Kornimate/medical-research-clean huggingface dataset:
ingenio mri/ fineline ii pacing system data collection in patients undergoing mri

Conditions: Bradycardia

Summary: the infinite mri study is a prospective, non-randomized, multicenter, single arm study aimed at collecting data on imageready™ mr conditional pacing system (consisting of an ingenio™ mri or advantio™ mri pacemaker with fineline™ ii sterox or fineline™ ii sterox ez endocardial pacing lead(s)) when used in the magnetic resonance imaging environment under the labeled conditions of use.

objective of the infinite mri study is to collect data on the imageready mr conditional pacing system in subjects undergoing a magnetic resonance scan (mri). the imageready system has ce mark and enrolled patients will undergo mri scan under the labeled conditions of use. subjects considered eligible for this studty are already implanted with the system according to standard medical guidelines for pm implantation. the study is aimed at providing confirmatory data of no impact of mri on device function, lead parameters and patient conditions. the study will collect standard device measurement through device interrogation pre- and post- mri scan. mri scan in this study is a non-clinically indicated procedure and is not planned for diagnostic purposes. data from this study will be used to support the evidence of clinical performance of the imageready™ mr conditional pacing system following a mri scan when used under the labeled conditions of use, and may be used to support regulatory submissions for the approval of the system where requested. the study has no primary endpoint and is not hypothesis driven.

Eligibility criteria:
inclusion criteria: * age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law; * patients already implanted with the imageready™ mr conditional pacing system, single or dual chamber, including ingenio™ mri or advantio™ mri pulse generators with fineline™ ii sterox or fineline ii sterox ez endocardial lead(s), or accessories (see table 5.1-1) according to standard medical guidelines for pacemaker implantation; * willing and capable of participation to the procedures indicated in the protocol. exclusion criteria: * patients implanted with pulse generator location outside of left or right pectoral regions; * patients implanted with other cardiac-related implanted devices or accessories other than the imagereadytm mr conditional pacing system; * abandoned leads or pgs; * evidence of a fractured lead or compromised pg-lead system integrity; * low life expectancy (\< 1 year); * severe comorbidities that, according to clinical judgment, pose patient at risk to undergo mri; * pregnant women or women of childbearing potential
evaluation of an osteoporosis prevention strategy in women with osteoporotic fracture of the upper limb

Conditions: Osteoporosis With Current Fragility Fracture

Summary: osteoporosis is a disease characterized by reduced bone mass and increased skeletal fragility, predisposing to an increased fracture risk. the presence of a low trauma fracture is a powerful predictor of future fractures and about 50% of patients with a fragility fracture will suffer a subsequent fracture in the next 10 years (center jacqueline r, 2007). osteoporotic fractures are associated with an increased morbidity and mortality but also high financial costs. however, less than 20% of patients presenting a low trauma fracture receive an appropriate post-fracture osteoporosis management (little and eccles, 2010). the hypothesis of a lack of information and an under assessment of consequences by both patients and physicians has been raised to explain this gap between recommended care and usual practices. the aim of the prevost program is to assess the efficiency of patient-centered osteoporosis prevention program, after a fragility fracture of the upper limb, to improve post-fracture management of osteoporosis (ie bmd test and / or osteoporosis treatment) in women over 50 years old. this open randomized controlled trial aims to compare the bmd or osteoporosis treatment prescription rate at 6 months after inclusion between two groups: "intervention" receiving information on fracture and osteoporosis (oral and written), phone call reminders and written information to give to their family physician, and "control" receiving usual care without information.


Eligibility criteria:
inclusion criteria: * women aged over 50 years * with a fragility fracture of wrist or humerus that occurred in the past 6 months * treated in an emergency department or orthopedic department * who signed the consent form exclusion criteria: * no signed consent * previous history of femoral neck fracture * poly-trauma or accident * patients under osteoporosis treatment * patients who performed a bmd test in the past 6 months * patients with severe renal impairment, hyperthyroidism, bone primary or secondary malignancy. * legal disability * difficulty in understanding french * psychiatric disorder

Keywords: osteoporosis fragility fracture secondary prevention
covid-19 pandemic lockdown effect in adolescents and young adults with type 1 diabetes: positive results of an unpreceded challenge for telemedicine and patient self-management

Conditions: Type 1 Diabetes

Summary: lockdown resulting from the covid-19 pandemic was an unpreceded model of the impact of lifestyle on chronic diseases, especially for adolescents and young adults with type 1 diabetes (t1d) whose lifestyle is known to strongly impact disease management. the investigators aimed to assess changes in self-monitoring and glycemic control in this population before, during, and after the two-month french lockdown. te investigators hypothesized an improvement in glucose control and glucose sensor usage. the protocol will include all patients with t1d from 13 to 25 years old using a flash glucose monitoring related to the libreview cloud platform. the primary outcome, evolution of percentage of glucose time in range 70-180 mg/dl (tir), and secondary outcomes (glucose management indicator gmi, time spent below range tbr, and sensor usage) will be analyzed with a linear mixed-effects regression model.

continuous glucose monitoring (cgm) data will be collected from the cloud-based platform, libreview. data will be collected for patients from sud-francilien hospital (corbeil-essonnes, france) and kremlin-bicêtre hospital (kremlin-bicêtre, france). data related to glucose control and sensor usage will be collected from the libreview platform. data related to patients' characteristics, treatment and telemedicine visits (number of contacts with health professionals) will be collected from the medical record and confirmed with telephone-administered questionnaire. the lockdown imposed by the french government occurred from march 17 to may 10, 2020. therefore, outcomes will be assessed 4 times: the month before lockdown, during the first month, the second month of lockdown, and one month after lockdown ended. potential confounding factors will be studied: age, gender, type of insulin delivery (multiple daily injections, mdi; insulin pump), contacts with health professionals (physician or nurse). descriptive statistics will include means with standard deviations, numbers of patients and percentages. outcomes will be analysed with a linear mixed-effects regression model. analyses will be performed with r studio version 3.5.0.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * age between 13 and 25 years * use of a flash glucose monitoring related to the libreview cloud platform * patients follow-up by the diabetes department of hopital sud francilien or the diabetes department of hôpital bicêtre. * patient informed of the study and not having objected to it. exclusion criteria: * patients out of france during lockdown * other type of diabetes * duration of diabetes of less than one year * patient aged under 13 years or above 26 years old

Keywords: type 1 diabetes adolescent covid-19 telemedicine
psma-pet and mri for detection of recurrent prostate cancer after radical treatment

Conditions: Prostatic Neoplasms

Summary: approximately one third of prostate cancer patients experience biochemical relapse following initial radical prostatectomy or curative radiotherapy. to determine further treatment, it is of utmost importance to accurately differentiate local and regional recurrence from distant metastatic disease. unfortunately, the currently used medical imaging methods (mri and bone scan) lack sensitivity for detection of nodal and skeletal metastases, which can lead to over-treatment of patients with occult metastatic disease. pet imaging with prostate specific membrane antigen (psma)-ligands has shown a promising potential for improving the detection accuracy in recurrent prostate cancer, especially when combined with the excellent soft-tissue contrast of mri. however, evidence is mostly based on retrospective single center studies so far, including patients with a wide variety of psa levels. improving the sensitivity for detection of metastatic disease is a crucial step in reducing over-treatment of prostate cancer patients with biochemical relapse following radical treatment. the purpose of this prospective multi-center study is to standardize psma pet/ct and pet/mri imaging across three university hospitals in norway, and investigate its merit for detection of recurrent prostate cancer. the long-term overall goal is offering prostate cancer patients a more personalized treatment plan aiming to improve the chances of survival and quality of life.


Eligibility criteria:
inclusion criteria (surgery cohort): * prostate cancer patients with biochemical relapse in accordance with the european association of urology (eau) guidelines on prostate cancer; two consecutive measurements with psa ≥ 0.2 ng/ml following radical prostatectomy or psa \> 2.0 ng/ml above the nadir following definitive radiotherapy * potential candidates for loco-regional pelvic salvage treatment based on age and co-morbidity exclusion criteria: * previous salvage therapy for recurrent prostate cancer * general contra-indications for an mri exam (pacemaker, aneurysm clips, any form of metal in the body, or severe claustrophobia) * serious concomitant systemic disorders or reduced cognitive functioning that in the opinion of the investigator would compromise the patient's ability to complete the study or interfere with the evaluation of the efficacy and safety of the study objectives * impaired renal function defined as estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73 m2 * hormonal treatment during the last three months

Keywords: diagnostic imaging positron-emission tomography magnetic resonance imaging prostate-specific antigen neoplasm recurrence, local
phase 3 trial of 90y-clivatuzumab tetraxetan & gemcitabine vs placebo & gemcitabine in metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer; Pancreatic Cancer

Summary: the is a double-blind, randomized phase 3 study of 90y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the pancreas * metastatic disease * received at least two prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease. * at least one of the prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease must have contained gemcitabine and have met the following criteria: * completed at least one cycle of the treatment * received gemcitabine administered at a minimum dose of 800 mg/m2 per week in the first cycle of treatment * progressed while receiving this gemcitabine regimen or within 3 months of completing gemcitabine * progression was documented, * preferentially radiologically by tumor growth or new lesions, or by * clear symptomatic deterioration supported by at least two of the following clinical criteria: ≥ 10% worsening in kps or ≥ 1 worsening in ecog; increasing weakness or fatigue; progressive weight loss; new/worsening pain requiring increased pain medication; new/worsening jaundice, nausea, or vomiting; new/worsening ascites or pleural effusions; other physical or laboratory findings consistent with disease progression. * kps \>/= 70 * adequate bone marrow function * adequate hepatic function * adequate renal function exclusion criteria: * cns metastatic disease * bulky disease (any single mass \>10 cm). -\>grade 2 nausea or vomiting, and/or signs of intestinal obstruction. * prior external beam irradiation to a field that includes more than 30% of the red bone marrow. * patients with clinically significant severe cardiorespiratory disease. please consult with the clinical trial site for the full detailed list of specific inclusion/exclusion criteria.

Keywords: clivatuzumab tetraxetan 90y-clivatuzumab tetraxetan immu-107
influence of a moderate physical exercise program in health of patients underwent bariatric surgery in talca city, chile

Conditions: Bariatric Surgery Candidate

Summary: obesity is a multifactorial disorder resulting from multivariate etiopathogenic factors. the current lifestyle, causes a gradual increase in weight both in the adult population and in the child population. among their treatments is bariatric surgery. about which there is little evidence in the literature regarding the health condition developed by patients operated on the same. objective: to know the influence of a moderate exercise program on health status in patients operated on with bariatric surgery. methodology: a controlled clinical trial, the population will consist of 32 women and 11 men. coming from the consultations of bariatric surgery of the clinic of the maule - talca. in the period between march 2017 and march 2018. it will be selected following a non-probabilistic sampling and for convenience. results analysis: the variables used in this study will be: cardiovascular function, respiratory function, strength, health perception, anthropometric measures and functional capacity to perform exercises. the shapiro-wilk normality test will be performed to determine the distribution of the data to be analyzed. the t-student test or its nonparametric counterpart will be applied to compare two variables. to compare three or more variables, the anova or kruskal-wallis test will be used depending on the results of the normality test.


Eligibility criteria:
inclusion criteria: * signed informed consent. * do not suffer any absolute contraindication. * patients who will undergo bariatric surgery and who reside in the city of talca. * age between 18 - 60 years. * with weight \<180 kilograms. exclusion criteria: * medical indication for basic pathologies. * post-operative complications. * acute angina-like pain during the 6-minute gait test. * absence of 2 or more trainings in a row. * pregnancy within the first 6 months post-surgery.

Keywords: obesity,bariatric surgery,physical activity
minor increase over minimal risk research in nicu

Conditions: Infant, Premature; Infant, Late; Infant, Preterm; Infant

Summary: infants comprise a potentially vulnerable research population that received special consideration and protections under the us code of federal regulations - subpart d. of the four categories of research involving children, 45 cfr 46.406 is of particular interest to researchers, ethicists, parents, and clinical staff members since it concerns the conduct of research with "more than minimal risk" without the prospect of direct benefit. parents are the surrogate decision makers for infants. when asked about this type of research in studies pertaining to older infants and children, parent themes include: concerns of medical research and research-related risk, desire to advance generalizable medical knowledge and knowledge specific to their own child's disease. there are no data on parents' perceptions regarding this category of research that target the premature, late-preterm and term newborn populations. this study involves a questionnaire for both staff (nurses and physicians) and parents. the questionnaire represented 4 different infant scenarios in a random order. respondents are asked to answer questions related to enrollment in a research study for each of the 4 scenarios.


Eligibility criteria:
inclusion criteria: * parents of infants in the nicu * parents of infants on well-baby nursery * nicu staff (nurses and physicians) exclusion criteria: * non-english speaking * less than 18 years old

Keywords: research vulnerable population 45 cfr 46.406
eaca vs cca in postoperative evaluation of middle ear pressure

Conditions: Adenoid Hypertrophy

Summary: is to evaluate the effect on eustachian tube (et) and changes in middle ear pressure in early period after adenoidectomy by using endoscopic assisted coblation adenoidectomy (eaca) vs conventional curettage adenoidectomy (cca)

adenoid hypertrophy is a common condition in children causing symptoms such as mouth breathing, nasal discharge, snoring, sleep apnea, and hypo nasal speech. it also plays a role in the pathogenesis of rhinosinusitis, recurrent otitis media, and otitis media with effusion. currently, adenoidectomy is one of the most commonly performed pediatric surgical procedures worldwide. although there is still poor evidence in the literature, recurrent upper respiratory infections, otitis media with effusion, and obstructive sleep apnea syndrome are considered to be the main indications of adenoidectomy . conventional curettage adenoidectomy (cca) is a widely adopted method for over a hundred years. conventional curettage adenoidectomy is performed blindly via adenoid curette; this may be associated with residual adenoid tissue existence and increased postoperative morbidity including, eustachian tube dysfunction, inadvertent injury to peripheral tissue and postoperative bleeding . an ideal adenoidectomy technique should be safe, quick, easy, and provide decreased postoperative complication and morbidity .recently adenoidectomy can be carried out with several techniques such as electrocautery, bipolar coagulation, radiofrequency ablation, and coblation techniques . eustachian tube dis function (etd) can develop due to surgical trauma , edema in surrounding tissues and clots in early period following adenoidectomy surgery performed with curettage technique .

Eligibility criteria:
inclusion criteria: - pediatric patients presented with adenoid hypertrophy who undergoing primary adenoidectomy with or without tonsillectomy , with the following criteria: * age: between ( 5-14 years ) * with or without chronic tonsillitis * clinicaly normal tympanic membrane without secretory otitis media . exclusion criteria: * patients with the following criteria will be excluded from the study : * patients with secretory otitis media . * previous adenoidectomy. * previous ear surgery, cleft palate, down's syndrome, congenital malformation of the ear and cholesteatoma. * recurrent upper respiratory tract infection.
evaluation of the safe use and tolerance of a peptide-based formula in a pediatric population

Conditions: Gastrointestinal Diseases; Feeding Intolerance

Summary: the objective of this study is to determine the safe use and tolerance of a peptide-based formula in children with gastrointestinal dysfunction and/or feeding intolerance.


Eligibility criteria:
inclusion criteria: * male or nonpregnant female between 1 and 13 years of age. * subject is diagnosed with gastrointestinal dysfunction and/or feeding intolerance. * subject requires enteral tube feeding as sole source of nutrition. exclusion criteria: * history of diabetes. * requires artificial ventilation. * requires parenteral nutrition. * subject has intestinal obstruction. * subject is receiving dialysis treatment. * subject has an allergy or intolerance to any ingredient in the study product.
thermal ablation combined with external beam radiation therapy for patients with inoperable non-small cell lung cancer > 3.5 cm in size

Conditions: Non-small Cell Lung Cancer

Summary: the main objective of this study is to assess the initial safety of the combination of interventional ablation and external beam radiotherapy including acute and late toxicity (90 days) for patients with early stage lung cancer.


Eligibility criteria:
inclusion criteria: * patients with ajcc sixth edition stage ib or ii non-small-cell lung cancer with cytology or biopsy proven disease and a minimum tumor size of 3.5 cm are eligible. * to be considered node negative for n2 disease, patients will have mediastinal lymph nodes ≤ 1.5 cm and no clinically suspicious uptake on fdg pet in those areas. * all patients are required to have been evaluated by a thoracic surgeon and have either refused surgery or been deemed medically inoperable due to co-morbid conditions. * the ct images of the chest must be reviewed by an experienced interventional radiologist and the target lesion is determined to be in a location where rfa is technically achievable based on the proximity of adjacent organs and structures. * age ≥ 18 years old * performance status 0-2 (ecog) exclusion criteria: * history of prior malignancy within the past 2 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, t1n0 squamous cell carcinoma of the larynx, or localized prostate cancer with a current psa of \< 1.0 mg/dl on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry * previous chest radiation to the region of interest. * pregnant or lactating women. * a clinical diagnosis of bronchoalveolar carcinoma (bac) will be made for patients in whom tissue diagnosis is by cytology alone with adenocarcinoma shown and the following radiographic criteria are met.