Kornimate/medical-research-clean huggingface dataset:
clinical trial of phenylbutyrate and vitamin d in tuberculosis (tb)

Conditions: Pulmonary Tuberculosis

Summary: vitamin d exerts its effects via the vitamin d receptor (vdr) present in activated macrophages and induces expression and release of the cathelicidin, ll-37, a human antimicrobial peptide involved in killing of mtb. we aimed to investigate whether treatment of newly diagnosed pulmonary tb patients for 2 months with adjunctive pba and vitamin d (cholecalciferol) in combination with standard dots therapy (i) can improve response to standard short course tb therapy towards a rapid recovery; (ii) can induce expression of ll-37 in macrophages; (iii) can enhance killing capacity of macrophages isolated from tb patients infected in vitro with mtb; and (iv) does not evoke any adverse effects.

this is a double-blind, randomized, placebo controlled clinical trial on clinical efficacy of phenylbutyrate and vitamin d3 therapy daily for 2 months in newly diagnosed sputum smear positive pulmonary tb patients. the clinical trial will take place in the national institute of the diseases of the chest and hospital (nidch) in dhaka, bangladesh. our specific aims are: objective 1: to determine the optimal oral dose of pba required for induction of antimicrobial peptide in macrophages from healthy adults. objective 2 the second aim of this study is to determine whether adjunctive sodium phenylbutyrate and vitamin d treatment (for 2 months) of newly diagnosed pulmonary tb patients: 1. can improve response to standard short course tb therapy towards a rapid recovery (clinical, radiological, mycobacterial). 2. can induce expression of ll-37 in macrophages (immunological). 3. can enhance killing capacity of macrophages from tb patients infected in vitro with mtb (functional measures of treatment outcome). study design: the study will be a randomized, double blind (subject, caregiver, investigator, outcomes assessor), placebo control trial for 2 months. it will also be a safety and efficacy phase iii study. the study will have a 4x4 factorial design with 4-cell interventions. enrolled patients will be randomized into the following four treatment arms in a 1:1:1:1 ratio: group 1: pba group 2: vitamin d3 (cholecalciferol) group 3: pba plus vitamin d3 group 4: placebo

Eligibility criteria:
inclusion criteria: * adults, 18-60 years with sputum smear positive pulmonary tb * new cases only * gender, both * consent to enroll in the study exclusion criteria: * hypercalcaemia (serum calcium \> 2.6 mmol/l) identified at baseline * taking vitamin d * pregnant and lactating * any known liver or kidney function abnormality, malignancy

Keywords: tuberculosis phenylbutyrate vitamin d cathelicidin antimicrobial peptide in adults
physical activity after stroke: how does it effect chronical inflammation and insulin sensitivity

Conditions: Cerebral Infarction

Summary: decreased insulin sensitivity is and independent risk factor for stroke despite glycemic control. it is known that physical exercise increases insulin sensitivity in healthy subjects. wether stroke patients can increase insulin sensitivity via physical exercise is not known. chronic low-grade inflammation is associated with an increased risk of stroke. physical exercise has shown to increase il-6 directly after exercise in untrained subjects. when fitness is increased in each subject then the peak il-6 concentration after exercise decreases and so does the basal level of il-6. it is not known whether stroke patients can increase physical activity level to a degree where chronic inflammation are decreased. this study is designed to evaluate if physical exercise after stroke will increases insulin sensitivity and reduce low-grade chronic inflammation. stroke patients have been randomized to intervention with physical exercise or control in the exstroke pilot trial and followed for 2 years. using the study population from the exstroke pilot trail blood samples will be obtained at the last control. insulin sensitivity can be measured from fasting glucose and insulin using the homeostasis model assessment (homa). interleukin-6, tnf-alfa and crp is measured to estimate chronic inflammation.


Eligibility criteria:
inclusion criteria: * participated in the exstroke pilot trail exclusion criteria: * diabetes mellitus * not able to give informed consent

Keywords: cerebral infarct physical exercise insulin sensitivity low grade chronic inflammation intervention homa pase
danon disease natural history study

Conditions: Danon Disease

Summary: the goal of this international observational study is to learn about the natural history of danon disease in male patients \>8 years of age and female patients \<30 years of age. the key objectives include assessing change over time in cardiac structure (left ventricular mass and wall thickness), cardiac biomarkers, symptoms, and quality of life and the incidence of clinical events such as hf hospitalization, cardiac transplantation, and death.

this is an international observational study with both retrospective and prospective data collection. the study is designed to describe the natural history of danon disease which is a rare x-linked genetic disorder and one of the most severe and penetrant forms of inherited cardiomyopathy. this study will collect data about the clinical course of danon disease including signs and symptoms, key clinical events, and the impact of the disease on quality of life managed with current standard of care. a hybrid (retrospective and prospective data collection) approach is being taken with the aim of achieving robust and longitudinal data generation. subset of patients will be used as an external control arm for comparison to rp-a501 trial participants.

Eligibility criteria:
inclusion criteria: prospective cohort: 1. documentation of a pathogenic or likely pathogenic variant of the lamp2 gene by a clia-certified genetic testing laboratory 2. patient or parent/legal guardian are capable and willing to provide signed informed consent 3. age ≥ 8 years at enrollment female prospective cohort: 4. evidence of left ventricular hypertrophy with preserved systolic function in the 12 months prior to or at enrollment as defined by each of the following: retrospective (only) cohort: 5. documentation of a pathogenic or likely pathogenic variant of the lamp2 gene by a clia-certified genetic testing laboratory 6. patient or parent/legal guardian are capable and willing to provide signed informed consent, as required by local regulations 7. age ≥ 8 years at enrollment 8. prior cardiac transplantation or prior mechanical circulatory support 9. at least 30 days of retrospective medical records available prior to cardiac transplantation or mechanical circulatory support female retrospective (only) cohort: 10. prior evidence of left ventricular hypertrophy. exclusion criteria: all cohorts: 1. concurrent enrollment in any other clinical investigation involving use of an investigational agent for any condition at time of enrollment to this study that could confound interpretation of this study 2. previous treatment with a gene therapy prospective cohort: 3. prior mechanical circulatory support at time of enrollment to this study 4. prior cardiac transplantation at time of enrollment to this study female patients: 5. age \>30 years at enrollment

Keywords: danon disease lamp2 lysosome-associated membrane protein 2 cardiomyopathy x-linked
open cholecystectomy among patients undergoing laparoscopic cholecystectomy.

Conditions: Cholelithiasis; Laparoscopic Cholecystectomy; Cholecystectomy

Summary: in the current era, laparoscopic cholecystectomy is the treatment of choice for symptomatic gallstone disease. the aim of this study is to find out the prevalence of open cholecystectomy among patients undergoing laparoscopic cholecystectomy in a tertiary care center.

laparoscopic cholecystectomy (lc) is the gold standard surgery for symptomatic cholelithiasis with low mortality and morbidity.1,2 however, 1% to 15% of conversion rate to open cholecystectomy (oc) during laparoscopic cholecystectomy has been reported.3 converted cases were associated with increased perioperative time, complication rates, perioperative costs, the length of hospital stay, and a higher 30-day readmission rate.3,4 conversion was also associated with complications including bile leak, bile duct injury, or bleeding, requiring reoperation or transfusion, and death. a recent detailed critical review found that preoperative variables like male gender, older age, high body mass index, previous abdominal surgery, the severity of cholecystitis, and gallbladder wall thickness were associated with the higher rate of conversion to oc.4 however, data regarding its prevalence lacking in our setting. the aim of this study is to find out the prevalence of open cholecystectomy among patients undergoing laparoscopic cholecystectomy in a tertiary care centre.

Eligibility criteria:
inclusion criteria: * all the cases of symptomatic cholelithiasis elected for laparoscopic cholecystectomy exclusion criteria: * age \<10 years, * gall bladder malignancy, * adults with preoperative choledocholithiasis, and * perforated gall bladder
s-shearwave elastography for assessment of hepatic fibrosis

Conditions: Liver Fibroses

Summary: the purpose of this multi-center prospective study is to evaluate the diagnostic performance of s-shearwave, a newly developed ultrasound shear wave elastography, for the assessment of hepatic fibrosis.


Eligibility criteria:
inclusion criteria: * patients with chronic liver disease or cirrhosis, or living-donor candidates for liver transplantation, or volunteers * signed informed consent exclusion criteria: * acute hepatitis or bile duct obstruction * serum alt\> 5 times the upper limit of normal within 3 months * s/p rt. hemihepatectomy * s/p liver transplantation * large mass or infiltrative lesion in the right lobe of the liver

Keywords: ultrasound elastography s-shearwave liver fibrosis
biomarkers related to psci: an fnirs study

Conditions: Stroke; Cognitive Decline

Summary: this is an fnirs study performed to identify biomarkers related to post-stroke cognitive impairment.

this was an initial screening and preliminary intervention study. both healthy subject and stroke patients will be included in this study. brain functional activation of each subject during the cognitive task (stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fnirs). cognitive function related scale assessment included mental state examination scale (mmse), montreal cognitive assessment (moca), drawing clock test (dct), shape trials test a.b (stt-a, stt-b), standardized digital modal test (sdmt), auditory verbal learning test-huashan version (avlt-h), and activity of daily living (adl) scale will be used to evaluate the function of each patient. biomarkers related to post-stroke cognitive impairment will be identified by by comparing differences in brain activation and brain network connectivity between patients and healthy subjects.

Eligibility criteria:
inclusion criteria: stroke patients: 1. diagnosis of stroke confirmed by neuroimaging (ct or mri) 2. 18-80 years old 3. able to complete the cognitive task 4. able to follow instructions to complete the trial 5. patients who signed an informed consent form. healthy subjects: 1. no abnormalities on cranial 2. 18-80 years old 3. able to complete cognitive task 4. able to follow instructions to complete the trial 5. not taking medications. 6. subjects who signed an informed consent form. exclusion criteria: stroke patients: 1. inability to tolerate the test due to organic diseases 2. serious mental illness that prevents them from cooperating with or tolerating the trial 3. pregnant or lactating women 4. had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction. healthy subjects: 1. inability to tolerate the test due to organic diseases 2. serious mental illness that prevents them from cooperating with or tolerating the trial. 3. pregnant or lactating women 4. had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction

Keywords: stroke post-stroke cognitive impairment fnirs
otc mouthpiece for snoring

Conditions: Snoring

Summary: online patient registration to participate in clinical trial to test otc mouthpiece that controls position of the tongue to reduce snoring.

patient will complete informed consent, inclusion/exclusion criteria, sleep apnea and snoring surveys online. if patient meets all criteria for the study, patient will be provided with a treatment device for use for a 10 day treatment period. patient will complete the trial upon providing final online surveys.

Eligibility criteria:
inclusion criteria: * over 18 years of age * living in the united states * signing the informed consent form exclusion criteria: * missing teeth (as the device won't be properly fitted) * any severe breathing or respiratory disorder, such as chronic asthma, emphysema, copd, or a similar condition * poor dental health, such as severe gum disease, loose teeth, an abscess, mouth sores, or bleeding gums * a dental implant placed within the last three months * diagnosed with a temporomandibular joint condition (tmj) * actively experiencing any mouth or jaw pain, including clenching of the teeth, grinding, or any other physical injury to the jaw or teeth * full dentures * braces * diagnosis of sleep apnea * less than 18 years of age
magnetic resonance imaging in radiotherapy for breast cancer

Conditions: Breast Cancer

Summary: this is a single-center, prospective pilot study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (mri) simulation into the planning of radiation treatment (rt) for breast cancer.

primary objective: i. to determine feasibility of acquiring mri simulation prior to rt planning. exploratory objective: i. to determine change in target volume with mri simulation compared to computerized tomography (ct) simulation. outline: mri simulation will be performed once at baseline. there is no follow up planned for study purposes. patients will be followed as part of their regular clinical care.

Eligibility criteria:
inclusion criteria: 1. participants with an eastern cooperative oncology group (ecog) performance status \ =60%, see appendix a). 2. participants with the ability to understand and the willingness to sign a written informed consent document. 3. participants may separately enroll on therapeutic clinical trials when they enroll on this trial. note: all interventions on this protocol are standard of care, so enrollment on other therapeutic protocols is allowed at the discretion of the treating physician. 4. patients must have pathologically confirmed invasive or in situ breast cancer. 5. patients must have tumors in which adjuvant breast radiotherapy following breast conserving surgery is indicated, as determined by the treating physician. 6. patients must be female. note: male patients are excluded due to the rarity of male breast cancer and difficulty in pursuing breast conserving surgery for male patients. exclusion criteria: 1. participants with a contraindication to mri per the mri checklist. 2. patients with breast tumor or tumor bed not visualized at ct or mri during rt planning.

Keywords: imaging
characterization of placebo responses in stable asthma

Conditions: Asthma Placebo Effects

Summary: the investigators hypothesize that different placebos will have different effects on subjective and objective asthma outcomes compared with actual therapy and natural history. . subjects with asthma are randomly treated with placebo inhaler, placebo acupuncture, albuterol inhaler, or "no treatment" in random order, on three different occasions each. at each of the 12 visits, spirometry is performed repeatedly over 2 hours. maximum fev1 achieved and an 11-point, self-reported scale of improvement are examined.


Eligibility criteria:
inclusion criteria: * uncontrolled asthma exclusion criteria: * no bronchodilator response
effect of staphylococcus and neisseria tablets on clinical outcome among patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is a multi-center, prospective study. this study aims to investigate the incidence of acute exacerbation within 12 months, as well as the safety of staphylococcus and neisseria tablets on patients with chronic obstructive pulmonary disease (copd). in addition, this study investigates the improvement of hospitalization, improvement of pulmonary function, improvement of symptoms, and the use of anti-infective drugs among copd patients.

a total of 750 eligible copd patients were enrolled, and were randomly divided into experimental group and control group with a ratio of 2:1. experimental group will receive staphylococcus and neisseria tablets (0.3mg/tablet) and standard care. drug administration is 4 tablets each time and 3 times a day, and treatment period ranges from 3 to 6 months. control group will receive standard care without interventions. all participants have to sign informed consent. after baseline (v0/v1), participants will be followed up for 12 months with four follow-up visits at 4 weeks ± 14d (v2), 13 weeks ± 14d (v3), 26 weeks ± 14d (v4), and 52 weeks ± 14d (v5). among them, v2 can be phone interview.

Eligibility criteria:
inclusion criteria: * 18-80 years, males and females. * clinical diagnosis of copd, defined as fev1/fvc\<70% after inhaling bronchodilators. * at least 1 moderate to severe acute exacerbation of copd in the past year. * patient or their legal agent sign informed consent with a date after understanding the purpose and procedures of the research, and be willing to participate in the study. exclusion criteria: * patients with active pulmonary tuberculosis, asthma, or uncontrolled advanced malignant tumors; or after partial, lobar, or total pneumonectomy. * patients with acute cardio cerebral vascular disease such as acute myocardial infarction, acute stroke and acute heart failure. * patients with liver failure or renal failure and need blood purification treatment. * patients with rheumatic diseases and autoimmune diseases. * have participated or currently in interventional clinical trials within 30 days. * patients with previous (within 3 months before signing the informed consent) or current use of immunomodulatory drugs (including thymosin, thymosin, interferon, transfer factor, bcg vaccine polysaccharide, and any kind of bacterial extract such as biostim, pneumonia vaccine, and influenza vaccine). * currently pregnant or breast-feeding women, or those who have fertility but cannot take contraceptive measures during the study period. * other conditions that are not suitable for the trials according to investigator's judgement.
visceral fat, metabolic rate, and chd risk in young adults

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Obesity

Summary: to measure visceral (intraabdominal) fat by computerized tomography (ct) scan and to measure resting metabolic rate by indirect calorimetry in 400 cardia subjects, ages 28-40 years (100 of each race/gender group) from the oakland, california and birmingham, alabama centers.

background: the prevalence of obesity increased markedly in the united states from the 1960's to the 1980's, and varied by race and gender with particularly high rates of obesity among black women. reasons for the ethnic differences in the prevalence of obesity were not understood. this cross-sectional study was performed in conjunction with the 10-year follow-up examination for the coronary artery risk development in young adults (cardia) study, an nhlbi-funded longitudinal study of development of risk factors for coronary heart disease (chd) in young black and white adults. this study represented a unique opportunity to investigate factors that may influence the development of obesity, to better understand the relationship between obesity and cardiovascular risk factors, and to increase understanding of racial differences in adiposity. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record. design narrative: the cross-sectional study tested the hypothesis that visceral adipose tissue, the component of fat considered to be most strongly related to coronary heart disease (chd) risk factors, differed in black and white subjects. specifically, the investigators proposed that black subjects had less visceral adipose tissue for a given level of total body fat than white subjects. further, the relationship between visceral adipose tissue and risk factors for chd was similar in all subjects. this would explain the different relationship between obesity and chd risk factors seen in black vs white subjects. a second specific aim was to determine whether black women had a lower resting energy expenditure than black men or whites. this could explain the higher prevalence of obesity in black women than in black men or whites of either gender. ct scans were recorded on tape and shipped to the university of colorado health sciences center where visceral adipose tissue was quantified. dietary intake and physical activity were measured as important covariates in the relationship between metabolic rate and adiposity, and thyroid function was measured as a determinant of resting energy expenditure. the cardia study provided funding for cardiovascular risk factor measurements, including blood pressure, lipids, insulin, glucose, smoking, and anthropometric measurements including dual energy absorptiometry (dexa) measurements of total and regional body fat. the study was renewed in 1999 through march 2004 to perform a five-year follow-up of the cohort.

Eligibility criteria:
sj4 post approval study in implantable cardioverter-defibrillator and cardiac resynchronization therapy defibrillator patients

Conditions: Tachyarrhythmias; Sudden Cardiac Death; Heart Failure

Summary: the purpose of this study is to characterize the chronic performance of the st. jude medical sj4 connector and rv high voltage sj4 leads.


Eligibility criteria:
inclusion criteria: * have an approved indication per acc/aha/hrs guidelines for implantation of heart failure or life-threatening ventricular tachyarrhythmias and will be implanted with a st. jude medical sj4 system. * have the ability to provide informed consent for study participating and be willing and able to comply with the prescribed follow-up test and schedule of evaluations. exclusion criteria: * be currently participating in a clinical investigation that includes an active treatment arm. * have a life expectancy of less than 6 months due to any condition. * be less than 18 years of age.

Keywords: icd crtd heart failure df4