Kornimate/medical-research-clean huggingface dataset:
sinus disease in young children with cystic fibrosis

Conditions: Cystic Fibrosis in Children; Cystic Fibrosis; Chronic Rhinosinusitis (Diagnosis); Olfactory Disorder; Olfactory Impairment

Summary: this is a prospective, observational study examining the impact of highly effective cystic fibrosis transmembrane conductance regulator (cftr) modulators on chronic rhinosinusitis (crs) and olfactory dysfunction (od) in young children with cystic fibrosis (ycwcf). this study involves two groups: children 2-8 years old, inclusive at initial visit, receiving highly effective modulator therapy (hemt), and a control group of children 2-8 years old, inclusive at initial visit, not receiving hemt. outcomes will include sinus magnetic resonance imaging (mri) scans, olfactory tests, and quality of life surveys obtained over a two-year period.

this multi-center, prospective, observational study investigates the effects of highly effective modulator therapy (hemt) on chronic rhinosinusitis (crs) and olfactory dysfunction (od) in young children with cystic fibrosis (ycwcf). the study spans two years and includes two distinct groups of children with cystic fibrosis: children ≤ 8 years old receiving hemt and a control group of children ≤ 8 not receiving hemt. the study aims to assess the efficacy of hemt in improving sinus health and olfactory capabilities in this young demographic. key assessments include magnetic resonance imaging (mri) sinus opacification, olfactory bulb volume measured via mri, objective olfactory testing, and various quality (qol) surveys. this investigation seeks to characterize the severity of crs and od in ycwcf, and to elucidate if early initiation of hemt improves crs and od . in the hemt group, participants will have a pre-hemt assessment followed by 1-year and 2-year post-hemt evaluations. in the control/non-hemt group, participants will undergo parallel assessments at baseline, 1-year, and 2-year intervals to track the natural progression of crs and od without hemt.

Eligibility criteria:
inclusion criteria: hemt group: * children with documentation of a cf diagnosis * age 2-8 years old at first study visit * cftr mutation consistent with fda labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor) * clinician intent to prescribe ivacaftor or eti so that enrollment is before start of hemt non-hemt/control group: * children with documentation of a cf diagnosis * age 2-8 years at first study visit * ineligible for highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor) based on cftr mutation or clinical decision not to initiate hemt if eligible exclusion criteria: for both groups: * use of an investigational drug within 28 days prior to the first study visit * use of ivacaftor or elexacaftor/tezacaftor/ivacaftor within the 180 days prior to and including the first study visit * use of chronic oral corticosteroids within the 28 days prior to and including the first study visit. * sinus surgery within 180 days prior to the first study visit

Keywords: cystic fibrosis chronic rhinosinusitis olfactory dysfunction
phase 2, multicenter, open-label extension study with abt-122 in rheumatoid arthritis subjects who have completed the preceding m12-963 study

Conditions: Rheumatoid Arthritis

Summary: this is a phase 2, multicenter, 24-week ole study to assess the safety and tolerability of abt-122 in participants with rheumatoid arthritis (ra) who had had an inadequate response to methotrexate (mtx) therapy and who completed the preceding study m12-963 randomized controlled trial, in which participants had been randomized to receive 1 of 3 doses of abt-122 (60 mg every other week \[eow\], 120 mg eow, or 120 mg every week \[ew\]) or adalimumab 40 mg eow given on background methotrexate.


Eligibility criteria:
inclusion criteria: - subjects who have completed the preceding study m12-963 (abt-122) randomized controlled study and have not developed any discontinuation criteria, as defined in study m12-963. * if female, subject must meet one of the following criteria: 1. postmenopausal (defined as no menses for at least 1 year). 2. surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). 3. practicing appropriate birth control, from the time of enrollment in this study until at least 150 days after the last dose of study drug. * male who agrees to follow one of the protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 150 days post last dose of study drug. * subjects must voluntarily sign and date an informed consent, approved by an independent ethics committee (iec)/institutional review board (irb), prior to the initiation of any screening or study-specific procedures. * subject is judged to be in good health as determined by the investigator based on the results of medical history, physical examination and laboratory profile performed. exclusion criteria: - pregnant or breastfeeding female. * ongoing infections at day 1 (week 0) that have not been successfully treated within 14 days. * anticipated requirement or receipt of any live vaccine during study participation including up to 120 days after the last dose of study drug. * current enrollment in another investigational study; with the exception of study m12-963, which is required. * consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive abt-122.

Keywords: tolerability methotrexate safety
integrating the esdm in asd preschools in israel

Conditions: Autism Spectrum Disorder

Summary: the current study evaluates the effectiveness of the early start denver model (esdm) when integrated in existing community preschools for children with asd. the study compares developmental gains made a group of children receiving preschool-based esdm compared to a group of children receiving eclectic interventions in their preschools (treatment as usual).

the early start denver model is a comprehensive treatment model for young children with autism spectrum disorders (asd), which builds upon behavioral, relationship, play-based and developmental theories and practices. utilizing the plasticity of the young brain, while managing social attention, employing multi-modal teaching, and tapping into the child's motivation, the esdm aims to alter the child's developmental trajectories by creating rich and meaningful learning experiences in daily and naturalistic routines. this model focuses on all areas of development, with significant stress on communication, language, social skills, play and imitation. in the esdm, parents are seen as a main motivational factor for the child, and a focal part in planning and implementing key components of the intervention. currently, community preschool settings are the main providers of intervention programs for children with asd in israel. the prevalent mode of intervention in these settings is a multi-disciplinary eclectic model, in which professionals from various disciplines deliver intervention comprising several theories and practices. while quite ubiquitous, this type of intervention was shown in previous research as less effective than specialized, comprehensive treatment models. the esdm was previously shown efficacious in intensive home-based delivery, and effective as a center-based group model. however, there are currently no studies that assess the effectiveness of the esdm when integrated in existing community preschool settings. additionally, previous research in center-based group delivery of the esdm did not focus on the effects of routine parental involvement in child treatment (when delivered in a preschool setting) on child and parental outcomes. the current study aims to explore the effects of esdm implementation in community preschool settings, together with incorporation of parents in the treatment process.

Eligibility criteria:
inclusion criteria: * children learning in asd schools with a diagnosis of asd validated by the autism diagnostic observation schedule - 2nd edition. * esdm group: parents who have agreed to participate in weekly joint sessions at the preschool. exclusion criteria: -
pnf exercises on treatment of temporomandibular dysfunction

Conditions: Temporomandibular Joint Disorders

Summary: temporomandibular joint dysfunction (tmjd) is an important health problem that occurs approximately in 22 to 35 percent of adults, different physiotherapy methods are reported as treatment options for management of tmjd. although that, there is no previous studies about the efficacy of pnf exercises in treatment of tmjd in patients with forward head posture. so, the purpose of the present double-blind, randomized, controlled trial is to investigate the efficacy of pnf exercises in treatment of tmjd in patients with forward head posture.


Eligibility criteria:
inclusion criteria: * patients of both genders of age between 20-40 years * having symptoms of tmd for at least six weeks duration established by an expert physician or orthopaedician * having forward head posture with cva \< 53 * pain over tmj between 3 to 6 on nprs * mouth opening \< 25mm. exclusion criteria: patients will be excluded if they exhibited any of the following criteria: * tmj fracture undergone any surgical procedure for tmj * fracture surrounding tmj * dislocation or subluxation of tmj * systemic generalized joint diseases, such as rheumatoid arthritis, and osteoporosis, congenital diseases, or facial paralysis * recently any dental treatment is taken or surgery over tmj * hematological cervical disorders which may affect the jaw * neurological deficits e.g. bells palsy, trigeminal neuralgia. * recent infections (within the last six months) affecting the head and neck e.g. bone infections, meningitis, encephalitis, malaria, ear infection * participants who were using any functional appliances e.g. dentures, braces, bite appliances which had been adjusted or fitted in the last 12 weeks prior to the commencement of this study * ddwr, ddwor * patients were excluded from the study if they were receiving any other form of treatment for their tmj dysfunction.
use therapeutic chinese massage to treat peripheral neuropathy in people with hiv

Conditions: Peripheral Neuropathy

Summary: background: peripheral neuropathy (pn) occurs in half of the people with human immunodeficiency virus (phiv). currently, there is no food and drug administration-approved treatment for hiv-related pn. only half of phiv who take medications report a significant reduction in pain. therapeutic chinese massage, structured palpations or movements of soft tissues of the body, is a promising non-harmful, and non-costly intervention that can potentially alleviate or even treat pn but relevant research is limited. method: investigators conducted a single centered, two-arm, single-blinded randomized controlled trial pilot study to examine if a series of three weekly 25-minute therapeutic chinese massage sessions by a therapist of therapeutic chinese massage, compared with placebo massage, could reduce pn-related pain and improve lower extremity functioning in phiv. twenty phiv were recruited from the aids foundation houston, inc in texas. pain, lower extremity functioning, and health-related quality of life were assessed for both groups prior to and post-massage.


Eligibility criteria:
inclusion criteria: clinical diagnosis of hiv and peripheral neuropathy have self-reported pn-related pain in lower extremity are not taking any kind of medications to alleviate pn symptoms age at least 18 years old not pregnant or lactating exclusion criteria: have received any kind of massage in the past three months can not give informed consent
in vivo kinematics of scapolunate interosseous ligament injuries

Conditions: Scapholunate Ligament Tear

Summary: the investigators hypothesize that there is no relationship between in vivo kinematic abnormalities and patient-rated outcomes for scapholunate interosseous ligament injuries (slil) the secondary null hypotheses are that: there are no kinematic differences between subjects with unilateral, symptomatic, full thickness scapholunate ligament tears in comparison to the contralateral wrist without scapholunate ligament injury. the investigators aim to answer to the below questions: * what are baseline validated outcomes for subjects with slil injury? * what are baseline physical measures (range of motion, jamar dynamometry)?

in vivo kinematics of the normal wrist has been studied previously, but few studies have characterized the wrist with a slil injury. there are few studies evaluating validated patient-rated outcomes for patients with slil injury. the goal of this study would be to evaluate to what degree kinematic abnormalities affect patient-rated outcomes.

Eligibility criteria:
inclusion criteria: * all patients with a unilateral full thickness scapholunate ligament tear diagnosed by radiographs or advanced imaging exclusion criteria: * patients with a partial thickness scapholunate ligament tear * patients with radiographic arthrosis * patients with prior wrist injury * pregnant women
rct of psychoeducational program of depression

Conditions: Unipolar Depression

Summary: the purpose of the study is to test the efficacy of a psychoeducational group program on unipolar depression

unipolar depression is a common disorder which may be treated by drugs or psychological intervention. many patients prefer psychological treatment, but there is a lack of professional skills and methods for effectively dealing with this in the primary health services,where most of the depressed patients are seen.for this reason it is of great importance to develop and test psychological methods which may be applied in the primary health services, as well as in the specialized psychiatric services.in the present study a psychoeducational group method is tested, with trained psychiatric nurses as the most common group leaders. comparison: people with unipolar depression receiving "treatment as usual"

Eligibility criteria:
inclusion criteria:unipolar depression - exclusion criteria:psychosis, other psychiatric disorders, subclinical depression, suicidal ideation, learning disabilities -

Keywords: depression psychoeducation rct primary health services
expressive interviewing agents to support health-related behavior change

Conditions: Mental Stress

Summary: expressive writing and motivational interviewing are well-known approaches to help patients handle stressful life events. while these methods are often applied by human counselors, it is less well understood if an automated approach can encourage behavior changes in patients. this study presents an automated writing system and evaluates its impact on individual behavior related to the covid-19 pandemic. the investigators developed a rule-based dialogue system for "expressive interviewing" to elicit writing from participants on the subject of how covid-19 has impacted their lives. in may-june 2021, the investigators randomly assigned online participants (n=151) to the expressive interviewing task and a control condition. the investigators examined their behavior with a survey before the intervention, immediately after, and two weeks after. in aggregate, task participants experienced a significant decrease in stress in the short-term (\~23% decrease, p \< 0.001) and no significant changes in longer-term outcomes compared to the control group. within the task, participants showed different outcomes based on their writing. participants who wrote with more anxiety-related words showed a greater short-term decrease in stress (r=-0.264, p\<0.001), and those who wrote with more positive emotion words reported a more meaningful experience (r=0.243, p=0.001). for longer-term effects, participants who wrote with more lexical diversity underwent an increase in social activity (r=0.266, p\<0.001). expressive interviewing can generally help with mental health in the short term but not longer-term, and participants' writing choices may make a difference in outcomes. while there were no significant long-term effects observed, the positive short term effect points to potential future directions with a series of expressive interviewing interventions for longer-term effects.


Eligibility criteria:
inclusion criteria: * using prolific platform as crowd worker * living in united states exclusion criteria: * participating in another condition of the same study
phase iii study of l-cysteine in patients with erythropoietic protoporphyria

Conditions: Erythropoietic Protoporphyria

Summary: objectives: i. determine the long-term efficacy and safety of l-cysteine in the prevention photosensitivity in patients with erythropoietic protoporphyria.

protocol outline: this is a phase iii study, lasting 3 years; 1996-1999. patients are administered l-cysteine orally twice daily, 2 capsules with breakfast and 2 with lunch. patients fill in questionnaires and diary sheets about their reaction to sunlight exposure, and have blood tested 3 times a year. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- erythropoietic protoporphyria rbc protoporphyrin greater than 50 micrograms/100 dl --prior/concurrent therapy-- at least 3 months since prior betacarotene or l-cysteine no concurrent betacarotene --patient characteristics-- * fertile female patients must use effective contraception for duration of trial and for 3 weeks thereafter * not pregnant or nursing

Keywords: erythropoietic protoporphyria inborn errors of metabolism porphyria rare disease
study evaluating safety, tolerability and pharmacokinetics (pk) of tarlatamab in adults with small cell lung cancer (sclc)

Conditions: Small Cell Lung Carcinoma

Summary: a study to assess the safety, tolerability, and pk of tarlatamab in participants with sclc

this is an open-label, ascending, multiple doses, phase 1 study evaluating tarlatamab monotherapy, in combination with anti-pd1 therapy and with additional cytokine release syndrome (crs) mitigation strategies. tarlatamab will be administered as a short term intravenous (iv) infusion in participants with sclc. tarlatamab is a half-life extended (hle) bispecific t cell engager (bite®) targeting delta-like protein 3 (dll3)

Eligibility criteria:
inclusion criteria: * participant has provided informed consent prior to initiation of any study-specific activities/procedures * age greater than or equal to 18 years old at the time of signing the informed consent * histologically or cytologically confirmed sclc. for parts a, c, d, e, f, and g: relapsed/refractory small cell lung cancer (r/r sclc) who progressed or recurred following platinum-based regimen * eastern cooperative oncology group (ecog) performance status of 0-2 * participants with treated brain metastases are eligible provided they meet defined criteria * adequate organ function as defined in protocol exclusion criteria: * history of other malignancy within the past 2 years prior to first dose of tarlatamab with exceptions * major surgery within 28 days of first dose tarlatamab * untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease (regardless of symptomatic or not). * prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of tarlatamab with the following exceptions: participants who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to grade less than or equal to 1; and prior palliative radiotherapy must have been completed at least 7 days before the first dose of tarlatamab * participants who experienced severe, life-threatening or recurrent (grade 2 or higher) immune-mediated aes or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents * has evidence of interstitial lung disease or active, non-infectious pneumonitis * has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab * part c only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years * participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration

Keywords: half-life extended (hle) bispecific t cell engager (bite®) delta-like protein 3 (dll3) tarlatamab oncology immunology
perioperative inhaled therapy in carcinological thoracic surgery in patients at high risk of postoperative pulmonary complications

Conditions: Thoracic Surgery; Postoperative Pulmonary Complications (PPCs)

Summary: the objective of the study is to evaluate, in a clinical trial, the efficacy of peri operative administration of long-acting inhaled ß-2 mimetics on the occurrence of postoperative pulmonary complications


Eligibility criteria:
inclusion criteria: * adult (\>18 years) * lung cancer eligible for surgical management by lung resection (non-small cell lung carcinoma = nsclc) by any route * naïve to long-term inhaled bronchodilator therapy * high risk of post-operative pulmonary complications (pre-operative fev1 \< 80%) exclusion criteria: * patient refusal * pregnancy * emergency surgery * patient with a physiological status of who iv or asa ≥ iv * asthma * patients treated with long-acting bronchodilators * severe heart failure (nyha iv), unstable ischaemic heart disease (angina or recent infarction \< 3 months), obstructive hypertrophic cardiomyopathy, subvalvular aortic stenosis, severe uncontrolled hypertension recent stroke \< 3 months * high-grade unresponsive conductive disorders or unstable arrhythmia * thyrotoxicosis, pheochromocytoma * unbalanced diabetes * hypersensitivity to ß-2 mimetics or lactose * current participation in a trial of another drug therapy

Keywords: thoracic surgery postoperative pulmonary complications inhaled therapy bronchodilators b2 mimetics