Kornimate/medical-research-clean huggingface dataset:
fetal alcohol syndrome: socio-cognitive habilitation

Conditions: Fetal Alcohol Syndrome

Summary: comprehensive evaluation (geneticist, psychologist, social worker, education specialist, others as indicated) to determine individual needs and treatment plan. referrals for specific services (e.g., ot, counseling, medications, etc) will be to clinicians within the families' own communities. all families will receive evaluation, parent education/advocacy, and learning readiness program. only the intervention group will receive the math intervention.

learning readiness program: this program will include: case management to secure needed services, medication consultation (psychiatrist), educational consultation/ liaison, behavioral regulation training (brt). brt will include teaching parents about: 1) recognizing their child's arousal level (to avoid negative episodes), 2) recognizing their own arousal and how it contributes to a situation, 3) principles of social reinforcement (e.g., praise, ignore, etc), 4) "accidental teaching" (i.e., teaching when a situation/opportunity arises), 5) resource/support source identification, 6) to communicate choices rather than authoritative commands, and 6) reduction of repetitive prompts (nagging). the child will be taught: 1) the technique of escape/no escape for undesirable tasks, 2) arousal awareness, and 3) verbalization of situations and actions (e.g., i don't like it when mom yells at me for running in the house, so i won't run in the house). targeted area of intervention: math - 6 weeks of individualized math tutoring. content of the tutoring will be tailored to age levels (either 3-6 yr olds or 6-9 yr olds). the high/scope curriculum will be used (modified so that it can be individualized). in addition, visual materials and visual aids will be developed to address deficits in the visual-spatial skills of children with fas/arnd. for teachers, a manual will be prepared to assist them in working with children who have fas/arnd. the educational specialist will review the manual and techniques with each teacher involved with the child. parent component: individual and small group sessions to include: fas education, information on education system procedures, instruction for communicating with professionals, and support for advocating for their child. a caregiver manual will be prepared. evaluation plan: treatment and control groups will be compared using pre- and post-tests measures. post-tests will be at the conclusion of the intervention and at a 6-month follow-up. process (e.g., parent satisfaction, compliance, etc) and outcome (e.g., math skill, behavior, family functioning, etc) measures will be evaluated.

Eligibility criteria:
inclusion criteria: * diagnosis of fas or related condition * age 3 years six month or older exclusion criteria: * age 6 years 9 months or older

Keywords: treatment control
levosimendan in congenital cardiac surgery

Conditions: Congenital Cardiovascular Defects; Low Cardiac Output Syndrome

Summary: many pediatric patients undergoing cardiac surgery under cardiopulmonary bypass for repair of complex congenital malformations, require inotropic support for low cardiac output syndrome. milrinone through its positive inotropic and vasodilatory effects is widely used for this purpose. the aim of the study is to compare milrinone with levosimendan, a novel inotope with calcium-sensitizing properties. we hypothesized that using levosimendan would result in reduced serum lactate through a higher cardiac index.


Eligibility criteria:
inclusion criteria: * pediatric patients undergoing complex cardiac surgery under cardiopulmonary bypass and requiring inotropic support exclusion criteria: * patients with renal and/or hepatic dysfunction * patients requiring inotropic support before their surgery * septic patients

Keywords: cardiac surgery with cardiopulmonary bypass
study to assess adverse events when ubrogepant tablets in combination with atogepant tablets are used to treat adult participants with migraine

Conditions: Episodic Migraine

Summary: migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. this study will assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants taking atogepant once daily for preventive treatment of migraine. ubrogepant is an approved drug for the acute treatment of migraine. atogepant is an approved drug for the preventive treatment of migraine. approximately 235 adult participants with em will be enrolled in approximately 45 sites in the united states. participants will receive oral atogepant tablets once daily (qd) for 12 weeks followed by continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * at least 1-year history of migraine with or without aura consistent with a diagnosis according to the international classification of headache disorders (ichd)-3, 2018. * history of 4 to 14 migraine days per month on average in the 3 months prior to screening (visit 1) in the investigator's judgment. exclusion criteria: - clinically significant hematologic, endocrine, cardiovascular, cerebrovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Keywords: episodic migraine ubrogepant atogepant qulipta ubrelvy
vr for pain management during adult burn dressing change

Conditions: Pain; Burns

Summary: a randomized controlled trial to evaluate the efficacy of the vr-based pain alleviation tool (vr-pat) in reducing opioid pain medication use during adult burn dressing changes.

a pilot three group gender-balanced randomized clinical trial (rct) among adult burn patients (18 years old or above) at osu medical center inpatient burn program. the intervention group will receive vr-pat as a distraction tool during the dressing change procedure (active vr group) while the comparison groups will receive either a comparable passive vr distraction tool that uses the same hardware and visual/audio features, but requires no active interaction (control group 1), or no distraction at all (control group 2).

Eligibility criteria:
inclusion criteria: 1. adult burn patient age 18-70 2. first admission for acute burn requiring dressing change 3. first admission for burn injury 4. using opioids for dressing changes 5. burn is ≤ 4 days post burn exclusion criteria: 1. severe burn(s) on the face/head preventing utilization of vr 2. cognitive/motor impairment preventing valid administration of study measures 3. unable to communicate in english 4. prisoners and patients who were pregnant 5. patients admitted to the icu
multi-electrode radiofrequency renal denervation system feasibility study

Conditions: Uncontrolled Hypertension

Summary: this is a prospective, single-arm, non-randomized and open label feasibility study. the study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.


Eligibility criteria:
inclusion criteria: * individual is ≥ 18 and ≤ 80 years old. * individual has an office systolic blood pressure of 160 mmhg or greater (≥ 150 mmhg for type 2 diabetics) based on an average of 3 office/clinic blood pressure readings * individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening. exclusion criteria: * individual has an estimated glomerular filtration rate (egfr) of \< 45 ml/min/1.73 m2 * individual has type 1 diabetes mellitus * individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, cpap, bipap) other than nocturnal respiratory support for sleep apnea. * individual has primary pulmonary hypertension. * individual is pregnant, nursing or planning to be pregnant.
evaluation of performance and usability of n6 in the paediatric population

Conditions: Transplants and Implants; Hearing Loss

Summary: the purpose of this study is to evaluate the performance and usability of the n6 system in children with the n5 system.

this study will evaluate the user benefits of the n6 system in the paediatric population currently equipped with n5. the performance and usability of both systems will be evaluated and compared. the performance of the n6 is expected to be at least equivalent to the n5. outcome measures: * city university of new york (cuny) sentence test in quiet and noise * consonant-nucleus-consonant (cnc) words in quiet * in-house designed usability questionnaires of the n6 system (information to be used internally) * peach, teach and self questionnaires - developed by ching \& hill (2007). peach - the parents' evaluation of aural/oral performance of children teach - the teachers' evaluation of aural/oral performance of children for teachers self - the child's self evaluation of aural/oral performance. speech perception tests will be administered at baseline, then again three times, two weeks apart with the n6 processor - i.e. week 0, week 2, week 4 \& week 6. total time: 2 months. questionnaires will also be given at the same time points, to get baseline information, as well as n6 information

Eligibility criteria:
inclusion criteria: * age 5-14 years, currently using n5 * minimum speech perception ability in noise of 30% at +10 decibels (db) signal-to-noise ratio (snr). * minimum of 2 years cochlear implant (ci) experience, including at least 6 months experience with their current processor * excellent verbal reporters * excellent record of attending clinical appointments. * attend a regular school, * english 1st language. * excellent record of compliance with habilitation tasks. exclusion criteria: * cognitive impairment, or other significant impairment that would impact on their ability to undertake task requirements * inability to attend study appointments.
shock wave therapy for sural myofascial pain associated to chronic heel pain

Conditions: Tendinopathy

Summary: the aim of this randomized controlled study in to investigate if a shock wave treatment extended to the gastrocnemius-soleus trigger points (trp) is more effective than a standard treatment exclusively targeted at the plantar fascia in a population affected by unilateral plantar fasciitis with concomitant sural myofascial pain syndrome.


Eligibility criteria:
inclusion criteria: * adult age (18 to 75 years) and written informed consent; * unilateral heel pain of four weeks or longer duration; * pain to digital pressure in the insertional area of the plantar fascia at the calcaneum; * sonographic examination showing a plantar fascia thickness greater than 3.8mm (see procedures for details); * concomitant presence of a sural myofascial pain syndrome (smps), diagnosed on the basis of the finding, at the physical examination, of trigger points of the gastrocnemius-soleus muscle complex, according to travel and simons' original description. exclusion criteria: * no corticosteroid injections or other physical therapies since the onset of the current pain episode (except pharmacological pain treatments and foot orthoses); * no general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area); * no clinical signs of lumbar radiculopathy at physical examination; * no ankle osteoarthritis, diagnosed on the basis of clinical and radiographic findings; * no previous fractures or surgery in the affected ankle and foot; * no rheumatologic diseases, no plantar fibromatosis

Keywords: myofascial pain syndrome
minimally invasive closure of umbilical hernias

Conditions: Umbilical Hernia

Summary: the purpose of the study is to test the use of "deflux" injections in a minimally invasive closure of umbilical (belly button) hernias in infants between birth and five years. the study is designed to demonstrate that the use of this device can safely and effectively close an umbilical hernia.

all patients will undergo general anesthesia for their primary procedure, i.e. inguinal hernia repair. once under general anesthesia, the abdomen will be prepped and draped in the usual sterile surgical fashion. the edge of the umbilical hernia defect will be palpated and in case there are any contents of the hernia present, they will be pushed into the abdominal cavity. adequate relaxation, again, will be assured. a 24 gauge needle will be used to inject 1cc of deflux ("study product") into each quadrant at the junction between the preperitoneal space and the inner palpable rim of the fascial defect. the surgeon's index finger stays in the center of the hernia defect, protecting the hernia sac contents from re-herniating. closure of the umbilical defect will be confirmed by palpation immediately after injection. a sterile wound dressing will be applied and the primary surgical procedure will be performed afterwards. definition of primary and secondary outcomes/endpoints: the endpoint of this study is closure of the umbilical hernia. data collection methods, assessments, and schedule (what assessments performed, how often): a data collection file is started at the time of enrollment in the study. data collection includes patient age, gender, and weight at the time of operation, inner diameter of the umbilical hernia defect at the time of operation, description of the immediate postoperative results and follow-up exams at two weeks, one month, and six months.

Eligibility criteria:
inclusion criteria: * age 1-5 years * umbilical hernia\>1cm. diameter. * undergoing either a general surgical or urologic procedure under general anesthesia other than umbilical hernia repair. * no previous umbilical hernia repair. exclusion criteria: * over 5 years * no umbilical hernia * no other surgery required * previous umbilical hernia repair

Keywords: minimally invasive surgery umbilical hernia infant
determination in-vivo kuf for diacap pro hemodialyser

Conditions: Kidney Failure,Chronic; Renal Insufficiency,Chronic; Kidney Disease, End-Stage; Kidney Insufficiency

Summary: the main purpose of this study is the determination of the in-vivo ultrafiltration coefficient (in-vivo kuf) for diacap pro dialyzers following routine dialysis prescription in the united states.

the in-vivo kuf for diacap pro high flux dialysers with the surface sizes of 1.3/ 1.6/ 1.9 sqm will be determined as required by the us guideline "guidance for the content of premarket notifications for conventional and high permeability hemodialyzers 1998" for comparison with the in-vitro kuf data. clinical data of at least 12 patients will be collected for determination of the in-vivo kuf complemented by safety-, performance-data for the removal of small and middle molecular substances and hemocompatibility data.

Eligibility criteria:
inclusion criteria: 1. written informed consent obtained from patient or parents/ guardian. 2. subject age \> 18 3. effective blood flow 350 ml/min and dialysate flow in the range of 500 - 800 ml/min 4. on hemodialysis for a minimum of 3 months 5. use of cimino- or gore-tex shunts 6. routine dialysis-treatment for 240 min and 3 times per week 7. documented dialysis adequacy parameter spkt/v \>=1.2 that has been stable for past 3 months 8. plan to dialyze at participating hemodialysis center for at least 3-months duration. 9. free from any currently known unusual clotting or access problems 10. hepatitis b surface antigen (hbsag) negative, documented within the past 90 days or hepatitis b surface antibody (anti-hbs) positive. 11. anti hcv negative, documented within the past 90 days 12. anti hiv negative, documented within the past 90 days hematocrit (hct) between 25 and 40% or haemoglobin (hb) not less than 8 g/dl exclusion criteria: 1. patients who are unable to tolerate an effective blood flow of 350 ml/min 2. patients using catheter for dialysis 3. pregnant or nursing woman. women of childbearing potential must agree to avoid pregnancy during the study period 4. previous plan for extended absences from the participating hemodialysis centre 5. expected to be transplanted (living related donor) within the maximum of 3 months for the study period 6. any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
phase i study to assess the safety and efficacy of ocu200 for center-involved diabetic macular edema (dme)

Conditions: Center Involved Diabetic Macular Edema; Diabetic Macular Edema

Summary: a phase 1 study to assess the safety and efficacy of ocu200 for center-involved diabetic macular edema

this is a multicenter, open-label, dose ranging study with 3 cohorts in the dose-escalation portion of the study and 1 cohort in the combination therapy portion of the study. an accelerated 3+3 design with parallel and sequential dosing will be used. a total of 9 to 22 participants will be enrolled in the dose-escalation portion of the study to receive ocu200 alone (9 to 18 participants enrolled according to the 3+3 design and up to 4 participants replaced due to parallel cohort initiation). for the combination therapy cohort, a total of 3 to 6 participants will be enrolled to receive ocu200 (mtd) + lucentis. a total of up to 28 participants will be included in this study. the dsmb will continue to review all available safety data two weeks post-dosing of participants. cohort 2 medium dose (1 mg/ml): 3+3 participants will receive intravitreal injection of ocu200 medium dose concentration. following the same algorithm as cohort 1. cohort 3 high dose (2 mg/ml): 3+3 participants will receive intravitreal injection of ocu200 high dose concentration. following the same algorithm as cohort 2.

Eligibility criteria:
inclusion criteria: 1. diagnosis of type 1 or type 2 diabetes mellitus 2. decreased visual acuity attributable primarily to dme 3. central-involved dme with central retinal subfield thickness (cst) values, as assessed with spectral-domain optical coherence tomography (sd-oct) of: 1. ≥ 320 if male or ≥ 305 µm if female on heidelberg spectralis 2. ≥ 305 if male or ≥ 290 if female on zeiss cirrus 3. bcva ≤ 78 and ≥ 24 letters on etdrs chart 4. sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging 5. no history of prior anti-vegf injection for treatment of dme or history of at least 2 consecutive anti-vegf intravitreal injection with documented incomplete resolution. exclusion criteria: 1. presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage) 2. uncontrolled hypertension 3. uncontrolled glaucoma 4. concurrent disease in the study eye, other than central-involved dme 5. intravitreal or periocular steroid treatment within 3 months prior to the screening visit 6. any ocular surgery within 3 months prior to the screening visit in the study eye 7. uncontrolled/poorly controlled diabetes 8. history of retinal detachment in the study eye or other retinal vascular disease in the study eye 9. focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit 10. presence of any inherited retinal disease or proliferative diabetic retinopathy

Keywords: anti-vegf transferrin tumstatin dme
patient's pretreatment expectations about post-lyme symptoms

Conditions: Erythema Migrans

Summary: the investigators will focus on pretreatment expectations of patients with early lyme disease manifested as erythema migrans with the aim of assessing the association between pretreatment expectations quantified with a questionnaire and treatment outcome quantified with the presence of post-lyme symptoms. furthermore, the investigators will compare the prevalence of nonspecific symptoms among patients and among age-matched controls without a history of lyme borreliosis.


Eligibility criteria:
inclusion criteria: * erythema migrans exclusion criteria: * pregnancy or lactation * immunocompromised * taking antibiotic with antiborrelial activity within 10 days

Keywords: post-lyme symptoms pretreatment expectations
immunogenicity & reactogenicity of hbv-mpl vaccine and engerix™-b in healthy adults following 2 different schedules

Conditions: Hepatitis B

Summary: the purpose of this study is to evaluate the safety, immunogenicity and reactogenicity of mpl-adjuvanted recombinant hepatitis b vaccine in comparison with those of engerix™-b in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * between 18 and 40 years old. * written informed consent will have been obtained from the subjects. * good physical condition as established by physical examination and history taking at the time of entry. * female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry. exclusion criteria: * positive titres for anti hepatitis b antibodies. * any vaccination against hepatitis b in the past. * elevated serum liver enzymes. * history of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. * axillary temperature \> 37°c at the time of injection. * any acute disease at the moment of entry. * chronic alcohol consumption. * any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study. * history of allergic disease likely to be stimulated by any component of the vaccine. * administration of any other vaccine(s) or any immunoglobulin during the study period. * simultaneous participation in any other clinical trial.

Keywords: hepatitis b engerix™-b recombinant hepatitis b vaccine
study of the predictive marker flt in patients suffering from aml

Conditions: Acute Myeloid Leukemia

Summary: positron emission tomography uses various radioactive tracers to measure the metabolic activity in a none-invasive way, and specially to follow the activity of the disease during the treatments. among those new tracers, fluorothymidine (18f-flt) arouses a lot of interest. this new tool would allow to image and follow time wise acute myeloid leukemia (aml). the investigators want, with the (18f-flt), to characterise the aggressivity of the tumors and the prognostic before and after chemotherapy treatment. the aim of this study is to be able to identify earlier the responders, because if they are detected sooner, these patients will benefit from more aggressive treatments.


Eligibility criteria:
inclusion criteria: 1. patients 18 years or above at the time of inclusion; 2. patients newly diagnosed with acute myeloid leukemia; 3. no contraindication or intolerance to any of the components of the standard chemotherapy by induction (7+3); 4. patients able to give written informed consent. exclusion criteria: 1. patients unable to tolerate decubitus position for at least 45 minutes; 2. any previous neoplasia or other neoplasia simultaneously; 3. previously treated buy radiotherapy, with bone marrow in the field of radiation; 4. other chemotherapy treatment than the standard chemotherapy by induction (7+3), before the second flt-tep was done.

Keywords: aml / lma