Kornimate/medical-research-clean huggingface dataset:
long-term observational study to evaluate the dfs and os of adjuvant folfirinox regimen in pancreatic cancer patients

Conditions: Adjuvant Chemotherapy

Summary: this study is designed to evaluate the safety and efficacy of adjuvant folfirinox regimen in pancreatic cancer patients after curative surgery.

this study is multi-center, prospective, long-term follow-up observational study.

Eligibility criteria:
inclusion criteria: * age over 19 at the time of obtaining the informed consent form * planning to folfirinox as adjuvant therapy after pancreatic cancer surgery * ecog 0 or 1 * scheduled to ro or r1 resection * organ function capable of chemotherapy exclusion criteria: * folfirinox contraindications among the drug approval requirements * palliative therapy * experienced toxic reactions or hypersensitivity reactions of folfirinox
comparsion of gross motor task training and trunk trageted training

Conditions: Cerebral Palsy

Summary: in this study trunk, targeted training and gross motor function training were compared their effect on functional status, range of motion, and community participation of cerebral palsy children

in this project a randomized clinical trial was be conducted to determine the comparison of gross motor training technique and trunk training therapy on balance, range of motion and community participation in children with diplegic cerebral palsy. this study aim to compare the effects of both the treatments to improve balance, quality of life and community participation. the sample was being collected according to inclusion and exclusion criteria using a convenient sampling technique within period of 6 months. the participants were be randomly allocated in two groups' .group a received gross motor training which included sit to stand, step up and walking for 1 hour/day/3 days a week for 3 months. group b received trunk targeted training for 1 hour/day/3 days a week for 3 months which included treadmill walking, reaching forward to the limits of stability and specific truncal activities with vibration and proprioception. the post treatment assessments was done via early assessment of balance, goniometer, and functional mobility assessment

Eligibility criteria:
inclusion criteria male \& female. * gmfcs iii v * age 8to12 years * diplegic cerebral palsy * hypoxic brain injury * diagnosed with a gross motor delay by the pediatrician. exclusion criteria: * children having a cognitive or psychiatric disorder. * children with known congenital limb anomaly * children with some chromosomal defect

Keywords: cerebral plasy trunk targeted training gross motor trageted training balance
a phase 2 study of rta 901 (biib143) in participants with diabetic peripheral neuropathic pain (cypress)

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: this is a 2-part, randomized, placebo-controlled, double-blind, phase 2 study to evaluate the safety, tolerability, efficacy, and pharmacokinetics (pk) of rta 901 in qualified participants with diabetic peripheral neuropathic pain (dpnp). each study part will be randomized into 3 treatment arms; 2 different doses of rta 901 and rta 901-maching placebo. the doses of rta 901 in part 2 will be selected based on the exposure-response (e-r) analyses of data from part 1. a total of 384 participants will be randomized in this study. each part will have 192 participants, with 64 participants randomized 1:1:1 to each treatment arm. the duration of each part of the study will be approximately 20 weeks, including a screening period of up to 2 weeks, a run-in-period of 2 weeks, a treatment period of 12 weeks, and a follow-up period of 4 weeks. all participants in part 1 and part 2 of the study will follow the same visit and assessment schedule. eligibility will be assessed during the screening and run-in-periods.


Eligibility criteria:
run-in inclusion criteria: * diagnosis of type 1 diabetes mellitus (t1dm) or type 2 diabetes mellitus (t2dm) at least 1 year prior to screening * clinical diagnosis of dpnp defined as symptomatic distal symmetric polyneuropathy (secondary to diabetes) in the lower extremities, which may include symptoms of pain that is burning, lancinating, tingling, or shooting (electric shock-like). pain in the lower extremities may occur with paresthesia or dysesthesia (unpleasant sensations of burning). neuropathic pain may be accompanied by an exaggerated response to painful stimuli (hyperalgesia) and pain evoked by light touch or contact, eg, with socks, shoes, and bedclothes (allodynia); * nprs pain intensity score ≥ 4 on an 11-point scale at screening * a score ≥ 2.5 on the michigan neuropathy screening instrument (mnsi) part b run-in exclusion criteria: * has neuropathy from a cause other than t1dm or t2dm * has a condition other than dpnp that could confound the assessment of pain (eg, fibromyalgia or regional pain caused by lumbar or cervical compression); * diabetic foot ulceration or infection within 90 days prior to screening * prior participation in a study with rta 901; note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: rta 901
study to investigate the pharmacodynamic effects of ip2015 in healthy male subjects using the intradermal capsaicin model

Conditions: Pain

Summary: this is a phase i, randomised, double-blind, placebo-controlled, 4-way crossover study to investigate the pd effects, safety, tolerability and pk/pd correlation of two single oral dose levels of ip2015 compared to 300 mg pregabalin and placebo in healthy male subjects using the id capsaicin model.


Eligibility criteria:
inclusion criteria: * subject is male, with a skin type compatible with capsaicin measurements. * healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ecg, clinical laboratory evaluations. * subject must be in good general health with a skin type compatible with the measures, and without significant skin allergies, pigmentary disorders, or any active dermatological conditions that might interfere with the conduct of the study. exclusion criteria: * any significant cns, cardiac, pulmonary, metabolic, renal, hepatic (including gilbert's syndrome), gastrointestinal (gi) or psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of the investigator, may place the subject at an unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion (adme) of drugs, or with the completion of treatment according to this protocol. * clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during screening as judged by the investigator (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, gi, hepatic, or renal disorder). * clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ecg and vital signs, or physical findings at screening. in case of uncertain or questionable results, tests performed during screening may be repeated to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
can ultrasound replace amniocentesis for confirming fetal lung maturation among premature fetuses?

Conditions: Fetal Lung Maturity

Summary: the purpose of this study is to measure prenatally with ultrasound the intratracheal flow volume displaced during breathing cycle in premature fetuses and to check whether a relationship exists between the inspired fluid and fetal lung maturation.


Eligibility criteria:
inclusion criteria: * women delivering between 27 to 37 weeks. * women undergoing amniocentesis for determining fetal lung maturity between 27 to 37 weeks. exclusion criteria: * major fetal malformation. * oligohydramnios or rupture of membranes diagnosed before 24 weeks of gestation.
a clinical trial to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers

Conditions: Hypertension

Summary: the purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers.

this is an open-label, randomized, multiple-dose, two-period and single-sequence study to evaluate the pharmacokinetics and safety.

Eligibility criteria:
1. inclusion criteria (total: 5): 1. 19-50 year-old healthy male. 2. 18.5kg/m2 ≤ body mass index(bmi) ≤ 27kg/m2 3. subject who has no clinically significant medical history. 4. subject whose informed consent is obtained and who is willing to comply with protocol. 2. exclusion criteria (total: 19): 1. sitting systolic blood pressure(sisbp) ≥ 140mmhg or \< 115mmhg / sitting diastolic blood pressure(sidbp) ≥ 90mmhg or \< 70mmhg 2. upper limits of normal x 1.5 \< aspartate transaminase(ast), alanine transminase(alt), total bilirubin 3. creatinine clearance(crcl) \< 80ml/min (using cockcroft-gault formula) 4. positive results in hbsag, hepatitis c virus(hcv) ab, hiv ag/ab, venereal disease research laboratory(vdrl) 5. participate in another clinical trial within 12 weeks prior to the first administration of investigational product(ip).

Keywords: fimasartan
prediction of sepsis after flexible ureteroscopy

Conditions: Urolithiasis; Sepsis; Surgery--Complications

Summary: sepsis is a lethal complication of flexible ureteroscopy. the aim of this study is to identify predictors of sepsis after flexible ureteroscopy in patients with solitary proximal ureteral stones.


Eligibility criteria:
inclusion criteria: * history of furs to treat unilateral, solitary, and proximal ureteral stones * age ≥18 years exclusion criteria: * anatomical renal abnormalities such as transplant kidney, solitary kidney, horseshoe kidney, and kidney duplication
relation between bone density and the regulation of mineral metabolism in renal stone formers

Conditions: Calcium Nephrolithiasis

Summary: accumulating evidence indicated that renal calcium stone formers often exhibit a low bone density. therefore we want to test the hypothesis, that the mineral (calcium) metabolism is differently regulated in calcium stone formers with low as opposed to high bone density.

there is epidemiological evidence associating renal calcium stones and decreased bone mineral density (bmd). the decreased bmd in calcium stone formers is linked to hypercalciuria and both subtypes, fasting as well as absorptive hypercalciuria are associated with a diminished bmd. higher 1,25-vitamin d plasma concentrations and lower pth levels are encountered under free-choice diet conditions in patients diagnosed with absorptive and fasting hypercalciuria when compared to normocalciuric stone formers. reports studying the bmd of stone formers and its link with mineral metabolism variables and urinary calcium excretion under different calcium intakes are rare. we hypothesize now that pth and 1,25-vitamin d change differently when calcium stone formers with high, intermediate and low bmd are challenged by a low calcium diet.

Eligibility criteria:
inclusion criteria: * passage of at least one calcium containing kidney stone exclusion criteria: * established cause of calcium stone formation (sarcoidosis, primary hyperparathyroidism etc.) * creatinine clearance \< 60 ml/min * urinary tract infection

Keywords: calcium calciuria pth 1,25-vitamin d calcitriol bone mineral density osteodensitometry
a study evaluating efficacy and safety of vx-548 for acute pain after an abdominoplasty

Conditions: Acute Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of vx-548 doses in treating acute pain after an abdominoplasty.


Eligibility criteria:
key inclusion criteria: * before surgery: * participant scheduled to undergo an abdominoplasty without collateral procedures * after surgery: * participant is lucid and able to follow commands * all analgesic guidelines were followed during and after the abdominoplasty * abdominoplasty procedure duration \<=3 hours without collateral procedures (for example., liposuction) key exclusion criteria * before surgery: * prior history of abdominoplasty, intra-abdominal and/or pelvic surgery * history of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) * any prior surgery within 1 month before the first study drug * after surgery: * participant had medical complications during the abdominoplasty that, in the opinion of the investigator, should preclude randomization * participant had collateral procedures during the abdominoplasty other protocol defined inclusion/exclusion criteria may apply.
eccentric exercise or radiofrequent microtenotomy as treatment of lateral epicondylalgia

Conditions: Tennis Elbow

Summary: the aim is to study the effects related to function and pain during eccentric exercise and surgery with radiofrequency microtenotomy as post-surgical rehabilitation, compared with only eccentric exercise, in patients with lateral epicondylalgia unilaterally.

of those affected by lateral epicondylalgia will 90% be free of symptoms within 8 months to 2 years with conservative treatment. in this study surgical radiofrequency microtenotomy and eccentric exercise for chronic (more than two year) lateral epicondylalgia that is unilaterally will be used as treatment. patients is randomized to a group with eccentric exercise or a group with surgical radiofrequency microtenotomy and postoperatively eccentric exercise. home based eccentric exercise program is instructed by a physical therapist and is performed for three months. women start with 0.5 kg and men 1.0 kg weight, they perform 3 sets with 5 reps once a day and register pain and exercise in a diary. function, pain and quality of life will be followed and are carried out after 6 weeks and after 3, 6 and 12 months. the surgery and eccentric exercise is instructed and followed at the investigators clinic.

Eligibility criteria:
inclusion criteria: * over the age of 18 and under the age of 70 year * lateral epicondylalgia at least two year * tried conservative treatment exclusion criteria: * complicated systemic diseases (such as diabetes) * understand spoken and or/written instructions in swedish

Keywords: lateral epicondylalgia pain function physiotherapy quality of life
histocompatibility leukocyte antigen (hla)-a*0201 restricted peptide vaccine therapy in patients with gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the safety and time to progression of hla-a\*0201 restricted epitope peptides urlc10, vegfr1 and vegfr2 emulsified with montanide isa 51.

urlc10 has been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cdna microarray technique. in a prior study, it has been shown that urlc10 is upregulated in human gastric tumors. vegf receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific ctl response in vitro and vivo. according to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. patients will be vaccinated twice a week for 8 weeks. on each vaccination day, the urlc10-117 peptide (1mg), vegfr1 peptide (1mg) and vegfr2 peptide (1mg) mixed with montanide isa 51 will be administered by subcutaneous injection. the patients will also receive oral chemotherapy (s-1) simultaneously. repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. in the phase i study, we evaluate the safety and tolerability of these peptide vaccines. in the following phase ii study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility criteria:
inclusion criteria: * advanced or recurrent gastric cancer * resistant against conventional chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s) * ecog performance status 0-2 * life expectancy \> 3 months * hla-a\*0201 * laboratory values as follows 2000/mm3\ 100000/mm3 bilirubin \< 3.0mg/dl asparate transaminase \< 150iu/l alanine transaminase \< 150iu/l creatinine \< 3.0mg/dl * able to receive oral ts-1 therapy * able and willing to give valid written informed consent exclusion criteria: * pregnancy (woman of childbearing potential:refusal or inability to use effective means of contraception) * breastfeeding * active or uncontrolled infection * unhealed external wound * concurrent treatment with steroids or immunosuppressing agent * prior chemotherapy, radiation therapy, and/or immunotherapy within 4 weeks * uncontrolled brain and/or intraspinal metastasis * history of allergy to tegaful, gimeracil and/or oteracil * decision of unsuitableness by principal investigator or physician-in-charge

Keywords: peptide vaccine urlc10 vegfr1 vegfr2
a study of glutathione in children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the aim of this study is to investigate if taking a supplement called glutathione by mouth is safe and practical for children and teenagers with autism spectrum disorder (asd). the researchers plan to involve 24 individuals with asd and give them oral glutathione for 12 weeks.

the goal of the proposed study is to evaluate the safety and feasibility of oral glutathione in children and adolescents who have autism spectrum disorder. twenty-four subjects with asd will receive 12 weeks of oral glutathione reduced. the hypothesis to be tested is that: oral glutathione will be effective in increasing the blood level of glutathione, which may help to decrease some problem behaviors and irritability in this particular asd population. the second aim of this study is to evaluate the tolerability of oral glutathione. the proposed study may provide needed data for future studies aimed at the treatment of aggressive behaviors that can be seen in this patient population.

Eligibility criteria:
inclusion criteria: * boys and girls ages 4-17 * current diagnosis of autism spectrum disorder as determined by criteria in dsm-5 * parents of children ages 4-17 with a current diagnosis of autism spectrum disorder as determined by criteria in dsm-5 exclusion criteria: * unstable medical illness or clinically significant abnormalities on physical examination; * history of seizures; * history of hematological disorders; * myocardial infarction within 6 months; * current pregnancy or lactation, or inadequate contraception in girls of childbearing potential; * current or recent (past 3 months) dsm-5 substance abuse or dependence; * illegal substance use within 2 weeks of study initiation; * previous treatment with glutathione; * current treatment with n-acetylcysteine, milk thistle, vitamin c, vitamin b, grape seed extract, amino acids, or zinc * current treatment with dextromethorphan, d-cycloserine, amantadine, memantine, lamotrigine or riluzole * asthma

Keywords: autism
home-based exercise in covid-19 survivors

Conditions: Covid19; SARS (Severe Acute Respiratory Syndrome); SARS-CoV Infection

Summary: the physical inactivity promoted by the patient's hospitalization, including those infected with the coronavirus, can lead to an important health impairment, including atrophy and loss of muscle function. thus, a prospective study will be conducted to assess the effect of a home-based exercise training program on health outcomes and quality of life in covid-19 survivors.


Eligibility criteria:
inclusion criteria: * patients diagnosed with covid-19 * positive rt-pcr test and/or serology assay to detect igg against sars-cov-2 in addition to acute symptomatology compatible with the disease * admitted in intensive care unit exclusion criteria: * cardiovascular disease * resting dyspnea * acute pulmonary embolism or pulmonary infarction * deep venous thromboembolism * uncontrolled visual or vestibular disorders * pregnancy * uncontrolled resting tachycardia * uncontrolled hypertension * uncontrolled type ii diabetes * acute infections * neurological disorders * patients with chronic kidney disease who are in need of hemodialysis * recent malignant neoplasm (\<5 years) * autoimmune diseases * complex ventricular arrhythmias, atrial fibrillation or complete heart block * transplant patients * any physical disabilities that could hamper physical testing and exercise program
neonatal thrombocytopenia among newborns admitted to neonatal intensive care unit

Conditions: Thrombocytopenia Neonatal

Summary: thrombocytopenia is diagnosed when platelet count is lower than 150,000 u/l, it is a common hemostatic problem in neonatal intensive care units according to platelets count, it is classified into mild thrombocytopenia with platelet count 100,000 to 150,000 u/l, moderate thrombocytopenia with platelet count 50,000 to 100,000 u/l and severe thrombocytopenia that have platelet count less than or equal to 50,000 u/l.

platelets are seen under microscope as small anucleated fragments of megakaryocytes that circulate in the blood as discs with an average volume of about 7.5 fimtolitre , 14 times smaller than erythrocytes. platelets count in premature infant is slightly lower than that of healthy term infant but is still within the normal range (150,000 to 450,000 unit/ litre ). the most common risk factors for thrombocytopenia are 1. sepsis: thrombocytopenia is a frequent problem in neonatal sepsis and is among the most predictive, independent risk factors for sepsis-associated mortality 2. low birth weight: it is recorded that thrombocytopenia was more common among the smallest patients; 85% incidence among those ⩽800 gram, 60% among those 801 to 900 gram, and 53% among those 901 to 1000 gram 3. perinatal asphyxia: thrombocytopenia occurred in 31% of neonates with asphyxia versus 5% of matched non asphyxiated controls admitted to a neonatal intensive care unit 4. prematurity: in a normal pregnancy, the fetal platelet count reaches adult levels (150-450 × 106/ millilitre) by the second trimester of pregnancy. thrombocytopenia , defined as less than 150,000/ millilitre, occurs in 18 to 40% of all preterm neonates (gestational age \<37 weeks) admitted to neonatal intensive care units

Eligibility criteria:
inclusion criteria: 1. newborn (term and preterm, inborn or out born) aged from 1-28 day 2. platelet count below one hundred and fifty thousands unit/liter exclusion criteria: 1. infant above 28 days old. 2. newborns have platelet count one hundred and fifty thousands unit/liter exclusion criteria:
microparticles, vector of genetic information during hiv infection

Conditions: HIV,

Summary: the aim of the investigators study is to demonstrate in healthy subjects and a cohort of patients infected with hiv, the presence of mirnas in circulating peripheral blood microparticles (mps).


Eligibility criteria:
inclusion criteria: * age of 40 +/-10 years * seronegativity for the hiv 2 * patients of the group a: seropositivity for the hiv 1 confirmed in elisa and western blot for at least 2 years and having never received from antiretroviral treatment, with a viral plasmatique load \> 1000 copies / ml * patients of the group b: seropositivity for the hiv 1 confirmed in elisa and western blot for at least 2 years and under stable antiretroviral treatment for at least 6 months, with a viral load undetectable plasmatique (\< 40 copies / ml) * patients of the group c : matching on the age (+/-3 years) to a patient * be considered healthy by the investigator after a clinical examination seronegativity for the hiv 1 confirmed in elisa the day of the taking exclusion criteria: group a et b * age of \ in 50 years * seropositivity for the hiv 2 group c seropositivity for the hiv 2 - be under medicinal treatment