Kornimate/medical-research-clean huggingface dataset:
bright light therapy for sleep disturbance in people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: sleep disturbance is common in people with multiple sclerosis (ms) and contributes to diminished quality of life. bright light therapy may be an innovative strategy to reduce sleep disturbance in ms, possibly through its effects on a subtype of retinal ganglion cells that help regulate circadian rhythms and sleep. this pilot study will evaluate whether, in people with ms, bright light therapy reduces sleep disturbance and explore whether light therapy improves function of these cells.

multiple sclerosis (ms), an inflammatory and neurodegenerative disorder of the central nervous system (cns), is the most common cause of progressive neurologic dysfunction in early to middle adulthood. people with ms are a markedly high risk for sleep disturbance. estimates of the lifetime prevalence of sleep disturbance in ms reach 50%; sleep disturbance is also associated with excess ms-associated morbidity and diminished quality of life. despite the high burden of impaired sleep and its contribution to adverse ms outcomes, effective approaches to treat and ameliorate disturbed sleep in people with ms remain poorly understood. there is unmet need to develop safe and effective rehabilitative alternatives to mitigate sleep disturbance in ms. prior research supports the use of timed bright light therapy (lt) as one such approach for insomnia and sleepiness in those with sleep disorders or other neurologic diseases. yet, the safety and potential effectiveness of timed lt have yet to be tested in ms. the goal of the proposed study is to conduct a detailed intervention study testing if timed bright lt in people with ms is 1) safe (primary outcome) and 2) potentially effective for reducing sleep disturbance (specifically, reducing insomnia, fatigue and improving sleep efficiency, quantity and quality as secondary outcomes). the study will also explore whether lt stimulates a novel subtype of retinal ganglion cells which are central to the regulation of circadian rhythms and sleep.

Eligibility criteria:
inclusion criteria: * diagnosis of ms * evidence of sleep disturbance * stable on immunomodulatory ms therapy or no therapy for at least 6 months prior to study initiation * stable on antidepressants for at least 3 months prior to study initiation and no evidence * stable on fatigue medication for at least 3 months prior to study initiation * willing and able to provide informed consent and follow study procedures. exclusion criteria: * evidence of cognitive impairment * low risk for sleep disordered breathing * other comorbid ophthalmologic disorders (e.g. cataracts, glaucoma, blindness) * traveled across two time zones within 90 days of study screening. * not participating in shift work * ms relapse or history of acute optic neuritis within 30 days * no prior history of bipolar disorder * no evidence of current depression * diagnosis of severe periodic limb movement disorder or severe restless legs syndrome

Keywords: sleep disturbance insomnia fatigue
a study of the safety and effects of adh-1 given daily to subjects with solid tumors

Conditions: Neoplasms

Summary: n-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. adh-1 blocks n-cadherin. this study will test the safety and effects of adh-1 in subjects with incurable, solid tumors with a protein biomarker called n-cadherin. this study will identify the amount of adh-1 that subjects can tolerate.


Eligibility criteria:
inclusion criteria: * signed written informed consent * male and female patients \> or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists * clinically or radiologically documented measurable disease. * immunohistochemical evidence of n-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue * adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ecg) exclusion criteria: * receipt of adh-1 prior to this clinical study * chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry * history of primary brain tumors or brain metastases * history of spinal cord compression or tumors that have shown any evidence of active bleeding within 30 days before study entry. * stroke, major surgery, or other major tissue injury within 30 days before study entry * history of congestive heart failure, myocardial infarction, angina, life threatening arrhythmias, significant electrocardiogram (ecg) abnormalities, or known hypercoagulable states

Keywords: cancer; tumors; neoplasms; anticarcinogenic agents; antineoplastic agents; cadherins
high dose candesartan versus quinapril for restenosis prophylaxis after stent angioplasty

Conditions: Arterial Occlusive Diseases

Summary: the study is designed to test the hypothesis that high dose candesartan treatment compared to quinapril is able to reduce intima hyperproliferation and the restenosis rate after stent angioplasty in peripheral occlusive artery disease.

patients are randomly assigned to treatment with either candesartan 32 mg/d or quinapril 20 mg/d before the angioplasty. walking distance, intima media thickness and crurobrachial pressure ratios are compared after 6 weeks, 3 months and 6 months. after 6 months an angiographic control is performed.

Eligibility criteria:
inclusion criteria: * male and female * peripheral occlusive arterial disease stad iib fontaine classification exclusion criteria: * patients with lesions not available for pta * renal insufficiency * patients on calcium-antagonists

Keywords: restenosis intima hyperproliferation stent angioplasty pain-free walking distance
study to analyze the risk factors associated with pertussis/whooping cough infection among infants

Conditions: Diphtheria; Acellular Pertussis; Tetanus

Summary: this study aims to estimate the risk factors associated with pertussis/whopping cough infection among infants less than one year of age in a united states (u.s.) commercially insured population. the study will utilize a large research data base associated with a geographically diverse u.s. health plan not limited by one geographic area or disease outbreak to evaluate pertussis in infants between 2005 and 2010. healthcare costs and utilization among infants with a reported diagnosis of pertussis/whooping cough stratified by the number of dtap vaccinations received prior to infection will also be reported.

this study will utilize the optuminsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans to estimate the measureable demographic, clinical and historical economic risk factors that may be associated with medically diagnosed pertussis/whooping cough infection among commercially insured infants less than one-year of age. healthcare costs and utilization among infants with a reported diagnosis of pertussis/whooping cough will be stratified by the number of dtap vaccinations received prior to infection.

Eligibility criteria:
inclusion criteria: * date of birth between july 1, 2005 and september 30, 2010. * enrollment in a commercial health plan within one month of birth. * known sex and geographic region. * infants will be included as a pertussis/whooping cough case if they meet the diagnosis criteria infants not identified as a pertussis/whooping cough case are eligible for inclusion as a control. exclusion criteria: • enrollment does not include medical and pharmacy coverage.

Keywords: risk factors u.s. commercially insured population pertussis/whooping cough infection retrospective database study
effect of magnesium supplementation on polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: this is a double-blind randomized clinical trial which will start at june 2014 and end on june 2015 in isfahan city. serum insulin level is considered as a key variable and the sample size calculated 70 persons (35 persons for control group and 35 persons for patient group). patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. all subjects will complete 4 physical activity and 4 dietary records. outcome measurements including sex hormone levels, metabolic and inflammatory profiles will be measured at the beginning and end of the study as well as anthropetric measurements.


Eligibility criteria:
inclusion criteria: * having pcos according to the rotterdam criteria, * age between 20-45 years, * lack of pregnancy and lactation, * not having certain regime during last 3 months, * non-smoking, * not having diseases, including: diabetes, cardiovascular , hepatic, renal and thyroid, * not taking supplements, * being overweight (kg / m 25 ≤ bmi) exclusion criteria: * hormone therapy, * pregnancy and lactation during the study, * severe weight loss (more than 2.5 kg per month) during the study

Keywords: magnesium insulin resistance lipid profile sex hormones inflammatory factors
validity and predictive value of manual clinical test to identify symptomatic segments in lumbar chronic patients

Conditions: Low Back Pain

Summary: this study evaluates the predictor value of manual test in lumbar chronic patients blocks. bibliography has show limited evidence of clinical predictors in lumbar blocks. prior to lumbar facet block or medial branch denervation patient will be evaluated with manual provocative segmental movements, lumbar sagittal range of motion, manual segmental movement and slump neural test . immediate, one and six months effect will be registered.

clinical tests have sown limit evidence to predict efficacy of lumbar facet blocks. segmental mobility tests have been included into the protocol to evaluate the efficacy of the lumbar blocks. chronic low back pain patients will be tested to evaluate the predictor value of manual clinical tests. patients from the "lozano blesa" hospital pain clinic will be evaluate before, one month and six months after the lumbar facet block.

Eligibility criteria:
inclusion criteria: * more than 3 months of low back pain. * lumbar with or without leg pain. * patient treated with a lumbar facet block or medial nerve denervation. * capable to be physically explored. * capable to fill a questionaire. exclusion criteria: * no mechanical pain. * severe medical condition. * severe lumbar trauma. * severe lumbar instability. * severe lumbar deformity * psychiatric disorder.

Keywords: low back pain physical examination local anesthesia
efficacy of physical exercise in cardiac rehabilitation

Conditions: Coronary Heart Disease; Heart Failure; Ischemic Heart Diseases

Summary: physical rehabilitation is a key element in the treatment of patients with cardiovascular diseases, and recent evidence has shown that supervised exercise programmes can prevent cardiovascular events, improve physical function and quality of life. individualized exercise prescription based on appropriate frequency, intensity and duration is recommended. furthermore, recent studies have shown that physical cardiac exercise training can influence inflammation of the vessel wall and hence reduce development of arteriosclerosis in coronary vessels. in the literature are divergent conclusions on appropriate frequency and duration of physical rehabilitation programs in order to improve physical function and reduce arteriosclerosis. the purpose of this study is to investigate the efficacy of an optimized physical rehabilitation programme compared to a conventional programme on physical fitness, health related quality of life and vascular inflammation.

both trial groups carry out physical exercise training in groups. the exercise training is instructed by two physiotherapists with expertise in cardiac rehabilitation. each training session takes 60 minutes and is based on current evidence for physical training for ihd and chf patients. exercise intensity progresses within the first week of the training program from moderate intensity (40-59% of vo2max), to high intensity (60-84% of vo2max). exercise intensity of the individual training sessions is monitored by heart rate. the training program includes the following: warm-up and stretching: each training sessions starts 10 min. warm-up and ends with 5 min. stretching. aerobic exercise : takes place on treadmill, stairs, ergometer bikes and interval training with different strength-endurance exercises. muscle strength: is performed on machines with weight training equipment or by floor exercises. 10-15 repetitions are performed with a load equivalent to 50-60% of 1 rm. the exercise programs for both groups are performed using a standardized exercise protocol. all patients per a sub-maximal and a maximal exercise test prior to participation in the physical exercise training program.

Eligibility criteria:
inclusion criteria: patients prescribed to physical exercise training at skejby university hospital with: * stable and unstable angina pectoris, * acute myocardial infarction with and without ecg changes * chronic heart failure exclusion criteria: * patients with bmi\>35 * patients with musculoskeletal or neurological diseases that unable them to participate in physical exercise training programmes * patients who can not read or understand danish language
effect of foot reflexology on postpartum afterpains

Conditions: Pain, Labor

Summary: this study will be conducted to determine the effect of foot reflexology on afterpains after normal labor.

afterpains are among the most prevalent complaints after natural vaginal delivery. non-pharmacological treatment modalities to relieve afterpains are an important care priority as they can lead to maternal and neonatal complications including anxiety, sleep disturbances, emotional disorders, depression, inability to care for the baby and continue breastfeeding, delays in early breastfeeding, reduced maternal ability to perform daily chores. it was reported that pain in the early hours postpartum is one of the most important factors contributing to chronic postpartum pain and depression. furthermore, pain and stress increase adrenaline release and decrease oxytocin release, thus leading to the cessation of the oxytocin reflex and disrupting breast milk production in addition to causing discomfort for the mother. since afterpains is a common problem that affects the physical and mental well-being of mothers, it requires the attention of healthcare providers. there is only one study that investigated the effect of reflexology on the pain level of afterpains after normal vaginal delivery. moreover, no study investigated the effect of reflexology on either the behavioral response toward pain or the pressure pain threshold. therefore, this study will be conducted to provide physiotherapists with updated scientific knowledge concerning the effect of foot reflexology on afterpains after normal labor. this study may expand the role of physiotherapy in women's health.

Eligibility criteria:
inclusion criteria: * they will be multipara (2-3). * they will be normal vaginal labor exclusion criteria: * high-risk pregnancy. * post-partum hemorrhage. * neonatal birth weight over 4 kg. * over distension of the uterus. * cesarean section.
study of the bioequivalence of two tablet forms of mk0431 (0431-027)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will establish that the mk0431 100 mg anhydrous formulation tablets are bioequivalent to the mk0431 100 mg monohydrate final market image (fmi) tablets.


Eligibility criteria:
inclusion criteria: * subject is in good health * female subjects must have a negative pregnancy test * subject is within 30% of ideal body weight * subject does not smoke * subject agrees to follow the study guidelines exclusion criteria: * subject has a history of any illness that might confound the results of the study or make participation unsafe for the subject * subject has a history of hypoglycemia * subject has a history of any hepatic disease * subject is taking any oral, parenteral, topical or implantable contraceptives
anti-pd(l)1 and sbrt in the treatment of advanced, platinum-refractory urothelial carcinoma

Conditions: Urothelial Carcinoma

Summary: this is a feasibility trial of anti-pdl1/pd1 (pembrolizumab) and stereotactic body radiation therapy (sbrt) in patients with advanced, platinum-refractory urothelial carcinoma.


Eligibility criteria:
inclusion criteria: * subjects must have a histologic diagnosis of urothelial carcinoma * subjects must have radiologic evidence of metastatic disease with measurable disease by recist 1.1 criteria other than the target lesion(s) for sbrt * subjects must have at least 1 metastatic lesion previously not radiated that is amenable to sbrt per treating radiation oncologist. * subjects must have had progression of disease within 12 months of platinum-containing chemotherapy (chemotherapy could have been given in the neoadjuvant, adjuvant or metastatic setting) for urothelial cancer * ecog performance status of 0 to 2 (eastern cooperative oncology group performance status: an attempt to quantify cancer patients' general well-being and activities of daily life. the score ranges from 0 to 5 where 0 is asymptomatic and 5 is death.) * absolute neutrophil count of ≥ 1000/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 8.0 g/dl; total bilirubin/alt/ast \< 2.5 x upper limit of normal (patients with known gilbert disease who have serum bilirubin ≤3x uln may be enrolled); serum creatinine \<3.0mg/dl or if elevated, a calculated estimated glomerular filtration rate (egfr) of ≥30 ml/min/1.73 m2 * subjects must have recovered to baseline or ≤ grade 1 ctcae v 4.03 from toxicities related to any prior treatments unless ae(s) are clinically non-significant and/or stable on supportive therapy * subjects must be ≥ 2 weeks from most recent systemic therapy or most recent radiation therapy * women of childbearing potential must have a negative serum or urine pregnancy test within 28 days prior to registration. * age ≥ 18 years exclusion criteria: * prior treatment with anti-pd-1/pd-l1 and anti-ctla-4 is not allowed. prior intravesical bcg (bacillus calmette-guerin) therapy is allowed * treatment with any investigational agent or on an interventional clinical trial within 30 days prior to registration. * no prior or concurrent malignancy is allowed except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, localized or locally advanced prostate cancer definitively treated without recurrence or with biochemical recurrence only, or any other cancer fully treated or from which the subject has been disease-free for at least 2 years. * autoimmune diseases such as rheumatoid arthritis are not allowed. vitiligo, mild psoriasis (topical therapy only) or hypothyroidism are allowed * need for systemic corticosteroids \>10mg prednisone daily or equivalent alternative steroid * any history of organ allografts * any history of hiv or hepatitis b infection * known brain metastases
efficacy and safety study of allogenic mesenchymal stem cells for patients with chronic graft versus host disease

Conditions: Chronic Graft Versus Host Disease

Summary: the primary purpose of the study is to evaluate the safety and efficacy of mesenchymal stem cells (msc) for the treatment of patients who have developed an extensive chronic graft versus host disease (with skin and/or liver damage) after hscs transplantation and do not respond to first-line therapy. the secondary purpose of the study is to evaluate the effect of mesenchymal stem cells (msc) on one-year survival rate, long-term survival rate, life quality and recurrence of patients who have developed an extensive chronic graft versus host disease (with skin and/or liver damage) after hscs transplantation and do not respond to hormone treatment.

chronic graft-versus-host disease (gvhd)， with the incidence of 30%-60%, is a serious late complication of allogeneic hematopoietic stem cell transplantation (hsct) and is the major cause of death in the late stage of transplantation. according to targeted organs, cgvhd is divided into two types, limited cgvhd and extensive cgvhd. extensive cgvhd needs systemic immunosuppressant treatment. however, currently standard first-line regimen including cyclophosphamide and prednisolone is only effective for some patients. novel treatment is urgently needed. our previous study has shown that mesenchymal stem cells (mscs) are effective for cgvhd patients with multiple skin damage. to further explore the therapeutic effect of mscs for extensive cgvhd, we plan to conduct a multi-center clinical trial. patients who developed an extensive cgvhd (with skin and/or liver damage) after hscs transplantation and do not respond to first-line therapy are enrolled. they will be randomly divided into two groups which will receive mscs and routine second-line drugs respectively. we will evaluate the efficacy and safety of mscs for extensive cgvhd by comparison of symptom improvement, survival rate, recurrence as well as side effects in the two groups.

Eligibility criteria:
inclusion criteria: * extensive cgvhd with skin and/or liver damage developed after allogeneic hematopoietic stem cell transplantation * cgvhd that do not response to conventional immunosuppressant treatment for two months * kps\>= 30 * informed consent from the patient exclusion criteria: * extensive cgvhd without skin or liver damage * with other acute severe complications * in pregnancy or lactation * disease relapses * with non-hematological malignancy * have a history of mental disorder, drug or alcohol abuse over the past five years * allergic * participate in other clinical trial within three months before the start of this trial * with bone marrow fibrosis * have undergone hematopoietic stem cell transplantation to treat solid tumor

Keywords: cgvhd
effect of 60-days saccharomyces boulardii and superoxide dismutase supplementation in obese adults

Conditions: Obesity; Superoxide Dismutase

Summary: in animals it has been demonstrated that saccharomyces boulardii decrease low-grade inflammation and fat mass; also superoxide dismutase (sod) decrease low-grade inflammation. therefore, the aim of this double-blind, placebo-controlled clinical trial was to assess the effect of a 60-days s. boulardii and sod supplementation on circulating markers of inflammation, body composition, hunger sensation, pro/antioxidant ratio, hormonal, lipid profile, glucose, insulin and homa-ir, in obese adults (bmi 30-35 kg/m2).


Eligibility criteria:
inclusion criteria: * i class of obesity (bmi: 30-35 kg/m2) exclusion criteria: * evidence of heart, kidney or liver disease * diagnosis of major depressive disorder * current medications for weight loss, for control of cholesterol and triglycerides * anti-inflammatory treatments * pregrancy of lactation * type 1 diabetes mellitus, intestinal inflammatory bowel disease, celiac disease, chronic pancreatitis * probiotic/prebiotic treatment in the last 4 weeks * antibiotic use within the last 3 months