uln; * age 18-80 years old; * sign the informed consent form. exclusion criteria: * other causes of liver injury, including viral hepatitis, cytomegalovirus infection, epstein-barr virus infection, herpes virus infection, autoimmune liver disease, alcoholic liver disease, hypoxic/ischemic liver disease, budd-chiari syndrome, biliary tract disease, wilson's disease, hemochromatosis, and α1-antitrypsin deficiency; * immune checkpoint inhibitors or gynura segetum induced dili; * absolute contraindications to glucocorticoids, such as systemic mold infections or allergies; * a history of glucocorticoid therapy within 3 months before enrollment; * a history of diseases requiring glucocorticoid maintenance therapy, such as rheumatoid arthritis, systemic lupus erythematosus, systemic dermatomyositis, etc; * a history of liver transplantation; * received artificial liver therapy before enrollment; * malignant tumor of the liver, bile duct, pancreas or liver metastasis * acute liver failure; * renal dysfunction, creatinine cr≥133μmol/l; * neutrophil count \<1,000,000,000/l; * active tuberculosis; * severe cardiopulmonary diseases; * recent surgery or trauma; * mental illness; * pregnancy or lactation; * participated in other clinical studies within 3 months before enrollment; * other conditions judged by the clinician to be inappropriate for study participation.

Keywords: drug induced liver injury liver failure glucocorticoids clinical trial hyperbilirubinemia
prospective evaluation of delayed effects of pediatric car t cell therapy

Conditions: B-ALL; Hematologic Malignancy; Solid Tumor

Summary: this study is being done to learn more about the short-term and long-term side effects of car-t cell therapy. specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.

primary objectives * bone marrow function: to report on the incidence, timing, severity of, and risk factors for bone marrow dysfunction in participants in remission or without bone marrow involvement of disease at 3- and 6-months following car t cell therapy. (b-all cohort) * infection/immune reconstitution: to evaluate the incidence, timing, severity of and risk factors for clinically significant infections following car t cell therapy at 3- and 6-months following car t cell therapy. (b-all cohort) * neurotoxicity: to evaluate the incidence, timing, severity of, and risk factors for persistent icans at 3- and 6-months post car t cell therapy. (b-all cohort) secondary objectives * to evaluate bone marrow function, infection/immune reconstitution, and neurotoxicity at 12 months and 24 months post car t cell therapy in participants with b-all. * to characterize bone marrow function, infection/immune reconstitution, and neurotoxicity between 3 and 24 months after car t cell therapy in other hematologic malignancies and solid tumor cohorts. participants will have an assessment of preexisting morbidity and potential risk factors, collection of specimens for banking, scheduled late effects monitoring, laboratory analysis, and screening studies. data and biospecimens will be collected at 3 months, 6 months, 1 year and 2 years after car t cell infusion.

Eligibility criteria:
inclusion criteria: * participants must have received an initial systemically-administered car t cell infusion within the last 1-3 months (+/- 14 days). * initial infusion is defined as the first administration of a car t cell product the participant has not previously received or receipt of a car t cell product previously received after an interval allogeneic hsct. * age ≤ 30 years at car t cell infusion. exclusion criteria: * active malignancy other than the disease under study. * planned consolidative hsct within 3 months post car t cell infusion. * received or planned additional disease directed therapy post car t cell infusion. * inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Keywords: car t cell infusion late effects
postural assessment of stroke patients by pose estimation and effects of dynamic core postural chain stabilization

Conditions: Stroke

Summary: this study focuses on a two-pronged strategy to enhance the rehabilitation of stroke patients. it first investigates the application of pose estimating technologies to objectively measure posture.

this can entail capturing a patient's body position with cameras or other sensors in order to detect any imbalances or variations from normal posture brought on by the stroke. the study also looks at how well dynamic core postural chain stabilization (dcs) methods work for stroke recovery. the goal of dcs exercises is to increase stability and strength in the core, which can help with general postural control. this research aims to optimize stroke patient rehabilitation by combining a precise evaluation approach with a focused intervention strategy, which may result in improved balance, movement, and functional abilities.

Eligibility criteria:
inclusion criteria: * stroke, either ischemic or hemorrhagic * standing ability and ability to perform basic movements with assistance * willingness to take part in the intervention and evaluations exclusion criteria: * severe cognitive impairment hindering participation * unstable medical conditions affecting rehabilitation * history of other neurological disorders affecting posture
simulated home therapy program for the hand after stroke

Conditions: Stroke

Summary: the purpose of this study is to investigate the benefits of incorporating an actuated, emg-controlled glove into occupational therapy of the hand.

stroke survivors with chronic hemiparesis of the upper extremity undertook 18 one-hour training sessions over a 6-week period. participants received occupational therapy focusing on grasp-and-release using a task-oriented protocol developed at the rehabilitation institute of chicago by dr. mary ellen stoykov. over 90% of all repetitions performed during each session were focused on functional activities, as opposed to active exercise. the skills and strategies developed in therapy were then implemented into activities identified as goals by the participant, such as donning socks. difficulty of the task, activity, or exercise was progressed for each participant to provide optimal challenge to enhance skill. subjects were assigned to one of two groups by casting lots. one group (vaeda glove) performed all tasks while wearing a custom voice and emg-driven actuated glove, the vaeda glove. the other group (no-glove) performed the same types of tasks without use of the vaeda glove. the vaeda glove is a portable active-assistance glove, designed to assist digit extension in order to allow repeated practice of specified tasks. the glove contains cables traversing the dorsal side of the digits in order to provide extension and resist flexion. forces are transmitted through the cables from a servomotor located remotely to the digits. the servomotor controls torque or displacement in the cable. along the digits, the cables traverse through custom plastic blocks, which serve both to guide the cable and to prevent joint hyperextension. the vaeda glove can be controlled with up to 3 channels of electromyography (emg). for this study, electrodes were placed above flexor digitorum superficialis (fds) and extensor digitorum communis (edc). the group using the j-glove could receive assistance during hand opening, but only if appropriate emg activity was detected. the edc emg activity had to reach a prescribed threshold before extension assistance would be provided. similarly, fds emg activity had to surpass a threshold level during hand closing before the user was allowed to flex the digits. feedback of muscle activity was available to the user through a custom graphical user interface.

Eligibility criteria:
inclusion criteria: * chronic upper extremity hemiparesis subsequent to stroke (minimum of 6 months post-stroke) * moderate hand impairment classified as stage 4 on the chedoke mcmaster stroke assessment exclusion criteria: * anti-spasticity medications/injections taken less than 6 month prior to enrollment * contractures greater than 20 degrees * inability to follow single-step commands * significant upper extremity pain (self-reported pain of greater than 6 on a 10-point scale)

Keywords: stroke hand fingers rehabilitation training