Kornimate/medical-research-clean huggingface dataset:
a study of ly900014 formulation at different injection sites in healthy participants

Conditions: Diabetes Mellitus, Type 2

Summary: this study evaluates a new formulation of insulin lispro, ly900014, a drug that lowers blood sugar. it is administered by injection into the vein and under the skin of the abdomen, thigh and arm. the study will be conducted in healthy people to investigate the effect of different injection sites on the amount of insulin lispro in the bloodstream. side effects and tolerability will be documented. the study will last for about 10 weeks for each participant, including screening and follow up. screening is required within 28 days prior to entering the study.


Eligibility criteria:
inclusion criteria: * overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion) * have a body mass index (bmi) of 18 to 30 kilogram per square meter (kg/m²) * have normal blood pressure, pulse rate, electrocardiogram (ecg), blood and urine laboratory test results that are acceptable for the study * are nonsmokers, have not smoked for at least 6 months prior to entering the study exclusion criteria: * are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study * have previously participated or withdrawn from this study * had blood loss of more than 450 milliliters (ml) within the last 3 months
lsa4 protocol for the treatment of advanced pediatric and adolescent non-hodgkins lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: non-hodgin's lymphoma is curable in 76% of patients. in nonlymphoblastic lymphmas, cancer may return on average 3 months from beginning treatment and for lymphoblastic lymphomas, 6 months. to aggressively treat this cancer this study uses effective drugs in three parts: * induction ends on day 19 * consolidation ends on day 38 or 42 * maintenance may include up to 6 cycles


Eligibility criteria:
inclusion criteria: * non-hodgkin's lymphoma stages iii, iv, iva with 1. t cell lymphomas, any primary site irrespective of ldh level 2. large cell lymphomas, any primary site irrespective of ldh level 3. b cell lymphomas, any primary site with initial ldh of less than 500 exclusion criteria: * b cell lymphomas, any primary site with initial ldh of less than 500 and initial cns or bone involvement
clinical relevance of typing hla-dr7-dq2

Conditions: Celiac Disease Patients Following Recommendations of ESPGHAN; HLA-DQ2 Typing Include HLA-DR7-DQ2 Haplotypes

Summary: celiac disease patients with hla-dr7-dq2 haplotype have the same histological, analytical and clinical behaviour as patients with hla-dr3-dq2 haplotype.


Eligibility criteria:
inclusion criteria: * diagnosis of celiac disease following espghan recommendations * hla-dq2 typing including hla-dr3-dq2 and hla-dr7-dq2 haplotypes exclusion criteria: * patients who have not been diagnosed for celiac disease * hla-dq2 typing that not include hla-dr7-dq2 haplotype

Keywords: celiac disease hla-dq2.2 hla-dq2.5 hla-dr7-dq2 hla-dr3-dq2
yag vitreolysis for floaters

Conditions: Weiss Ring; Floaters; Posterior Vitreous Detachment

Summary: this is a single-center, prospective randomized controlled trial evaluating the safety and efficacy of yag vitreolysis versus sham for symptomatic weiss ring due to posterior vitreous detachment.

52 subjects will be enrolled in the trial and randomized in a 2:1 ratio to receive either yag laser vitreolysis or sham laser for symptomatic weiss ring due to posterior vitreous detachment. subjects will follow up at one week, one month, three months, and six months after the procedure. assessments will include a questionnaire regarding duration of floater symptoms prior to presentation, severity of floater symptoms, number of floaters, and activity most inconvenienced by presence of floaters; medical, ocular history and demographics collected; etdrs and snellen visual acuity; optos color photography; heidelberg spectralis optical coherence tomography (oct) and infrared photo; b scan ultrasound of weiss ring with caliper measurement of nearest distance between weiss ring and retina, weiss ring and posterior lens capsule (only in phakic eyes); slit lamp and indirect ophthalmoscopy with scleral depression of study eye; applanation tonometry; visual functioning questionnaire-25 (vfq 25). qualitative change in optos photography will evaluated by a masked physician.

Eligibility criteria:
inclusion criteria: 1. symptoms of floaters that correlate to the presence of a posterior vitreous detachment for at least 6 months 2. documented posterior vitreous detachment on clinical examination, oct, and b scan 3. self-rating of visual disturbance by the floaters must be at least 4 on a 0-10 scale, with 0 being no symptoms to 10 being debilitating symptoms. 4. symptomatic weiss ring (pvd) must be at least 3 mm away from the retina and 5 mm from the posterior lens capsule of the crystalline lens, as measured on b-scan. for pseudophakic patients, there is no minimum required distance from the intraocular lens. 5. able to position for the yag laser procedure. 6. accept the risks of yag laser including but not limited to retinal detachment, intraocular hemorrhage, retinal damage, cataract formation, optic nerve damage, inflammation, and irreversible loss of vision. 7. willing and able to comply with clinic visits and study-related procedures 8. if the patient has two symptomatic eyes, only one eye can be randomized and included in the study. 9. provide signed informed consent exclusion criteria: 1. snellen best corrected visual acuity worse than 20/50 in the fellow eye 2. history of retinal tear, retinal detachment, or uveitis in the study eye 3. history of diabetic retinopathy, macular edema, retinal vein occlusion, or aphakia in the study eye 4. history of glaucoma or high intraocular pressure defined as having a history of glaucoma surgery or currently taking two or more topical glaucoma medications in the study eye
the effects of breathing retraining in patients with interstitial lung diseases

Conditions: Interstitial Lung Disease

Summary: breathing retraining has been reported to lead to improvements in dyspnoea and walking distance in chronic obstructive pulmonary disease (copd) patients. evidence regarding the effects of such an intervention in ild patients is though lacking. in view of this, the aims of such a study were to identify whether breathing retraining led to better management of dyspnoea and improved walking distance in ild patients.

one of the commonest symptoms experienced in patients with a diagnosis of interstitial lung disease (ild) is shortness of breath, a symptom which greatly affects their abilities to carry out activities of daily living. breathing retraining has been reported to lead to improvements in dyspnoea and walking distance in chronic obstructive pulmonary disease (copd) patients. evidence regarding the effects of such an intervention in ild patients is though lacking. in view of this, the aims of such a study were to identify whether breathing retraining led to better management of dyspnoea and improved walking distance in ild patients. twenty seven ild patients were randomly distributed to either the control group (n=15) which received a 12-week pulmonary rehabilitation (pr) programme without breathing retraining or the active group (n=12) which received a 12-week pr programme with breathing retraining. all patients had both the 6-minute walk test and their level of breathlessness assessed using the dyspnoea borg scale assessed at baseline and at 4 weekly intervals for a 12-week period throughout the programme.

Eligibility criteria:
inclusion criteria: * patients with a confirmed diagnosis of ild and who were referred for pr exclusion criteria: * patients who had musculoskeletal or neurological conditions affecting the outcome measures * patients who required oxygen therapy and did not accept administration * patients with unstable cardiovascular conditions * patients who were not willing to participate
cyp2d6 pharmacogenetics in risperidone-treated children

Conditions: Psychiatric Disorders; Neurodevelopmental Disorders

Summary: risperidone is an important medication used to treat children with psychiatric illnesses or neurodevelopmental disorders, such as autism. despite excellent symptom control, the potential for side effects is worrisome. treating these disorders is difficult because not everyone responds the same way to the same risperidone dose. one reason for this is genetic differences in how people break down the drug. understanding these differences will help clinicians choose a dose and better predict the response so patients will be treated successfully with a lower risk for side effects. this study will research these genetic differences in children with psychiatric or neurodevelopmental disorders. hypothesis: the inter-patient variability in risperidone pharmacokinetics and exposure, adverse events, and clinical response in patients with psychiatric or neurodevelopmental disorders is associated with identifiable pharmacogenetic factors, such as cyp2d6 single nucleotide polymorphisms (snps).


Eligibility criteria:
inclusion criteria: * previous risperidone pk study participation (cchmc, rainbow babies and children's hospital or osu) * cyp2d6 pm predicted phenotype * actively taking risperidone * under 18 years of age at time of enrollment * signed, dated informed consent forms exclusion criteria: * investigators are unable to contact the subject/legal guardian(s) * subject is no longer taking risperidone * cyp2d6 predicted phenotype other than pm * subject is non-white, with respect to race, for pk study participation * subject is 18 years of age or older * subject is less than 5 years of age * subject is pregnant at the time of the full pk study * subject/legal guardian unwilling or unable to participate in the study

Keywords: psychiatric disorders neurodevelopmental disorders autism risperidone pharmacogenetics pharmacokinetics
uric acid lowering trial in youth onset t2d

Conditions: Diabetic Kidney Disease; Hyperuricemia; Diabetes; Diabetes Mellitus, Type 2; Type2 Diabetes; Type 2 Diabetes Mellitus; Diabetic Nephropathies; Diabetes Complications

Summary: adolescents and young adults with youth-onset type 2 diabetes (t2d) are disproportionally impacted by hyperuricemia compared to non-diabetic peers and youth with type 1 diabetes (t1d). in fact, 50% of males with youth-onset t2d have serum uric acid (sua) greater than 6.8 mg/dl. the investigators also recently demonstrated that higher sua conferred greater odds of developing hypertension and diabetic kidney disease (dkd) in youth with t2d over 7 years follow-up. elevated sua is thought to lead to cardiovascular disease (cvd) and dkd by inflammation, mitochondrial dysfunction and deleterious effects on nephron mass. while there are studies demonstrating beneficial effects of uric acid (ua) lowering on vascular health in the general population, there are no studies in youth-onset t2d. youth-onset t2d carries a greater risk of dkd and cvd compared to adult-onset t2d and t1d. accordingly, a clinical trial evaluating ua lowering therapies is needed in youth-onset t2d. krystexxa (pegloticase), a uricase, effectively lowers sua and therefore holds promise as a novel therapy to impede the development of cvd and dkd in youth-onset t2d. this proposal describes a pilot and feasibility trial evaluating the effect of ua lowering by pegloticase on markers of cvd and dkd in ten (n=10) youth aged 18-25 with youth-onset t2d (diagnosed \<21 years of age) over 7 days. the overarching hypothesis is that pegloticase improves marker of cardiorenal health by lowering ua.


Eligibility criteria:
inclusion criteria: * men * ages 18-25 * youth-onset t2d (diagnosis \<21 years) * serum uric acid ≥ 5 mg/dl exclusion criteria: * glucose-6-phosphate (g6p) deficiency * allergies to seafood or iodine * mri contraindications (severe claustrophobia, non-mri compatible implantable devices, weight ≥ 450 lbs) * hba1c ≥ 12% * recent (1 month prior) diagnosis of diabetic ketoacidosis (dka) or hyperosmolar hyperglycemia * congestive heart failure * history of multiple and/or severe allergies or anaphylactic reactions * uric acid lowering medications (ie: allopurinol, febuxostat) * pegvisomant, pegvaliase, peginterferon alfa 2b, peginterferon alfa 2a, pegfilgrastim, pegaspargase, pegaptanib, pegademase and certolizumab pegol * participation in another investigational study within 2 weeks prior to study
evaluation of the role of mesenchymal stem cells in the treatment of graft versus host disease

Conditions: Graft vs Host Disease

Summary: mesenchymal stem cells (msc) have been shown to have immunosuppressive properties. following a bone marrow/peripheral blood stem cell transplant, a proportion of patients develop a condition called 'graft versus host disease' (gvhd). in this condition the transplanted cells recognize the recipient as foreign and bring about an immune-mediated destruction of tissues. the treatment for this condition is to use drugs that will cause immunosuppression. a small subset of these patients develop a severe form of gvhd (grade iii or iv) which, in spite of the best currently available treatment, is associated with eventual death in more than 90% of cases. the investigators propose to use infusions of expanded msc from the donor to treat this condition. a few reports on this approach have already been published in peer reviewed journals and preliminary results appear to be promising. the investigators are also aware that larger trials have been initiated to study this. after getting written informed consent, the investigators will infuse expanded msc into patients who develop steroid-resistant gvhd.

a single center non randomized, non blinded phase i/ii clinical trial is proposed to study the role of mesenchymal stem cells (msc) in the management of steroid refractory graft versus host disease (gvhd) following an allogeneic stem cell transplant. patients who develop grade ii to iv gvhd following an allogeneic stem cell transplant will be enrolled. msc will be expanded from the donors of all patients who develop gvhd. expanded msc will be infused at a dose of 1-2 million cells/kg in patients who have steroid refractory gvhd. response to therapy will be studied using established criteria for grading gvhd.

Eligibility criteria:
inclusion criteria: * informed consent obtained from patient and donor * any patient who has undergone hla-matched related allogeneic stem cell transplantation with steroid refractory grades ii-iv acute gvhd * prednisolone 2 mg/kg/day (or equivalent doses of methylprednisolone, etc.) for at least one week exclusion criteria: * invasive fungal disease * active cytomegalovirus (cmv)/epstein-barr virus (ebv)/varicella disease * relapsed malignancy

Keywords: mesenchymal stem cells gvhd treatment steroid refractory gvhd
prospective study on the feasibility and results of poem in idiopathic achalasia

Conditions: Achalasia

Summary: treatment options for achalasia include endoscopic dilations and surgical myotomy. recently the poem (per oral endoscopic myotoymy) technique has been described. patients undergo myotomy under endoscopic control. it has advantage over endoscopic dilation since myotomy is performed, and has advantage over surgery because it is performed endoscopically, thus is less invasive. one potential disadvantage in respect to surgery may be that it may determine higher rates of post-operative reflux. the purpose of this study is to prospectively assess the feasibility of peom in our center with the new hybrid knife, and clinical results at 1, 3 and 12 months. this is a prospective, phase ii study. ten patients (age 18-75 years old) with diagnosis of achalasia, without megaesophagus or colonic esophagus, will be included for the poem procedure. this study will last about 2 years. the aim is the feasibility, security and success rate of poem for achalasia. patients will be followed for at least one year.


Eligibility criteria:
inclusion criteria: * age 18 to 75 years * manometric diagnosis of achalasia * eckardt score more than 3 * informed consent exclusion criteria: * increased surgical risk for important comorbidities, * pseudoachalasia * mega-esophagus (more than 7 cm) and or sigmoid esophagus, * previous esophageal or gastric surgery (with the exception of gastric perforation) * inability of completing the questionnarie * inability to keep a commitment for follow-up * esophageal diverticulum

Keywords: achalasia per oral endoscopic myotoymy endoscopy
a study to evaluate the effectiveness of juvéderm® volift®™ with lidocaine for dynamic radial cheek line skin depressions

Conditions: Cheek Line Depressions

Summary: this study will evaluate the effectiveness of juvéderm® volift®™ with lidocaine for dynamic radial cheek line skin depressions.


Eligibility criteria:
inclusion criteria: * presence of dynamic radial cheek lines * agrees not to make any changes to skin care routines, or to have any facial procedures or treatments during the study exclusion criteria: * previous facial surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent dermal fillers or be planning to undergo any of these procedures during the study * undergone temporary facial dermal filler injections with any substance in the face in the 12 months prior to study entry * received botulinum toxin therapy of any serotype in any facial area within the previous 6 months agrees not to receive it during the study
oral lichen planus treatment

Conditions: Oral Lichen Planus

Summary: oral lichen planus (olp) is a chronic inflammatory and immune-mediated disease affecting the oral mucosa. olp presents with asymptomatic, lacelike white stripes and/or symptomatic red, ulcerated mucous membranes. eating, drinking and oral hygiene procedures may be painful resulting in reduced quality of life (qol). photodynamic therapy (pdt) is a new suggestion for olp treatment pdt is a successful treatment mo- dality for premalignant and malignant diseases of head and neck,gastrointestinal tract, lung, and skin in this study, the effect of photodynamic therapy with topical corticosteroid in oral lichen planus patients was compared

in this study, the efficacy of toluidine blue-mediated photodynamic therapy and topical triamcinolone acetonide 0.2% on decreasing pain and size of olp lesions was compared. this randomized, clinical trial compared the therapeutic effect of photodynamic therapy on symptomatic olp (atrophic/ erosive/ulcerative forms) with triamcinolone acetonide 0.2%. the protocol of the clinical trial, which was conducted according to the ethical principles of helsinki group i toluidine blue-mediated photodynamic therapy group ii photodynamic therapy groupiii laser sham + triamcinolone acetonide 0.2%

Eligibility criteria:
inclusion criteria: * . the patients with clinical or histopathological diagnosis of bilateral atrophic or erosive olp (symptomatic olp) who signed the written consent form were recruited. exclusion criteria: * patients with drug-induced or contact lichenoid reactions, patients receiving any treatment for olp in 2 months prior to the study, pregnant or lactating women, patients with uncontrolled systemic disease, and patients with photosensitivity

Keywords: pain, oral lichen planus ; photodynamic therapy
individualised exercise for kneecap dislocations

Conditions: Patella Dislocation; Patella Dislocation Recurrent

Summary: this study is a feasibility study. it will assess areas of uncertainty relating to the implementation of an individualised exercise programme for patients with a recent kneecap dislocation. this will help determine if a future larger study is feasible, and inform the design and conduct of future research that would aim to optimise outcomes after a kneecap dislocation.

the investigators aim to recruit 15 adult participants with a recent, first-time or recurrent kneecap dislocation, from an acute hospital. participants will receive up to 6 physiotherapy sessions over 3 months. the investigator's exercise programme aims to improve leg muscle strength and facilitate a return to the participant's usual activities. this may include activities such as hopping and changing direction which differentiates it from other programmes. participants will be required to perform the exercise programme 3 times a week independently. strategies to increase adherence to the exercise programme will also be used. this study is part of a masters in clinical research funded by the national institute for health research

Eligibility criteria:
inclusion criteria: * first time or recurrent lateral patella dislocation meeting the diagnostic criteria of 1) requiring reduction by paramedics or 2) diagnosed by a member of the trauma and orthopaedic team. exclusion criteria: * concurrent anterior cruciate ligament or posterior cruciate ligament injury confirmed by negative lachman's and posterior drawer test or confirmed by magnetic resonance imagery (mri); medial collateral and lateral collateral ligament injury requiring application of a hinged knee brace or surgical repair; concomitant injury that would prohibit participation in the exercise intervention * \> 4 weeks from injury to presentation to acute care (ed or trauma services) * unable to give written informed consent * previous surgery on the affected knee * presence of fracture on plain radiograph including osteochondral fractures * medial patellar dislocation * considered inappropriate for referral to physiotherapy (by member of trauma and orthopaedic team assessing the patient) * history of severe neuromuscular or congenital disorders * patients referred for orthopaedic opinion who are subsequently listed for surgery prior to completion of the study intervention * unable to understand written or spoken english * unable to attend physiotherapy sessions at the john radcliffe trauma outpatient physiotherapy department
the effectiveness of reconstructive microsurgery on the clinical and functional state of laryngeal stenosis

Conditions: Larynx Disease; Laryngeal Stenosis

Summary: to improve diagnostic methods for patients with laryngeal stenosis for the optimal determination of the technique of surgical treatment.

the study include patients with laryngeal pathology in the otorhinolaryngology clinic of the 1-city hospital at nur-sultan city. all patients cheek up the necessary clinical, functional, diagnostic studies and treatment measures. it is planned to examine and operate on 70 patients with laryngeal pathology. 1. to study the features of the course of stenosis of the larynx under the influence of various factors, as well as traumatic injuries. 2. to develop optimal diagnostic methods for patients with laryngeal stenosis. 3. to assess the effectiveness of endolaryngeal microsurgery in patients with laryngeal stenosis. 4. to develop recommendations for the organization of treatment for stenosis of the larynx with an increase its functional state.

Eligibility criteria:
inclusion criteria: * medically diagnosed with stenosis of larynx * patients who were observed larynx by mri and ct * patients who need surgical treatment of stenosis of larynx exclusion criteria: * pregnancy * patients who has positive electromyography findings of motion of laryngeal muscles * patients who has contraindications to surgical treatment on the other diseases * patients who has not normal results of lab. analyses

Keywords: laryngeal stenosis laryngeal mri laryngeal ct pulmonary test laryngoscopy