Kornimate/medical-research-clean huggingface dataset:
a study of atezolizumab (anti-pd-l1 antibody) as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck

Conditions: Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Summary: this study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (scchn)


Eligibility criteria:
inclusion criteria * histologically or cytologically confirmed squamous cell carcinoma of the head and neck (scchn) * human papilloma virus (hpv) status * completed definitive local therapy * absence of metastatic disease as documented by radiographic scans * adequate hematologic and end-organ function * for patients receiving therapeutic anticoagulation: stable anticoagulant regimen * for women of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 5 months after the last dose of study treatment. women must refrain from donating eggs during this same period. * confirmed response of complete response (cr), partial response (pr), or stable disease (sd) to definitive local therapy documented by ct with contrast or mri with contract to head and neck region done \>= 8 weeks after completion of definitive local therapy and within 28 days prior to initiation of study drug. exclusion criteria: * patients who have received surgery alone or radiotherapy alone as definitive local therapy * squamous cell carcinoma of the nasopharynx or paranasal sinuses or non-squamous histology * evidence of disease progression or metastatic disease during or following definitive local therapy documented in post-definitive local therapy screening scans * uncontrolled or symptomatic hypercalcemia * active or history of autoimmune disease or immune deficiency * active tuberculosis * significant cardiovascular disease * history of malignancy, including prior scchn primary tumors within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * prior allogeneic stem cell or solid organ transplantation * current treatment with anti-viral therapy for hepatitis b virus (hbv) * treatment with systemic immunostimulatory agents * treatment with systemic immunosuppressive medication * history of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins * pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the last dose of study treatment * patients who have received a non-fda or non-ema approved anti-egfr agent or any other non-fda or non-ema, approved agent as part of definitive local therapy, unless the unapproved agent was given in addition to an approved agent * any systemic therapies after permitted definitive local therapies
virtual anatomical reconstruction of mandibular bone defects using a statistical shape model

Conditions: Mandibular Diseases; SSM

Summary: hundred already taken ct-scans (50 male and 50 female) will be anonymized. these scans will be segmented and implemented into a statistical shape model that will be used to predict missing hard tissue of a mandible based on the remaining bone.

together with the radiology and craniomaxillofacial (cmf) department, 100 scans will be selected from the database (50 males and 50 females, between 20 and 60 years old). first, they will be anonymized (except the sex and age/date of birth). afterwards, they will be segmented using materialise mimics software. the segmented mandibles will then be used to create a statistical shape model (ssm) using principal component analysis. this model will afterwards be used to predict the mandibular shapes.

Eligibility criteria:
inclusion criteria: * healthy mandibles exclusion criteria: * mandibles with major deformities * mandibles with obvious problems * mandibles that already underwent surgery
microvascular dysfunction in adults with congenital heart disease and the effect of exercise training

Conditions: Congenital Heart Defect; Congenital Heart Disease; Microvascular Dysfunction; Exercise Training; Oxidative Stress; Coronary Microvascular Dysfunction; Peripheral Microvascular Dysfunction

Summary: the goal of this prospective cohort study is to deepen the understanding of the pathophysiology in adults with congenital heart disease (chd). through this research, the investigators aim to identify potential strategies to improve the prevention and treatment of these patients. in this context, the effects of exercise training will also be assessed. the main questions it aims to answer are: * is coronary microvascular dysfunction (mvd) present in adults with diverse types of chd? * is peripheral mvd present in adults with diverse types of chd? * are coronary and peripheral mvd correlated in adults with diverse types of chd? * is microvascular function correlated with inflammation and oxidative stress in adults with diverse types of chd? * are inflammation and oxidative stress correlated with ventricular function in adults with diverse types of chd? * are mvd and diminished ventricular function interrelated and associated with reduced exercise capacity in adults with diverse types of chd? * does exercise training in adults with chd result in improvements in coronary and peripheral microvascular function, inflammation and oxidative stress, biventricular function, muscle strength, exercise capacity and quality of life? for the last research question, patients were randomized to receive either conventional care or home-based aerobic and strength exercise training.


Eligibility criteria:
inclusion criteria: * adults with congenital heart disease: as many different types of chd as possible were incorporated * new york heart association (nyha) class i-ii * who visited the out-patient clinic at the antwerp university hospital exclusion criteria: * smoking * body mass index \>35 kg/m² * professional endurance athlete * the presence of macrovascular coronary artery disease * diabetes mellitus * a systemic disease (e.g., malignancies, acute and chronic inflammatory diseases in the preceding 3 months) * a contraindication for adenosine administration.
celiac disease in childhood-adulthood transition

Conditions: Celiac Disease; Celiac Disease in Children; Transition of Care; Follow-up; Diet, Gluten-Free

Summary: aims of this study are to evaluate adolescents with celiac disease during their transition from pediatrics to adult care, and to develop better healthcare follow-up practices.

celiac disease is one of the most common chronic gastrointestinal diseases affecting 1-3% of population worldwide. it is treated with life-long and strict gluten-free diet. when dietary treatment is successful, prognosis of pediatric patients seems to be excellent whereas ongoing predisposition to gluten may increase the risk even to permanent complications. however, gluten-free diet may cause burden and restrictions in everyday life impairing quality of life. regular follow-up is recommended to support the treatment and to detect early possible comorbidities and complications, but, in practice, patients are often lost to follow-up. studies about the significance of follow-up and its optimal implementation are scarce. pediatric patients form a special group here as they may not even remember the reason for the diagnosis if it was set in early childhood, and the education about the disease and its treatment are often given primarily to the caregivers. responsibility of the treatment shifts to patients themselves in adolescence at the same time with other significant changes in life and they have more often challenges with gluten-free diet than other patients. despite this, studies about the transition from pediatrics to adult-care are very few. this study evaluates 13-19 years old patients diagnosed with celiac disease in childhood (\<16 years of age) and compares them to adolescents without celiac disease in selected variables. study focuses on healthcare follow-up practices and pilot a celicat transition form in a randomized, controlled study design. the main hypothesis is that structured follow-up and transition of pediatric patients to adult care predicts better health, quality of life and adherence to the dietary treatment later in life. data is collected with physical examination, questionnaires and with blood and urine samples. follow-up is arranged at one and three years from the first visit.

Eligibility criteria:
inclusion criteria: * verified celiac disease diagnosis in childhood (\<16 years of age) * age 13-19 years at recruitment * finnish-speaking exclusion criteria: * disease or condition preventing the completing of the study questionnaire inclusion criteria for controls * no celiac disease diagnosis * age 13-19 years at recruitment * finnish-speaking

Keywords: celiac disease adolescents transition follow-up gluten-free diet quality of life health symptoms
a study to evaluate leuprolide acetate 45 mg 6-month formulation in children with central precocious puberty (cpp)

Conditions: Central Precocious Puberty (CPP)

Summary: the primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (la) 45 mg 6-month depot formulation for the treatment of cpp in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (gnrha) or who have been previously treated with a gnrha.


Eligibility criteria:
inclusion criteria: * children with cpp who are naïve to treatment with a gonadotropin-releasing hormone agonist (gnrha) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard gnrha therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of age). * no history of clinically significant medical conditions or any other reason that the investigator determines would make the participant an unsuitable candidate to receive study drug.

Keywords: central precocious puberty (cpp) leuprolide acetate (la)
effectiveness of personalized alternating current stimulation for treating emotional disorders in cns demyelination patients

Conditions: Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System

Summary: this study is designed to evaluate the efficacy of personalized alternating current stimulation in the treatment of emotional disorders in patients with inflammatory demyelination of the central nervous system.


Eligibility criteria:
inclusion criteria: * patients diagnosed with inflammatory demyelinating diseases of the central nervous system, such as neuromyelitis optica spectrum disorders (nmosd) and multiple sclerosis (ms) * hamilton anxiety scale (ham-a) score \> 14 * aged between 18 and 65 years, with no gender restrictions * receiving stable doses of immunosuppressive therapy for at least one month * expanded disability status scale (edss) score ≤ 6 * right-handed * willing to participate and sign informed consent exclusion criteria: * recorded relapse within the past month * recent medication adjustments or treatments involving modified electroconvulsive therapy, transcranial magnetic stimulation, or other neuromodulation techniques within the past month * participation in any other clinical study within the past month or currently * presence of cochlear implants, cardiac pacemakers, or implanted stimulators in the brain * impaired skin integrity at the electrode placement site or allergies to electrode gel or adhesives * history of epilepsy, hydrocephalus, central nervous system tumors, brain injury, or intracranial infections * pregnant or breastfeeding women, or those planning to conceive in the near future * hamilton depression scale suicide item score ≥ 3 or comorbid severe mental disorders * presence of severe or unstable organic diseases * poor compliance preventing cooperation with treatment, follow-up, or clinical, eeg, and imaging data collection * any condition deemed unsuitable for study participation by the investigator
ngs-based large-panel in targeted drug delivery and immunotherapy of lung cancer

Conditions: Lung Neoplasms

Summary: companion diagnosis by large-panel is in increasing acceptance and need during clinical cancer management. the purpose of this trial is to investigate the benefit of large-panel ngs analysis in companion diagnosis of advanced lung cancer patients and further optimize the parameters.

fresh tumor tissues and matched blood cells will be analyzed by large-panel (berryoncology, lnc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, tumor mutational burden (tmb), microsatellite instability (msi) status, etc., therapeutic approach and outcome will be followed-up to inspect the clinical benefit by large-panel analysis. in addition, selected samples will be analyzed by wes to assess the correctness of tmb estimated by large-panel.

Eligibility criteria:
inclusion criteria: * participant aged 18 or above, and gender unrestricted * individual with pathologically diagnosed lung cancer exclusion criteria: * patients with concomitant other tumors * individual with severe cardiopulmonary insufficiency and hypoproteinemia * women who were pregnant and were during their lactation
prognostic indicators in pituitary adenoma surgery: a comprehensive analysis of surgical outcomes and complications.

Conditions: Pituitary Adenoma; Surgery-Complications

Summary: predicting the outcome of pituitary surgery, particularly the risk of complications, is a critical determinant in selecting the appropriate treatment modality for patients. to date, only a limited number of risk factors have been identified for complications following pituitary surgery, including tumor size, younger age, and previous surgical intervention. furthermore, existing studies have demonstrated that prolactin levels can serve as a surrogate marker for assessing pituitary function, specifically revealing associations between elevated prolactin levels and anterior pituitary insufficiencies. in a retrospective study on the "hyp'op" cohort, the aim of the study is to identify predictive factors for both surgical outcomes and complications.


Eligibility criteria:
inclusion criteria: * transsphenoidal pituitary surgery at nancy university hospital (france) between 2012 and 2022 for a pituitary adenoma. exclusion criteria: * no 4 month evaluation.

Keywords: transsphenoidal surgery pituitary adenoma post-operative complications
pregnancy surveillance program of patients exposed to epidiolex/epidyolex during pregnancy

Conditions: Maternal Complications; Pregnancy Complication; Birth Outcomes, Adverse; Pregnancy

Summary: the purpose of this study is to evaluate pregnancy-related health outcomes in participants who are exposed to epidiolex/epidyolex during pregnancy and their infant up to 12 months of life.


Eligibility criteria:
inclusion criteria: 1. patients with exposure to at least 1 dose of epidiolex/epidyolex during the 13 days prior to their lmp or at any time during pregnancy. 2. verbal or written informed consent to participate exclusion criteria: 1) patients exposed to a non-regulatory approved product containing cannabidiol (cbd) during pregnancy who do not also have exposure to epidiolex during the 13 days prior to their lmp or during the pregnancy.

Keywords: epidiolex epidyolex
biib057 in subjects with rheumatoid arthritis and inadequate response to disease-modifying antirheumatic drugs

Conditions: Rheumatoid Arthritis

Summary: phase ii study designed to evaluate the safety and efficacy of biib057 in subjects with rheumatoid arthritis who have experienced an inadequate response to disease-modifying antirheumatic drugs (dmards).


Eligibility criteria:
inclusion criteria: * adult onset ra satisfying 2010 revised acr criteria for the classification of ra with a disease history of at least 6 months * active ra as defined by: at least 4 swollen joints (based on 28-joint count), at least 4 tender joints (based on 28-joint count), and high-sensitivity crp (hscrp) 10mg/l or greater * no prior treatment with biologics * receiving a dmard therapy for at least 3 months, using a regimen that has been stable for at least 28 days prior to screening exclusion criteria: * history of inflammatory joint disease other than ra * abnormal chest x-ray consistent with tuberculosis, malignancy, or infection * history of malignancy, carcinoma in situ, or high-grade dysplasia * history of opportunistic infection, infection requiring treatment, serious local infection, recent fever, active herpes zoster or epstein-barr virus, or diagnosis or family history of creutzfeldt-jakob disease. * clinically significant cardiac disease * treatment with prednisone \>10 mg orally daily * intra-articular steroid injection within 28 days before screening * clinically significant abnormality in hematology or blood chemistry values at screening

Keywords: rheumatoid arthritis dmard-ir
correlation of radiological lesions with vestibular function in patients with bilateral vestibulopathy

Conditions: Hearing Loss, Sensorineural; Bilateral Vestibular Deficiency; DFNA9; Radiology

Summary: in 2014 radiologic lesions were detected at one or more semicircular canals using ct and mr imaging of temporal bone in subjects carrying the p.p51s mutation in coch. these lesions are believed to present at more advanced stages of the hearing and vestibular deterioration. since then, other authors have described similar lesions in advanced non-genetic hearing and vestibular impairment as well. the purpose of this study is therefore to assess the radiologic investigation using ct and mr imaging of temporal bone to all subjects presenting with bilateral vestibulopathy, using the barany criteria, compared to the p.p51s population.


Eligibility criteria:
inclusion criteria: * must meet the barany criteria for bilateral vestibulopathy: bilaterally pathological horizontal angu- lar vor gain \<0.6, measured by the video-hit5 or scleral-coil technique and/or * reduced caloric response6 (sum of bither- mal max. peak spv on each side \<6◦/sec7) and/or * reduced horizontal angular vor gain \ 68 degrees (time constant \<5 sec). * must be 18 or older exclusion criteria: * \< 18 y * does not meet barany criteria for bv * contraindication for ct and mr imaging
treatment of adults with growth hormone deficiency

Conditions: Pituitary Disorders; Adult Growth Hormone Deficiency

Summary: the objective of this rollover study is to evaluate the long term (1 year) safety of a new weekly administered growth hormone preparation in adults with growth hormone deficiency who were treated with the same experimental preparation in study bplg-005. in addition, further change in efficacy endpoints of bplg-005 by prolonged treatment will be evaluated. additional efficacy and safety data of the experimental preparation will be obtained from the switch-over patients.


Eligibility criteria:
inclusion criteria: * patients (male and female) who have completed the visit 8 of preceding main study (bplg-005) and are willing to continue their participation in an extension study * if female, women of child-bearing potential who are using a reliable method of contraception and be willing to use it throughout the study. a negative urine pregnancy test at visit 0 is required for females of child-bearing potential * written informed consent of the patient exclusion criteria: * evidence of active malignancy or growth of a previously stable tumor * benign intracranial hypertension * clinically significant respiratory, cardiac, hepatic, renal, neuromuscular disease * non-compliance with medications, un-cooperativeness or drug abuse during the bplg-005 study * patients who are not able to comply with the study protocol for any reason

Keywords: growth hormone deficiency
using technology to investigate lapses in a weight loss program among individuals with overweight and obesity

Conditions: Obesity; Weight Loss

Summary: approximately 70% of american adults have overweight/obesity, which increases risk of major medical issues and preventable death (abdelaal et. al, 2017). many individuals with overweight/obesity attempt to lose weight through behavioral strategies, e.g., adopting a reduced-calorie diet and/or increased physical activity. however, it is exceedingly difficult to consistently adhere to a reduced-calorie diet and high levels of physical activity; as such, most individuals attempting to lose weight via these methods experience repeated instances of non-adherence, i.e., dietary and physical activity lapses. these lapses are a core driver of weight loss failure, undermining individuals' ability to achieve weight control (forman et al, 2017). as such, it is important to understand what predicts these lapses, which in turn allows for better lapse prevention. the current study proposes to measure these risk factors in an ecologically valid manner, i.e., in the moment they occur and in the context of individuals' everyday lives, using advanced technology. specifically, the current study will use ecological momentary assessments (ema; brief, repeated surveys delivered in one's natural environment, typically via a smartphone) and sensor technology (e.g., fitbit and sensors on smartphone devices) to measure momentary risk factors of dietary and physical activity lapse, as well as the lapses themselves. findings from this research project will lay the groundwork for a sophisticated just-in-time adaptive intervention (jitai), a tailored, personalized intervention that targets momentary risk factors (e.g., cravings) via in-the-moment support, thereby reducing lapse occurrence and improving adherence to behavioral weight control prescriptions.


Eligibility criteria:
inclusion criteria: * current bmi = 27-50 kg/m2 * adult (aged 18-65) * lives in the united states * possession of a smartphone with a data plan that allows for app data collection * ability to understand and provide informed consent * proficiency in speaking, reading, and writing english exclusion criteria: * presently involved in another weight loss program * currently pregnant or plan to become pregnant within the study period * have a medical condition or psychiatric symptoms that: may pose a risk to the participant during the program; cause a change in weight, appetite, or eating behavior; or limit ability to comply with the program * endorse eating disordered behavior, including loss of control (loc) eating, or the subjective experience that one cannot control how much food he or she consumes * have experienced a recent (i.e., within the last 3 months) change in a weight-influencing medication

Keywords: obesity weight loss behavioral treatment dietary lapse physical activity lapse