Kornimate/medical-research-clean huggingface dataset:
study to investigate the effects of food on the pharmacokinetics/pharmacodynamics of ckd-519

Conditions: Healthy Volunteers

Summary: the purpose of this study is to investigate the effects of food on the pharmacokinetics/pharmacodynamics of ckd-519.

a randomized, open-label, single dose, 1-sequence, 3-treatment, 3-period crossover study to investigate the effects of food on the pharmacokinetics/pharmacodynamics of ckd-519 in healthy male subjects.

Eligibility criteria:
inclusion criteria: * between 20 aged and 45 aged in healthy adult male * body weight more than 50, body mass index between 18 and 29kg/m² * necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products * those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent exclusion criteria: * clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system * have a acute disease within 28 days before the beginning of study treatment * have a disease history that can effect drug absorption, distribution, metabolism, excretion * have a clinically significant chronic disease * systolic blood pressure\ 140mmhg, diastolic blood pressure\ 90mmhg * defined by the following 12-lead ecg, qtc\>450msec * positive for serology test (hbsag, anti-hcv ab, anti-hiv ab, vdrl(venereal disease research laboratories)) * subject treated ethical drug within 14 days before the beginning of study treatment * subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment * have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs) * cannot take standard meal * whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing * blood transfusion within 30 days * taking drugs have received any other investigational drug within 90 days prior to the first dosing * subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days * continuously taking caffeine(caffeine\>5 cups/day), drinking alcohol(alcohol\>210g/week), smoking excessive cigarettes(cigarette\>10cigarettes/day) * impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasons(for example, noncompliance, a disobliging manner)

Keywords: dyslipidemia ckd-519 cetp inhibitor food drug interaction
comparison of efficiency between practicing of knee chest position and external cephalic version in cases of breech presentation.

Conditions: Breech Presentation

Summary: background: the incidence of breech presentation in pregnant women is 4%. the situation can be treated by two methods. the first is a version of the fetus from breech presentation to head presentation, which can be performed in several ways, such as, an action called external cephalic version as well as the knee-chest position by the pregnant mother and the second is a cesarean section. in this study we wish to investigate if the knee-chest position is as effective as the ecv action and as a result to decrease the need for ecv. hypotheses: according to our assumption, the knee-chest position can reduce the need for the ecv action. objectives: investigate whether daily knee-chest position is as effective as ecv. methods: the investigators will conduct a "randomized clinical trial" study. every pregnant woman in a breech presentation with a singleton between weeks 28-32 will be randomly assigned into one of two groups. in the first group the women will perform daily the knee-chest position between weeks 32-37. in week 37 the investigators will check via ultra sound if there was a successful version (if not, the woman would go to ecv) in the second group we will perform ecv without doing maternal knee-chest position before. every woman will fill a questionnaire which includes gynecological history and details regarding the degree of persistence and performance of the activity. at the end of this process the investigators will analyze the results and will come to the conclusions. significance: with ecv there are number of risks and complications such as fetal distress, placental abruption, rupture of membrane, amniotic fluid embolism or damage to the uterus. the frequency of these complications is 1%-2%. if it is discovered that the knee-chest position is effective as the ecv action, the investigators will recommend every patient to persist with this position and avoid the ecv action and the risks it entails.


Eligibility criteria:
inclusion criteria: pregnant woman in a breech presentation with a singleton between weeks 28-32. exclusion criteria: * antepartum hemorrhage. * premature rupture of membranes. * placenta previa. * oligohydramnios. * twin pregnancy. * uterine malformation.

Keywords: breech presentation, external cephalic version, maternal posture, pregnancy, caesarean section.
mesenchymal stem cell therapy for type 1 diabetes mellitus patients

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (mscs) transplantation for type 1 diabetes mellitus patients.

mesenchymal stem cells (mscs) are collected from autologous bone marrow mononuclear cells and allogeneic umbilical cord tissue (uc-msc). 15 patients with type 1 diabetes mellitus will be enrolled and will receive mscs by intravenous infusion. they were followed up for 6 months after transplantation. safety is to assess the occurrence of adverse events (aes) during either stem cells infusion or by physician assessments. the primary endpoint is to assess the improvement of patients' fasting blood glucose, hba1c, c-peptide, and blood insulin level.

Eligibility criteria:
inclusion criteria: * who is diagnosed with type 1 diabetes mellitus according to the ada, the patients meet at least one of the following criteria: * at least one autoantibody associated with type 1 diabetes mellitus such as ica or gad. * previously diagnosed at a medical facility with type 1 diabetes. * having evidence of insulin depletion based on the test results during screening. * patients treated with fixed insulin dose for at least 3 months. * males and females between age 18 and 45 years at the screening. * patients able to read, write and understand icf form exclusion criteria: * uncontrolled blood pressure at the time of enrollment: systolic pressure \>160 mmhg and/or diastolic blood pressure \> 100 mmhg. * having evidence related to renal dysfunction: * creatinine \> 1.5 mg/dl or (\>133 mmol/l) for men. * creatinine \> 1.4 mg/dl or (\>124 mmol/l) for woman. * egrf \< 40 ml/ min * proteinuria \> 300 mg/day * having evidence of ketoacidosis at the time of selection. * having evidence of ongoing or frequent hypoglycemia. * having severe infection * infected with hepatitis b virus or hepatitis c or tuberculosis. positive results of hbsag or anti hcv or/and pcr tuberculosis are only acceptable in case of vaccination and without suspicious signs. all other cases are not accepted even in the absence of clinical signs. * diseases detected before/during screening such as cardiovascular disease, respiratory disease ( pulmonary, fibrosis, chronic respiratory failure), liver disease, cancer, neurology, metabolism. * having abnormalities in red blood cells such as sickle cells disease. * using alcohol and/or tobacco. * blood clotting disorders (inr \> 1.5, ptt \>40, pt \> 15). * taking any anticoagulant. * taking systemic steroids. * participate in another clinical study involving experimenting drugs and/or medical equipment. * patients who are unable to perform the tests and assessments needed for the study (eg, patients who are unable to perform bone marrow transplantation) or patients who do not agree to participate in the study.
multi-modal intervention in frail and prefrail older people with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the mid-frail study project focuses on the use of interventions designed to improve functional status and enhance quality of life (rather than traditional treatments such as glucose- and blood pressure- lowering) by acting on the mechanisms involved in producing frailty and its progression to adverse outcomes.

detailed description: subjects enrolled in the main study will also be invited to join the following sub-studies: genefrail: this sub-study aims to determine the polymorphisms of several genes associated to frailty, in order to establish its predictive value for developing disability and response to treatment as well metabofrail: this sub-study aims to investigate the metabolomic profile of frail and pre-frail patients. sartrain: the combination of the assessment tools used in sartrain (arfi us, mri, posturographic measurements) will provide a comprehensive study of the structural and functional characteristics of muscle and adjacent tissues and their change with time and the intervention. mid- pow: this sub-study aims to investigate changes in muscle power. the project also include an randomized controlled ancillary study: sensole for which the aim is to investigate the potential effects of vibrating insoles device on gait and posture.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give written informed consent for participation in the study. * subjects aged 70 years or older, with a diagnosis of type 2 diabetes mellitus for at least 2 years. * require to fulfill fried ́s criteria for frail or pre-frail individuals. exclusion criteria: * barthel score lower than 60 points. * inability to carry out sppb test (total score=0). * mini mental state examination score less than 20 points. * subjects unwilling or unable to consent or unable to participate safely in intervention program. * previous history of myocardial infarction within 6 months, unstable angina or congestive heart failure in iii-iv nyha stage. * clinically instable patients in the clinical judgment of the investigator. * terminal illness (life expectancy \< 6 months). * any other condition that, in the clinical judgment of the investigator, means that it would not in the patient's best interests to enter the study. * current participation in clinical trial or any other investigational study.
effects of education on stigma and quality of life in individuals with type 1 diabetes

Conditions: Diabetes Mellitus, Type I; Stigma; Quality of Life (QOL)

Summary: this clinical trial aimed to examine the effects of anti-stigma psychoeducation based on the roy adaptation model on stigma and quality of life in individuals with type 1 diabetes.the main questions it aims to answer are: 1. does anti-stigma psychoeducation reduce stigma of individuals diagnosed with type 1 diabetes? 2. does anti-stigma psychoeducation improve the quality of life of individuals diagnosed with type 1 diabetes? researchers will compare the group that did not receive stigma prevention psychoeducation with those that did. participants will receive 7 sessions of the psychoeducation once a week. an evaluation session will be administered 3 months after the psychoeducation. researchers will assess all participants' stigma and quality of life before, after and 3 months after the psychoeducation.

individuals who were diagnosed with type 1 diabetes at least 6 months ago, are between the ages of 18-75, and can speak and understand the language spoken will be included in the study. individuals with hearing and visual impairments and those diagnosed with mental retardation will not be included in the study. participants will be assigned to the intervention and control groups by the statistician through randomization. each group will consist of 18 people. stigma prevention psychoeducation will be applied to the intervention group. this psychoeducation will be conducted as a group education. no intervention will be applied to the control group. the researcher will evaluate the stigma and quality of life of the intervention and control groups before, after and 3 months after the education. pre-test and post-test and 3-month follow-up group psychoeducation will be applied to the participants in the intervention group once a week. after the education, they will be evaluated according to the nursing outcome criteria

Eligibility criteria:
inclusion criteria: * diagnosed with type 1 diabetes at least 6 months ago, * being between the ages of 18 and 75, * speaking and understanding turkish, exclusion criteria: * having hearing and vision impairment * being diagnosed with mental retardation

Keywords: diabetes mellitus, type i stigma quality of life roy adaptation model
effectiveness and safety of tisagenlecleucel therapy in brazilian patients with b-lymphocyte malignancies

Conditions: Diffuse Large B-cell Lymphoma; Acute Lymphoblastic Leukemia; Follicular Lymphoma

Summary: this will be a multicenter, national, non-interventional, prospective cohort study

eligible participants will be pediatric (\<18 years) and adult patients (aged 18 years or older) with b-cell malignancies who have received tisagenlecleucel through the commercial setting or out-of-specification (oos) use in brazil. we will collect data prospectively and complement missing information with retrospective data collection, when necessary. it is anticipated that approximately 200 patients will be enrolled in the cohort over 5 years divided among the study indications. since this is a non-interventional study, no administration of study drug or application of questionnaires will be mandated by this protocol. the study will consist of a "pre-infusion" and a "post infusion follow-up period" for up to 15 years post tisagenlecleucel infusion. all patients will be followed until death or last scheduled visit, whichever comes first. for the study, "pre-infusion" and "follow-up post infusion" phases are defined as: * "pre-infusion" will consist of the patient's information from the time of diagnosis untiljust prior to infusion with tisagenlecleucel. * "follow-up post infusion" information will comprise any information from the infusionof tisagenlecleucel onwards.

Eligibility criteria:
inclusion criteria: patients eligible for inclusion in this study must meet the following criteria: 1. patients who receive tisagenlecleucel infusion in the commercial setting or out-of-specification (oos) use, and 2. signed informed consent must be obtained prior to participation in study, and for all participants: 3. patients of any gender aged 0-17 years (named as pediatric) with relapsed/ refractory b-cell all diagnosis that received tisagenlecleucel infusion, or 4. patients of any gender, aged 18-25 years (named as adults) - with relapsed/ refractory b-cell all diagnosis that received tisagenlecleucel infusion, or for dblcl and fl participants: 5. patients of any gender aged 18 years or older, who have been diagnosed with relapsed/ refractory diffuse large b-cell lymphoma and received tisagenlecleucel infusion. exclusion criteria: 1. patients who did not consent to data collection. 2. patients who received tisagenlecleucel infusion as part of any interventional clinical trial.

Keywords: diffuse large b-cell lymphoma dlbcl acute lymphoblastic leukemia all tisagenlecleucel brazil nis follicular lymphoma
prospective registry of ihtdestiny® coronary stent in regular pci practice

Conditions: Coronary Artery Disease; Ischemic Heart Disease

Summary: prospective registry intended to evaluate clinical outcomes of ihtdestiny drug eluting coronary stent.

prospective registry intended to evaluate clinical outcomes of ihtdestiny drug eluting coronary stent use in real-world percutaneous coronary intervention

Eligibility criteria:
inclusion criteria: * ≥18 years old * pci and stent implantation indication according to esc myocardial revascularization guidelines * 1 or more stenosis at native coronary anatomy, in a 2-4mm vessel size, where 1 or more ihtdestiny® drug eluting stent were implanted (or attempted to be implanted). * informed consent signed after pci exclusion criteria: * patient refusal to participate in the study * pregnancy * other des implantation during index pci, or 30 days before of after index pci * pci at surgical grafts * pci for in-stent restenosis * killip class 3-4 acute coronary syndromes (acs) * high bleeding risk with dual antiplatelet intolerance for at least 3 months (or 6 months for acs pci) * allergy or hypersensitivity to sirolimus * patients requiring surgery (cardiac or non-cardiac) in the next 3 months after index pci * patients with life expectancy \<2 years * patients included in other trials or clinical studies

Keywords: percutaneous coronary intervention drug eluting stent
the prognosis of colorectal cancer patients after indocyanine green fluorescence-guided radical surgery

Conditions: Colorectal Cancer

Summary: previous studies of indocyanine green (icg) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. however, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. the present study assessed the prognosis of colorectal cancer patients following icg fluorescence-guided surgery as compared to conventional surgery without the use of icg fluorescence imaging


Eligibility criteria:
inclusion criteria: * age \&gt; 18 years, * confirmed diagnosis of primary crc, * preoperative tumor stage of ct1 to ct4, n-/+, m0 as determined by contrast-enhanced computed tomography (ct), * no distant metastasis, -american society of anesthesiologists(asa)physical status classification score of 1, 2, or 3- exclusion criteria: * history of previous colorectal surgery, emergent surgery, or palliative resection; * pregnancy or breastfeeding; * allergy or history of an adverse reaction to icg; and * severe mental disorder.

Keywords: indocyanine green colorectal cancer prognosis
efficacy of loteprednol ointment following eyelid surgery

Conditions: Post-operative Healing Following Blepharoplasty and Ptosis Repair

Summary: inflammation occurs after any type of incisional surgery. this study will evaluate the efficacy of loteprednol etabonate ointment vs. soothe ointment (vehicle) for postoperative inflammation after routine eyelid surgery.

eyelid surgery such as blepharoplasty is often performed for functional and cosmetic indications. following any incisional surgery, postoperative inflammation occurs at the surgical site. this study will evaluate the efficacy of reducing postoperative inflammation after bilateral eyelid surgery using loteprednol etabonate (steroid) vs. soothe ointment (vehicle of loteprednol etabonate). common postoperative changes at the incision include: erythema, thickening/elevation of the skin, pigmentary changes and pain. the use of a topically applied steroid would be expected to reduce inflammation and this study will evaluate this. for each patient, one eyelid will be randomly chosen to treat with medication and the other eyelid will be treated with vehicle ointment and by using the same patient, each patient will be internally controlled. antibiotic prophylaxis is often given after eyelid surgery and this will be used in all patients in the study.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * scheduled for bilateral eyelid surgery * willing and able to return for all study visits * willing and able to administer treatments as required * understand and sign informed consent approved by ucsd institutional review board exclusion criteria: * history of allergy to investigational drug (loteprednol etabonate) or ingredient in drug including petrolatum * history of collagen vascular disease and receiving concurrent treatment that could interfere with interpretation of study results * concurrent ocular therapy with nonsteroidal anti-inflammatory drugs, mast cell stabilizers, antihistamines, decongestants, immunosuppresants, and systemic or ocular corticosteroids * history of immunodeficiency * prior eyelid or facial surgery * prior ocular or orbital trauma * history of ocular hypertension, steroid responder, or glaucoma * pregnancy or lactation * uncontrolled systemic disease or significant illness * any other condition the investigator believe would pose a significant hazard to the subject if the investigational therapy were initiated
sof (sovaldi®) +rbv for 16 or 24 weeks and sof+rbv+peg-ifn for 12 weeks in adults with genotype 2 or 3 chronic hcv infection

Conditions: Hepatitis C

Summary: this study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (sovaldi®; sof) + ribavirin (rbv), and 12 weeks of sof+rbv+ pegylated interferon (peg-ifn) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis c virus (hcv) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 hcv infection.


Eligibility criteria:
key inclusion criteria: * male or female, age greater than or equal to 18 years. * confirmed chronic hcv infection. * subjects will have cirrhosis status assessment; liver biopsy may be required. * genotype 2 subjects must have cirrhosis of the liver to be eligible. * treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event * infection with hcv genotype 2 or 3 as determined at screening * body mass index (bmi) greater than or equal to 18 kg/m\^2 * screening laboratory values within predefined thresholds. * liver imaging (e.g., ultrasound) within 6 months of baseline/day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (hcc). in the event of intrahepatic lesions, triple phase ct scan or mri should be performed to exclude hcc. * subject must be of generally good health as determined by the investigator. key exclusion criteria: * prior use of any other inhibitor of the hcv nonstructural protein (ns)5b polymerase * pregnant or nursing female or male with pregnant female partner * history of any other clinically significant chronic liver disease. * hiv or chronic hepatitis b virus (hbv) infection. * malignancy with the exception of certain resolved skin cancers. * chronic use of systemically administered immunosuppressive agents. * clinically-relevant drug or alcohol abuse. * history of solid organ transplantation. * current or prior history of clinical hepatic decompensation. * history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. * known hypersensitivity to interferon, rbv, the study investigational medicinal product, the metabolites, or formulation excipients. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: 7977 gs-7977 psi-7977 sofosbuvir (sof) pegylated interferon (peg-ifn) ribavirin (rbv)