Kornimate/medical-research-clean huggingface dataset:
mobile cognitive behavior therapy targeting anxiety disorders

Conditions: Anxiety Disorders and Symptoms

Summary: this study aims to examine different ways of motivating people to make use of maya, a mobile cognitive behavior therapy (cbt) program for adolescents and young adults experiencing anxiety symptoms, and to assess whether social supports are as efficacious, or more efficacious, than other non-monetary incentives. subjects will use the maya app for at least 20 minutes per day, 2 days per week, for 6 weeks. assessments will include a weekly check in with a member of the research team, questionnaires, and an optional magnetic resonance imaging (mri) recording.

there is a growing need for easily accessed anxiety treatments designed for young adults. mobile app-based interventions can be disseminated more broadly than traditional psychosocial interventions and may be particularly appealing to this age group, which uses mobile devices frequently. mobile apps can also collect real-time data about patient symptom severity and provide tailored, in-the-moment coping strategies. this study aims to examine different ways of motivating people to make use of maya, a mobile cognitive behavior therapy (cbt) app for adolescents and young adults experiencing anxiety symptoms, and to assess whether social supports are as efficacious, or more efficacious, than other non-monetary incentives. young adults with anxiety will be randomized to one of three conditions: a social support condition, a gain-framed condition in which participants can earn "points" for completing their assigned sessions, and a loss-framed condition in which participants lose "points" for failing to complete their assigned sessions. subjects will use the maya app for at least 20 minutes per day, 2 days per week, for 6 weeks and will complete assessments at baseline, week 3, week 6 (end of treatment), and a follow-up assessment at week 12. subjects may also choose to complete an optional magnetic resonance imaging (mri) recording at the baseline and end of treatment (week 6).

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 25 * primary diagnosis of an anxiety disorder, as determined by a score of 4 on the clinical severity rating from the anxiety disorders interview schedule (adis) exclusion criteria: * score of \< 4 on the adis * primary psychiatric diagnosis other than an anxiety disorder * currently in cognitive behavioral therapy outside of the study * change in dose of a psychiatric medication in the past 12 weeks * intent or plan to attempt suicide

Keywords: anxiety mental health adolescents young adults cbt mobile app cognitive behavior therapy
phase i study of subcutaneous ocaratuzumab in patients with previously treated cd20+ b-cell malignancies

Conditions: Previously Treated CD20+ B-cell Malignancies

Summary: ocaratuzumab is a third-generation, fully humanized igg1 monoclonal antibody (mab) targeting the cd20 surface marker on normal and malignant b lymphocytes. it has been optimized for an increased binding for cd20 and an enhanced antibody dependent cell medicated cytotoxicity (adcc) effector function. a previous phase i/ii study of intravenously (iv) administered ocaratuzumab in refractory/relapsed follicular lymphoma patients has concluded that ocaratuzumab is safe and well-tolerated at doses up to 375mg/ m2 weekly for four weeks. in this proposed phase i study, ocaratuzumab will be administered subcutaneously to patients with previously treated cd20+ b-cell malignancies. three dose levels (40 mg weekly x 4 doses, 80 mg weekly x 4 doses, and 80 mg weekly x 8 doses) will be investigated for safety, tolerability, pharmacokinetic, and pharmacodynamic analyses.


Eligibility criteria:
inclusion criteria: * age \>18 years; * histologically confirmed diagnosis of a cd20+ b-cell malignancy; * received at least one prior treatment regimen;historically documented cd20-positivity is acceptable; * appropriate for single agent study drug therapy as prescribed by this protocol; * ecog performance status 0 to 2; * adequate hematopoietic, renal, and hepatic functions defined as: * absolute neutrophil count greater than 1000 /mm³ * platelet count greater than 75,000/mm³ * hemoglobin greater than 8.5 g/dl * serum creatinine ≤ 1.5x upper limit of normal * ast, alt, and total bilirubin ≤ 3x upper limit of normal; * ability to understand and the willingness to sign a written informed consent document; * life expectancy of 6 months or greater. exclusion criteria: * anti-cd20 therapy within 4 weeks of enrollment; * systemic chemotherapy or immunotherapy within 14 days of enrollment; * chronic systemic steroid therapy defined as prednisone or equivalent 10 mg/day or greater; * systemic cytotoxic or immunosuppressive therapy to be administered concomitantly while participating on this study; * active infection, chronic or severe infection requiring ongoing antimicrobial therapy. * positivity for hepatitis b (defined as hepbs antigen +), hepatitis c (defined as hepc antibody +), or hiv; hiv positive patients on antiretroviral therapy will be excluded; * history of allergic reactions attributed to compounds of similar chemical or biologic composition; * significant cardiac disease (new york heart association classes iii or iv) or unstable angina despite medication; * women who are pregnant or breast-feeding; * women of child bearing potential who are unwilling to use effective contraception for the duration of the study drug administration and 6 months after final dose of drug is administered; * psychiatric illness/social situations that would limit compliance with study requirements; * participation in other investigational studies while enrolled on this trial.
follow heart transplant for achieving the heart primitive related scleroderma systemic

Conditions: Systemic Sclerosis

Summary: systemic sclerosis is a rare disease. the early cardiac disease affects 10% of patients sclérodemiques. heart transplantation in the early cardiac involvement in systemic sclerosis is exceptional. we see patient data analysis with systemic sclerosis who used cardiac transplantation to understand the primitive cardiac damage associated with systemic sclerosis


Eligibility criteria:
inclusion criteria: * adult patients meet the criteria for classification of systemic sclerosis * adverse primitive heart that required a heart transplant * patients who have given their verbal agreement to use their data for research purposes. exclusion criteria: * localized scleroderma or sclerodermiform syndrome * heart disease secondary to pulmonary or renal impairment * refusal to participate in the study

Keywords: systemic sclerosis cardiac disease heart transplantation primitive cardiac damage
study evaluating hki-272 (neratinib) in subjects with advanced breast cancer

Conditions: Breast Neoplasms; Neoplasms

Summary: the purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (her2) positive breast cancer.

arm a: her2 gene amplification and disease progression following at least 6 weeks of standard doses of herceptin; arm b: her2 gene amplification and no prior herceptin or her2-targeted treatment.

Eligibility criteria:
inclusion criteria: * pathologic diagnosis of breast cancer and current stage iiib, iiic, or iv * progression following at least 6 weeks of standard doses of herceptin (arm a only) * over-expression of her2 * tumor tissue available and adequate for analysis at screening * at least one measurable lesion exclusion criteria: * prior treatment with herceptin (arm b only) * more than 4 prior cytotoxic chemotherapy regimens * subjects with bone or skin as the only site of measurable disease * inadequate cardiac function * major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1 * active central nervous system metastases * pregnant or breastfeeding women * inability to swallow the hki-272 capsules

Keywords: phase 2 her2+ breast cancer monotherapy neratinib hki-272 neratinib nerlynx pb-272
the novel unloading device "hephaistos" and its effects upon bone, muscle and vasculature

Conditions: Bone Resorption

Summary: the present study aimed to investigate the importance of gravitational induced forces that appear during normal ambulation for the health of muscles, bones and blood vessels. the main hypothesis of the present study is that gravitational loading alone, without muscle contractions, is insufficient to maintain bone strength.

the 56day unloading intervention with hephaistos had the following key objectives: 1. primary objective: assessment and evaluation of bone adaptation. 2. secondary objective: assessment and evaluation of functional and structural muscular adaptations. 3. third objective: assessment and evaluation of functional and structural vascular adaptations. 4. fourth objective: assessment and evaluation if the present findings deviate from findings observed in established unloading models.

Eligibility criteria:
inclusion criteria: * male * age: 20-40 years * bmi: 20-30 * passing the psychological and medical check up. * signed consent to participate in the study * faultless certificate of good conduct exclusion criteria: * smoking * professional athletes * diabetes * muscle or joint disease * trabecular bone density in the distal tibia epiphysis \< 160mg/cm3 * increase risk of thrombosis * bone fractures 12 months prior to the study * metal implants, any material of osteosynthesis * participation in another clinical intervention study 2 months prior to the study * bleeding disorder * anesthetic intolerance * vascular disease * epilepsy * claustrophobia * herniated disk * pacemaker * alcohol or drug abuse * anti-inflammatory drug intake during the study * hyperlipidemia * kidney disease * hyperhomocysteinaemia * vitamin d deficit * chronical back pain * detained

Keywords: bone density weight bearing muscle atrophy vascular degeneration gravitational loading muscular unloading
study assessing cognition in relapsing remitting multiple sclerosis (rrms) patients treated with bg00012

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the primary objective(s) of the study are to assess the bg00012 (dimethyl fumarate) treatment effect on cognition over 2 year period in rrms patients. the secondary objectives of this study are to further assess bg00012 treatment effect on cognition, predictors of cognitive impairment, clinical efficacy, and patient reported outcomes (pro): depression, fatigue, quality of life, and work and social life activity.


Eligibility criteria:
key inclusion criteria: * must have a confirmed diagnosis of rrms according to mcdonald criteria (polman, reingold et al. 2005). * must have a baseline edss between 0.0 and 5.0, inclusive. * must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain mri demonstrating lesion(s) consistent with ms, or show evidence of gadolinium-enhancing lesion(s) of the brain on an mri performed within the 6 weeks prior to randomization. key exclusion criteria: candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening: * primary progressive, secondary progressive, or progressive relapsing ms, as defined by lublin and reingold (lublin and reingold 1996) * severe depression (madrs score \>34) (montgomery and asberg 1979) * history of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment) * an ms relapse that has occurred within the 30 days prior to inclusion and/or the participant has not stabilized from a previous relapse prior to inclusion.

Keywords: cognition tecfidera rrms bg00012
stenting with or without coating compared with angioplasty in non-benestent disease

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * stable, or unstable angina and/or objective signs of myocardial ischaemia * informed consent * optimal result (\< 35% residual stenosis and \< type c dissection) after balloon angioplasty * lesions should be de novo and located in native vessels with a diameter \> 2.25 mm. * complex lesions to be included should have at least one of the following characteristics: * ostial in location (\< 5 mm from ostium) * total occlusions with a length ≥ 15 mm * bifurcational (side branch \> 1.75 mm in diameter) * angulated (\> 45° within lesion) exclusion criteria: patients: * other severe disease with an expected survival \< 1 year * other significant cardiac disease * known allergy against paclitaxel, clopidogrel (or ticlopidine), * myocardial infarction within 3 days of the index procedure * linguistic difficulties needing an interpreter * renal insufficiency (p-creatinine \> 200 micromol/l) * gastrointestinal bleeding within 1 month * childbearing potential or pregnancy * participation in another study lesions: * unprotected left main disease * restenosis * lesions containing visible thrombus * treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure * diffuse coronary disease distal to the treated lesion * heavily calcification * lesion located in saphenous vein graft

Keywords: percutaneous coronary intervention balloon angioplasty restenosis stents
comparison of intra ocular pressure after insertion of the lma supreme and lma proseal in pediatric patients

Conditions: Intra Ocular Pressure

Summary: the investigators enrolled pediatric patients who are undergoing strabismus surgery. the investigators insert either an i-gel or laryngeal mask airway supreme and measure the intraocular pressures.

we already know that tracheal intubation increased intraocular pressure. we tried to evaluate the change of the intra ocular pressure increase before, during and after insertion the i-gel and lma supreme supraglottic airway devices. we enrolled the pediatric patients who are undergoing to strabismus surgery.

Eligibility criteria:
inclusion criteria: * pediatrics \> 2 years * pediatrics \< 7 years * undergoing strabismus surgery exclusion criteria: * pediatrics \< 2 years * pediatrics \> 7 years * neuromuscular blockage using

Keywords: intra ocular pressure i-gel lma supreme strabismus surgery
a study of vintafolide (mk-8109) in participants with advanced solid tumor (mk-8109-011)

Conditions: Solid Tumor

Summary: this study will evaluate thrice weekly dosing with vintafolide to find the maximum tolerable dose. the primary study hypothesis is that administration of vintafolide to participants with advanced solid tumors will have acceptable safety and tolerability.


Eligibility criteria:
inclusion criteria: * histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate organ function exclusion criteria: * chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to drug administration (6 weeks for nitrosoureas or mitomycin c) or not recovered from adverse events due to agents administered more than 4 weeks earlier * primary central nervous system (cns) tumor * active cns metastases and/or carcinomatous meningitis * known hypersensitivity to the components of the study therapy or its analogs * recent history of abdominal surgery or peritonitis * bowel occlusion or sub occlusion * prior abdominal or pelvis radiation therapy or radiation therapy to \> 10% of the bone marrow at any time in the past or prior radiation therapy within the last three years to the breast / sternum, head, or neck * requires anti-folate therapy * symptomatic ascites or pleural effusion * prior stem cell or bone marrow transplant
hypothermia for cardiac arrest in paediatrics

Conditions: Cardiac Arrest

Summary: the investigators hypothesized that, following cardiac arrest in pediatric patients, hypothermia therapy will improve the proportion of patients with a good functional outcome compared to a normothermic control group.

cardiac arrest is associated with a high morbidity and mortality in children and hypothermia therapy has the potential to be beneficial in children following cardiac arrest. we have a track record of both clinical and laboratory research of hypothermia therapy following cardiac arrest at the hospital for sick children and have completed a 3-site randomized controlled pilot study of hypothermia therapy following cardiac arrest in children funded by the hospital for sick children research institute and the heart and stroke foundation of ontario. this protocol was used to develop the protocol for the thapca trials (see 2 manuscripts published moler et al nejm 2015 and 2017 and multiple other manuscripts). hypothermia therapy, compared to active maintenance of normothermia, had no beneficial effect on functional outcome or mortality in children with out-of-hospital or in-hospital cardiac arrest.

Eligibility criteria:
inclusion criteria: * informed consent by parent or legal guardian * age ≥ 38 weeks gestation up to and including 17 years * patient admitted with a diagnosis of a cardiac arrest requiring compressions ≥3 minutes * remain comatose i.e. have glasgow coma score less than or equal to 10 assessed at the tertiary level pediatric hospital at least 1 hour post- cardiac arrest * invasive mechanical ventilation exclusion criteria: * cardiac arrest lasting ≥45 minutes, irregardless of commencement of ecmo * refractory hemorrhagic shock * dysrhythmia leading to cardiac arrest, where cooling would be part of standard therapy * suspected diagnosis of brain death as defined as fixed and dilated pupils, glasgow coma score of 3 and no evidence of brain function on neurological examination * patients who have had a prolonged cardiac arrest at the scene of a trauma * decision to withhold (dnr) or withdraw life sustaining therapies * acute birth asphyxia * terminal illness, not expected to survive 12 months * cardiac arrest caused by septic shock * severe neurodevelopmental disability or persistent vegetative state prior to cardiac arrest * near drowning in ice water and temperature \<32ºc on admission to study site * it has been more than 6 hours following cardiac arrest (estimated by first responder) * previous enrolment in the hypcap pilot study * pregnant * parent/guardian refuse consent * responsible physician refuses to enrol patient

Keywords: paediatrics
risk-stratified testing for safe removal of penicillin allergy labels

Conditions: Penicillin Allergy; Hypersensitivity, Immediate; Hypersensitivity, Delayed; Hypersensitivity Response

Summary: the aim of this clinical trial is to analyze the negative predictive capacity and safety of risk-stratified direct drug provocation tests for patients with self-reported penicillin allergies. patients reporting immediate or delayed penicillin allergies and defined as low-risk by the pen-fast score will receive drug provocation tests without prior skin testing.

the pen-fast clinical decision rule is an internationally validated scoring system (0-5 points) that identifies low-risk patients (= a score of 0-2 points) with self-reported penicillin allergies with a negative predictive value (npv) of over 95%. performing direct drug provocation tests without prior skin testing on these low-risk patients was shown to be non-inferior in terms of safety and prediction of immediate allergic reactions. however, several studies have questioned the negative predictive capacity of the pen-fast score. in these studies, misclassifications of the pen-fast score were mainly based on positive skin test findings that can show false-positive results. this study aims to validate the npv and safety of direct drug provocation tests using the pen-fast score. participants with a pen-fast score of 0-2 points will directly receive a two-dose challenge (50%-50%) or single challenge (100%) with the culprit penicillin and will be monitored for at least 4 hours. no skin tests will be performed prior to the drug provocation test. patients will be instructed to contact the hospital after the drug provocation test to monitor any delayed allergic reactions. the outcomes will be compared to those of patients with a pen-fast score of 0-2 points who do not wish to skip the skin tests and who will, in parallel, receive the standard-of-care testing. currently, this study is approved as a single-site study.

Eligibility criteria:
inclusion criteria: 1. adult outpatients or inpatients with a penicillin allergy label 2. willing and able to give consent. 3. pen-fast score of 0-2 points exclusion criteria: 1. age \<18 years 2. concurrent immunosuppressive therapy with 20 mg of prednisolone per day or steroid equivalent 3. concurrent antihistamine therapy 4. pregnancy 5. significantly impaired general condition 6. unstable or therapeutically inadequately controlled bronchial asthma 7. history of stem cell transplantation 8. history of acute interstitial nephritis 9. chronic urticaria 10. mastocytosis

Keywords: pen-fast penicillin allergy allergy delabeling
treatment of skeletal class ii malocclusion with modified twin-block appliance with clear plates

Conditions: Malocclusion, Angle Class II

Summary: patients with skeletal class ii malocclusion who have a retracted lower jaw will be treated in this study. the efficacy of clear plates in the treatment of skeletal class ii malocclusion will be assessed. the skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of traditional treatment with fixed appliances.

there are two group: 1. a group of patients in which participants will be undergo to modified twin-block appliance with clear plates. 2. a group of patients in which participants will be undergo to the traditional twin-block appliance. phase intervention/treatment condition or disease not applicable other: modified twin-block appliance with clear plates. other: traditional twin-block appliance. skeletal class ii malocclusion

Eligibility criteria:
inclusion criteria: * - patients with mixed dentition at age 10.5-13 years. * the patient has skeletal class ii malocclusion caused by mandibular retraction anb \> 5, 8 mm \>o.j\> 5 mm, snb\<78, angle (nsar) ≥ ° 125 and normal placement of the upper jaw. * the patient is willing to accept treatment with a removable device. * no previous orthodontic treatment * the growth model is within the normal or horizontal maxillary opening angle of 30 \>mm or angle of 400 \> björk * patients do not have an upper alveolar dental protrusion. exclusion criteria: * -patients with periodontal disease. * patients with a neuromuscular disorder. * patients of class i or iii of malocclusion. * patients with temporomandibular joint disorder. * patients with skeletal open bite. * patients with poor oral and gingival health * the presence of a unilateral or bilateral posterior crossbite. * patients who have upper jaw stenosis and need to be prepared by expansion before functional treatment. * any patient who does not meet one or more of the inclusion criteria will be removed from the study.