Kornimate/medical-research-clean huggingface dataset:
high definition white light endoscopy and narrow band imaging for the assessment of barrett's disease after endoscopic therapy

Conditions: Barrett's Esophagus

Summary: the investigators seek to test the hypothesis that the improved version of high definition white light endoscopes and narrow band imaging (nbi) are more accurate in detecting residual barrett's metaplasia and dysplasia disease after previous resection or ablation treatments than current versions of these endoscopes.

information will be collected. images will be taken.

Eligibility criteria:
inclusion criteria: * age 18 years and older * patients with barrett's esophagus (be) dysplasia as the original indication for treatment * undergoing any type of endoscopic be resection or ablation treatment including rfa, cryotherapy, photodynamic therapy, or emr, or combinations of these. * \<1cm of circumferential, peninsular, or island-type be on prior endoscopy or ablation * ability to provide written, informed consent deferral criteria: this category is for patients in two specific situations, 1) erosive esophagitis, and, 2) presence of a nodule suspicious for the presence of neoplasia. 1. erosive esophagitis: patients found to have erosive esophagitis, will be deferred for up to 3 months from their index study procedure, to permit more aggressive medical therapy to heal the erosive esophagitis. after healing, the index study procedure will be performed up to 3 months later, and the follow-up endoscopy (and study closure) performed 3 to 6 months after that (total of no more than 9 months). 2. presence of nodule suspicious for neoplasia: for patients found to have such nodular lesions, the index study procedure will be deferred for 3 months, while endoscopic mucosal resection is performed and subsequently heals. note: only one deferral per patient is permitted, and this one deferral is allowed only for these specific criteria. the end of the study will be defined by the time of follow-up of the last patient who was not deferred; any deferred patients who have not completed follow-up procedures by that time, may miss their follow-up visit as part of the study. (this is to prevent the possibility of delaying the close of the study due to deferral of a procedure late in the study.) exclusion criteria: * current participation in another clinical study * complete eradication of be documented by biopsies in 3 or more previous endoscopic procedures performed after resection/ablation * inability to obtain biopsies due to anticoagulation, varices, etc. * pregnancy * worse than grade c erosive esophagitis * less than 3 weeks from previous endoscopy with biopsy or 6 weeks from previous endoscopic therapy (ablation or resection).
study on the recovery of pulmonary function, chest ct, airway microbiota, hematologic, and immune & inflammatory conditions in covid-19 rehabilitation patients

Conditions: COVID-19

Summary: the intent of this study was to examine the health status of individuals who had been confirmed with covid-19 in the year after their recovery. parameters studied included serum levels of sars coronavirus 2 (sars-cov 2) igg antibody, sars-cov-2 nucleic acid test, hematology indicators (blood routine, liver function, kidney function, myocardial enzymes, coagulation function, etc), lung function test, imaging data and airway microbiota data. in addition, we explored the systematic immune \& inflammation in some of the individuals recovering from covid-19.

about 20% of covid-19 developed into a critical illness and about 2% died. the global epidemic continues to develop, but some patients in china have entered the rehabilitation period, which is accompanied by a large number of respiratory symptoms and pulmonary fibrosis, bringing serious harm to the country. therefore, early accurate detection and prediction of the development trend of patients in rehabilitation period and targeted treatment measures for corresponding patients are the key to the success of covid-19 rehabilitation period. it will play a key role in the stratified management of the post-epidemic situation, which is crucial to improve the quality of life of covid-19 patients. we aim to explore the clinical characteristics of rehabilitation patients by detecting some indicators of patients in rehabilitation period, including serum igg and igm antibody of sars-cov 2, sars-cov-2 nucleic acid, hematology indicators (blood routine, liver function, kidney function, myocardial enzymes, coagulation function, etc), pulmonary function, chest ct imaging, systematic immune \& inflammation states.

Eligibility criteria:
inclusion criteria: 1. individuals recovering from covid-19, or asymptomatic covid-19 patients with laboratory test for srars-cov2 turning negative, or healthy volunteers without covid-19. 2. the age range is 18-80 years. 3. subjects or their family members agree to participate in the study and sign informed consent. 4. the previously diagnosed individuals have been cured for about 1 month. exclusion criteria: 1. woman who is breastfeeding, pregnant, or preparing to become pregnant. 2. patients with cognitive impairment or poor compliance as determined by the investigator. 3. participants in other clinical trials. 4. subjects who were not suitable for clinical trials determined by the investigator.
patterns of physical activity and sedentary time in survivors of a critical illness during a hospital admission

Conditions: Motor Activity; Sedentary Lifestyle; Critical Illness

Summary: this study aims to describe the pattern of active and sedentary time in survivors of a critical illness, at three time points during their hospital admission (awakening in the icu after ≥ 5 days of mechanical ventilation, discharge to ward and discharge from hospital). the specific research objectives are to 1. determine the duration of active and sedentary parameters including time and bouts in 24 hour periods 2. examine changes in the active and sedentary parameters including time and bouts between time points of awakening and both icu and hospital discharge. 3. conduct a preliminary examination of relationships between activity and sedentary behaviour metrics with measures of muscle strength, physical function and hospital length of stay.

this is a prospective observational study that consecutively samples eligible patients with a critical illness, requiring intensive care. this study will use two activity monitors (accelerometers) to measure physical activity and sedentary variables from patients recovering from a critical illness in a single tertiary hospital on three occasions during their acute hospital admission. accelerometer derived measures will be obtained from continuous 24 hour monitoring periods once patients are sufficiently awake and attentive within the icu, at icu discharge and again at acute hospital discharge. measurements of patients muscle strength and physical function will also be made at the time of accelerometry.

Eligibility criteria:
inclusion criteria: * adult patient ≥ 18 years of age * patient is/was intubated (endotracheal, nasotracheal or tracheostomy) and required ≥ 5 days of mechanical ventilation (irrespective of reason for ventilatory support) exclusion criteria: * unable to ambulate independently (either with or without gait aids) at least 10 meters within the last 3 months * ordinarily unable to understand written and spoken english sufficient to provide consent (e.g. due to non-english speaking background or pre-existing cognitive impairment) * assessed by medical staff as approaching imminent death or withdrawal of medical management

Keywords: accelerometry
metabolic mechanisms induced by enteral dha and ara supplementation in preterm infants

Conditions: Premature

Summary: a comprehensive analysis of the impact of exogenous enteral dha and ara supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors.

infants will be randomized to receive the combined enteral dha/ara supplement within the first 48 hours after birth to 36 weeks postmenstrual age. the randomization procedure will follow a stratified permuted block scheme to fulfill two goals: (1) randomize infants into one of four arms and (2) ensure an adequate sample size within each week of gestational age. preterm infants will be randomized using random permuted blocks within each of the 5 birth gestational age strata. when treatment assignment is open and sample size is not overtly large, a block randomization procedure with randomly chosen block sizes can maintain treatment assignment balance and reduce the potential for selection bias. this approach will also ensure that preterm infants of all eligible gestational ages at birth are approximately equally represented in each of 4 arms of the trial, thus ensuring that important comorbidities and standard of care applicable to infants of different gestational ages at birth are also approximately equally distributed across the study arms. there is no placebo for this study. there is no blinding in this study. consent will also be obtained from the mother of the infant, as they will be asked to provide milk samples if they're breastfeeding their infant, and maternal medical history and demographical data will be recorded.

Eligibility criteria:
inclusion criteria: * born between 25 0/7 and 29 6/7 weeks of gestation * less than 48 hours of age at first lipid dose (the cohort is defined by gestational age rather than birth weight to avoid an over-represented sample of growth-restricted infants in birth weight defined cohorts.) exclusion criteria: * serious congenital anomalies * conditions at birth that will require surgery prior to discharge * imminent death such that withdrawal of intensive care support is anticipated within the first 72 hours after birth

Keywords: infant, premature fatty acids nutrition
a study to test the possibility of cross reaction induced by the idursulfase drug to gsk2788723

Conditions: Mucopolysaccharidosis II

Summary: study ids116406 will be a non-interventional, phlebotomy study in hunter syndrome patients who are currently being treated with idursulfase, an enzyme replacement therapy, and in at least a single patient who is naïve to treatment, if possible to recruit. all patients enrolled into the study will have a single blood draw for the analysis of antibodies induced by this enzyme replacement therapy (idursulfase). patient samples with positive responses to antibodies induced by idursulfase will be used to further evaluate whether the antibodies induced by idursulfase bind to gsk2788723 molecules in vitro and if these antibodies neutralize the bioactivity of gsk2788723 in vitro. each subject will have a screening visit, which may occur at their regularly scheduled out-patient visit. if the patient consents to participate in the study, a blood sample (total volume of approximately 3ml) for immunogenicity analysis will be drawn before their current treatment infusion

study ids116406 will be a non-interventional, phlebotomy study in hunter syndrome patients who are currently being treated with idursulfase, an enzyme replacement therapy, and in at least a single patient who is naïve to treatment, if possible to recruit. all patients enrolled into the study will have a single blood draw for the analysis of antibodies induced by this enzyme replacement therapy (idursulfase). patient samples with positive responses to antibodies induced by idursulfase will be used to further evaluate whether the antibodies induced by idursulfase bind to gsk2788723 molecules in vitro and if these antibodies neutralize the bioactivity of gsk2788723 in vitro. each subject will have a screening visit, which may occur at their regularly scheduled out-patient visit. if the patient consents to participate in the study, a blood sample (total volume of approximately 3ml) for immunogenicity analysis will be drawn before their current treatment infusion

Eligibility criteria:
inclusion criteria: a subject will be eligible for inclusion in this study only if patient meets criteria 1 and 2 or 1 and 3: * diagnosed with hunter syndrome * patients with hunter syndrome who are being treated with idursulfase * patients with hunter syndrome who are naïve of idursulfase treatment (if possible\*) \*this study will also attempt to recruit 1 patient who has never received idursulfase. if a naïve patient has not been identified within an agreed amount of time between gsk and the investigator, the study will concluded without this sample exclusion criteria: * subjects who are currently participating in another clinical trial are not permitted to be enrolled in this study.

Keywords: hunter syndrome, immunogenicity, antibodies
exercise performance on ambient air vs. low-flow oxygen therapy with chronic lung diseases

Conditions: Lung Disease Chronic; Lung Diseases, Interstitial; Lung Diseases, Obstructive

Summary: the investigators aim to study the effect of sot in subjects with chronic lung disease in submaximal exercise.

participants with lung disease who live in switzerland will have 6-minute walk distance (6mwd) test with and without sot at approximately 3l/min via nasal cannula according to a randomized cross-over design. the trial aims to test that the 6mwd with sot is non-inferior to a 6mwd in the same participant under ambient air. our effect size was estimated with a difference of less or equal to 35m compared under sot compared to ambient air.

Eligibility criteria:
inclusion criteria: * minimum 18 years of age * written informed consent * patients with diagnosed chronic lung disease * former desaturation under exercise defined as spo2-decrease \>3%- page 3 of 4 * treated with a stable drug therapy (with no changes for at least 14 days prior to screening) exclusion criteria: * severe hypoxemia needing supplemental oxygen therapy defined as (partial pressure of oxygen (pao2) \< 6.9 kilopascal (kpa) * pregnancy * unability or contraindications to undergo the investigated intervention * unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

Keywords: supplemental oxygen therapy 6 minute walking distance chronic lung diseases
blood-borne infection screening in an afghan antenatal population

Conditions: Viral Hepatitis B; Contraception; Breast Feeding, Exclusive; Effects of; Lack of Care of Infants

Summary: baseline information indicates there are measurable levels of hepatitis b sag and low utilization of postpartum contraception, correct breastfeeding practices, or adherence to infant vaccination schedules in kabul, afghanistan. this intervention will randomize hospitals to assess the following aims: aim 1: to determine whether the re-training and assignment of health care providers dedicated to intrapartum rapid testing and post-partum counseling will positively impact maternal and neonatal health indicators as compared to utilization of existing health providers for these services among women delivering in publish health maternity hospitals in kabul, afghanistan. aim 2: to assess whether patients randomized to the intervention and their spouses perceive value in concentrated post-partum counseling. aim 3: to investigate whether an intervention providing immediate post-partum provision of a long-acting family planning method would be feasible and acceptable to both men and women in kabul, afghanistan.

outcomes are assessed through questionnaire responses and inspection of vaccination cards at six month intervals by trained study staff through one year total study time. differences between groups will be assessed with generalized linear mixed modeling. information obtained to address aim 3 will be gathered at the 12 month follow-up and analyzed with simple proportions and chi-square test to assess differences between sexes and other socioeconomic indicators.

Eligibility criteria:
inclusion criteria: * admitted for obstetric care * dari or pashto speaking * not previously participated in the study * in medically stable condition * accompanied by and have approval of a spouse * able to provide informed consent male participants must be the confirmed spouses of the female participants, have a working telephone, and able to provide informed consent. exclusion criteria: * medically unstable or imminently delivering (complete cervical dilation) * husband unavailable or does not approve participation * unable to provide consent
a phase 2 study of lenalidomide to evaluate the efficacy in japanese patients with newly diagnosed multiple myeloma

Conditions: Multiple Myeloma

Summary: to determine the efficacy of lenalidomide in combination with low-dose dexamethasone in japanese subjects with previously untreated multiple myeloma.


Eligibility criteria:
inclusion criteria: * age ≥ 20 years at the time of signing the informed consent document * understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted * able to adhere to the study visit schedule and other protocol requirements * previously untreated, symptomatic multiple myeloma * have measurable disease by protein electrophoresis analyses * at least 65 years of age or older or, if younger than 65 years of age, not candidates for hematopoietic stem cell transplantation * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * must agree to comply to lenalidomide pregnancy prevention risk management plan exclusion criteria: * any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study * any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study * any condition that confounds the ability to interpret data from the study * previous treatment with anti-myeloma therapy * pregnant or lactating females * any of the following laboratory abnormalities: * absolute neutrophil count (anc) \< 1,000/microl (1.0 × 10\^9/l ) * untransfused platelet count (a platelet count drawn at least 7 days after the administration of the last platelet transfusion) \< 50,000 cells/microl (50 × 10\^9/l) * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 3.0 × upper limit of normal * renal failure requiring hemodialysis or peritoneal dialysis * prior history of malignancies, other than mm, unless the subject has been free of the disease for ≥ 5 years * subjects who are unable or unwilling to undergo antithrombotic therapy. * peripheral neuropathy of ≥ grade 2 severity. * uncontrolled systemic fungal, bacterial, or viral infection * known human immunodeficiency virus (hiv) positivity (subjects who are receiving antiretroviral therapy for hiv disease) * hepatitis bs (hbs) antigen-positive, or hepatitis c virus (hcv) antibody-positive. in case hbc antibody and/or hbs antibody is positive even if hbs antigen-negative, a hepatitis b virus (hbv) dna test should be performed and if positive the subject will be excluded. * primary al (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis. * ineligible for dexamethasone or dexamethasone is contraindicated.

Keywords: lenalidomide dexamethasone newly diagnosed multiple myeloma
all-poly versus metal-backed

Conditions: Osteoarthritis

Summary: the primary objective is the assessment of prosthetic migration results after two years of the triathlon ps knee system with all-polyethylene tibial components compared to the triathlon ps knee system with metal-backed modular components by means of roentgen stereophotogrammetry.

the secondary objective will be the prediction of the long-term survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. in order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the rsa outcome.

Eligibility criteria:
1. the subject is morbidly obese, defined as body mass index (bmi) of \> 40. 2. patient has a flexion contracture of 15° and more. 3. patient has a varus/valgus contracture of 15° and more. 4. patients with a pre-operative knee score of \>70. 5. the subject has a history of total or unicompartmental reconstruction of the affected joint. 6. the subject will be operated bilaterally. 7. patients who had a total hip arthroplasty (tha) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (patients with contralateral and/or ipsilateral tha \> 1 year ago with good outcome can be included in the study). 8. patients who had a total knee arthroplasty (tka) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (patients with contralateral tka \> 6 months ago with good outcome can be included in the study). 9. the subject has an active or suspected latent infection in or about the knee joint. 10. osteomyelitis 11. sepsis 12. patient who is expected to need lower limb joint replacement for another joint within one year. 13. the subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. 14. the subject has a systemic or metabolic disorder leading to progressive bone deterioration. 15. the subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements. 16. the subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 17. the subject has had a knee fusion to the affected joint. 18. female patients planning a pregnancy during the course of the study. 19. the patient is unable or unwilling to sign the informed consent specific to this study
puncture template assisted biopsy for pulmonary nodules

Conditions: Pulmonary Nodule; CT Guided Biopsy

Summary: pulmonary nodules are small in size and easy to move with breathing. ct guided puncture is highly dependent on the personal experience of physicians, that is, the accuracy, efficiency and incidence of complications of puncture vary greatly among physicians. puncture template (pt) assisted ct guided needle biopsy of pulmonary nodules has good clinical feasibility, which is expected to make up for the deficiency of simple ct guided needle biopsy, and make the needle biopsy of pulmonary nodules more accurate and standardized. this study intends to carry out a randomized controlled study to further evaluate the safety and effectiveness of pt assisted ct guided needle biopsy of pulmonary nodules, and provide higher quality data reference for its clinical application. patients were randomly divided into two groups: pt assisted ct guided or simple ct guided lung biopsy. the operation related information, complications and postoperative pathological results of the two groups were collected. primary end point: puncture accuracy secondary end point: success rate of first needle puncture; complication rate (such as pneumothorax, bleeding, etc.); operation time; ct scan times; pathologic findings.


Eligibility criteria:
inclusion criteria: * single or multiple pulmonary nodules (solid, partially solid, pure ground glass), with the maximum diameter of 5mm to 20mm and need for pathological diagnosis. * no drugs affecting blood coagulation and (or) platelet aggregation were used; if used, the drugs had been stopped for enough time according to the drug elution period. * kps \> 60, no serious or uncontrollable underlying diseases, the patients can tolerate lung puncture according to clinical evaluation. * there is an appropriate puncture path. exclusion criteria: * poor lung function (such as fev1 \< 40% in the first second and / or dlco \< 50%) and / or isolated pulmonary bullae on the puncture path. * the nodule is close to small airway and blood vessels, or has pulmonary hypertension and superior vena cava compression, so the risk of puncture bleeding and hemoptysis is expected to be high. * poor compliance, unable to complete the cooperation. * due to other reasons which is not suitable to participate in this clinical trial.

Keywords: pulmonary nodule biopsy puncture template