Kornimate/medical-research-clean huggingface dataset:
bariatric surgery telemedicine study

Conditions: Obesity

Summary: the purpose of this study is to evaluate a new educational program for people who have recently had gastric bypass surgery. this program involves both the use of newly developed wireless home monitoring technology (medication box, weight scale, and pedometer) and telephone-based, individually tailored health counseling with a bariatric dietician.

obesity, defined as a body mass index (bmi) \>30 in kg/m2, has reached epidemic levels in the united states (us). morbid obesity, which is classified as a bmi\>=40, is the fastest growing obesity category. it has increased 52% between 2000 and 2005, to now affect 15 million us adults. morbid obesity is associated with serious medical co-morbidities, and these obesity-related diseases have a significant impact on the individual patient, as well as on our healthcare system as a whole. gastric bypass surgery is the only current effective treatment for mo. approximately 220,000 operations were carried out in 2008, making it one of the most commonly performed procedures in the u.s. the most common form (80%) of bariatric surgery performed in the u.s. is laparoscopic gastric bypass (lgb). while there has been considerable clinical focus on multidisciplinary pre-surgical screening regarding medical, behavioral, and psychosocial suitability of candidates for bariatric surgery, there is a paucity of post-surgical follow-up examining behavioral adaptation and adherence. the purpose of this study is to examine such post-surgical behavioral components that are relevant to weight loss surgery. specifically, the investigators will assess the feasibility, reliability, usability, and satisfaction of some newly developed wireless home monitoring technology (i.e., medication box, weight scale, and pedometer) in a group of patients who have recently had gastric bypass surgery. a prospective cohort study design will be conducted. questionnaire data will be collected and data analysis will be descriptive in nature.

Eligibility criteria:
inclusion criteria: * 6 weeks-1 year post gastric bypass surgery * \> 18 years of age * english-speaking and able to read and understand consent form and study questionnaires. * land line analog telephone service at home exclusion criteria: * suffered unexpected complications from surgery as judged by the surgeons * anyone judged not fit to participate in the study, as per the surgeon or dietician's clinical judgment * weight \>440 lbs. at enrollment (upper limit of our weight scale) * planning to relocate from the area within the next 2-3 months (i.e., during study timeframe)

Keywords: bariatric surgery gastric bypass surgery
pet/ct imaging of malignant brain tumors with 124i-nm404

Conditions: Glioblastoma; Brain Metastases

Summary: the purpose of this study is to evaluate diagnostic imaging techniques using 124i-nm404 pet/ct in humans with brain metastases and gbms. this goal will be accomplished by determining the optimal pet/ct protocol and comparing pet tumor uptake to mri and calculating tumor dosimetry. a future aim of this study will be to compare non-invasive pet/ct and mri findings with pathological specimens, which is the gold standard but is invasive and impractical in many cases, to determine the sensitivity and specificity of both techniques for accurately detecting tumor infiltration. the data obtained from this study will be used to develop larger diagnostic and therapeutic trials in brain tumors. the long-term goals of this research are to improve the diagnosis and treatment of malignant brain tumors by using radioiodinated nm404.


Eligibility criteria:
inclusion criteria: 1. participants will have a contrast enhanced brain mri which documents evidence of gbm or metastatic brain tumor 2. tumor size at least 1.5 cm in greatest axial dimension on mri. mri must be obtained within 2 months of study inclusion 3. female patients must not be pregnant or breast feeding and both women of childbearing potential, and men, must use appropriate means of contraception and must be maintained for at least 45 days after injection of i-124 nm404. participants must not attempt to become pregnant during this time 4. platelet count must be ≥ 160,000/µl, hematocrit must be ≥ 22%, leukocyte count must be ≥ 3,000/µl, creatinine must be ≤ 2.5 mg/dl, alt must be ≤ 130 u/l, ast must be ≤ 100 u/l, and urine or serum pregnancy test must be negative for pregnancy 5. karnofsky score ≥ 60 6. for brain metastases patients: targeted brain therapy (radiation or drug) must have concluded ≥2 months prior to injection of 124i-nm404 7. for gbm tumors confirmed by surgical biopsy or suspected by mri: no previous surgical resection (except for biopsy) or systemic or radiation therapy targeted to the gbm tumor - exclusion criteria: 1. life expectancy of \< 3 months 2. allergy to potassium iodide (sski or thyroshield) 3. planned surgical resection or biopsy after injection of 124i-nm404 and prior to completion of the 3rd pet/ct scan 4. unwilling or unable to complete 3 separate pet/ct imaging sessions of 90 minutes each over 3 days -
radiotherapy alone versus concurrent chemo-radiotherapy for nasopharyngeal carcincoma patients with undectable ebv dna after one cylce neoadjuvant chemotherpy

Conditions: Nasopharyngeal Carcinoma

Summary: the goal of this multicenter randomized non-inferior study is to compare radiotherapy alone versus concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose ebv dna drop to undetectable level after one cycle neoadjuvant chemotherapy using gp regimen. the main question it aims to answer is: the omission of concurrent chemotherapy is safe in the relatively good prognostic patients identified by the response of ebv dna. participants will be randomized to either radiotherapy alone or the standard treatment concurrent chemoradiotherapy if their ebv dna decrease to undetectable level post first cycle of neoadjuvant chemotherapy and don't rebound in the second and third cycle.


Eligibility criteria:
inclusion criteria: 1. patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of who ii or iii. 2. age 18-70 years. 3. clinical stage iii-iva (based on the 8th american joint committee on cancer\[ajcc\] edition). 4. patients with detectable pre-treatment plasma ebv dna but undetectable ebv dna after one cycle neoadjuvant and no ebv dna rebound during the second and third cycle. 5. ecog (eastern cooperative oncology group) score: 0-1 6. hemoglobin (hgb) ≥90 g/l, white blood cell (wbc) ≥4×109 /l, platelet (plt) ≥100×109 /l. 7. liver function: alanine transaminase(alt), aspartate aminotransferase(ast)\< 1.5 times the upper limit of normal value (uln), total bilirubin \<1.0×uln. 8. renal function: serum creatinine \<1×uln. 9. patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule. exclusion criteria: 1. histologically confirmed keratinizing squamous cell carcinoma (who i) 2. suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously. 3. receiving radiotherapy or chemotherapy or targeted therapy previously 4. women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 5. patients with significantly lower heart, liver, lung, kidney and bone marrow function. 6. severe, uncontrolled medical conditions and infections. 7. at the same time using other test drugs or in other clinical trials. 8. refusal or inability to sign informed consent to participate in the trial. 9. emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct
simulator training to improve interventional cardiologist skills (starters) trial

Conditions: Coronary Artery Disease

Summary: the goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes. the main questions it aims to answer are: * does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision? * will major and minor procedural complications be reduced after simulator-based training? interventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period. they will be supervised during their cath lab period as first operators by senior interventional cardiologists. during their first 50 procedures performed as supervised first operator, specific procedural data will be collected.


Eligibility criteria:
inclusion criteria: * specializing doctors who are about to start dedicated training in the interventional cardiology room * patients who must undergo coronary angiography examination. exclusion criteria: specializing doctors: * no interest in performing interventional cardiology procedures as first supervised operator (classical training) * experience as first supervised operator in interventional cardiology procedures * absence of informed consent patients: * acute coronary syndrome * severe left ventricular dysfunction with ejection fraction less than 30% * severe chronic renal failure (with glomerular filtration rate less than 30 ml/min) * absence of informed consent

Keywords: simulation training fellows coronary artery disease coronary angiography
combo-pep: multipurpose prevention of post-exposure prophylaxis regimens

Conditions: Sexually Transmitted Diseases

Summary: the study will determine tissue pharmacology of a single dose of doxycycline for sexually transmitted infection (sti) post-exposure prophylaxis (pep).

to determine tissue pharmacology of a single dose of doxycycline for sti pep, investigators at emory university will collaborate with the centers for disease control and prevention (cdc) to conduct a clinical trial of up to 20 men who have sex with men (msm) and women aged 18-59, with measurement of anti-retroviral drug and doxycycline concentrations in the rectum and vaginal regions.

Eligibility criteria:
inclusion criteria: 1. hiv negative person, who was assigned male or female at birth, who reports sex with another man in the last year and is in good general health 2. aged 18-59 years 3. not currently taking prep and no plans to initiate during study 4. not currently taking pep 5. not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study 6. willing to use condoms consistently for the duration of the study 7. able to provide informed consent in english 8. no plans for relocation in the next 4 months 9. willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure 10. willing to use study products as directed 11. hepatitis b surface antigen (hbsag) negative (screening lab test) 12. creatinine clearance \>60 ml/min exclusion criteria: 1. currently infected with hepatitis virus and/ or has liver disease 2. current or chronic history of kidney disease or creatinine clearance (crcl)\<60 ml/min 3. continued need for, or use during the 90 days prior to enrollment, of the following medications: 1. systemic immunomodulatory agents 2. supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators) 3. chemotherapy or radiation for treatment of malignancy 4. experimental medications, vaccines, or biologicals 4. intent to use hiv antiretroviral pre/post-exposure prophylaxis (prep or pep) during the study, outside of the study procedures 5. intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures 6. any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements 7. not pregnant and no plans on getting pregnant throughout the duration of the study 8. known allergic reaction to study drugs

Keywords: post-exposure prophylaxis hiv sti pep prevention
protective effect of n-acetylcysteine on early outcomes of deceased renal transplant

Conditions: Renal Transplantation

Summary: investigate the therapeutic effects of the antioxidant n-acetylcysteine on early outcomes of deceased renal transplant patients.

investigate the therapeutic effects of 600 mg bid po of n-acetylcysteine on early outcomes of deceased renal transplant patients regarding oxidative stress and renal function. adult primary graft recipients of deceased renal donors will be randomly assign to treatment (nac) or control group and prospectively evaluated for 90 days. treatment group will receive n-acetylcysteine 600 mg bid po from 0 to 7th postoperative day (po). renal function will be determined by serum creatinine, cockroft-gault estimated gfr (egfr) at 7th, 15th, 30th, 60th and 90th po and dialysis free kaplan-meier estimate curve. serum levels of thiobarbituric acid reactive substances (tbars), which are markers of lipid peroxidation and oxidative stress, will be determined using the thiobarbituric acid assay from 0-7th po. statistical analysis will be performed using spss 16.0.

Eligibility criteria:
inclusion criteria: * primary deceased renal transplant recipients * adult (\>18 yo) exclusion criteria: * unable to drink n-acetylcysteine during the first 7 po * participation in other study

Keywords: kidney transplantation oxidative stress acetylcysteine graft rejection
study of bb-031 in acute ischemic stroke patients (raise)

Conditions: Acute Ischemic Stroke

Summary: the purpose of this study is to evaluate the safety and tolerability of ascending doses (part a) and selected doses (part b) of bb-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset. participants will be randomized to receive one dose of either the investigational drug or placebo and will be followed for 90 days. a total of 156 patients are planned in this study.

this is a two-part, randomized, placebo-controlled, double-blinded study in acute ischemic stroke patients. in part a, approximately 36 participants will be randomized in a 3:1 ratio (investigational drug: placebo) into 1 of 3 planned ascending dose groups to determine the dose levels to be studied in part b. two dose levels will be chosen based upon a review of all available data including safety, pk, pd and preliminary efficacy. in part b, approximately 120 participants will be randomized in a 1:1:1 ratio to receive a single dose of two dose levels of study drug or placebo. all participants will be screened for participation after confirmed diagnosis of an anterior circulation ischemic stroke by neurovascular imaging. enrolled participants will be followed for 90 days. radiological outcomes will be assessed by a central blinded reviewer. a data safety monitoring committee will review safety and preliminary efficacy data throughout the study.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute ischemic stroke * 18 years or older * anterior circulation intra-cranial occlusion * onset of stroke symptoms within 24 hours of enrollment exclusion criteria: * large volume ischemic stroke * intracranial hemorrhage on baseline imaging or previous intracranial hemorrhage * chronic intracranial occlusion * weight \>125kg * administration of thrombolytic drug or glycoprotein iib/iiia inhibitors * ongoing clinically significant coagulopathy, history of bleeding disorder or other conditions for high-risk bleeding or active uncontrolled bleeding * prior stroke within 90 days * unable to undergo a contrast brain perfusion scan with either mri or ct

Keywords: stroke wake-up stroke large vessel occlusion intracranial hemorrhage
topical compound tripterygium wilfordii hook f for patients with active rheumatoid arthritis

Conditions: Active Rheumatoid Arthritis

Summary: rheumatoid arthritis (ra) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. it has been confirmed that tripterygium wilfordii hook f has effects of anti-inflammatory, immunosuppressive and cartilage protection. this is a prospective randomized controlled study to evaluated the efficacy and safety of external application with compound tripterygium wilfordii hook f in treating of patients with rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * documented diagnosis of rheumatoid arthritis, as defined by the american rheumatism association 1987 revised criteria or european league against rheumatism criteria (2009). * patients must have moderately to severely active ra,and the das-28 score should be from 3.2 to 5.1. * if taking disease modifying antirheumatic drug (dmards)(e.g.methotrexate), subject must have been on a stable dose for ≥ 3 months prior to randomization. * if taking non-steroidal anti-inflammatory drugs (nsaids), subject must have been on a stable dose for ≥ 4 weeks prior to randomization. * 16 to 65 years old, having signed the informed consent. exclusion criteria: * patients who have skin burst or allergies. * patients with sever diseases in cardiovascular, brain, lung, liver, kidney and hematopoietic system. * patients who have been treated by tripterygium, hormones or biological agents. * patients who have not been treated by dmards before. * patients who are unwilling to comply with all study procedures.
preoperative chemoradiotherapy combined with nimotuzumab for cervical cancer

Conditions: Locally Advanced Cervical Cancer

Summary: the purpose of this study is to determine the feasibility and efficacy of preoperative nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable, locally advanced cervical cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven squamous cell cervical cancer * stages ib2-iiib according to figo staging system * age:18-75 * ecog\<2 * normal bone marrow function * initial assessed and considered not candidates for operation * signed study-specific consent form exclusion criteria: * pregnant or lactating women * patients with other malignancies * patients who received radiotherapy or chemotherapy previously * presence of uncontrolled life-threatening illness * allergy to platinum or monoclonal antibody

Keywords: cervical cancer nimotuzumab intensity-modulated radiation therapy concurrent chemoradiotherapy
a clinical trial of the administration of light therapy to prevent and treat mouth sores in children with cancer

Conditions: Mucositis Oral

Summary: the goal of this clinical trial is to learn if light therapy can prevent and/or treat mouth sores in children with cancer. the main questions it aims to answer are: is it reasonable and acceptable to provide light therapy for children with cancer? does light therapy prevent and treat mouth sores related to medical treatment? researchers will compare children who did not receive light therapy before the clinical trial to children who receive light therapy during the clinical trial to see if light therapy helps to prevent and treat mucositis. participants will: * tell the nurse their pain score, related to their mouth sores, before receiving light therapy. * have picture taken of their mouth to look for mouth sores. * receive light therapy every other day while admitted to the hospital on the cancer unit or while admitted to an alternate unit.


Eligibility criteria:
inclusion criteria: * admitted to oncology unit, picu, or on an alternate acute care unit. * diagnosis: * following diagnoses until achieve count recover (anc≥500), the patient has no clinical signs of mucositis, or is discharged i. all interim-maintenance high dose methotrexate ii. all with trisomy 21 receiving high dose methotrexate iii. aml iv. neuroblastoma (excluding admissions for antibody treatment) v. burkitt lymphoma vi. osteosarcoma receiving high dose methotrexate vii. germ cell tumors receiving etoposide viii. rhabdomyosarcoma ix. ewing sarcoma * head/neck cancers receiving radiation * able to speak and understand english or spanish exclusion criteria: * unwilling to participate * do not meet eligibility criteria outline above

Keywords: photobiomodulation mucositis oral mucositis
innovative measures of speech and swallowing dysfunction in neurological disorders

Conditions: Amyotrophic Lateral Sclerosis (ALS); Myasthenia Gravis; Myopathies; Stroke; Parkinson's Disease

Summary: this study is evaluating the use of two painless, non-invasive technologies in the assessment of muscle health over time in both healthy volunteers and patients who have diseases that affect the nervous system.

speech and swallowing abnormalities are important symptoms associated with disorders of the central nervous system, motor neuron disease (such as amyotrophic lateral sclerosis), myasthenia gravis, and primary muscle conditions. in addition to characterizing the evolution in muscle architecture that could underlie associated orofacial weakness, identifying new ways to measure these abnormalities is critical to the development and testing of novel treatment approaches. as painless, non-invasive, portable technologies, quantitative ultrasonography (qus) and electrical impedance myography (eim) could meet the need for objective measures of speech and swallowing dysfunction. in qus, acoustic energy is applied to a muscle of interest; the resultant pictorial data are translated into a single value that reflects the health of the imaged muscle. similarly, in eim, a high-frequency, low-intensity alternating electrical current is applied to individual muscles, and the resulting voltages measured. impedance values reflect changes in muscle architecture, including fiber atrophy, inflammation, and the replacement of muscle with fat or connective tissue. both of these user-friendly methods can provide sensitive indicators of neuromuscular disease status when applied to the limbs. although they have also been used to evaluate orofacial muscles in healthy volunteers and patients with primary muscle disorders, they have not yet been systematically studied in patients with a range of neurological conditions. when applied to muscles of the face and tongue, such tools could 1. improve accuracy of early diagnosis; 2. allow monitoring of speech and swallowing dysfunction over time; 3. help individualize care; and 4. serve as biomarkers in clinical trials. we propose that qus and eim will provide convenient, reliable, clinically meaningful surrogate markers of orofacial dysfunction in a variety of neurologic conditions.

Eligibility criteria:
inclusion criteria: * established, or clinically probable, neurologic diagnosis with at least the potential for associated bulbar dysfunction * age 20-90 years exclusion criteria: * history or presence of a medical condition that substantially impacts bulbar function * age under 20 or over 90 years

Keywords: als myasthenia gravis myopathy stroke parkinson's disease bulbar orofacial ultrasound electrical impedance myography