Kornimate/medical-research-clean huggingface dataset:
direct thrombin inhibitors versus lmwh in staphylococcus aureus bacteraemia

Conditions: Staphylococcus Aureus Bacteraemia

Summary: safety and efficacy of direct thrombin inhibitors versus enoxaparin in patients with staphylococcus aureus bacteraemia. the study hypothesizes that inhibition of the coagulase-activity of s. aureus by direct thrombin inhibitors is safe and translates into a better outcome of patients with s. aureus bacteremia.

single center randomized controlled trial of direct thrombin inhibitors versus standard enoxaparin. * feasibility: proportion of patients eligible for randomization; clinically attained concentration of dti and resulting staphylothrombin inhibition * safety: bleeding events (major/ clinically relevant non-major) * efficacy: thrombotic events during the thromboprophylactic treatment + 3 days * secondary outcome measures * coagulation parameters: evolution of d-dimers from day 0-4; other lab parameters of coagulation (pt/aptt/fibrinogen/platelet count) * inflammatory parameters: crp, white blood cell count, neutrophilia * clinical outcomes: metastatic infections, assessed clinically or by pet/ct; relapse of s. aureus bacteremia; defervescence; persistent positive blood cultures; hospital stay, mortality.

Eligibility criteria:
inclusion criteria: * positive blood culture for staphylococcus aureus * symptoms or signs of infection * indication for thromboprophylaxis exclusion criteria: * contraindication for thromboprophylaxis * significant active bleeding or risk of excessive bleeding * heparin-induced thrombocytopenia * severe liver and kidney disease * pregnancy and lactation.
an fmri study of the effects of clavulanic acid on drug addiction

Conditions: Tobacco Use Disorder

Summary: this research study is looking into the effects of clavulanic on smoking behavior in adult cigarette smokers. the primary study hypothesis is that, compared to placebo, clavulanic acid will reduce smoking over the course of the study.


Eligibility criteria:
entry criteria: inclusion criteria all subjects: 1. age 18-65 years 2. english fluency 3. functional vision (with corrective lenses as needed) to complete assigned assessments and tasks 4. smoke \> 10 cigarettes/day for a minimum of 2 yrs. and have an expired carbon monoxide (co) concentration of ≥ 10 ppm (to confirm inhalation at screening and scanning) 5. if female, provide a negative urine pregnancy test. 6. agrees to refrain from all other tobacco (i.e., dip/chew, cigars, cigarillos) and/or nicotine products (i.e., e-cigs, patches, gum/lozenges, inhalers/sprays) for the duration of study participation exclusion criteria all subjects: 1. sensitivity or allergy to clavulanic acid/antibiotics 2. past head injury or primary neurological disorder associated with mri abnormalities, including dementia, mci, brain tumors, epilepsy, parkinson's disease, or demyelinating diseases 3. any physical or intellectual disability affecting completion of assessments 4. any contraindication to mri 5. use of antidepressants medications with smoking cessation efficacy 6. presence of an untreated illness or serious medical condition 7. current or past psychosis 8. electroconvulsive therapy in last 6 months 9. positive pregnancy test (urine pregnancy testing at screening and prior to fmri scan) or currently breast feeding or bac greater than 0.0 10. use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with clav) within 14 days of study participation 11. abnormal liver function determined by complete metabolic panel - liver enzymes outside normal ranges of ast (sgot) 5-40 unites/l and alt( sgpt) 7-56units/l 12. abnormal renal function determined by complete metabolic panel - outside normal ranges of bun 6-24 mg /dl and creatinine level 0.6 -1.2 mg /dl male, 0.5-1.1mg /dl female 13. any other condition or concern that in the investigator's opinion would impact participant safety, compliance with study instructions, or potentially confound the interpretation of the study results
clinical and neuropsychological investigations in batten disease

Conditions: Neuronal Ceroid Lipofuscinosis; Neuronal Ceroid Lipofuscinosis CLN1; Neuronal Ceroid Lipofuscinosis CLN2; Neuronal Ceroid Lipofuscinosis CLN3; Neuronal Ceroid Lipofuscinosis CLN5; Neuronal Ceroid Lipofuscinosis CLN6; Neuronal Ceroid Lipofuscinosis CLN7; Neuronal Ceroid Lipofuscinosis CLN8; Neuronal Ceroid Lipofuscinosis CLN10; Batten Disease

Summary: this study aims to assess the natural history of batten disease (neuronal ceroid lipofuscinosis) by obtaining information about the motor, behavioral, and functional capabilities of individuals with batten disease. this study will also refine and validate the unified batten disease rating scale (ubdrs) as a clinical rating instrument for batten disease.

batten disease is an inherited disorder that causes progressive cognitive and behavioral decline in children. there have been no systematic clinical studies of batten disease using standardized rating instruments with known inter-rater reliability and validity. the batten study group developed the unified batten disease rating scale (ubdrs), a clinical rating instrument used to assess the motor, behavioral, and functional capabilities of individuals with batten disease. using the ubdrs, study investigators will evaluate participants approximately every year to track disease progression. the ubdrs is the primary natural history tool, but the study also includes neuropsychological assessment, adaptive function, quality of life measures, and other measures to assess the impact of batten disease. participants will be examined at the university of rochester batten center, batten disease support and research association annual meeting, or remotely via televideo. information related to racial and ethnic background, medical history, symptoms, medications, and diagnostic testing will be collected.

Eligibility criteria:
inclusion criteria: * child or adult with any form of batten disease * parent or legal guardian of a child or adult with any form of batten disease exclusion criteria: - parent or guardian unable or unwilling to provide permission for the affected individual

Keywords: batten disease ncl neuronal ceroid lipofuscinosis
long-term fasting in patients with a history of pci

Conditions: Coronary Artery Disease

Summary: patients in this prospective cohort study were selected if they had a history of pci more than 1 year previously. 405 patients were divided based on their preferences to fasting and non fasting and after 1 month of fasting major adverse cardiovascular events were measured

between 18 march 2019 and 18 april 2020, patients seen at professor kojuri cardiovascular clinic in shiraz, iran (email:kojurij@yahoo.com, webpage: http://kojuriclinic.com) for their annual check-up were selected. we explained the research project to them, and volunteers were selected. patients were assigned to the fasting or non-fasting group according to their preference. all volunteers were informed about the details of this research, and provided their written informed consent. patients who declined to participate in the study were excluded. patients were instructed how to divide their medication across the two daily meals before dawn and after sunset during the month of ramadan. we informed patients to immediately stop fasting and consult the clinic if they experienced any signs of cardiovascular disease, including shortness of breath, chest pain, or palpitations. at the end of ramadan, patients were contacted by telephone and asked about their symptoms, including chest pain and dyspnea, hospitalization, and mace. the mace were defined as acute myocardial infarction, hospitalization due to congestive heart failure, new-onset atrial fibrillation, stroke, or cardiac arrest \[19, 20\]. symptomatic patients were referred to the clinic for cardiovascular examination. the study was double-blinded. to blind the researchers, the clinic secretary contacted the patients and asked them not to specify their group (fasting or non-fasting), and then passed the phone to the researcher. we used alphabetical order in each group to blind the statisticians. patients who fasted during ramadan were designated with the letter x, and patients who did not fast during ramadan were designated with the letter y. for statistical analyses we used ibm spss software version 25. we used the chi-squared test to compare categorical variables and student's t-test to compare the mean values of continuous variables. the mann-whitney u test and kruskal-wallis test were used for nonparametric variables.

Eligibility criteria:
inclusion criteria: * history of pci, and a minimum of 1 year between angioplasty and enrollment in this study exclusion criteria: * heart failure (ejection fraction \<50 %) * advanced kidney failure (glomerular filtration rate \<60 ml/min * unsuccessful revascularization * coronary artery bypass graft * liver cirrhosis * any acute conditions such as infection * needed repetitive treatment * diabetes who were on insulin treatment

Keywords: prolonged fasting percutaneous coronary angioplasty major adverse cardiac events
study to evaluate the use of a probiotic in scorad reduction in young patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the study's objective is to confirm that an oral probiotic treatment reduces the signs and symptoms of moderate atopic dermatitis determined by scorad, in patients aged 4 to 17 years, as compared to placebo. it will also be examined if the probiotic treatment, as compared to placebo, reduces the quantity of topical steroids used to treat disease flares, and increases the time till the first disease flare after the end of treatment.


Eligibility criteria:
inclusion criteria: * aged 4 to 17 years, both inclusive. * diagnosed with atopic dermatitis according to hanifin and rajka criteria. * scorad index of 20-40, both inclusive. * patients whose parents or legal guardian sign the informed consent. * the minor over 12 years must also give their consent to participate in the trial. exclusion criteria: * pregnancy. * breast feeding. * women of childbearing age who, in the opinion of the investigator, do not commit to using an effective method of contraception, if they have an active sex life or start during the trial. * treated with phototherapy for the atopic dermatitis in the previous 2 months. * treated with systemic corticosteroids in the previous 2 months or need for corticosteroids anticipated during the first 12 weeks of the study. * having undergone cytotoxic or immunosuppressive therapy in the previous 2 months or having an anticipated need for cytotoxic or immunosuppressive therapy during the first 12 weeks of the study. * treated with probiotics in the previous two months. * treated with systemic antibiotics in the previous four days. * patients with a fever (temperature \> 37.5°c, axillary or equivalent). * serious allergic diseases. * diseases related to immunodeficiency processes or cancer. * other skin diseases that can make assessment of the atopic dermatitis difficult or which require the continuous use of topical corticosteroids. * patients in whom any of the study products is contraindicated according to its summary of product characteristics. * patients who have participated in research studies with medicinal products during the previous 3 months. * patients with gluten or lactose intolerance or inflammatory bowel disease (crohn's disease or ulcerative colitis).

Keywords: probiotic
stroke and tocotrienol: unique role in neuroprotection

Conditions: Ischemic Stroke

Summary: phase iii, single-centre, double-blind, randomised, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of oral vitamin e (mixed tocotrienol) for 6 months in patients with moderate ischemic stroke. 150 patients will be recruited and randomized to receive either placebo or mixed tocotrienol 200mg twice a day for 6 months. patients will be followed up and assessed on their functional recovery.


Eligibility criteria:
adult patients within 1-10 days ischaemic stroke of moderate severity (nihss 6-20) inclusion criteria: 1. age 35 years old and above. 2. subject will be included within the time frame of 1-10 days after the first onset of acute cerebral ischaemic stroke with nihss between 6 - 20. 3. subject is neurologically stable after stroke onset, i.e. no fluctuation in clinical conditions. 4. subject has a modified rankin scale from 2-4. 5. subject has a clinical stroke diagnosis according to who stroke diagnosis. 6. subject is willing to attend at least four sessions of physiotherapy during the study or as deemed needed by the physiotherapist 7. subjects or his/her legally acceptable representative is willing to provide written informed consent. exclusion criteria: 1. subject has evidence of intra-cerebral hemorrhage on brain ct scan or mri 2. recurrent stroke or previous hospitalisation due to suspected cerebrovascular event. 3. severe stroke as assessed clinically and/or by appropriate imaging techniques 4. subject has other significant non-ischemic brain lesion(s) which could affect function or disability. 5. time of ischemic stroke onset not exactly known 6. subject has documented underlying medical conditions which may affect assessment or follow-up such as (but not limited to) terminal cancer, liver cirrhosis, severe dementia or psychosis, connective tissue disease, rheumatoid arthritis, severe heart disease, severe liver disease or renal failure (based on recent medical history) 7. subject has active systemic infection such as (but not limited to) hepatitis and pneumonia 8. subject has definite indication for full dose or long term anti-coagulation therapy (such as warfarin) 9. any condition that in the judgment of the investigator would place the patient under undue risk 10. traumatic brain injury within the previous 30 days. 11. symptoms which are rapidly improving (as in transient ischemic stroke) 12. the patient is pregnant, breast feeding or female of childbearing potential (unless the subject is willing to practice on double contraception measures for the study duration) until up to 1 month (30 days) after last treatment dose. 13. patients who have been included in any other clinical trial within the previous three months.
local anaesthetic for transvaginal egg collection in ivf

Conditions: Infertility

Summary: the purpose of this study is to see whether injecting local anaesthetic into the vaginal tissues,just prior to transvaginal egg collection,will decrease the amount of pain experienced by women having their eggs collected on an ivf cycle. all women will also receive intravenous sedation as required as well as a sleeping tablet thirty minutes prior to the procedure which is our routine procedure for egg collection.

transvaginal oocyte retrieval is the most common method of oocyte collection in ivf cycles. a variety of different methods are used to provide analgesia/anesthesia for oocyte collection. our unit has always used an oral pre-medication followed by intravenous fentanyl during the procedure but this doesn't seem to provide adequate analgesia for some women. the aim of this study was to compare the addition of intravaginal local anaesthetic injection versus saline placebo to our usual analgesia regime to see whether less intravenous fentanyl was required and whether the women experienced less pain during oocyte collection.

Eligibility criteria:
inclusion criteria: * about to undergo transvaginal oocyte retrieval exclusion criteria: * already undergone oocyte retrieval and participated in study (i.e. 2nd or more oocyte collection procedure during study period) * allergy to lignocaine * oocytes only to be collected from one ovary * procedure expected to be exceptionally painful

Keywords: oocyte retrieval pain relief local anaesthetic
phase 3 crossover trial of two formulations of setmelanotide in participants with specific gene defects in the mc4r pathway

Conditions: Bardet-Biedl Syndrome; POMC Deficiency

Summary: a trial to compare the weekly and daily formulations of setmelanotide in participants with genetic defects in the melanocortin-4 receptor pathway.

this study is designed to compare the safety, pharmacokinetics, and efficacy of weekly and daily formulations of setmelanotide in participants with obesity associated with biallelic or heterozygous pomc (pro-opiomelanocortin), pcsk1 (proprotein convertase subtilisin/kexin type 1), lepr (leptin receptor) genetic variants, and participants with bardet-biedl syndrome (bbs).

Eligibility criteria:
key inclusion criteria: * biallelic or heterozygous pomc/pcsk1 or lepr (ppl) genetic variants or bardet-biedl syndrome (bbs), for which they are being treated with qd setmelanotide. * 6 years or older at screening. * taking the setmelanotide qd formulation for at least 6 months in the rm-493-022 (nct03013543) study with acceptable safety and tolerability, and dose level. * participant and/or parent or guardian is able to communicate well with the investigator, to understand and comply with the requirements of the study and is able to understand and sign the written informed consent/assent. * use of a highly effective form of contraception throughout the study and for 90 days following the study. key exclusion criteria: * glycosylated hemoglobin (hba1c) \>9.0% at screening. * anti-obesity medications within 3 months prior to starting the run-in period. * history of significant liver disease or liver injury. * glomerular filtration rate \<30 milliliter per minute (ml/min). * significant dermatologic findings relating to melanoma or pre-melanoma skin lesions. * major psychiatric disorders. * any suicidal ideation or behavior, or any lifetime history of a suicide attempt. * significant hypersensitivity to any excipient in the study drug. * inability to comply with the qw and qd injection regimens. * participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing, with the exception of a setmelanotide clinical trial. other protocol defined inclusion/exclusion criteria may apply.

Keywords: melanocortin-4 receptor pathway genetic obesity hunger hyperphagia
genetic and epidemiologic studies of premature coronary artery disease - scor in arteriosclerosis

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease

Summary: to identify genetic mechanisms controlling apolipoprotein levels and other 'non-traditional' risk factors in families ascertained through probands with premature coronary artery disease (cad).

background: preliminary work for this project was carried out as part of the johns hopkins coronary artery disease study (r01-hl-34791) which provided extensive data on families ascertained through equal numbers of white male and female probands undergoing elective angiography. design narrative: the study, a subproject within an arteriosclerosis scor, had three components. in component 1, the group of 203 probands under study r01hl34791 was expanded with an additional 50 black patients undergoing angiography, meeting identical criteria. in component 2, segregation analysis was carried out on lipoproteins, apolipoproteins, and selected non-traditional risk factors on families of all probands and the etiologic heterogeneity among different groups of families was tested. in component 3, linkage was tested between putative mendelian loci defined in component 2 and markers in and around candidate loci involved in lipid metabolism. preliminary results provided evidence of mendelian control for apolipoprotein a1 and b, and the candidate loci examined included apo b, lipoprotein lipase, and the a1-ciii-a4 gene cluster. the major hypothesis was that these apolipoprotein levels and other non-traditional risk factors might be under genetic control. genetic analysis of these risk factors was used to direct molecular studies to identify specific mutations. the study completion date listed in this record was obtained from the "completed date" entered in the query view report system (qvr).

Eligibility criteria:
no eligibility criteria
safety and efficacy of bi 1744 cl in patients with chronic obstructive pulmonary disease i

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of bi 1744 cl inhalation solution (5 and 10 mcg) delivered via the respimat® inhaler, in patients with copd.


Eligibility criteria:
inclusion criteria: 1. all patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:post-bronchodilator fev1\<80% of predicted normal (ecsc) and a post-bronchodilator fev1/fvc \<70% at visit 1 2. male or female patients, 40 years of age or older 3. patients must be current or ex-smokers with a smoking history of more than 10 pack years: exclusion criteria: 1. patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an sgot \>x2 uln, sgpt \>x2 uln, bilirubin \>x2 uln or creatinine \>x2 uln 2. patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3 3. patients with thyrotoxicosis, paroxysmal tachycardia (\>100 beats per minute) 4. patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse 5. patients who have undergone thoracotomy with pulmonary resection 6. patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day. 7. patients who regularly use daytime oxygen therapy for more than one hour per day. 8. patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (visit 1) or patients who are currently in a pulmonary rehabilitation program 9. pregnant or nursing women 10. women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).