Kornimate/medical-research-clean huggingface dataset:
collection of research data and samples from patients who experience immunotherapy side effects

Conditions: Malignancy

Summary: this trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.

primary objectives: to establish a national biorepository including biospecimen and clinical data collections from patients treated with immuno-oncology (io) therapeutics who experience one or more serious (grade 3-4) immune-related adverse events (iraes), rare infections or hyperprogression (acceleration of tumor growth). outline: patients undergo collection of tissue and blood samples (and optional stool samples from patients experiencing colitis) at the time of registration (within 72 hours of confirmation of one or more severe iraes) and at 1 month after registration. patients' medical records are also reviewed for up to 1 year.

Eligibility criteria:
inclusion criteria: * received a regimen containing one or more immuno-oncology therapeutics * must have experienced one or more of the following: * one or more serious (grade 3-4) aes that are likely immune-related * one or more grade 2 dermatologic or rheumatologic aes that are likely immune-related * diagnosis of a rare infection, e.g., fungal or mycobacterial, after starting io treatment \*\* note: diagnosis of sars-cov-2 (covid-19) is excluded * hyperprogression. image submission for patients experiencing hyperprogression is required. for assistance in determining hyperprogression for purposes of eligibility, institutions may contact the study chair and submit images for central review * has not previously been registered to this study
effect of physical training combined cardiac resynchronization therapy in heart failure patients

Conditions: Heart Failure

Summary: the investigators hypothesis that exercise training would potentiate the effects of cardiac resynchronization therapy in heart failure patients.


Eligibility criteria:
inclusion criteria: * qrs\> 150 ms or 120-150ms associated dyssynchrony * the etiology can be idiopathic, ischemic, hypertensive and chagas' disease * ejection fraction \<35% * the optimal pharmacological treatment for heart failureexclusion criteria: exclusion criteria: * patients with pulmonary diseases, neurological diseases, renal, skeletal muscle diseases * patients with contraindications to implant a cardiac pacemaker * pregnancy * new york heart association functional class iv * atrial fibrillation

Keywords: cardiac resynchronization therapy (crt)
angiotensin receptor blockade as an anti-fibrotic intervention in patients with chronic hepatitis c

Conditions: Hepatitis C

Summary: hepatitis c is the most common reason for liver transplantation in the united states and affects nearly 4 million americans. treatments for hepatitis c are available but are poorly tolerated and are not always effective. morbidity and mortality from hepatitis c are related to the development and progression of hepatic fibrosis to cirrhosis and end stage liver disease. efforts to block progression of liver disease would thus result in prevention of morbidity and mortality as well as costs incurred by the health system in the care of these conditions. scar tissue in the liver is secreted by a type of cell, called the stellate cell, in an activated state. this cell carries a receptor for angiotensin, a hormone, when activated. if this receptor is blocked, the cell becomes inactive and does not participate in scar tissue formation. thus, we hypothesize that using a drug such as candesartan, which blocks angiotensin receptors, should result in less scar tissue formation in the livers of patients with hepatitis c.


Eligibility criteria:
inclusion criteria: * adults, age 21 and older * patients with viral hepatitis c that are not on interferon based therapy. * detectable viral load * baseline biopsy within six months or willing to undergo biopsy prior to drug initiation * at least grade 2 inflammation on biopsy, fibrosis of stage 1 or higher * willing to undergo biopsy at the end of treatment * no interferon for at least 6 months prior to or after initial biopsy for study exclusion criteria: * renal impairment defined by a serum creatinine of \>1.8 * congestive heart failure * hepatocellular cancer * concurrent treatment with pentoxyfylline, steroids, interferon alpha or interferon gamma. * active psychosis (affective disorders without loss of reality testing acceptable) * active iv drug use * prior liver transplant * pregnancy * decompensated cirrhosis as defined by the presence of ascites, hepatic encephalopathy or coagulopathy with an inr\>1.4 * hiv seropositivity * hypotension defined by a baseline systolic blood pressure of less than 90mm of mercury * contraindication to arb use or allergy to medication * treatment with potassium sparing diuretics
effect of evolocumab on chronic total occlusions (evolo-cto)

Conditions: In-stent Restenosis; Major Adverse Cardiovascular Events

Summary: the purpose of this study is to evaluate the effect of proprotein convertase subtilisin/kexin type-9 (pcsk9) inhibitors added to regular statin therapy on target lesion failure (tlf) and arteriosclerosis progression in patients with chronic total occlusions (ctos) undergoing successful percutaneous coronary intervention (pci).

chronic total occlusions (ctos) are found in 15-25% of patients with stable angina pectoris. the presence of a cto indicates unfavorable prognosis, with higher rate of major adverse cardiovascular events. statins are frequently used after pci in order to lower ldl cholesterol levels and reduce the chances of coronary artery obstruction recurring. despite this preventive measure, high risk for restenosis and re-occlusion was observed a significant proportion of patients with ctos undergoing pci. proprotein convertase subtilisin/kexin type-9 (pcsk9) inhibitors represent a novel class of lipid-lowering drugs leading to rapid, profound, and consistent reductions in ldl-c levels. the effect of pcsk9 inhibitor in patients with cto, after a recent pci is not known. in this study the investigators want to evaluate the effect of the pcsk9 inhibitor on neointimal hyperplasia and target lesion failure (tlf) in patients with ctos receiving regular statin treatment. a serial of intravascular ultrasound imaging study will be performed to determine the arteriosclerosis progression at 48 weeks.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age with written informed consent * presence of a cto in native coronary artery. * stable angina or myocardial ischemia in a territory supplied by cto * cto located in segments 1-3 (rca), 6-7 (lad), 11-12 (lcx) * target artery ≥2.5mm * scheduled to undergo percutaneous coronary intervention (pci) * ldl-c ≥70 mg/dl (≥1.8 mmol/l) in patients who have been on any stable statin regimen for ≥ 4 weeks prior to enrollment; or ldl-c ≥125 mg/dl (≥3.2 mmol/l) in patients who are statin-naïve or have not been receiving stable statin regimen for ≥ 4 weeks prior to enrollment exclusion criteria: * acute myocardial infarction within 1 month * known severe chronic kidney disease (estimated glomerular filtration rate \[egfr\] \ 2.5 mg/dl); * history of allergy to iodine contrast agents * allergy to pcsk9 inhibitors or any other ingredients contained in study drug * pregnancy or breastfeeding * persistent or permanent atrial fibrillation * patients with history of coronary artery bypass graft * inability or unwilling to provide informed consent * malignant neoplasms or major illness with life expectancy \<1 year * planned coronary revascularization or major non-cardiac surgery 12 months after intervention * patients previously treated with pcsk9 inhibitors.

Keywords: chronic total occlusion restenosis
vitamin d and zinc supplementation for improving treatment outcomes among covid-19 patients in india

Conditions: COVID-19

Summary: the purpose of this study is to assess the effect of vitamin d and/or zinc supplementation on improving covid-19 treatment outcomes. the effects of vitamin d, zinc, and both vitamin d and zinc together will be investigated among covid-19 patients in india.

this study is a 2x2 factorial randomized double-blind, placebo-controlled trial to examine the effectiveness of vitamin d and zinc supplements as immune-based therapy among covid-19 patients in india. the study is also examining the immunological response to covid-19 and the effect of the intervention on specific biomarkers of immune and endothelial activation that are independent and quantitative predictors of severity and mortality in other severe infections. the primary aims are to determine the effect of vitamin d supplementation versus placebo on time to recovery among patients hospitalized with covid-19; and to determine the effect of zinc supplementation versus placebo on time to recovery among patients hospitalized with covid-19. as secondary aims, this study is also investigating the effect of vitamin d or zinc supplementation on all-cause mortality. necessity for assisted ventilation, individual symptoms duration, duration of hospital stay and biomarkers including vitamin d, zinc, interleukin 6 (il-6), angiopoietin-2, strem-1, immunoglobulin g (igg) and immunoglobulin m (igm). eligible individuals are randomly assigned to one of four groups: (1) vitamin d (180,000 iu bolus at enrollment, followed by 2000 iu daily); (2) zinc (placebo at enrollment followed by one daily dose of 40 mg); (3) vitamin d and zinc; or (4) placebo. daily supplements start at the hospital and continue after discharge for a total of 8 weeks. active data collection occurs daily while patients are hospitalized and at least twice per week via telephone after discharge. a clinical exam occurs at 8 weeks and longer-term symptoms are assessed at 3 months.

Eligibility criteria:
inclusion criteria: * aged \>=18 years old * polymerase chain reaction (pcr) or rapid antigen test (rat)-confirmed infection with sars-cov2 * provide informed consent exclusion criteria: * pregnancy * enrollment in other clinical trials

Keywords: covid-19 vitamin-d3 zinc nutrition support host-directed therapy clinical management india
positron emission tomography for the diagnosis of immune checkpoint inhibitor-related myocarditis

Conditions: Myocarditis Acute

Summary: this study evaluates positron emission tomography for the diagnosis of immune checkpoint inhibitor-related myocarditis. immune checkpoint inhibitors have shown promising results in various malignancies however, several immune related adverse events have been described of which myocarditis carries the highest reported mortality. diagnostic procedures, such as positron emission tomography, help find and diagnose myocarditis and provide functional or disease activity information as opposed to the largely structural/anatomic information.

primary objective: i. to prospectively evaluate the sensitivity, specificity, positive predictive value, and negative predictive value of fludeoxyglucose f-18 (18 fluorodeoxyglucose) positive emission tomography computed tomography (pet ct) for the diagnosis of immune checkpoint inhibitor (ici) related myocarditis. secondary objectives: i. to explore the clinical presentation and disease course of ici-related myocarditis which include presenting symptoms (chest pain, dyspnea, fatigue), time from ici initiation to symptom onset, hospitalization duration, time to peak troponin levels, and peak troponin levels. ii. to evaluate biomarkers, including peak troponin, peak no probnp, admission troponin level, and admission nt probnp level, and imaging modalities of ici-related myocarditis which include sensitivity, specificity, positive predictive value, and negative predictive value of cardiac magnetic resonance imaging (mri). iii. to determine the response to various treatments of ici-related myocarditis which include time to resolution of symptoms, hospitalization duration, and peak troponin value stratified by treatment. iv. to observe the long-term outcomes, including late decline in left ventricular ejection fraction (lvef) to \< 50%, and survival after ici related myocarditis, and monitoring of ici-related myocarditis. v. to assess differences in pet ct imaging results between patients on steroid therapy versus not on steroid therapy for myocarditis. outline: patients receive a low carbohydrate and high fat diet for 48-72 hours. patients receive 18 fluorodeoxyglucose (fdg) then undergo pet ct.

Eligibility criteria:
inclusion criteria: * patients of age \>= 18 years * patients must be able to understand and be willing to sign a written informed consent document. surrogate decision-makers of patients will be allowed to consent patients for this study * patients must be receiving or have a history of receiving any ici therapy in monotherapy or combination therapy * patients must have a suspicion of ici-related myocarditis either by clinical presentation, biomarkers, or other diagnostic modalities exclusion criteria: * pregnant or lactating patients will be excluded
qingdao diabetes prevention project

Conditions: Type 2 Diabetes

Summary: qingdao diabetes prevention project aims to translate the trial experience to communities with specific objectives to: * raise the public awareness of diabetes and diabetes risk factors * promote healthy lifestyle of the entire targeting population * reduce the number of people with obesity * reduce the number of high-risk people developing diabetes through lifestyle intervention * prevent the diabetic complications * evaluate the effect and the cost of the community-based prevention project. the project is community-based targeting at the entire population of 1.94 million living in four administration districts of the city of qingdao in china. in the first phase of the project (2005-2008) the work emphasis is on health promotion, training over 2000 primary care professionals and 300 school health nurses and establishing a network consisting of 600 community clinics. in the second phase (2008-2012) lifestyle counseling sessions will be provided to about 242112 high-risk individuals identified, and the efficacy and the cost of the project will be evaluated at the end of the project in 2012.

the qingdao diabetes prevention project targets at two urban districts of shinan and shibei and two rural counties of huangdao and jiaonan, covering 1.94 million of people living in 512 urban communities and 1128 rural natural villages. there are 637000 households in the targeting districts. in the first 3-years (2005-2008) we have focused on preparing educational materials, health promotion, distributing the project materials, training health professionals, establishing the project networks, identifying high-risk individuals etc., while from 2008-2011 we will transfer our working emphasis on lifestyle intervention to those with high-risk for diabetes. according to the data collected in 2006, about 456288 individuals aged 35 years or older are estimated to have a risk score \>=14. we estimate that at least 65% of the non-diabetic high-risk individuals (n=242112) will be identified and referred to one of the 600 community clinics for lifestyle counseling and intervention. lifestyle intervention includes individual and group counseling sessions organised by the community doctors in a real life setting. the intervals of the counseling sessions depend on the glucose levels of the high-risk individuals, every three months for those having impaired fasting glucose or/and impaired glucose tolerance and every six months for those with normal glucose levels but with high risk score. at the end of the project, the cost-effectiveness of the community-based intervention will be evaluated.

Eligibility criteria:
inclusion criteria: * individuals aged 35 years or older * individuals at high risk for diabetes identified by a risk score assessment * individuals with baseline measurement of glucose exclusion criteria: * individuals with a prior history of diabetes or taking antidiabetic drugs

Keywords: diabetes prevention intervention
observation of treatment patterns with lucentis® in real-life conditions in all approved indications

Conditions: Neovascular (Wet) Age-related Macular Degeneration

Summary: this study is designed as an observational, non-interventional, multicenter, open label, single arm study in patients being treated with lucentis® for any approved indication included in the local product posology.

the prospective observation period per patient will be up to 24 months. a minimum of one follow-up visit per year is required in order to maintain patient's participation in the study. the baseline visit will be used to assess eligibility and collect baseline characteristics information. the follow-up visits will take place at a frequency defined as per investigator's discretion. the study eye is defined as the first eye treated during the study, the other eye will be considered as the fellow eye. if both eyes are treated at baseline, the right eye will be chosen as the study eye.

Eligibility criteria:
inclusion criteria: * male or female patients, ≥18 years of age, being treated with lucentis® for any approved indication in the local lucentis® smpc * written informed consent exclusion criteria: * as described in lucentis® smpc * participation in any other clinical study or nis with lucentis® as the investigational drug (such as ocean or luminous)

Keywords: lucentis ranibizumab neovascular (wet) age-related macular degeneration namd diabetic macular edema retinal vein occlusions choroidal neovascularizations
methotrexate-inadequate response autoinjector device sub study

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to implement a substudy in approximately 120 rheumatoid arthritis (ra) subjects to compare the steady-state serum trough concentration (cminss), cmax and area under the curve (auc) during the dosing interval (tau) of subcutaneous (sc) abatacept injection of 125 mg via the autoinjector and via the bd hypak™ physiolis prefilled syringe.

study classification: * safety: show if the drug is safe under conditions of proposed use * efficacy: measure of an intervention's influence on a disease or health condition * safety/efficacy * pharmacokinetics: the action of a drug in the body over a period of time including the process of absorption, distribution and localization in tissue, biotransformation, and excretion of the compound.

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subjects who have been treated in the long term (lt) with open-label sc abatacept for at least 3 months * must continue to meet inclusion criteria specified in main im101-174 study protocol exclusion criteria: * participation in previous device substudy (implemented by amendment 10) * must continue to meet exclusion criteria specified in main im101-174 study protocol
evaluation of quality of care - risk assessment management programme, ha

Conditions: Diabetes Mellitus

Summary: diabetes mellitus (dm) is one of the major cause of morbidity and among the top 10 causes of deaths in hong kong in 2008 (department of health 2009). the hospital authority (ha) has initiated service improvement through introducing the risk assessment and management programme (ramp) to improve the quality of care (qoc) for dm patients in general outpatient clinics (gopc). the evaluation on the qoc is an essential part of the programme in order to inform future policy. the department of family medicine and primary care (fmpc) of the university of hong kong (hku) has been appointed by the ha to carry out the evaluation of the qoc of the programme. the action learning and audit spiral methodologies to measure whether the target standard of care intended by the ramp programme is achieved. each ramp participating clinic and hospital will be invited to complete a structured evaluation questionnaire. the data of all patients who have enrolled into the ramp for more than one year will be included in the evaluation on the process and outcomes of care. one thousand two hundred and forty-eight age and disease matched control patients who have not been enrolled into the ramp programme will be selected for the comparison in the outcomes of care. a hundred and thirty participants will be followed up by telephone to evaluate the effect of the programme in quality of life (qol), patient enablement, and global rating of change in health condition at baseline and 6 months after enrolment. data on the process of care will be retrieved from the ha medical records. main outcome measures: the primary outcomes are the proportion of participants who have received the criterion process of care, and achieved the target hba1c and blood pressure levels. data analysis: descriptive statistics on proportions of centers or subjects meeting the qoc criteria will be calculated. the changes in the clinical and patient reported outcomes of ramp subjects will be compared at 12, 24, 36 and 48 months will be compared by paired sample t-test. the clinical outcomes between ramp subjects and control group will be compared by independent sample t-test or chi-square test. results: the qoc of the ramp programme will be determined. areas of deficiency and possible areas for quality enhancement will be identified. conclusion: the results of this study will provide empirical evidence on whether the ha's ramp programme can achieve improvement in qoc for dm patients. the information will be used to guide service planning and policy decision making.


Eligibility criteria:
inclusion criteria: * patients with dm who are mostly independent in their activities of daily living and being followed up at gopc regularly will be recruited. exclusion criteria: * patients will be excluded if they are unable to understand or communicate in chinese language, or refuse to give consent.

Keywords: diabetes mellitus