Kornimate/medical-research-clean huggingface dataset:
safety study of nicotinamide to treat alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine whether nicotinamide, or vitamin b3, is safe and effective in the treatment of alzheimer's disease.

the goal of this proposal is to show that, nicotinamide (na), a b3 vitamin, is safe and effective for the treatment of patients with mild to moderate alzheimer's disease (ad). na is known to block the ability of certain proteins to regulate other proteins by removing their acetyl groups. recent evidence has demonstrated that inhibitors such as na prevent nerve cell degeneration in models of huntington's disease (hd), parkinson's disease and lou gehrig's disease (or als). despite these beneficial effects in many different animal models, there have been no studies to date using these inhibitors in ad. in some of our recent studies we found that the potent inhibitor, na, significantly improves learning and memory in transgenic mice that develop ad. na treatment also resulted in striking changes in tau, a protein that abnormally accumulates in ad. na has been extensively used in clinical studies over the last 40 years and is generally safe and well-tolerated. as na is a safe and readily available vitamin supplement, our recent results provide a strong argument for a study of na in patients with ad. we therefore propose to treat 50 patients with mild to moderate ad with either na (1500 milligrams twice a day) or an identical but inactive drug (placebo) for 24 weeks. at 6 week intervals we will assess functions such as learning and memory, and ability to carry out daily activities as well as caregiver reports using standardized tests. we will also perform spinal taps at the beginning and end of the study to measure the level of abnormal tau protein in the cerebrospinal fluid. blood tests will periodically be done to assess liver function and complete blood counts. the results of this study may provide the basis for a more extensive study of na for the treatment of mild to moderate ad.

Eligibility criteria:
inclusion criteria: * diagnosis of probable ad according to dsm-iv criteria * mild to moderate dementia based on mini-mental state examination \[mmse\] score between 13-25 * minimum age 50 years * brain imaging (computed tomographic scan or magnetic resonance image) within 12 months consistent with a diagnosis of probable ad * hachinski ischemic score of \<4. * stable doses of concomitant medications, including cholinesterase inhibitors (cheis) and/or memantine. exclusion criteria: * dementia due to another cause * other neurological or psychiatric diseases * pseudodementia * unstable medical condition * initial treatment within 30 days of screening with a chei, memantine or any investigational drug * history of alcoholism, drug abuse, liver disease, peptic ulcer disease * pregnancy, or the potential to become pregnant.

Keywords: nutraceutical, dementia, cognition, hdac inhibitor
utility of the somalogic cardiovascular disease (cvd) secondary risk panel for cardiovascular risk

Conditions: Cardiovascular Risk Factor; Cardiovascular Diseases

Summary: this is a prospective pilot study of participants who have stable coronary heart disease (chd). participants undergo risk stratification using the somalogic cardiovascular disease (cvd) risk panel blood test at baseline and again 4-12 months after the initial test. participant surveys and chart abstractions are conducted at baseline and follow-up to collect feedback about the test report and actions taken. care teams may consider using the risk information from the somalogic panel to address care gaps. medical treatment decisions and recommendations are confirmed by established clinical methods, including blood pressure monitoring, body mass index (bmi), lipid and c-reactive protein (crp) measurements, and physician's clinical judgment.

this is a prospective pilot study of participants who have stable coronary heart disease (chd). objectives of this study are to understand whether cvd secondary risk panel scores change from baseline to follow-up (4-12 months after baseline) and actions taken, if any, based upon the results. participants are surveyed to learn what the test results mean to them and assess if the results affect adherence to therapy and lifestyle choices (diet, exercise, alcohol, and tobacco use). in addition, this study will investigate the characteristics of patients that physicians choose to test with the cvd secondary risk panel, and what actions the care team takes because of the results of the test. medical treatment decisions and recommendations are confirmed by established clinical methods, including blood pressure monitoring, bmi, lipid and crp measurements, and physician's clinical judgement. chart abstractions and participants surveys occur at the baseline and follow-up visits, and charts may be abstracted annually for up to 10 years post enrollment.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 40 * stable chd documented by at least one of the following: history of myocardial infarction \>6 months prior to study enrollment, angiographic evidence of at least 50% stenosis, abnormal cac score, prior evidence of inducible ischemia by treadmill or nuclear testing, or a history of coronary revascularization * ability to provide informed consent exclusion criteria: * inability or unwillingness to provide informed consent * less than 40 years of age * history of myocardial infarction in the prior 6 months. * treatment for malignancy (other than basal or squamous cell carcinomas of the skin) within the last 2 years * pregnancy * individuals deemed ineligible by the investigator
effect of bupropion on smoking behavior in smokers with schizophrenia

Conditions: Schizophrenia; Tobacco Use Disorder

Summary: many individuals with schizophrenia smoke cigarettes but little is known about the factors that control smoking in people with schizophrenia. the purpose of this trial is to evaluate how bupropion, an antidepressant medication, affects smoking behaviors in individuals with schizophrenia who smoke.

there is a high prevalence of cigarette smoking among people with schizophrenia and few smoking cessation interventions have been developed for these individuals. bupropion is an antidepressant medication commonly used to treat smoking in smokers without psychiatric disorder. this study compares how smokers with schizophrenia and smokers without psychiatric illness respond to bupropion (0, 300 mg/day). participants will be randomly assigned to receive either bupropion or placebo. study visits will occur after one-week treatment with placebo or bupropion. during study sessions, participants will come to the laboratory at 9 am and will remain abstinent in the laboratory for 5 hrs. participants will then be assessed for craving and withdrawal symptoms after viewing and handling neutral cues and smoking cues. after that, participants will have a 90-min period to smoke, and smoking topography will be measured.

Eligibility criteria:
inclusion criteria: * diagnosed with schizophrenia or schizo-affective disorder * smokes between 20 and 50 cigarettes per day * moderate to high nicotine dependence score * interest in quitting smoking exclusion criteria: * currently trying to quit smoking * seizure disorder or lowered seizure threshold due to anorexia, bulimia, head trauma, diabetes with insulin, or hypoglycemics * alcohol or drug use disorders * requires certain medications * pregnant or breastfeeding

Keywords: schizophrenia tobacco dependence nicotine
spermidine supplementation on metabolic, neuronal and cardiovascular response to exercise training

Conditions: Heart Failure, Diastolic

Summary: this study explores whether spermidine supplementation improves the metabolic, neurological-cognitive and cardiovascular response to structured exercise training in patients with heart failure with preserved ejection fraction. the investigators aim to show that a faster adaptation to exercise may improve long term adherence to a more active lifestyle.

heart failure with preserved ejection fraction is the largest unmet need in medicine. exercise training is a pivotal lifestyle intervention which has been shown to have beneficial effects with regards to metabolic, neurological-cognitive and cardiovascular outcomes in these patients. yet, not every patients responds equally fast to an exercise training intervention. this trial explores whether the supplementation of spermidine can increase the response to a structured aerobic exercise training. the investigators will recruit 30 patients who will either receive a spermidine supplement or a placebo. the study participants are invited for a first follow-up visit after four weeks. the exercise intervention starts at week 5 and continues for 12 weeks. hence, overall there are three visits (baseline, week four and week twelve).

Eligibility criteria:
inclusion criteria: * diastolic heart failure (e/e' \> 8, left ventricular ejection fraction (lvef) =\> 50 %, dyspnea) exclusion criteria: * nutritional supplements with polyamines * acute myo-, endo- or pericarditis * aortic valve stenosis (2nd degree) * cardiomyopathy or severe left ventricular hypertrophy (interventricular septal end diastolic thickness or posterior wall thickness \> 17 mm) * av block (second degree) * pulmonary hypertension * thromboembolic event in the last six months * anemia * infection (with fever) within the last four weeks * cancer

Keywords: exercise spermidine
the influence of pilates exercises training volume on metabolic outcomes in dyslipidemic women.

Conditions: Dyslipidemias

Summary: the aim of the present study was to assess the influence of different volumes of pilates training exercises on metabolic, blood pressure (bp), functional physical fitness (pf) and quality of life (ql) outcomes in postmenopausal dyslipidemic women. in total, 26 women participated in the controlled clinical trial, being allocated into three groups: high volume group (hvg; n=9), low volume group (lvg; n=11) and control group (cg, n=6). hvg performed four weekly sessions and lvg performed only twice a week, during 10 weeks with 45 to 55 minutes per session. before and after the intervention period, metabolic, bp, pf, ql and cardiovascular risk score (crs) outcomes were measured. the results were described by mean values with lower and upper limits (95% confidence interval). comparisons between groups and intra-groups were performed adopting generalized estimating equations (gee) method, with post hoc of bonferroni and significance level of ɑ=0,05.


Eligibility criteria:
inclusion criteria: * dyslipidemic, postmenopausal and sedentary. exclusion criteria: * women taking statins and smokers.

Keywords: training volume elderly lipid profile postmenopausal
haploidentical hematopoietic stem cell transplantation for patients with thalassemia major

Conditions: Thalassemia Major

Summary: the purpose of the study is to assess the safety and efficacy of haploidentical hematopoietic stem cell transplantation for patients with thalassemia major.

the only curative therapy for thalassemia major remains the replacement of the defective erythropoiesis by allogeneic hematopoietic stem cell transplantation(hsct). however, this option is unavailable to many patients as a result of a lack of compatible donors.haploidentical transplantation has been certified as a valuable alternative for hematological malignancy patients lacking a well-matched donor, with results comparable matched hla-identical sibling donors or unrelated donors.the objective of this study is to test the feasibility of haploidentical hsct for patients with thalassemia major.

Eligibility criteria:
inclusion criteria: 1. diagnosed with thalassemia major 2. lacking of a hla-identical sibling donor or unrelated donor 3. indication of haploidentical hematopoietic stem cell transplantation 4. no restrictions for transplantation exclusion criteria: 1. any restriction for transplantation 2. no indication of haploidentical hematopoietic stem cell transplantation
influence of episodic memory on healthy eating

Conditions: Eating Behavior

Summary: the present research project investigates if recall of recent eating episodes enhances consumption of fruits and vegetables

episodic memory is the capacity to remember past autobiographic events, including eating episodes. recalling a previous meal decreases the amount eaten in a subsequent snack occasion. recall of recent eating episodes could alert individuals about the relationship between their eating behaviour and wellbeing. this is supported by the observation in slimming trials that participants who keep a food diary lose more weight than those who do not record their intake. lab experiments have focused on the effect of eating episodic memory on later intake of unhealthy food. however, less is known about the effect on intake of healthy food. increasing consumption of food that contains nutritious elements like fruit could protect against chronic disease. if eating episodic memory would increase intake of healthy food, this would benefit individuals' health. the aim of the present between-subjects experiment is to test the influence of memory of recent eating episodes on fruit and vegetable consumption. the interest is to assess differences in amount of fruit/vegetables eaten in each of two conditions: (i) after a recall of eating episodes of the day before and (ii) after recall of activities of the day before excluding eating episodes. the hypothesis is that fruit/vegetable consumption after recalling eating episodes would be higher than after recalling non-eating related activities. the project will consist of four individual studies varying weight status of participants and test food: i) female with healthy weight, and fruit as test food; ii) female with healthy weight, and vegetable as test food; iii) female with unhealthy weight, and fruit as test food; and iv) female with unhealthy weight, and vegetable as test food.

Eligibility criteria:
inclusion criteria: * age 18-25 years old * body mass index within ranges of healthy weight and overweight or slight obesity (18.5 to 24.9 and 25.0 to 34.9 kilograms divided by squared height) exclusion criteria: * fruit hypersensibility * vegetable hypersensibility * chronic ill health

Keywords: episodic memory eating episodes fruit and vegetable intake
the effect of oxycodone to the placental circulation at early labour

Conditions: Labor Pain

Summary: oxycodone is used to treat pain in early labor, however the effect of oxycodone to placental or fetal circulation has not been evaluated. oxycodone is increasingly used to treat labor pain in the early phase. the aim of the randomised, double blinded, placebo controlled study was to evaluate the effects of oxycodone in placental circulation, efficacy and safety of oxycodone and the effects to the newborn.


Eligibility criteria:
inclusion criteria: * oxycodone planned for pain relief * age 18 years or more * informed consent obtained * full term pregnancy exclusion criteria: * no oxycodone planned * age less than 18 years * no informed consent * not full term pregnancy * other contraindication to oxycodone

Keywords: labor pain oxycodone placenta
oral taxane in combination with pemetrexed (alimta) in patients with recurrent non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: a phase i-ii dose ranging study of bms-275183 (oral taxane) in combination with pemetrexed (alimta) in patients with recurrent non-small cell lung cancer (nsclc). the safety and efficacy of this combination will be studied.


Eligibility criteria:
inclusion criteria: * advanced or metastatic pretreated nsclc * measurable disease * adequate hematologic, hepatic and renal functions. * ecog performance status 0-2 exclusion criteria: * inability to swallow capsules * recent significant cardiovascular disease * women who are pregnant or breastfeeding

Keywords: nsclc - non-small cell lung cancer
study of anti-r-huepo associated pure red cell aplasia (prca) treatment

Conditions: Anti-r-HuEpo Associated PRCA Subjects

Summary: recombinant human erythropoietin (r-huepo) has been used to treat renal anemia and improve morbidity and mortality in chronic kidney disease. subcutaneous use of r-huepo causes immunogenicity and develops anti-r-huepo associated pure red cell aplasia (prca). the treatment of anti-r-huepo associated pure red cell aplasia is controversial. the investigators aim to evaluate the treatment for anti-r-huepo associated pure red cell aplasia in this study.

recombinant human erythropoietin was the first biotherapeutic medicinal product derived from recombinant dna technology for the treatment of anemia in patients with chronic kidney disease (ckd). although r-huepo raises hemoglobin levels in ckd and improves morbidity associated with anemia in ckd patients, the adverse immunological effect of r-huepo administered subcutaneously can result in anti-r-huepo associated prca. we aim to evaluate the effectiveness of two treatment protocol, cyclosporine combined with mycophenolate mofetil and cyclophosphamide combined with prednisolone for treatment of anti-r-huepo associated prca.

Eligibility criteria:
inclusion criteria: * age more than 18 years old * ckd patient with anti-r-huepo associated prca exclusion criteria: * pregnancy or lactating women * receiving immunosuppression * active infection * previous history of allergic reaction to cyclosporine, mycophenolate mofetil, cyclophosphamide, prednisolone

Keywords: anti-r-huepo antibody anti-r-huepo associated prca treatment absolute reticulocyte count
pct and clinical algorithm for determination of duration of antibiotics

Conditions: Infection

Summary: patients in the icu whose infection is resolving will be randomized to standard duration of antibiotics compared to duration determined by a combination of a procalcitonin value and a simple evaluation of clinical status.


Eligibility criteria:
inclusion criteria: * adult patients (19 years and older) treated with abx for reasons other than prophylaxis within the last 24 hours and who are admitted to a critical care environment. exclusion criteria: * declined consent * any infection that according to evidence-based guidelines which would usually receive more than 2 weeks of antibiotic therapy including, but not limited to; * infective endocarditis * osteomyelitis * undrained abscess * not expected to survive 48 hours * immunosuppression (hiv positive, any immunosuppressive medications, any steroid dose, neutrophil count less than 1.0) * previously enrolled in this study * presently enrolled in a separate study which is felt by study investigators to have biological or clinical process in conflict with this study.

Keywords: antibiotic cessation rules procalcitonin infection critical care
a study to test the efficacy, safety and pharmacokinetics of bimekizumab in subjects with moderate to severe hidradenitis suppurativa.

Conditions: Hidradenitis Suppurativa

Summary: hidradenitis suppurativa (hs) is a painful, long-term skin condition that causes abscesses and scarring on the skin.


Eligibility criteria:
inclusion criteria: * adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of hs for at least 1 year prior to baseline * stable hs for at least 2 months prior to screening and also at the baseline visit * inadequate response to at least a 3-month study of an oral antibiotic for treatment of hs * total abscess and inflammatory nodule count \>=3 at the baseline visit * subject must agree to daily use (and throughout the entirety of the study) of 1 pre-specified over-the-counter topical antiseptics on their hs lesions * female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug and have a negative pregnancy test at visit 1 (screening) and immediately prior to first dose * male subjects must be willing to use a method of contraception when sexually active, up till 20 weeks after the last administration of study medication exclusion criteria: * prior treatment with anti-il17s or participation in an anti-il17 study * previously received anti-tnfs * subject requires, or is expected to require, opioid analgesics for any reason (excluding tramadol) * subject received prescription topical therapies for the treatment of hs within 14 days prior to the baseline visit * subject received systemic non-biologic therapies for hs with potential therapeutic impact for hs less than 28 days prior to baseline visit * draining fistula count \>20 at the baseline visit * diagnosis of inflammatory conditions other than hs

Keywords: hidradenitis suppurativa bimekizumab hs moderate to severe hs
social information processing in children: an oculo-pupillometric tool for standard evaluation

Conditions: Autism Spectrum Disorder

Summary: the goal of this observational study is to identify behavioral and physiological markers of social alterations in autism spectrum disorders compared to typically developping peers. this single-centre study plan to use eye tracking to evaluate social disorders in autism spectrum disorders (asd). the investigators will estimate oculometric and pupillometric indices as potential asd biomarkers. the study will last 4 years and will be organized in two phases.

in a first phase (expected to last 12-16 months), after an experimental validation in typical adults, relevant oculometric and pupillometric indices will be identified in a typical population of children and in a clinically diagnosed population of asd children. in a second phase of the protocol (expected to last 32-36 months), biomarkers identified in the first phase will be tested on a larger population including other neurodevelopmental disorders.

Eligibility criteria:
inclusion criteria: phase 1 all groups have these 2 criteria in common: free, informed and signed consent of both parents enrolment in the social security system the other criteria per group are as follows: group of adult subjects without asd : age between 18 and 50 years group of children without asd * age between 2 and 12 years * group of children with asd age between 2 and 12 years conformity with the diagnostic criteria of asd according to dsm-v, icd-10 or icd-11 phase 2 * group of children without tnd : age between 0 and 12 years * group of children with tnd, or whose diagnosis is in progress (via pco referral) : age between 0 and 12 years conformity to the diagnostic criteria of tnd exclusion criteria: phase 1: all groups have the 2 common exclusion criteria known uncorrected visual pathologies known personal neurological pathologies and they have these criteria per group: * group of adult subjects without asd: subject under guardianship or trusteeship diagnosis of asd group of children without asd : diagnosis of asd * group of children with asd icd-10 diagnosis of pdd (rett syndrome and hayler syndrome) phase 2 * group of children without asd : diagnosis of asd (confirmed or ongoing)