Kornimate/medical-research-clean huggingface dataset:
metabolic cost of bodyweight training

Conditions: Body Composition; Physical Fitness; Energy Expenditure; Resting Metabolic Rate

Summary: in this study, the investigators will be able to estimate the metabolic cost of several foundational bodyweight training exercises.

bodyweight training has become a popular cardiovascular training choice in fitness centers and athletic performance enhancement facilities. despite widespread use and growing popularity, little is known about the metabolic demands of such a training method. therefore, the purpose of this study was to quantify the cardiovascular and metabolic cost from various foundational bodyweight exercises in order to contribute to a better planning of exercise programs in the real world. ten healthy young adults were assigned to execute seven bodyweight exercises (acute bout) for 30 and 45 seconds. anthropometric, metabolic, and performance measurements were conducted at baseline. the metabolic cost was estimated from heart rate, blood lactate, resting oxygen uptake, exercise oxygen uptake, and excess post-exercise oxygen consumption measurements using a portable gas analyzer.

Eligibility criteria:
inclusion criteria: * aged between 18 and 35 years * physically active individuals * free of chronic diseases * free of musculoskeletal injuries * nonsmokers exclusion criteria: * musculoskeletal injuries * chronic diseases * use of alcohol, caffeine and any type of ergogenic supplements or medication before (≤6 months) and throughout the study.

Keywords: functional fitness training bodyweight training energy expenditure oxygen consumption resistance training
nlg802 indoleamine 2,3-dioxygenase (ido) inhibitor in advanced solid tumors

Conditions: Solid Tumor

Summary: this is an open-label phase i study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of nlg802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (ido1) enzyme and help the human immune system attack solid tumor cells more effectively.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed solid tumor cancer (including glioblastoma) * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate hematologic and organ function exclusion criteria: * active or history of medically significant autoimmune disease * cytotoxic therapy or investigational agent use within 28 days * human immunodeficiency virus (hiv), active hepatitis b or c * untreated brain metastases * known qt interval prolongation * use of concomitant medications with high risk of causing torsades des pointes. * use of immune suppressive agents within 30 days * more than one active malignancy at the time of enrollment
a study of losartan compared to losartan/hctz in pediatric patients with hypertension (0954a-327)

Conditions: Hypertension

Summary: the purpose of this study is to test the safety and effectiveness of losartan as compared to losartan/hctz in pediatric patients (6 to 17 years) with high blood pressure.

participants who meet eligibility requirements will enter the single-blind filter period. participants with either sitting systolic blood pressure (sisbp) or sitting diastolic blood pressure (sidbp) \>=95th percentile for gender/age/height will be administered either losartan 25 mg or losartan 50 mg depending on body weight (\ =50 kg, respectively). after 3 weeks, if sisbp or sidbp is \>=95th percentile, participants will titrate to either losartan 50 mg or 100 mg according to weight. participants with both sisbp and sidbp \ =95th percentile will then enter the double-blind phase. participants who meet all entry criteria will be randomized in a 1:1 fashion to either losartan or losartan/hydrochlorothiazide (hctz) for 4 weeks and will be stratified according to body weight (\ =50 kg). participants whose weight is \ =50 kg will be randomized to losartan 100 mg or losartan/hctz 100 mg/12.5 mg. at the end of double-blind treatment, participants may enter a 20-week double-blind extension and will continue on their randomized therapy with losartan or losartan/hctz. 40 participants were enrolled and screened; the trial was terminated before any participants were randomized into the double-blind treatment period.

Eligibility criteria:
inclusion criteria: * patient is male/female and 6 to 17 years of age at the time of study with hypertension (high blood pressure) * patient is able to swallow tablets * females of child bearing potential must use acceptable contraception throughout the trial exclusion criteria: * patient has a history of heart, metabolic or kidney disease * patient has a history of known heart, lung, liver and other body system disorders * patient is pregnant or nursing * patient has participated in another clinical trial within the last 28 days
interrogation of exosome-mediated intercellular signaling in patients with pancreatic cancer

Conditions: Pancreatic Cancer; Benign Pancreatic Disease

Summary: the purpose of this study is to isolate and analyze exosomes, which are tiny carriers of important proteins and nucleic acids that serve as messenger systems in the blood and tissue. blood and tissue from patients with pancreatic cancer will be compared with blood and tissue from patients with noncancerous pancreatic disease. including patients without cancer will allow the investigators to establish "normal" values, which currently do not exist. the investigators will then look to see whether exosome activity has a connection to disease recurrence and outcomes in patients. the results of this study will be the basis for future studies exploring this area.


Eligibility criteria:
inclusion criteria: * all patients ≥ 18 years of age undergoing pancreaticoduodenectomy, partial or complete pancreatectomy, and duodenal ampullectomy for presumed ductal adenocarcinoma, intraductal papillary mucinous neoplasm (ipmn) or pancreatic neuroendocrine tumors, without an invasive component; or other benign pancreatic disease will be eligible. * for third part of the study, recipient of neoadjuvant chemotherapy will be accrued to the neoadjuvant group (25 patients). patients without neoadjuvant chemotherapy will be accrued to the non-neoadjuvant group (25 patients). exclusion criteria: * the presence of metastatic disease or disease that precludes resection * for first and second part of the study, receipt of neoadjuvant chemotherapy or radiation for the index cancer within 6 months of being enrolled in the study * for third part of the study, receipt of neoadjuvant radiation for the index cancer within 6 months of being enrolled in the study * inr \>2 * known clotting factor deficiency or hypercoagulable state * any patient with the need or anticipated need for full anti-coagulation during hospitalization for the resection. * receipt of antiplatelet agents (other than aspirin) in the preceding week prior to resection. * ipmn or pancreatic neuroendocrine tumors by radiographic imaging with high suspicion for invasive component additionally, if at the discretion of the operating surgeon, blood collection would lead to undue morbidity, the patient will be excluded and replaced

Keywords: exosomes 15-015
virtual reality and congenital diaphragmatic hernia

Conditions: Virtual Reality; Congenital Diaphragmatic Hernia; Children

Summary: the study has been designed to investigate the effect of 12 weeks of using virtual reality based exercises on pulmonary functions, exercise capacity, functional performance, and quality of life in children with surgically-repaired congenital diaphragmatic hernia.

children with cdh have significant disruptions in their quality of life (qol) due to their poor health, in this randomized controlled clinical trial, one important aspect of virtual reality is the interactivity of children and their interests in choosing the exercised game. each child in two groups perform a specific virtual reality based respiratory exercises for 3 months.

Eligibility criteria:
inclusion criteria: * age between 6 and 10 years. * bmi was between 20 and 24 kg/m2. * surgically-repaired congenital diaphragmatic hernia. * respiratory distress symptoms. * under follow-up care in pediatric and physical therapy clinic. exclusion criteria: * children were excluded if they have growth abnormality. * neuromotor disorders. * children with cardiac problems. * unable to do understand all procedures.
bioavailability study of leflunomide tablets under fed conditions

Conditions: To Determine Bioequivalence Under Fed Conditions

Summary: to compare the single-dose bioavailability of kali and aventis

to compare the relative bioavailability of leflunomide 20mg tablets with that of arava 20mg tablets in healthy female subjects under fed conditions

Eligibility criteria:
inclusion criteria: * subjects will meet all of the following criteria within 30 days prior to first drug administration(except inclusion #8) * healthy, surgically sterile (hysterectomy, bilateral oophorectomy) or postmenopausal (for al least 1 year)female subjects, 18 to 65 years of age(inclusive) * indicate non-child bearing status by one of the following criteria: indication of successful hysterectomy. no spontaneous menses for al least 1 year, must have luteinizing hormone (lh) and follicle stimulating hormone(fsh) levels within postmenopausal range. indication of successful bilateral oophorectomy. * body weight within 20% of the appropriate weight for the subject's height and frame (as published in the 1983 metropolitan life insurance company scale, statistical bureau) * negative for: hiv hepatitis b surface antigen and hepatitis c antibody urine tests for drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone). serum hcg consistent with pregnancy. * no significant disease or clinically significant findings in a physical examination. * no clinically significant findings in vital signs measurements and a 12-lead electrocardiogram(ecg) * subjects who have received leflunomide within 4 months must have an a77-1726(metabolite) level below 0.01ug/ml and no subsequent administration of leflunomide since that test. note: the 30 day screening limit does not apply to this inclusion criterion. * be informed of the nature of the study and given written consent prior to receiving any study procedures. exclusion criteria: * subject fulfilling any of the following criteria will be excluded from the study. * known history or presence of any clinically significant medical condition. * known or suspected carcinoma. * known history or presence of: * hypersensitivity or idiosyncratic reaction to leflunomide and/or any other drug substances with similar activity. * alcoholism within the last 12 months. * drug dependence and/ or substance abuse. * on a special diet within 4 weeks prior to drug administration(e.g. liquid, protein, raw food diet). * participated in another clinical trail or received an investigational product 30 days prior to drug administration. * donated up to 250 ml of blood in the past 45 days or donated from 250 ml to 500 ml in the past 45 days or donated 501 ml or more of blood in the past 56 days (based on the canadian blood services guideline for blood donation). * requirement of any medication (prescription and/ or over-the-counter) on a routine basis, with the exception of hormonal replacement therapy, nutritional supplements and/or occasional use of common analgesics. * difficulty fasting or consuming the standard meals.

Keywords: bioequivalence, leflunomide, fed
a local register study for major depression of paroxetine controlled release

Conditions: Depressive Disorder, Major; Major Depressive Disorder (MDD)

Summary: the study is to investigate the non-inferior efficacy of paroxetine controlled release to paroxetine immediate release, as well as the drug tolerability profile when treated on patients with major depression.


Eligibility criteria:
inclusion criteria: * patients with major depressive disorder,score on depression rating scale reach a specific point(17 item hamilton depression scale\>18). exclusion criteria: * patients use monoamine oxidase inhibitors (maois), benzodiazepines, chinese herbal medicines, acupuncture, moxibustion or other psychoactive medications other than zolpidem, zopiclone;diagnosed with other axis i disorder other; not responsive to paroxetine therapy before; pregnant or lactating, have serious medical disorder or condition that would preclude the administration of paroxetine; have a history of seizure disorders (except for febrile seizures in childhood); require treatment with warfarin anticoagulants, phenytoin, cimetidine, sumatriptan, type 1c antiarrhythmics, quinidine or sulfonylurea derivatives; are substance abuse or dependence (alcohol or drugs) within 6 months prior to this trial; have had electroconvulsive therapy within 2 months of entry into the study; pose a current, serious suicidal or homicidal risk; have taken other psychotropic drugs or antidepressants other than mao inhibitors within 7 days of baseline and mao inhibitors within 14 days of baseline; have taken any investigational drug, or participated in a clinical trial within the past 3 months; are hypersensitivity to paroxetine; have undergoing formal psychotherapy/psychoanalysis.

Keywords: major depression paroxetine controlled release (cr) paroxetine immediate release (ir)
analysis of the immune parameters of covid-19 infection in patients with multiple myeloma

Conditions: Multiple Myeloma; Covid19

Summary: among all mm patients included in the cohort at the time of diagnosis of sars-cov-2 infection, blood samples will be collected at inclusion, at time of the infection acute phase in the most severe cases (when admitted in intensive care units), and at recovery. the following immune function tests will be evaluated, gammaglobulin measurements, lymphocytes counts, b, t, and nk cells analyses by cytometry, including exhaustion analyses. in addition, t cell repertoire sequencing looking for sars-cov-2- specific t cells, and serologies, will be evaluated at recovery and 6 months after mm treatment re-initiation.

mm is a hematological malignancy, supposed mainly not curable, except for some exceptional patients, despite the availability of numerous new drugs. the patients are highly susceptible to infections, both bacterial and viral, due to a defect immune status, both at the antibody level (hypogammaglobulinemia) and the cellular level. this immunosuppression is further worsened by the treatments, and especially high dose glucocorticoids used at each phase of the disease. consequently, mm patients are highly susceptible to contract covid19, and to develop a severe form. this has been confirmed in a first study in spring, showing a mortality rate of 37%. among all mm patients included in the cohort at the time of diagnosis of sars-cov-2 infection, blood samples will be collected at inclusion, at time of the infection acute phase in the most severe cases (when admitted in intensive care units), and at recovery. the following immune function tests will be evaluated, gammaglobulin measurements, lymphocytes counts, b, t, and nk cells analyses by cytometry, including exhaustion analyses. in addition, t cell repertoire sequencing looking for sars-cov-2- specific t cells, and serologies, will be evaluated at recovery and 6 months after mm treatment re-initiation.

Eligibility criteria:
inclusion criteria: * patients with a multiple myeloma and a documented covid19 (by rt-pcr, thoracic tdm, and/or antigenix test). * patients having received the information to participate in the research and having expressed their non-opposition * patients with social security insurance or equivalent exclusion criteria: * patients without multiple myeloma * patients without covid19 * patients under juridical protection guardianship, or tutelage measure

Keywords: multiple myeloma covid19
pilot sugar reduction intervention in kiritimati teenagers

Conditions: Type 2 Diabetes; Obesity

Summary: kiritimati is an isolated coral atoll in the pacific ocean, and is one of 32 islands that comprise the republic of kiribati. obesity and type 2 diabetes rates are high in kiribati, but the causes and rates of childhood obesity/diabetes are unknown. however, it has been hypothesized that high consumption of sugar-sweetened beverages on kiritimati may be a contributing factor. the investigators therefore conducted a study in kiritimati in september 2018 with the aim of 1) quantifying obesity and diabetes rates amongst children on kiritimati and 2) testing the feasibility of a sugar-reduction intervention in kiritimati schools. the investigators randomized the two high schools on the island to either the control group or the intervention group. the investigators measured height/weight, continuous blood glucose (using flash glucose monitoring), and diet (using 24-hour diet recalls). one week into the study, the intervention school received an intervention, which consisted of installation of a water filter at the school, the provision of water bottles to each student at the school, and a 30-minute educational presentation on the link between sugar consumption and type 2 diabetes. the investigators then measured how blood glucose and diet changed the week following the intervention, and compared this to the control school.


Eligibility criteria:
inclusion criteria: * enrolled in one of the two high schools on kiritimati exclusion criteria: * \> 18 years of age
the elderly acs ii trial

Conditions: Acute Coronary Syndrome; Coronary Arteriosclerosis; Myocardial Ischemia; Cardiovascular Diseases

Summary: the objective of this study is to compare reduced-dose prasugrel and standard dose clopidogrel in patients older than 74 years with acs, including non-st-elevation (nsteacs) and st-elevation (stemi) patients, undergoing early pci. the primary endpoint of the trial will be the one-year composite of (all-cause)death, myocardial infarction, stroke and re-hospitalization due to cardiovascular reasons or bleeding.


Eligibility criteria:
inclusion criteria: - patients \>74 years of age hospitalized for an acs, with or without ste, with an onset of symptoms during the previous 72 hours, and candidates to an early pci. * stemi patients may be randomized upon first diagnosis, provided they do not meet any exclusion criteria. stemi patients should not exceed 50 percent of the global population of the study * eligible nsteacs patients may be randomized after coronary angiography. to be eligible, nsteacs patients must have at least one of the following characteristics: * elevated troponin levels; * diabetes mellitus; * prior mi; * at least one new ischemic episode while on standard treatment during the index hospitalization; * acs due to stent thrombosis. exclusion criteria: * history of stroke or transient ischemic attack (tia) * gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization. * hemoglobin level on admission \<10 g/dl, unless this is considered to be secondary to renal dysfunction or known myelodysplasia. * secondary causes of acute myocardial ischemia. * known current platelet count \< 90,000 cells/ml. * ongoing oral anticoagulant treatment or an inr known to be \>1.5 at the time of screening. * concomitant severe obstructive lung disease, malignancy or neurologic deficit limiting follow-up or adherence to the study protocol. * participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization * inability to give at least verbal informed consent to the study. * contraindications to the use of clopidogrel or prasugrel as per package leaflet.

Keywords: acute coronary syndrome elderly percutaneous revascularization antiaggregant drugs
digital pet/ct using [ga-68]psma for characterization of prostate lesions

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate a radioactive diagnostic study drug, which is called gallium-68 prostate specific membrane antigen (\[ga-68\]psma) for characterization of prostate abnormalities.

individuals with clinical suspicion of prostate cancer and without prior prostate biopsy are offered abbreviated bi-parametric prostate mri. as standard of care (soc), mris will be examined and scored for likelihood for malignancy using the pi-rads version 2.1 criteria. those with pi-rads 3, 4 or 5 lesions or those with pi-rads 1 or 2 lesions with clinical suspicion for prostate cancer based on serum psa level, family history or clinical examination (positive digital rectal examination) will be included on study. only those receiving care at university hospitals cleveland medical center will be included into the study. this study is to evaluate (\[ga-68\]psma) for characterization of prostate abnormalities. for imaging, an fda approved imaging technology, digital positron emission tomography (pet/ct) will be used. the study team would like to know if digital pet/ct using \[ga-68\]psma provides accurate information whether or not a participant has prostate cancer and if there is potential spread of the disease within the body. \[ga-68\]psma is an investigational (experimental) drug that works by binding to prostate specific membrane antigen (psa), which is overexpressed in prostate cancer. \[ga-68\]psma is experimental because it is not approved by the food and drug administration (fda). however, fda approval has been obtained for this study protocol by an investigational new drug (ind) application.

Eligibility criteria:
inclusion criteria: * patients who have a clinical suspicion of prostate cancer defined by pi-rads 3, 4 or 5 lesions detected on mri as well as patients with negative prostate mri or those with pi-rads 1 or 2 lesions if they have continued suspicion for prostate cancer. patients who cannot undergo mri imaging but have a clinical suspicion for prostate cancer based on serum psa level, family history or clinical examination (positive digital rectal examination) can also be included. * able to tolerate pet/ct scans * informed consent must be given and signed exclusion criteria: * anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks * known allergy against ga-68 psma * prior prostate biopsy within the last 2 weeks
perioperative recovery of moods, opioids, and pain trial (prompt)

Conditions: Opioid Cessation

Summary: the investigators aim to characterize the relationship between changes in emotional distress, opioid use, and pain throughout surgery and recovery. additionally, the investigators aim to compare the effectiveness of post-surgical motivational interviewing and physician-guided opioid weaning vs. usual care on reducing persistent opioid use. overall, the proposed research will advance knowledge regarding the role of psychological factors contributing to persistent opioid use after surgery.


Eligibility criteria:
inclusion criteria: * age 18+ * undergoing a scheduled surgery * english speaking * ability and willingness to complete questionnaires and assessments. exclusion criteria: * any conditions causing inability to complete baseline, telephone and internet assessments (e.g. education, cognitive ability, mental status, medical status)at the discretion of the investigator. * known pregnancy * elevated suicidality as assessed by an answer of 2 or greater on question 9 of the beck depression inventory assessing suicidal thoughts. * coexisting chronic pain disorder of moderate severity in area other than surgical target