Kornimate/medical-research-clean huggingface dataset:
europe-japan diagnostic study for egfr testing

Conditions: EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.

Summary: this is a non-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. this study will be conducted in japan and europe and will assess the concordance of egfr mutation status derived from tumour samples and blood based circulating free dna. the data generated will inform the use of less-invasive sample types in diagnostic practice. the study also aims to assess the current status of egfr mutation testing across japan and europe and gaps in currently available data including egfr mutation frequency in particular populations and demographic subgroups, egfr mutation frequency in histological subtypes of nsclc, egfr mutation test process and methodology, utility of multiple sample types in the assessment of egfr mutation status, and impact of egfr mutation status on therapy choice. the data may be used to drive improvements to the egfr mutation testing process, ensuring that patients have access to testing and are treated appropriately on the basis of the molecular features of their disease.

a diagnostic study of european and japanese advanced nsclc patients to evaluate suitable sample types for egfr testing,

Eligibility criteria:
inclusion criteria: * patients aged 18 years and older in europe and aged 20 years and older in japan * 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 naïve (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 * provision of a routine blood sample exclusion criteria: * evidence of severe or uncontrolled systemic 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, europe, japan
evaluation of evening versus morning levothyroxine intake in elderly

Conditions: Aging; Primary Hypothyroidism; Interaction Drug Food

Summary: a study designed to compare evening versus morning levothyroxine intake in the elderly.

this is a randomized crossover trial of two dosing strategies for pharmacological treatment of hypothyroidism in a sample of individuals aged 60 years or older, performed at an outpatient healthcare in a tertiary center.

Eligibility criteria:
inclusion criteria: * individuals aged 60 years or older who consult at the geriatrics, endocrinology and internal medicine clinic at hospital clinicas de porto alegre * patients diagnosed with primary hypothyroidism * patients on levothyroxine for at least 6 months * patients with the same dose of levothyroxine for at least 3 months exclusion criteria: * severe dementia * severe congestive heart failure (nyha iv or / and three or more hospitalizations for heart failure within 1-year interval) * diagnosis of advanced stage neoplasia * diagnosis of thyroid cancer

Keywords: polypharmacy elderly
phase ii randomized study of alendronate sodium for osteopenia in patients with gaucher's disease

Conditions: Gaucher's Disease; Osteopenia

Summary: objectives: i. determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with gaucher's disease.

protocol outline: this is a randomized, double blind, placebo controlled study. all patients receive oral calcium carbonate and cholecalciferol daily. patients are randomized to receive oral alendronate sodium or placebo daily for 24 months. patients are followed every 6 months for 2 years. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of type 1 gaucher's disease enzymatically proven to have acid beta glucosidase deficiency must have been on stable dose (8-60 u/kg/every 2 weeks) of alglucerase enzyme therapy (cerezyme or ceredase) for at least 24 months lumbar spine bone density below the mean for age, sex, and race --prior/concurrent therapy-- at least 6 months since prior medications that directly affect skeletal metabolism including, but not limited to, bisphosphonates, calcitonin, parathyroid hormone, or estrogen --patient characteristics-- renal: no chronic renal failure; no recurrent renal stones esophageal: no history of dysphagia; no frequent heartburn; no esophagitis requiring treatment other: no untreated hyperthyroidism or hypothyroidism; no concurrent hyperparathyroidism; no concurrent malignancy; no history of alcohol or drug abuse; not pregnant; negative pregnancy test; fertile patients must use effective contraception

Keywords: gaucher's disease inborn errors of metabolism rare disease sphingolipidoses
systemic sclerosis and innate t cells

Conditions: Systemic Sclerosis

Summary: innate t cells (itc) are decreased in systemic sclerosis (ss) and an early lymphocyte innateness has been reported. in the other part, itc are implicated on inflammatory process, including the il-33/st2 axis, which is also involved in scs endotheliopathy. data are however scarce and physiopathological mechanisms have not been assessed to date. the investigators hypothesize a global lymphocyte innateness in ssc, linked to a chronic itc stimulation by innate signals leading to itc exhaustion, and their potential role in endotheliopathy and fibroblast activation in ssc.


Eligibility criteria:
inclusion criteria: * ssc according to the 2013 acr/eular 2013 criteria (or the 2001 leroy's criteria for early ssc) * patients with others connective tissue disease: * systemic erythematosus lupus (sle) according to the 2019 acr/eular criteria * primary sjögren syndrome (pss) according to the 2016 acr/eular criteria * rheumatoid arthritis according to the 2010 acr/eular criteria * idiopathic inflammatory myopathy (iim) according to the 2017 acr/eular criteria * healthy subjects from general population without known autoimmune disease or connective tissue disease * ≥18 years-old exclusion criteria: * overlap syndrome (including secondary sjögren syndrome) * weight \<55 kgs * known primary cell immunodeficiency * past of autologous or allogenic hematopoietic stem cell transplantation * solid neoplasia or malignant hemopathy in remission for less than 12 months an * chemotherapy and/or immune checkpoint inhibitors in the last 12 months * systemic retinoids * active infection and/or antibiotics in the last 2 weeks * known active chronic infection among hiv, htlv, viral hepatitis, syphilis * vaccination in the last 4 weeks * subject refusing genetic analysis for the present study * pregnancy or breastfeeding
post-extubation nasal humidified high-flow oxygen versus non-invasive positive pressure ventilation

Conditions: Respiratory Failure With Hypercapnia

Summary: acute hypercapnic respiratory failure (ahrf), which is commonly defined as arterial partial pressure of carbon dioxide (paco2) ≥ 45 mmhg and frequently accompanied by reduced levels of arterial partial pressure of oxygen (pao2), can occur in a variety of etiologies, mainly in chronic respiratory diseases, such as exacerbation of chronic obstructive pulmonary disease, cystic fibrosis, thoracic deformities, as well as other conditions, such as neuromuscular disease the purpose of this research is to to compare efficacy of administration of high flow nasal canula versus non-invasive mechanical ventilation on preventing reintubation during 72 hours postextubation of patients with type 2 respiratory failure with difficult weaning.


Eligibility criteria:
inclusion criteria: * the study will be recruited on type ii respiratory failure patients with difficult weaning from invasive mechanical. patients who will fulfil the eligibility criteria will be randomly divided into hfnc or niv groups to receive sequential treatment after extubation. hypercapnic respiratory failure is defined as an elevation in paco2 greater than 45 mmhg and a ph lower than 7.35 resulting from respiratory pump failure and/or production. type 2 respiratory failure common causes : 1. neuromuscular disorders such as: amyotrophic lateral sclerosis (als), myasthenia gravis, muscular dystrophy. 2. spinal cord injuries or damage to the spinal cord that can impair respiratory function. 3. pulmonary disorders like chronic obstructive pulmonary disease (copd) ,cystic fibrosis, pneumonia severe infection can cause respiratory failure , pulmonary embolism. 4. obesity and sleep-related disorders like obesity hypoventilation syndrome (ohs), obstructive sleep apnea(osa). 5. chest wall and pleural disorders as kyphoscoliosis, pleural effusion, pneumothorax. 6. other causes: sedative overdose, neurological disorders, high altitude exclusion criteria: * 1. lack of informed consent. 2. a contraindication to niv (oral and facial trauma, excessive phlegm with poor expectoration ability, hemodynamic instability, recent esophageal surgery). 3. patients with poor short-term prognosis (very high risk of death within seven days or receiving palliative care). 4. other organs' failure e.g severe heart, brain, liver, or kidney failure. 5. tracheostomised patients. 6. loss of follow up and uncertain 28 day survival.

Keywords: difficult weaning-hypoxia-hypercapnea-postextubation-reintubation
dexlansoprazole absorption and marginal ulceration after gastric bypass

Conditions: Bariatric Surgery

Summary: in switzerland, the most commonly performed bariatric procedure is the proximal roux-en-y gastric bypass surgery. since marginal ulceration is a known complication after this operation, a proton pump inhibitor (ppi) prophylaxis is prescribed postoperatively. bariatric surgery may have an impact on the absorption and consequently on the efficacy of drugs. there are only very little data on the pharmacokinetics of ppis following prygb. the aim of this study is to analyze the serum concentration of dexlansoprazole preoperative and after prygb surgery in patients taking ppi prophylaxis and to examine the incidence of marginal ulcers postoperatively in the same population.

this prospective, monocentric study includes 30 patients undergoing a proximal roux-en-y gastric bypass surgery and receiving 6 months of postoperative ppi prophylaxis with dexilant (dexlansoprazole). the aim is to examine if the lprygb has an impact on the absorption of dexlansoprazole. peripheral blood samples from the study participants are obtained at fixed time points after oral administration of a capsule dexilant preoperatively as well as 3 and 6 months after surgery. the incidence of marginal ulceration in the same patient population is assessed by upper endoscopy 6 and 12 months after surgery. the surgery, the ppi prophylaxis and the upper endoscopy 12 months post-surgery aren't for study purpose. data collection is made by measuring serum drug concentration, patient questionnaires, pill count and upper endoscopy.

Eligibility criteria:
inclusion criteria: * informed consent for study and surgery as documented by signature * male and female patients over 18 years old eligible for bariatric surgery at the department of general surgery, limmattal hospital, according to criteria of the swiss study group for morbid obesity (smob) and international guidelines * bmi ≥ 35 * failure of conservative treatment for 2 years * type of surgery: lprygb * helicobacter pylori negative * smoker (≥ 1 cigarette daily) * women in reproductive age: negative pregnancy test exclusion criteria: * contraindication for a bariatric surgery according to smob-criteria * contraindication for ppis * pregnant or breastfeeding women * pre- or intraoperative decision for other type of surgery than lprygb * active malignancy * chronic liver disease child-pugh b or c * abuse of drugs or alcohol * suspect of non-compliance

Keywords: proton pump inhibitor
comparative effectiveness of readmission reduction interventions for individuals with sepsis or pneumonia

Conditions: Sepsis; Pneumonia; Lower Resp Tract Infection; Covid19

Summary: an adaptive platform trial to compare effectiveness of different care models to prevent readmissions for patients hospitalized with sepsis or lower respiratory tract infection. the primary outcome is number of days spent at home within 90 days after hospital discharge.

this study implements an adaptive platform trial to compare effectiveness of different care models to prevent readmissions for patients hospitalized with sepsis or lower respiratory tract infection and discharged to home (with or without a short stay in a skilled nursing facility prior to going home): structured telephone support (sts); low-intensity remote patient monitoring (rpm-low); and high-intensity remote patient monitoring (rpm-high). the remote patient monitoring models will be staffed by a physician or a nurse (standard team) or by a dedicated nurse-practitioner (np)-led multidisciplinary team (enhanced team). patients will be randomized to one of five arms: sts, rpm-low + standard team, rpm-low + enhanced team, rpm-high + standard team, and rpm-high + enhanced team. using response adaptive randomization (rar), interim outcome results will be used to modify the random allocation of patients to each study arm. the primary outcome is number of days spent at home within 90 days after hospital discharge. patient-reported functional status and quality of life data will be collected in addition to electronic health record (ehr) and claims-based data to measure health care utilization. qualitative interviews with patients and providers will provide insight into the effectiveness of the implementation process.

Eligibility criteria:
inclusion criteria: * upmc health plan members * medicare fee-for-service enrollees * age 21+ -hospitalized with a primary diagnosis of sepsis or lower respiratory tract infection, -- * discharged to home, independent living facility, or skilled nursing facility * readmission risk is moderate or high exclusion criteria: * admitted from hospice; * discharged to hospice, inpatient rehabilitation, or a long term acute care facility; * known to be pregnant; * current enrollment in another remote patient monitoring program; * failure of the callahan 6 item cognitive screen and do not have a proxy to consent; * no access to a technological device required to participate in remote patient monitoring program; * current enrollment in upmc advanced illness care program; * severe, persistent cognitive impairment; * no documented pcp; * pcp disapproves of the patient being enrolled in remote patient monitoring; * discharged from hospital to skilled nursing facility and stay at the skilled nursing facility for greater than 28 days
awake nasal intubation in laryngopharyngeal tumors

Conditions: Airway Management

Summary: this study evaluates the efficiency of awake naso-tracheal intubation and patient satisfaction when using a small diameter flexible nasolaryngoscope together with topical anaesthesia and light sedation with a combination of benzodiazepine and fentanyl. the selected patients will have difficult airway access because of obstructing oro- and hypo-pharynx tumours.

awake naso-tracheal fiberoptic intubation is an established method of securing a difficult airway. the patient's comfort and optimum intubation conditions are paramount for success. the study proposes to analyse a series of patients with obstructive pharyngo-laryngeal pathology, following the degree of satisfaction, reliability of the procedure and any incidents or complications. awake intubation could be the safest way to control difficult airway as the patient maintains spontaneous respiration and intact reflexes. main concerns for the success of this procedure should be a good technique, a calm and cooperative patient and good preparation with careful topical anaesthesia and appropriate sedation. the tool used in this study will be a flexible nasolaryngoscope of 2.9 mm diameter and 300 mm working length which might offer an advantage over lengthier fiberscopes in matter of manoeuvrability and patient comfort. prior intubation the patients will have an upper airway fiberscopic exam from nostrils to tracheae with the same tool.

Eligibility criteria:
inclusion criteria: * patients with tumours of larynx, oro and hypo-pharynx that obstruct airway access. exclusion criteria: * patients who refuse the procedure, with bleeding disorders, acute respiratory failure manifested by stridor or the impossibility of nasal passage are excluded from the study.

Keywords: awake intubation nasal fiberscope topical anesthesia
trail evaluating carbon ion radiotherapy for locally recurrent nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the purpose of this study is to determine the maximal tolerated dose (mtd) of re-irradiation using carbon ion radiotherapy (cirt) in the treatment of locally recurrent nasopharyngeal cancer (npc) and to evaluate the efficacy of such treatment at the mtd. participants will be treated with cirt with escalating dose regimens to evaluate the maximal tolerated dose (mtd) in terms of acute and subactue toxicity observed during and within 4 months after the completion of cirt. once the mtd for locally recurrent npc is determined, the mtd will be used as the recommended dose to patients fulfilling the inclusion criteria in the phase ii part of the trial.

the purpose of this study is to determine the maximal tolerated dose (mtd) of re-irradiation using carbon ion radiotherapy (cirt) in the treatment of locally recurrent nasopharyngeal cancer (npc) and to evaluate the efficacy of such treatment at the mtd. participants will be treated with cirt with escalating dose starting from 55gye (2.5gye/daily fraction) to potentially 65gye (2.5gye/daily fraction) to evaluate the maximal tolerated dose (mtd) in terms of acute and subactue toxicity observed during and within 4 months after the completion of cirt. time-to-event continual reassessment method (tite-crm) is used for the phase i dose escalating part of the trial and approximately 25 patients will be accrued. once the mtd for locally recurrent npc is determined, the mtd will be used as the recommended dose to patients fulfilling the inclusion criteria in the phase ii part of the trial. the phase ii part of the trial will be a single phase single arm study.

Eligibility criteria:
inclusion criteria: * pathologically confirmed npc * completed a definitive course of intensity-modulated photon radiation therapy (imxt) to a total dose of ≥ 66 gy * recurrence diagnosed more than 12 months after the initial course of imxt * age ≥ 14 and \< 70 years of age * karnofsky performance score ≥70 * willing to accept adequate contraception for women with childbearing potential * ability to understand character and individual consequences of the clinical trial * willing to sign the written informed consent; informed consent must be signed before the enrollment in the trial exclusion criteria: * local recurrence of npc diagnosed within 12 months from the completion of previous course of radiation therapy * presence of distant metastasis * technology used other than imxt (including brachytherapy following imxt) for the treatment of initial diagnosis of npc * pregnant or lactating women * patients who have not yet recovered from acute toxicities of prior therapies * a diagnosis of malignancy other than cis of the cervix, bcc and scc of the skin within the past 5 years * refusal of the patient to participate into the study

Keywords: re-irradiation carbon ion radiotherapy
neural-derived plasma exosomal micrornas as promising novel biomarkers for suicidality and treatment outcome in adolescents

Conditions: Major Depressive Disorder; Suicidal Ideas; Suicide, Attempted; MDD; Depression; Depression, Teen; Depression and Suicide; Depression in Adolescence; Suicide

Summary: this study is dedicated to help identify biomarkers for depression and suicide. the purpose of the study is to better understand these links to improve medical and psychiatric care in the future. this research is also to test the effects of standard treatment of depression on improvement in depressive and suicidal behavior and on biomarkers (e.g. mirna) for these disorders.


Eligibility criteria:
inclusion criteria: all participants: 1. physically healthy 2. willing and able to provide informed consent (if under 18 also parent or guardian consent) mdd participants: 1. a definite diagnosis of dsm-5 2. a children's depression rating scale-revised (cdrs-r) score \>=30. suicidal ideation participants: columbia suicide severity rating scale (c-ssrs) score \>=4 rated over the last two weeks. suicide attempt group: 1. participants will have had an attempt in the previous two weeks that is serious enough to require medical attention and shows evidence of at least a medium level of intent on the suicide intent scale. non-psychiatric controls: 1. no history of any major mental illness (excluding specific phobia) or substance use disorder. exclusion criteria: * exclusion criteria: 1. pregnancy or lactation 2. post-partum state (being within 2 months of delivery or miscarriage); 3. homicide risk as determined by clinical interview 4. any of the following dsm-v diagnoses or categories: a) a lifetime history of psychotic disorder; b) alcohol or drug use disorder (except nicotine/caffeine) within the last month; the use of any hallucinogen (except cannabis), including phencyclidine in the last month; c) bipolar disorder; d) pervasive developmental disorder; e) cognitive disorder; f) dsm-5 paranoid, schizoid, or schizotypal personality disorders (pds) (participants with other pds will be allowed as long as mdd criteria are met); g) anorexia nervosa. 5. recent myocardial infarction or unstable angina, active neoplasm in the past 6 months, immunosuppressive or corticosteroid therapy within the last month, chemotherapy, and head injury or loss of consciousness in the past 6 months 6. use of hallucinogens (except for cannabis), methamphetamine, or cocaine in the last 2 weeks.
dynamic guided implant surgery vs static guided surgery.

Conditions: Partially Edentulous Patients; Bone Crest of at Least 10 mm Length and 6 mm Width; Patients of at Least 18 Years Old

Summary: this study aims to evaluate if dynamic-guided surgery is an accurate system for placing dental implants. researchers will assess the dental implant accuracy of the dynamic guided system compared to the static pilot guide. participants will: * receive implant treatment that will be placed by a dynamic or static pilot drill guided system. * receive post-operative radiological exam for comparative (on the same appointment).


Eligibility criteria:
inclusion criteria: * 18 years or older, * asa type 1 or 2, * full mouth plaque scores up to 25% (o'leary tj. the plaque control record 1972;43:38), -partially edentulous with at least one missing tooth * having a bone crest of at least 10mm in length and 6mm in width. exclusion criteria: * medical conditions contraindicating surgery, * untreated periodontal disease or caries * the need for bone augmentation * acute local infections * history of head/neck radiation.