Kornimate/medical-research-clean huggingface dataset:
transcranial direct current stimulation for attention deficit

Conditions: Infantile Hemiplegia

Summary: infantile hemiplegia due to brain injury is associated with poor attention. left-sided infantile hemiplegia affects the learning and acquisition of new skills. this study is aiming to improve the selective visual attention (sva) through transcranial direct current stimulation (tdcs) in children with left-sided infantile hemiplegia .

infantile hemiplegia (ih) refers to brain injuries that occur before or at birth and lead to hemiplegia/ total paralysis of one side of the body, including the face, arm and leg. the ih is quit rare condition and occurs in 1 in 1000 live births. however, the condition is reported to cause functional and cognitive disability. children with ih suffer from poor attention particularly visual attention, that is essential to be understand the written language. a focused reading is essential in learning and children with ih possess moderate intelligence and attend school. transcranial direct current stimulation(ttcs) is a novel intervention that use small amplitude electrical currents to stimulate the essential areas of the brain through surface electrodes placed on the corresponding areas of the brain. the eligible children were divided into two groups. one group received tdcs with visual attention activities and the second group received sham tdcs with similar activities. the effect will be assessed before and after with strops-color testing and a academic reading test. the experiment intends to explore the affect of ttcs on visual attention span among children with left-sided infantile hemiplegia.

Eligibility criteria:
inclusion criteria: * age between 8-15 years * left-sided infantile hemiplegia * lesion to non-dominant hemisphere exclusion criteria: * history of epilepsy * second stroke * color blind * under medication for psychiatric illness
evidence-based intervention for improved head impact safety in youth football - aim 1 and aim 3

Conditions: Head Injury; Sport Injury

Summary: two middle school (ages 11-14) football teams will be in aim 1 of this study. all interested athletes on these teams will be invited to voluntarily participate in biomechanical data collection; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. in aim 3, two youth football teams at the middle school level will be recruited to pilot an intervention developed this study. the football coaches of each team will be prospectively recruited and enrolled. all interested athletes on these teams will be enrolled; of those enrolled, 15-20 per team will be randomly selected for instrumentation with head impact sensors. baseline and post-season neurocognitive data will be collected.

this study hypothesizes that (a) determinants at the individual (athlete), interpersonal (team \& coach), and community levels (built \& social environment) of the social ecological model may be identified and targeted to reduce head impact exposure in youth football practices, and (b) an evidence-based strategy to reduce head impact exposure in practices may be developed and pilot tested using a community-engaged approach.

Eligibility criteria:
inclusion criteria: * all athletes participating on the prospective teams will be eligible for the study, including those with braces longer than 6 months. exclusion criteria: * athletes will be excluded from participation if they have had braces less than 6 months, or have dental appliances that may impede the fit of the mouthpiece device (e.g., herbst appliance).

Keywords: sport safety youth football head impact exposure
hypoxia, appetite, and energy intake in young female adults

Conditions: Hypoxia; Altitude; Appetite; Energy Intake

Summary: the goal of this clinical trial is to investigate the effects of acute passive continuous hypoxemia (simulated high-altitude at rest) on appetite and energy intake in healthy young female adults. the main questions it aims to answer are: * does six hours of simulated high-altitude (5000 meters) reduce scores of subjective appetite and energy intake? * do changes in appetite and energy intake persist in the hours following the end of hypoxic exposure? researchers will compare the effects of simulated high-altitude to a control normoxia (sea-level) condition to see if exposure to low oxygen levels independently affect appetite and energy intake. participants will: * visit the laboratory for a preliminary screening session to assess eligibility. * undergo two randomized, single-blind, experimental sessions consisting of six hours of passive exposure to normoxia or hypoxia in a climate-controlled chamber. * consume foods provided from a curated list, served in ad libitum quantities, after leaving the laboratory to assess post-exposure energy intake.


Eligibility criteria:
inclusion criteria: * english or french speaking * ability to provide informed consent exclusion criteria: * history or evidence of chronic disease * current use of hypolipemic medication * current use of hormonal contraceptives * current use of antidepressants * current use of anticoagulants * ongoing smoking status * experiencing pregnancy, puerperium, or irregular menstrual cycles
cardsup - swiss circulatory support registry

Conditions: Cardiogenic Shock

Summary: the project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ecmo or impella implantation at all included sites. all patients undergoing ecmo and/or impella implantation will be prospectively registered. device use is according to the decision of the treating physician and independent of this registry.

this prospective data collection is made up of an all-comers design, including all eligible consecutive patients receiving an impella (2.5, 5, cp, or rp) or va-ecmo device via femoral access who gave their consent (or, if not possible, their relative). the project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ecmo or impella implantation at all included sites. all patients undergoing ecmo and/or impella implantation will be prospectively registered. device use is according to the decision of the treating physician and independent of this registry.

Eligibility criteria:
inclusion criteria: * age \> 18 years * medical indication for implantation of a peripheral cannulated va-ecmo or microaxial flow pump (impella) or newer lv / la-ascending aorta devices. * signed informed consent by patient or relative or waived consent by ec exclusion criteria: * none
pms study to confirm the ongoing safety and performance of silver ii non-woven dressing in chronic and acute wounds

Conditions: Wound

Summary: post market surveillance study to confirm the safety and performance of silver ii non-woven dressing in chronic and acute wounds

the design of the study is an open-label, multicentre, single arm clinical trial in subjects with moderate to heavily exuding infected chronic and acute wounds consisting of pressure ulcers, leg ulcers, diabetic ulcers, post-operative surgical wounds, graft and donor sites, cavity wounds, trauma wounds (dermal lesions, trauma injuries or incisions) and superficial and partial thickness burns. the performance data from this study will support clinically meaningful rates of successful improvement in the signs and symptoms of infection, without re-infection during 6-week treatment and follow up period.

Eligibility criteria:
inclusion criteria: * males or females, age 18 years or above. (females must not be pregnant and if of reproductive age should be using contraception). * patients who are able to understand and give informed consent to take part in the study. * have one or more of the following: pressure ulcer, leg ulcer, diabetic ulcers, post-operative surgical wounds, graft and donor sites, cavity wounds, trauma wounds (dermal lesions, trauma injuries or incisions) and superficial and partial thickness burn wounds that are infected, or are at high risk of infection , that are moderate to heavy levels of exudate. * for partial thickness second degree burns that require grafting - only those grafts with single thickness mesh grafts that have x % epithelialization will be enrolled \[note: % epithelization to be added once sites/countries are chosen as this is specific to the territory where the silver ii non woven dressing study is likely to be performed\]. exclusion criteria: * patients who are known to be non-compliant with medical treatment, * patients who are known to be sensitive to any of the device components * subject is pregnant or actively breastfeeding; * subject has a known sensitivity to silver; * life expectancy of \<6 months; * maximum burn area of \> 20% total body area. using the rule of nines assessment tool. \[note: criteria to be confirmed once sites/countries are chosen\] * subject has any significant or unstable medical or psychiatric condition that, in the opinion of the investigator, would interfere with his/her ability to participate in the study;
ultrasound needle transducer for regional anesthesia validation study

Conditions: Thorax; Pain, Spine, With Radicular and Visceral Pain; Acute Post-thoracotomy Pain; Pain, Postoperative; Ultrasound Therapy; Complications

Summary: to validate the efficacy of miniaturized ultrasound needle transducer as the primary guide for thoracic regional anesthesia.

paravertebral (pvb) and intercostal nerve block (icnb) are both techniques of injecting local anesthetics for pain management at thoracic and upper abdominal region. today, pvb and icnb are performed under the guidance of surface two dimensional b-mode ultrasound. however, the procedure still carries potential risks for inexperienced operators since the target zone is very close (2-3 mm) to the pleura. in certain patients, such as those with obesity, the steep needle trajectory and poor quality of the anatomic image make the nerve block even more difficult. inaccurate identification of the anatomical structures or suboptimal positioning of the needle tip could result in complications and blockade failure. we designed an intra-needle ultrasound (inus) system to improve the identification of anatomical structures and needle tip position. the system passed all safety standards including electrical safety test, biocompatibility test, software certification. this study is to investigate the feasibility and image quality of inus during icnb and pvb. the study protocol is approved and under monitoring for safety and compliance from both institutional review board of taipei veterans general hospital and ministry of health and welfare, taiwan, republic of china.

Eligibility criteria:
inclusion criteria: 1. patients scheduled for elective thoracic surgery 2. patients scheduled for elective upper abdominal surgery 3. patients scheduled for elective breast surgeries. exclusion criteria: 1. known coagulopathies, 2. skin lesion or infection at site of nerve block 3. pregnant women 4. allergic to local anesthetics 5. cognitive diseases 6. unstable hemodynamics 7. chronic substance abuse (ex. alcohol, hypnotics, opioids)

Keywords: intercostal nerve block paravertebral block ultrasound-guided pain intervention thoracic surgery breast surgery abdominal surgery ultrasound-guided peripheral nerve block postoperative pain
a new mechanical decontamination method in peri-implantitis, ti-brush, a randomized controlled clinical trial

Conditions: Peri-Implantitis

Summary: objective: the objective of this study was to evaluate a new mechanical method (ti-brush, straumann, ag, basel, switzerland) of implant surface decontamination. material and methods: a randomized double-blinded controlled clinical trial with a 1-year follow-up it is being carried out. after a hygienic phase, defects were randomly assigned to a control (n=18) or to a test group (n=18). in control group, implant surface was decontaminated both mechanically and chemically with 3% h2o2 and plastic ultrasonic scalers, respectively, while in test group ti-brush was added. infrabony defects in both groups were regenerated with boneceramic (straumann, ag, basel switzerland) and collagen barrier membrane cytoplast (osteogenics, lubbock, united states). clinical and radiographic parameters were measured at baseline, 6, and 12 months after surgery.


Eligibility criteria:
inclusion criteria: * healthy or treated periodontal patients * a good level of oral hygiene (plaque index ≤ 25%) (o'leary et al., 1972). * presence of at least one titanium implant exhibiting peri-implantitis (peri-implant bone loss \> 30% and implant ppd ≥ 6 mm with bleeding and/or pus suppuration on probing) * osseous defect had to be circumferential, or present at least two walls and 3mm depth. * presence of \>1 mm of keratinized peri-implant mucosa * absence of systemic diseases that could influence the outcome of the therapy. exclusion criteria: * pregnant or lactating women * esthetically compromised patients * patients who received systemic antibiotics in the past 3 months or treatment of peri-implantitis in the last 12 months. * smokers of more than 10 cigarettes a day

Keywords: regenera
study to evaluate the pharmacokinetic profiles of biib017 (peginterferon beta-1a) and rebif® (interferon beta-1a) in healthy volunteers

Conditions: Multiple Sclerosis

Summary: the primary outcome of the study is to evaluate the cumulative area under the concentration time curve (auc) over 2 weeks, as measured by auc from time 0 to 336 hours post dose (auc0-336h), for serum concentrations of biib017 and rebif. the secondary outcomes are to evaluate the maximum observed serum concentrations (cmax) of biib017 and rebif and to evaluate the safety and tolerability of biib017 and rebif over 2 weeks in healthy volunteers.


Eligibility criteria:
key inclusion criteria: - must have a body mass index of 19 to 30 kg/m2, inclusive, and minimum body weight of 45.0 kg at screening and day -1 key exclusion criteria: * history or positive test result at screening for human immunodeficiency virus, hepatitis c virus antibody or current hepatitis b infection (defined as positive for hepatitis b surface antigen \[hbsag\] and/or hepatitis b core antibody \[hbcab\]) * history of premalignant and malignant disease including solid tumors and hematologic malignancies * known allergy to any interferon or any component of biib017 * prior treatment with any investigational drug within the 30 days prior to day 1, or within 5 half-lives of the drug, whichever is longer note: other protocol defined inclusion/ exclusion criteria may apply.
efficacy and safety study of pregabalin (lyrica) as monotherapy in patients with partial seizures

Conditions: Epilepsies, Partial

Summary: this study will determine the safety and efficacy of pregabalin (lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. the duration of the trial is about 6 months.

after review of the interim analysis results, the independent data monitoring committee (dmc) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. pfizer accepted the dmc recommendation and made the decision to stop the study on september 7, 2011.

Eligibility criteria:
inclusion criteria: * diagnosis of epilepsy with partial seizures. * males or females, age 18 years or older. * documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit. * stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit. exclusion criteria: * current diagnosis of febrile seizures or seizures related to an ongoing acute medical event. * seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin. * primary generalized epilepsy or status epilepticus within the previous year.

Keywords: epilepsy partial seizures pregabalin monotherapy double-blind and randomized trial
comparison of noascope to the conventional stethoscope for auscultation of heart and lung sounds

Conditions: Chest Pathology

Summary: assessing non-inferiority of a newly developed electronic stethoscope noascope in comparison with the conventional 3m littmann stethoscope

the enrolled population will include adults with a history of heart and lung complications. the enhanced sound quality of the electronic stethoscope and its non-inferiority to the traditional/conventional 3m littmann stethoscope will be assessed through auscultation examination of every patient by a health professional (consultant, medical resident, and house officer) with both the electronic stethoscope and 3m littmann/traditional/conventional stethoscope

Eligibility criteria:
inclusion criteria: * ages: 18 years or older (male and female) * hospital admitted or out patient department * written consent provided exclusion criteria: * age \<18 * icu admitted * written consent not provided
the effect of virtual reality application on anxiety and patient satisfaction during intrauterine insemination (iui)

Conditions: Virtual Reality; Anxiety; Patient Satisfaction; Intrauterine Insemination (IUI)

Summary: this study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (vrg) application during the iui procedure on anxiety and patient satisfaction. the population of the research will consist of women who were treated with assisted reproductive techniques and underwent iui at the infertility polyclinic of ministry of health adana city training and research hospital between may and december 2024 and who meet the research criteria. the research sample was calculated as a total of 90 people (at least 45 people in each group) using the power program. data; personal information form, visual assessment scale (vas), state trait anxiety inventory (stai) and patient's perception of nursing care scale will be collected from women who agree to participate in the research. virtual reality glasses will be applied to the intervention group.

this study will conduct as a randomized pretest-posttest study to examine the effect of virtual reality glasses (vrg) application during the iui procedure on anxiety and patient satisfaction. the population of the research will consist of women who were treated with assisted reproductive techniques and underwent iui at the infertility polyclinic of ministry of health adana city training and research hospital between may and december 2024 and who meet the research criteria. the research sample was calculated as a total of 90 people (at least 45 people in each group) using the power program. data; personal information form, visual assessment scale (vas), state trait anxiety inventory (stai) and patient's perception of nursing care scale will be collected from women who agree to participate in the research. these scales will be applied to both groups before and after intrauterine insemination (iui). virtual reality glasses will be applied to the intervention group during intrauterine insemination (iui). keywords: virtual reality, anxiety, patient satisfaction, intrauterine insemination (iui)

Eligibility criteria:
inclusion criteria: * 18-45 age group * primary infertile, * able to speak and understand turkish, * are cognitive, effective and have no problems preventing communication, * having no psychiatric problems, * not diagnosed with epilepsy (due to the possibility of virtual reality (vr) glasses triggering epileptic seizures), * women who volunteer to participate in the study will be recruited. exclusion criteria: * having a psychiatric problem, * diagnosed with epilepsy * those who want to leave the study
study to determine the effect of a newly formulated tetracaine product pet500 on penile skin sensation

Conditions: Healthy Volunteers

Summary: an open label, placebo and positive controlled, randomised, cross-over study in healthy male volunteers to determine the effect on penile skin sensation of a newly formulated tetracaine product pet500

this was an open label, placebo and positive controlled, randomised, dose-ranging, cross-over pilot study. on each dosing day the subjects each received one dose of tetracaine (0.26 or 0.65 or 1.3mg), or placebo, or stud100® (which served as a positive control) on the glans penis the doses of pet500 were applied in liquid spray form (260μl) at approximately the same time of the day as the previous application to locations on the glans penis in a randomised fashion. von frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of imp. the first two volunteers included in the trial piloted the sensitivity assessments prior to the inclusion of all other subjects. changes could be made to the assessment times on the basis of the pilot data to ensure subsequent timings were relevant. however any such changes were not to expose volunteers to more assessments than were specified in the study protocol.

Eligibility criteria:
inclusion criteria: a subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. male healthy subject aged 18 to 65 years, inclusive. 2. the subject is capable of understanding and complying with protocol requirements. 3. the subject is in good health as determined by medical history and physical examination at screening. 4. the subject signs a written, informed consent form prior to the initiation of any study procedures exclusion criteria: a subject will not be eligible for inclusion in this study if any of the following criteria apply: 1 history or hypersensitivity to tetracaine or ethanol. 2. history or signs of a sexually transmitted disease. 3. any current penile abnormalities. 4. known current drug abuser or alcoholic as determined by medical history. 5. participation in a clinical trial within the last month prior to dosing on day 1. 6. the use of concomitant systemic or topical medications or foods that may affect the study outcome and / or impair drug metabolising capacity. 7. a positive hiv 1 \& 2 antibodies, hepatitis b surface antigen, and/or hepatitis c antibody result. 8. unfit to participate in the study in the opinion of the principal investigator.
transfemoral versus transradial approach in transarterial chemoembolization of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: transfemoral versus transradial approach in transarterial chemoembolization of hepatocellular carcinoma

to compare transfemoral approach (tfa) and transradial approach (tra) in patients undergoing hepatic chemoembolization in terms of safety, feasibility, and procedural variables, including fluoroscopy time and patient preference.

Eligibility criteria:
inclusion criteria: * patients with hepatocellular carcinoma of bclc (barcelona clinic liver cancer) stage b * also for bclc stage a patients, in whom ablative therapy has technical limitations. * downsizing tumor for resection or transplantation. exclusion criteria: * factors related to liver cirrhosis: * decompensated cirrhosis (child-pugh b and c, score \>8), including jaundice, clinical hepatic encephalopathy, and refractory ascites and/ or hepatorenal syndrome * impaired portal-vein blood flow (portal-vein thrombus, hepatofugal blood flow) * factors related to hcc: * extensive tumor involving the entirety of both lobes of the liver * malignant portal vein thrombosis * extra-hepatic metastases * impaired renal function: * creatinine ≥2 mg/dl or creatinine clearance \<30 ml/min * factors related to procedure (radial artery access): * existing av (arteriovenous) fistula or graft * pervious major surgery to forearm or wrist * vasculitis * pervious access failure * skin infection or compromised integrity * artery size \<2mm * intolerance of hyperextended wrist positioning * severe vasospasm * vessel tortuosity * radial loops * absent or occluded radial artery * atherosclerotic or calcific pad (peripheral artery disease) * coagulopathy inr\>1.5 platelets count \<50.000/mmc