Kornimate/medical-research-clean huggingface dataset:
escalating clopidogrel by involving a genetic strategy - thrombolysis in myocardial infarction 56

Conditions: Myocardial Infarction; Percutaneous Coronary Intervention

Summary: to determine whether higher as compared with lower maintenance doses of clopidogrel can adequately improve the degree of platelet inhibition in carriers of a reduced-function cyp2c19 allele.

clopidogrel blocks the p2y12 adp receptor on platelets and has been shown to reduce cardiovascular events in acute coronary syndrome (acs) patients.however, inter-patient variability in the pharmacodynamic response to clopidogrel is well recognized, and patients with lesser degrees of platelet inhibition in response to clopidogrel have been shown to be at increased risk of cardiovascular events. one potential source of this variability is the metabolism of clopidogrel, which is a pro-drug requiring biotransformation to become an active antiplatelet compound. cytochrome p-450 (cyp) enzymes play a role in the metabolism, and carriers of reduced-function genetic variants in cyp2c19 (\~30% of the population) have lower active clopidogrel metabolite levels, diminished platelet inhibition, and higher rates of adverse cardiovascular events as compared with non-carriers in the setting of treatment with standard maintenance doses of clopidogrel. aim: to determine whether higher as compared with lower maintenance doses of clopidogrel can adequately improve the degree of platelet inhibition in carriers of a reduced-function cyp2c19 allele. hypotheses: the primary hypothesis is that subjects who carry a reduced-function cyp2c19 allele will have improvement in platelet inhibition with higher maintenance doses of clopidogrel.the secondary hypothesis is that higher maintenance doses of clopidogrel in carriers of a reduced-function cyp2c19 allele will result in similar platelet inhibition as compared to a standard maintenance dose of clopidogrel in non-carriers.

Eligibility criteria:
inclusion criteria (major): 1. between 18 and 75 years of age, inclusive. 2. have an indication for the use of clopidogrel defined as either spontaneous mi \[hospitalized with final diagnosis of mi, excluding periprocedural or definite secondary mi (e.g., due to anemia or hypertensive emergency)\] or pci within the past 6 months. 3. clinically stable and at least 4 weeks following the mi or pci. exclusion criteria (major): 1. conditions that alter platelet function. 2. conditions that increase bleeding risk.

Keywords: myocardial infarction percutaneous coronary intervention clopidogrel genetics platelet function
wincati software tool for survey research

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to design computer aided telephone interviewing (cati) software tools for survey research.

background: cati (computer aided telephone interviewing) became a primary means of obtaining quality epidemiological data. its use steadily increased and in 1995 it was a major technology in use by almost every nih institute. although cati had been used for many years, its implementation had not kept up with technological developments in computers. available cati software products were deficient in features, inflexible, difficult to learn to use and had copious problems. modern computer technology had the potential to satisfy the growing need for an improved product. this product had applications in over 3000 u.s. companies engaged in public opinion and market research. design narrative: in phase i the investigators identified approaches that could be used to develop this software; justified and chose an approach; created requirements and designed specifications for the tool; developed a prototype; and produced a detailed project plan for implementation. in phase ii, the investigators completed and improved the prototype software and tested it in several areas

Eligibility criteria:
no eligibility criteria
pulse acth vs. mp for ms

Conditions: Multiple Sclerosis

Summary: we hypothesize that corticotropin or adrenocorticotrophic hormone (acth), administered as acthar gel® (manufacturer name) is effective in the control of clinical disease activity as a pulse therapy for relapsing-remitting ms when added to standard treatment with beta-interferon. we wish to determine whether acth, when administered as clustered monthly intramuscular injections (monthly pulse therapy) as add-on to beta-interferons, may be a safe and effective alternative to monthly pulse therapy with mp. in addition, we hypothesize that pulse therapy with acth alters immune function to favor a regulatory, rather than a pro-inflammatory t cell environment.

please see the final manuscript

Eligibility criteria:
inclusion criteria: 1. clinically definite multiple sclerosis defined by mcdonald criteria. 2. between 18-65 years of age. 3. subject must able to understand and sign the irb- approved informed consent form prior to the performance of any study-specific procedures and is willing to comply with the required scheduling and assessments of the protocol, including self-administration of study drug (if assigned to the acth arm). 4. subjects who are women of childbearing potential, must have a negative serum pregnancy test at the screening visit, and must be willing to practice a reliable birth-control method. 5. subjects must have at least one ms relapse within last year and/or at least one new t2 or gadolinium-enhanced lesion on mri while on stable interferon therapy. 6. edss (expanded disability status scale) score of 3.0 - 6.5 7. currently on one of the approved beta-interferon drugs (avonex, betaseron, or rebif) for a minimum of 6 months. exclusion criteria: 1. women who are either pregnant or breastfeeding, and women of child-bearing potential (defined as not surgically sterile or at least two years post menopausal) who are not using one of the following birth control methods: tubal ligation, implantable contraception device, oral, patch, injectable or transdermal contraceptive, barrier method or sexual activity restricted to vasectomized partner. 2. uncontrolled hypertension, clinically significant cardiac arrhythmias, gastrointestinal ulcer, uncontrolled diabetes mellitus, osteoporosis, any stage of renal failure, psychiatric disorders or any other clinically significant general health conditions that may interfere with the trial participation. 3. subject has a history of drug or alcohol abuse within the past year. 4. subject had corticosteroid treatment within last 90 days. 5. subject started new medication within last 30 days. 6. subject is on tysabri treatment presently or within 6 months of screening. 7. subject is on novantrone, cellcept, rituxan or other chemotherapeutic treatment presently or within 6 months of screening. 8. subject is a participant in another research project. 9. subject has contraindications for either acth or mp administration.

Keywords: multiple sclerosis acth steroids
transobturator verus single incision slings

Conditions: Urinary Incontinence, Stress

Summary: a randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling

transobturator slings are one type of sling that has become standard treatment for stress urinary incontinence. however, this procedure involves a total of 3 incisions to perform. in contrast, single incision slings have been developed to treat stress urinary incontinence by using only one incision. however, to date the success and complications of these two procedures have not been compared or studied.

Eligibility criteria:
inclusion criteria: * patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment. exclusion criteria: * patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.
safety and efficacy study of tenalisib (rp6530) in combination with pembrolizumab in relapsed or refractory chl

Conditions: Classical Hodgkin Lymphoma

Summary: to characterize safety, tolerability and to establish the maximum tolerated dose (mtd) for tenalisib in combination with pembrolizumab in patients with chl.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years on the day of signing informed consent. 2. histologically confirmed diagnosis of chl. 3. disease status as defined as. * refractory patients who are naïve to anti-pd-1/pdl-1 therapy or relapsed after 3 or more lines of therapies; and are naïve to anti-pd-1/pdl-1 therapy or * patients currently on pembrolizumab and achieve a less than complete response 4. must have ecog performance status of 0 or 1 5. at least one bi-dimensional measurable lesion with minimum measurement of \> 15 mm in the longest diameter. 6. toxicities related to prior therapy must have returned to grade 1 or less, except for alopecia. 1. adequate bone marrows, liver and renal function as assessed by the following laboratory requirements. hemoglobin ≥8.0 g/dl (may not be transfused or treated with erythropoietin in preceding week to maintain or exceed this level) 2. absolute neutrophil count (anc) ≥1,000/µl 3. platelet count ≥75,000/μl 4. total bilirubin ≤1.5 times the uln (or ≤3 x uln, if patient has gilbert syndrome) 5. alt and ast ≤2.5 x uln 6. serum creatinine ≤ 1.5 x uln or crcl \> 60 ml/min (cockcroft-gault formula) 7. use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential 8. provide written informed consent prior to any study-specific screening procedures. 9. willingness and capability to comply with the requirements of the study. exclusion criteria: 1. patient receiving anticancer therapy (e.g. chemotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) ≤3 weeks or 5 half-lives (whichever is shorter) prior to c1d1, 2. prior therapy with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137 or anti ctla-4 antibody or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways) 3. radiotherapy within the last 21 days prior to c1d1 (limited field palliative radiation is allowed if ≥ 14 days prior to c1d1); 4. investigational drug therapy outside of this trial during or within 3 weeks prior to c1d1. 5. patients with allo-sct on active gvhd or immunosuppression therapy within 3 months prior to c1d1. 6. patient with active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications . 7. pregnancy or lactation. 8. known clinically active cns involvement. 9. evidence of active hepatitis b, active hepatitis c infection (hcv) or cytomegalovirus (cmv) or known history of hiv. 10. subjects with concomitant second malignancies 11. patient with any active immune toxicity of grade 1 or greater or any other severe or grade 3 treatment-related adverse event. 12. history of grade 4 anaphylactic reaction to monoclonal antibody therapy.

Keywords: hodgkin lymphoma rp6530 pembrolizumab tenalisib
weexpand: prep demonstration project among women at risk for hiv infection - preexposure prophylaxis (prep)

Conditions: HIV-infection/AIDS

Summary: the objective of this application is to increase prep uptake among aa women vulnerable to hiv acquisition in the rural south, specifically those seeking care at federally qualified healthcare centers (fqhc) in rural alabama. the investigators will use a mixed-methods approach to adapt and pilot test a patient-provider communication tool from the cdc prep toolkit that focuses on the first three steps of the prep cascade (e.g., recognizing hiv risk, identifying as a prep candidate, and interested in prep) to increase prep uptake via referrals to local prep clinics.

the investigators propose: (1) to explore the hiv risk perceptions of aa women with recent prep use, aa women who are candidates for prep, and providers and identify preferences around patient-provider communication about hiv risk and prep services that address the needs of aa women. (2a) to systematically adapt a patient-provider communication tool to increase prep uptake at two fqhcs in rural alabama, using an iterative implementation process; and (2b). to assess the feasibility, acceptability, and preliminary impact of the patient-provider communication intervention on prep uptake among aa women and their providers in a pilot pre-/post-intervention design. as part of aim 2b), the investigators will also systematically document and evaluate reasons for declining a prep referral, reasons for incomplete referrals, reasons for failing to initiate prep after a successful referral, and ongoing prep use at 3 months and 12 months post prep initiation among our sample.

Eligibility criteria:
inclusion/exclusion criteria patients * cisgender * hiv-uninfected women * age 18 years or older * english speaking * report sexual activity or anticipate sexual activity within 6 months providers * physicians, nurse practitioners, physician assistants, nurses, medical assistants, social workers/counselors or other potential/actual prep service providers * english speaking

Keywords: pre exposure prophylaxis (prep) hiv prevention african american women cisgender women
effects of natural sourdough fermentation duration and acid development on postprandial blood glucose in prediabetic adults

Conditions: Insulin Resistance

Summary: the primary intervention for management of prediabetes is lifestyle changes. eating healthier and increasing physical activity was found to slow the progression of prediabetes into diabetes, reduce the risk of other diseases like cardiovascular disease and hypertension, and have a lasting impact even after the intervention is discontinued. studies found that increasing the intake of fiber, pre- and probiotics, and fermented foods have been linked to improved glycemic biomarkers. the goal of this crossover randomized trial is to assess the relationship between lengthened fermentation time of sourdough bread, e.g., an increased amount of lactic acid and acetic acid in the bread product, and postprandial glycemic response in healthy adults with prediabetes.

sourdough bread has been proven to have higher fiber content and contains beneficial microorganisms from the fermentation process and has been linked to reduced risk of various diseases like diabetes, cardiovascular disease, and dyslipidemia. the fermentation of sourdough bread products converts starch and sugar in the dough into resistant starches and other slower digesting compounds. sourdough bread products also have a lower glycemic index value, meaning they do not cause the blood sugar to rise as quickly, thus slowing the release of insulin in the body, leading to reduced risk of insulin resistance. however, very few studies exist studying the effects of naturally fermented sourdough products in individuals with prediabetes. it is worth exploring if increasing the fermentation time of naturally fermented sourdough bread increases the effects on relevant biomarkers relating to postprandial glycemia and insulinemia in prediabetic adults. this study examined the acute effect of varying lengths of sourdough fermentation times on postprandial blood glucose levels over a 4-week period in adults with prediabetes (as evidenced by fasting glucose ≥100 or diagnosis by physician), but not taking diabetic medications. for each trial, the sourdough bread was ingested after an overnight fasting period in order to evaluate the effects of the bread when incorporated into the diet in place of breads made with baker's yeast. the goal of this crossover randomized trial was to assess the relationship between lengthened fermentation time, meaning an increased amount of lactic acid and acetic acid in the bread product, and glycemic and insulinemic response.

Eligibility criteria:
inclusion criteria: * prediabetes; not on metformin; no known food allergies or sensitivities; not supplementing pre/post biotics exclusion criteria: * following diet that restricts carbohydrates; medication use affecting blood glucose; acute illness; smoker; pregnant; lactating; gi tract surgery; not willing to follow protocol

Keywords: fermentation pre-diabetes sourdough bread post-prandial glycemia
reverse remodeling after ptsma in severe but asymptomatic lvot obstruction

Conditions: HOCM, Hypertrophic Obstructive Cardiomyopathy; LVOTO - Left Ventricular Outflow Tract Obstruction; Remodeling, Ventricular

Summary: patients with hocm and severe lvot obstruction can remain asymptomatic while significant cellular and structural changes of the heart (adverse remodeling) may occur preceding heart failure and rhythm disorders. hence, preventing adverse remodeling through lvot desobstruction may have significant impact on cardiac function and geometry in this particular population, as it is in symptomatic patients. the investigators will assess functional and structural characteristics of the myocardium in asymptomatic vs. symptomatic patients with severe lvot obstruction before and after ptsma, using advanced imaging studies with lge-cmr and echocardiography.

the trial consists of three cohorts 1. symptomatic hocm patients with severe lvot obstruction undergoing ptsma (reference group) 2. asymptomatic hocm patients with severe lvot obstruction undergoing ptsma (study group) 3. asymptomatic hocm patients with severe lvot obstruction with no intervention (observation group)

Eligibility criteria:
inclusion criteria: * age \> 40 yrs * hocm diagnosed by experienced cardiologists (european society of cardiology (esc)-certified imaging cardiologists and/or finalized fellowship imaging) * lvot obstruction \>30 mmhg pressure gradient in rest, or \>50 mmhg during exercise by tte and/or invasive measurement, performed experienced (imaging) cardiologists * symptomatic (nyha class \>2 or ccs class \>2) * asymptomatic: free of any dyspnea/chest pain or discomfort associated with lvot obstruction exclusion criteria: * lv wall thickness \<15 mm * other conditions responsible for hypertrophy (e.g. hypertension, aortic valve disease) * moderate to severe mitral valve regurgitation * systolic anterior motion of the mitral valve * coronary artery disease requiring intervention * pregnancy

Keywords: hocm hypertrophic obstructive cardiomyopathy left ventricular outflow tract obstruction adverse remodeling reverse remodeling alcohol septal ablation percutaneous transluminal septal myocardial ablation ptsma extracellular volume fraction global longitudinal strain deformation imaging 4d velocity mapping
a study to evaluate the tolerability, safety and effectiveness of edratide in the treatment of lupus

Conditions: Systemic Lupus Erythematosus

Summary: it is thought that edratide may be able to reduce the symptoms of sle.


Eligibility criteria:
inclusion criteria: 1. willing and able to give written informed consent 2. between the ages of 18 and 65 years (inclusive) 3. fulfilled at least 4 acr classification criteria 4. sle patients with moderate, active disease 5. subjects on stable dose of sle medications for at least 4 weeks before randomization. 6. women of child-bearing potential must practice a medically acceptable method of contraception.. 7. must understand the requirements of the study and agree to comply with the study protocol. exclusion criteria: 1. any condition which the investigator feels may interfere with participation in the study. 2. subjects having a history of chronic infection 3. subjects with a history of immunodeficiency syndrome or malignancy, 4. subjects who received any investigational medication (including dhea) within 3 months prior to randomization, 5. subjects treated with any cytotoxic agents in the 3 months prior to randomization.
missed serious medical illness in psychiatric patients seen in an academic emergency department

Conditions: Psychiatric Patients, Serious Medical Illness

Summary: the purpose of this study is to determine the prevalence, etiology, and timing of missed serious medical illness (smi) in patients referred to adult psychiatry by emergency physicians, as well as to determine admission rates for smi soon after discharge from an inpatient psychiatry admission.


Eligibility criteria:
inclusion criteria: * all patients greater than or equal to 18 years of age presenting to london health sciences centre, victoria hospital emergency department between october 1, 2014 - july 31, 2015 who were referred to adult psychiatry by the emergency physician. exclusion criteria: * none
late cardial assessment in children who were diagnosed with post streptococcal reactive arthritis - a long term study

Conditions: Post Streptococcal Reactive Arthritis

Summary: the purpose of this study is to determine whether there is late cardial involvement in children diagnosed with post streptococcal reactive arthritis after discontinuation of prophylactic antibiotic therapy.


Eligibility criteria:
inclusion criteria: * psra patients under 18 who were diagnosed at least one year prior to the study exclusion criteria: * psra patients under 18 who were diagnosed less one year prior to the study * patients who do not fulfill psra criteria * patients who fulfill jones criteria * patients with a known heart defect
efficacy study of a preseasonal treatment with allert in subjects with birch pollen allergy

Conditions: Allergic Rhinitis; Rhinoconjunctivitis

Summary: the main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with allert 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season


Eligibility criteria:
inclusion criteria: * moderate to severe allergic rhinoconjunctivitis to birch pollen: 1. score of symptoms of the rhinoconjunctivitis symptom score (rss) ≥ 12 during the two preceding birch pollen seasons 2. previous use of anti-allergy medications during the two preceding birch pollen seasons 3. positive spt to birch pollen extract 4. positive specific ige cap test for bet v 1 exclusion criteria: * uncontrolled asthma, fev1 \< 80% of predicted * previous sit (specific immunotherapy) to birch pollen or any other sit within 5 years * clinical symptoms due to allergens other than birch pollen during the whole trial period * history of anaphylaxis * positive skin prick test to allert * any other treatment or conditions which may increase the risk of the study for the subject or affect the efficacy assessments during the birch pollen season

Keywords: allergic rhinitis birch pollen immunotherapy