Kornimate/medical-research-clean huggingface dataset:
targeting beta cell dysfunction with liraglutide or golimumab in longstanding t1d

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to determine whether 8 weeks of liraglutide or golimumab can transiently improve beta cell function in patients with longstanding type 1 diabetes (t1d) who secrete proinsulin and little/no c-peptide.


Eligibility criteria:
inclusion criteria: 1. ≥ 3 years from type 1 diabetes diagnosis 2. males and females 18-50 years of age, inclusive 3. peak mmtt stimulated c-peptide \<0.017 pmol/ml 4. proinsulin levels ≥ 2 pm (either fasting or stimulated) 5. females of child-bearing potential must be willing to use effective birth control for 12 weeks 6. willing and able to give informed consent for participation 7. hba1c ≤ 8.5% exclusion criteria: 1. concurrent use of non-insulin therapies aimed to control hyperglycemia or use within the past 30 days of screening mmtt (v-2). 2. history of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies. 3. diagnosis of liver disease or elevated hepatic enzymes, as defined by alt or ast\> 1.5 x the upper limit of age-determined normal (uln) . 4. females who are pregnant or lactating. 5. receipt of an immune modulating biologic or investigational drug within 3 months or 5 half-lives before enrollment. 6. history of other clinically significant autoimmune disease needing chronic therapy with biologics or steroids with the exception of celiac and stable thyroid disease. 7. current use of any medication known to significantly influence glucose tolerance (e.g. oral steroids, atypical antipsychotics, diphenylhydantoin, niacin). 8. any medical or psychological condition that in the opinion of the principal investigator would interfere with the safe completion of the trial. 9. for study a (liraglutide) 1. any history of pancreatitis or elevated amylase or lipase. 2. any personal or family history of thyroid c-cell tumors, including medullary thyroid carcinoma (mtc). 3. any personal or family history of multiple endocrine neoplasia syndrome type 2. 4. hypersensitivity to liraglutide. 5. previous treatment with liraglutide. 6. known history of clinically significant gastroparesis. 10. for study b (golimumab) 1. any history of recent (within 3 months) serious bacterial, viral, fungal, or other opportunistic infections. 2. any history of demyelinating diseases (such as multiple sclerosis), heart failure, or left ventricular dysfunction. 3. serologic evidence of current or past hiv, hepatitis b, or hepatitis c. 4. positive quantiferon or ppd tb test, history of tuberculosis, or active tb infection. 5. active infection with ebv, defined by real-time pcr. 6. active infection with cmv, defined by real-time pcr. 7. any of the following hematologic abnormalities at screening: * white blood count \ 14,000/μl * lymphocyte count \<500/μl * platelet count \<140,000 /μl * hemoglobin \<8.5 g/dl * neutrophil count \<2,000 cells/μl 8. receipt of live vaccine (in the 6 weeks before treatment)
efficacy and safety of bms-986165 compared with placebo in participants with active psoriatic arthritis (psa)

Conditions: Active Psoriatic Arthritis

Summary: the main purpose of study is to assess the dose-response relationship of bms-986165 (dose a or dose b once daily \[qd\]) at week 16 in the treatment of participants with active psa.

the study is intended to evaluate the safety and efficacy of bms-986165 dose a or b once daily (qd) compared with placebo in adults with active psa. the primary endpoint is american college of rheumatology (acr) 20 response at week 16 (part a).

Eligibility criteria:
inclusion criteria: * diagnosed with psa for at least 6 months before screening, and who meet the classification criteria for psoriatic arthritis (caspar) at screening * participants either (i) cannot have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 tumor necrosis factor -inhibitor (tnfi) (tnfi-experienced). failure is defined as lack of response or loss of response with at least 3 months of therapy with an approved dose of a tnfi, as judged by the investigator. failure must have occurred at least 2 months prior to day 1 * participants have at least 1 confirmed greater than or equal to (\>=) 2 centimeter (cm) lesion of plaque psoriasis at screening * participants have active arthritis as shown by a minimum of \>= 3 swollen joints and \>= 3 tender joints (66/68 joint counts) at screening and day 1 * high sensitivity c-reactive protein (hscrp) \>= 3milligram per liter (mg/l) at screening * women of childbearing potential (wocbp) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment exclusion criteria: * has non-plaque psoriasis (that is (i.e.), guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at screening or day 1 * has any other autoimmune condition such as rheumatoid arthritis, etc. there are exceptions for inflammatory bowel disease or uveitis as follows: currently active disease is excluded but, a history of no longer active disease for at least 12 months (including not being on medication) is allowed * has active (i.e. currently symptomatic) fibromyalgia * history or evidence of active infection and/or febrile illness within 7 days prior to day 1 (example, bronchopulmonary, urinary, gastrointestinal, etc.) * history of recent serious bacterial, fungal, or viral infections requiring hospitalization and intravenous (iv) antimicrobial treatment within 90 days prior to screening, or any infection requiring antimicrobial treatment within 15 days prior to day 1 * history of active tuberculosis (tb) prior to screening visit, regardless of completion of adequate treatment
phase i endovenous administration of oncolytic adenovirus icovir-5 in patients with advanced or metastatic melanoma

Conditions: Locally Advanced or Metastatic Melanoma

Summary: the investigators will evaluate the safety of a single endovenous infusion of icovir5 in adults with locally advanced and metastatic melanoma. icovir5 consists in a conditionally replicative or oncolytic adenovirus.


Eligibility criteria:
inclusion criteria: * malignant melanoma advanced or metastatic. * other than 18 years * karnofsky index \> 60 % * life expectancy \> 3 months * alt/ast \<=2.5 times the upper normal limit * creatinine clearance \>= 50 ml/min. * bilirubin \<25 umol/l * alkaline phosphatase \<= 2.5 time upper normal limit * normal bone marrow function: neutrophils \>=1.5 e9/l, platelets \>= 1e11/l, hemoglobin \>= 100 g/l, normal prothrombin time and thromboplastin time, * hiv negative * measurable disease * signed informed consent. exclusion criteria: * geographical, social or psychological conditions that may impair the protocol compliance. * active infections or other severe medical status. * history of liver disease. * other or concomitant treatments for melanoma or investigational product. * previous participation in studies with adenovirus. * virus diseases diagnosed two weeks before inclusion. * immunosuppressive concomitant treatments * concomitant malignant haematological disease. * patients having family members with immunodeficient status or disease * patients with li fraumeni syndrome or germinal retinoblastoma gene defects.

Keywords: melanoma oncolytic adenovirus virotherapy locally advanced metastatic
telehealth delivery (tele-b6)

Conditions: HIV Seropositivity; Bisexuality

Summary: the research team has developed an interventional group program for young men living with hiv and will be adapting it for telehealth delivery. the purpose of the study is to determine whether or not this program can help improve social connections and the health of young men in online delivery and evaluate its potential for implementation in a community setting. the study has three phases: (1) engaging a community advisory board to create and adapt the intervention for online delivery, (2) a randomized clinical trial of the online intervention, and (3) evaluation of the program for community implementation with our partner organization. participants in the second phase of the study will meet with a study team member to discuss the research process and provide informed consent. the community organization employees will provide consent online prior to completion of a survey and indicate whether they consent to be contacted further for in-depth interviews.

subjects will participate in synchronous, online discussion sessions via videoconference for two hours per week over a six-week period. sessions will include engaging educational components and interactive activities including discussions of case scenarios and sharing of personal experiences where desired. at the end of each videoconference session, participants will be asked to complete a brief session evaluation form in which they will rate the content, facilitation, and overall experience for the week. the long-term goal is to improve engagement across the hiv continuum of care (hiv-coc) by enhancing individual- and community-level resilience processes among young black gay, bisexual and other men who have sex with men (yb-gbmsm) living with hiv. to this end, the research team has used community-based participatory research methods to develop brothers building brothers by breaking barriers (b6), a novel group-level intervention designed to affirm intersectional identities and augment social capital among yb-gbmsm. the goal of this current study is to adapt and pilot b6 for telehealth delivery (creating tele-b6) within the context of an established community-based organization (cbo), as a strategy for enhancing feasibility and scalability prior to a larger efficacy trial.

Eligibility criteria:
inclusion criteria: * black race, inclusive of multiracial identities; male gender, inclusive of transgender men; * self-identification as gay, bisexual, or another non-heterosexual orientation, and/or any history of consensual anal or oral sex with men; * hiv-positive serostatus; * age 18-29 years inclusive; * residence in the atlanta metropolitan statistical area; * available and interested to meet for two hours weekly over a six-week period. exclusion criteria: * age \ 30 years * unwilling or unable to provide written informed consent * enrollment in one phase of the study is an exclusion criterion for enrollment in other phases

Keywords: black multiracial identity
paclitaxel-binding albumin and cisplatin as neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer

Conditions: Bladder Cancer

Summary: this is a phase ii study of paclitaxel-binding albumin, cisplatin as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. patients must have histologically confirmed resectable（stage t2，t3 and t4a） urothelial carcinoma following 2017 v8 ajcc，including renal pelvic carcinoma，ureteral carcinoma，bladder carcinoma and urethral carcinoma. 3. there was at least one measurable tumor lesion following recist 1.1. 4. treatment naïve. 5. eastern cooperative oncology group (ecog) performance status 0-2. 6. left ventricular ejection fraction≥50%. 7. absolute neutrophil count (anc) ≥ 1.5 × 109/l，platelets (plt) ≥ 100 × 109/l，hemoglobin (hb) ≥ 90 g/l，leucocyte ≥ 3.0 × 109/l. 8. total bilirubin (tbil) ≤ 1.5 ×institutional upper limit of normal (uln)， alanine aminotransferase (alt) (serum glutamic pyruvate transaminase \[sgpt\]) /aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase \[sgot\]≤ 2.5 ×uln ，creatinine (cre) ≤ 1.5 ×uln. 9. signed informed content obtained prior to treatment. exclusion criteria: 1. patients who are pregnant or may be pregnant or nursing. 2. patients with coagulation dysfunction or active internal hemorrhage. 3. patients with uncontrolled active infection，hiv，viral hepatitis. 4. peripheral nerve lesion≥grade 1 following nci-ctc 5.0. 5. patients with serious cardiovasculardisease including history of cerebral vascular accident ， myocardial infarction，hypertension，angina，heart failure（nyha grade 2-4） within the last 6 months. 6. history of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in this study. 7. patients was involved in another study within the last 30 days. 8. patients was mental disorders. 9. any other patients deemed by the attending physician to be unsuitable to allow the feasible for this study.

Keywords: bladder cancer；paclitaxel-binding albumin；cisplatin；neoadjuvant chemotherapy
yao strategy for the treatment of de novo medina 0,1,0 or 0,0,1 bifurcation lesion

Conditions: Coronary Artery Disease; Bifurcation Lesion

Summary: percutaneous coronary intervention for coronary bifurcation lesions represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increased risk of procedural complications. the study is designed to enroll 200 patients with acute or chronic coronary syndromes that meet the indications for intervention and with angiographic confirmed de novo medina type 0,1,0 or 0,0,1 bifurcation lesion. in view of the potential risks of using dcb alone in the treatment of de novo bifurcation lesions, the following 2 treatment strategies are available. (1) dcb combined with provisional des implantation 1-2 mm distally to the lesion ostium whenever this was required (dcb+pdes strategy). (2) des implantation 1-2 mm distally to the lesion ostium followed by dcb (des+dcb strategy). the primary endpoint was late lumen loss and major adverse cardiovascular events.


Eligibility criteria:
inclusion criteria: 1. subjects at the age between ≥18 and ≤80 years old; 2. de novo native lesion, median type 010/001 bifurcation lesion; 3. the reference diameter of the target vessel was 2.75-4.0mm and the length was less than 40mm; 4. subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up. exclusion criteria: 1. the diameter stenosis of adjacent branch vessel ostium ≥50%; 2. acute st-segment elevation myocardial infarction; 3. stents implanted within 10 mm proximal or distal to the target lesion; 4. aneurysm within 10 mm proximal or distal to the target lesion; 5. there is target vessel distortion or severe calcification lesion, so balloon catheter fails to pass; 6. previous coronary artery bypass grafting; 7. evidence for extensive thrombus within target vessel; 8. evidence of heart failure by at least one of the following: a. most recent lvef ≤35%, or b. current heart failure defined as dyspnea at rest (nyha class iv assessed day of procedure), or c. killip class ≥2 (post stemi patients); 9. subjects with a life expectancy of ≤1 year; 10. subjects with stroke, peptic ulcer, or gastrointestinal bleeding within the past 6 months; 11. subjects with severe renal failure (egfr\<30ml/minute), failure to comply with angiography conditions; 12. subjects who are intolerance to aspirin and/or clopidogrel or ticagrelor or have contraindications; 13. subjects who are intolerance or allergic to heparin, contrast agent; 14. patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint; 15. subjects who are not applicable to be enrolled by investigators due to other reasons.

Keywords: drug-coated balloon percutaneous coronary intervention drug-eluting stent yao strategy
community-based integrated treatment for adolescents

Conditions: Depression; Alcohol Use

Summary: this study will examine the effectiveness of an integrated treatment for adolescents who are depressed and use alcohol in an intensive outpatient setting in the community.

studies have consistently shown that alcohol use disorders (auds) and mental health disorders are related in adolescence. for example, in a community sample, teens who reported a history of aud were almost four times as likely to have a history of major depressive disorder (mdd) than teens with no history of aud. the scientific community has only recently begun to examine how to treat adolescents with both aud and mdd. reviews have concluded that depression negatively affects treatment for substance abuse. at the same time, substance use issues are often not assessed or addressed in outpatient psychotherapy. thus, we believe that protocols are needed to specifically address substance abusing, depressed adolescents. this study is designed to determine if an integrated (cbt-i) protocol designed to treat both substance use and depression in adolescents aged 12 to 18 years with aud/mdd will produce better treatment outcomes compared to standard care (cbt-sc). both the integrated cbt-i and cbt-sc conditions will be delivered by licensed mental health workers at a community mental health clinic - gateway - that uses an intensive outpatient program (iop) model to treat adolescents with aud and mental health disorders. two hundred adolescents (50 per year for 4 years) will be recruited from gateway's dual diagnosis iop. if an adolescent screens in by reporting both depressed mood and substance abuse, these eligible families will complete a thorough baseline assessment and will then be assigned to either cbt-i or cbt-sc. the baseline battery will be repeated at the end of treatment, and 6 and 12 months after treatment completion to determine how families in the study do over time.

Eligibility criteria:
inclusion criteria: * english speaking adolescent and parent * current substance use disorder * co-occurring psychiatric symptomatology exclusion criteria: * iq \< 80 * diagnosis of psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa * adolescent use of illicit "hard" substances such as cocaine, heroine, and opiates 13 or more times over the prior 90 days

Keywords: depression alcohol use outpatient therapy
abbreviated breast mri in cancer detection

Conditions: Breast Cancer Female

Summary: breast cancer is one of the leading causes of death among women, with early detection being the key to improve prognosis and survival. randomized controlled trials have found that screening mammography has decreased the mortality of breast cancer by 30%. however, with a sensitivity of 70%, mammography has its limitations particularly in women with dense breasts. the use of breast mri for screening has increased over the past decade. most experiences exist in women at elevated familial risk of breast cancer. in these women, mri screening shifts the stage distribution of breast cancers toward lower stages and reduces the fraction of interval cancers. kuhl et al in 2014 were the first to report on the feasibility of an abbreviated breast mri protocol for breast cancer screening. their protocol consisting of an unenhanced t1-weighted and first contrast-enhanced t1-weighted sequence, subtraction imaging, and a single mip image. this groundbreaking study found that image acquisition and interpretation time could be reduced without having a negative impact on diagnostic accuracy.

breast mri screening is associated with high direct and indirect costs. these, together with the lack of sites that offer high-level breast mri, limit clinical access to screening mris. one reason for the high cost is that current breast mri protocols are time consuming to acquire and read. a typical mri study occupies the mri system for up to 40 minutes and generates several hundred images. dce-mri allows the assessment of high-resolution breast morphology and enhancement kinetics to depict angiogenesis as a tumor-specific feature. at any given field strength, dce-mri is the most sensitive modality for breast cancer detection, with a pooled sensitivity of 93%; dce-mri has good pooled specificity of 71%. with the abbreviated mri protocol, the acquisition time was substantially decreased to 3 minutes, compared with 17 minutes for the full diagnostic protocol. the interpretation time of the abbreviated protocol was 28 seconds on average and 2.8 seconds when the mip image alone was evaluated.

Eligibility criteria:
inclusion criteria: - all women referred to our radiology department at assiut university hospital for performing breast mri exclusion crieria: * no exclusion criteria
the effects of synbiotics supplement on biochemical factors and hepatic fibrosis in patients with nonalcoholic steatohepatitis

Conditions: Non Alcoholic Steatohepatitis

Summary: to study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with nonalcoholic steatohepatitis (nash), 50 patients who referred to gastrointestinal (gi) clinic with steatosis grade 1 or more will be randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will be advised to adherence our diet and exercise program too. at the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.


Eligibility criteria:
inclusion criteria: * age of 18 to 70 years * body mass index (bmi) between 25-40 * serum alaninaminotransferase more than 1.5 fold of upper limit of normal range * sonographic findings compatible with hepatic steatosis (degree 2 or more) exclusion criteria: * diabetes * taking any kind of antibiotics two weeks before recruitment * history of alcohol consumption * pregnancy or lactation * professional athletes * other liver disease (viral/etc) * use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin e * a history of hypertension, cardiovascular disease, pulmonary disease, renal disease \& celiac disease; cirrhosis * history of upper gi surgery / prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty * following program to lose weight in recent 3 mo * a history of hypothyroidism or cushing's syndrome
phase 1 study of dw-0919 & dw-0920 in healthy male volunteers under fasting condition

Conditions: Healthy

Summary: the purpose of this study is to evaluate safety and pharmacokinetics of dw-0919 and dw-0920 in healthy male volunteers under fasting condition.


Eligibility criteria:
inclusion criteria: * adult males aged 20 to 55 years at screening. * no significant congenital/chronic disease. * no symptoms in physical examination. * appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis. * be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. subject must provide written informed consent prior to study participation. exclusion criteria: * history of hyperreactivity with drug ingredients(acetaminophen, tramadol) or opioids. * history or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders. * history of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.