Kornimate/medical-research-clean huggingface dataset:
a study to investigate the effect of mce on glucose and insulin responses in healthy males

Conditions: Dysglycemia

Summary: maize cob extract (mce) is intended to be used as a bulking agent in food. the purpose of this study is to determine the glycaemic and insulinemic response of mce consumed in isolation compared to glucose; the glycaemic and insulinemic response will also be determined for mce alone and in combination with glucose. this is a randomised, double-blind, single-centre trial in 10 healthy male participants.


Eligibility criteria:
inclusion criteria: * be able to give written informed consent; * be between 18 and 60 years of age inclusive; * have a body mass index \<30 kg/m2; * have a fasting glucose level of ≤6.0 mmol/l * be in general good health, as determined by the investigator; * be willing to fast for at least 10 hours before the study visit. exclusion criteria: * the presence of any of the following criteria will exclude the participant from participating in the study: * are less than 18 or greater than 60 years of age; * recent gastroenteritis or food borne illness such as confirmed food poisoning within the past 4 weeks; * have taken a medication or dietary supplement that may influence gi activity within the 2-weeks prior to screening; * have a history of abdominal surgery (excluding appendectomy); * have taken anaesthesia within the past 4 weeks; * have taken antibiotics within the past 12-weeks; * have a recent history of drug and/or alcohol abuse at the time of enrolment; * are a smoker (defined as \>5 cigarettes/week); * have made any major dietary change in the past 3 months; * have planned major changes in lifestyle (i.e. diet, dieting, exercise level, travelling) during the duration of the study; * have an active gastrointestinal disorder or previous gastrointestinal surgery; * have irritable bowel syndrome, diagnosed or undiagnosed and treated with chronic medications; * have a metabolic or endocrine disorder such as diabetes, thyroidism, or other metabolic disorder; * have a severe chronic disease i.e. cancer, renal failure, hepatitis, hiv, cirrhosis etc., or with a history of such diseases; * have a gastrointestinal disease i.e., chronic diarrhoea, crohn's disease, ulcerative colitis, diverticulosis, stomach or duodenal ulcers, or with a history of such diseases; * are severely immunocompromised (hiv positive, transplant patient, on antirejection medications, on a systemic steroid for \>30 days, or chemotherapy or radiotherapy within the last year); * experiences alarm features such as weight loss, rectal bleeding, recent change in bowel habit (\<3 months) or abdominal pain; * participants who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial; * participant is currently receiving treatment involving experimental drugs. if the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study
comcancer: use of let's discuss health website by patients with prostate cancer undergoing radiation oncology treatment

Conditions: Prostatic Neoplasms; Psychological Distress; Physician-Patient Relations; Communication; Patient Participation; Adherence, Treatment; Men

Summary: in canada, the prevalence of cancer is growing and contributes significantly to health costs. the prevention and treatment of cancer is a major concern of our health system. many men with prostate cancer develop psychological distress. the emotional consequences of a cancer diagnosis and its treatments can prevent patients from communicating effectively with their healthcare team. it is recognized that the quality of communication between cancer patients and their caregivers plays an important role in the management of their disease. however, few tools are being developed to help clinicians and patients better communicate and decrease patients' psychological distress. let's discuss health (www.discutonssante.ca) is a french-language website that offers several tools to support collaboration between caregivers and cancer patients. the objectives of this research project are to assess the experience of using the let's discuss health website and the impact of its use on the quality of communication between radiation oncologists and patients, the level of distress of patients with prostate cancer, recall of the information discussed as well as adherence to the trajectory in radiation oncology. the project will take place in three radiation oncology centers in quebec. two groups of prostate cancer patients will be recruited. patients in the first group will be assessed on the basis of regular consultations and those in the second group will be encouraged to prepare for their medical visits using the let's discuss health website. patients and their caregivers will answer short questionnaires before and after four targeted consultations (initial visit, mid-treatment visit, end-of-treatment visit and 3-month post-treatment visit). focus groups will also be organized to explore the impact of the website. this project offers the potential to transform clinical practices in radiation oncology to reduce the burden of cancer and improve the quality of care offered to patients with cancer.


Eligibility criteria:
inclusion criteria: * have a diagnosis of prostate cancer * understand, speak and read french * report being comfortable using the internet * have access to a computer, tablet or smartphone or know someone who does and is willing to accompany them exclusion criteria: * being considered unfit to give free and informed consent (e.g. dementia, severe psychiatric condition) * any other clinical reason (poor health of the patient at the time of the consultation) that the clinician deems relevant

Keywords: prostate cancer patient-physician communication patient recall of information adult
assessment in a real world setting of the effect of inhaled steroid-based triple therapy versus the combination of tiotropium and olodaterol on reducing chronic obstructive pulmonary disease (copd) exacerbations [airwise]

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objective of this pragmatic study is to compare the time to first moderate or severe copd exacerbation in patients, not controlled on their current therapy, randomized to stiolto respimat versus triple therapy over 12 months of treatment the secondary objectives of this study include: 1. to compare the annual rate of moderate or severe copd exacerbations for patients on stiolto respimat with patients on triple therapy. 2. to compare the time to first severe copd exacerbation in both treatment arms. 3. to compare the annual rate of severe copd exacerbations in both treatment arms. 4. to compare the proportion of patients with moderate or severe copd exacerbations in both treatment arms.


Eligibility criteria:
inclusion criteria: * copd diagnosis as defined by the study physician * currently on one of the following maintenance therapies: * lama monotherapy * laba monotherapy * ics/laba (fdc) * physician determination that patient is not controlled on current pharmacotherapy * adult patient 40 years of age or older at time of study enrollment * willingness and ability to understand and provide documented informed consent form (icf) and health insurance portability and accountability act (hipaa) authorization form prior to commencement of any study required assessments, either directly or through legally authorized representative. exclusion criteria: * currently on lama/laba (free or fdc) or triple therapy (ics plus laba plus lama) * contraindication to any study medications (lama, laba or ics) * documented diagnosis of current asthma * pregnant or nursing women * women of childbearing potential are not restricted in this trial, however it is expected that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment.
prostate cancer patients initiating hormone therapy: effect of exercise on cardiovascular health (proscardio)

Conditions: Prostate Cancer

Summary: this study evaluates whether exercise can reduce treatment-related adverse effects in prostate cancer patients initiating androgen deprivation therapy. half of recruited participants completed a 3-month exercise intervention, while the other half did not perform any supervised exercise. it was anticipated that exercise would have a positive effect on body composition, cardiorespiratory fitness and quality of life.

androgen deprivation therapy (adt) is routinely used as first-line treatment for locally advanced and metastatic prostate cancer. however, it is associated with many side effects such as increased fat mass and reduced skeletal muscle mass, cardiorespiratory fitness and metabolic health. ultimately, these negative changes induced by adt contribute to reduced health-related quality of life (hrqol). this study evaluates whether 3-months of exercise can mitigate treatment toxicity in prostate cancer patients initiating adt. in a parallel groups, prospective, randomised controlled design, participants were randomly allocated to a standard care control group or standard care plus exercise group. the exercise group completed 3-months of combined aerobic and resistance training. the standard care group did not receive any supervised exercise or specific physical activity recommendations. outcomes were assessed at baseline, 3-month (post-intervention), and 6-month (follow-up) endpoints.

Eligibility criteria:
inclusion criteria: * male * aged 50 to 80 years * histologically confirmed stage i-iv prostate cancer * scheduled for treatment with a luteinizing hormone-releasing hormone (lhrh) agonist either alone or combined with radiotherapy * anticipated to remain on androgen deprivation therapy (adt) for at least the next 6 months * willing and able to give written informed consent. * understand written and verbal instructions in english * world health organisation (who) performance status 0 to 1 exclusion criteria: * previously treated with adt * diagnosed or suspected metastatic bone disease * absolute contraindications to exercise testing and training as defined by the american college of sports medicine (acsm, 2010) * prior myocardial infarction or heart failure * chronic obstructive pulmonary disease (copd) * poorly controlled hypertension (≥ 200/110 mmhg) * uncontrolled supraventricular tachycardia (≥ 100 bpm) * pre-existing severe musculoskeletal, neurological or psychiatric condition that may affect their ability to complete the testing battery or exercise training, as determined by the patient's physician * involvement in any other clinical trial or exercise trial

Keywords: prostate cancer androgen deprivation therapy exercise
tms stimulation and cognitive training in alzheimer patients

Conditions: Alzheimer Disease; Mild to Moderate

Summary: the aim of this study is to examine if combined treatment with tms and cognitive training (cotra) for several weeks can produce a sustained improvement in cognitive and behavioral symptomatology of mild to moderate alzheimer's disease (ad) patients.

the current available pharmaceutical treatment for alzheimer disease (ad) is only partially and temporary effective. therefore, new approaches are needed. rtms is a non-invasive technique which generates a small electric current that induces a modulation in cortical excitability. in addition, cognitive training was suggested to improve cognitive functions in alzheimer patients. in this study we intend to treat mild to moderate ad patients with rtms interlaced with cognitive training (rtms- cog). patients with probable ad will be treated with rtms-cog daily for 6 weeks followed by maintenance sessions for additional 3 months.

Eligibility criteria:
inclusion criteria: * male or female age 55-85 years * patients diagnosed with early or moderate stage of alzheimer's disease, according to the dsm-iv criteria. * mmse score 18 to 24 * global dementia rating 1 or 2 * physically acceptable for the study as confirmed by medical history and exam, clinical laboratory results and ekg * spouse, family member or professional caregiver agree and capable of taking care and responsibility for the participation of the patient in the study (answering questions regarding the patient's condition and assuming responsibility for medication) * written informed consent by both patient and legally responsible caregiver. * able to undergo mri scan and eeg recordings prior to the onset of the study. * agreement to participate in up to 9 months the study. * right handed * hebrew or russian as mother tongue and/or ability to read and understand the inform consent form (icf), and the patient information document in hebrew or russian. exclusion criteria: * severe agitation; * mental retardation; * unstable medical condition; * use of benzodiazepines or other hypnotics during the study and preceding two weeks; * pharmacological immunosuppression; * participation in a clinical trial with any investigational agent within two weeks prior to study enrollment; * alcoholism; * history of epileptic seizures or epilepsy; * contraindication for performing mri scanning; * contraindication for receiving tms treatment according to a tms questionnaire; * clinically significant abnormal laboratory findings which have not been approved by the principle investigator; * patients treated with cholinesterase inhibitors, or memantine or ginko-biloba will be allowed to participate, if the treatment has started at least 2 months previous to recruited.

Keywords: alzheimer disease dementia brain diseases central nervous system diseases nervous system disease cognitive training cortical reorganization brain plasticity
efficacy and safety study of oral fludarabine phosphate in combination with mitoxantrone as first line treatment in follicular nhl

Conditions: Non Hodgkin Lymphoma

Summary: the purpose of the study is to demonstrate that oral fludarabine phosphate is comparable to i.v. formulation used in combination with mitoxantrone in terms of efficacy, safety and risk/benefit profile

as of 29 may 2009, the clinical trial sponsor is genzyme corporation. note: this study was originally posted by sponsor schering ag, germany, which was subsequently renamed to bayer schering pharma ag, germany.

Eligibility criteria:
inclusion criteria: * indolent b-cell follicular non-hodgkin's lymphoma (grade i-ii according to real classification) * stage ii to iv according to ann arbor staging system * who performance status grade 0, 1 or 2 and life expectancy of greater than 6 months exclusion criteria: * patients who have received any previous treatment for follicular nhl * patients with severe or life-threatening cardiac, pulmonary, neurological, psychiatric or metabolic disease * pregnant and lactating women * women of childbearing potential, and all men, not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy * laboratory screens positive for hepatitis b, c or hiv infections * patients with autoimmune thrombocytopenia or hemolytic anemia with clinical evidence. nb. a positive coombs test alone (with no clinical evidence of hemolysis) would not preclude entry in the study. * histological transformation to aggressive b-cell lymphoma * patients with prior malignancies except non melanoma skin tumors or stage 0 (in situ) cervical carcinoma * impairment of hepatic function unless disease related indicated by bilirubin, asat, alat or gamma-gt raised 2 times above the upper limit of the local laboratory range * impairment of renal function indicated by serum creatinine \< 30 ml/min * patients who require systemic long-term therapy with glucocorticoids * participation at the same time in another study in which investigational drugs are used * patients unable to regularly attend outpatient clinic for treatment and assessments * any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent * patients with active infection

Keywords: non hodgkin lymphoma
breast cancer risk in women who are brca1/brca2 mutation carriers

Conditions: BRCA1 Mutation Carrier; BRCA2 Mutation Carrier; Breast Carcinoma

Summary: this research study is looking at breast cancer risk in women who are brca1/brca2 mutation carriers. studying samples of dna in the laboratory from women who are brca1/brca2 mutation carriers may help doctors identify biomarkers related to cancer.

objective: i. to identify potential genetic modifiers of breast cancer risk in women who are carriers of the breast cancer susceptibility genes, brca1/2, by collecting data and genetic information from gog-0199 and contributing it to the consortium of investigators of modifiers of brca-associated breast cancer (cimba), an international consortium of clinical cancer genetics investigators. outline: this is a multicenter study. patients are stratified by study, country of residence, ethnicity, and birth cohort. joint analyses of brca1 and brca2 mutation carriers are further stratified by mutation. previously collected dna samples and associated clinical information obtained from brca mutation-positive participants enrolled on gog-0199 are studied. dna samples are analyzed by mutation testing for variants (i.e., single nucleotide polymorphisms \[snps\]) in candidate genes of interest. once genetic testing for a given set of variants has been completed, the coded laboratory data file is merged with selected demographic, clinical, and epidemiological data obtained from the gog-0199 baseline questionnaire and submitted to the consortium of investigators of modifiers of brca-associated breast cancer (cimba) central database to analyze and publish the data. the epidemiological and snp data contributed to the central database are then distributed to the investigators responsible for analysis of a particular snp or set of snps from a candidate gene or genetic pathway.

Eligibility criteria:
inclusion criteria: * women with or without a personal history of breast cancer prior to enrollment in gynecologic oncology group (gog)-0199 * known currently to be brca1/2 mutation carrier either by confirmed outside report or by research testing * no brca1/2 mutation-negative or mutation-unknown status * enrolled on clinical trial gog-0199 and meets the following criteria: * completed baseline questionnaire (bq-199) * provided information on previous breast cancer history, including date of diagnosis * provided complete data from the dna analysis on the genetic variants of interest * available dna samples for analysis * hormone receptor status not specified * pre- or post-menopausal status
hydronephrosis arfi study

Conditions: Hydronephrosis

Summary: pediatric upper urinary tract dilatation (hydronephrosis) is relatively common and may be either obstructive or nonobstructive. while the upper urinary tract is commonly evaluated by ultrasound, this imaging technique often fails to distinguish obstructed from nonobstructed systems. arfi svi is a new ultrasound technology that can be used to determine stiffness by measuring a tissue's shear wave velocity, may show alterations in parenchymal shear wave velocity in kidneys that show obstruction on drs (diuretic renal scintigraphy)which serves as the reference standard.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or younger 2. you are scheduled for diuretic scintigraphy (drs)testing - exclusion criteria: none -
using digital health technologies to prevent rapid infant weight gain.

Conditions: Breastfeeding; Bottle Feeding; Child Obesity

Summary: a digital intervention to provide supplemental infant feeding support to mothers enrolled in wic. the trial begins prenatally and continues through 3-months postpartum and tests the feasibility and acceptability of a text messaging intervention aimed at increasing responsive bottle feeding as well as breastfeeding duration and exclusivity among mothers enrolled in wic using evidence-based components such as interactive self-monitoring and feedback. recruitment and enrollment never started at duke for the intervention represented in this record. the overall status of recruiting and actual start date were previously entered in error.


Eligibility criteria:
inclusion criteria: * enrolled in wic, english or spanish speaking, at least 18 years old, between 18-28 weeks' gestation, and planning to remain enrolled in wic for 6 months, intention to breastfeed or undecided about breastfeeding, and willingness to send and receive daily text messages. exclusion criteria: * postpartum exclusions include infant prematurity (\ 3 days in neonatal intensive care unit, major medical problem affecting breastfeeding (i.e., maternal hiv), or birth weight \<5 lbs.
the effect of d3 on selected cytokines involved in cytokine storm in the covid-19 uninfected jordanian people

Conditions: Cytokine Storm

Summary: the effect of weekly 50,000 iu vitamin d3 supplements on the serum levels of selected cytokines involved in cytokine storm of covid-19; a randomized clinical trial in the covid-19 uninfected people with vitamin d deficiency.

no data are available on the effect of weekly 50,000 iu vitamin d3 supplements on the serum levels of selected cytokines involved in cytokine storm of covid-19 in the covid-19 uninfected jordanian people with vitamin d deficiency. this study was designed to investigate whether a high dose of vitamin d3 (50,000 iu) / week for 8 weeks supplementation has a potential effect on cytokine storm of covid-19; such as il-1 beta, il-6, and tnf in the covid-19 uninfected jordanian people with vitamin d deficiency. this study aims to assess whether high doses of vitamin d3 may improve immune responses against covid-19 infection in uninfected jordanian peoples. we hypothesize that weekly 50,000 iu vitamin d3 supplements will significantly change immune responses compared with the control group.

Eligibility criteria:
inclusion criteria: age ≥30 years old male and female jordanian asu students and employees who live in amman. informed written consent from the participant prior to the start of the study. a serum 25(oh)d concentration less than 30 ng/ml. exclusion criteria: any eligible subject refuses to apply with informed written consent before the start of the study. men or women previously diagnosed with chronic diseases, including kidney disease or git problems. who are receiving vitamin d3 supplements (3 months before the start of the study). pregnant, breastfeeding females, females using hormonal contraceptives

Keywords: covid -19 uninfected il-1 il-6 tnf vdd vitamin d3 50,000iu