Kornimate/medical-research-clean huggingface dataset:
scd-heft 10 year follow-up

Conditions: Left Ventricular Systolic Dysfunction; Congestive Heart Failure; Ischemic and Non-ischemic Cardiomyopathy; Sudden Cardiac Death Primary Prevention

Summary: no clinical trial that has examined the role of implantable cardioverter defibrillator (icd) therapy in the prevention of sudden cardiac death (scd) has provided outcome data for longer than a few years. the nhlbi sponsored and placebo-controlled sudden cardiac death in heart failure trial (scd-heft) conducted from 1997 to 2003 had the largest number of patients and the longest average follow-up at 45.5 months. this study changed the national reimbursement policy for icd therapy and remains the reference point for all other icd evaluations in patients with congestive heart failure from ischemic or non-ischemic systolic dysfunction. despite the outcome, the role of icd therapy in the management of patients with heart failure has been questioned because of four principal concerns: numbers needed to treat to save a life, lead integrity over time, the negative consequences of shock therapy, and the cost of therapy. the purpose of this trial is to track down the remaining patients for a one-time follow-up regarding key outcome data.

long-term outcome data for implantable cardioverter defibrillator (icd) therapy is sorely needed. we will acquire these data by re-approaching the patient population from the original sudden cardiac death in heart failure trial (scd-heft).\[bardy 2005\] this research is supported by the national heart lung and blood institute of the national institutes of health. scd-heft was originally conducted from 1997 to 2003. it demonstrated unequivocally that icd's save lives in patients with heart failure compared to placebo or amiodarone. more than 26 peer-reviewed publications, including three nejm papers, have resulted from this work.\[bardy 2005, poole 2008, mark 2008\] despite the quality of scd-heft and the evidence of the life-saving ability of icd therapy, the role of icd therapy in the management of patients with heart failure continues to be questioned. this study will provide long-term follow-up of the scd-heft patients, which will now exceed 10 years on average.

Eligibility criteria:
inclusion criteria: this is a one time follow-up on patients previously enrolled. - exclusion criteria: this is a one time follow-up on patients previously enrolled. -

Keywords: sudden cardiac death implantable cardioverter defibrillator ventricular fibrillation
circuit-based deep brain stimulation for parkinson's disease; udall project 1 aim 2 and 3

Conditions: Parkinson Disease

Summary: this study will test the hypothesis that deep brain stimulation (dbs) targeting specific changes in oscillatory activity at the site of stimulation will prove superior to continuous isochronal dbs thus providing the rationale for development and optimization of closed loop paradigms and determine whether the optimal closed-loop biomarker varies across subcortical targets, is task dependent, or serves to re-establish a default network that removes an underlying disruptive physiological state leading to greater improvement in motor signs and task performance.


Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pd * dbs surgery or ipg battery replacement at umn is planned as part of routine clinical care. exclusion criteria: * other significant neurological disorder * history of dementia * prior history of stereotactic neurosurgery * patients with post-operative complications or adverse effects (e.g. on stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study * pregnant women
safety and efficiency of ire plus γδ t cell against locally advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: in this study, effects of γδt cells on human pancreatic cancer in combination with tumor reducing surgery, for example ire going to be investigated.

pancreatic tumor will be removed using tumor reducing surgery such as ire. pbmc of the healthy donor will be separated from peripheral blood. after making them potential cancer killer γδ t cell, they will be infused to the patients as an immunotherapy treatment.

Eligibility criteria:
inclusion criteria: 1. age: \>18 years 2. participants older than 18 years with either lapc according to the american joint committee on cancer (ajcc) criteria or isolated local recurrence with a maximum tumor diameter of 5 cm were considered eligible after pathologic confirmation 3. will receive ire, gd tcells 4. life expectancy: more than 3 months 5. ability to understand the study protocol and a willingness to sign a written informed consent document 6. adequate liver and renal function were required 7. intolerant or refused to chemotherapy or to chemotherapy exclusion criteria: 1. patients with other kinds of cancer 2. history of coagulation disorders or anemia 3. heart disease and diabetes 4. history of epilepsy, severe coronary disease, a history of level 3 hypertension，myelosuppression, autoimmune disease 5. a performance status score of \>2

Keywords: immunotherapy γδ t cell pancreatic cancer
: effect of probiotic supplementation on atypical antipsychotic induced weight gain in patients attending psychiatric clinics at ainshams university hospitals (a randomized controlled trial)

Conditions: Antipsychotic Induced Weight Gain

Summary: the goal of the study is to improve the quality of life of patients on antipsychotic medications and increase the rate of compliance to treatment. primary objective: 1.to determine the effectiveness of probiotics to decrease the weight gained as a result of antipsychotic medications. secondary objective: 1. to determine the effect of probiotic supplementation on the psychological state of patients.


Eligibility criteria:
inclusion criteria: * adult schizophrenia patients (18-45 years) on second generation antipsychotics stable patients with a total positive and negative syndrome scale (panss) score of ≤60. with more than 10% weight gain after taking atypical antipsychotics for at least 3 months with treatment duration not more than two years. exclusion criteria: 1. taking probiotics, fiber supplements, antibiotics and laxatives in the last 6 weeks. 2. comorbid gastrointestinal diseases, including active peptic ulcer, uncontrolled and recurrent diarrhea, gastrointestinal bleeding, and digestive system neoplastic diseases. -
rapid diagnostic test for covid-19 based on antibody detection (ycovid)

Conditions: Covid-19

Summary: ycovid-19 aims to be a rapid diagnostic test for sars-cov-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices. this test will be developed using innovative technology developed at the parc taulí university hospital, which increases the immunogenicity of sars-cov-2 differential antigens. the increased immunogenicity of these antigens will allow to detect, with a high sensitivity and specificity, the antibodies in the serum of patients infected with sars-cov-2. this test will serve to confirm dubious results as well as reduce false negatives from the pcr test, which will ultimately help reduce transmission of the infection.


Eligibility criteria:
inclusion criteria: * professional from parc taulí university hospital * patients with clinical, radiological and/or pcr covid-19 positive exclusion criteria: * patients or professionals who do not sign informed consent

Keywords: antibodies covid-19 rapid test rbd
impaired hdl and coronary artery disease in anabolic androgenic steroid users

Conditions: Coronary Artery Disease

Summary: anabolic androgenic steroids (aass) have been associated with coronary artery disease (cad). the illicit use of these substances also leads to a remarkable decrease in high-density lipoprotein (hdl) plasma concentration, which could be a key factor in the atherosclerotic process. the investigators tested the functionality of hdl by cholesterol efflux and antioxidant capacity and its association with cad in young men.

twenty strength-trained aas users (aasu) age 29±5 yr, 20 age-matched strength-trained aas nonusers (aasnu), and 10 sedentary controls (sc) were enrolled. hdl concentration and functionality by measuring the 14c-cholesterol efflux mediated by hdl and the ability of hdl in inhibiting ldl oxidation were evaluated. coronary artery was evaluated with coronary computed tomography angiography.

Eligibility criteria:
inclusion criteria: * anabolic androgenic steroids users and anabolic androgenic steroids nonusers groups had been involved in strength training for at least 2 years; * anabolic androgenic steroids users should be self-administering anabolic androgenic steroids in periodic cycles lasting from 8 to 12 weeks for at least 2 years with 2-4 cycles per year; * all anabolic androgenic steroids users were on a cycle over the course of the study; * sedentary control group: sedentary men without cardiovascular disease. exclusion criteria: * smoking; * alcohol consumption; * use of diuretics and/or antihypertensive medications; * liver and kidney disease

Keywords: coronary artery disease; hdl; anabolic steroids
observational study to monitor safety and effectiveness of obinutuzumab in follicular lymphoma or previously untreated chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia; Follicular Lymphoma

Summary: this study aims to collect clinical data, mainly focused on safety, in the local target population as per the requirement of korea ministry of food and drug safety for market authorization. the study population comprises patients with approved local indications chronic lymphocytic leukemia (cll) and/or follicular lymphoma (fl) in routine clinical practice after launch.


Eligibility criteria:
inclusion criteria: * administered obinutuzumab under the approved indications in korea at investigator's discretion * previously untreated with obinutuzumab exclusion criteria: * out-of locally approved indications, dosage, and administration * pregnant women, breastfeeding women * hepatic disease * participate in other clinical trials
a long-term follow-up study of gaucher disease

Conditions: Gaucher Disease

Summary: the study aims are to: a) identify the long-term natural history of gaucher disease, b) evaluate long-term treatment efficacy of enzyme replacement therapy (ert) and substrate reduction therapy (srt), and c) identify potential long-term complications of this disorder. these aims will be accomplished through long-term record review of individuals with all three types of gaucher disease.

the study aims (aims a-c) will be accomplished by the systematic monitoring of health records. health information will be extracted from medical records for patients followed at duke. medical records will be requested from treating physicians outside of duke. the pi, (dr. kishnani) a recognized expert in gaucher disease, is a consultant to the treating physician of virtually all subjects in this study. subject health status will be monitored at least on an annual basis and as regularly as the medical information is obtained from the treating physician. enrollment in this study will not alter the standard of care treatment for patients with gaucher disease.

Eligibility criteria:
inclusion criteria: * diagnosis of gaucher disease exclusion criteria: * not meeting inclusion criteria

Keywords: gaucher gaucher disease
prognosis stratification for pt4bn0m0 colorectal cancer following multivisceral resection

Conditions: Colorectal Cancer

Summary: the purpose of this study was to identify the prognostic factors of affecting pt4bn0m0 colorectal cancer patients, so as to better stratify the prognostic differences among patients with the same stage.

patients with pt4b stage colorectal cancer (crc) are a complex and special group due to the diversity of infiltrated organs, patients with the same stage often have different prognosis after multivisceral resection (mvr), some important prognostic factors have not been deeply explored, and additional prognostic factors are needed to improve the survival assessment of these patients. in this study, investigators attempted to evaluate the prognostic factors of pt4bn0m0 colorectal cancer, and then stratify the prognosis of such patients to distinguish the survival differences among different patients. this study was a multicenter retrospective cohort study based on a multicenter database which contained hospitalization.the prognostic factors of pt4bn0m0 colorectal cancer patients were analyzed, and the prognostic grading system was constructed to accurately stratify the survival of pt4bn0m0 patients.

Eligibility criteria:
inclusion criteria: 1. the patient was pathologically diagnosed as colorectal adenocarcinoma. 2. patients with pt4bn0m0 colorectal cancer. 3. patients with r0 resection. exclusion criteria: 1. patients with distant metastasis. 2. patients with r1 or r2 resection. 3. patients with lymph node metastasis 4. recurrent colorectal cancer.

Keywords: colorectal cancer multivisceral resection prognosis
ultrasound-guided biopsy of the pleura as a supplement to extraction of fluid in patients with one-sided fluid in the pleura

Conditions: Malignant Pleural Effusion; Exudative Pleural Effusion

Summary: the research group will investigate the diagnostic effect of early introduction of ultrasound guided pleural biopsy in the work-up of patients with one-sided pleural effusion, suspected of malignant pleural effusion.

patients with unilateral pleural effusion with high protein content (exudative pleural effusion) are likely to have malignant pleural effusion. in the danish guidelines, patient undergo two thoracentesis before more invasive procedures, due to the relatively low incidens of pleural tb and mesothelioma. the aim of the research group is to investigate the effect of early introduction of ultrasound-guided pleural biopsy taken at the optimal sport for thoracentesis. the research group will randomise half of our patients with unilateral pleural exudate to up-front ultrasound-guided biopsy and the other half usual care eg. a second thoracentesis, to see if there is a benefit of early pleural biopsy in the work-up of patients with unilateral pleural effusion, suspected of malignant pleural effusion.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * patients with a previous thoracentesis of a unilateral exudative pleural effusion according to light's criteria (1) without malignant cells. * ct thorax or pet-ct with contrast performed. * clinical suspicion of cancer such as (but not limited to) weight loss or pet-ct results or former cancer diagnosis. * patients must be able to give informed consent. exclusion criteria: * bilateral pleural effusions. * known cause of pleural effusions. * life expectancy \<3 months. * inability to understand written or spoken danish.
exercise-based cardiac rehabilitation program on hospitalized heart failure patients submitted to cardiac transplantation

Conditions: Heart Failure; Transplant; Failure, Heart; Physical Activity

Summary: objective: to evaluate the effects of an early-based cardiac rehabilitation program on the functional capacity, inspiratory muscular strength and clinical outcomes in hospitalized heart failure patients before and after heart transplantation. method: 30 hospitalized heart failure patients awaiting cardiac transplantation will be selected and randomized in 2 groups: conventional group (n = 15) - conventional exercise protocol: breathing exercises and global active exercises of upper and lower limbs in the sitting position; and intervention group (n = 15) - cycle ergometer exercise protocol: each session consists of cycling on a stationary bicycle in the seated position for 20 minutes. in both groups, the exercise protocols will be applied twice a day until the hospital discharge, always supervised by a physiotherapist and a doctor. the evaluation procedures in all patients of the research will be: functional capacity measured by the 6 minute walk test and inspiratory muscle strength measured by manovacuometry. evaluations will be repeated in 3 distinct moments: after 24h of hospital admission and/or clinical stabilization; before transplantation and after transplantation in hospital discharge.


Eligibility criteria:
inclusion criteria: * heart failure diagnosis determined by clinical presentation and confirmed on echocardiography by clinicians, with a left ventricular ejection fraction (lvef) \< 40% * new york heart association (nyha) classes iii and iv. exclusion criteria: * chronic lung disease confirmed by pulmonary function testing * unstable angina pectoris and acute coronary syndromes * dialysis * neuromuscular and psychiatric conditions that interfere in exercise
a study of mycophenolate mofetil (cellcept) in management of patients with lupus nephritis.

Conditions: Lupus Nephritis

Summary: this 2 arm study assessed the efficacy of mycophenolate mofetil (mmf; cellcept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of mmf compared to azathioprine in maintaining remission and renal function. patients were randomized to receive either mmf (1.5 g twice daily \[bid\]) or cyclophosphamide (0.5-1.0 g/m\^2 in monthly pulses) in the induction phase. those patients meeting criteria for response were re-randomized for entry into the maintenance phase, to receive either mmf (1 g bid) or azathioprine (2 mg/kg/day).


Eligibility criteria:
inclusion criteria: * male or female patients, 12-75 years of age; * diagnosis of systemic lupus erythematosus; * kidney biopsy within 6 months of study, with histological diagnosis of lupus nephritis; * laboratory evidence of active nephritis. exclusion criteria: * continuous dialysis starting \>2 weeks before randomization into induction phase, and/or with an anticipated duration of \>8 weeks; * previous or planned kidney transplant; * other clinically significant active medical conditions.
the changes of cd8+t cells frequency and function during antiviral therapy

Conditions: Chronic Hepatitis B Infection

Summary: pegylated interferon α-2a(peg-ifn-α) not only inhibit viral replication, but also play an important role in immune regulation, while nucleoside analog(ue) drugs only inhibit viral replication. in hepatitis b infection, cd8+t cells are the main effector cells in adaptive immune response. this study was aimed at investigating the changes of cd8+t cells frequency and function, and the expression of costimulatory molecules during peg-ifn-αand nucleoside analog(ue) therapy.meanwhile, the investigators want to verify whether peg-ifn-α suppressed the virus and the reduction of virus led to the recovery of cd8+t cells function, or peg ifn - alpha enhanced cd8+t cells function which gave rise to the decline of the virus.

pegylated interferon α-2a(peg-ifn-α)and nucleoside analog(ue) drugs can inhibit viral replication , but peg-ifn-α also play an important role in immune regulation. in hepatitis b infection, cd8+t cells are the main effector cells in adaptive immune response.peg-ifn-α recommended as the first-line treatment has a higher chance to achieve hbeag seroconversion and even hbsag disappearance than nucleoside analog(ue) drugs, which may be related to the functional activation of cd8+t cells in the case of hepatitis and the function enhancement of cd8+t cells during peg-ifn-α therapy. this study was aimed at investigating the changes of cd8+t cells frequency and function, and the expression of costimulatory molecules during peg-ifn-αand nucleoside analog(ue) therapy.meanwhile, the investigators want to explore whether the decline of hbsag and hbeag resulted in recovery of cd8+t cells function, or recovery of cd8+t cells function led to the decrease of hbsag and hbeag. several studies demonstrated that hbsag and hbeag could damage cd8+t cells function, and the loss of hbsag and hbeag led to recovery of cd8+t cells function.

Eligibility criteria:
inclusion criteria: * hbsag and hbeag positive for more than 6 months, hbv dna detectable with alt level abnormal lasted for three months and at least time190 iu/l or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled. exclusion criteria: * active consumption of alcohol and/or drugs * co-infection with human immunodeficiency virus, hepatitis c virus, or hepatitis d virus * history of autoimmune hepatitis * psychiatric disease * evidence of neoplastic diseases of the liver

Keywords: chronic hepatitis b hepatitis b virus cd8+t cells pegylated interferon α-2a nucleoside analogues
microclinic social induction pilot intervention for diabetes and obesity management in qatar

Conditions: Diabetes Mellitus, Type II; Overweight and Obesity; Hypertension; Behavioral Lifestyle Change; Social Change

Summary: the purpose of the study is to pilot-phase test the effectiveness of the microclinic social induction model and its effects on behavioral and metabolic outcomes in different levels of social and familial relationships in qatar. the investigators novel microclinic model is based on the principle that both healthy and unhealthy behaviors spread through preexisting social networks. a microclinic is a small group of approximately 2-8 friends or family members who are taught to modify their own behaviors as well as the behaviors of those around them, with a particular focus on the four "m's": meals, movement, monitoring, and medication. more than social support groups or peer-to-peer interventions, the microclinic model is unique in its focus on the long-term propagation of healthy behaviors throughout a participant's entire social network. qatar is uniquely positioned (with its central geographic location in the gulf region and its leadership in science and education) to spearhead a regional intervention focused on managing and preventing diabetes in the gulf region.

this pilot study, "microclinic social induction intervention for diabetes and obesity management in qatar," is a two-arm randomized controlled trial of a 7-week condensed intervention to evaluate the efficacy of the microclinic social induction model on propagating lifestyle changes and in improving glycemic and metabolic control in doha, qatar. the microclinic social induction model leverages different levels of social and familial relationships to positively influence behaviors relating to diabetes and other metabolic conditions through small treatment units called 'microclinic groups,' consisting of 2-8 peers and family members of the same social network. the intervention model brings microclinic groups to a larger classroom network (\~25 people/class) where each class shares access to a culturally salient diabetes educational curriculum and group support to promote health behavior changes such as improvement in diet, exercise, medication adherence, and blood pressure management to then influence better glycemic and metabolic control.

Eligibility criteria:
inclusion criteria: * over 18 years old * mentally competent * body mass index of 30 or higher * body mass index of 25 or higher and self-reported pre-diabetes or type ii diabetes exclusion criteria: * they do not meet the above criteria * they are pregnant * they have significant medical complications that prevent them from making changes to diet or level of physical activity.

Keywords: diabetes mellitus, type ii disease management obesity social network chronic disease prevention and control education