Kornimate/medical-research-clean huggingface dataset:
bone health and vitamin d status

Conditions: Osteopenia; Vitamin D Deficiency; HIV Infection

Summary: this study will compare and assess the prevalence of osteopenia and vitamin d deficiency as well as effects of tdf on the patients' bone among hiv positive and negative patients.

to determine the prevalence of osteopenia and vitamin d deficiency in hiv-1 infected, haart naive thai patients compared to hiv-1 uninfected thai participants. furthermore, to determine the change in bmd after twelve months in hiv-1 infected thai patients on a tdf-based haart regimen compared to patients on a non-tdf containing regimen.

Eligibility criteria:
inclusion criteria: * hiv uninfected: * hiv negative confirmed by hiv testing * age 30 years and older * thai nationality * signed informed consent form for the study * hiv-infected, haart naïve: * recorded hiv infection * age 30 years and older * thai nationality * signed informed consent form for the study * hiv-infected, haart group: * recorded hiv infection * age 30 years and older * thai nationality * haart naïve at baseline, planned to start haart within 90 days. past exposure to antiretroviral therapy during pregnancy for the prevention of mother to child transmission of hiv ≥ 3 months prior to screening will be allowed * signed informed consent form for the study exclusion criteria: * hiv uninfected * currently pregnant or lactating * recent hospitalization * use of anticonvulsants, steroids or vitamin d supplements * hiv-infected, haart naïve * cd4 \< 350 * currently pregnant/lactating * recent hospitalization * signs of wasting * use of anticonvulsants, steroids or vitamin d supplements * hiv-infected, haart group: * prior antiretroviral therapy use * currently pregnant/lactating * recent hospitalization * signs of wasting * active opportunistic infection * use of anticonvulsants, steroids or vitamin d supplements

Keywords: osteopenia vitamin d deficiency hiv-infected patients bone health bone mineral density (bmd) hiv-uninfected patients effects of tdf on the patients' bone
glycemic index variation during low-carbohydrate enteral formula with and without fructose in critically ill patients

Conditions: Critical Illness

Summary: hyperglycemia is a known risk factor for mortality in critically ill patients. most of these patients receive enteral feeding. there is controversy about ideal carbohydrate composition of these diets. the aim of this study was to compare an enteral formula with the same proportion of carbohydrates with and without fructose on blood glucose levels.

randomized, cross-over, controlled, double-blind clinical trial without washout. adult patients admitted to the icu who presented capillary glycemia values\> 180mg / dl with a full and exclusive enteral diet. they were randomized and observed for 4 days (2 days with each diet: with / without fructose). capillary glycemia was measured 4 / 4h.

Eligibility criteria:
inclusion criteria: * critical illness * exclusive enteral diet * enteral diet with full nutritional value * hyperglycemia ≥180 mg / dl exclusion criteria: * oral feeding * npt (total or partial parenteral nutrition) * patient without indication of use of study diets

Keywords: hyperglycemia fructose diabetes mellitus enteral nutrition glycemic variability
study of the pathogenesis of rett syndrome

Conditions: Rett Syndrome

Summary: objectives: i. extend current knowledge of the phenotype and natural history of rett syndrome (rs). ii. continue the search for a cytogenetic and/or dna marker. iii. study the effects of cholinergic drugs based on preliminary evidence for reduced levels of brain acetylcholine, while continuing supportive care to modify seizures, respiratory abnormalities, and motor disturbances, and improve nutrition, behavior, and learning. iv. identify targets for future therapeutic interventions, e.g., growth factors, to influence neurologic recovery.

protocol outline: patients receive a comprehensive clinical evaluation including an ophthalmologic exam; speech, communication, and developmental assessment; nutritional evaluation; neurologic exam; respiratory monitoring; and cytogenetic studies. selected patients with malnutrition are given night feedings of pediasure with fiber by nasogastric tube. specific recommendations for feeding techniques and diet are made. selected patients with seizures or severe hyperventilation and progressive rigidity are nonrandomly assigned to dextromethorphan or topiramate therapy. oral dextromethorphan is maintained 6 months to 1 year; duration of therapy depends on response. oral topiramate is given for 6 months to 1 year, and aricept for 6 months to 1 year. concurrent anticonvulsants may require dose adjustments while on above protocols. supportive care for constipation, scoliosis, and weight loss is allowed.

Eligibility criteria:
protocol entry criteria: rett syndrome diagnosis confirmed on study

Keywords: rett syndrome neurologic and psychiatric disorders rare disease
vitamin d supplementation for treatment of heart failure

Conditions: Heart Failure

Summary: the central objective of this proposal is to establish that vitamin d supplementation in heart failure patients with low vitamin d levels will have improved outcomes compared to placebo. in addition the investigators will also evaluate the role of genetics in regard to vitamin d and heart failure. the investigators will be evaluating what is currently a novel approach of identifying patients with low vitamin d and treating this low vitamin d level. the investigators will be able to evaluate the importance of vitamin d supplementation in these patients and the role of genetics on our defined outcomes.

primary objective to determine how rapid vitamin d supplementation affects biomarkers and submaximal exercise capacity in systolic hf patients with low vitamin d status. working hypothesis 1: hf patients when supplemented with vitamin d for 6 months will have lower measures of inflammation and extracellular-matrix remodeling compared with placebo. working hypothesis 2: hf patients when supplemented with vitamin d for 6 months will have longer 6-minute walk length compared with placebo. secondary objectives to establish a relationship between the cyp2r1 variant and surrogate markers in systolic hf patients. working hypothesis 3: hf patients with the cyp2r1 g allele will have higher measures of inflammation and extracellular-matrix remodeling compared to aa subjects. this relationship will also be seen in subjects with the cyp2r1 tagsnp variants. working hypothesis 4: hf patients with cyp2r1 variant alleles will have shorter 6-minute walk length compared to subjects without these variants. to genotype hf subjects for the vdr variants and additional tag snps, to ascertain the relationship between vdr genetic variation and surrogate markers in systolic hf patients. working hypothesis 5: hf patients with vdr variants will have greater measures of inflammation and extracellular-matrix remodeling compared to subjects without vdr variants. working hypothesis 6: hf patients with vdr variants will have a shorter 6-minute walk length compared to subjects without these variants.

Eligibility criteria:
inclusion criteria: * hf patients with lv systolic dysfunction of ischemic or non-ischemic origin and an lvef \<40% using nuclear ventriculography or echocardiography within the last 6 months. * attempts should have been made at optimizing medical therapy and the participant should be stable on these medications for at least 3 months. * patients with a 25(oh)d level between 10-25 ng/ml exclusion criteria: * inability to give informed consent * patients with sarcoidosis or other granulomatous disease that can alter vitamin d metabolism * patients with primary valvular hf, hypertrophic cardiomyopathy, and drug-induced hf * renal dysfunction defined as serum creatinine \> 2.5 mg/dl * pregnant women * patients \<18 years of age * patients on vitamin d supplementation

Keywords: vitamin d systolic failure genomics biomarkers exercise quality of life
safety and pharmacokinetic study of oral mk-8527 qm in participants at low-risk for hiv-1 infection (mk-8527-007)

Conditions: HIV; HIV Pre-exposure Prophylaxis

Summary: this double-blind, placebo-controlled study is designed to assess the safety, tolerability, and pharmacokinetics of oral mk-8527 taken once monthly (qm) in participants at low risk for human immunodeficiency virus type 1 (hiv-1) infection.


Eligibility criteria:
inclusion criteria: * is confirmed hiv-uninfected based on negative hiv-1/hiv-2 test result before randomization * has low-risk of hiv infection * females: is not pregnant or breastfeeding and is either not a participant of childbearing potential (pocbp) or is a pocbp and uses an acceptable contraception or is abstinent from penile-vaginal intercourse exclusion criteria: * has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator * has an active diagnosis of hepatitis due to any cause, including active hepatitis b (hbv) infection (defined as hbsag-positive) or hepatitis c virus (hcv) infection (defined as detectable hcv ribonucleic acid \[rna\]) * prior use of mk-8527 or islatravir (mk-8591)
safety study of an aerosolized, recombinant alpha 1-antitrypsin in subjects with alpha 1-antitrypsin deficiency

Conditions: Alpha1-antitrypsin Deficiency

Summary: the purpose of this randomized, double-blind, placebo-controlled study is to evaluate the short-term safety of inhaled recombinant alpha 1-antitrypsin (raat) in subjects with alpha 1-antitrypsin deficiency. the subjects are randomized to receive placebo or one of 4 doses of raat. the 4 doses are tested in a consecutive manner from lowest to highest.


Eligibility criteria:
inclusion criteria: * male or female 18 years of age or older * endogenous plasma aat levels \< 11 µm (\< 80 mg/dl) * baseline forced expiratory volume at one second (fev1) that is \>= 50% of predicted, measured 30 minutes after a short-acting inhaled bronchodilator * baseline arterial oxygen percent saturation (sao2) within the normal limits for the individual study site * for subjects receiving an inhaled corticosteroid, β-2 agonist (eg, albuterol via metered dose inhaler \[mdi\]) or anticholinergic bronchodilator (eg, ipratropium bromide), treatment on a stable dose for at least 14 days prior to randomization * if female of childbearing potential, negative urine pregnancy test within 3 days prior to randomization and agreement to employ adequate birth control measures * no clinically significant abnormalities detected on a 12-lead electrocardiogram (ecg) performed no more than 7 days prior to randomization * baseline laboratory results, obtained no more than 7 days prior to randomization, meeting the following criteria: * serum aspartate transaminase (ast) and alanine transaminase (alt) \<= 2 times upper limit of normal range (uln) * serum total bilirubin \<= 2 times uln * \< 2+ proteinuria on urine dipstick * serum creatinine \<= 1.5 times uln * absolute neutrophil count \>= 1500 cells/mm3 * hemoglobin \>= 10.0 g/dl * platelet count \>= 100,000/mm3 * signed informed consent exclusion criteria: * clinically significant pulmonary impairment, other than emphysema and/or chronic bronchitis * clinically significant cardiac, hemostatic, or neurologic impairment, or other significant medical condition that, in the opinion of the investigator, would affect subject safety or compliance * psychiatric or cognitive disturbance or illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect subject safety or compliance * acute exacerbation of emphysema (as defined in section 8.5.10) within 28 days prior to randomization * pregnancy or lactation * known history of allergy to yeast products * medical history precluding the use of epinephrine or other rescue medication for treatment of anaphylaxis * use of antihistamines within 7 days prior to randomization * use of oral steroids, beta-blockers, or tricyclic antidepressants within 28 days prior to randomization * use of another investigational drug or investigational device within 28 days prior to randomization * any upper or lower respiratory infection within 28 days prior to randomization
efficacy and safety study of simeprevir in combination with sofosbuvir in subjects with chronic genotype 4 hepatitis c virus infection

Conditions: Chronic Hepatitis C; Genotype 4 Chronic Hepatitis C

Summary: the purpose of this study is to show superiority of simeprevir (smv) in combination with sofosbuvir for 12 weeks versus a historical control. historical control will be a composite of the observed historical sustained virological response at week 12 (svr12) rates of smv in combination with (pegylated) interferon (pegifn)/ribavirin (rbv) of the subpopulations in study hpc3011 (nct01567735) and will depend on the percentage of treatment-naive, prior relapser, prior non-responder, interferon (ifn)-intolerant and other subjects enrolled in this study.

this is a phase 3, open-label (all people know the identity of the intervention), single-arm, multicenter study (conducted at multiple sites). the study consists of 3 periods: a screening period (up to 4 weeks), treatment period (12 weeks) and post treatment follow-up period (until 24 weeks after end of treatment). the duration of the subjects' participation will be approximately 40 weeks. in the treatment period subjects will receive oral capsule simeprevir along with oral tablet sofosbuvir once daily for 12 weeks. primarily efficacy will be evaluated as percentage of subjects with sustained virologic response at week 12 after the end of treatment. subjects' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * subjects with confirmed hepatitis c virus (hcv) with hcv rna greater than (\>) 10000 international unit per milliliter (iu/ml) * subjects who are treatment naive or treatment-experienced. * subjects must have documentation of a liver biopsy or fibroscan or agree to have one during screening * subjects with cirrhosis must have an hepatic imaging procedure (ultrasound, ct scan or magnetic resonance imaging \[mri\]) within 6 months before the screening visit (or during the screening period) with no findings suspicious for hepatocellular carcinoma (hcc) * women of childbearing potential or men with a female partner of childbearing potential must agree to use an effective form of contraception, or not be heterosexually active, or of nonchildbearing potential exclusion criteria: * evidence of clinical hepatic decompensation * any liver disease of non-hcv etiology * subjects with a past history of treatment with an approved or investigational daa * co-infection with human immunodeficiency virus (hiv) type 1 or type 2 (hiv-1 or hiv-2) (positive hiv-1 or hiv-2 antibodies test at screening) * infection/co-infection with hcv non-genotype 4

Keywords: chronic hepatitis c genotype 4 chronic hepatitis c simeprevir sofosbuvir
mesalazine (pentasa®) in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this non-interventional study examines whether the patient's level of information and the consideration of the patient's preference have a positive effect on the compliance and thus also on the therapeutic success.


Eligibility criteria:
inclusion criteria: * patients are treated for the first time with oral pentasa®, e.g. following first diagnosis of ulcerative colitis for treatment of an acute episode or * following a therapy-free period (no previous mesalazine therapy) or due to poor response or underdosage oder lacking acceptance of the previous medication the patients are re-adjusted to oral pentasa®, * the patients (≥ 18 years) have been informed about the nis and have given their written consent for participation.
radiotherapy for prostate cancer: conventional dose versus high dose

Conditions: Prostatic Neoplasms

Summary: 3-d conformal radiotherapy offers the opportunity to reach higher tumor doses with acceptable complication rates compared to conventional radiotherapy. there are retrospective and preliminary prospective reports of a better local control / disease free survival (including psa control) using higher tumor doses. a prospective randomised phase iii study is required to validate these reports. the purpose of this randomized phase iii study is to investigate and compare the tumor control and toxicity in prostate cancer patients treated to 68 gy and 78 gy;

patients were stratified by hospital, treatment group, age and (neo)adjuvant hormonal therapy. four treatment groups with specific radiation volumes were defined depending on the estimated risk of tumour involvement of the seminal vesicles (based on t-stage, initial psa and gleason score or differentiation grade).the dose was delivered with daily fractions of 2 gy, five times a week. the total duration of the treatment was 7 weeks for patients treated to 68 gy and 8 week for 78 gy. objectives: * to test in a phase iii randomised study the hypothesis that higher radiation doses lead to a higher freedom from failure rate for localized prostate cancer. * to test the hypothesis that a higher freedom from failure rate leads to a longer disease-free survival and overall survival. * to limit acute and late toxicity with respect to gastro-intestinal and urological toxicity. * to evaluate different psa related endpoints for local failure and distant metastasis. * to establish a database of patients treated to escalated doses with dose volume histograms of the normal tissues at risk for each individual patient and common toxicity endpoints. * to validate a model to estimate normal tissue complication probabilities (ntcps) of rectum and bladder, based on the above-mentioned database, and to obtain reliable parameter values for ntcp estimations.

Eligibility criteria:
inclusion criteria: * locally confined adenocarcinoma of the prostate * all t-stages with a psa \< 60ng/ml, except any t1a tumor and well-differentiated (or gleason score \< 5) t1b-c tumors with psa-levels ≤ 4 ng/ml * karnofsky performance status of 80 or more exclusion criteria: * distant metastases * positive regional lymph nodes proven by surgical or cytological sampling * on anticoagulants * previous prostatectomy * previous pelvic irradiation

Keywords: radiotherapy dose
toronto and oak ridge photobiomodulation study for dry age related macular degeneration

Conditions: Nonexudative Age-related Macular Degeneration

Summary: the purpose of this study is to evaluate clinical outcomes of photobiomodulation treatment on patients with dry age related macular degeneration (amd). photobiomodulation is the use of non thermal, non laser light of specific wavelengths and energy directly on the eye to improve retinal function and delay amd progression. this is a prospective 2 center phase 2 clinical pilot study with no placebo group.

dry amd is a progressive sight threatening disease affecting central acute vision. dry amd may progress to the wet form where leaking and bleeding in the retina can cause sudden severe visual loss. there are no proven active treatments for dry amd. dry amd accounts for over 80% of amd cases. there are estimated to be 30 million people afflicted with amd by the year 2020 in north america. photobiomodulation in this study is utilised by using two devices that are already approved for other indications by the fda and health canada. photobiomodulation is a novel clinical application for treating dry amd. as this is a pilot study there is no placebo or control group.

Eligibility criteria:
inclusion criteria: * patients of both genders aged 50 years inclusive and over * patients must have dry macular degeneration in the study eye * best corrected visual acuity between 20/40 and 20/200 * patients must be competent to sign and have signed a consent form before study entry exclusion criteria: * visually significant cataracts * presence of a visually significant posterior capsule if prior cataract has been performed * any visually significant disease process in any ocular structure that would affect vision unrelated to macular degeneration * a patient can be enrolled if only one of their eyes meets the criteria * patients with severe clinically significant medical disease or unstable medical conditions including cardiovascular, hepatic, renal, neurological, endocrine, gastrointestinal, cns or life threatening disease or current malignancy at the discretion of the investigators * patients who are non-ambulatory or bed ridden * female patients who are pregnant or of childbearing potential as the effects of pbm on the developing fetus are unknown * patients with a history of epilepsy * patients with a history of alcohol, drug or substance abuse in the past 6 months * patients deemed uncooperative or non compliant with the requirements of the protocol * patients who have received any investigational drug or treatment within 30 days prior to study entry * patients who are not competent to understand and sign consent form

Keywords: dry amd light treatment armd photobiomodulation macular eye disease ageing eye disease
pd-hf: a trial of peritoneal dialysis in patients with severe heart failure and chronic kidney disease

Conditions: Heart Failure; Chronic Kidney Disease

Summary: this trial is to establish whether ultrafiltration by peritoneal dialysis is a clinically effective treatment for patients with severe heart failure and moderate chronic kidney disease, thus improving quality of life and symptoms.

the trial is a multi-centre, prospective, randomised, unblended, controlled trial of intermittent pd with a single daily exchange of icodextrin plus best standard care versus best standard care for the treatment of severe hf and moderate ckd. a second exchange with glucose based solution may be given, should it be required in the investigator's/clinician's opinion. investigators will randomise 130 participants for 32 weeks with randomisation stratified by participating centre. participants will be recruited from specialist-led outpatient hf services in 6 nhs trusts and be managed by both cardiologists and nephrologists. pd catheter insertion will occur according to the participating centre's institutional protocol. treatment begins 1 week after catheter insertion and consists of a single nightly exchange.

Eligibility criteria:
inclusion criteria: * severe heart failure (nyha grade iii or iv) * chronic kidney disease stage 3-4 * fluid overload resistant to diuretics or hospital admission for hf in last 6 months * left ventricular ejection fraction ≤40% in last 2 years (moderate/severe) * using optimal hf medication for ≥ 4 weeks including ace-inhibitor (angiotensin-converting-enzyme inhibitor) or angiotensin receptor blocker and aldosterone antagonist and beta-blocker unless intolerant and without dose change for ≥ 4 weeks * appropriately screened for revascularization and/or cardiac resynchronization therapy if clinically indicated. exclusion criteria: * does not wish to participate * mental incapacity to consent * ckd stage 5 * normal renal excretory function * haemodynamically significant valvular disease amenable to surgery * cardiac or renal transplantation * considered by the investigator to unsuitable for pd due to previous abdominal surgeries, peritonitis, social circumstances or other reason