Kornimate/medical-research-clean huggingface dataset:
safety and tolerability of liraglutide in healthy japanese male volunteers

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in japan. the aim of this trial is to assess the safety and tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy japanese male subjects.


Eligibility criteria:
inclusion criteria: * healthy japanese subjects * bmi (body mass index) between 18.0-27.0 kg/m\^2 inclusive exclusion criteria: * any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal ecg (electrocardiogram) findings at the screening * presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders * hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive * history of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders * history of significant allergy or hypersensitivity * known or suspected allergy to trial product or related products * history of drug or alcohol abuse * the subjects who smoke more than 15 cigarettes, or the equivalent, per day and is unwilling to refrain from smoking whenever required for the trial procedure
comparison of epm-ix to currently used specimen transportation and extraction devices ( cgi-epm-ix )

Conditions: SARS-CoV-2

Summary: this is a research study to evaluate the clinical utility of the enhanced preservation media with integrated extraction (epm-ix)

this is a minimal risk study where patients at uropartners urology group will consent to sars-cov-2 nasopharyngeal swab testing using both, a standard of care test with standard viral transport medium and a second test using convergent genomics' proprietary enhanced preservation media (epm-ix). subjects will self-swab each nostril during their medical appointment at uropartners. uropartners designated staff with then send the collection kits out for testing. clinical information will be collected that includes age, gender, race, ethnicity and history of cancer. all of these data points will be anonymized.

Eligibility criteria:
inclusion criteria: * subject must be ≥18 years of age * subject is a current patient at uropartners and is willing to be tested for covid- 19 during a routine visit * subject must be able to understand and willingly provide informed consent exclusion criteria: * cannot provide informed consent

Keywords: epm-ix covid-19 sars-cov-2 nasopharyngeal swab med schenker's stm viral media
phase i/ii trial rhukfg for the treatment of steroid refractory gastrointestinal acute gvhd

Conditions: Acute Graft Versus Host Disease

Summary: phase ii efficacy evaluation, phase i/ii efficacy and toxicity trial of recombinant human keratinocyte growth factor for the treatment of steroid refractory gastrointestinal graft versus host disease.

there are two processes that cause diarrhea as the clinical manifestation of graft versus host disease. the first is the obvious immunologic attack on the colonic epithelium of the recipient. once this immunologic attack has been abated the recipient is left with a colonic mucosa that is devoid of microvilli and has a smooth intestinal boarder. this is frequently subject to superinfections from bacteria all of which cause the diarrhea to continue. researchers only endpoint to measure clinical response of immunosuppression is the resolution of diarrhea. the human recombinant keratinocyte growth factor stimulates the growth of colonic epithelium. the growth of colonic epithelium will in turn probably ameliorate some of the diarrhea associated with graft versus host disease.

Eligibility criteria:
inclusion criteria: * patients post allogeneic bone marrow transplant with watery diarrhea progressed on 2mg/kg of steroids after 3 days or failed to improve after 5 days. * patients may have skin or liver involvement with graft versus host disease. * patients should not have any infections etiology for diarrhea. exclusion criteria: * none

Keywords: acute graft versus host disease refractory
natural history of wilson disease

Conditions: Wilson Disease

Summary: the purpose of the registry/repository is to provide a mechanism to store data and specimens to support the conduct of future research about wilson disease (wd). the overall aim is to determine the optimal testing for diagnosis and parameters for monitoring treatment of wd that will aid product utilization and development.

there are three aims outlined as part of this research study. aim 1 is to study the natural history of a carefully characterized cohort of patients with wd followed longitudinally at centers of excellence for wd in the united states and in the united kingdom. aim 2 seeks to evaluate parameters for diagnosis and treatment monitoring for patients on chelation therapy and zinc treatment for their wd. data gathered in specific aim 1 will be used for analyzing the components of the diagnostic scores for patients. aim 3 is intended to determine whether a composite index or a biomarker can be used as surrogate marker for treatment monitoring for current patients on therapy that can be used for future patient treatment trials.

Eligibility criteria:
inclusion criteria: * known diagnosis of wd * able and willing to provide informed consent for adults (parental/guardian permission (informed consent) and if appropriate, child assent for participants \<18 (or per local institutional review board (irb) regulation) exclusion criteria: * diagnosis of wd has been excluded * unwilling to provide informed consent or assent

Keywords: wilson disease
elderly sleep disturbance through home care solution

Conditions: Aging; Sleep Disturbance

Summary: humans spend a third of their time on sleep. therefore, maintaining a deep, stable and consistent sleep is very important for a good quality of life. aging is often related to a decrease in the ability to fall asleep and maintain sleep. getting older, various factors can worsen the normal sleep process, which is essential for restoring function and body function. aging-related diseases, life changes, or own aging can disrupt the normal sleep cycle and seriously affect healthy aging. for example, the circadian rhythm and sleep consolidation will be broken with normal aging. these changes may lead to aging, or become part of the risk factors for diseases such as alzheimer's disease. how to avoid disability and dementia by improving the quality of sleep to make the elderly healthy and aging, will bring huge effects to the economy, society, and health care. from this plan, investigators will participate in an integrated plan (main plan)-" integrating systematic data of geriatric medicine to explore the solution for healthy aging". in the main plan, 500 subjects will be enrolled. all subjects consent to provide medical record and will be tested for sarcopenia, including body composition, 4-meter walk, handgrip strength. the subjects screened sleep-affected subjects. it is estimated that 250 people will be invited for home sleep testing, such as continuous positive pressure breathing aid (cpap) for sleep apnea (osa) (approximately 120 subjects). for non-osa and non-periodic limb movement disorder (plms) sleep problems, take a phototherapy program (about 60 subjects). the following goals are expected to be achieved: 1. link to the main project to explore the correlation between common sleep disorders in the elderly and blood pressure, cognition, sarcopenia, metabolomics or intestinal microbiome 2. to verify the prognosis of sleep apnea and sleep disorders after intervention.


Eligibility criteria:
inclusion criteria: * those who are willing to sign the written subject consent * participants who participated in the integrated project (main project) - "integrating systematic data of geriatric medicine to explore the solution for healthy aging" * the results of the sleep questionnaire meet one of the following: 1. pittsburgh sleep quality scale (psqi) \> 5 points 2. the self-sleep assessment questionnaire (stop-bang) is at high risk for sleep apnea (osa) exclusion criteria: * patients with severe cataracts who have not received treatment, patients with color blindness and chronic skin diseases (including psoriasis, eczema), or those who are considered by the host to be unable to receive light therapy. * those who are unsuitable after evaluation by a physician.

Keywords: aging sleep disturbance cpap phototherapy omics
trial comparing three strategies of vaccination against the virus of hepatitis b in hiv infected patients

Conditions: HIV Infections

Summary: in hiv infected patients, individuals exposed to the virus of hepatitis b are more susceptible to develop a chronic and severe liver disease with a major risk of cirrhosis and liver cancer. however, the existing protocol of vaccination against hepatitis b is less efficient in hiv-infected patients than in non hiv-infected-patients, and, in case of response, its longevity has to be followed up carefully. this study compares the efficacy of the standard protocol vaccination with genhevac-b and 2 other protocols, a double-dose of genhevac-b and a set of intradermal injections of genhevac-b, in hiv-infected patients with lymphocytes t cd4 level above 200 permm3.

comparison of 3 vaccination strategy against hepatitis b in patients with hiv infection t cd4 above 200 per mm3 intervention: 1. arm a: genhevac-b 20 microgramme intramuscular use at m0, m1, m6 2. arm b: genhevac-b 40 microgramme intramuscular use at m0, m1, m2, m6 3. arm c: genhevac-b 4 microgramme intradermal use at m0, m1, m2, m6

Eligibility criteria:
inclusion criteria: age eligible for study: 18 years - na, genders eligible for study: both criteria inclusion criteria: * hiv infection * t cd4 count cell level above 200 per mm3 * serology hepatitis b negative (aghbs, abhbs and abhbc negative) * unchanged arv for the last 3 months for patients who are receiving arv at the screening visit * undetectable for the last 6 months with arv for any patient with t cd4 level below 350 per mm3 * pregnancy test negative at the screening and inclusion visits exclusion criteria: * any injection of the vaccine against hepatitis b in the medical history * acute cytolysis in the last 3 months with transaminases equal or above 5 times the upper normal range for hiv-hcv coinfected patients, or transaminases equal or above 2 times the upper normal for non coinfected patients * any vaccine received one month before the inclusion * history of intolerance to any component of genhevac-b * evolutive opportunistic infection treated the month before the screening visit * severe and acute pyretic infection or unexplained fever the week before inclusion * evolutive hemopathy or solid-organ cancer * prothrombin factor equal or below 50 percent and/or platelets equal or below 50 000 per mm3 * immunosuppressive treatment or general corticotherapy (equal or above 0,5 mg per kg per day during above 7 days) in the last 6 months before the screening visit * previous immunomodulating treatment (interferon, interleukin-2,etc) or plan in the next 6 months * splenectomy * decompensated cirrhosis (child pugh b or c) * kidney deficient function (creatinine clearance below 50 ml per mn) * other immunocompromised condition not related to hiv infection (solid-organ transplantation, chemotherapy in the last 6 months) * any participation to another clinical trial plan until week 28

Keywords: hepatitis b vaccination genhevac-b pasteur hiv infections
a randomized, double-blind, placebo-controlled study of zsp1601 in adult subjects with nonalcoholic steatohepatitis (nash)

Conditions: Nonalcoholic Steatohepatitis (NASH)

Summary: the purpose of this research is to evaluate the efficacy and the safety of two doses of zsp1601 for 48 weeks versus placebo in adult nash patients.


Eligibility criteria:
inclusion criteria: 1. nash histological diagnosis on a liver biopsy performed ≤ 24 weeks before randomization, and nas≥4 (at least 1 point each in inflammation and ballooning), and fibrosis score f2 or f3, and no other chronic liver disease 2. subjects having given her/his written informed consent 3. good compliance with the protocol and agree to have liver biopsy performed 4. subjects (including their partners) agreed to use effective contraception throughout the study period and up to 24 weeks after discontinuation exclusion criteria: 1. history of cirrhosis or liver biopsy suggestive of cirrhosis 2. metabolic surgery or new technology treatment for weight loss within 5 years prior to randomization or planned during the study period 3. type 1 diabetes 4. hiv infection 5. patients with severe or uncontrollable underlying diseases, unsuitable for treatment with zsp1601, unable to complete study follow-up, or likely to affect the evaluation of trial results judged by investigator 6. previous malignancy within 5 years 7. treatment with hepatoprotective drugs 8. excessive alcohol consumption for 12 or more consecutive weeks within 1 year prior to screening 9. pregnant and lactating women or those with a positive serum pregnancy test.
a study of hydroxycholoroquine compared to placebo as treatment for people with covid-19

Conditions: COVID-19; COVID19; Sars-CoV2; SARS-Cov-2

Summary: this study is being done to see if hydroxychloroquine is an effective treatment for covid-19.


Eligibility criteria:
inclusion criteria: * age 18 years and older * subjects must have a documented positive test for the sars-cov-2 infection within 7 days of randomization * subject must be hospitalized within 72 hours of randomization * subjects must be receiving standard of care for sars-cov-2 * subject/legally authorized representative (lar) must have the ability to understand and give informed consent * subject must be able to take and absorb hydroxychloroquine at the discretion of the investigator exclusion criteria: * prior receipt of hydroxychloroquine for treatment or prophylaxis of sars-cov-2 or patient is taking hydroxychloroquine for other approved indications (e.g., lupus, rheumatoid arthritis) * no documented sars-cov-2 infection * mechanical ventilation * known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives preexisting retinopathy documented in medical history * pregnancy or breastfeeding * concurrent use of any other quinine derivative (chloroquine, mefloquine) or rifamycins (rifampin, rifabutin) * antiarrhythmic medications (amiodarone, sotalol, dofetilide, procainamide, quinidine, flecainide) * history of glucose-6-phosphate dehydrogenase deficiency * pre-treatment corrected qt interval (qtc) \>500 milliseconds * pressor requirement to maintain blood pressure * alanine aminotransferase (alt) and/or asparate aminotransferase (ast) level \> 5x upper limit of normal * creatinine clearance \<30 ml/min or requirement of dialysis or continuous venovenous hemofiltration * concomitant participation in a therapeutic trial for sars-cov-2 or receiving any experimental treatment for sars-cov-2 within 7 days of randomization * any condition that in the opinion of the principal investigator would prevent participation in the trial or would interfere with the trial endpoints

Keywords: sars-cov2 sars-cov-2 covid-19 covid19 hydroxycholoroquine memorial sloan kettering cancer center 20-187
a study comparing ceftazidime-avibactam versus meropenem in hospitalized adults with nosocomial pneumonia

Conditions: Nosocomial Pneumonia (NP); Ventilator-associated Pneumonia (VAP)

Summary: the purpose of the study is to evaluate the effects of ceftazidime-avibactam compared to meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia

a phase iii, randomized, multicentre, double-blind, double-dummy, parallel-group comparative study to determine the efficacy, safety and tolerability of ceftazidime-avibactam versus meropenem in the treatment of nosocomial pneumonia including ventilator-associated pneumonia in hospitalized adults

Eligibility criteria:
inclusion criteria: * 18 to 90 years of age inclusive * females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after * onset of symptoms ≥ 48 hours after admission or \<7 days after discharge from an inpatient acute or chronic care facility * new or worsening infiltrate on chest x-ray obtained within 48 hours prior to randomization * at least 1 of the following systemic signs:fever (temperature \>38 c) or hypothermia (rectal/core temperature \ 10,000 cells/mm3, or white blood cell count \ 15% band forms. exclusion criteria: * pulmonary disease that, in the investigator's judgment, would preclude evaluation of therapeutic response (e.g. lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism). * patients with lung abscess, pleural empyema or post obstructive pneumonia. * patients with an estimated creatinine clearance \<16ml/min by cockcroft gault formula or patients expected to require haemodialysis or other renal support while on study therapy. * acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure. * patients receiving hemodialysis or peritoneal dialysis.

Keywords: ceftazidime, meropenem, anti-bacterial agents, anti-infective agents, therapeutic uses, pharmacologic actions, physiological effects of drugs
using an artificial pancreas system in older adult type 1 diabetes mellitus patients

Conditions: Type1 Diabetes Mellitus

Summary: to demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged type 1 diabetes mellitus subjects.

the goals of this proposal are to implement a close-loop/artificial pancreas (cl/ap) system in older patients with type 1 diabetes mellitus (t1dm) in order to reverse brain metabolic adaptations and restore metabolic sensitivity, hypoglycemia awareness and appropriate hormonal counterregulatory responses (crr). for purposes of this study we are looking to enroll aged t1dm subjects under insulin pump treatment.

Eligibility criteria:
inclusion criteria: * provide signed and dated informed consent form * male or female * age 50-75 years (at least 50% over the age of 65) * t1dm (\>20 years duration) * c-peptide undetectable * hba1c of \< 8% * insulin pump therapy * history of frequent hypoglycemia with unawareness (defined as 2 or more episodes of severe hypoglycemia within one year requiring assistance) and 2 or more glucose values \< 54 mg/dl during the week of continuous glucose monitoring (cgm) (ipro monitor, medtronic) prior to enrollment * bmi \<27 kg/m2 * good general health as evidenced by medical history and blood screening * willing to comply with all study procedures and be available for the duration of the study * willing to fast for a limited time period on the morning of a clamp study exclusion criteria: * significant diabetic complications (untreated proliferative retinopathy, creatinine ≥1.5 mg/dl, urinary albumin levels 300 mg/day, autonomic neuropathy, painful peripheral neuropathy) * significant alcohol intake and vegetarian diet since both are known to have an impact on counterregulation and brain metabolism * any contraindications for mri scanning, including presence of metallic implants or claustrophobia. * heavy exercise on a regular basis (i.e. marathon runners) * known allergic reactions to components of the study product(s) * treatment with another investigational drug or other intervention * active infection including hepatitis c, hepatitis b, hiv * any past or current history of alcohol or substance abuse * psychiatric or neurological disorders under active treatment * baseline hemoglobin \< 10.5 g/dl in females, or \< 12.5 g/dl in males. blood donation within 30 days of the study * history of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed) * co-existing cardiac, liver, and kidney disease * abnormal liver function tests * women that are on oral contraceptives, post-menopausal, pregnant (as assessed by pregnancy test that will be performed on female participants at reproductive age), or lactating. * any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
a multicenter prospective study of "high risk" molecular typing in patients with adult t lymphoblastic lymphoma

Conditions: T-Lymphoblastic Lymphoma/Leukemia

Summary: the purpose of this study is to determine the indicative value of "high risk" molecular typing in patients with adult t lymphoblastic lymphoma


Eligibility criteria:
inclusion criteria: * biopsy proved t lymphoblastic lymphoma * newly diagnosed patients exclusion criteria: * patients with biopsy samples unavailable
study of cytochrome p450 polymorphisms (cyp2d6, cyp3a4/5 and cyp2c19) in breast cancer patients

Conditions: Breast Neoplasms; Survival Analysis; Antineoplastic Agents; Therapeutic Uses

Summary: the genetic polymorphisms of the cytochrome p450 may influence on the metabolism of tamoxifen. the investigators want to * evaluate the frequency or incidence of the genetic polymorphisms of cytochrome p450 subfamilies(cyp2d6, cyp3a4/5 and cyp2c19) in breast cancer patients, and * analyze the association between the genetic polymorphisms of cytochrome p450 subfamilies and clinical outcomes in breast cancer patients treated by adjuvant tamoxifen therapy.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * breast cancer patients who underwent surgery exclusion criteria: * none

Keywords: tamoxifen cytochrome p-450 cyp2d6 polymorphism single nucleotide antineoplastic agents, hormonal