Kornimate/medical-research-clean huggingface dataset:
a community partnership to treat stroke

Conditions: Stroke

Summary: getting to the hospital quickly is the key to treating stroke. african americans suffer more strokes with worse outcomes and receive stroke treatments less often than european americans. this project will work to reduce these health disparities by creating and testing the feasibility of a peer-led faith-based behavioral intervention in an african american community with a goal to increase calls to 911 so stroke patients can be treated quickly.


Eligibility criteria:
inclusion criteria: to meet participant eligibility criteria, individuals must be 18 years of age or older (adult intervention) or between 10-17 years of age (youth intervention), a resident of the flint or greater flint community, and english speaking. exclusion criteria: we will attempt to exclude those who cannot read english because they will not be able to benefit from the intervention materials. these criteria will be confirmed during assessment procedures prior to enrollment.
the impact of different filling pressures in operative outpatient hysteroscopy on the procedure success rates and associated pain.

Conditions: Hysteroscopy

Summary: the study aims to compare different filling pressures in operative outpatient hysteroscopy. women will be divided into 3 groups. the hysteroscope will be introduced in the uterine cavity. saline will be used as the distension medium and the pressure will be 80mm hg in group1, 60mm hg in group 2 and 40mmhg in group 3.

240 women will be randomly divided into 3 groups, each containing 80 women. randomisation will be performed using a computer generated random numbers and sealed envelopes. full history will be taken followed by general and local examination. one hour before the procedure all women will receive diclofenac 100mg (voltaren@ novartis switzerland). the procedure will be done in the lithotomy position. hysteroscopy will be done using a 5mm outer diameter continuous flow hysteroscope with a french working channel and a 30 degrees direction of view provided by techno gmbh and co. the hysteroscope will be introduced using the vaginoscopy technique, in which no speculum will be used. the cervix will be detected and the external os will be identified using the hysteroscope. the hysteroscope will be introduced in the uterine cavity. saline will be used as the distension medium and the pressure will be 80mm hg in group1, 60mm hg in group 2 and 40 mmhg in group 3. randomisation will be double blind, neither the operator nor the patient will know the pressure during the procedure, a third party will set the pressure according to the computer generated random numbers. if the procedure cannot be completed, the operator will ask for the pressure to be adjusted to 80mm hg, which is the usual pressure used in cairo university hospitals, or more if needed. in this case the operator will document in the data collection form that the procedure could not be completed with the pre-set pressure. the anterior wall, posterior wall and tubal ostea will be visualised, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted. endometrial biopsy will be taken using a semi-rigid, double action oval serrated biopsy forceps 40cm 50charr tecchno medical gmbh. the used scissor will be a single action semi-rigid rounded tip scissors tecchno medical gmbh.

Eligibility criteria:
inclusion criteria: * age 18-60 years * indication to have an operative outpatient hysteroscopy like endometrial polyp, need for endometrial biopsy, intrauterine adhesions, intra uterine device (iud) retrieval or intrauterine septum resection. * consents to participate in the study exclusion criteria: * premenstrual and mid-menstrual patients. * patients with missed periods. * patients with known cardiac disease.

Keywords: operative hysteroscopy filling pressure
the pneumatic tourniquet technique for endoscopic radial artery harvest; does it affect patient hemodynamics?

Conditions: Ischemic Heart Disease; Coronary Artery Bypass Graft

Summary: this study aims to investigate the effect of the pneumatic tourniquet technique on the patients' hemodynamics; heart rate (hr), systolic blood pressure (sbp) and diastolic blood pressure (dbp).

coronary artery bypass graft surgery (cabg) is the most common cardiac surgical procedure. radial artery of the non-dominant hand with better ulnar collaterals is preferred over the saphenous vein because of long term patency of the radial artery. radial artery is the preferred second or third arterial conduits for vessels with sub occlusive stenosis. there are two techniques of radial artery harvesting; open and endoscopic techniques. endoscopic radial artery harvesting (erah) is increasing and it is possible but the evidence regarding its safety is scarce. erah is cosmetically better than the open technique. erah technique is performed after applying a tourniquet over the distal arm proximally to the elbow. allen test will be done first and if the hand has a good blood supply through the ulnar artery, the tourniquet pressure is increased 75-100 mmhg over the systolic pressure and the tourniquet time is kept under one hour and the left radial artery will be endoscopically harvested. during the time of tourniquet inflation, there is ischemia of the forearm with subsequent cellular ischemic changes like; cellular acidosis, cellular edema, and activation of cellular apoptosis. on deflating the tourniquet, there is reperfusion of the limb and development of ischemic / reperfusion injury with a subsequent increase of inflammatory mediators and reactive oxygen species (ros). these changes may be associated with some hemodynamic instability that might be dangerous, especially in patients with ischemic heart disease (ihd).

Eligibility criteria:
inclusion criteria: * listed for cabg surgery with the use of erah technique. exclusion criteria: * emergency cabg surgery. * cabg plus any other cardiac surgery. * the use of inopressor drugs before erah
pertussis immunization during pregnancy & hiv infection

Conditions: Immunization; Infection; Pertussis; HIV-1-infection; Pregnancy

Summary: the impact of chronic hiv infection and pregnancy on different aspects of the humoral response to pertussis immunization with the tdap vaccine will be studied. the parameters will be measured in 3 groups (hiv-infected pregnant, hiv-uninfected pregnant and hiv-uninfected non pregnant) at different time points before and after immunization (7-10 days, 30 days and at delivery). the transfer ratio and the quality of maternal antibodies will be studied in cord blood.

despite the growing importance of maternal immunization in the control of infectious pathogens in early life, the impact of pregnancy on vaccine immunogenicity remains poorly understood. evidence suggests that pregnancy may influence the quality of the antibody response to vaccines. pregnancy is associated with modifications in the glycosylation profile of immunoglobulins g (igg). different patterns of glycosylation are associated with differential regulation of the effector functions of igg such as antibody-dependent cell cytotoxicity, complement activation or antibody dependent phagocytosis. whether similar modifications affect vaccine-induced igg in pregnant women is unknown. hiv infection is associated with important alterations in b cells and antibodies. although antiretroviral therapy partly corrects the proportions of memory b cells (mbc) subsets, it does not restore b cell responses to vaccines, measured as seroconversion rates and antibody persistence. reduced igg responses to vaccines have been observed in hiv-infected pregnant women but the impact of hiv on the quality of vaccine-induced igg has not been reported. on the other hand, hiv infection in pregnancy has a strong impact on the transfer of maternal igg to the newborn, possibly as a consequence of hypergammaglobulinemia and immune activation. the investigators will: 1. assess the respective impact of pregnancy and hiv infection on the magnitude and quality of b cell and antibody responses to pertussis immunization with the tdap vaccine. 2. assess the impact of hiv infection and of the timing of maternal immunization on the transplacental transfer and on the quality of pertussis-specific igg in the newborn.

Eligibility criteria:
inclusion criteria: * age over 18 * hiv-infected or uninfected pregnant women in their second/third trimester with an indication of tdap vaccination * non pregnant hiv negative women (having a negative hiv test in the last 6 months or at screening) with an indication of tdap vaccination exclusion criteria: * grade iii/iv anemia * active bacterial infection * opportunistic infection (tuberculosis, cmv, toxoplasmosis, etc) * inability to understand the nature and extent of the study and the procedures required * current or recent use of immunosuppressive drugs (corticosteroids, anti-tnf, methotrexate, etc) * active neoplasia
informed consents for withholding/withdrawing life support in intensive care units

Conditions: Death Occurring in Intensive Care Units

Summary: end-of- life care is a major issue in medical ethics with life support technology progress. intensive care may prolong the dying process in patients who have been unresponsive to the treatment already provided. withholding or withdrawing of life support (wls) care was introduced to avoid the suffering of critically ill patients. decision to wls is a difficult and affected by several factors including not only disease severity but also ethics, religion, culture, and legal background. in western countries, advance directives had an important role to wls for dying patients and honor patient autonomy. however, the illegality of advance directives in korea and korean culture under confucianism, requiring children to do the best to treat their parents in the name of filial piety make physicians and family members difficult to wls in terminally ill patients. additionally, wls in intensive care unit had been usually decided without official documentation before the final legal decision by supreme court in korea. scanty information exists about end-of-life practices because informed consents of wls were taken after the legal decision. thus, we aimed to investigate the current status of informed consent at the time of decision to wls and difference between wls group and non-wls group in korea.


Eligibility criteria:
inclusion criteria: * patients who died from january 2012 to december 2012 in the surgical or medical intensive care unit (icu) at severance hospital, yonsei university health system, in seoul, korea. exclusion criteria: * patients diagnosed with brain death

Keywords: informed consents withholding/withdrawing life support (wls) intensive care unit (icu)
study of betatrophin levels in patients with type 2 diabetes and gestational diabetes and healthy subjects

Conditions: Pregnancy; Gestational Diabetes Mellitus (GDM); Type 2 Diabetes

Summary: betatrophin is a newly identified hormone that promotes pancreatic beta cell proliferation, improves glucose tolerance and regulates lipids metabolism. a recent study showed that circulating concentrations of betatrophin doubled in type 1 diabetes. the objective of this study is to investigate the association of serum betatrophin levels with the progression of diabetic retinopathy in patients with type 2 diabetes and the level of betatrophin in gestational diabetes patients and pregnant women.

200 subjects were recruited in this study and divided into six groups for comparison of the serum betatrophin. 70 healthy subjects and 20 healthy young volunteers were enrolled for investigating the role of betatrophin in energy homeostasis and the circadian rhythm. 50 patients with type 2 diabetes were classified into three groups by the stage of diabetic retinopathy. rank test was used to analyze the correlation between the progression of diabetic retinopathy and circulating betatrophin. betatrophin were measured by a commercially available enzyme-linked immunosorbent assay and confirmed via western blot.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patients * patients with hba1c \>or= 7.0% exclusion criteria: * participation in other investigational clinical trial * type 1 diabetes mellitus patients * patients with history of severe hepatic dysfunction * treatment with antifungal agent especially miconazole * patients with active smoking or history of smoking cessation less than 2 months
effect of docosahexaenoic acid (dha)-enriched human milk in premature newborns

Conditions: Premature

Summary: several recent publications showed a reduction in the level of dha and/or an increase in the arachidonic acid (aa)/dha ratio in the milk of mother. we hypothesized that the polyunsaturated fatty acid (pufa) status of the premature newborn fed mother's milk is unbalanced because the content of dha of the milk of mother nowadays is insufficient, whereas scientific arguments point-out the essential role of dha and balanced aa/dha ratio of human milk to explain the beneficial role of the breast-feeding at short, medium and long term. we will study the benefits of dha supplements (tg-dha versus gpl-dha) of mothers in puga status improvement in their premature newborn consecutive to dha enrichment and balanced aa/dha ratio of human milk. gpl-dha should be more effective than tg-dha by protecting both n-3 and n-6 fatty acids pathways.


Eligibility criteria:
inclusion criteria: * childbirth between 34 and 35 ga * breast-feeding * caucasian * affiliation to social security * obtained consent from mother, and parents for the child * mother with balanced diet * no allergy to eggs * single pregnancy exclusion criteria: * allergy to egg * unbalanced diet * diabetes * known digestive disease * counter-indication with breast-feeding * cigarettes (more than 5 per day) * alcoholism (daily consumption of alcohol) * multiple pregnancy

Keywords: premature newborns human milk dha mother-child
safety and efficacy evaluation of dotarem® in mri of central nervous system (cns) lesions

Conditions: Diagnostic Self Evaluation; Central Nervous System Diseases

Summary: the purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of dotarem® when used in taking images of the brain / spine. the results will be compared to the results of mri taken without dotarem.

this is a study involving the use of magnetic resonance imaging (mri) contrast agents called dotarem®. the purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of dotarem® when used for taking images of the brain and spine. the results of the mri will be compared to the results of images taken without dotarem®.

Eligibility criteria:
inclusion criteria: * adult subject and pediatric subjects (aged greater than or equal to two (2) years). * is referred for a contrast-enhanced mri of the cns based on the results of a previous imaging procedure. * female of childbearing potential patients must have effective contraception (contraceptive pill or intra-uterine device) or be surgically sterilized or post-menopausal (minimum 12 months amenorrhea), or have a documented negative urine pregnancy test within 24 hours prior to study mri. * has been fully informed about the study, and has consented to participate. exclusion criteria: * having acute or chronic grade iv or v renal insufficiency. * known class iii/iv congestive heart failure. * suffering from long qt syndrome. * unstable health condition or circumstances (e.g. suffering from severe claustrophobia). * having any contraindications to mri such as a pace-maker, magnetic material or any other conditions that would preclude proximity to a strong magnetic field. * known allergy to gadolinium chelates. * having received any contrast agent within 3 days prior to study contrast administration, or is scheduled to receive any contrast agent within 24 hours after the study contrast administration. * pregnant, breast feeding, or planning to become pregnant during the trial. * previously participated in this trial. * having participated within 30 days in another clinical trial involving an investigational drug. * any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits. * inability or unwillingness to cooperate with the requirements of this trial.

Keywords: cns contrast agent mri dotarem magnevist
can vitamin d supplementation prevent bone loss in persons with multiple sclerosis

Conditions: Multiple Sclerosis, Osteoporosis

Summary: several studies have shown that bone mineral density (bmd) at the femoral neck decreases with increasing physical handicap (edss-score) in ms patients. possible explanations are less weightbearing exercise or less uv-exposure resulting in reduced vitamin d generation in the skin. prevention of osteoporosis is a high priority, because treatment of the established disease remains sub-optimal. we have designed a double-blind randomised controlled trial of two years' duration including 90-100 persons with ms age 18-50 to assess whether supplementation with vitamin d, given as a weekly dose of 20,000 iu cholecalciferol, can prevent bone loss. the primary objective of this study is to determine changes in bmd over the 2 year study period comparing treatment and placebo groups. the most important secondary objective is to determine cytokine profiles in blood samples. we will also assess parameters related to vitamin d status and physical performance.


Eligibility criteria:
inclusion criteria: * age 18 to 50 years * edss \< 4.0 (able to walk without rest some 500 m) * women have to be premenopausal * ms according to the mcdonald criteria; prepared and considered able to follow the protocol; using appropriate contraceptive methods (women of childbearing potential) * having given written informed consent. exclusion criteria: * pregnancy or unwillingness to use contraception; alcohol or drug abuse * use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses * known allergy to cholecalciferol or arachis oil (peanuts) * therapy with digitalis, calcitonin, active vitamin d3 analogues, fluoride, or bisphosphonates during the previous 12 months * any condition predisposing to hypercalcaemia * nephrolithiasis or renal insufficiency * presence of primary hyperparathyroidism, hyperthyroidism, or hypothyroidism in the year before the study began; a history of nephrolithiasis during the previous five years.
testing a causal model of cognitive control deficits in posttraumatic stress disorder (ptsd)

Conditions: PTSD

Summary: testing a causal model of cognitive control deficits in posttraumatic stress disorder (ptsd)

the purpose of the present study is to examine the effects of transcranial magnetic stimulation (tms) on cognitive control among individuals with posttraumatic stress disorder (ptsd).

Eligibility criteria:
inclusion criteria: * over 18 years of age * endorse lifetime exposure to at least one criterion a traumatic event * report clinically significant posttraumatic stress disorder (ptsd) symptoms (score of ≥ 33 on the ptsd checklist for dsm-5 \[pcl-5\]). exclusion criteria: * endorse medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.) * report an unstable medical condition or any current medical condition that precludes safe participation in the trial (e.g., unstable metabolic abnormality, unstable angina, etc.) * report any history or diagnosis of dementia or other cognitive disorder, which may interfere with engagement * report any history or diagnosis of severe traumatic brain injury * report any history or diagnosis of schizophrenia, schizoaffective disorder, delusional disorder or other psychotic illness, which precludes safe participation in the trial * report a primary obsessive-compulsive disorder (ocd) diagnosis * report an active substance use disorder (within last 3 months) or any current substance use that precludes safe participation in the trial * report suicide risk that precludes safe participation in the trial, defined as clinical impression that the participant is at significant risk for suicide (i.e., greater than moderate level of suicide risk, in accordance with the joiner et al. (1999) suicide risk framework) * report an inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.) * report a current, planned, or suspected pregnancy

Keywords: transcranial magnetic stimulation
study to evaluate the safety, tolerability, and efficacy of srp-9004 administered by systemic infusion in limb girdle muscular dystrophy type 2d/r3 participants in the united states

Conditions: Limb Girdle Muscular Dystrophy; Limb Girdle Muscular Dystrophy Type 2D/R3

Summary: the primary objective of this study is to evaluate the safety of srp-9004.


Eligibility criteria:
key inclusion criteria: * ambulatory participants, defined as able to walk without assistive aid, 10mwr \<30 seconds, and nsad total score ≥25; non-ambulatory participant, defined as 10mwr ≥30 seconds or unable to perform, and pul 2.0 entry scale score ≥3. * ambulatory participants must be 4 to 20 years of age and the non-ambulatory participant must be ≥4 years of age. * all participants must be ≤70 kilograms * possess 1 homozygous or 2 heterozygous pathogenic and/or likely pathogenic α-sg deoxyribonucleic acid (dna) gene mutations as documented prior to screening. * able to cooperate with muscle testing. * participants must have adeno-associated virus (aav) serotype rh74 (rh74) antibody titers \<1:400 (that is, not elevated) as determined by an enzyme-linked immunosorbent assay (elisa). key exclusion criteria: * left ventricular ejection fraction \<40% or clinical signs and/or symptoms of cardiomyopathy * fvc ≤40% of predicted value and/or requirement for nocturnal ventilation * any other clinically significant illness, including neuromuscular (other than limb girdle muscular dystrophy type 2d/r3 \[lgmd2d/r3\]), that in the opinion of the investigator might compromise the participant's ability to comply with the protocol required testing or procedures or compromise the participant's wellbeing, safety, or clinical interpretability. other inclusion/exclusion criteria apply.

Keywords: limb girdle muscular dystrophy type 2d/r3 srp-9004