Kornimate/medical-research-clean huggingface dataset:
a study of ino-1001, an intravenous parp (poly [adp ribose] polymerase) inhibitor in acute heart attack patients undergoing primary percutaneous coronary intervention

Conditions: Acute Myocardial Infarction

Summary: the primary purpose of this study is to assess the safety of ino-1001 in subjects who have experienced a heart attack and are to be treated with coronary angioplasty.

currently, heart attacks may be treated with clot-dissolving medicines, coronary angioplasty, or a combination of both. unblocking of blood flow to the heart following coronary angioplasty can cause side effects such as heart tissue and blood vessel damage, abnormal heart rhythms and death of heart muscle cells. in animal studies, the parp enzyme has been shown to be involved in damaging heart muscle after the sudden unblocking of coronary arteries. ino-1001 blocks the parp enzyme, and so it may reduce heart damage in humans who have had their coronary arteries unblocked after a heart attack. a total of 40 patients will be selected and randomly assigned to either ino-1001 or placebo (sugar water). one dose only of the drug will be given prior to coronary angioplasty. patients will be followed until 30 days after surgery. the following information will be gathered: vital signs, symptoms, physical examination, blood and urine tests, electrocardiograms, and other information from medical charts. the information provided in this listing is disclosed solely to comply with regulatory requirements. the drug ino-1001 has not yet been approved for marketing and is only available to patients who participate in a clinical trial and are chosen for the treatment group.

Eligibility criteria:
inclusion criteria: * subjects with acute myocardial infarction (as defined in protocol) with onset within 24 hours prior to randomization. * scheduled for primary percutaneous coronary intervention within 3 hours of presentation at a hospital participating in this study. * males and non-pregnant, non-lactating females. exclusion criteria: * subjects will be required to undergo a full medical review in order to exclude serious medical, or psychological illness prior to inclusion. * history of a hypersensitivity reaction to more than three drugs or mannitol. * participation in any investigational study within 30 days of randomization * treatment with certain restricted medications within a specified time prior to participation in the study.

Keywords: myocardial infarction coronary angioplasty parp inhibitor parp inhibition heart attack
epidural dexamethasone for labor analgesia: the effects on ropivacaine consumption and labour outcome

Conditions: Obstetric Pain; Other Complications of Obstetric Anesthesia - Delivered

Summary: to assess the efficacy of epidural dexamethasone administration, compared to placebo, in reducing local anesthetics consumption during labor epidural analgesia in parturient women

it is hypothesized that reducing the consumption of local anesthetics during labor epidural analgesia could lower their side effects (rate of motor block, nausea and emesis during labor, maternal hypotension, maternal fever) and improve the duration of the second part of the labor, and the new-born adaptation to child-birth and during the first 24 hours. the use of instruments for assisted vaginal delivery and the needs to perform emergency cesarean could also be impacted. the efficacy of the dexamethasone will be assessed by the hourly ropivacaine consumption (milligrams/hour) measured from randomization time to the end of epidural analgesia.

Eligibility criteria:
inclusion criteria: * first and single pregnancy, full term (\> 37 wks amenorrhea), cephalic presentation, spontaneous labor, epidural analgesia requested by the parturient exclusion criteria: * minor patient, planned cesarean section, gestational hypertension and preeclampsia, gestational diabetes, opioids or ocytocin administration before epidural analgesia preparation, allergy to dexamethasone, untreated gastroduodenal ulcer, epidural analgesia contraindications
ultrasound guided epidural block in axial spa

Conditions: Epidural Block in Axial Spondyloarthritis

Summary: study design: a randomized, prospective, pilot, controlled trial. setting: rheumatology and rehabilitation department minia university and sohag university objectives: to evaluate the effectiveness of caudal epidural injections with triamcinolone and lidocaine in managing limited spine mobility in axial spa. methods: patients were randomly assigned to one of 2 groups, group i patients received caudal epidural injections with 1% lidocaine hydrochloride (xylocaine astrazeneca) 9 ml mixed with 1 ml of triamcinolone 40 milligrams (kenacort bristol myers squip), whereas group ii patients did not receive. both groups were age and sex matched and both were under treatment with anti tnf and nsaids with or without sdmards.


Eligibility criteria:
inclusion criteria: * all participants fulfilled the asas criteria for axial spa * all participants under treatment including bdmards and sdmards beside nsaids exclusion criteria: * naive patients not under treatment * limitation of spine flexion due to non inflammatory causes
efficacy of umbilical cord cleansing with a single application of 4% chlorhexidine for the prevention of newborn infections in uganda: a randomized controlled trial

Conditions: Omphalitis; Septicaemia

Summary: background: nearly all the yearly 3.3 million neonatal deaths occur in low and middle income countries. infections, including those affecting the umbilical cord (omphalitis) are a significant factor in approximately a third of these deaths. in fact, the odds of all-cause mortality are 46% higher among infants with umbilical cord infection than those without infection. five large randomized controlled trials in asia and sub-saharan africa have examined the effect of multiple applications (for at least 7 days) of 4% chlorhexidine (chx) on the umbilical cord on omphalitis and neonatal death. these studies show a consitent positive effect of multiple applications on omphalitis but not on neonatal mortality. whereas there is mounting evidence for the effect of 7 day chlorhexidine application, there is no data from africa and only one study from asia that examines the effect of a single application of chx as soon as possible after birth. in this single asian study, chx led to a reduction in the risk of mild-moderate omphalitis and neonatal death. it is important, in an african setting to explore the effect of a single application, which is programmatically much simpler to implement than daily application for 7 days. therefore, the investigators' study will compare umbilical cord cleansing with a single application of 4% chlorhexidine at birth with dry cord care in both community and facility births on omphalitis and severe illness in the neonatal period. methods: the chlorhexidine study is a community based, individually randomised controlled trial conducted on 4,760 mother-infant pairs in uganda. the primary outcomes are severe illness and umbilical cord infection (omphalitis). severe illness is defined as any illness associated with at least one of the following danger signs observed by study research assistants: inability to drink or breastfeed or (a history of) convulsions, lethargy or unconsciousness, vomiting of all feeds, and/or results in hospitalization and/or results in death. discussion: this study will provide novel evidence, from a sub-saharan african setting of the effect of umbilical cord cleansing with a single application of 4% chlorhexidine at birth in both community and facility births.


Eligibility criteria:
inclusion criteria: * newborns weighing 1.5kg or more at birth * newborns born to mothers whose hiv i status is negative exclusion criteria: * newborns with severe congenital anomalies * newborns with infection of the umbilical cord at birth * twins or triplets * severely ill infants requiring hospitalization immediately after birth * children of mothers who cannot appropriately give consent within 12 h of birth
platelet inhibition and bleeding in patients undergoing non-cardiac surgery

Conditions: Postoperative Bleeding

Summary: the aim of the study is to evaluate if there is an association between platelet inhibition and surgery-related bleeding in patients undergoing non-cardiac surgery during dual antiplatelet therapy.


Eligibility criteria:
inclusion criteria: * intake of clopidogrel, prasugrel, or ticagrelor within the last 7 days * spontaneous bleeding or impeding surgery (major vascular surgery, intraperitoneal or intrathoracic surgery, ent-surgery, orthopedic or trauma surgery, prostatic surgery) exclusion criteria: * concomitant medication with warfarin * renal insufficiency needing dialysis * concomitant therapy with gpiib/iiia antagonists * expected duration of operation \>30min
a phase 4 study of imrecoxib in treatment of knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to evaluate the efficacy and safety of imrecoxib in the treatment of patients with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * aged form 18 years to 75 years old * diagnosed with osteoarthritis of the knee according to the american college of rheumatology * functional capacity class of ⅰ-ⅲ exclusion criteria: * unstable angina * history of myocardial infarction within the last 6 months * stroke in the 6 months before screening * new york heart association class ⅲ-ⅳ congestive heart-failure * systolic blood pressure\>180mmhg,and/or diastolic blood pressure\>100mmhg * peptic ulcer * known contraindications to non-steroidal anti-inflammatory drug（nsaid） * received aspirin within 3 days of baseline visit * aspirin dosage\>150mg/d * known to be allergic to sulfa and cox-2 inhibitors * pregnancy or lactation * glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase\>2 times upper limit of normal * blood urine nitrogen\>1.5 times upper limit of normal
use of dynamic elastometric body in preterm newborns

Conditions: Premature Birth

Summary: the goal of this prospective pilot study is to test the use of dynamic elastomeric body in a population of preterm newborns with hyperexcitability syndrome. the main questions it aims to answer are: * to evaluate the effectiveness of the body in elasto-compressive material (flexa) in addition to standard care; * to evaluate how the use of dynamic elastomeric body promote postural containment, reduce hyperexcitability (tremor and crying), improve the organization of movement and reduce respiratory distress. participants will be given to routine clinical evaluations that are part of the standard of care of the premature infant admitted to neonatology. the clinical evaluation shall consist of: * hammersmith neonatal neurological examination; * neonatal intensive care unit network neurobehavioural scale (nnns); * general movement's (gm's) * goal attainment scaling (gas) researchers will compare a study group that will be subjected to treatment with the body in elasto-compressive material and a control group without using the body in elasto-compressive material.


Eligibility criteria:
inclusion criteria: * signs of hyperexcitability such as tremors, sudden and chaotic movements, prevalent extensor tone, postural instability and/or neurovegetative phenomena; * low neurological risk, i.e., according to the protocols implemented in the standard clinical practice of the neonatology unit, a cerebral ultrasound is performed for those born between 28-32 weeks of ga, and for those born before 28 weeks of ga, an mri of the brain) from which it may derive; * cerebral ultrasound normal or with minor ultrasound findings such as grade 1 intraventricular hemorrhage (germinal matrix hemorrhage with intraventricular hemorrhage covering less than 10% of the ventricular area in the parasagittal window), or evidence of transient focal white matter hyperechogenicity. * issue of informed consent by the parent or legal guardian. exclusion criteria: * neuroimaging findings of major brain lesions, such as evidence of grade 2 or greater intraventricular hemorrhage on cerebral ultrasonography (germinal matrix hemorrhage with intraventricular hemorrhage over 10% of the ventricular area in the parasagittal window/with periventricular hyperechogenicity ) or persistent hyperechogenicity for more than a week; * presence of: ongoing infectious states and/or sepsis, ostomy wearers, severe cardio-respiratory disorders at the time of enrolment; diagnosis of genetic or metabolic diseases; carriers of cerebral malformations; invasive or non-invasive respiratory assistance; * failure to issue informed consent by the parent or legal guardian.

Keywords: prematurity hyperexcitability syndrome neonatal intensive care dynamic elastometric device
pilot study of a computer-based intervention for alcohol misuse in the emergency department

Conditions: Alcohol Consumption

Summary: alcohol misuse amongst youth is a significant clinical and public health problem. the emergency department (ed) is an important setting for the treatment of alcohol-related problems as it is often the first point of contact between youth, their families, and the healthcare system. this pilot study will assess the feasibility and acceptability of a computer-based intervention in the ed for youth with alcohol-related presentations. the investigators research team will: (1) evaluate the methodological and operational processes involved in study recruitment and intervention implementation, (2) determine recruitment and retention rates, and (3) obtain preliminary data on the difference in alcohol consumption at different time points. the clinical and health service implications of this research will be used to plan further investigations designed to improve the standard of ed care among youth aged 12 to 16 with alcohol-related presentations. this research will also help optimize the planning and development of a full-scale randomized controlled clinical trial of a computer-based intervention designed to reduce higher-risk alcohol consumption and alcohol-related health and social problems in this target population.


Eligibility criteria:
study inclusion criteria: * youth aged 12 to 17 years who present to the emergency department (ed) with an alcohol-related problem. * medically stable alcohol involvement will be determined by youth self-report of drinking alcohol prior to event necessitating a visit to the ed and/or a positive blood alcohol content (bac). study exclusion criteria: * youth who require hospital admission * youth whose ed presentation is linked to drugs aside from alcohol * youth who report other drug use within the last 24 hours prior to ed presentation * youth who do not speak or understand english * youth who are currently enrolled in a treatment program for alcohol use * youth who are accompanied by a non-guardianship adult but are not considered mature minors * youth who do not have the capacity to give informed consent as determined by their attending ed physician * youth do not have regular access to their own telephone

Keywords: alcohol consumption personalized assessment feedback youth emergency department
safety and immunogenicity of one dose of an inactivated trivalent sub-unit influenza vaccine administered to non-elderly adult and elderly subjects

Conditions: Influenza

Summary: this study will evaluate safety and immunogenicity of a sub-unit influenza vaccine when administered to adult and elderly subjects.


Eligibility criteria:
inclusion criteria: healthy, adult and elderly volunteers over 18 years exclusion criteria: individuals with any serious chronic or acute disease or known or suspected impairment of the immune system.

Keywords: seasonal influenza vaccine
clinical study to assess the efficacy and safety of df289 plus df277 otic solution in the treatment of middle ear infections in pediatric patients

Conditions: Acute Otitis Media

Summary: the purpose of this study is to determine if the combination of df289 plus df277 is safe and effective in treating middle ear infections in children with ear tubes.


Eligibility criteria:
inclusion criteria: * 6 months to 12 years * ear tube in the ear which will be treated * otorrhea for 3 weeks or less * moderate or severe otorrhea exclusion criteria: * other ear diseases

Keywords: with tubes
symptoms and function during and after pregnancy

Conditions: Pelvic Girdle Pain

Summary: the purpose of this study is to: 1. describe degree of symptoms and disability during and after pregnancy 2. to examine if women with pelvic girdle pain are able to correctly mark their pain location on a pain drawing 3. to examine the responsiveness of the pelvic girdle questionnaire


Eligibility criteria:
inclusion criteria: * pregnancy week 32-36 * understand and read/write a questionnaire in norwegian or english exclusion criteria: * not able to understand and fill in a questionnaire
joint infant and young child nutrition program and malnutrition prevention

Conditions: Growth Failure; Good Infant and Young Child Feeding Practices

Summary: study title: joint infant and young children nutrition program in burkina faso: impact evaluation hypothesis: the fortification of complementary foods associated with a counseling on feeding practices for infants and young children prevents malnutrition in 6-23 months-old children. objective: to assess the effectiveness of a promotional care package in preventing malnutrition among children aged 6-23 months.

the 'institut de recherche en sciences de la santé (irss)', in collaboration with micronutrient initiative (mi), the institute of tropical medicine (itm) antwerp (belgium), and the health district of tougan, will conduct a study to assess the effectiveness of a promotional package in the prevention and management of malnutrition among children aged 6-23 months. this promotional package includes: 1. a monthly follow-up sessions promoting growth in which detailed advice on feeding practices infant and young child feeding (iycf) will be given to the mothers of children 6-23 months . these behavioral change informations be developed based on the rapid assessment of practices and foods available in the community and adaptation of the who manual. 2. the distribution of micronutrient powders (mnp) (15 micronutrients) to mothers of children 6-23 months of age for home fortification of complementary foods 3. intensive counseling sessions and cooking demonstrations every two weeks for moderately malnourished children . cooking demonstrations will include instructions on adding micronutrient powders and oil to meals .

Eligibility criteria:
inclusion criteria: * mothers of 6 to 23 months old children * reside in the study area * accept to use mnp exclusion criteria: * mothers of children aged less than 6 months or more than 23 months. * refusal
effectiveness of immersive virtual reality combined with task-specific training on hemiplegic arm function following stroke

Conditions: Stroke

Summary: the purpose of this research study is to understand the efficacy of using an immersive virtual reality (vr) environment, with task-specific training, to encourage arm movement following stroke.

the study will investigate how people who have had a stroke use their weakened arm in everyday tasks, and how this relates to measurements of movement ability from standardized clinic tests. results of this research will ultimately help develop more effective training approaches to be used with stroke survivors.

Eligibility criteria:
inclusion criteria: * age 18 or older. * diagnosed as having an ischemic or hemorrhagic stroke (with documented confirmatory neuroimaging in the medical record) that occurred at least 6-months prior to study enrollment. * lack of full active range of motion in the involved shoulder, elbow, and wrist as the result of the injury. * at the time of study enrollment, participant completed structured therapeutic interventions at least 2-months prior. * participants will not participate in yoga, tai-chi, or other wellness lifestyle classes while participating in the study. * absence of significant cognitive impairment as determined by a mini-mental status examination score of greater than or equal to 24. * the absence of upper extremity injury limiting functional use of the arm prior to the incident stroke. exclusion criteria: * unable to provide informed consent. * sensory loss as determined by a score of 2 on the sensory item of the nih stroke scale. * pain in the involved upper limb that could interfere with daily activities as evidenced by a pain score of 5 or greater on the numeric pain rating scale. * history of greater than two strokes. * suffered a stroke less than 6-months prior to participating in the study. * a history of, or being susceptible to, cyber-sickness (i.e., motion sickness). * unable to don/doff accelerometer independently, or the lack of support in the home to assist with donning/doffing device; and * a history of seizures.
dmta07 combine with amlodipine treatment in patients with hypertension

Conditions: Hypertension

Summary: the purpose of this study is to compare the different dose of dmta07 (dm) combine with amlodipine in the treatment of mild to moderate essential hypertension, and to define the optimized dose of dm in the combination therapy.

to compare the different dose of dm combine with amlodipine in the treatment of mild to moderate essential hypertension, and to define the optimized dose of dm in the combination therapy. the purpose of this study is to compare the antihypertensive efficacy and tolerability of different dose of dm combines with amlodipine treatment, further to explore the optimized combination dose of dm.

Eligibility criteria:
inclusion criteria: 1. male or female patient aged between 50 to 75 years old (both included); 2. patient with mild to moderate essential hypertension at enrollment, which defined as the following: patient must have mean sitting sbp ≥140 and \<180 mmhg or mean sitting dbp ≥90 and \<110 mmhg at enrollment; 3. patient with normal serum potassium; 4. patient or his/her legally acceptance representative has signed the written informed consent form. exclusion criteria: 1. patient with severe hypertension (mean sitting dbp ≥ 110 mmhg or mean sitting sbp ≥ 180 mmhg); 2. patient with secondary hypertension, such as coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, cushing's disease, pheochromocytoma, polycystic kidney disease, etc; 3. patient is under treatment with beta-blocker prior to enrollment; 4. a definite diagnosis or unstable of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, arrhythmia and heart failure within 3 months before signing the written informed consent form; 5. patient with concomitant endocrine diseases or type 1 diabetes mellitus; 6. patient with type 2 diabetes mellitus with poor glucose control (glycosylated hemoglobin \> 9% or fasting blood sugar \> 250 mg/dl at enrollment) or under insulin treatment; 7. patient with clinically unstable disease such as known collagen or auto-immune disease or other malignant disease requiring current medication; 8. patient with bilateral renal artery stenosis, solitary kidney or post renal transplant; 9. patient with clinically relevant hematological disease; 10. hepatic or renal dysfunction as defined by the following parameters: * alt or ast \> 2 times upper limit of normal, * total bilirubin \> 2 times upper limit of normal, * serum creatinine \>2.0 mg/dl; 11. female patient who is pregnant or lactating; 12. patient with substance abuse (including alcohol) history for the past two years; 13. known or suspected contraindications, including allergy to dmta07 or calcium channel blockers; 14. patient received other investigational drug or device within 30 days before signing the written informed consent form; 15. patient with any other serious disease considered by the investigator(s) not in the condition to enter the trial.

Keywords: amlodipine dmta07 hypertension