Kornimate/medical-research-clean huggingface dataset:
web-based intervention to improve executive functioning in teens with epilepsy (epilepsy journey)

Conditions: Epilepsy

Summary: the purpose of this study is to establish the feasibility, accessibility, acceptability, and preliminary efficacy of an individually-tailored intervention to improve ef in adolescents with epilepsy (efi-e).

epilepsy is a common childhood condition affecting approximately 326,000 youth in the united states. adolescents with epilepsy are at significant risk for poor social and academic outcomes, neurobehavioral comorbidities (i.e., internalizing and externalizing symptoms), and poor treatment adherence. studies have shown that one potential reason for these poor outcomes are deficits in executive functioning (ef), defined as the skills necessary for goal-directed and complex activities, including problem-solving, initiation, monitoring, organization, planning, self-regulation and working memory. ef deficits have been documented in 1/3 of youth with epilepsy, which is 3 times the prevalence in healthy youth. evidence-based interventions to improve ef could play a critical role in preventing adverse outcomes (e.g., psychological comorbidities, non-adherence to the treatment regimen) and promoting optimal functioning in adolescents with epilepsy; however none exists for this vulnerable population. the aim of the current study is to establish the feasibility, accessibility, acceptability, and preliminary effects of an individually-tailored intervention to improve ef in adolescents with epilepsy (executive functioning intervention-epilepsy; efi-e). thirty participants will be recruited who have at least one clinically-elevated ef subscale or at least two at-risk subscale scores (\> 1 standard deviation above the mean) on the parent behavior rating inventory of executive function (brief®)) to qualify for the efi-e. efi-e will consist of 10 web-based modules addressing foundational ef skills. each online module will be accompanied by a videoconference with a therapist to review the skills and problem solve around adolescent-identified goals. baseline and post-treatment questionnaires will be completed by adolescents and primary caregivers and electronically-monitored adherence will be obtained throughout the open trial. participants will be in the trial for 9 months.

Eligibility criteria:
inclusion criteria * age 13-17 years * diagnosis of epilepsy * have at least two subclinical (\>1 sd; t score between 60-65) or one clinically-elevated brief subscale (t score \> 65) * primary caregiver consent and adolescent assent to participate in study exclusion criteria * diagnosis of non-epilepsy medical disorders requiring daily medications with the exception of asthma and/or allergies * diagnosis of significant developmental disorders (e.g. autism) * inability to read and speak english due to the questionnaires and intervention only been developed in english * family lives greater than 100 miles away from cchmc * if patient is planning to wean from their antiepileptic medication within the next 6 months

Keywords: executive functioning
asia pacific and russia diagnostic study for egfr testing

Conditions: EGFR Mutation Status in aNSCLC Patients

Summary: interventional diagnostic, international, multicenter and non-comparative study of egfr mutation status in ansclc patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. it will be conducted in asia pacific and russia and will assess the current status of egfr mutation testing, and the concordance of egfr mutation status derived from tumour samples and blood based circulating free dna.

a diagnostic study to determine the prevalence of egfr mutations in asian and russian patients with advanced nsclc of adenocarcinoma and non-adenocarcinoma histologies

Eligibility criteria:
inclusion criteria: * histological or cytological confirmed locally advanced nsclc (stage iiia/b) not suitable for curative treatment or metastatic (stage iv) nsclc * newly diagnosed patients with locally advanced and/or metastatic nsclc who are systemic treatment naive (i.e. no chemotherapy or egfr-tki) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including egfr-tki) * provision of diagnostic cancer tissue or cytology sample upon inclusion (surgical specimen, biopsy sample, or cytology sample is acceptable) and provision of a routine blood (plasma) sample in china, russia, taiwan and korea * patients aged 18 years and older exclusion criteria: * as judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease) * evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study * pregnancy or breast-feeding

Keywords: egfr ansclc mutation status diagnostic study russia china asia
evaluation of the use of levemir® in insufficiently controlled patients with type 1 or type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study conducted in europe. the aim of this study is to evaluated the use of insulin detemir (levemir®) in insufficiently controlled patients with type 1 or type 2 diabetes.


Eligibility criteria:
inclusion criteria: * patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy
prospective registry to evaluate the effective incidence of chronic thromboembolic pulmonary hypertension in germany

Conditions: CTEPH; Chronic Thromboembolic Pulmonary Hypertension

Summary: the incidence of chronic thromboembolic pulmonary hypertension (cteph) after acute pulmonary embolism ist not clear. it is estimated to be up to 3.8%. prospective data registration does not exist. treatment of choice is pulmonary endarterectomy if the thromboembolic lesions are surgically accessible. otherwise interventional therapy by means of pulmonary balloon-angioplasty (bpa) or medical therapy is indicated. in germany, the majority of the patients is referred to three cteph centers: kerckhoff clinic, saarland university hospital and hannover medical school to evaluate the therapeutic options. starting in january 2016 all incident patients will be de-identified and included prospectively. risk factors, outcome and treatment will be documented.

all patients referred to the participating centers will be diagnosed in a standardized manner to confirm the diagnosis "cteph". no additional intervention or blood sampling is necessary. the recommended treatment option is the result of weekly cteph conferences. every patient will be discussed. the registry contains the following data: center plz sex age body mass index history of venous thromboembolism (vte), date ff 1st vte anticoagulation and type of anticoagulation blood group v/q scan ct-agiography pulmonary angiogram world health organisation-functional class six-minute walk distance right heart catheter: rap, paps, papd, papm, pawp, co, ci, pvr, svo2 treatment: pea, ballon pulmonary angioplasty (bpa), medically therapy, vena cava filter cteph special risk factors: thrombophilia, antiphospholipid antibody syndrome, splenectomy, va shunt; pacemakers

Eligibility criteria:
inclusion criteria: * diagnosis "cteph" confirmed exclusion criteria: -

Keywords: incidence risk factors
cytochrome p450 inhibition to decrease dosage of dasatinib for chronic myelogenous leukemia

Conditions: Chronic Myeloid Leukemia, Chronic Phase

Summary: this phase 2 single-arm study aims to demonstrate the efficacy of strong cytochrome inhibition with ketoconazole to reduce dasatinib dosage for adults with chronic myelogenous leukemia. researchers will describe response rates and adverse events.

dasatinib is a second-generation tyrosine kinase inhibitor that is metabolized by the cytochrome p450. dasatinib has shown efficacy in patients with chronic myelogenous leukemia. standard-dose dasatinib is 50mg-140mg/day orally, continuously. however, when combined with a strong cyp3a4 inhibitor, a dose reduction of 75% is warranted. this phase 2 single-arm study aims to demonstrate the efficacy of strong cytochrome inhibition with ketoconazole to reduce the dosage and costs of dasatinib for adults with chronic myelogenous leukemia. researchers will describe cytogenetic and molecular response rates at 3, 6, and 12 months and adverse events (i.e., pleural effusion) associated with this strategy.

Eligibility criteria:
inclusion criteria: 1. age \>18 years 2. chronic myeloid leukemia in chronic phase according to the world health organization 2016 3. eastern cooperative oncology group (ecog) 0-2 exclusion criteria: 1. chronic heart disease (nyha iii-iv) 2. bleeding disorders not attributed to the hematological malignancy 3. pregnancy 4. lactation 5. chronic myeloid leukemia in blast phase 6. organic dysfunction (marshall score ≥2)
safety study of fsme-immun new in healthy children and adolescents aged 1 to 15 years

Conditions: Tick-borne Encephalitis

Summary: the purpose of this study is to investigate the safety of five consecutive lots of fsme-immun new in healthy volunteers. the main criterion for investigation is the fever rate after the first vaccination in three different age classes. the immunogenicity of 0.25 ml fsme-immun new has been demonstrated in previous clinical studies in children; therefore, in the present study, immunogenicity was investigated in a subgroup only.


Eligibility criteria:
inclusion criteria: male and female children and adolescents will be eligible for participation in this study if: * they are aged 1 year (from the 1st birthday) to \< 16 years (to the last day before the 16th birthday); * they are clinically healthy, (i. e. the physician would have no reservations vaccinating with fsme-immun new outside the scope of a clinical trial); * their parents/legal guardians understand the nature of the study and agree to its provisions; * written informed consent is available from both parents/legal guardians, * for germany/austria: additional written informed consent is available for children older than 8 years * they or their parents/legal guardians agree to keep a volunteer diary. for safety reasons, female volunteers who have reached sexual maturity at study start have to meet the following additional inclusion criteria: - negative pregnancy test at study entry; exclusion criteria: children and adolescents will be excluded from participation in this study if they: * have a history of any tbe vaccination; * have a history of tbe infection; * have a history of allergic reactions to one of the components of the vaccine; * suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions; * are known to be hiv positive (a special hiv test is not required for the purpose of the study); * have received banked blood or immunoglobulins within one month of study entry; * have a history of vaccination against yellow fever and/or japanese b-encephalitis; * suffer from hemorrhagic diathesis; * are participating simultaneously in another clinical trial; * if female: are pregnant or breastfeeding. volunteers who meet the inclusion/exclusion criteria, but have a febrile illness (body temperature \> 38°c) at the scheduled time of vaccination, will not be vaccinated before their body temperature returns to normal. volunteers who have received any other vaccination within 4 weeks prior to visit 1 will not be vaccinated until an interval of 4 weeks has passed. in this case visit 1 will take place separately. if volunteers have received antipyretics within 4 hours prior to the intended tbe vaccination, the vaccination should be performed at a later time. volunteers who have a positive tbe antibody value prior to the first vaccination will be excluded from the statistical analysis of the primary endpoint.
effect of transcranial direct current stimulation on risk of falling in cerebral palsy spastic hemiplegic children

Conditions: Cerebral Palsy (CP)

Summary: the purpose of this study was to determine: * if there is an effect of transcranial direct current stimulation in improvement the functional balance in cp spastic hemiplegic children. * if there are any changes in risk of falling in cp spastic hemiplegic children or not.

with the decline of mobility comes a drastic increase in falling. however, people of all ages with cerebral palsy can fall easily due to imbalance issues and non-voluntary movements. individuals with cerebral palsy (cp) can experience a variety of sensorimotor impairments that impact balance, making excessive tripping and falling among the most common concerns for ambulatory individuals with cp. approximately 53-97% of ambulatory individuals fall at least once per year, causing injury, embarrassment, frustration, activity avoidance, and isolation. although a study of over 1000 children found fall frequency was highest in gross motor function classification system (gmfcs) level ii, research has not explored if this holds across the decades of adulthood.

Eligibility criteria:
inclusion criteria: * age range between 8-12 years old. * classified on levels ii and iii of the gross motor function classification system (gmfcs) (palisiano et al.,1997). * the ability to walk without the assistance of another individual for at least 12 months prior to the onset of the study, regardless of whether a gait-assistance device was needed (gmfcs level iii) or not (gmfcs level ii). * (pediatric balance scale, timed up and go test 'tugt') and acceptance of the tdcs procedure. * ability to understand and follow simple instructions. * parent or guardian consent obtained exclusion criteria: * orthopedic deformities, a history of surgery or neurolytic block in the previous 12 months, * diagnosis of epilepsy or having experienced convulsive crises (whether treated with medication or not) in at least the two years prior to the onset of the study, metal implants in the skull, or the use of hearing aids. * previous participation in a tdcs study within the past 6 months.

Keywords: cerebral palsy spastic hemiplegia risk of falling
a prospective study evaluating the performance of nanotite osseotite implants when placed by graduate student programs

Conditions: Tooth Disease; Partial Edentulism

Summary: this study will evaluate the contributions of the nanotite implant design when used by graduate students in their first year of placing implants.

this multicenter, prospective, randomized-controlled study will compare the performance of the nanotite vs. the standard ossotite implants when placed by graduate students with little or no prior experience. enrolled patients will have the study site(s) randomized to either a nanotite (test) or an osseotite (control) implant. the manner of treatment observed at the participating center will be followed for this study. study hypothesis: the performance of the nanotite implant in this study will be no different than or superior to that of the osseotite implant placed during the early period of graduate student training.

Eligibility criteria:
inclusion criteria: * patients of either sex and of any race, 18 years of age or older * patients for whom a decision has already been made to use dental implants for treating edentulism in the mandible or maxilla exclusion criteria: * patients who are known to be pregnant

Keywords: dental implants nanotite implant osseotite implants multicenter randomized clinical study partial edentulism prosthesis
analgesic and subjective effects of terpenes

Conditions: Pain; Abuse, Drug

Summary: the purpose of this research is to assess the analgesic and subjective effects of terpenes administered alone and in combination of thc.

the overall aim of this placebo-controlled study is to examine dose-dependent analgesia, intoxication, abuse liability, and pharmacokinetics of ecologically relevant doses of vaporized myrcene and beta-caryophyllene administered alone or with vaporized thc.

Eligibility criteria:
inclusion criteria: * male or non-pregnant female aged 21-55 years * report non-medical use of cannabis 1-7 days per week over the 1 month prior to screening * not currently seeking treatment for cannabis use * urine test positive for recent cannabis use * have a body mass index from 18.5 - 34kg/m2. * able to perform all study procedures * must be using a contraceptive method (hormonal or barrier methods) exclusion criteria: * meeting dsm-v criteria for any substance use disorder other than nicotine, caffeine, or mild cud * report using other illicit drugs in the prior 4 weeks * • if medical history, physical and psychiatric examination, or laboratory tests performed during the screening process not within the normal range and / or reveal any significant illness (e.g., hypertension) as judged by the study physician and to put the participant at greater risk of experiencing adverse events due to completion of study procedures. * current licit use of cannabis primarily for medical purposes, prescription analgesics, or any medications that may affect study outcomes * current pain * pregnancy is exclusionary due to the possible effects of the study medication on fetal development. * history of an allergic reaction or adverse reaction to cannabis is exclusionary. * history of respiratory illness or current respiratory illness * history of seizure disorder or current seizure disorder * insensitivity to the cold water stimulus of the cold pressor test * currently enrolled in another research protocol * current major axis 1 disorders (mood, anxiety, or psychotic disorder) * not using a contraceptive method (hormonal or barrier methods) * the evaluating physician reviews all medical assessments along with medical history. any disorders that might make cannabis administration hazardous are exclusionary.

Keywords: cannabis analgesia pain thc terpenes
immunogenicity safety study of wockhardt's recombinant insulin analogue in type 1 diabetic patients

Conditions: Type I Diabetes

Summary: this is an open label, randomized, parallel group comparison of the immunogenicity safety of wockhardt's recombinant insulin analogue with the innovator's glargine in type 1 diabetics patients.

to evaluate and compare the immunogenicity safety of wockhardt's recombinant insulin analogue with innovator's glargine.

Eligibility criteria:
inclusion criteria: 1. patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year 2. male or female patients \>= 18 and =\< 55 years of age. 3. patients with bmi of 18.0 to 30.0 kg/m2 4. patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures. exclusion criteria: 1. a patient who is pregnant or is currently breast-feeding. 2. a patient with history of severe hypoglycemia within the past year 3. a patient who is an employee of the investigator, or a patient who has a direct involvement with the trial or other trials under the direction of the investigator. 4. patients who are hepatitis b or c positive on testing or have positive medical history of hiv at screening. 5. patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.

Keywords: type i diabetes wockhardt insulin analogue
a study to investigate the radiological onset of action after treatment initiation with subcutaneous (sc) natalizumab in participants with relapsing-remitting multiple sclerosis (rrms)

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the primary objective of this study is to evaluate the radiological efficacy of sc natalizumab over time through week 24 in natalizumab-naïve participants, as measured by brain magnetic resonance imaging (mri). the secondary objectives of this study are to evaluate additional lesion-related radiological efficacy measures over time, relapse-based clinical efficacy measures, disability improvement and worsening (edss), pharmacokinetic and pharmacodynamic parameters, the immunogenicity of repeated doses, and safety in treatment-naïve participants of sc natalizumab.


Eligibility criteria:
key inclusion criteria: * diagnosis of rrms according to the mcdonald criteria * treatment-naïve in respect to natalizumab as disease modifying monotherapy for rrms * no or not more than one prior ms disease-modifying therapy * highly active rrms, as defined by at least one relapse in the previous year and at least one t1 gadolinium-enhancing lesion or ≥3 new or enlarging t2 lesions * edss score ≤ 5.5 at screening * estimated glomerular filtration rate (egfr) \>30 millilitre per min (ml/min), as estimated using the cockcroft-gault formula. key exclusion criteria: * primary- and secondary-progressive ms * participants for whom mri is contraindicated * history of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for rrms), dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study * history of severe allergic or anaphylactic reactions or known hypersensitivity to any antibody drug therapy. note: other protocol defined inclusion/exclusion criteria may apply.
nudge to gynecologic oncology

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Summary: ovarian cancer lacks an effective screening test, and prompt treatment at diagnosis is the only way to improve outcomes. referral to gynecologic oncology at diagnosis of adnexal mass is recommend by guidelines from every major medical organization. yet, 1 in 4 patients with ovarian cancer nationwide and at penn medicine never see a gynecologic oncologist. even when referred to gynecologic oncology, patients from historically-marginalized groups have twice as long duration from diagnosis to seeing gynecologic oncology. in this project, the investigators will pilot a clinician nudge to gynecologic oncology referral and compare the impact to historical controls.

the study consists of one intervention, a clinician nudge to gynecologic oncology referral. referral to gynecologic oncology is recommended when patients are diagnosed with a complex adnexal mass on imaging (i.e., ovarian-adnexal reporting and data system \[o-rads\] 4 or 5 on ultrasound or magnetic resonance imaging \[mri\]). when patients are identified as having a complex adnexal mass, the order will be pended by the clinical research coordinator and sent to the ordering provider with a message to sign. the message will include content about national guidelines on referral to gynecologic oncology with opt-out framed language.

Eligibility criteria:
inclusion criteria: * women ages 18 years or older * adnexal mass identified on imaging (i.e., o-rads 4 or 5 on ultrasound or mri, codex 4 or 5 on ct scan) ordered by penn medicine clinician exclusion criteria: * known diagnosis of ovarian cancer * patient already established in gynecologic oncology

Keywords: abnormal adnexal mass