Kornimate/medical-research-clean huggingface dataset:
corevitas spheres (synergy of prospective health & experimental research for emerging solutions) registry for neuromyelitis optica spectrum disorder (nmosd)

Conditions: Neuromyelitis Optica Spectrum Disorder

Summary: this is a prospective, observational research study for patients with nmosd under the care of a licensed neurologist. approximately 800 patients and 35 clinical sites in north america will be recruited to participate with no defined upper limit for either target.

the objective of the registry is to create a cohort of patients with nmosd. data collected will be used to prospectively study the natural history of nmosd, real-word effectiveness and safety of medications used to treat nmosd, and drug utilization treatment patterns. additionally, the data will be used to systematically evaluate the burden for patients with nmosd and the impact of therapies on quality of life. this will be done through real time capture and adjudication of relapses, the standardized collection of patient-reported outcomes (pro) and clinician-reported outcomes (clinro), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. personal information is also collected from each consenting registry patient allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of nmosd for the purposes of clinical, market, or outcomes research. this provides an opportunity to evaluate other aspects of the disease and its treatment including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and patient adherence. consent for additional ad hoc surveys will be solicited which can allow evaluation of additional aspects of the disease impact such as care giver burden or impact of disease on productivity.

Eligibility criteria:
inclusion criteria: 1. has a diagnosis of nmosd at the time of enrollment according to the 2015 ipnd consensus diagnostic criteria for nmosd†. 2. age 18 years or older at the time of enrollment. 3. willing to provide personal information. exclusion criteria: 1. has had a clinically confirmed nmosd neuro-episode within the 12 weeks prior to enrollment. 2. is participating or planning to participate in a double-blind randomized trial for an nmosd drug. note: concurrent participation in another observational registry or open-label phase 3b/4 trial is allowed. * all serology types (apq4 +/- and mog +/-) are eligible to enroll in the registry given they meet the 2015 ipnd diagnostic criteria.
gvd±r regimen for asct-eligible patients with refractory/relapsed dlbcl

Conditions: Lymphoma, Large B-Cell, Diffuse

Summary: the purpose of this multi-center,single arm,phase ⅱ clinical trail is to determine the safety and efficacy of gvd±r (gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab) regimen for autologous hematopoietic stem cell transplantation(asct)-eligible patients with refractory/relapsed diffuse large b-cell lymphoma.


Eligibility criteria:
inclusion criteria: * biopsy proved cd20+ dlbcl; * previously received at least one systemic treatment (including chemotherapy) without remission or relapse after remission; * at least one evaluable lesion； * ecog ps 0-1; * 18-65 years; * proper functioning of the major organs. exclusion criteria: * involvement of central nervous system; * with other malignancy; * patients receiving or received drug of other clinical trial within 30 days； * previously received doxorubicin liposome or have used other anthracycline drug with accumulated restricted doses (adriamycin 450mg/m2, epirubicin 935mg/m2, acrarubicin 900mg/m2)； * patients who received treatment for hematologic toxicity caused by previous chemotherapy within 7 days before enrollment; * grade 2 or more peripheral neuropathy.
probiotic use in patients with prior copd exacerbation

Conditions: COPD; Obstructive Lung Disease

Summary: the purpose of the study is to examine the hypothesis test that probiotics will reduce the frequency of exacerbation in patients with copd.


Eligibility criteria:
inclusion criteria: 1. patients admitted to oumc or vamc with a copd exacerbation and pneumonia with underlying copd will be eligible and screened. 2. patients seen in va chest medicine clinic, ou physicians clinic and pulmonary fellows clinic at ppob who have had a copd exacerbation within the last year. 3. patients over age 18 4. patients who have a pulmonary function test (pft) showing copd within 1 year of enrollment in the study or if the treating physician plans to obtain pft as part of the patient's care plan. 5. patients will be considered to have a diagnosis of copd if they have a fev1 of less than 80% of predicted and a fvc/fev1 ratio of less than 0.70 (as defined by gold criteria). exclusion criteria: 1. patients with less than one year of life expectancy from a concomitant diagnosis 2. any gi motility disorders or previous bowel resection surgery (short gut syndrome) 3. any patients with decreased immune function or on medication that may decrease immune function (other than low dose steroid or steroid taper). 4. patients admitted within the last one year with a diagnosis of pancreatitis 5. patients unable to give consent will not be included in the study. 6. patients unable to sign consent 7. patients already on azithromycin daily for copd exacerbations 8. patients under department of corrections custody.

Keywords: exacerbations copd pneumonia probiotic
efficacy and safety of relex smile for laser correction of myopia

Conditions: Myopia

Summary: evaluation of the safety and efficacy of the carl zeiss meditec visumax femtosecond laser for lamellar resection (relex smile) in the reduction of myopia.

quality control study of patients treated with relex smile for myopia at the department of ophthalmology, aarhus university hospital. the patients will be followed with standard clinical techniques (slit-lamp examination, refraction, topography) during their normal follow-up up to 12 months after treatment.

Eligibility criteria:
inclusion criteria: * indication for keratorefractive correction of myopia * patient consent to undergo keratorefractive correction of myopia exclusion criteria: * pregnant or lactating women

Keywords: keratorefractive surgical procedures
observational registry data on gist patients

Conditions: Gastrointestinal Stromal Tumors

Summary: this is a longitudinal, multi-center, registry study, collecting data via a web-based portal in patients with gist (gastrointestinal stromal tumor) from hospitals in taiwan.

research question and objectives: this study is to collect and describe real-world data for taiwanese gist on: * prevalence and demographic characteristics of taiwanese gist * treatment pattern of gist therapies * bio-marker and/or gene expression characteristics of taiwanese gist * treatment outcome of tki therapies, including recurrence-free, progression-free and overall survival * safety profile for tki therapies study design: retrospective and prospective observational cohort study population: taiwan gist patients during 01 january 2010 to 31 december 2020 data sources: medical records and investigator-established data bank study size: data from up to 3,000 eligible subjects will be collected data analysis: descriptive statistics for longitudinally assess nationwide trends on current and evolving diagnostic, treatment, and outcome measures in the gist population and estimate the prevalence of gist in taiwan. milestones: interim report before 31 december 2018 and final study report before 30 june 2026.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with gastrointestinal stromal tumor 2. ≥20 years old 3. histology-confirmed gist between 01 january 2010 and 31 december 2020. 4. patient with prospective data collection: willing to provide singed inform-consent as per local regulatory requirements. exclusion criteria: 1. inability and unwillingness to give informed consent if required by site ethic committee. 2. patient that is unlikely candidate to obtain long-term follow-up information for reasons of unavailability or with severe concomitant illnesses per investigator judgement
a prospective multi-center study on total hip arthroplasty with e1

Conditions: Hip Osteoarthritis

Summary: the primary objectives of this clinical study include: * evaluate e1 wear including early bedding-in process, clinical outcomes on patients who received total hip arthroplasty with e1 * compare e1 wear used with cocr and biolox delta heads

this study is designed as prospective, randomized, multi-center study to compare two different materials (cocr and delta ceramic) articulating against e1 highly crosslinked polyethylene in hip replacement. patient population is 160 (80 each). follow-up period is 10 year postoperatively. e1 liners with thickness of 4.8mm at 45 degrees position (load bearing direction) will be used in all cases. randomization will occur via random number generator by 4 blocks randomization.

Eligibility criteria:
inclusion criteria: * osteoarthritis * age between 20 - 75 at the time of operation * patients with limited co-morbidity -asa i-iii * patients must be able to understand instructions and be willing to return for follow up exclusion criteria: * in accordance with approved absolute and relative contraindications for use in participating countries for e1 liner and delta ceramic and cocr femoral head hip system system. absolute contraindications include: infection, sepsis, and osteomyelitis. relative contraindications include: 1. uncooperative patient or patient with neurologic disorders who are incapable of following directions, 2. osteoporosis, 3. metabolic disorders which may impair bone formation, 4. osteomalacia, 5. distant foci of infections which may spread to the implant site, 6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7. vascular insufficiency, muscular atrophy, or neuromuscular disease. 8. pregnancy

Keywords: only female age between 20 - 75 at the time of operation
therapeutic yoga and resistance exercise for lung cancer

Conditions: Lung Cancer

Summary: the purpose of the study is to determine the feasibility and preliminary efficacy of a combined therapeutic yoga and resistance exercise intervention for individuals with lung cancer and their caregivers. the investigators aim is to help reduce the fear of exercise by tailoring the program to meet the specific needs of the survivor with lung cancer. the investigators want to see whether individuals with lung cancer and their caregivers are interested in participating in this type of program, and if they are able to attend the intervention sessions and complete the program. the investigators also plan to study the preliminary effects of therapeutic yoga and resistance exercise on fitness outcomes for both individuals with lung cancer and their caregivers.

to determine the feasibility of a combined therapeutic yoga and resistance exercise intervention for lung cancer survivors and their caregivers. a single group before and after intervention study design will be used for this pilot feasibility trial. brochures and information about the study will be distributed at the cross cancer institute, and interested individuals will be screened for eligibility. a convenient sampling technique will be used to recruit individuals with lung cancer and their caregiver. participants deemed eligible to take part in the study will provide written informed consent to participate in the study and will undergo baseline testing. the intervention will be carried out over a period of 8 weeks. the feasibility outcomes will include eligibility rate, completion rate, adherence rate and adverse events. dyspnea will be the primary self-reported outcome to be measured for individuals with lung cancer. the secondary outcomes will include fatigue, shoulder range of motion, chest expansion, and muscular strength. the outcome measures for the caregivers will include quality of life (qol) and muscular strength.

Eligibility criteria:
inclusion criteria: 1. diagnosis of primary lung cancer stage i-iv (all stages) 2. any form of lung cancer included: small cell lung cancer and non-small cell lung cancer 3. age: 18 years or above 4. patients at any time point during treatment: ongoing treatment, completed treatment or recently diagnosed and about to start treatment 5. karnofsky performance status ≥ 50 (appendix a) 6. life expectancy at least one year - exclusion criteria: 1. metastatic lung disease that would preclude safe exercise prescription 2. secondary lung cancer due to metastasis from other parts of body 3. co-morbid conditions such as diabetes, congestive heart failure, dementia, cerebrovascular diseases. 4. individuals who would be unsafe to participate in an intervention program. 5. unable to provide consent in english 6. unable to complete either testing or intervention components (e.g. extended holiday) caregiver eligibility: caregivers will be screened using the par-q + questionnaire and will be required to obtain approval from a family physician should any safety concerns be identified.

Keywords: caregiver lung cancer yoga resistance exercise
sentinel lymph node mapping in esophageal cancer using icg dye and nir imaging

Conditions: Esophageal Cancer

Summary: the purpose of this study is to find out whether sentinel lymph node (sln) mapping with icg dye and nir imaging can be used to identify esophageal or esophagogastric junction cancer that has spread to the lymph nodes. if sln mapping is successful in these types of cancer, surgeons in the future could identify the sentinel lymph nodes and only remove these instead of removing all the lymph nodes which is currently done.


Eligibility criteria:
inclusion criteria: * pathological diagnosis of adenocarcinoma tumor located in distal 1/3 of esophagus or esophagogastric junction , with a plan to undergo minimally invasive esophagectomy. * all patients with stage iva (ajcc cancer staging manual, 8th edition) disease will be eligible * ≥18 years of age. * documented, signed, and dated informed consent, obtained before any procedures, for the proposed research study and for standard surgical resection. exclusion criteria: * no plan to undergo surgical resection. * severe iodide or seafood allergy. * women of childbearing potential without a negative pregnancy test; or women who are lactating. * prior diagnosis of severe hepatic or renal dysfunction. * patients with stage ivb or m1 disease (ajcc cancer staging manual, 8th edition) * patients with local recurrence and planning to undergo salvage esophagectomy

Keywords: sentinel lymph node mapping lymphadenectomy esophagectomy icg injection intraoperative nir imaging 20-201
a comparative study of ai methods for fetal diagnostic accuracy in ultrasound

Conditions: Fetal Growth Retardation; Fetal Macrosomia; Fetal Growth

Summary: this study serves as a supplemental investigation to the randomized controlled scan-aid study (nct0632187). this study will evaluate and compare the fetal growth estimation outcomes of ai-supported groups, expert sonographers, and control groups using a secondary ai predictive model.

the goal of this study is to compare the effects of two distinct ai methods on fetal ultrasound diagnostic accuracy. it serves as a supplementary investigation to the scan-aid study (nct nct06232187). this study aims will compare the diagnostic accuracy of two types of ai methods. from the scan-aid study ultrasound novices were randomized into one of three groups with different levels of ai support: control group, ai feedback group 1 where the participants are presented with basic black box ai feedback, and ai feedback group 2 where the participants are presented with a more detailed explainable ai feedback. all the participants are tasked to perform an ultrasound fetal weight estimation (efw) on pregnant women at gestational age 30-37. the outcomes were than compared to the expert sonographers measurements. in this study an operator independent ai method that predicts the fetal weight is used on the scan-aid ultrasound examinations. .

Eligibility criteria:
pregnant women: inclusion criteria: * singelton pregnant. * gestational age: 30-38 weeks * maternal age \< 40 years exclusion criteria: * oligo hydramnion * severe fetal anomaly e.g. fetal heart anomaly, omphalocele etc. * severe fetal macrosomia or growth restriction.

Keywords: artificial intelligence fetal weight estimation ultrasound
study evaluating psi-697 in patients with scleritis

Conditions: Scleritis

Summary: to evaluate the safety of an orally administered single dose of psi-697 in subjects with scleritis, as a model of inflammatory disease. to evaluate by in vivo confocal microscopy (ivcm) the effect of a single dose of psi-697 on leukocyte rolling in the scleral blood vessels of subjects with scleritis.


Eligibility criteria:
inclusion: age 18 or higher; a negative urine pregnancy test at screening for female subjects; female subjects must be postmenopausal or surgically sterile. exclusion: isolated episcleritis; isolated posterior scleritis; infectious scleritis.

Keywords: scleritis
trial of filgrastim versus placebo following allogeneic bone marrow transplantation

Conditions: Graft vs Host Disease

Summary: the effect of haematopoietic growth factors on neutrophil recovery after allogeneic bone marrow transplantation is well recognized. recent laboratory studies demonstrated that these cytokines may also modify t-cell and dendritic cell function, but whether the effect is strong enough to alter the risk of graft-versus-host disease (gvhd) is unclear. the aim of this randomised study is to determine the effect of granulocyte colony-stimulating factor \[g-csf\] (neupogen; filgrastim) on the risk of acute gvhd after allogeneic bone marrow transplantation.


Eligibility criteria:
inclusion criteria: * age: \> 16 years and \< 46 years * geno-identical allogeneic bone marrow transplantation * myeloablative conditioning regimen * haematological malignancies and acquired aplastic anemia * written and informed consent exclusion criteria: * ecog performance score \> 2 * t-cell depletion * serum creatinine level \> 133 µmol/l * abnormal liver function * positive hiv test * pregnant women

Keywords: granulocyte colony stimulating factor
comparison of slow efficiency daily dialysis (sledd) with unfractionated heparin versus citrasate in critically ill patients.

Conditions: Acute Kidney Injury; Hemodialysis

Summary: the purpose of this study is to compare the feasibility, safety and efficacy of hemodialysis with unfractionated heparin compared to hemodialysis with citrasate in critically ill patients.

objective : to compare the feasibility, safety and efficacy of sustained low efficiency daily hemodialysis (sledd) using regional anticoagulation with citrasate® compared to systemic anticoagulation with unfractionated heparin in critically ill patients. design : prospective, randomized, single-center clinical trial setting : mixed medical-surgical 45 bed icu in a tertiary university hospital patients : 250 patients with acute kidney injury (aki) stage iii needing renal replacement therapy interventions : patients are randomized to receive sledd using standard dialysate and systemic anticoagulation with uf versus sledd using citrasate®-dialysate with no additional uf. measurements and main results : primary end point : - the incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting. secondary end points : * the incidence of bleeding episodes as defined by the who-criteria * the transfusion requirements * the incidence of technique failure * the incidence of metabolic derangements (metabolic alkalosis, metabolic acidosis, hypocalcemia, hypercalcemia, hypernatremia, hyponatremia) * the incidence of citrate intoxication * the dialysis efficiency expressed as kt/v and urr tertiary end points : - all cause mortality at day 28 and day 90 after inclusion

Eligibility criteria:
inclusion criteria: * need for hemodialysis in the icu for at least one treatment * no prior hemodialysis treatment in the icu except continuous renal replacement therapy exclusion criteria: * need for systemic anticoagulation with unfractionated or fractionated heparin, oral anticoagulants or intravenous anti-aggregants for other reasons * need for continued thrombolysis therapy within the 6 hours before inclusion * need for continued treatment with activated protein c (drotrecogin alfa) within the 12 hours before inclusion * need for continued treatment with intravenous anti-aggregants (abciximab, eptifabide) within 12 hours before inclusion * liver failure (acute and acute-on-chronic) * confirmed or suspected heparin induced thrombocytopenia (hit) * heparin allergies * severe uncorrected hypocalcemia (ionized calcium \< 0,8 mmol/l) * refusal of informed consent

Keywords: anticoagulation intensive care medicine hemodialysis critical ill patients
assessment of the hemodynamic effect of hydroxocabalamin in refractory vasodilatory shock

Conditions: Vasoplegia; Hemodynamics; Intensive Care Unit; Shock

Summary: through clinical cases or retrospective work with small sample size, some authors have observed an improvement in hemodynamic parameters, with a reduction or even withdrawal of norepinephrine after administration of a single dose of hydroxocobolamin (hcb) in refractory vasoplegic shock (cardiac surgery, liver transplantation and septic shock). hcb produces beneficial alterations in no metabolism and may be suitable in vasoplegic syndrome. in addition, hcb seems to be involved in the elimination of hydrogen sulfide which also has an endogenous vasodilator function in the vascular endothelium. by these different actions it would cause vasoconstriction in vascular smooth muscle cells. previous reports demonstrate that hcb was useful for refractory vasoplegic syndrome. the investigators will conduct a retrospective data collection of patients who was given intravenous hcb for refractory vasoplegic shock since january 2019.

vasoplegic shock is defined by arterial hypotension, a high cardiac output with a normal or high cardiac index, collapsed systemic vascular resistance (svr) and high dose of norepinephrine in the absence of hypovolaemia. the drop in secondary organ perfusion pressure ultimately leads to multiple organ failure and death. through clinical cases or retrospective work with small sample size, some authors have observed an improvement in hemodynamic parameters, with a reduction or even withdrawal of norepinephrine after administration of a single dose of hydroxocobolamin (hcb) in refractory vasoplegic shock (cardiac surgery, liver transplantation and septic shock). hcb produces beneficial alterations in no metabolism and may be suitable in vasoplegic syndrome. in addition, hcb seems to be involved in the elimination of hydrogen sulfide which also has an endogenous vasodilator function in the vascular endothelium. by these different actions it would cause vasoconstriction in vascular smooth muscle cells. previous reports demonstrate that hcb was useful for refractory vasoplegic syndrome. the investigators will conduct a retrospective data collection of patients who was given intravenous hcb for refractory vasoplegic shock since january 2019.

Eligibility criteria:
inclusion criteria: * all svr patients over 18 years of age who had received a dose of hcb since january 1 2019 will be included. exclusion criteria: * patients who received treatment for another indication were not included.

Keywords: vasoplegia hydroxocobalamin hemodynamics intensive care unit shock