Kornimate/medical-research-clean huggingface dataset:
creatine supplementation in patients with intermittent claudication.

Conditions: Intermittent Claudication

Summary: the aim of this study will be to verify the effect of creatine supplementation associated to clinical treatment of the functional capacity in patients with intermittent claudication.

the aim of this study will be to verify the effect of creatine supplementation associated to clinical treatment of the functional capacity in patients with intermittent claudication. the sample will be composed by patients with intermittent claudication of both sexes. the patients will be ramdomized in a double-blind procedure to receive during seven days (loading) and posteriorly 49 days (maintenance) a creatine (cr) supplementation or placebo (pla), associated to the clinical treatment. before ("baseline"), after "loading" period and after the maintenance period of supplementation, the patients will go through a functional capacity evaluation. the fuctional capacity evaluation will be evaluated by a six minute-walking test. for statistical analysis it will be used the anova of two factors for repeated measurements, having the (cr and pla) group and the time (pre, post-loading and post-maintenance), and when needed the post-hoc of newman keuls. the adopted level of significance will be p\<0.05.

Eligibility criteria:
inclusion criteria: * symptom of pain during the six-minute walk test limited by leg pain due to intermittent claudication. * present peripheral artery disease (ankle-arm index \< 0.90) in one or both limbs. * asymptomatic intermittent claudication determined from the clinical history. * not have muscle or joint injuries that make it impossible to practice physical activity. exclusion criteria: * not attending more than 15% of the intervention sessions or visits to the laboratory. * stick to a physical activity program in addition to that offered by the study. * do not use medication regularly. * aggravation of the disease

Keywords: ergonemic resources walking capacity peripheral artery disease
evaluate safety and efficacy of 25 mg hydrocortisone acetate suppositories in treatment of internal hemorrhoids

Conditions: Internal Hemorrhoids

Summary: a randomized, double-blind, placebo-controlled, multicenter, parallel group study of the safety and efficacy of hydrocortisone acetate suppositories, 25 mg compared to placebo suppositories in the treatment of symptomatic internal hemorrhoids.

study design: 25 mg hydrocortisone suppositories administered twice daily compared to a vehicle placebo in approximately 100 subjects with symptomatic internal hemorrhoids. subjects will be randomized in a 1:1 ratio (test product: placebo). the study will consist of 2 periods: 1. treatment period (2 weeks/ days 1-14) 2. follow-up period (2 weeks/ days 15-28) the visits are as follows: visit 1 (day 1 baseline/randomization) visit 2 (day 8±1, interim visit) visit 3 (day 15±2, end of treatment visit) visit 4 (day 29±3, end of study visit) endpoints: 1. clinician reported outcome (clinro) - anoscopy (visits 1, 3). anoscopy - visual assessment of hemorrhoids. video of the procedure will be recorded for blinded central reading and assessment 2. patient reported outcome: subjects will use daily diaries to record the time and date of each medication application, concomitant medication and adverse events. the subjects will complete the subject questionnaire at visits 1, 2, 3 and 4 (or early termination) and daily between visits.

Eligibility criteria:
inclusion criteria: * internal hemorrhoids. * hemorrhoidal bleeding. * male or female aged 18 years and older. * willing to forego the use of non-prescription (otc) and prescription medication or procedures for the treatment of hemorrhoidal disease and/or pain for the duration of the study. * agree to not change their diet during the study. exclusion criteria: * external hemorrhoids. * using other otc or prescription medications for treatment of hemorrhoidal disease and/or pain. * pregnant or nursing female. * received systemic glucocorticoids within the last 2 months prior to starting study. * participated in an investigational drug study within 30 days prior to baseline.
linezolid for treatment of nontuberculous mycobacterial diseases

Conditions: Non-tuberculous Mycobacterial Infections

Summary: a prospective open study to determine the efficacy and tolerability of oral linezolid 600mg./day for the treatment of 40 patients with nontuberculous mycobacterial diseases will be conducted at siriraj hospital, mahidol university, bangkok, thailand.

this will be an open label clinical study of oral linezolid combination with another oral antimycobacterial drug as the maintenance treatment of nontuberculous mycobacterial diseases in adult. the eligible patients will be treated and monitored for the efficacy and safety every 6 weeks until 6 months then every 3 months for a total duration of 18 months.

Eligibility criteria:
inclusion criteria: * diagnosis of non-tuberculous mycobacterial (ntm) diseases * active or stable diseases receiving either parenteral or oral antimycobacterial treatment * require at least more than 6 months of treatment from enrollment exclusion criteria: * stable ntm diseases with a plan to discontinue treatment within 3 months * history of allergy to linezolid * hemoglobin \< 7 g/dl) or total white blood count \< 3,000 /cu.mm. or thrombocytopenia \< 50,000 cells/cu.mm. * concomitant uses of serotoninergic drugs (ssris) or monoamine oxidase inhibitor (maois) within 30 days prior to enrollment * abnormal neurological findings such as numbness, abnormal vision etc.
overweight children - musculoskeletal consequences

Conditions: Pediatric Overweight

Summary: the purpose was to investigate the consequences of pediatric overweight on the musculoskeletal system, postural control and proprioception, and to analyze prospectively the influence of ball games and nutrition counseling.


Eligibility criteria:
inclusion criteria: overweight children: * bmi = or \> than the gender, race, and age specific 92nd percentile from the national children health and nutrition examination survey all participants: - 6-11 y. old exclusion criteria: * severe impairment with functional restriction of the upper or lower extremities (due to injuries) * neurological deficits/diseases compromising the postural control * important communication problems due to another mother language
developing circulating and imaging biomarkers towards personalised radiotherapy in lung cancer

Conditions: Lung Cancer Stage III

Summary: in stage 3 nsclc, treatment and follow-up are generally performed in a 'one-size-fits-all' manner. in the setting of metastatic lung cancer there has been considerable success identifying biomarkers, which allow treatments to be tailored and lead to more personalised medicine. in patients with stage 3 disease there exists a significant unmet clinical need for equivalent biomarkers to guide treatment decisions such as to identify poor responders, predict benefit from treatment and diagnose relapse before standard of care imaging. recent advances have made it possible to detect and quantify circulating-tumour dna in peripheral blood of patients with stage 3 nsclc, a promising prognostic biomarker and a measure of minimal residual disease. in addition, the information contained in routine medical images and electronic patient reported outcome measure (eprom) questionnaires can add further predictive power to circulating tumour dna and other clinical factors to determine patient's outcome. there is scope to integrate biomarkers in treatment decision algorithms aiming to make personalised treatment modifications (e.g. decision to treat with immunotherapy or not). vigilance is a highly exploratory observational study to understand how these biomarkers might inform a future hypothesis driven interventional study.


Eligibility criteria:
inclusion criteria: * histological or cytologically confirmed nsclc. * unsuitable for surgery due to tumour or patient factors. * stage 3 a, b or c (tnm version 8). * planned to receive radical radiotherapy or sequential chemoradiotherapy or concurrent chemoradiotherapy +/- consolidation immunotherapy. * predicted life expectancy \>12 weeks. * ability to provide written informed consent. * willingness to comply with study procedures. exclusion criteria: * mixed non-small cell and small cell tumours. * adjuvant radiotherapy post-surgery. * participation in a study of an interventional study as part of lung cancer treatment. * recent/active malignant disease which might impact study results. * psychotic disorders/cognitive impairment.

Keywords: non small cell lung cancer nsclc stage iii radiotherapy biomarker circulating-tumour dna radiomics prom
survey of predictors of human papillomavirus (hpv) vaccination among parents of rural adolescent girls in mysore, india

Conditions: Human Papillomavirus; Cervical Cancer

Summary: to conduct a quantitative survey to measure knowledge about human papillomavirus (hpv) and cervical cancer, and hpv vaccine acceptability among parents of rural adolescent girls in mysore district, india. hypothesis: general knowledge and attitudes about the severity and treat ability of cancer will predict acceptability of hpv vaccination among parents of rural adolescent girls in mysore, india.


Eligibility criteria:
inclusion criteria: * over 18 years of age * parent of an adolescent girl (10 -15 years of age) * able to speak english or kannada * willing to undergo informed consent process exclusion criteria: * does not have the capacity to undergo informed consent process

Keywords: parental acceptability of hpv vaccine
bovine colostrum in prevention of necrotizing enterocolitis and sepsis in very low birth weight neonates

Conditions: NEC

Summary: primary aim: the aim of this study is to investigate the efficacy of bovine colostrum in prevention of necrotizing enterocolitis (nec) and sepsis in very low birth weight (vlbw) infants. secondary aim: to improve outcomes of neonatal sepsis and nec in the pe-terrms and to decrease their hospital stay.

necrotizing enterocolitis (nec) primarily occurs in premature and very low birth weight (vlbw) babies, the incidence varying from 5 to 10% in various neonatal intensive care unit (nicus) . many researchers believe that an exaggerated inflammatory response mounted by immature intestinal epithelial cells in response to abnormal intestinal colonization plays a vital role in the pathogenesis of nec and bacteria belonging to enterobacteriaceae have often been linked to nec . colonization with commensal bacteria soon after birth is essential for the development of normal intestinal function however, this process is often altered in premature babies in nicus, leading to colonization with pathogenic bacteria . commercially available bovine colostrum has high concentrations of anti-infective factors such as immunoglobulins, lactoferrin, organism-specific antibodies, lactoperoxidase, insulin-like growth factors and transforming growth factors. these components have substantial homology to their human counterparts . bovine colostrums has been tried in the treatment of escherichia coli and shigella and rotavirus diarrhea in children, helicobacter pylori infection in children and e. coli intestinal infection in term and preterm neonates. no major adverse effects were reported in any of the studies using bovine colostrum in infants and preterm babies . in an in vitro study, the authors showed that bovine colostrum significantly reduces the adherence of various enterobacteriaceae species known to be associated with nec to human intestinal epithelial cells . a randomized controlled trial has shown that the use of bovine lactoferrin reduced the incidence of neonatal sepsis . till date, there are no studies in neonates on the use of bovine colostrum for the prevention of nec.

Eligibility criteria:
inclusion criteria: * babies with birth weight ≤ 1500 g exclusion criteria: * babies who have any contraindication for initiating milk feeds; who will fail to achieve adequate feed volume to be able to administer the study drug. * those with suspected/ proven gastrointestinal malformations. * preexisting sepsis (definite or suspect) or nec at the time of enrollment. * those with a family history of an inborn error metabolism (that precludes exposure to proteins/lactose).
a 24-week open-label, phase 3b trial with a 28-week extension to evaluate the efficacy and safety of saxagliptin co-administered with dapagliflozin compared to insulin glargine in subjects withtype 2 diabetes who have glycemic control on metformin

Conditions: Type 2 Diabetes Mellitus

Summary: this research study of subjects with inadequately controlled type 2 diabetes mellitus (t2dm) will compare the glycemic control (measured by hba1c) in subjects co-administered saxagliptin and dapagliflozin, in addition to metformin with or without sulfonylurea, to subjects receiving insulin glargine, in addition to metformin with or without sulfonylurea, over a treatment period of 52 weeks.

cv181-369; a 24 week international, open-label trial with a 28 week extension to evaluate the efficacy of saxagliptin co-administered with dapagliflozin compared to insulin glargine in subjects with type 2 diabetes on metformin with or without sulfonylurea therapy

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * at least 18 years of age at screening * hba1c ≥ 8% and ≤ 12% at screening * fasting plasma glucose (fpg) ≤ 270 mg/dl (15mmol/l) * stable dose metformin ≥ 1500 mg per day with or without a stable dose of sulfonylurea (defined as at least 50% maximal dose per local label) for at least 8 weeks * estimated glomerular filtration rate (egfr) \&lt; 60 ml/ml/1.73m2 * body mass index ≤ 45.0 kg/m2 exclusion criteria: * clinical diagnosis of type 1 diabetes * history of ketoacidosis * renal, hepatic or pancreatic disease * impairment of renal function (defined as creatinine clearance \[crcl\] \< 60 ml/min * cardiovascular or vascular diseases identified within 3 months of participationimpairment of renal function (defined as creatinine clearance \[crcl\] \< 60 ml/min
cognitive-motor training post-stroke - a pilot randomized controlled trial

Conditions: Stroke Sequelae; Motor Skills Disorders

Summary: stroke is a leading and growing cause of long-term adult disability. up to 80% of stroke patients have impaired manual dexterity reducing their independence, return to work and quality of life. cognitive impairment is also common after stroke and growing evidence suggests a cognitive-motor interdependence with relevance for motor recovery. previous studies show increased cognitive-motor interference (measured in dual-task) in stroke patients and that combining motor and cognitive task training (in a dual-task) may improve motor function above that achieved by single-task training. this project addresses post-stroke dexterity impairment and its relation to dual-task interference, i.e., the decrease in motor performance when performing a concurrent cognitive task. the overall goal is to provide a proof-of-concept for a dual-task interference training protocol post-stroke. we aim to establish therapeutic efficacy of dual-task vs single-task dexterity training in chronic stroke patients.single-task training involves visuomotor finger force tracking and dual-task has an additional cognitive components including visual distraction and working memory. training will be done 4 days/week over four weeks (total 16 sessions). each session will include 20 mins of conventional therapy (stretching, functional exercises) followed by 40 mins motor task training (either single or dual task). this pilot randomized clinical trial will include 40 stroke patients (\> 6 months after stroke). repeated clinical and fine-grained motor measurements will be obtained pre and post intervention and at 3 months follow-up.


Eligibility criteria:
inclusion criteria: * adults with clinical diagnosis of stroke and history of upper limb hemiparesis. arm and hand paresis is defined as weakness according to manual muscle testing (score less than 4/5 in one upper limb muscles) * reported difficulty in opening/closing of hand or difficulty in using the hand in daily activities exclusion criteria: * inability to grasp and displace an object (minimum score of 1 on box and block test, bbt) * impaired cognition (moca score \<23) * cerebellar stroke * aphasia disturbing communication and understanding of training task * neglect interfering with ability to see task on screen
functional abdominal wall reconstruction

Conditions: Prune Belly Syndrome

Summary: assessement of outcomes of functional reconstruction of underdeveloped abdominal muscles with the use od pedicled vastus lateralis muscle flaps.


Eligibility criteria:
inclusion criteria: * patients diagnoes with prune belly syndrome * severe underdevelopment of rectus abdomini muscles * patients who underwent microsurgical bipedicled vastus lateralis muscle flaps transposition * patient undery 18 y.o. exclusion criteria: * patient over the age of 18 * patients who did not agreed for proposed microsurgical reconstruction of the abdominal wall exclusion criteria: patient over the age of 18 -
methodology study of novel outcome measures to assess progression of als

Conditions: Amyotrophic Lateral Sclerosis

Summary: the primary objectives of the study are to estimate and rank-order the longitudinal standardized mean changes over 6 months and over 12 months, for a set of outcome measures administered to participants with amyotrophic lateral sclerosis (als), in order to identify measures that are more sensitive to disease progression than amyotrophic lateral sclerosis functional rating scale-revised (alsfrs-r). the secondary objectives of this study are: to evaluate the test-retest reproducibility of each outcome measure; to determine correlations between 6 and 12-month changes in all exploratory measures with 18 and 24-month changes in alsfrs-r and survival; to assess correlations between/among the various measures; to obtain biological samples in order to identify molecular correlates to the clinical measures and to further characterize previously identified and novel molecular biomarkers of disease progression for incorporation into future clinical studies.


Eligibility criteria:
key inclusion criteria: * a diagnosis of sporadic or familial als * als onset within ≤5 years * must be 16 to 85 years of age, inclusive, for sites in the united states and 18 to 85 years of age, inclusive, for all sites outside of the united states key exclusion criteria: * history of or positive test result at screening for human immunodeficiency virus (hiv) * history of or positive test result at screening for hepatitis c virus (hcv) antibody or hepatitis b virus (hbv) * possibility of neuromuscular weakness other than als * unspecified reasons that, in the opinion of the site investigator, make the subject unsuitable for enrollment or unlikely to be able to complete, at a minimum, the month 6 visit note: other protocol defined inclusion/ exclusion criteria may apply
radiation therapy and combination chemotherapy in treating patients with stage iii or stage iv head and neck cancer

Conditions: Squamous Neck Carcinoma of the Head and Neck Cancer (SCCHN)

Summary: purpose: randomized phase 2 trial to compare the effectiveness of chemo-radiation therapy (rt + cisplatin + 5-fu) with or without tirapazamine for the treatment of patients with stage iii or iv squamous cell carcinomas of the head and neck cancer (scchn). rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. radiation therapy uses high-energy x-rays to damage tumor cells. tirapazamine may increase the effectiveness of chemotherapy and radiation therapy by making tumor cells more sensitive to therapy.

subjects were stratified according to po2 values (high vs low), and randomized to 1 of 2 treatment arms, differing by the addition of tirapazamine to the therapeutic regimen. treatment consists of two 21-day cycles of induction chemotherapy, followed by radiotherapy (rt). induction chemotherapy was cisplatin 100 mg/m2 per day administered over 4 hours on study days 1 and 22 (ie, 1st day of both induction cycles) with continuous infusion (ci) 5-fu at a dose of 1000 mg/m2 per day for 120 hours per cycle starting on study days 1 and 22 (ie, days 1 to 5 of both induction cycles). patients who achieve at least partial response proceeded to chemoradiotherapy (crt) consisting of localized rt + cisplatin iv + 5-fu +/- tirapazamine. location of rt was based on whether the site had a cr or pr. radiotherapy began on day 43 (week 1), and continued for 5.5 weeks. subjects with no response or progressive disease proceeded to salvage surgery. a total of 63 patients were accrued for this study over approximately 5 years. 1 subject withdrew consent prior to treatment for personal reasons.

Eligibility criteria:
disease characteristics: biopsy proven squamous cell carcinoma of the following head and neck sites: hypopharynx oral cavity larynx oropharynx nasal cavity unknown primary paranasal sinus histologically proven poorly-differentiated carcinoma of the following head and neck sites: hypopharynx oral cavity larynx oropharynx nasal cavity paranasal sinus stage iii/iv (t0-4 n1-3 m0-2) disease patient characteristics: wbc at least 3,000/mm3 bilirubin no greater than 2.0 mg/dl ast no greater than 100 u/l creatinine no greater than 2.0 mg/dl creatinine clearance at least 60 ml/min (patients in group n2-n3) no second malignancy within 5 years except curatively treated nonmelanomatous skin carcinoma no prior rt or chemotherapy, except prior radiotherapy to primary tumor allowed not pregnant or nursing. negative pregnancy test required effective contraception required of fertile women subjects with unknown primary cancers who had metastatic cervical lymph nodes are eligible signed informed consent previously approved by the institutional review board.

Keywords: stage iii stage iv recurrent