Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of clopidogrel in neonates /infants with systemic to pulmonary artery shunt palliation

Conditions: Heart Defects, Congenital

Summary: contemporary management of cyanotic congenital heart disease includes three stages of surgery. incidence of shunt thrombosis and death between the two first stages of palliation remains important. the primary objective of the study is to evaluate the efficacy of clopidogrel 0.2 mg/kg/day for the reduction of all cause mortality and shunt related morbidity in neonates or infants with cyanotic congenital heart disease palliated with a systemic-to-pulmonary artery shunt (e.g. modified blalock taussig shunt \[bts\]). the secondary objective was to assess the safety of clopidogrel in the study population.

in this event-driven study, participants were to be randomized and treated as soon as possible after shunt placement. they were then to be treated and followed until the primary endpoint criteria was reached i.e. (shunt thrombosis, the next surgical procedure for correction of the congenital heart disease or death) or one year of age or the common study-end-date, which ever came first. the common study-en-date was defined as the date when it was projected that 172 participants would have reached the primary endpoint criteria.

Eligibility criteria:
inclusion criteria: * cyanotic congenital heart disease treated by any palliative systemic-to-pulmonary artery shunt. exclusion criteria: * active bleeding or increase risk of bleeding, * allergy to 2 or more classes of drug, * unable to receive drug orally or enterically, * current clinically significant or persistent thrombocytopenia, neutropenia, severe hepatic or renal failure.

Keywords: cyanotic congenital heart disease shunt palliation thrombosis clopidogrel
improved management and in-hospital mortality

Conditions: Mortality; Malaria

Summary: the study intend to evaluate whether the use of standardised malaria case management protocol plus financial incentives added to the availability of free drugs reduce the case-fatality at the paediatric ward.

mortality at the national paediatric ward in guinea-bissau is very high. during a civil war in 1998/1999 the hospital case fatality (cf) decreased by more than 40%, increasing again after the the war. this was attributed to the available free drugs from the humanitarian aid and food incentives to the personnel. free emergency kits for treatment of severe malaria was introduced, however the cf did not decline. therefore, the ward was split into two groups of rooms: intervention and control. all the staff of the ward was trained in the use of a standardised guideline for treatment of severe malaria and randomly assigned to one of the groups. all children hospitalised for malaria received the drug emergency kits. the only difference in the intervention group were the small financial incentives and supervision for strict adherence to the guidelines procedures.

Eligibility criteria:
inclusion criteria: * hospitalization due to malaria * non per os exclusion criteria: * consent from parent/caretaker declined

Keywords: malaria mortality hospital incentive personnel paediatric
transcatheter aortic-valve implantation with or without on-site cardiac surgery: the tracs trial

Conditions: Aortic Stenosis, Severe

Summary: the primary efficacy objective is to determine whether a tavi procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to tavi procedure performed by the same operators in centers with on-site cardiac surgery in terms of all-cause death, stroke and rehospitalization for cardiovascular cause. the primary safety objective is to demonstrate that mortality associated with periprocedural complications actionable by emergent cardiac surgery did not differ between study arms.

tracs is an all-comer, prospective, randomized, multicenter, open-label trial with blinded adjudicated evaluation of outcomes (probe). the tracs trial will involve centers without on-site cardiac surgery, but with experienced operators already performing tavi at the referring center with on-site cardiac surgery. thus, participating centers and their study tavi operators must follow selective criteria for eligibility. participants will be recruited after heart team indication to tavi procedure. the eligibility of each single patient to the study must be confirmed and validated by unanimous decision of the heart team. study patients will be randomized in a 2:1 fashion to tavi procedure performed by the same experienced operators either in the center without on-site cardiac surgery or in the referring center with on-site cardiac surgery.

Eligibility criteria:
inclusion criteria: * severe aortic stenosis * indication to tavi confirmed by the study heart team and one of the following: * inoperable due to prohibitive operative risk * high surgical risk as defined as sts score \>8% the presence of at least one clinical factor that, by unanimous judgment of the study heart team, compromises the benefit/risk ratio in the case of emergent cardiac surgery: * porcelain aorta or severely atherosclerotic aorta * frailty/reduced physical performance * cognitive impairment, dementia, or parkinson's disease * severe liver disease/cirrhosis * hostile chest * internal mammalian artery or other critical conduit(s) crossing midline and/or adhering to the posterior table of the sternum * severe pulmonary hypertension and/or severe right ventricular dysfunction * severe chronic obstructive pulmonary disease (copd) * age ≥85 years exclusion criteria: * unsuitable for transfemoral tavi * emergent tavi * noncardiovascular comorbidity reducing life expectancy to \<1 year * any factor precluding 1-year follow-up * refusal informed consent
assessing and improving patient knowledge about keloid scars (keloids)

Conditions: Keloid Scar

Summary: the purpose of this study is: * to identify how knowledge about keloid scars and self-treatments differs between patients who use the internet as a source of information and patients who do not * to determine if patients who are at a high risk of developing additional keloid scars are more or less likely to change their behavior based on an educational information talk about keloid scar prevention

keloids scars differ from other scar types in that they grow beyond the borders of the injury that caused them. patients with darker pigmented skin are more likely to develop keloids, and blacks are especially predisposed to keloid formation. treatment options for keloids are limited in that new keloids often form at the treated location. the limited efficacy of professional treatment options and the harmless appearance of small keloid scars may lead a patient to try to manage their keloid scars on their own. one source of information that patients may turn to for self-treatment advice is the internet.

Eligibility criteria:
inclusion criteria: * subjects with a clinical diagnosis of keloid scarring * subjects over the age of 18 exclusion criteria: * that which does not fit the inclusion criteria
efficacy of besifloxacin ophthalmic suspension in the treatment of bacterial conjunctivitis

Conditions: Bacterial Conjunctivitis

Summary: this study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. this study was conducted as a phase iib study and continued with further enrollment as a phase iii study.


Eligibility criteria:
inclusion criteria: * subjects who are at least one year of age. * subjects who have a clinical diagnosis of acute bacterial conjunctivitis. * subjects who are willing to discontinue contact lens wear for the duration of the study. exclusion criteria: * subjects who have any uncontrolled systemic disease or debilitating disease. * subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs. * subjects who are expected to require treatment with any disallowed medications.
local heat therapy versus sodium stibogluconate for the treatment of cutaneous leishmaniasis

Conditions: Cutaneous Leishmaniasis

Summary: this study serves to compare the effectiveness of treating cutaneous leishmaniasis with either intravenous sodium stibogluconate or direct heat therapy using the thermomed-tm device.

a total of 56 department of defense health care beneficiaries, 18 years of age or older and diagnosed with cutaneous leishmaniasis, were planned to be treated with either intravenous sodium stibogluconate (pentostam-tm) or the thermomed-tm device of thermosurgery technologies, inc. at the walter reed army medical center. pentostam is the standard of care for this disease, but the i.v. administration and the many known side effects prompt the search for an improved method of treating this disease, especially for milder cases. this study compares the safety and efficacy of these two treatment approached.

Eligibility criteria:
inclusion criteria: * department of defense (dod) healthcare beneficiary * parasitologic diagnosis of cutaneous leishmania infection (inclusion criteria for randomization includes that must be leishmania major species) * willing to locate to wramc area during treatment and perform subsequent follow-up visits if needed (if not active duty on orders, then the participant will bear the cost of food and lodging during the initial 10-day outpatient treatment period at walter reed army medical center) * able to provide informed consent * all participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving sodium stibogluconate exclusion criteria: * unable to provide informed consent * pregnancy (females of child bearing potential must have negative urine human chorionic gonadotropic hormone \[hcg\] within 48 hours of the start of infusion period) * history of hypersensitivity to pentavalent antimonials * serious medical illness: 1. qtc interval \>/= 0.5 sec 2. severe cardiac disease 3. history of current pancreatitis 4. liver failure or active hepatitis with transaminases \>3x normal 5. renal failure or creatinine \>2.5 6. thrombocytopenia (platelets \<75,000) 7. white blood cell count \<2000 8. hematocrit \<25 9. absence of palpable extremity pulses in the limb requiring treatment * history of serious allergic reaction to local anesthetics * location of lesion not amenable to local therapy (such as close to eye, mucous membranes, face, cartilage) * presence of pacemaker and/or other implanted metallic devices * breast feeding * men unwilling to avoid fathering a child during and/or in the two months following receiving the treatment * women unwilling to avoid pregnancy for at least two months after receiving the treatment * more than 20 lesions, or multiple lesions which in the opinion of the investigator would not be well treated with heat therapy
study to evaluate safety, tolerability, pharmacokinetics & pharmacodynamics of jtt-662 in subjects with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of jtt-662 administered once daily for 28 days in subjects with type 2 diabetes mellitus (t2dm) who are receiving metformin monotherapy


Eligibility criteria:
inclusion criteria: * diagnosis of t2dm for at least 12 weeks prior to the screening visit * currently treated with a stable oral dose of metformin monotherapy for at least 12 weeks prior to the screening visit and until day -3 * have a glycosylated hemoglobin (hba1c) value of between 6.5% and 10.0% at the screening visit * have a fasting plasma glucose (fpg) value of no more than 280 mg/dl at the screening visit and on day -3 * body mass index (bmi) of 25 to 40 kg/m2 (inclusive) exclusion criteria: * known medical history or presence of type 1 diabetes mellitus, maturity onset diabetes of the young or secondary forms of diabetes * known medical history or presence of diabetic complications * have taken anti-diabetic medications (other than metformin) or medications that act mainly in the gastrointestinal tract (e.g., orlistat, acarbose) within 12 weeks prior to the screening visit or from the screening visit to day -3 * have uncontrolled hypertension (systolic blood pressure of at least 160 mmhg or diastolic blood pressure of at least 95 mmhg) at the screening visit * have impaired renal function (estimated glomerular filtration rate (egfr) \<60 ml/min/1.73 m2)

Keywords: jtt-662 diabetes safety tolerability pharmacokinetics pharmacodynamics
implantable cardioverter defibrillator (icd) patients and inhalation aromatherapy

Conditions: Implantable Cardioverter Defibrillator (ICD); Aromatherapy; Anxiety; Fatigue Symptom

Summary: the effective management of anxiety and fatigue, which lead to negative physical, social, and psychological impacts and increase treatment costs in individuals with implanted cardioverter-defibrillators (icd), is of great importance. complementary and integrative therapy (cit) methods offer a non-pharmacological, easy-to-apply, and safe intervention alternative for nurses and patients experiencing these symptoms. this study was conducted to investigate the effect of lavender oil aromatherapy, applied by inhalation for two minutes with two drops before bedtime for one month, on anxiety and fatigue levels in individuals with icd, in a randomized controlled single-blind study design. a total of 86 patients with icd implantation were included in the study, and 43 patients were randomly assigned to the intervention and control groups. the intervention group received lavender aromatherapy for two minutes with two drops of lavender oil inhaled before bedtime every night for one month, in addition to their routine treatment. the control group received only routine treatment. the study was conducted after obtaining the necessary ethical approval, institutional permission, and informed consent from the patients. the patient diagnosis form, piper fatigue scale (pfs), spielberger state-trait anxiety inventory short form (stai-sf and stai-tf), and visual analogue scale (vas) for fatigue were used in data collection. the data were analyzed using the statistical package for social sciences (spss) 25.0 and g\*power program. a value of p\<0.05 was considered statistically significant in comparisons.


Eligibility criteria:
inclusion criteria: * individuals who were willing to participate in the study, * aged between 18 and 65 years, * with no physical or mental health issues that would hinder communication, * had an icd implanted at least 6 months ago, * had a battery life of at least 3 months, * had a fatigue level of 3 or higher on the visual analog scale for fatigue (vas-f), * had an ef of 40% or higher, * and were visiting the cardiology outpatient clinic for icd control exclusion criteria: * individuals receiving anxiolytic or antidepressant treatment, * those with respiratory system diseases (such as asthma, bronchitis, or chronic obstructive pulmonary disease), 19,231 characters left * those with a known sensitivity to the essential oils used, and individuals with an olfactory impairment

Keywords: aromatherapy anxiety implantable cardioverter defibrillator (icd) nursing fatigue
comparison of transfers of fresh and thawed embryos in patients with prior failed embryo transfer cycles

Conditions: Infertility; Subfertility

Summary: this study seeks to determine if patients with a history of failed fresh embryo transfer(s) will have increased success rates with embryo cryopreservation and subsequent thawed embryo transfer when compared to fresh embryo transfer.

implantation failure remains a significant problem in cycles of in vitro fertilization (ivf). patients with a history of implantation failure in fresh autologous cycles have been shown have reduced chance of success in subsequent fresh autologous cycles. a potentially frequent cause of implantation failure is reduced endometrial receptivity following ovarian stimulation, perhaps due to the effects of supraphysiologic hormone levels on endometrial development. therefore, such patients may have a greater chance of success if all of their embryos are cryopreserved for use in a subsequent cycle in which endometrial development can be more carefully controlled, absent the effects of ovarian stimulation. therefore this study compares success rates in cycles of fresh embryo transfer and cycles with transfer of frozen-thawed embryos.

Eligibility criteria:
inclusion criteria: * age 18 to 40 years * cycle day 3 fsh less than 10 iu/l * at least 8 antral follicles * at least one previous autologous embryo transfer cycle that did not result in ongoing pregnancy at 10 weeks. exclusion criteria: * embryo biopsy * any prior fresh embryo transfer that resulted in live birth

Keywords: ivf blastocyst transfer endometrium embryo cryopreservation
use of the nine holes peg test in multiple sclerosis: participation of elementary neurological components in the functional evaluation of manual dexterity

Conditions: Multiple Sclerosis

Summary: this study lies in the continuity of the study with identification number nct02805634. it will be performed on the same group of patients and will aim to assess the manual dexterity, in order to better assign kinesitherapy treatments and increase the utilisation capacity of the hand.


Eligibility criteria:
inclusion criteria: * all patients included in the nct02805634 study exclusion criteria: * none

Keywords: hand dexterity multiple sclerosis nine holes peg
visual cue as prevention of pulmonary infection under mechanical ventilation

Conditions: Pulmonary Infection

Summary: nosocomial pneumonia is the third causes of nosocomial infection. in intensive care unit, their incidence is even higher, of the order of 10 to 30% in patients with invasive mechanical ventilation (imv). one of the main mechanisms behind vap (ventilator-associated pneumonia) is the passage of germs colonizing the oropharynx to the subglottic airways. the presence of a nasogastric tube, immobilization, and strict dorsal decubitus increase the risk of colonization of the tracheobronchial tree and pneumonia in these patients. to reduce the incidence of vap, several strategies have been developed in intensive care to try to control these different risk factors. these sets of measures, also called "bundle" systematically include the control of the elevation of the patient's head more than 30 °. nevertheless, the strict and permanent control of the elevation of the patient's head is difficult to obtain. one of the reasons that may explain the difficulty of ensuring a correct elevation is the absence of visual cues that are easy to obtain on the beds of patients. an easily identifiable visual cue at the head of the bed would probably provide a satisfactory elevation (greater than 30 °) in patients intubated in intensive care. our hypothesis is that the addition to the head of the patient's bed of a visible mark that is easily visible and easily interpretable by all the nurses will improve the elevation of the head of the patients in intensive care.


Eligibility criteria:
inclusion criteria: - patient admitted to intensive care with invasive mechanical ventilation more than two days exclusion criteria: * pregnancy * spinal trauma * brain trauma
clabsi prevention with tissue adhesive

Conditions: Central-line Associated Blood Stream Infections (CLABSI)

Summary: our aim is to test the effect of tissue adhesive application at the central-line exit-site on clabsi rates in high-risk pediatric congenital heart disease patients.

health-care associated infections (hai) and especially central-line associated blood stream infections (clabsi) are a well described burden in the intensive care units. there are two main possible pathways leading to central-venous line (cvl) related infection: the first is migration of microbes down the catheter tract (between the cvl and the skin), and the second is via the catheter hub/lumen. cyanoacrylate adhesive is a commonly used tissue adhesive in children and adults with frequent use in pediatric facial lacerations. several studies have shown its feasibility and safety in the general pediatric population, including neonates and in children after cardiac surgery. to our knowledge, no study to date has explored the use of 2-octyl cyanoacrylate at central-line exit site as a mean to decreases pediatric clabsi. our aim is to assess 2-octyl cyanoacrylate association with clabsi rate in pediatric cardiac intensive care population.

Eligibility criteria:
inclusion criteria: all patients admitted to pediatric cardiac icu (pcicu) defined as high-risk for clabsi (any of): * young age\<1y \& congenital heart surgery mortality category (stat\\sts-eacts) score 2-5 * risk adjustment for congenital heart surgery (rachs) category ≥3 * preoperative length-of-stay (los) \>7 days * preoperative ventilator support * presence of a genetic abnormality * extracorporeal membrane oxygenation (ecmo) support exclusion criteria: * patients with on-going bacteremia * patients with pre-existing central-line or peripherally inserted central catheter (picc) * parental refusal to participate.

Keywords: clabsi pediatric cardiac intensive care cyanoacrylate tissue adhesive
study to evaluate the safety and efficacy of pep005 (ingenol mebutate) gel, 0.015%, in patients with photo-damaged skin

Conditions: Photo-damage

Summary: this study is primarily designed to evaluate the safety and tolerability of pep005 gel, 0.015% when administered for up to three consecutive days to photo-damaged skin on the face. the secondary endpoint is to determine the efficacy of pep005 gel, 0.015% when administered for up to three consecutive days in patients with photo-damaged skin on the face.


Eligibility criteria:
inclusion criteria 1. male and female patients aged 30 to 65 years. 2. female patients must be of either: * non-childbearing potential, provided there is a laboratory confirmed serum follicle stimulating hormone (fsh) level ≥ 40miu/ml or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus); or * childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy. 3. patient has provided informed consent documented by signing the informed consent form (icf) prior to any study-related procedures, including any alteration of medications in preparation for study entry. 4. patient has agreed to allow photographs of the selected treatment area to be taken and used as part of the study data package. exclusion criteria 1. known sensitivity or allergy to any of the ingredients in pep005 (ingenol mebutate) gel. 2. current enrolment or participation in a clinical research study within 30 days of entry into this study.

Keywords: pep005 peplin photo-damage
abciximab i.v. versus i.c. in primary pci patients with stemi

Conditions: Myocardial Infarction

Summary: randomized comparison of abciximab i.v. versus i.c. in patients with stemi undergoing primary pci. the hypothesis is, that higher concentration of abciximab i.c. leads to improved epicardial flow, perfusion, reduction of no-reflow, reduction in infarct size and subsequently better outcome.


Eligibility criteria:
inclusion criteria: 1. clinical symptoms: * angina \ 30 min. 2. ecg-criteria: * st-elevation \> 1mm in ≥ 2 extremity leads * st-elevation \> 2mm in ≥ 2 contiguous anterior leads 3. informed consent exclusion criteria: 1. no consent 2. pregnancy 3. allergy against abciximab, asa or heparin 4. active peptic ulcus ventriculi or duodeni 5. active non-superficial bleeding 6. major surgical intervention, intracerebral interventions, puncture central artery \< 4 weeks 7. active internal bleeding 8. cerebrovascular complications \< 2 years 9. known coagulation disorders, thrombocytopenia 10. arteriovenous malformations or aneurysms 11. severe liver or renal dysfunction 12. severe untreated hypertension 13. active vasculitis 14. previous thrombolysis \< 12 h

Keywords: stemi infarct size primary pci no-reflow st-elevation myocardial infarction