Kornimate/medical-research-clean huggingface dataset:
bioequivalence study of bay77-1931 granule

Conditions: Hyperphosphatemia

Summary: the study is conducted as a randomized, non-blinded, 2-way crossover study. target population is 60 japanese healthy male adult subjects selected by screening examination which will be conducted within 4 weeks before the first drug administration of period 1 (before the hospitalization of period 1). subjects will admit in the clinical institute on day -3 and be discharged on day 6 in each period. during hospitalization, standardized phosphate diet from day -2 to day 4 will start approximately 20 minutes before dosing. subject will take about 1300 mg of phosphate evenly at breakfast lunch and dinner for each day. subject should consume at least 95% of a meal. distilled water not to include phosphate will be used for drinking water and meal. subjects are to drink at least 1 l of distilled water every day in clinic to make sure enough urine volume. the 24 hours urine collection will be conducted between day -2 and day 4 to investigate the urinary phosphate excretion.bay77-1931 granule 500 mg or fosrenol chewable tablet 500 mg will be administered three times daily after each meal from day 1 to day 4. on day 4 single dose after breakfast will be administered. study drugs will be administered immediately after each meal, that is within 20 minutes after start of each meal with 240 ml of distilled water. a fosrenol chewable tablet 500 mg will be taken after chewing completely.


Eligibility criteria:
inclusion criteria: * japanese male volunteers who must have given their written informed consent to participate in the study * age is between 20 and 45 years * body mass index (bmi) is between 17.6 and 26.4 kg/m2. * volunteers who are judged by the investigators to be suitable for enrollment in this clinical trial based upon the data from a screening test. exclusion criteria: * a history of relevant diseases of internal organs (diseases that may significantly jeopardize body systems, such as severe liver or renal dysfunction, active peptic ulcer, ulcerative colitis, crohn's disease, narrowing of colon lumen) or, of the central nervous system (e.g., epilepsy), or other organs which are likely to show inappropriateness for participation in this study * conditions of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator (mental diseases that are thought to be ineligible for the communal life in the study participation, unable to consent to the participation, disables) * known drug hypersensitivity or idiosyncrasy

Keywords: hyperphosphatemia be granule healthy volunteers
pilot study of oral fluconazole in the treatment of acute cryptococcal meningitis

Conditions: Meningitis, Cryptococcal; HIV Infections

Summary: to evaluate the safety and effectiveness of fluconazole as treatment for acute cryptococcal meningitis in aids patients. both newly diagnosed and relapsed patients are eligible.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * antiviral therapy such as zidovudine. * prophylaxis for pneumocystis carinii pneumonia. * aerosolized pentamidine. concurrent treatment: allowed: * radiation therapy for mucocutaneous kaposi's sarcoma. written informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian. * no prior systemic antifungal therapy for cryptococcosis. * success of prior therapy must have been documented by negative cerebrospinal fluid (csf) culture at the end of therapy. following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin b in the 4 weeks before entry into study. prior medication: allowed: * antiviral therapy such as zidovudine. * prophylaxis for pneumocystis carinii pneumonia. * aerosolized pentamidine. exclusion criteria co-existing condition: patients with the following are excluded: * evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. * history of allergy to or intolerance of imidazoles, azoles, or amphotericin b. * moderate or severe liver disease defined by specified lab values. * patients who are unable to take oral medication. * unlikely to survive more than 2 weeks. * renal impairment. concurrent medication: excluded: * coumarin-type anticoagulants. * oral hypoglycemics. * barbiturates. * phenytoin. * immunostimulants. * investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine. * excluded within 4 weeks of study entry: * greater than 1 mg/kg/wk amphotericin b. * any exceptions to these prohibitions of concomitant medications must be approved by pfizer central research. concurrent treatment: excluded: * lymphocyte replacement. patients with the following are excluded: * evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis. * history of allergy to or intolerance of imidazoles or azoles. * moderate or severe liver disease defined by specified lab values. * patients who are unable to take oral medication. * life expectancy of \< 2 weeks. * any condition that may impair absorption of oral medication. prior medication: excluded: * coumarin-type anticoagulants. * oral hypoglycemics. * barbiturates. * phenytoin. * immunostimulants. * investigational drugs or approved (licensed) drugs for investigational indications other than aerosolized pentamidine. * excluded within 4 weeks of study entry: * greater than 1 mg/kg/wk amphotericin b. prior treatment: excluded: * lymphocyte replacement.

Keywords: aids-related opportunistic infections meningitis cryptococcosis fluconazole administration, oral acquired immunodeficiency syndrome
lipoic acid as a treatment for acute optic neuritis

Conditions: Optic Neuritis

Summary: the purpose of this study is to determine if oral lipoic acid can safely help relieve permanent optic nerve injury in patients diagnosed with acute optic neuritis. it will also explore how the body absorbs and breaks down the study drug, and what effects it has on the immune system.

oral lipoic acid is an antioxidant that helps proteins work in the body. it is available in oral and intravenous formulations and has been used in the past to treat nerve damage like that seen in diabetes and some other metabolic disorders. it is available as a dietary supplement in the united states. patients with a diagnosis of acute optic neuritis who are enrolled in the study will undergo medical and nervous system examinations, and blood draws. the study doctor will take a medical history and perform physical examinations. research assistants at the ms center, who are trained in blood draws, will perform the blood draws. patients will also undergo optical coherence tomography (oct) examination at casey eye institute, and receive two mris at oregon health and science university (ohsu). because it is a placebo-controlled trial, subjects will have a 50:50 chance of receiving either placebo (inactive) or study drug. if enrolled in the study, patients will take two gel capsules of the study drug or placebo at the same time every day for six weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of acute, unilateral aon with visual symptoms (vision loss) of 14 days or less * 18 - 65 years of age, inclusive * aon as a first event (possibly idiopathic) or in relationship to clinically isolated syndrome or to ms according to mcdonald criteria * no previous history of optic neuritis or ophthalmoscopic signs of optic atrophy in the affected eye * subject is available for treatment initiation within 14 days of onset of aon symptoms exclusion criteria: * other causes of visual loss in the affected eye (e.g. amblyopia or glaucoma * oct is non-evaluable at screening visit due to edema. * aon symptoms improve before administration of study medication. * subject has fever or active infection at time of enrollment. * subject is pregnant or breast-feeding. * subject has diabetes mellitus. * subject has another significant health problem (e.g. active coronary heart disease, liver disease, significant pulmonary disease).

Keywords: optic neuritis lipoic acid multiple sclerosis antioxidant oct acute
active symptom control alone or in combination with oral topotecan in patients with relapsed resistant small cell lung cancer

Conditions: Lung Cancer, Small Cell

Summary: the purpose of this study is to find out if giving oral hycamtin to patients with relapsed small cell lung cancer benefits them. the study will compare how long patients live when they are given therapy to make them feel better (active symptom control) to the length of time patients live when they are also receiving oral hycamtin.


Eligibility criteria:
inclusion criteria: * received one prior chemotherapy regimen only. * documented partial or complete response to first-line therapy. * documented relapse of limited or extensive sclc at least 45 days after the cessation of first-line chemotherapy. * not considered suitable for further intravenous chemotherapy. * considered to have adequate bone marrow reserve. * performance status of 0, 1 or 2. exclusion criteria: * pregnant or lactating. * received more than one prior regimen of chemotherapy. * uncontrolled vomiting. * brain metastases. * active uncontrolled infection. * received previous treatment with hycamtin. * received an investigational product within 30 days.

Keywords: relapsed lung cancer resistant small cel topotecan (hycamtin)
observational study concerning covid-19 infection in transplanted kidney, pancreas or pancreatic islet patients

Conditions: Kidney Transplant; Pancreas Tranplant; Pancreatic Islet Transplantation

Summary: collect informations on the health status of transplanted patients (kidney, kidney / pancreas, pancreas or pancreatic islet) during the covid-19 pandemic. all informations will be collected by short questionnaire via phone.


Eligibility criteria:
inclusion criteria: transplanted kidney or kidney/pancreas or pancreas or pancreatic islet patients at transplant medicine unit - san raffaele scientif institute

Keywords: covid-19 infection transplanted patients kidney transplant pancreas transplant pancreatic islet transplantation
digitalis investigation group (dig)

Conditions: Arrhythmia; Cardiovascular Diseases; Heart Diseases; Heart Failure, Congestive; Sinus Arrhythmia; Heart Failure

Summary: to determine if digitalis had a beneficial, harmful, or no effect on total mortality in patients with clinical heart failure and sinus rhythm.

background: despite widespread use of digitalis and its availability for nearly two centuries, uncertainty surrounded the appropriateness of its role and value in treating congestive heart failure patients in sinus rhythm. the study was a multicenter collaborative effort with the department of veteran affairs cooperative studies program which provided support for a data coordinating center and a pharmacy coordinating center. design narrative: randomized, double-blind, simple, multicenter, international trial with 186 centers in the united states and 116 in canada. in the main trial, patients with left ventricular ejection fractions of 0.45 or less were randomly assigned to digoxin (3397 patients) or placebo (3403 patients) in addition to diuretics and ace inhibitors. in an ancillary trial of patients with ejection fractions greater than 0.45, 492 patients were randomly assigned to digoxin and 496 to placebo. patients were recruited over a three-year period at the 302 centers and followed for a minimum of two years. patient enrollment began in february 1991 and ended in september 1993. follow-up ended in december 1995. the main results paper was published in 1997. three substudies were conducted. the quality of life/6-minute walk test substudy determined the effect of treatment on a patient's well-being, daily activities, and functional status. the holter/signal averaging electrocardiogram substudy examined the pathophysiology of sudden cardiac death. the neurohormonal substudy determined whether long-term administration of digoxin attenuated the neuroendocrine response in patients with heart failure. the study completion date listed in this record was obtained from the "completed date" entered in the query view report system (qvr).

Eligibility criteria:
men and women with clinical heart failure, sinus rhythm, and an ejection fraction less than or equal to 45 percent.
comparison of hemodialysis with medium cut-off dialyzer (theranova) and high flux dialyzer

Conditions: End Stage Renal Disease; Dialysis Related Complication; Dialysis Amyloidosis

Summary: the aim of this study is to evaluate the removal of midle molecules and inflammatory cytokines with the theranova-500 ™ dialyzer (medium cut-off membrane, baxter®) versus a high flux dialyzer elisio-21h ™ (high-flux membrane, nipro®) in chronic hemodialysis. evaluation of nutritional parameters, inflamatory parameters and oxidative stress will also be carried out. finally, the investigators will compare hepcidin levels and the erythropoietin resistance index between the two groups.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient suffering from chronic terminal renal failure excluding nephropathy with myelomatous cylinders, hemodialysis for more than 6 months, * patient under dialyser elisio-21h ™ for more than 3 months * patient including the protocol scheme and able to comply with it * free subject, without guardianship or curatorship or subordination * patients benefiting from a social security scheme or benefiting from it through a third party * non-opposition given by the patient after clear and fair information on the study exclusion criteria: * age \<18 years * patient with an associated pathology (evolutionary cancer, progressive infectious disease or chronic inflammatory disease) that may excessively influence crp levels (crp\> 60 mg / l) * patient following another protocol of research or period of exclusion of another protocol * patients not benefiting from a social security scheme or not benefiting from it through a third party * persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies . * pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy ).

Keywords: dialyzer beta2-microglobilin myoglobin
effectiveness between two surgical techniques for reconstruction of humeral proximal extremity fractures

Conditions: A02.835.232.087.090.400.400

Summary: the purpose of this study is to evaluate the effectiveness and safety of two surgical techniques for the treatments of proximal extremity humeral fractures and fractures luxation in three o four fragments of neer's classification.

proximal extremity humeral fractures present high prevalence. it's estimated about 10% of all fractures. their incidence is 6,6/1000 people-year and this amount increases from 40 years old. the majority are successfully treated with immobilization and rehabilitation. the surgical treatment is recommended in case of displacement. in elderly population with fractures types three or four of neer's classification there is no consensus on which technique is the best surgical option. classically hemiarthroplasty has been widely performed as a reconstruction method but its outcomes in old patients are unclear due to the bad bone quality and joint features. recently some authors recommend the reverse arthroplasty in patients over 70 years old . the aim of this study is to compare the results between hemiarthroplasty and reverse arthroplasty in patients over 70 years old. as far as the investigators are concerned there's no published studies like this.

Eligibility criteria:
inclusion criteria: * patients with humeral proximal extremity fracture or fracture luxation in three or four fragments of neer's classification. * patient 70 years older * signed informed consent. exclusion criteria: * any condition to make worse the functional recovery or avoid the patient collaboration with the rehabilitation program ( cognitive disability, neurological pathology...) * glenohumeral osteoarthritis * inflammatory arthropathies * previous cuff arthropatyy * high surgical or anesthesia risk * any disease or condition that the investigator finds decisive for exclusion.

Keywords: fracture-luxation humeral proximal extremity hemiarthroplasty reverse arthroplasty
ivig trial for the treatment of bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia

Summary: it is intended to examine the efficacy and safety of intravenous immunoglobulin(ivig) for the bronchopulmonary dysplasia in preterms. participants will received continuous infusion ivig 1 g/kg/day for the first 2 days, 0.5 g/kg/day for next 3 days (total does 3.5 g/kg), repeatable 1\~2 times if necessary (5 days after the last infusion).


Eligibility criteria:
inclusion criteria: * gestational age between 25 weeks and 31 weeks + 6 days * admission within 24 hours after birth. * clinical symptoms and chest x-ray results show a highly suspicion of bpd.clinical symptoms develop in several days or weeks after birth, including respiratory symptoms and signs such as shortness of breath, cyanosis or pulmonary rales, intermittent hypoxic attacks, and chronic oxygen dependence (increased oxygen concentration and assisted ventilation) .one of the following signs present in chest x-ray: lung texture thickening or ground glass opacity in early stage, diffuse lung texture blurred, lung hyperinflation, shadow of linear density increased, and shadow of triangular density increased under the pleura. exclusion criteria: * major congenital anomalies(e.g., congenital heart disease, congenital craniocerebral deformity, congenital structural abnormality of respiratory system, congenital hereditary metabolic disease) * chromosomal defects (e.g., trisomy 13, 18, 21) * severe intracranial hemorrhage * multiple organ failure * infants who received hydrocortisone or other systemic glucocorticoids for at least 14 cumulative days or within 7 days before trial entry * with severe lung infections * other circumstances that the investigator determines are not suitable for participation in this study
effects of postoperative residual paralysis on hospital costs

Conditions: Residual Paralysis, Post-Anesthesia

Summary: this is a secondary analysis of a previously performed prospective, observer-blinded, observational study at massachusetts general hospital. the primary aim of this study is to evaluate the effects of residual paralysis at admission to the post-anesthesia care unit (pacu) on total costs of hospital care. secondary analyses will be conducted to evaluate the effects of postoperative residual paralysis on potential cost-influencing factors, i.e. incidence of minor and major postoperative respiratory complications, hospital length of stay (los), unplanned intensive care unit (icu) admission rate, as well as length of stay in the pacu.


Eligibility criteria:
inclusion criteria: * each subject has been given non-depolarizing neuromuscular blocking agents as part of general anesthesia. * each subject must be at least 18 years of age * train-of-four monitoring in the post-anesthesia care unit exclusion criteria: * the subject is scheduled to be transferred to an intensive care unit after surgery. * children and pregnant women

Keywords: cost analysis postoperative complications length of stay intensive care units
project eat: eating and attitudes in teens

Conditions: Obesity; Adolescent Development; Stress

Summary: research suggests there is a connection between mood and weight. people who feel stressed or depressed are more likely to be overweight than people who don't have these feelings. some individuals turn to food to cope, which can lead to gaining too much weight over time. adolescence is an important time to understand these connections. patterns of handling stress learned during adolescence set the stage for stress management in adulthood. this study is a randomized controlled pilot study with 60 adolescents who are at-risk for future, chronic obesity. the investigators will test if taking part in a 6-week group program to lower stress and improve mood will be helpful to teens at-risk.


Eligibility criteria:
inclusion criteria: * age 12-17 years * at-risk for long-term obesity by virtue of current bmi (≥70th percentile for age and sex) or obesity (bmi ≥30 kg/m2) in both biological parents * good general health exclusion criteria: * current full-syndrome psychiatric disorder that in the investigators' opinion would impede study compliance * major medical problem such as type 2 diabetes * use of medication affecting mood or body weight such as stimulants or anti-depressants * any medical issues that could be acutely worsened by exercise such as asthma or musculoskeletal problems. * pregnancy in females
pregnancy outcomes of patients having nc-fet regarding the progesterone levels

Conditions: Infertility

Summary: we recently identify in our previous study 'nct052115832' the progesterone levels for the embryo transfer in natural thaw cycles. since it is shown that progesterone levels work better than lh levels in order to detect the time to transfer, we aimed to show the pregnancy outcomes of the natural thaw cycles which had the transfer date regarding the progesterone levels.


Eligibility criteria:
inclusion criteria: * patients with regular menstrual cycle * patients aged btw 20-40 * patients with pregnancy with nc-fet by using the progesterone for the detection of ovulation exclusion criteria: * spontenous pregnancies * multiple pregnancies
the effects of pumpkin seed oil supplementation on cardiovascular function in postmenopausal women.

Conditions: Elevated Blood Pressure; Hypertension

Summary: postmenopausal women have a higher prevalence of cardiovascular (cv) disease than age-match men. growing evidence from rat studies have demonstrated cv-protective effects of pumpkin seed oil (pso). the investigators hypothesis is that pso would improve cv health in postmenopausal women.

the purpose of the study is to examine the effects of 6 weeks of pso on arterial and autonomic function in postmenopausal women. specific aims of the study are to: to investigate the extent to which pso will improve cardiovascular disease risk factors by assessing arterial stiffness, aortic bp and wave reflection, and autonomic function (heart rate variability).

Eligibility criteria:
inclusion criteria: * female * 45 to 65 years of age * at least 1 year after menopause * bmi \<39.9 * sedentary or low active (less than 2 hr per wk) exclusion criteria: * known heart disease * peripheral vascular disease * diabetes, body mass index * bmi\> 40 kg/m2 * other chronic diseases * taking medications (e.g., hormone replacement therapy, beta blockers, calcium channel blockers, antidepressants and stimulants) that could affect the outcome variables * smokers * history of steady exercise or received exercise training and dietary changes in the last year