Kornimate/medical-research-clean huggingface dataset:
the phase i clinical study to evaluate the pharmacokinetics of dw1029m in healthy male volunteer

Conditions: Diabetic Kidney Disease

Summary: 1. objective after single dose in healthy adults the capacity of the group for dw1029m evaluate the pharmacokinetic characteristics. 2. indication diabetic kidney disease 3. efficacy 1. primary * auclast, aucinf, auclast/d, aucinf/d * cmax, cmax/d 2. secondary * tmax, t1/2, cl/f, vz/f 4. safety 1. adverse event monitoring 2. v/s, ekg, laboratory test, p/e

healthy volunteers for clinical trials targeting drug administration date (1d) within 3 weeks from the (-21d \~-1d) in the interview, physical examination and laboratory tests , including through the screening is performed. through screening deems appropriate in this clinical trial is intended for the final subjects randomized to three groups to order . the first phase one clinical trial subjects performed one day before (the -1 ) 18:00 chonbuk national university hospital, convened as a physical examination and perform hwalryeong signs . one person to dinner , except for the drinking water should be fasting . one clinical trials (the first day) 20:00 subjects randomly assigned to groups according to the order in which the test is administered in a single oral medication . the subjects for clinical trials with 240 ml water, medicines and swallow whole , chew before swallowing drugs should . blood according to the schedule after the clinical trial , including vital signs and physical examination is performed. the subjects that had a fixed schedule and is discharged on the morning of the second . is at least one week washout period . since the two groups according to the order group and three creeping dose , except for the one the same tiles to proceed. after a period of three clinical trials, three day period from taking drugs for clinical trials after 3-5 days to perform the post-study visit .

Eligibility criteria:
inclusion criteria: * more than 20 years of age at the time of screening and less than 55 years old healthy male * (17.5 \~ 30.5 kg/m2 body mass index (bmi) and weight 45 kg or more ☞ body mass index (bmi) = weight (kg) / height (m) 2 * no congenital or chronic diseases, internal medicine examination results who does not have psychotic symptoms or findings exclusion criteria: * clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but, at the time of administration of seasonal allergic untreated asymptomatic except for sex), medical history or evidence * drugs that may affect the absorption of all the states (eg, gastrectomy) * investigational drugs within two months before the first dose participated in other clinical trials
phase i study of amifostine in patients with bone marrow failure related to fanconi's anemia

Conditions: Fanconi's Anemia

Summary: objectives: i. evaluate the toxicity of amifostine in patients with bone marrow failure related to fanconi's anemia. ii. determine the efficacy of this treatment regimen in this patient population. iii. evaluate the effect of this treatment regimen on bone marrow progenitor cell proliferation and peripheral blood mononuclear cell apoptosis in these patients.

protocol outline: this is a dose escalation study. patients receive amifostine iv over 3-5 minutes three times a week for three weeks. cohorts of 3 patients receive one of three dose levels of amifostine. the maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. patients are followed weekly for 3 weeks.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of fanconi's anemia by conventional diepoxybutane or mitomycin sensitivity assays, or molecular testing bone marrow failure verified on at least 3 occasions in the preceding 3 months by any one of the following: hemoglobin less than 8 g/dl; absolute neutrophil count less than 1,000/mm3; platelet count less than 30,000/mm3; symptomatic bone marrow failure (e.g., exercise limitation from anemia or spontaneous bleeding from thrombocytopenia) evidence consistent with myelodysplastic syndrome allowed if less than 5% blasts on bone marrow aspiration; clonality on bone marrow cytogenetic analysis or morphological changes on bone marrow aspirate refusal of or unsuccessful with prior conventional therapies --prior/concurrent therapy-- biologic therapy: no prior bone marrow transplantation; no concurrent hematopoietic growth factors endocrine therapy: no concurrent androgens --patient characteristics-- hepatic: bilirubin no greater than 2 times normal ast no greater than 3 times normal alt no greater than 6 times normal renal: creatinine no greater than 2 times normal other: no prior malignancy; no active bacterial, viral, or fungal infection requiring therapy other than prophylaxis; not pregnant; negative pregnancy test

Keywords: fanconi's anemia aplastic anemia hematologic disorders rare disease
virtual reality exercise on copd patient

Conditions: COPD

Summary: the program allows the patient to interact with the simulated vr technology using motion sensors, focusing on patients' fitness through various tests providing them a clinically stable environment; to counter moderate level of diseases according to gold criteria and to monitor the effects of exercise program on dyspnea. the purpose of this study is to facilitate the patients so that they get acquainted with the digital technology with significant contribution towards pulmonary rehabilitation program for copd patients. it also analysis the satisfaction of the patients and encourages the use of emerging technology integrated with clinical trials.

chronic obstructive lung disease (copd) is a reversible lung disease which is a principal cause of morbidity and mortality worldwide. it is the third leading cause of death worldwide according to the reports of american thoracic society (ats) and european- respiratory society. according to world health organization (who), every year death and in 2030 it will become the third most common cause of death. copd risk factors includes smoking tobacco, exposure to dusts, hereditary predisposition, and fumes, indoor and outdoor air pollutants, ageing, and asthma. out of all these risk factors, the main reason that develops copd fastest is smoking which is further linked with depression

Eligibility criteria:
inclusion criteria: * age:50-70 years * both genders * clinical signs and symptoms of moderate copd (gold criteria) * clinically stable * ratio of fev1/ fvc is \<0.7 * reported smoking history exclusion criteria: * pneumonia, tuberculosis, and other respiratory * inflammatory disease * heart failure * advanced uncontrolled hypertension * post cardiac or thoracic surgery (\< 6 months) * neuromuscular disorders * metal implant in lower limb * cardiac pacemaker * cognitive dysfunction or mini-mental scale scores \<24 * long- term non-invasive ventilation * comorbidity that could limit exercise testing and training i.e., arthritis, osteoporosis, fracture, diabetic neuropathy etc.

Keywords: physical fitness virtual reality rehabilitation
non-inferiority trial of conditional vs universal follow up for children with fever in democratic republic of congo

Conditions: Fever

Summary: providers in integrated community case management (iccm) programs in low resource settings often see children without any danger signs, presenting with fever but not having pneumonia, malaria, or diarrhea. these children are sent home (often with analgesic only), and caretakers are advised to return in 2 or 3 days. in this study, we are evaluating if conditional return advice (i.e. return in 2 or 3 day only if your child is still sick") results in the same proportion of children remaining with fever one week after identification, as the current universal return advice.

fevers in childhood are common and usually self resolve. in rural democratic republic of congo (and many other settings), when a febrile child presents to a community health worker (chw), the child is assessed for malaria, pneumonia, and diarrhea, and other danger signs, according to world health organization (who) guidelines for integrated community case management (iccm) of childhood illnesses. in the cases where 1) there are no danger signs present, and 2) malaria, pneumonia, and diarrhea have been ruled out, the chw provides an antipyretic only, sends the child home, and advises all such cases to come back in 3 days. we hypothesize, however, that health outcomes for these cases will be equivalent if the chw advises to come back in 3 days, only if symptoms have not resolved. to test this hypothesis, we are conducting a cluster-randomized, community-based non-inferiority trial in two zones of kalemie, katanga province, democratic republic of congo. in this area, the international rescue committee (irc) has been supporting the training, scale-up, and rollout of community health workers who conduct iccm as per who guidelines and with ministry of health oversight. chws have unique non-overlapping catchment areas, and groups of chws (average 5-7) are associated with health clinics. we will utilize this group structure as the unit of randomization; health clinics (and thereby, groups of chws) will be randomly allocated to one of two groups in terms of the advice given to caretakers of children who have no danger signs, have neither malaria, pneumonia, nor diarrhea, and are thus classified as having fever of non-identified origin. * group 1 (universal follow-up): chws in this group will advise caretakers to follow up in 3 days * group 2 (conditional follow-up): chws in this group will advise caretakers to follow up in 3 days if symptoms/signs remain the same (or worsen).

Eligibility criteria:
inclusion criteria: * agree to recruitment script provided by chws at the time of identification of eligible exclusion criteria: * none

Keywords: pediatrics epidemiology fever democratic republic of the congo randomized controlled trial
clinical trial of ara-c, aclarubicin combined with peg-g-csf for initial treatment of aml patients

Conditions: Acute Myeloid Leukemia

Summary: most of patients with acute myeloid leukemia (aml) are elder and have poor prognosis despite induction chemotherapy.the regimen of cytarabine(ara-c), aclarubicin and g-csf (cag regimen ) has been widely used in china for the treatment of acute myeloid leukemia (aml). strategies to reduce the toxicity associated with intensive chemotherapy include the attenuated doses of standard regimens and myeloid growth factors. granulocyte colony-stimulating factor(g-csf) is efective in the prophylaxis and management of chemotherapy-induced neutropenia，but requires daily administration because of its short half-life． pegylated granulocyte colony-stimulating factor (peg-g-csf )is a long-acting reagent that permits less frequent injection．the project is undertaken by qilu hospital of shandong university and other well-known hospitals in china.in order to report the efficacy and safety of peg-g-csf combined with ara-c and aclarubicin for the treatment of acute myeloid leukemia, compared to the regimen of ara-c, aclarubicin and g-csf (cag ).

the investigators are undertaking a parallel, multicentre, randomised open-label trial of newly diagnosed aml (not apl) patients in china. participants are randomised selected to receive the regimen of ara-c, aclarubicin and peg-g-csf , or the regimen of ara-c, aclarubicin and g-csf (cag ).platelet count, bleeding and other symptoms are evaluated before and after treatment. adverse events are also recorded throughout the study.

Eligibility criteria:
inclusion criteria: 1. age 60 years and older, with an upper age limit of 75 years; 2. diagnosis of aml other than apl 3. adequate hepatic and renal function (aspartate aminotransferase \[ast\], alanine aminotransferase \[alt\], bilirubin and creatinine \< 2.5 x upper normal limit). exclusion criteria: 1. history of severe congestive heart failure or other cardiac disease that contraindicates the use of anthracyclines, including idarubicin 2. use of recreational drugs or history of drug addiction, within the prior 6 months 3. known history of positive hepatitis b surface antigens or hepatitis c virus (hcv) antibodies 4. patients with documented cases of human immunodeficiency virus (hiv)

Keywords: acute myeloid leukemia peg-g-csf
serum vancomycin levels in patients receiving enteral vancomycin

Conditions: Clostridium Difficle Colitis; Clostridium Difficle Associated Disease

Summary: the study is based on the hypothesis that decreased creatinine clearance may be associated with detectable vancomycin levels in patients on enteral (oral / vancomycin enemas) vancomyicn for cdad. the objective of the study is to see whether enteral vancomycin is absorbed through the inflamed gi mucosa in cdad, and if it is absorbed, does it achieve measurable serum concentration.

vancomycin is a large glycopeptide compound with a molecular weight of about 1450 da. it is not appreciably absorbed orally and is eliminated primarily via the renal route. enteral vancomycin therapy (oral/intracolonic ) is used inpatients with severe clostridium difficile associated colitis who are unable to take oral metronidazole or have failed treatment with metronidazole. oral vancomycin is not detectable in serum of normal persons, but concentrations below therapeutic range may be found in patients with colitis. there are a few case reports of serum concentrations within the therapeutic range after oral/intracolonic administration of vancomycin, in association with renal failure. the use of enteral vancomycin in our geriatric population with variable creatinine clearance prompted us to measure the serum vancomycin levels in these patients.

Eligibility criteria:
inclusion criteria: * patients on enteral vancomycin therapy exclusion criteria: * coadministration of intravenous vancomycin therapy,intravenousvancomycin administration in previous10 days.

Keywords: enteral vancomycin therapy, serum vancomycin levels, renal failure
study to compare conivaptan pharmacokinetics in subjects with mild & moderate kidney function impairment to subjects with normal kidney function

Conditions: Kidney Diseases; Hyponatremia

Summary: a study to compare a conivaptan pk in subjects with mild or moderate kidney function impairment to subjects with normal kidney function after a 48-hour continuous infusion of conivaptan.


Eligibility criteria:
inclusion criteria: * weighs at least 45 kg * body mass index between 18 and 40 kg/m2 inclusive * must be in good health other than renal function impairment and related stable diseases for the renal impaired subjects * must have a screening and pre-dose estimated glomerular filtration rate (gfr) that corresponds with the level of renal impairment based on the abbreviated modification of diet in renal disease (mdrd) formula * female subject of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test, utilizes adequate contraceptive methods while in this study or may be surgically sterile and/or two years post menopausal exclusion criteria: * subject is known to be hiv positive or has hiv antibodies * has clinically significant history or presence of illness, medical condition, or laboratory abnormality * is hepatitis positive * subject with renal impairment has not been on a stable dose of concomitant medications for at least 4 weeks prior to start of study and/or dose changes are likely during the study * history of substance abuse within 6 months prior to screening * has clinically significant history or presence of psychiatric illness, malignancy, or immunodeficiency syndrome * has abnormal liver function tests (alt, ast, and/or bilirubin) * has had a blood transfusion or donated/lost more than 450ml of blood within 56 days of study drug administration or has donated plasma within 7 days prior to study drug administration

Keywords: pharmacokinetics protein binding conivaptan vaprisol kidney diseases
the effect of minimally invasive surgery on systemic inflammatory response in rectal cancer

Conditions: Colorectal Cancer; Colorectal Adenocarcinoma; Rectal Cancer; Rectal Cancer Stage; Immune System Disorder

Summary: as a hypothesis and shown in many meta-analyses and randomized controlled studies, minimally invasive surgery causes less surgical trauma and therefore less proinflammatory response and immunosuppression develop, and postoperative recovery is faster. although various prognostic studies on the relationship between gastrointestinal cancer types and sii (systemic inflammatory index) and the use of minimally invasive surgery have been published, the high level of this response and the type of surgery in the treatment of colorectal cancer have not yet been shown to have a direct effect on sii.

minimally invasive surgery has been demonstrated to significantly enhance the host immune response in colorectal cancer. the effect and the sii marker may be reliable indicators of this enhancement. a retrospective analysis was conducted on the records of patients who underwent surgery for colorectal cancer at our clinic over a four-year period. the patients were divided into three groups according to the surgical approach employed: open surgery, laparoscopic surgery and robotic surgery. the primary outcome is: a comparison of the open surgery group with those undergoing minimally invasive surgery (laparoscopic and robotic) revealed lower sii values in the robotic surgery group than in the laparoscopic surgery group. the secondary outcome : the sii values were determined as neutrophil/lymphocyte and platelet/lymphocyte, which had been previously investigated in other studies. a comparison will be made with the relevant markers. the research team adheres to the principles set forth in the declaration of helsinki and good clinical practice guidelines. they will conduct the study in an appropriate manner. no intervention will be made in the follow-up and treatment of patients, in accordance with the approval of the hospital ethics committee. the laboratory records typically examined in the postoperative phase will be re-examined in a retrospective manner. furthermore, the personal data of the participants will not be incorporated into the study.

Eligibility criteria:
inclusion criteria: patients operated for rectal cancer * open surgery * laparoscopic surgery * robotic surgery exclusion criteria: * patients with diagnosed immune deficiency * patients with recurrent colorectal cancer * patients with co-existent tumors

Keywords: minimally invasive surgery robotic surgery colorectal cancer immune system response
the effect of intranasal insulin on hepatic and intestinal triglyceride-rich lipoprotein production

Conditions: Hyperlipidemia

Summary: this study compares the effect of insulin given as a nasal spray with a placebo. insulin is a chemical messenger (hormone) in the body that controls fat (triglyceride) levels in the blood by controlling the amount of fat made by the liver and gut. recent research suggests that insulin may work through the brain. the investigators hypothesize that preferential delivery of insulin into the brain, through nasal spray of the hormone, may affect the amount of fats made by the liver and gut.

each subject will be studied twice 4-6 weeks apart in random order in this single blinded study. in study a they will receive a single dose of insulin 40 iu through nasal spray. in study b they will receive placebo. on the day of the study subjects will drink regular liquid nutrient formula to maintain a constant fed state. a pancreatic clamp (octreotide with replacement glucose, insulin and growth hormone) will be started at 7am. from 9am a regular infusion of a stable isotope tracer will be started together with nasal spray of either insulin/placebo. regular blood samples will be drawn to assess lipoprotein kinetics.

Eligibility criteria:
inclusion criteria: 1. men and women, aged 18 to 60 years 2. body mass index 20 to 40 kg/m2 3. hemoglobin in the normal range. 4. normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test 5. women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 2 months prior to and after the study. exclusion criteria: 1. study participant with a history of hepatitis/hepatic disease that has been active within the previous two years. 2. any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis. 3. any current or previous history of endocrine disease, dyslipidemia or malignancy 4. any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (creatinine \> 1.5 mg/dl) genitourinary, hematological systems, or has severe uncontrolled treated or untreated hyper/ hypotension (sitting diastolic pressure \> 100 or systolic \> 180 or systolic pressure \<100) or proliferative retinopathy 5. use of immunosuppressive agents at any time during the study 6. allergy to any study medication 7. pregnancy or breastfeeding 8. heavy smoker 9. fasting blood glucose \> 6.0 mmol/l or known diabetes. 10. any history of a myocardial infarction or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on electrocardiogram, unstable angina, or decompensated heart failure. 11. any nasal pathology. 12. any laboratory values: aspartate aminotransferase \> 2x upper limit of normal ; alanine aminotransferase \> 2x upper limit of normal; thyroid-stimulating hormone \> 6 milliunit per litre

Keywords: lipoprotein apolipoprotein pancreatic clamp insulin nasal