Kornimate/medical-research-clean huggingface dataset:
switch from tenofovir to raltegravir for low bone mineral density

Conditions: HIV; Osteopenia; Osteoporosis; HIV Infections

Summary: the purpose of this study is to determine if low bone mineral density (a measurement of how thick and strong bones are) improves in adults with hiv infection who switch their hiv medication tenofovir to another hiv medication raltegravir. hypothesis:that bone mineral density (bmd) will improve in osteopenic or osteoporotic patients switching from art including tenofovir disoproxil fumarate (tdf) and a ritonavir-boosted protease inhibitor (r/pi) to art including ral+r/pi.


Eligibility criteria:
inclusion criteria: 1. provision of written, informed consent 2. hiv-infected adults at least 18 years of age 3. receiving stable art including tdf and a r/pi for the previous 6 months 4. no prior pi genotypic resistance or known replication of hiv in patients receiving a pi 5. plasma hiv rna \< 50 copies/ml for at least the previous 3 months 6. spine or neck of femur t-score ≤ -1.0 (i.e. who-defined osteopenia) measured by dual energy x-ray absorptiometry (dexa) exclusion criteria: 7. participation in any other clinical trial (unless approved by the study pi) 8. use of tdf for previously active chronic hepatitis b infection 9. receiving or requiring therapy for low bmd (including prior fragility fracture) 10. using oral corticosteroids or inhaled fluticasone 11. virological failure on, or intolerance to, ral 12. contra-indication to ral therapy (see appendix 2) 13. breast-feeding 14. pregnancy 15. secondary, endocrinological cause of low bmd:25-hydroxy vitamin d deficiency, hypogonadism: a)symptomatic b)asymptomatic defined by total testosterone \> 25% below lower limit of reference range and/or luteinizing hormone \> 2 x upper limit of normal (uln),untreated hypothyroidism or hyperparathyroidism according to local reference ranges

Keywords: hiv+ raltegravir tenofovir osteopenia osteoporosis bone markers treatment experienced
radical hypofractionated radiotherapy for localized prostate cancer

Conditions: Localized Prostate Cancer

Summary: the aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer. hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects. accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.but for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.

the present study will be conducted as a prospective, open-label, single-arm clinical trial. the patients will receive hypofractionated radiation(54 gy in 15 daily fractions of 3.6 gy ). after completion of study treatment, patients were followed up once a month for the first 3 months and once every 3 months after 3 months for a total of 5 years. the primary endpoints of the study are the toxicities about gastrointestinal (gi),genitourinary (gu) symptoms and erectile dysfunction.the secondary endpoints include progression-free survival (bpfs), local progression-free-survival(lpfs) ,distant metastasis free survival(dmfs) ,overall survival (os)and quality of life (qol).

Eligibility criteria:
inclusion criteria: * age: ≥18 years old; * european cooperative oncology group score(ecog):≤ 2; * patients with pathologically diagnosed prostate cancer; * clinical stage was ctanyn0m0 any gleason / isup group; * expected survival time \>5 years; * the patient has no contraindications to radiotherapy and is suitable and willing to undergo radiotherapy; * patients who voluntarily accept the experimental study protocol after being informed about the existing treatment options; exclusion criteria: * patients who have received any other early treatment for prostate cancer, including radiotherapy, chemotherapy, focal therapy, etc; * a previous history of pelvic and abdominal radiotherapy; * prior hormonal therapy (castration or antiandrogen); * patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (hiv) (+), hepatitis c virus (hcv) (+) and/or positive syphilis; * patients that the investigator considers unsuitable to participate in the clinical trial; patients with other serious systemic diseases, evaluation and compliance of the trial, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary, and other systemic diseases; * patients with contraindications related to radiotherapy; * participate in other clinical trials that are mutually exclusive with the study intervention within 4 weeks prior to the start of the study; * patients unable to provide written informed consent or demonstrate poor treatment compliance
test of the efficacy and safety of insulin glulisine injected subcutaneously in patients with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: primary objective: to evaluate the efficacy and the safety of insulin glulisine in type i diabetes melittus (dm) patients secondary objective: to evaluate the insulin glulisine doses to assess the patient satisfaction


Eligibility criteria:
inclusion criteria: * patients with type 1 diabetes mellitus who need insulin basal+ bolus regimen * 6.5 \<=hba1c \<= 11% at visit 1 * bmi \<35 kg/m² * provision of signed and dated informed consent prior to any study procedures * ability and willingness to complete study diaries and questionnaires * demonstrated ability to use the self-glucose-monitoring device, and to self-inject insulin * a negative pregnancy test for all females of childbearing potential. exclusion criteria: * hypersensitivity to insulin glulisine, insulin glargine or one of their excipients * pregnant women * active proliferative diabetic retinopathy * impaired hepatic or renal function the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
validation of the turkish version of ptsd-ri-5

Conditions: Post-Traumatic Stress Disorder in Children

Summary: the aim of this study is to investigate the adaptation and validity of the dsm-5 ptsd-ri -5 scale in patients who have been exposed to traumatic events. thus, a scale useful for the diagnosis and follow-up of ptsd will be presented to the turkish population.

children worldwide are at risk of experiencing psychological trauma. in addition, one in every four children experiences major traumatic events such as domestic, school, or social violence, abuse, vehicle accidents, serious medical diseases, terrorist incidents, and war. these difficult experiences increase the incidence of post-traumatic stress disorder in children. it is reported that approximately 30% of children who have been exposed to trauma develop post-traumatic stress disorder. although it is sometimes difficult to diagnose post-traumatic stress disorder, it is important to detect symptoms of ptsd in children and adolescents early. many internalizing and externalizing symptoms occur in ptsd; there may be separation anxiety, shame, guilt, low tolerance, overstimulation, impulsivity, outbursts of anger, hostility, defiance, aggression, irritability, and mood changes. therefore, early evaluation of trauma experience and post-traumatic symptoms in children and adolescents seems important.

Eligibility criteria:
inclusion criteria: * being a child or adolescent between the ages of 11-17 * to have experience a traumatic event in the past * to have cognitive capacity to understand and complete the survey. exclusion criteria: -
a proof of concept, phase 2, double-blind, randomized trial with d-methadone product versus placebo

Conditions: Restless Legs Syndrome

Summary: proof of concept, double-blind, randomized, placebo-controlled trial with d-methadone proposed for the first time for use in the treatment of patients diagnosed with primary, moderate to very severe restless legs syndrome (rls). its glutamatergic mechanism of action might be effective on rls arousal pattern and sleep disturbance which highly impair the quality of life of rls's patients. patients will take the study drug/placebo once a day for 30 consecutive days.


Eligibility criteria:
inclusion criteria: * diagnosis of primary rls. * moderate to very severe rls defined as irls-rs score \> 10. * written informed consent. * willingness and ability to participate in the trial exclusion criteria: * positive history of known causes of secondary rls. * any other concomitant treatment for rls (wash-out period: at least 7 days). * moderate-severe sleep apnea defined as apnea hypopnea index ≥ 15. * history or presence of clinically significant abnormality as assessed by neurological examination which in the opinion of the investigator would jeopardize the safety of the patients or the validity of the study results. * evidence of clinically significant hepatic or renal impairment * history or family history of sudden unexplained death or long qt syndrome. * any 12-lead ecg with demonstration of qtc ≥ 450 msec or a qrs interval ≥ 120 msec at screening. * concomitant use of psycho-drugs dopamine agonists and opioids (wash-out period: at least 7 days). * history or presence of any condition in which an opioid is contraindicated * history of allergy or hypersensitivity to methadone or related drugs. * any clinically significant neurological, sleep, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, chronic pain, psychiatric or gastrointestinal disorder. * women who are pregnant or breast feeding. * inability to follow the procedures of the study, (e.g. due to language problems, psychological disorders, dementia, etc. of the participant). * previous enrolment into the current study. * enrolment of the investigator, his/her family members, employees and other dependent persons. * participation in another study with investigational drug within the 30 days preceding and during the present study.
integrase resistance analysis in hiv patients who interrupted raltegravir due to incomplete viral suppression

Conditions: HIV Infection

Summary: prospective study to evaluate the potential persistent viral effect of raltegravir in 20 treatment experienced hiv patients with incomplete viral suppression


Eligibility criteria:
inclusion criteria: * subjects on raltegravir-containing regimen with confirmed virological failure (vl \>500c/ml for \> 3 months). * patients treated with a raltegravir-containing regimen for at least for 24 weeks. * cd4 cell count \> 50 cell/mm3. * adherence \>90%, measured by short -self report questionnaire during the 3 months preceding the study entry. * no reasonable additional therapeutic options exclusion criteria: * history or suspicion of alcohol or drug use which in the investigator's opinion would likely compromise subjects' safety and/or study procedures. * a positive urine drug test for amphetamines, cocaine and opioids at two consecutive screenings (a positive drug test at study screening will be repeated at baseline). * life expectancy less than 6 months. * subject has any currently active aids defining illness (category c conditions according to the cdc classification system for hiv infection 1993) with the following 2 exceptions: 1. stable cutaneous kaposi's sarcoma that is unlikely to require any form of systemic therapy during the study period. 2. wasting syndrome due to hiv infection if, in the investigator's opinion, it is not actively progressive. * any active clinically significant disease (e.g. tb, cardiac dysfunction) or findings during screening of medical history or physical examination that in the investigator's opinion, would compromise the outcome of the study. * pregnant or breast-feeding female. * renal impairment: serum creatinine \> 2 x uln. * chronic hepatitis b or c with alt or ast \> 3 x uln. * acute hepatitis a, b or c. acute hepatitis a, b or c. * any grade 3 or 4 toxicity according to the enhanced actg grading severity list, except for grade 3 or 4 asymptomatic triglyceride/cholesterol elevations, isolated grade 3 increased in ggt, grade 3 increases in glucose, asymptomatic grade 3 increases in amylase with no elevation of lipase. * currently significant diarrhea, gastric stasis or constipation that in the investigator's opinion could influence drug absorption or bioavailability. * subjects with clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (inr \> 1.3 or albumin \ 2.5 x uln).

Keywords: hiv resistance integrase
clinical trial to evaluate efficacy and safety of rovasro 10mg versus crestor 10mg in hypercholesterolemic patients

Conditions: Hypercholesterolemia; Dyslipidemias

Summary: this 8 weeks, prospective, single center, randomized, open-label, parallel-group, non-inferiority study was performed from october 2015 to april 2018. this study as designed to evaluate the efficacy and safety of 10mg of the generic formulation (rosuvastatin, rovasro®) compared to the reference formulation (rosuvastatin, crestor®) in patients with primary hypercholesterolemia and complex dyslipidemia.


Eligibility criteria:
inclusion criteria: 1. individuals aged between 19 and 80 years old. 2. the following patients who belong to the low-risk group to the very-high risk group according to 2015 korean guidelines for the management of dyslipidemia (committee, kcj 2016). * very high risk group (coronary artery disease, ischemic stroke, peripheral vascular disease) were not receiving lipid-lowering agents (statins) within 4 weeks of the screening, regardless of ldl-c levels * high risk group (carotid artery disease, abnormal aneurysm, diabetes)\* : ldl-c ≥ 100 mg/dl * moderate risk group (2 or more major risk factors)\* : ldl-c ≥ 130 mg/dl * low risk group (less than 1 major risk factors)\* : ldl-c ≥ 160 mg/dl * if the patients taka a lipid-lowering agents (statin) within 4 weeks of screening, enrolled them after wash-out for 4 weeks or more. 3. patients who voluntarily participated in the trial and obtained document consent. exclusion criteria: 1. a history of acute arterial disease (patients with unstable angina myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft or percutaneous transluminal coronary angioplasty within 3 months prior to study enrollment) 2. uncontrolled hypertension (systolic blood pressure ≥180mmhg or diastolic blood pressure ≥100mmhg) 3. uncontrolled diabetes (hemoglobin a1c ≥9% or fasting glucose ≥160mg/dl) 4. uncontrolled thyroid dysfunction (thyroid stimulation hormone ≥1.5 times the upper limits of normal (uln)) 5. usage of antihyperlipidemic drugs (bile acid sequestrants, fibrates, niacin, etc.) within 4 weeks before enrollment 6. a history of myopathy, rhabdomyolysis or elevated serum creatinine kinase (ck) more than 2 times the uln 7. chronic kidney disease (serum creatinine ≥2 times the uln) 8. elevated liver enzymes (aspartate aminotransferase (ast) or alanine aminotransferase (alt) ≥2 times the uln) 9. a history of drug or alcohol abuse 10. a history of gastrointestinal surgery or gastrointestinal tract disorders 11. hypersensitivity to the components of this drug 12. those who disagree with contraception 13. pregnancy and/or lactation.
comparison of single vs. dual perclose devices for large-bore access closure in tavr

Conditions: Transcatheter Aortic Valve Replacement

Summary: this study will compare the use of one perclose device to the usual approach of two devices for pre-closure during transcatheter aortic valve replacement (tavr). the study will compare the time it takes for bleeding to stop using the different closure approaches. the study will also compare complications when using one perclose device versus two.

this single-center randomized trial compares single versus dual perclose devices for pre-closure of vascular access for transcatheter aortic valve replacement (tavr) and investigation will evaluate the efficacy and performance of these two pre-closure approaches. the study will provide valuable insights into optimizing pre-closure techniques, potentially enhancing patient outcomes and reducing complications associated with transcatheter aortic valve replacement (tavr) procedures. the trial will aim to enroll patients undergoing tavr, with an an equal number of patients randomized to each pre-closure strategy arm.

Eligibility criteria:
inclusion criteria: * patient age 18 or older * transfemoral transcatheter aortic valve replacement (tavr) * implantation of corevalve replacement valve * access using 14 or 16 french sheaths * english speaking exclusion criteria: * alternative access routes: patients undergoing transcatheter aortic valve replacement (tavr) via alternative access routes such as subclavian access or transapical access. * planned surgical cut-down: patients planned for surgical cut-down procedures rather than percutaneous access. * vascular access complications: patients with known vascular complications at the femoral access site, such as residual hematoma, recent femoral arteriotomy or venotomy within the past 10 days, history of significant vascular complications or prior intravascular closure device use within the previous 30 days. * arterial or venous issues: patients with small femoral arteries or veins (\<5 mm in diameter), patients with access sites located in vascular grafts. * infection or inflammation: active systemic or cutaneous infection or inflammation in the vicinity of the groin. * coagulation and hematological disorders: known history of bleeding diathesis, coagulopathy, hypercoagulability, or platelet count \<100,000 cells/mm³. pre-existing immunodeficiency disorder or chronic use of high-dose systemic steroids. * severe morbidity: severe co-existing morbidities with a life expectancy less than 12 months. * mobility issues: patients unable to routinely walk at least 20 feet without assistance. * recent anticoagulation: use of low molecular weight heparin (lmwh) within 8 hours before or after the procedure. * pregnancy and lactation: pregnant or lactating women. * incompatible procedure plan: patients receiving the edwards sapien valve (edwards lifesciences, irvine, ca) * contraindications: patients with contraindications for the use of perclose device.

Keywords: aortic valve diseases perclose device arteriotomy
phase 1/1b study of rilotumumab in japanese subjects with advanced solid tumors or advanced or metastatic gastric or gej

Conditions: Part 1- Advanced Solid Tumors; Part 2- Advanced or Metastatic Gastric Cancer; Part 2- Advanced or Metastatic GEJ

Summary: this is an open label phase 1/1b study of rilotumumab in japanese subjects with advanced solid tumors or metastatic gastric esphagogastric (gej) adenocarcinoma.


Eligibility criteria:
key inclusion criteria: * japanese subjects with pathologically confirmed unresectable locally advanced or metastatic carcinoma which is refractory to standard therapies or for which there is no standard therapy (part 1 only) * japanese subjects with pathologically confirmed met-positive (fulfilling the met ihc criteria as defined by validated ivd \[in vitro diagnostic\]) unresectable locally advanced or metastatic gastric or gej adenocarcinoma (part 2 only) * eastern cooperative oncology group (ecog) performance status (0 or 1) * availability of archival tumor tissue (part 2 only) * evaluable (measurable or non-measurable) disease by recist 1.1 criteria * able to tolerate infusions and take oral medications (part 2 only) key exclusion criteria: * previous systemic therapy (including chemotherapy, biologic, immunotherapy, or investigational therapy) for locally advanced or metstatic gastric or gej adenocarcinoma (part 2 only) * less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemotherapy to enrollment (part 2 only) * squamos cell history (part 2 only) * known her2-overexpressing unresectable locally advanced or metastatic gastric or gej adenocarcinoma (part 2 only) * resectable disease or suitable for definitive chemoradiation * subjects who have persistent gastric outlet obstruction, complete dysphagia or are dependent upon jejunostomy for feeding (part 2 only) * known central nervous system metastases

Keywords: advanced solid tumors advanced or metastatic gastric cancer advanced or metastatic gej gastric cancer
use of pressure garments for burn scars

Conditions: Burns

Summary: 1. will pressure garment therapy better control hypertrophic scarring than no pressure garment therapy. 2. how will pressure garment therapy affect functional capacity or scar contracture development across joints either in number or severity. 3. will pressure garment therapy diminish discomfort due to pruritus.


Eligibility criteria:
inclusion criteria: * at least 30% total body surface area(tbsa) second degree burns or at least 10% tbsa full-thickness burns including bilateral comparable burns to upper and/or lower extremities. * at least 1 year of age and no more than 17 years of age * wound closure * no evidence of deep venous thrombosis or other vascular compromise. * no concomitant conflicting study protocols. exclusion criteria: * burn injuries not bilateral to upper and/or lower extremities. * evidence of vascular compromise. * conflicting protocols.

Keywords: burn scar pressure garments wound healing burn injury
comparison of sar342434 to humalog as the rapid acting insulin in adult patients with type 2 diabetes mellitus also using insulin glargine

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to demonstrate non-inferiority of sar342434 versus humalog in glycated hemoglobin a1c (hba1c) change from baseline to week 26 in participants with type 2 diabetes mellitus (t2dm) also using insulin glargine. secondary objectives: to assess the immunogenicity of sar342434 and humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study; to assess the relationship of anti-insulin antibodies with efficacy and safety. to assess the efficacy of sar342434 and humalog on: proportion of participants reaching target hba1c \<7.0% and \<=6.5%, fasting plasma glucose (fpg) and self-measured plasma glucose (smpg) profiles, and insulin dose. to assess safety of sar342434 and humalog.

the study will consist of a: up to 2 weeks screening period, 26-week treatment period, and 1-day follow-up period. the maximum study duration will then be 28 weeks per participant and a 1-day safety follow-up.

Eligibility criteria:
inclusion criteria: * participants with t2dm diagnosed for at least 12 months and treated with insulin glargine and humalog®/liprolog® or novolog®/novorapid® (at least 3 times daily, before each meal) in the 6 months prior to the screening visit. * signed written informed consent. exclusion criteria: * at screening visit, age under legal age of adulthood. * hba1c \ 10.0% at screening. * diabetes other than t2dm. * pregnancy and lactation. * women of childbearing potential not protected by highly effective contraceptive method of birth control. * use of insulin pump in the 6 months before screening visit. * use of insulin other than insulin glargine and humalog or novolog/novorapid in the 6 months prior to screening visit. liprolog® is an european union (eu) approved insulin lispro and is allowed in those countries where it is marketed. * use of humalog/liprolog or novolog/novorapid less than 3 times daily, before each meal. * use of non-injectable peptides (eg, glucagon-like peptide-1 (glp-1) receptor-agonists or other peptides) in the 6 months prior to screening visit. * body mass index (bmi) \>=40kg/m² at screening visit. * hospitalization for diabetic ketoacidosis in the last 6 months before screening visit. * unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period. * the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial