Kornimate/medical-research-clean huggingface dataset:
efficacy of scleral contact lenses for daily wear for regular and irregular refractive errors compared to habitually worn scleral lenses

Conditions: Scleral Lens Wearers

Summary: this study will be done with subjects who already habitually wear scleral contact lenses. the study lens is made with a material that is already widely available and has a new design. it will be fit by the investigators and will be assessed and at one week and 1 month.


Eligibility criteria:
inclusion criteria: 1. subjects may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination. 2. subjects must habitually wear scleral contact lenses for an average wearing time of 6 hours per day. 3. the prospective eye(s) must have refractive hyperopia or myopia from +20.00 to -20.00 diopters sphere (spectacle plane), with up to -10.00 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance). 4. subjects must have best spectacle corrected visual acuity of at least 0.5 logmar in each eye. 5. subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months (minimum of 1 month from initial dispensing). exclusion criteria: 1. female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study. 2. subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis. note: the presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility. 3. subjects with active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection. 4. subjects who are participating in any other clinical trial (fda or other)
latinx teen depression treatment study

Conditions: Depression

Summary: the purpose of this study is determine facilitators of and barriers to receiving evidence-based psychotherapy for depression for latinx adolescents from multiple stakeholder perspectives.


Eligibility criteria:
inclusion criteria: * aged 13-17 * self-identify as hispanic/latinx * diagnosed with major depressive disorder or persistent depressive disorder/dysthymia * referred to psychotherapy or prescribed medication for depression. healthcare providers: * self-identify as regularly providing clinical care to latinx adolescents with depression * be in a role in which they can refer to or provide depression treatment. exclusion criteria: * teens will be excluded if they are experiencing intense psychological distress or imminent thoughts of suicide or have any condition in which, in the opinion of the investigator, precludes the study team from obtaining informed assent of the teen

Keywords: latinx adolescents psychotherapy focus groups
surgical management and outcome of tethered cord syndrome

Conditions: Tethered Cord Syndrome

Summary: the aim of this study is to assess surgical management and outcome of tethered cord syndrome

tethered cord syndrome (tcs) is a developmental abnormality of the neuroaxis which is usually diagnosed in childhood. the actual tethering has been attributed to a variety of pathologic entities, including a thickened tight filum terminale , intradural lipomas with or without a connecting extradural component, intradural fibrous adhesions, diastematomyelia, and adherence of the neural placode following previous closure of a myelomeningocele. however, sufficient differences in the mode of onset, clinical manifestations, and outcome exist between pediatric and adolescent patients with tethered cord to warrant a more detailed analysis of the adult syndrome. the most problematic technical consideration in surgery for the release of the tethered cord is how to preserve functioning neural elements and rebuild the dural sac to avoid csf leak. the purpose of this study is to review causes of tethered cord, clinical presentation, diagnostic tools, treatment options and outcome in school-aged children, adolescents, and young adults with tethered cord.

Eligibility criteria:
inclusion criteria: * patients with tethered cord syndrome presenting at our institute * patients with spinal dysraphism * lipomyelomeningocele with tethered cord * patients presented with neurological deficit after lipomyelomeningocele repair due to tethered cord * patients presented with neurological deficit after myelomeningocele repair due to tethered cord * diastematomyelia with tethered cord - tethered cord due to filum terminale. * tethered cord due to fibrous adhesions exclusion criteria: * asymptomatic patients with tethered cord discovered accidentally
post market clinical follow-up study of excia t® hip prosthesis

Conditions: Hip Arthritis

Summary: clinical and radiological 10 year results of excia t® hip stem


Eligibility criteria:
inclusion criteria: * patient gave written informed consent * age ≥ 18 years exclusion criteria: * pregnancy
a study to investigate the pharmacokinetics of ro7079901 and meropenem in participants with a complicated urinary tract infection

Conditions: Urinary Tract Infections

Summary: this is a non-randomized, open-label, one-treatment, one group study in participants with complicated urinary tract infection (cuti) including pyelonephritis to characterize the pharmacokinetics of ro7079901 co-administered with meropenem.


Eligibility criteria:
inclusion criteria: * requiring hospitalization for iv antibacterial therapy for the treatment of presumed/confirmed cuti (including pyelonephritis) * clinical signs and/or symptoms of pyelonephritis or a cuti * urine culture taken within the 48 hours (hr) period immediately preceding the first dose of study drug contains greater than (\>)1x10\^5 colony forming units (cfu) per milliliter (cfu/ml) of a gram negative organism * negative urine pregnancy test result confirmed by a blood test * agreement to remain abstinent or use a contraceptive method exclusion criteria: * has a concomitant infection requiring antibacterial therapy, in addition to study drug * confirmed fungal urinary tract infection * moderate or severe renal impairment, or end-stage renal disease requiring renal replacement therapy or a recipient of a renal transplant * documented presence of immunodeficiency, or a severely immunocompromised condition or use of systemic immunosuppressant therapy * any rapidly progressing disease or immediately life-threatening illness, or other terminal illness or condition with high risk of mortality meaning that the participant is considered, in the opinion of the investigator, unlikely to survive the study period * urinary tract surgery or clinically significant urogenital trauma in the one week immediately preceding study entry * urinary tract infection (uti) symptoms potentially attributable to another process (sexually transmitted infections or prostatitis) * suspected or confirmed perinephric or intra renal abscess * complete obstruction of any portion of the urinary tract, or a permanent urinary diversion * history of epilepsy, brain lesions or other significant neurological disorders * use of probenecid within the 7 days before enrollment * known history of clinically significant hypersensitivity or severe allergic reaction to meropenem or any other antibiotic * any other ongoing condition or disease, or clinically significant abnormalities in laboratory test results that the investigator considers would render the participant unsuitable for the study * women who are pregnant, planning to become pregnant, or lactating * participation in a clinical study of an investigational drug or device within one month prior to enrollment * prior enrollment in this study
distraction as multimodal pain management

Conditions: Pain, Acute; Burns; Pediatric ALL

Summary: a randomized controlled trial will be performed at the ngwelezana hospital, empangeni, south africa. paediatric patients between the age of 5-12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomized into two groups: the control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as additional method for potential pain alleviation. patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol. the primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. additionally, sub analyses will be performed to evaluate potentially modifying factors on the treatment effect. this will also be evaluated with a linear regression analysis. this will be correlated with care giver and health care worker observational pain scores.


Eligibility criteria:
inclusion criteria: * pediatric patients between the age of 5 and 12 years old with burn injuries requiring dressing changes in the outpatient clinic, who in regular practice (non-research setting) would not receive any analgesics other than paracetamol or a non-steroidal anti-inflammatory drug (nsaid); * superficial partial thickness burns \< 5% tbsa (total body surface area) at the time of injury * only the first change of dressing is included exclusion criteria: * patients who underwent split skin grafts for their burns; * patients on sedatives or anti-epileptics; * the use of pain-relieving medication other than paracetamol or nsaids; * if it is the patient's second presentation to ngwelezana hospital's outpatient burns department * painful additional injuries other than the burn injury; * physical or mental impairments which make it impossible to adequately comply with the trial protocol. for example, visual impairments, impaired ability to communicate, psychological comorbidities, and burns that limit the use of a kaleidoscope (facial burns or burns to both hands)

Keywords: distraction pain treatment pediatric burn injury dressing change
total-body irradiation, busulfan, and interferon alfa followed by peripheral stem cell or bone marrow transplantation in treating patients with multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: radiation therapy uses high-energy x-rays to damage cancer cells. drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. interferon alfa may interfere with the growth of cancer cells. purpose: phase ii trial to study the effectiveness of total-body irradiation, busulfan, and interferon alfa followed by peripheral stem cell or bone marrow transplantation in treating patients with multiple myeloma.

objectives: i. evaluate the effects of total marrow irradiation and busulfan followed by allogeneic peripheral blood stem cell or marrow transplantation on the outcomes of treatment related mortality, response, relapse, survival, and event free survival for patients with advanced multiple myeloma. outline: peripheral blood stem cell (pbsc) or bone marrow (bm) collection and infusion are performed according to standard practice. patients undergo total marrow irradiation (tmi) bid for 3 days. busulfan is administered every 6 hours on days -6 to -3. pbsc or bm is infused on day 0. interferon alfa is administered subcutaneously on mondays, wednesdays, and fridays beginning on day 80. interferon therapy may continue in the absence of graft versus host disease or disease progression. patients are followed on days 56 and 84, then every 6 months for 2 years, and annually thereafter. projected accrual: a maximum of 30 patients will be accrued over 3 years.

Eligibility criteria:
disease characteristics: histologically diagnosed stage ii or iii multiple myeloma stage i multiple myeloma progressing on conventional therapy hla matched donor related - ages 18-65 unrelated - ages 18-55 patient characteristics: age: 18 to 65 performance status: karnofsky 70-100% life expectancy: not specified hematopoietic: not specified hepatic: no significant hepatic disease bilirubin no greater than 2 mg/dl renal: creatinine clearance at least 40 ml/min calcium no greater than 15 mg/dl cardiovascular: no significant cardiac disease ejection fraction at least 40% pulmonary: no significant pulmonary disease fev1 at least 50% or dlco at least 50% other: no obesity chest wall no greater than 3 cm thick no pendulous breasts hiv negative prior concurrent therapy: must have received prior conventional therapy for stage i disease

Keywords: refractory multiple myeloma stage ii multiple myeloma stage iii multiple myeloma
bioequivalence of two formulations of ondansetron in healthy adults (0869-106)

Conditions: Chemotherapy-Induced Nausea and Vomiting

Summary: this study will assess the bioequivalence of a merck clinical trial formulation of ondansetron compared to a non-u.s. marketed formulation of ondansetron.


Eligibility criteria:
inclusion criteria: * if female, subject is not pregnant or breast-feeding * subject has been a nonsmoker for at least 6 months * subject is in good health exclusion criteria: * subject has a history of high blood pressure, asthma, other pulmonary disease, gastrointestinal (gi) abnormalities/peptic ulcers, or cardiovascular, liver, neurologic, or kidney disease * subject is a habitual and heavy consumer of caffeine
multicenter symphony il-6 monitoring sepsis icu validation study

Conditions: Sepsis, Septic Shock

Summary: the primary objective of this study is to validate a pre-defined il-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the icu diagnosed with sepsis or septic shock.


Eligibility criteria:
inclusion criteria: * adult patients (≥22 years of age) * diagnosis of sepsis or septic shock based on: the third international consensus definitions (sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator. * sepsis: suspected or documented infection (i.e., use or intent to use antibiotics as an indicator) and organ dysfunction defined by a sequential organ failure assessment (sofa) score ≥2 * septic shock: sepsis requiring vasopressors and serum lactate levels \>2 mmol/l (18 mg/dl) * admitted or intended to be admitted to the icu * at least 3 ml plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 24 hours of (i.e., up to 24 hours after) the earliest diagnosis of sepsis or septic shock. exclusion criteria: * prisoners or imprisonment at time of enrollment * prior enrollment into this study * informed consent as approved by irb is unable to be obtained.

Keywords: interleukin-6 il-6 risk stratification infections toxima systemic inflammatory response syndrome inflammation pathologic processes sepsis septic shock shock
allergen biocube study evaluating efficacy and safety of nasapaque nasal solution in adult subjects with allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the allergen biocube (abc).


Eligibility criteria:
key inclusion criteria: * must be 18 years of age and provide written informed consent and sign the hipaa form * must have history of allergic rhinitis * must have positive response to allergen biocube key exclusion criteria: * must not have a significant illness such as moderate to severe allergic asthmatic reactions * must not have compromised lung function * must not use any disallowed medications * must not have been in an investigational study in the last 30 days
augmented reality location-based games on physical activity

Conditions: Physical Activity; Quality of Life

Summary: this study aims to examine the effects of an augmented reality location-based game intervention on behavioral and psychological factors related to physical activity among middle-aged and older adults. the study adopts a quasi-experimental design, targeting community-dwelling individuals aged 40-59 or 60 and above, who engage in sedentary work patterns exceeding 6 hours daily. recruitment is scheduled to commence in february 2025 at the xinyi health service center in taipei city. participants will be assigned to either the experimental group or the control group based on enrollment timing. a minimum of 41 participants will be recruited, divided into two experimental groups and two control groups. the experimental group will participate in an augmented reality location-based game featuring different step count goals every two weeks, daily step count reporting, and goal achievement encouragement. the control group will maintain their usual routines without any intervention. the intervention will last for 8 weeks. research instruments will include a basic demographic questionnaire, the short-form taiwan physical activity questionnaire, the exercise self-efficacy scale, the exercise motivation and barriers scale, blood pressure measurements, and the quality of life scale.


Eligibility criteria:
inclusion criteria: 1. meet one of the following conditions: middle-aged to senior citizens aged 40 to 59 years old or senior citizens aged 60 years old or older who work more than 6 hours a day in a sedentary lifestyle 2. able to walk independently without the use of aids. 3. have a smart phone with an application (pikmin bloom) that can be installed and can access the internet and gps. exclusion criteria: 1. patients who have been diagnosed by a doctor as suffering from dementia, mental illness or major diseases. 2. those who are unable to do intense exercise as mentioned in the medical advice. 3. those who cannot go out for long time, such as family caregivers. 4. those who have regular exercise habits: average daily steps over 5,000 steps or 30 minutes of leisure-type physical activity more than 3 times a week. 5. those who will not use the ar adaptive game (pikmin bloom) at the end of the 2-day test period.
evaluation of the safety and efficacy of bbm-d101 to treat patients with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy (DMD)

Summary: the purpose of the study is to assess the safety, tolerability, and efficacy of bbm-d101 to treat patients with duchenne muscular dystrophy.

this is a single-arm, open-label study to evaluate the safety, tolerability, efficacy, pharmacokinetic, pharmacodynamic, and immune response of bbm-d101 within 52 weeks after a single intravenous infusion in dmd boys, as well as the long-term safety and efficacy of bbm-d101 for up to 5 years post infusion. bbm-d101 is gene addition therapy based on engineered aav delivery therapeutic protein gene cassette into muscle for treating dmd. therapeutic protein could mediate the dystrophin-associated protein complex to prevent muscular dystrophy and to rescue the function of muscle.

Eligibility criteria:
inclusion criteria: 1. the legal guardian of the subject fully understands the purpose, nature, methods, and possible risks of the study, and signs a written informed consent form; 2. the study includes ambulatory male subjects who are at least 4 years old and less than 8 years old (4 years old ≤ age \&lt; 8 years old) ; 3. genetically confirmed diagnosis of dmd; 4. have at least 1 of the following typical clinical signs or laboratory abnormalities of dmd: proximal muscle weakness, waddling gait, pseudo gastrocnemius hypertrophy, gower\&#39;s sign, pterygoid scapula; 5. ability to cooperate with motor assessment testing, magnetic resonance imaging (mri) and muscle biopsy according to the requirements of the study. exclusion criteria: 1. hepatitis b surface antigen (hbsag) positive, hepatitis b virus deoxyribonucleic acid (hbv-dna) ≥1000u/ml, hepatitis c virus ribonucleic acid (hcv-rna) positive or human immunodeficiency virus (hiv) positive; 2. receiving antiviral therapy for hepatitis b, hepatitis c, hiv, etc.; 3. left ventricular ejection fraction (lvef) \&lt;50% or ≥ class iii cardiac function defined by new york heart association (nyha); 4. with severe or persistent arrhythmias and congenital heart disease. 5. the subject\&#39;s preventive treatment/cardiomyopathy treatment changes within 1 month before the start of the study treatment; 6. with underlying liver disease, such as previous diagnosis of portal hypertension, splenomegaly, hepatic encephalopathy, or hepatic fibrosis ≥ stage 3; or nodules, cysts found by b-ultrasound in the past, or elevated alpha-fetoprotein in laboratory tests during the screening period, etc., and these abnormalities are judged by the investigator to be clinically significant;

Keywords: adeno-associated virus gene therapy duchenne muscular dystrophy
analysis of oxidative stress biomarkers and their determinants in art-experienced plwh

Conditions: HIV Infections

Summary: the project aims to assess the level of oxidative stress biomarkers in hiv patients on effective antiretroviral treatment in correlation with other therapeutic, clinical, and viro- immunological parameters. the analysis aims to better characterize the patient on treatment through an innovative approach based on two specific tests for complementary assessment of total oxidant and anti-oxidant plasma capacity.


Eligibility criteria:
inclusion criteria: * art-treated plwh * hiv-1 rna\< 50 copies/ml * stable art therapy (at least 48 weeks) * signature of informed consent for study participation exclusion criteria: * none