Kornimate/medical-research-clean huggingface dataset:
an open-label trial of intravenous immune globulin (ivig)in treating spinocerebellar ataxias

Conditions: Spinocerebellar Ataxias

Summary: the purpose of this study is to learn how intravenous immune globulin (ivig) will affect spinocerebellar ataxia (sca) symptoms and how it will affect motor and nervous system function in participants subtypes of sca to be examined will include sca types 1, 2, 3, 6, 10 and 11.


Eligibility criteria:
inclusion criteria: * outpatients with sca types 1, 2, 3, 6, 10, or 11, diagnosed by a movement disorder specialist. * age 18 years to 80 years. * able to ambulate with or without assistance for 30 feet. * women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study. * serum creatine kinase, complete metabolic panel, complete blood count, liver function tests, renal function tests, platelets and ekg do not reveal clinically significant abnormalities (results obtained from primary care physician and dated within the past 6 months or obtained at screening visit). * stable doses of all medications for 30 days prior to study entry and for the duration of the study. * diagnosis of peripheral neuropathy. see exclusion criteria 3 for specific types of peripheral neuropathy to be excluded. * throughout the study, all possible efforts will be made to maintain subject levels of activity, exercise or physical therapy. * subject permission (informed consent). exclusion criteria: * any unstable illness that in the investigator's opinion precludes participation in this study. * use of any investigational product within the past 30 days. * presence of diabetes (as determined by blood glucose labs within the past 6 months), nutritional deficiency causing neuropathy (vitamin b1, 3, 6, and 12 or vitamin e), injuries, autoimmune disorders (hiv, lupus, pediatric guillain-barre syndrome, neurosarcoidosis, monoclonal gammopathy), tumors, infections (leprosy), exposures to toxins (alcohol, arsenic, mercury), thyroid disease or hereditary causes (cerebral amyloid angiopathy) known to result in the presence of peripheral neuropathy. * dementia or other psychiatric illness that prevents the subject from giving informed consent (mmse less than 25). * legal incapacity or limited legal capacity. * presence of severe renal disease (estimated creatinine clearance \<50 ml/min) or hepatic disease (as evidenced by labs reported within the past 6 months). * clinically significantly abnormal white blood cell count, hemoglobin or platelet count (as evidenced by labs reported within the past 6 months). * immunoglobulin a, vitamin b (1, 3, 6, or 12), vitamin e or folate deficiencies (evidenced by screening lab evaluations).
arthritis self-management education program

Conditions: Arthritis

Summary: we will develop brief versions of the classic 6-week arthritis self-management program and evaluate their effectiveness.

many national statements have been made recently about the importance of evidence-based arthritis self-management to improvements in the public's health. the prevalence of arthritis is increasing as the us population ages; the prevalence of arthritis-related disability is higher among blacks than whites. effective arthritis self-management education programs with varying formats have been developed and found effective. despite this, many arthritis foundation chapters and arthritis units of state health departments have found dissemination difficult, and cite the time demands (6 weekly sessions, 2 hours/session) of the classic arthritis self-management education program (asmp) as a major barrier. researchers at the university of north carolina at chapel hill and stanford university will develop and evaluate two "low dose" arthritis self-management programs. the study will be conducted in three phases. phase one (development): researchers will conduct needs assessments with arthritis self-management program disseminators, rheumatologists and other arthritis health professionals, and potential program users to determine preferred content, length, and schedule. using findings from these assessments, researchers will develop two "low dose" versions of the asmp. phase two (implementation and evaluation): researchers will evaluate the "response" (effectiveness) of both "low dose" interventions in a randomized controlled trial (4 months) and a longitudinal study (one year). we will measure four outcomes: (1) self-management behaviors, (2) arthritis self-efficacy, (3) health-related quality of life (self-reported health, pain, disability, fatigue, activity limitation, and health distress); and (4) health care utilization. a sample of 700 adults with diagnosed arthritis or chronic joint pain, including 200 african americans, will participate in the study. all data will be gathered via self-administered mailed questionnaires, with telephone follow-up as needed. we will use analysis of co-variance and structural equation modeling to evaluate effectiveness. researchers will also compare the effectiveness of each new "low dose" program with the effectiveness of existing arthritis self-management education program options. phase three (dissemination): we will consult with arthritis units of state health departments and state chapters of the arthritis foundation on program adoption and distribution.

Eligibility criteria:
inclusion criteria: * adults, 18 years or older * arthritis diagnosis * no prior participation in arthritis self-management

Keywords: disease self-management community programs
resolute onyx post-approval study (bifurcation cohort)

Conditions: Coronary Artery Disease

Summary: to observe the continued performance of the medtronic resolute onyx™ zotarolimus-eluting coronary stent system in a real-world more-comer population. to collect data on the safety and efficacy of the medtronic resolute onyx™ zotarolimus-eluting coronary stent system in bifurcated lesions.


Eligibility criteria:
key inclusion criteria * symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-st elevation and st-elevation myocardial infarction * subject is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's instructions for use, and the declaration of helsinki * subject requires treatment of a single de novo bifurcated lesion amenable to treatment with resolute onyx using the provisional stenting technique exclusion criteria: * unprotected left main disease * subjects with planned pci of three vessel disease * planned two stent technique (main branch and side branch) of a bifurcation * subjects with more than one bifurcation lesion
immunological changes through narrative treatment of post-traumatic stress disorder (ptsd) in torture victims

Conditions: PTSD

Summary: posttraumatic stress disorder (ptsd) is associated with poor health, high health care utilization, and an increased risk for a variety of somatic, inflammatory and autoimmune diseases. research, including our own findings, indicates immunological alterations in ptsd patients. the aim of this study is to investigate whether alterations in the immune system of ptsd patients are reversible through a trauma-specific short-term therapy (narrative exposure therapy).


Eligibility criteria:
inclusion criteria: * ptsd diagnosis * experiences of organized violence/torture exclusion criteria: * psychotic disorder * chronic inflammatory diseases

Keywords: ptsd narrative exposure therapy torture victims immune system
treatment of nighttime pruritus in atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study will look at melatonin vs. first generation antihistamine vs. placebo in improving nighttime itching in children with atopic dermatitis.

this will be a 6 week study to determine the efficacy of melatonin vs. first generation antihistamine vs. placebo in improving nighttime pruritus in children with atopic dermatitis. secondary aims will include: 1. determine efficacy of melatonin vs. first generation antihistamine in management of sleep disturbance in children with atopic dermatitis 2. compare differences between treatment groups in disease improvement 3. compare differences between treatment groups in quality of life

Eligibility criteria:
inclusion criteria: * physician diagnosed eczema covering more than 5% of body surface area * ages 2-12 years old exclusion criteria: * sleep disorder, including underlying insomnia * neuropsychiatric disorder * condition that requires use of antihistamines * on systemic eczema therapy or monoclonal antibody for allergic diseases * unable to discontinue other antihistamine use * autoimmune disease as melatonin is contraindicated
anxiety disorders, depression and related factors in pcos

Conditions: PCOS

Summary: polycystic ovary syndrome (pcos) is a systemic neuro-endocrine-metabolic-reproductive disorder, common in women of reproductive age, affecting 21.27% of women worldwide and the rate of pcos has been increasing over the past decade. women with pcos have many health problems, including insulin resistance, hyperandrogenemia, and ovulation disorders. moreover, pcos is also associated with significant consequences such as increased risk of cardiovascular disease, glucose intolerance and diabetes mellitus (both type 2 and gestational), increased risk of endometrial hyperplasia and endometrial cancer and mental health disorders. a meta-analysis of 57 studies has been reported that women with pcos are more likely to have an increased risk of diagnosis of depression, anxiety, bipolar disorder, and obsessive-compulsive disorder. these psychological disorders may be related to biometric and biochemical characteristics in women with pcos, such as body image, hirsutism or acne. furthermore, researches showed that waist-to-hip ratio and plasmatic levels of testosterone is inversely related to anxiety, psychoticism, hostility and to the indexes of psychological distress. psychological consequences may also be related to other factors, including stigmatization and isolation, the lack of empathy from family and friends, the feeling of guilt and the diminished sense of self-worth, the costs of treatment and treatment outcomes. however, there has been no data on the psychological disorders in infertile women with pcos. therefore, the study aimed to determine the prevalence of anxiety disorders, depression in infertile women with pcos and associated factors.

* this trial will be conducted at my duc hospital, ho chi minh city, viet nam. * women who are potentially eligible will be provided information about the study purposes, procedures, related risk and benefits * screening for eligibility will be performed on the day of the first visit when diagnosis about pcos is established. * patients will be provided information related to the study together with the informed consent documents. signed informed consent forms will be obtained by the investigators from all women before the enrolment. * all patients selected for this study will answer the questionares and complete the gad-7 gad-7 (general anxiety disorder-7) and phq-9 (patient health questionnaire-9) following careful instruction on how to complete the instrument by investigator in a private room without the presence of their husband. * the survey will last about 15 minutes. if the result of the gad-7 and phq-9 suggested anxiety disorders, depression, the patient will refer to specialists for further assessment and treatment.

Eligibility criteria:
inclusion criteria: * infertile vietnamese women * reporting pcos according to rotterdam 2003 * agreement to participate in the study exclusion criteria: * having a family history of neuropsychiatric disease * patients who are deaf, blind, or born dumb * patents cannot understand vietnamese

Keywords: infertile women pcos anxiety disorders depression
comparative-effectiveness of a healthy lifestyle and asthma management program, in-person vs. online

Conditions: Overweight, Childhood; Obesity, Childhood; Asthma in Children

Summary: the goal of this study is to evaluate the effectiveness of champion ("comparative-effectiveness of a healthy lifestyle and asthma management program, in-person vs online"), a primary care-based intervention to address childhood obesity and asthma, and test the effectiveness of a telehealth-only version of the program. intensive health behavior and lifestyle treatment (ihblt), when delivered via telehealth vs. in-person among children with overweight or obesity and persistent asthma.

this study will evaluate the comparative effectiveness of 1) telehealth delivery of champion vs. 2) in-person (standard of care) delivery of champion in a two-arm, individually randomized non-inferiority trial among 500 children. obesity and asthma are two leading chronic diseases in children, and champion is an integration of the healthy weight clinic (hwc) and pediatric asthma population health management programming at mass general brigham. this study will address how to improve access to effective treatments consistent with united states preventive services task force (uspstf) and american academy of pediatrics (aap) guidelines that manage asthma and obesity concurrently in primary care among lower income diverse populations

Eligibility criteria:
caregiver-proxies will be 18 years old or older, english or spanish speaking, and a primary caregiver of a child meeting the following criteria: inclusion criteria * age 6-17.9 years at time of screening * bmi ≥ 85th percentile * asthma diagnosis, per child's electronic health record (ehr) documentation or caregiver report exclusion criteria * diagnosis of anorexia nervosa, per child's ehr or caregiver report * pregnant, per child's ehr * plan to change pediatricians in the next year, per caregiver report * opted out of research, per child's ehr * sibling currently enrolled in the research trial, per enrollment log or caregiver report

Keywords: telehealth
long-acting injectable naltrexone treatment of alcohol dependence in primary care vs. in specialized chemical dependence treatment: a pilot trial

Conditions: Alcohol Dependence; Veterans

Summary: the goal of the proposed project is to improve the primary care treatment of veterans with alcohol dependence. alcohol dependence is a common behavioral health problem among veterans treated in va primary care clinics. however, assessment and treatment of alcohol dependence in primary care remains problematic. assessment of veterans with positive alcohol use screens may not always be completed and referrals to specialty care may not always be made. moreover, the use of medications for alcohol dependence among veterans is rare, despite va treatment guidelines that recommend such use. finally, when medications are prescribed, patients may have difficulties with adherence. the primary aim of this study is to assess the feasibility of long-acting injectable naltrexone provided through primary care (lan/pc) versus long-acting injectable naltrexone in the specialized chemical dependence clinic (lan/cdc). the secondary aim is to obtain preliminary assessments of the relative effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.


Eligibility criteria:
inclusion criteria: * participants must be males or non-pregnant females between the ages of 18 and 69 who are receiving their primary medical care at the syracuse vamc. * participants must meet dsm-iv diagnostic criteria for current alcohol dependence. * participants must report drinking within the thirty days prior to study entry. * participants must receive approval from their primary care provider for study participation. * participants must be willing to consider accepting at least one of the two treatment conditions. exclusion criteria: * participants with a current dsm-iv diagnosis of current opioid abuse or dependence, or in opioid withdrawal * ast level is greater than 3 times the upper limit of the normal range * participants with a medical condition requiring opioid medication or a severe allergy to naltrexone * participants who received outpatient treatment at the syracuse va chemical dependence clinic in the past 90 days * any unstable medical or psychiatric conditions in the judgment of the principal investigator or the participants primary care provider

Keywords: alcohol veterans primary care naltrexone
study of dietary phosphate and mineral homeostasis in early chronic kidney disease

Conditions: Kidney Diseases

Summary: this study is designed to describe the physiological response to increased and decreased dietary phosphate intake on various parameters of mineral metabolism in the blood and urine of individuals with chronic kidney disease stage 3 and 4 with normal serum phosphate levels. this detailed study will give us a far greater understanding of the role of diet in abnormal mineral homeostasis early in the progression of this chronic disease. the findings of this study will help both physicians and dietitians better determine the optimal time to introduce dietary therapy in ckd.

the potential benefits of implementation of phosphate management earlier in ckd (stages 3/4) are threefold: 1) prevention of vascular damage early in the progression of ckd thus reducing risk of cardiovascular death 2) improved management of renal bone disease and resultant co-morbidities and 3) slowing the progression of renal failure lengthening the time required till dialysis is required. although dietary counseling is currently a normal part of ckd care, the utility and effectiveness of lowering phosphate has not previously been quantified. in part this is due to the difficulty of measurement of serum phosphate as it is so tightly controlled before gfr falls below 30mls/min. no studies have investigated whether is it possible to modulate circulating fgf-23 and phosphate excretion in early stages of renal failure using diet in individuals with normal serum phosphate levels. study objectives ; 1. to measure fgf-23 levels before and after a high phosphate diet, low phosphate diet and a low phosphate diet with phosphate binders. 2. to measure levels of calcium, phosphate, pth, 25 and 1,25 vitamin d and fractional phosphate excretion before and after a high phosphate diet, low phosphate diet and a low phosphate diet with phosphate binders.

Eligibility criteria:
inclusion criteria: * ckd patients with ckd stage 3 and 4 (egfr \ 15 ml/min per 1.73 m2, not requiring dialysis). * normal serum phosphate stable over three months (\> 0.87 mmol/l and \< 1.70 mmol/l) * not yet following a low phosphate diet as reported by the patient or the renal dietitian (\<1500mg/d) * over 19 years of age exclusion criteria: * body mass index \<20 kg/m2 * current use of phosphate binders or active vitamin d or phenytonin (which induces vitamin d catabolism) * primary parathyroid defects * diagnosed osteoporosis * gut absorption defects * liver disease * pregnancy or lactation * patients hospitalised within the last 4 weeks

Keywords: chronic kidney disease ckd diet dietary phosphate mineral metabolism fgf-23
use of conivaptan (vaprisol) for hyponatremic neuro-icu patients

Conditions: Hyponatremia

Summary: conivaptan (vaprisol) is fda-approved for the treatment of low serum sodium (hyponatremia), but there are few data in patients with neurologic disease. very low serum sodium in patients with brain injury can be life-threatening and is associated with cerebral edema (swelling of brain tissue). this can be important in patients with brain hemorrhage, brain tumors, or stroke (cerebral infarction). this is a pilot study to test the hypothesis that conivaptan (vaprisol) leads to a greater increase in sodium than usual care. patients will be randomly assigned to usual care or the lower fda-approved dose of conivaptan (vaprisol). we will track the use of other interventions, such as the use of hypertonic saline (concentrated salt solution), diuretics and salt tablets. a blinded co-investigator will record neurologic examination results (nih stroke scale and glasgow coma scale).


Eligibility criteria:
inclusion criteria: * severe hyponatremia (na \< 130 mmol/l) or * symptomatic hyponatremia - na \< 135 mmol/l for at least six hours with glasgow coma scale \< 15 exclusion criteria: * enrollment in the nmh high-risk spine protocol. these patients receive large amounts of fluids, have rapid changes in electrolytes, and are typically corrected in 48 hours * expected death from any cause * known sensitivity or allergy to conivaptan * renal failure (baseline creatinine \> 1.5 mg/dl) * clinical diagnosis of hypovolemia, or by central venous pressure (cvp) \< 5 mm hg if a central venous catheter is in place * concomitant use of potent inhibitors of cytochrome p-450 isoenzyme 3a4 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir). these agents are not commonly used in the neuro-icu * clinical diagnosis of liver failure or insufficiency * pregnancy (must be excluded before entry) * lack of informed consent from the patient or a legally authorized representative (lar) * use of intra-arterial vasodilators (e.g. verapamil, nicardipine) within 24 hours (e.g. for vasospasm after sah) * concern by the neuro-icu pharmacist of a drug-drug interaction that would meaningfully impact care (the neuro-icu pharmacist will review the medication regimen before recruitment) * patients with a diagnosis of diabetes insipidus or treated with vasopressin, since these patients are already treated for abnormal free water balance * patients with congestive heart failure, since this is an approved use of the drug (these patients are typically not cared for in the neuro-icu) * age\<18 years (these patients are not cared for at nmh) * inclusion declined by the attending physician or consulting study nephrologist
lanreotide and octreotide long acting release (lar) for patients with advanced gastroenteropancreatic neuroendocrine tumors (gep-nets)

Conditions: Gastroenteropancreatic Neuroendocrine Tumor

Summary: an observational time and motion study in a clinical oncology setting is utilized in order to measure and compare product attributes and overall product efficiency between lanreotide and octreotide lar.


Eligibility criteria:
inclusion criteria: * men and women must be 18 years of age or older * a current diagnosis of advanced, unresectable gep-net * provided written informed consent to participate in the study * currently receiving lanreotide or octreotide lar and has received at least one prior injection of current somatostatin analogues (ssa). exclusion criteria: * receiving treatment with lanreotide or octreotide lar as part of a clinical trial * scheduled to receive a dose of lanreotide or octreotide lar that would necessitate more than 1 injection on the same day * scheduled to receive any other treatment in the infusion center/room on the same day and as part of the same appointment * known hypersensitivity to somatostatin analogues