Kornimate/medical-research-clean huggingface dataset:
hydroxychloroquine in individuals at-risk for type 1 diabetes mellitus

Conditions: Type1 Diabetes Mellitus

Summary: the study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. subjects will receive hydroxychloroquine or placebo and close monitoring for progression of t1d.

this study is testing a medication, called hydroxychloroquine (hcq) to assess safety and effectiveness to prevent individuals at risk of type 1 diabetes (t1d) from progressing to type 1 diabetes. hcq is approved by the u.s. food and drug administration as a treatment for malaria, lupus, and rheumatoid arthritis. hcq has been used extensively for treatment of autoimmune disease in adults, children, and during pregnancy. this medication has not previously been studied as a treatment to prevent t1d. the goal of this study is to learn if hcq can help prevent or delay progression from normal glucose tolerance (stage 1) to abnormal glucose tolerance (stage 2) or type 1 diabetes (stage 3). the study involves 5 visits in the first 6 months, then 1 visit every 6 months for the remainder of the study.

Eligibility criteria:
inclusion criteria: 1. participant in trialnet pathway to prevention study (tn01) 2. age 3 years or greater at the time of randomization 3. willing to provide informed consent 4. normal glucose tolerance by ogtt within 7 weeks (no more than 52 days) of baseline 5. two or more diabetes-related autoantibodies present on two separate samples 6. weight of 12 kg or greater at screening 7. if a female participant with reproductive potential, willing to avoid pregnancy and undergo pregnancy testing prior to randomization and at each study visit 8. anticipated ability to swallow study medication. exclusion criteria: 1. abnormal glucose tolerance or diabetes 2. history of treatment with insulin or other diabetes therapies 3. ongoing use of medications known to influence glucose tolerance 4. ongoing or anticipated future use of medications known to have untoward interactions with hydroxychloroquine 5. known hypersensitivity to 4-aminoquinoline compounds 6. g6pd deficiency 7. history of retinopathy 8. have an active infection at time of randomization 9. have serologic evidence of current or past hiv, hepatitis b (positive for hepatitis b core antibody or surface antigen), or hepatitis c infection 10. deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged qt interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk. 11. deemed unlikely or unable to comply with the protocol or have any complicating medical issues, including prolonged qt interval, a disease previously or likely in the future to require immunosuppression, or abnormal clinical laboratory results that interfere with study conduct or cause increased risk. 12. be pregnant or breastfeeding.

Keywords: trialnet
eye-tracking fp "a pilot study of the quantitative evaluation of the attention paid to faces with facial palsy by the eye-tracking technology.

Conditions: Eye-tracking; Facial Palsy

Summary: the facial palsy concerns between 15 and 40 people per 100000 inhabitants. they are of various etiologies such as infectious, tumoral, traumatic or idiopathic. it has variable severities with sometimes heavy functional repercussions and different recovery potentials. the proposed palliative treatments are based on surgery, physiotherapy and botulinum toxin injections. however, when recovery is incomplete, acceptance is more difficult, with an impacted quality of life. in this context, patients' expectations and feelings about their care may become difficult for clinicians to apprehend. the eye-tracking is widely used in the marketing field, but it also finds medical applications including head and neck lesions and facial palsy in particular. published studies focus on the gaze of photographs, excluding any notion of dynamics and by the analysis of the gaze of outside observers, ignoring the patient's gaze.the main objective is to evaluate the attention paid to the facial side with abnormal facial movement by patients with facial paralysis compared to healthy volunteers.


Eligibility criteria:
inclusion criteria: * for patient with facial paralysis: * patient with peripheral facial palsy, irrespective of grade, whether or not previously treated * patient providing written informed consent * patient aged ≥ 18 years * patient affiliated to a social security system * for healthy voluntary subject : * subject without major facial sequelae * subject who provided written informed consent * major subject ≥ 18 years old * subject affiliated to a social security system exclusion criteria: * for patient with facial paralysis: * patient with recent peripheral facial palsy whose total recovery is possible * patient unable to provide written informed consent * patient with difficulties to follow instructions and especially to stand in front of a computer screen * minor patient \<18 years * patient under guardianship or curators or judicial safeguard * for healthy voluntary subject : * subject with major facial sequelae * subject not able to provide written informed consent * subject presenting difficulties in following instructions and in particular in standing still in front of a computer screen * minor subject \< 18 years old * subject under guardianship or curators or judicial safeguard

Keywords: facial mimics eye-tracking facial palsy
acute effects of exercises combined with blood flow restriction in healthy individuals

Conditions: Healthy Individuals

Summary: purpose of the study is; to investigate the acute effects of exercises combined with blood flow restriction on strength, proprioception and functional motor performance in healthy individuals. the investigators hypothesized that blood flow restriction exercises has a positive effect on strength, proprioception and functional motor performance.

60 healthy individuals will randomized into 3 groups of 20 people each. participants will be held in a familiarization session before 3-4 days the actual evaluation. elbow bending exercises with blood flow restriction will be performed to the blood flow restriction (bfr) group, elbow bending exercises without blood flow restriction will be performed to the exercise group and control group will not receive any interventions. participants will be evaluated before and after the exercise session. control group is going to rest for 10 minutes before the second evaluation. evaluation protocol includes; muscle strength measurement with digital hand dynamometer, shoulder and elbow proprioception evaluation with inclinometer, upper extremity closed kinetic chain stabilization test, functional throwing performance index and modified pull-up test.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-40 * do not smoke * having full range of motion in neck, shoulder, and elbow * body mass index (bmi)˂30 kg/m2 * able to complete the entire study procedure exclusion criteria: * having fracture and surgical history for the upper extremity, cervical or thoracic area * having any systemic musculoskeletal disease * having neck and upper extremity pain * having a diagnosis of scoliosis and chest deformity * regularly playing sports with overhead activities (tennis, volleyball, handball, etc.) * have been exercising regularly for the last 6 months * a history of anemia * a history of cerebrovascular disease or myocardial infarction

Keywords: blood flow restriction acute
intravenous immune globulin (ivig) to prevent neonatal infection

Conditions: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Sepsis

Summary: a controlled clinical trial was conducted at eight participating centers between january 1, 1988, and march 31, 1991. patients were randomly assigned to an intravenous immune globulin group or a control group. there were two phases to the study (see below). during phase 1 the control infants received infusions of placebo. during phase 2 the control infants received no infusion therapy.

although survival rates for very-low-birth-weight infants (≤ 1.5 kg) continue to increase, nosocomial infections remain a major cause of morbidity and mortality. prolonged hospitalization with exposure to resistant organisms and multiple invasive procedures, in the presence of immunologic immaturity, renders these infants vulnerable to hospital-acquired infections. prior studies testing the ability of intravenous immune globulin to prevent nosocomial infections in premature infants have varied in design and sample size. despite differences in the rates of observed infection, immune globulin preparations, doses, and infusion intervals, a meta-analysis of published reports suggests that nosocomial infections may be diminished by the prophylactic infusion of igg. the national institute of child health and human development (nichd) neonatal research network therefore performed a prospective, multicenter, randomized trial at eight participating centers to test the hypothesis that the intravenous administration of immune globulin to infants with birth weights between 501 and 1500g would reduce the incidence of nosocomial infections. patients were randomly assigned to an intravenous immune globulin group or a control group. during phase 1 the control infants received infusions of placebo. during phase 2 the control infants received no infusion therapy.

Eligibility criteria:
inclusion criteria: * all neonates with birth weights of 501 to 1500 g exclusion criteria: * more than 72 hours old * one of three or more fetuses from a multiple pregnancy * had infections associated with toxoplasma, rubella, cytomegalovirus, and herpes simplex viruses (the torch complex) * has a major congenital malformation, an identifiable syndrome, or a chromosomal abnormality * were considered nonviable * parental consent could not be obtained

Keywords: nichd neonatal research network extremely low birth weight (elbw) prematurity septicemia meningitis urinary tract infection immune globulin
proton pencil beam scanning grid for treatment of bulky tumors

Conditions: Sarcoma; Melanoma

Summary: this is a single arm, phase i study, evaluating the feasibility, toxicity, and degree of tumor response after novel proton pencil beam scanning (pbs grid) treatment in patients with bulky tumors that are difficult to manage.

the proton group at sibley memorial hospital has developed a new method for multi-beam proton delivery making it possible to arrange and optimize grid dosimetry and normal tissue sparing compared to other similar techniques. in this phase i pilot study, patients with bulky tumors will receive this novel method of grid-therapy also called spatially-fractionated radiotherapy which involves delivering high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor and is often aligned in a grid pattern. in so doing, this study will ascertain the feasibility, safety and tumor response i.e. shrinkage and resectability of this treatment. ultimately, the goal is to improve local outcomes of patients with bulky tumors and to offer new treatment options for patients with difficult-to-manage bulky tumors.

Eligibility criteria:
inclusion criteria: * age \> 18 * histologically or cytologically confirmed invasive cancer * bulky tumor \> 7 cm, determined clinically and/or radiographically, at the time of evaluation prior to enrollment * treated indicated for palliative intent * eastern cooperative oncology group (ecog) performance status \< 2 * anticipated treatment deemed safe on pre-review by pi * for patients with prior radiation therapy (rt): dicoms must be available for dose fusion if overlap anticipated with grid * willing and able to provide informed consent * discussion with medical oncology or surgical specialty exclusion criteria: * age \< 18 * ecog performance status 3-4 * planned for definitive, curative management * for patients with prior rt that overlaps with pro-grid: dicoms not available pregnant women * tumor encasing critical structure, as defined by the treating md.

Keywords: spatially-fractionated radiotherapy grid-therapy proton therapy sarcoma melanoma treatment resistant tumors
changes of ocular structures after hemodialysis in patients with chronic kidney diseases

Conditions: Chronic Kidney Diseases; Hemolysis

Summary: to evaluate the effect of hemodialysis on various ophthalmologic parameters in patients with end-stage kidney disease (esrd).

subjects: patients with esrd undergoing hemodialysis at the dialysis center of hanyang guri hospital ocular parameters: visual acuity, intraocular pressure, axial length, oct other systemic parameters: body weight, ultrafiltration volume, and systolic/diastolic blood pressure all measurements were performed near the dialysis center. measurements were performed on monday (for patients who underwent dialysis sessions on monday, wednesday, and friday) or tuesday (for patients who underwent dialysis sessions on tuesday, thursday, and saturday. all parameters were measured before and after the hemodialysis.

Eligibility criteria:
inclusion criteria: * 1) patients who are regularly dialyzed in our dialysis room to participate in the study * 2) patients who agree with our study protocol * 3) patients who have unstable general condition exclusion criteria: * 1) previous intraocular surgery, (2) baseline iop greater than 22 mmhg, (3) presence of glaucomatous optic disc changes including excavation, thinning, or notching of the neuroretinal rim, (4) axial length greater than 26 mm, and (5) combined macular and retinal diseases such as central serous chorioretinopathy and age-related macular degeneration, except diabetic retinopathy.
trial on the safety and efficacy of mls-101 in patients with uncontrolled hypertension

Conditions: Hypertension, Renal

Summary: a randomized, double-blind, placebo-controlled, dose-ranging, phase ii study to evaluate the safety, efficacy, and tolerability of mls-101 in subjects with uncontrolled hypertension


Eligibility criteria:
inclusion criteria: 1. male and nonpregnant, nonlactating female subjects ≥ 18 years of age. 2. written informed consent health insurance portability and accountability act authorization, and local patient privacy required documentation for this study have been obtained 3. automated office blood pressure (aobp) with sbp ≥ 130 mm hg 4. background antihypertensive treatment of ≥ 2 drugs 5. serum cortisol ≥ 18 mcg/dl exclusion criteria: 1. concomitant use of epithelial sodium channel inhibitors or mineralocorticoid receptor antagonists 3. subjects with hypokalemia 4. subjects with hyperkalemia 5. subjects with serum cortisol \< 3 mcg/dl 6. subjects with serum sodium \< 135 meq/l 7. subjects with estimated glomerular filtration rate \< 60 ml/min/1.73m2 8. subjects with type 1 or uncontrolled (hemoglobin a1c ≥ 9%) type 2 diabetes mellitus 9. subjects with body mass index \> 40 kg/m2 10. subjects with unstable angina 11. subjects with sbp ≥ 175 mm hg or dbp ≥ 100 mm hg for part 1 and sbp ≥ 160 mm hg or dbp ≥ 100 mm hg for part 2 at pre-screening, screening/start of placebo run-in, or randomization 12. subjects with a decrease in sbp ≥ 20 mm hg or dbp ≥ 10 mm hg from sitting to standing position at screening 13. subjects who, in the opinion of the investigator, have suspected nonadherence to antihypertensive treatment 14. subjects who, in the opinion of the investigator, have any major medical illness or symptoms 15. subjects who, in the opinion of the investigator, have any acute or chronic medical or psychiatric condition 16. subjects undergoing treatment with any of the following medications: 1. topical corticoids 2. sympathomimetic decongestants 3. theophylline 4. phosphodiesterase type 5 inhibitors 5. nsaids 6. intramuscular steroids 7. estrogen 8. cytochromes 9. strong cyp3a and cyp3a4 inducers 17. subjects with known hypersensitivity to mls-101 or any of the excipients 18. subjects who are night-shift workers

Keywords: blood pressure uncontrolled hypertension phase ii
magdi u.s. registry

Conditions: Anastomosis, Surgical; Internal Hernia; Bowel Obstruction

Summary: assess the incidence and severity of internal hernia and bowel obstruction at one year in a u.s. population following use of the magdi system to create side-to-side duodeno-ileal anastomoses.

small bowel obstruction (sbo) following various abdominal and pelvic surgeries (0.4% - 13.9% at 5 years post-surgery) across obese and non-obese patients has been well studied in the scientific literature and found to be primarily due to intraperitoneal adhesions, with surgical technique (open surgery versus laparoscopic) cited as a key risk factor as reported in a retrospective population-based registry in sweden (n=108,141). sbo incidence was reported as 3.2% for those undergoing bariatric surgery (n=1,896). given the magdi system premarket clinical study (gtm-001) was conducted outside the u.s., fda requires one post-market surveillance study to assess and characterize the incidence and severity of internal hernia and bowel obstruction in the u.s. intended use population treated with magdi system. this study will be conducted through an observational patient registry and compare registry data to the premarket magdi system clinical study data (gtm-001) and scientific literature. this post-market registry study was also a condition of the magdi system fda 510(k) clearances k242086 and k243359.

Eligibility criteria:
inclusion criteria: 1. \>21 years of age, at the time of informed consent. 2. body mass index (bmi) between 30-50 kg/m2. 3. indicated for a side-to-side duodeno-ileal anastomosis and is treated with the magdi system at a u.s. registry center. 4. participant has been informed of the nature of the registry. exclusion criteria: 1. participant does not provide informed consent to be enrolled and followed in the registry.

Keywords: gt metabolic magdi system magnetic anastomosis
artificially sweetened beverage feeding study

Conditions: Cardiovascular Disease

Summary: the aims of the study are to conduct a pre- and post- two week feeding study of artificial sweetened beverage consumption in middle-aged women. the study will also compare metabolic profiles before and after artificially sweetened beverage consumption.

the aims of the study are to: 1. to conduct a pre- and post- two week feeding study of artificially sweetened beverage (asb) in women. 2. to assess the general levels of asb consumption. 3. to compare metabolic profiles before and after beverage consumption

Eligibility criteria:
inclusion criteria: • healthy women exclusion criteria: • having a history of diabetes or cardiovascular disease and any other health or chronic condition that precludes participation in the study.
relationship of helicobacter pylori eradication therapy and long-term outcome in acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: objective: to investigate the relationship between helicobacter pylori (hp) infection and the prognosis of acute coronary syndrome (acs) in a chinese population and to explore the significance of hp eradication therapy in preventing major adverse cardiac events (mace) and upper gastrointestinal bleeding (ugib) in patients on dual antiplatelet treatment. methods: to analyze 472 acs patients with drug-eluting stent (des) implantation from january 1, 2008 to december 31, 2010 in the department of cardiology at beijing mentougou district hospital. patients were divided into three groups: group 1, the hp-negative patients (hp-); group 2, the hp-positive patients with eradication therapy (hp+ therapy); and group 3, the hp-positive patients without eradication therapy (hp+ no therapy). all patients took 13c urea breath test, high sensitive c-reactive protein (hs-crp)，homocysteine (hcy) and other biochemical indicators. the investigators explored the correlations of hp eradication therapy with mace (including recurrent myocardial infarction, revascularization and death) and ugib after 3 to 5 years of follow-up using survival analysis.

this study is a single-center and random analysis. the consecutive hospitalized patients with acs at beijing mentougou district hospital from january 1, 2008 to december 31, 2010 were enrolled. figure 1 is a flow diagram of the trial. there were 259 males (54.9%) and 213 females (45.1%) with an average age of 61.1 ± 11.0 years. patient's history, physical examination, and laboratory results were recorded. all patients were divided into the hp-negative group (hp-, group 1.) and the hp-positive group (hp+). the hp+ group were randomly divided into two groups: group 2, the hp+ with eradication therapy (hp+ therapy); and group 3, the hp+ without eradication therapy (hp+no therapy).

Eligibility criteria:
inclusion criteria: * patients were diagnosed acute coronary syndrome according to the 2012 esc guidlines. * all the patients took dual antiplatelet therapy after implanting drug eluting stent (des) during hospitalization and had no any digestive symptoms. exclusion criteria: * subjects who had suffered gastrointestinal bleeding within one week. * subjects had a history of gastrectomy, cardiac insufficiency, thyroid dysfunction, and any ongoing infections were eliminated. * patients with the use of antibiotics, bismuth, or sucralfate within one month and without impanting des because of acs during hospitalization were also excluded. * those who had gastrointestinal symptoms, such as acid reflux, heartburn, nausea, vomiting, stomach ache and diarrhea, or had a confirmed peptic ulcer with hp infection were excluded because these patients may be taken gastroenterology treatment.

Keywords: helicobacter pylori eradication therapy major adverse cardiac events long-term outcome to explore the significance of hp eradication therapy in preventing major adverse cardiac events (mace) and upper gastrointestinal bleeding (ugib).
effectiveness of the pelican instrument in medical care

Conditions: Asthma

Summary: the objective of this project is to establish the effectiveness of implementation of a self-administered electronic asthma-specific quality of life instrument for childhood asthma in primary care and specialist care.

health related quality of life (hrql) is important to the asthmatic child and if hrql aspects are taken into account in daily care this could result in improved treatment satisfaction, compliance, asthma control and, ultimately, improved hrql. the pelican instrument we have developed has the essential features to be useful in daily care. in this study, the effectiveness of implementing the pelican instrument in medical care is assessed. an intervention study with 9 months follow-up in primary and secondary care will be carried out.

Eligibility criteria:
inclusion criteria: * age 6 to 12 years * physician-diagnosed asthma * use of bronchodilators and / or inhaled corticosteroids for at least six weeks during the previous year * child is treated for its asthma by the recruiting physician * signed informed consent by parent (or caretaker) * child agrees to participate in the study exclusion criteria: * comorbid condition that significantly influences hrql * child does not master the dutch language sufficiently * not being able to attend a regular school class

Keywords: asthma health-related quality of life patient-centred care
safety and efficacy of vec-162 on circadian rhythm in healthy adult volunteers

Conditions: Circadian Rhythm Sleep Disorders

Summary: the purpose of this study is to assess the safety and efficacy of vec-162 compared to matching placebo on circadian phase shift and sleep parameters.


Eligibility criteria:
inclusion criteria: * no medical, psychiatric, or sleep disorders * ability to provide written informed consent exclusion criteria: * lifetime history of night shift work * evidence of any sleep disorder * psychiatric or neurological disorders