Kornimate/medical-research-clean huggingface dataset:
an efficacy and safety study of cofetuzumab pelidotin in participants with ptk7-expressing, recurrent non-small cell lung cancer

Conditions: Cancer; Non-small Cell Lung Cancer (NSCLC)

Summary: this study is being done to determine the efficacy and safety of cofetuzumab pelidotin in the ptk7-expressing, recurrent non-small cell lung cancer (nsclc) population.


Eligibility criteria:
inclusion criteria: * histologically confirmed non-small cell lung cancer (nsclc) with ptk7-expressing tumor using an immunohistochemistry (ihc) assay previously validated at a designated laboratory * recurrent nsclc that has progressed after treatment with at least the following approved therapies with demonstrated clinical benefit: a platinum-based chemotherapy doublet and an immune checkpoint inhibitor for tumors without targetable genetic alterations; a platinum-based chemotherapy doublet and targeted agent(s) for tumors with targeted genetic alterations * received ≤ 2 prior lines of systemic therapy, including no more than 1 line of systemic cytotoxic chemotherapy (≤ 3 prior lines for tumors treated with targeted agent(s) for genetic alterations, including no more than 1 line of systemic chemotherapy) * eastern cooperative oncology group (ecog) performance status of 0 to 1 * measurable disease per response evaluation criteria in solid tumors (recist) version 1.1 * adequate bone marrow, renal, and hepatic function per the protocol exclusion criteria: * known uncontrolled metastases to the central nervous system (cns). participants with cns metastases may be eligible provided that definitive therapy has been given, and participants are asymptomatic and off systemic steroids and anticonvulsants used for management of brain metastases for at least 2 weeks prior to the first dose of study drug * unresolved clinically significant adverse events grade ≥ 2 from prior anticancer therapy (with the exception of alopecia or anemia) * has clinically significant medical condition(s) as described in the protocol * received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 28 days prior to the first dose of study drug (no washout period required for participants on egfr tyrosine kinase inhibitors). palliative radiation therapy for bone, skin or subcutaneous metastases with 10 fractions or less is not subject to a washout period * received anti-cancer herbal therapies within 7 days prior to the first dose of study drug

Keywords: non-small cell lung cancer (ncslc) ptk7-expressing tumor antibody drug conjugate cofetuzumab pelidotin abbv-647 cancer
adverse drug reactions in pediatrics: experience of a regional pharmacovigilance center

Conditions: Child With Adverse Drug Reactions

Summary: aim. - to describe the adverse drug reactions (adr) and the drugs involved in pediatrics. methods. - an observational study on all adr notifications recorded in the french pharmaco-vigilance database by the regional pharmacovigilance center of champagne-ardenne between 1 january 1985 and 31 december 2014 involving children from 0 to 17 years inclusive was performed. for all notifications, we studied the patient and the adr characteristics

pediatry aged under 18 years accounted for around 22% of the french general population. data regarding drug safety from clinical trials are insufficient in this population. aim. - to describe the adverse drug reactions (adr) and the drugs involved in pediatrics. methods. - an observational study on all adr notifications recorded in the french pharmaco-vigilance database by the regional pharmacovigilance center of champagne-ardenne between 1 january 1985 and 31 december 2014 involving children from 0 to 17 years inclusive was performed. for all notifications, we studied the patient and the adr characteristics.

Eligibility criteria:
inclusion criteria: * children from 0 to 17 years inclusive * who presented an adverse drug reaction notified to the regional pharmacovigilance center of champagne-ardenne exclusion criteria: * none

Keywords: pediatry; adverse drug reactions; pharmacovigilance
predicting response to pd-1 checkpoint blockade using deep learning analysis of imaging and clinical data

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: immunotherapy has transformed cancer treatment with the pd-1 class of checkpoint inhibitors - pembrolizumab and nivolumab -- demonstrating durable responses in stage iv metastatic tumors such as non-small cell lung cancer and melanoma. despite these numerous successes, pd-1/pd-l1 checkpoint blockade therapies do have a number of shortcomings. many approaches to predict response to pd-1/pd-l1 checkpoint therapy have been investigated with limited success. recent efforts exploring the utility of quantitative imaging biomarkers to predict response to pd-\[l\]1 immunotherapy have shown promise. the purpose of this retrospective multicenter study is to develop a multi-omic classifier to predict response to pd-1/pd-l1 checkpoint blockade for mutation negative (egfr, alk and ros1) nsclc

recent phase iii studies have demonstrated the effectiveness of atezolizumab (pd-l1) in metastatic triple-negative breast cancer \[3\] and small cell lung cancer, while the standard of care for stage iii non-small cell lung cancer has changed with positive results of the pacific phase iii study, where durvalumab (pd-l1) administered after chemoradiation showed a significant increase in overall survival. low response rates, generally in the 15% to 20% range in most diseases when used as a single agent, high therapy cost globally ($150,000 or more per year in the u.s) and serious immune-mediated adverse events, particularly when pd-1/pd-l1 inhibitors are combined with the ctla-4 inhibitors (ipilimumab). unpredictable and low patient response rates coupled with high drugs costs and serious toxicities can significantly burden healthcare systems, third-party payers and patients. clearly, diagnostic tools to stratify patients according to response likelihood are necessary as pd-\[l\]1 checkpoint inhibitors continue to gain adoption. the standard-of-care biomarker is an immunohistochemistry (ihc) test that measures levels of the pd-l1 protein expressed in tumor samples. tumor mutational burden, presence of tumor-infiltrating lymphocytes and inflammatory cytokines are being explored in multiple clinical trials involving pd-(l)1 often in combination with additional immuno-oncology (io) therapies in such an approach, a non-invasive imaging scan can provide insight and information on the patient's entire tumor burden rather than a sample of a subset of lesions (as provided by biopsy or serum-based assays). when diagnostic images that depict all treatable lesions are further analyzed with computational techniques such as machine-learning and artificial intelligence, resulting in the identification of relevant imaging biomarkers, an accurate overall assessment of patient response to pd-\[l\]1 therapy may be attainable.

Eligibility criteria:
inclusion criteria:patients between 18 and 100 years of age - exclusion criteria: patient under 18 years of age -
a self-management energy conservation program for cancer-related fatigue

Conditions: Cancer-related Problem/Condition; Cancer, Breast; Fatigue

Summary: the purpose of this pilot study is to examine a 12-week self-management energy conservation program (ecam)'s effects on fatigue, and secondarily on sleep, physical activity, anxiety and depression, self-efficacy, and beliefs about fatigue in a group of thai women with breast cancer who are undergoing chemotherapy. we will also evaluate how well women like the intervention, how easy it is to use and whether women will do the activities.

cancer-related fatigue is a distressing and multidimensional symptom. research in the us has explored the efficacy of energy conservation interventions for fatigue and related symptoms but no previous ecam programs have been tested in thailand.

Eligibility criteria:
inclusion criteria: * thai women are age 18 or older; are diagnosed with stage i-iii breast cancer; are scheduled to receive at least four cycles of chemotherapy given in 21-day-intervals; report at least 4 out of 10 or higher on a fatigue scale in the past month; are able to read and write in thai and can be contacted by telephone. exclusion criteria: * thai women have a history of severe psychiatric illness, or have other illnesses that could be responsible for the fatigue other than cancer such as iron deficiency anemia, multiple sclerosis, congestive heart failure, chronic fatigue syndrome or fibromyalgia. with regard to anemia, women must have a certain hemoglobin in the normal range at baseline. they also cannot have acute or chronic bone, joint, or muscular abnormalities that would increase the risk of falls and injury. women scheduled to receive concurrent radiation therapy are not eligible.

Keywords: energy conservation self management
comparison of bone quality in type 2 diabetic patients with a non-diabetic control population

Conditions: Type 2 Diabetes

Summary: patients with type 2 diabetes have many complications in different organs. these complications are extremely frequent and severe: cardiovascular and renal disease, visual impairment, and, more recently, complications affecting bone such as fractures. conventional methods for the evaluation of fracture risk are based on the bone mineral density (bmd) or frax (algorithm for the prediction of osteoporotic fracture risk) are not sufficient in the context of diabetes. several metaanalyses have shown that, paradoxically, a higher bmd in patients with type 2 diabetes compared to patients not suffering from this disease, independently of body mass index (bmi). the paradoxal increase in fracture risk, despite a high bmd has led to the hypothesis that diabetes induces a modification of the quality and not the quantity of bone. however, there is a lack of data as to bone quality in patients with type 2 diabetes as studies of bone biopsies from patients with type 2 diabetes are extremely rare. the objective of the study is to compare bone quality in patients with type 2 diabetes to that in patients who do not suffer from type 2 diabetes: evaluation of vertebral fractures by osteodensitometry, measurement of trabecular bone score (tbs), and analysis of bone quality in biopsies (advanced glycation end products (age), contents of bone matrix and analysis of mineralization). the results will then be correlated with blood/urinary markers with the objective to determine one/several non-invasive biomarkers for bone status in diabetic patients.


Eligibility criteria:
inclusion criteria: * men and women aged greater than 40 years * patients requiring surgery of the lower limb * with a bone mineral density considered normal (t-score ≥ -2) * stage 1, 2, or 3 glomerular filtration rate (\> 30 ml/min) * for diabetic patients the diagnosis will have previously established by an endocrinologist exclusion criteria: * subjects treated with drugs known to interfere with bone metabolism, including steroids, anticonvulsants, diuretics, and bisphosphonates * patients with severe renal disease (\< 30 ml/mn); previous history of caner except skin cancer; myocardial infarction; uncontrolled hypertension; untreated hyperthyroidism; hyperthyroidism; malabsorption; bone metabolism diseases; rheumatoid arthritis or collagen diseases * pregnant or lactating woman * contraindication to taking tetracycline hydrochloride: * known hypersensitivity to antibiotics of the tetracycline family or any of the excipients in the medicine * severe chronic renal failure * chronic liver failure * systemic lupus erythematosus * concomitant prescription of retinoid or vitamin a (risk intracranial hypertension) * psychiatric pathology seriously hampering understanding * difficulty understanding oral french * not a beneficiary of a social security scheme

Keywords: type 2 diabetes bone quality bone biopsies vertebral fractures osteodensitometry trabecular bone score
postmarketing safety surveillance european registry of crohn's disease patients treated with remicade or standard therapy (mk-2155-035)

Conditions: Crohn's Disease

Summary: prospective, observational, parallel-group, postmarketing safety surveillance registry in participants treated with remicade or standard therapy for active or fistulizing crohn's disease (cd). the follow-up period is up to 5 years. the participants in the standard therapy group may switch over to remicade any time during the follow-up period


Eligibility criteria:
inclusion criteria: * at least 18 years of age, of either sex, and of any race. * must have active or fistulizing cd and must have experienced at least 1 of the following: * failed a tapering regimen of corticosteroids and will be initiating immunosuppressive therapy * required corticosteroid treatments for the previous 6 months and will be initiating immunosuppressive therapy * luminal or fistulizing cd, which, in the treating physician's judgment, qualifies for initiation of remicade. * willing to give written informed consent and must be able to adhere to the procedural requirements of the registry. * must be evaluated for active and inactive (latent) tuberculosis (tb) at the baseline visit. tb evaluation will consist of tb history questions (eg, medical history, possible previous contact with tb, tb vaccination history). tb evaluation and tb screening (eg, skin test, chest x-ray) are required when a subject starts treatment with remicade. in these cases, subjects must be screened for tb within 3 months prior to initiating remicade treatment. exclusion criteria: * female who is pregnant or nursing. * treated with remicade prior to baseline. * previously treated with other tumor necrosis factor (tnf)-active agents and other investigational drugs for cd prior to baseline. * active or untreated latent tb or other severe infections such as sepsis, abscesses, or opportunistic infections. * moderate or severe heart failure (new york heart association \[nyha\] class iii: subjects with marked limitation of activity; they are comfortable only at rest/class iv: subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest). * have lymphoproliferative disorders (eg, lymphoma) or malignancies. * in a situation or have any condition that, in the opinion of the treating physician, may interfere with their optimal participation in the registry. * are participating in any other clinical trials (excluding registries). in addition, subjects will be excluded from treatment with remicade if any of the criteria listed below are met: * females of childbearing potential unwilling to use a medically accepted method of birth control during treatment with remicade and to continue its use for at least 6 months after the last remicade treatment. * history of hypersensitivity to murine proteins or to any excipients of remicade formulation (sucrose, polysorbate 80, monobasic sodium phosphate, and dibasic sodium phosphate). * other conditions that are contraindicated in the remicade summary of product characteristics (spc).
physical stabilization in post-vats

Conditions: Lung Cancer; Pain, Postoperative

Summary: background: post-video-assisted thoracic surgery (vats) pain remains an open issue, though most patients experience less acute pain after vats than thoracotomy. so far, there was no gold standard regarding pain control post-vats. objective: to conduct a randomized controlled trial assessing the effect of physical thoracic stabilization on post-vats pain control. method: the investigators aimed to recruit 40 patients with operable lung cancer in the outpatient clinic from january to december 2021. the patients will be randomized into the intervention or control group. the intervention group will receive physical thoracic stabilization with posthorax thoraxbelt after the surgery, whereas the control group will have standard care. the follow-up period will last for 6 months.

the study has been approved by the hospital research ethics committee. arm 1: physical thoracic stabilization with thoraxbelt after vats arm 2: standard care after vats primary outcome: visual analog scale (vas) 6 hours, 24 hours, and 48 hours after the surgery. secondary outcomes: 1. the accumulated dose of the intervenous patient-controlled analgesic drug. 2. the dose of oral painkiller administered during the hospital stay. 3. complications related to the thoraxbelt. 4. hospital stay 5. vas before discharge 6. unanticipated events (icu admission, a second surgery, death) 7. vas during the 2-week, 1-month, 2-month, 6-month outpatient clinic visit after the surgery. 8. compliance on thoraxbelt.

Eligibility criteria:
inclusion criteria: * operable lung cancer * eligible for video-assisted thoracoscopic surgery exclusion criteria: * known allergy to thoraxbelt * chest wall infection or other diseases * pregnancy

Keywords: video-assisted thoracoscopic surgery vats post-operation pain control patient-controlled analgesia visual analogue scale posthorax thoraxbelt
the effect of brown adipose tissue activation on insulin sensitivity in humans

Conditions: Insulin Sensitivity; Obesity

Summary: recent findings document the presence of active brown adipose tissue (bat) in humans. cold exposure via adrenergic stimulation activates bat, which combusts significant amounts of blood glucose and free fatty acid (ffa) to produce heat. animal studies suggest that bat activation improves insulin sensitivity. however, the effect of cold-induced bat activation on insulin sensitivity and glucose kinetics in humans remains unknown. the investigators' central hypothesis is that cold-induced bat activation increases whole body insulin sensitivity in humans via augmented plasma glucose and ffa clearance. the specific aims of this study are to define the effects of prolonged (8h) cold exposure bat activation on: insulin sensitivity (aim 1); lipolysis and plasma glucose and ffa kinetics (aim 2); on thermoregulation (aim 3). moreover, the investigators plan to investigate for alternative ways, which can activate bat including cold water ingestion, a single meal ingestion, and a single bout of moderate intensity exercise (aim 4). for the cold exposure study, subjects will complete 3 trials: a) 8hrs of cold exposure at their individually determined shivering threshold; b) 8hrs of cold exposure at their individually determined shivering threshold plus propranolol; c) 8hrs in thermoneutral conditions (26 - 28°c). for the rest of the arms of subjects will complete two trials: cold or tepid water ingestion, a single meal ingestion or no food ingestion, and a single bout of moderate intensity exercise or no exercise.to study the above aims, the investigators will use positron emission tomography - computed tomography, hyperinsulinemic euglycemic clamp, infusion of stable isotopes, and tissue biopsies. the findings will illuminate the role of bat on plasma substrate regulation and insulin sensitivity and may aid in the development of lifestyle recommendations and pharmacotherapy for the prevention and treatment of diabetes and insulin resistance.


Eligibility criteria:
inclusion criteria: * men or women * 18-75 years old * bmi 20-40 kg/m2 exclusion criteria: * taking diabetes medications * liver/renal/endocrine/heart disease * obstructive disease of the gastrointestinal tract * impaired gag reflex or swallowing disorder * history of gi surgery or fenilization of esophagus * gi hypomotility disorder * cancer * thyroid or hormone replacement treatment * beta-blockers * anabolic or corticosteroids the last 6 mo * pregnant/lactating women * individuals that are likely to need pet/ct in the near future for medical reasons * bleeding disorders/ anemia * positive hepatitis or hiv screening * weight less than 36 kg * pacemaker or other implanted electromedical device * alcohol and drug abuse * tobacco use * impaired cognition * asthma * chronic obstructive pulmonary disease (copd) or other reactive airway diseases

Keywords: insulin sensitivity diabetes prevention obesity brown adipose tissue
vascular risk factors in inph-patients

Conditions: Hydrocephalus, Normal Pressure; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Summary: idiopathic normal pressure hydrocephalus (inph) is a treatable and a common disease of the elderly. the overall objective of this work is to describe cardio- and cerebrovascular risk factors and vascular disease in shunted inph-patients compared to an age- and sex matched elderly population, as well as the impact of vascular risk factors and vascular co-morbidity on clinical symptoms and outcome of surgery in inph-patients. the hypothesis is that inph-patients have a higher level of vascular risk factors and subclinical organ damage than a normal elderly population, and that the higher the level of existing vascular risk factors, the more severe the symptoms of the hydrocephalic disease.


Eligibility criteria:
inclusion criteria: * inph-patients who underwent surgery 2008-2010 and registered in the swedish national register of hydrocephalus * age \ 85 * (only for controls) living in umeå exclusion criteria: * death * a known mini mental state estimation \<23 * inability to communicate (because of severe stroke, aphasia, dementia) * (only for controls) individuals with inph who has not yet underwent surgery, or has not been chosen to undergo surgery.

Keywords: normal pressure hydrocephalus vascular risk factors
emotion regulation in binge eating and purging among adolescents

Conditions: Binge Eating; Purging (Eating Disorders)

Summary: the study will examine the neural and behavioral correlates of emotion regulation in adolescents engaging in binge eating and/or purging and healthy adolescents. furthermore, it will look at the influence of executive function on emotion regulation in this population. this study will allow us to gain further understanding of the neural basis of emotion regulation in this age group. moreover, this study supports the need to develop new treatment approaches based on a better understanding of the brain processes associated with eating disorders.


Eligibility criteria:
inclusion criteria: * female * ages 14-18 * with or without current binge eating and/or purging behaviors exclusion criteria: we exclude patients of clinically significant low weight (\<85% ideal body weight using cdc norms for height, age, and gender) and those with contraindications for mri (e.g., orthodontia, metallic implants). participants also will be without evidence of current or past major neurological (e.g., seizures, psychosis, head trauma) or major sensory deficit.