Kornimate/medical-research-clean huggingface dataset:
evaluation of the spectra optia® mononuclear cell collection procedure

Conditions: Multiple Myeloma

Summary: the purpose of this investigation is to establish that hematopoetic stem cells collected on a new centrifugal blood separator, caridianbct's spectra optia apheresis system, are able to reconstitute the hematopoetic systems of patients treated with myeloablative therapy, equivalent to hematopoetic cells harvested on the predicate cobe® spectra platform.

this is a multi-center (3-5) single-arm study that will compare the performance of the spectra optia apheresis system's mnc protocol to that of the historical performance of the cobe spectra mnc protocol. in order to demonstrate the substantial equivalence of the two devices, a non-inferiority design will be used. the study will enroll patients with multiple myeloma who are to be treated with myeloablative chemotherapy, followed by bone-marrow rescue with an autologous peripheral blood stem-cell transplant. peripheral blood stem cells will be collected using the spectra optia mnc protocol and re-infused following myeloablative chemotherapy.

Eligibility criteria:
inclusion criteria: * histologic confirmation of multiple myeloma * patients intended to be treated with myeloablative therapy and autologous hematopoetic stem-cell transplant within one month of stem-cell collection * patients whose stem-cell mobilization regimen includes g-csf (granulocyte-colony stimulating factor) * males or non-pregnant females, who are 18 years of age or older * karnofsky score of ≥70% exclusion criteria: * patients with pre-mobilization platelet count \< 75,000/µl * patients who have received pelvic bone marrow irradiation as part of their conditioning therapy * patients who have had a previous hematopoetic stem-cell transplant * patients who have had a previous hematopoetic stem-cell collection failure * impaired cardiac function, as evidenced by left ventricular ejection fraction \<40%. * impaired hepatic function, as evidenced by alanine transaminase \>2.5 x normal * impaired pulmonary function as evidenced by diffusion capacity of the lung for carbon monoxide (adjusted for patient hematocrit, if indicated) or forced expiratory volume in 1 second \<50% of predicted * impaired renal function, as evidenced by a creatinine clearance \< 40 ml/min * impaired coagulation, as evidenced by a prothrombin time (pt) \> twice normal * pregnancy or lactation * seropositivity for human immunodeficiency virus-1/2, hepatitis b virus, or hepatitis c virus * documented bacterial or fungal infection that requires intravenous antibiotics to be started or continued while undergoing apheresis collection on the spectra optia device * subjects enrolled in study protocols that could affect number of cd34+ cells (pluripoten hematopoetic stem stells) collected or kinetics of neutrophil recovery * altered mental status, as evidenced by the inability to provide effective informed consent
a study to assess the safety, tolerability and glucose-lowering efficacy of mk-0893 in participants with type 2 diabetes mellitus (mk-0893-005)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will assess the safety, tolerability and glucose-lowering efficacy of mk-0893 in participants with type 2 diabetes mellitus. the primary hypothesis is that mk-0893 will reduce 24-hour weighted mean glucose (wmg) significantly more than placebo.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * not currently on antihyperglycemic agent (aha) or aha monotherapy (not to include treatment with insulin or thiazolidinediones \[i.e., peroxisome proliferator activated receptor-gamma, pparγ agents\]) * male or a female of non-childbearing potential. women must be postmenopausal or premenopausal and documented surgically sterilized * a body mass index (bmi) that is \> 20 and ≤ 40 kg/m2 exclusion criteria: * history of type 1 diabetes or assessed by the investigator as possibly having type 1 diabetes * history of ketoacidosis; clinically unstable or rapidly progressive diabetic retinopathy, nephropathy, neuropathy * treatment for diabetes within 3 months of study participation with combination anti-hyperglycemic therapy, insulin or thiazolidinediones (e.g., rosiglitazone or pioglitazone) * oral corticosteroid medications within 2 weeks prior to study participation, or requires digoxin, warfarin, warfarin-like anticoagulants, theophylline, anti-dysrhythmic or anti-seizure medications, immunosuppressants, or anti-neoplastic agents, or herbal remedies * history of acquired immunodeficiency syndrome (aids) or human immunodeficiency virus (hiv) * history of gastrointestinal problems or disorders or extensive bowel or gastric surgery * history of significant or unstable cardiovascular disease * history of neoplastic disease * history of hepatic disease * history of seizures, epilepsy or other neurologic disease * history of myelodysplastic or pre-leukemic disorders or other severe hematological disorder

Keywords: diabetes mellitus diabetes mellitus, type 2 glucose metabolism disorders metabolic diseases endocrine system diseases therapeutic uses pharmacologic actions molecular mechanisms of pharmacological action physiological effects of drugs metformin
the effect of early switching from intravenous to oral antibiotics therapy

Conditions: Skin and Subcutaneous Tissue Infection

Summary: to date, many studies showed the great benefits of switching from iv to po antibiotics in some infectious diseases, especially skin and soft tissue, urinary tract, respiratory tract, gallbladder, and biliary tract infection. higher level of evidence is necessary to confirm the benefit of early switching protocol in infectious condition management. therefore, we conducted a clinical trial to investigate the effectiveness and cost of iv-to-po antibiotic switch therapy in some surgical infection conditions.

introduction: the benefit of early switching from intravenous (iv) to oral (po)was raising from the last decade. this randomized clinical trial was to evaluate the effect of early switching from iv to po antibiotics on the outcome of surgical patients at a public hospital. methods: patients admitted for a therapeutic antibiotic to orthopedic and general surgery conditions were randomly assigned to three groups: control (non-switching), early switching (within 48-72 hours), and late switching (after 72 hours). the rate of effectiveness of each arm, length of hospital stay, length of iv antibiotics, and cost were recorded prospectively.

Eligibility criteria:
inclusion criteria: * on the second day of iv antibiotic * no difficulties on taking oral medication * clinical improvement exclusion criteria: * n/a

Keywords: effectiveness antibiotics
pathophysiological implications of the incretin hormones in maturity onset of diabetes of the young (mody)

Conditions: Maturity-onset Diabetes of the Young

Summary: the purpose of this study is to describe the incretin effect and postprandial incretin response in patients with mody2 and mody3 and a group of matched healthy subjects. in sulphonyl urea treated subjects the purpose is also to compare the incretin effect with and without treatment. in healthy subjects the purpose is also to investigate the incretin effect under increased levels of endogen incretin hormones.

comparison of of insulin secretion (auc) during the experimental days. furthermore a comparison of gip, glp1 and glucagon responses as well as plasma glucose levels.

Eligibility criteria:
inclusion criteria: * caucasians above 18 years * bmi \> 19 kg/m2 * negative pancreatic beta cell- and glutamate decarboxylase-65(gad65)- autoantibodies * normal haemoglobin * normal bloodpressure * informed concent exclusion criteria: * known liver disease or affected liver enzymes (alat/asat \>2 x upper normal limit) * nephropathy (see creatinine\> 130 μm and / or albuminuria) * treatment with medications that cannot be discontinued for 12 hours * any condition that the investigators feel would interfere with trial participation * pregnancy or lactation

Keywords: monogenetic diabetes diabetes mellitus
the effect of patient-controlled teas vs sham teas for improve quality of life in patients with cancer pain

Conditions: Cancer Pain

Summary: the conduct of a pilot trial is of great significance as a means of assessing the feasibility and harmonization of the research and is a very necessary precursor to the better conduct of formal trials. the primary aim of this pilot study is to assess the feasibility of a pc-teas in improving the quality of life of cancer patients with pain, with the aspiration of providing process evidence base and an assessment of the intervention for conducting a formal trial. the secondary outcome is to assess the clinical efficacy of the pc-teas.


Eligibility criteria:
participants who had been diagnosed with cancer pain were eligible if they ①were 18 to 75 years old, ②had nrs pain score of ≥4 in the previous 1 week, or had regular use of analgesics, ③ anticipated survival of at least 6 months, ④ecog-ps score ≤2 points, ⑤stable vital signs, clear consciousness, and the ability to correctly judge their pain, communication is unhindered, able to cooperate with researchers to complete relevant research assessments, ⑥voluntarily participate in this study and sign the informed consent form. exclusion criteria included the following: ①have venous thrombosis of the upper and lower limbs (below the elbow/knee joint), active cerebrovascular disease, severe cardiopulmonary dysfunction, or patient is clinically unstable (eg, acute infections, electrolyte disturbances).②patients with pacemaker implantation or metal implantation in the body. ③people with local skin at acupoints lesions, poor skin conditions, or other people unsuitable for pc-teas treatment. ④cancer patients who are planning to become pregnant recently or are pregnant. ⑤have a psychiatric disorder or severe cognitive impairment who are unable to communicate. ⑥participating in other clinical trials.

Keywords: transcutaneous electrical nerve stimulation
smcv assessment on brain swelling in patients with sah

Conditions: Aneurysm; Subarachnoid Hemorrhage; Brain Swelling

Summary: cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage.this study is a retrospective cohort aimed to predict the extent of brain swelling. cerebral venous assessment can identify the risk of brain swelling and improve surgical outcomes.

cerebral swelling is a major complication following aneurysmal subarachnoid hemorrhage (sah).this study is a retrospective cohort aimed to predict the extent of brain swelling (bs). cerebral venous assessment can identify the risk of cerebral swelling and improve surgical outcomes. this study is a retrospective cohort analysis. cerebral venous angiography (cva) will be adopted and the superficial middle cerebral vein (smcvs) will be evaluated.

Eligibility criteria:
inclusion criteria: patients with anterior communicating aneurysm exclusion criteria: hunt-hess grade i- patients with posterior communicating aneurysm, poor general condition or combined with pregnancy , malignant tumors were excluded.
hypothesizing the genesis of infectious diseases and epidemics through an integrated systems biology approach

Conditions: SARS-CoV-2 Infection; Influenza Viral Infections

Summary: in this study, the investigators aim to collect phenotypical and extensive unbiased multimodal biological data, at two different time points, and to integrate them using a systems biology approach. the present project aims at generating a systems biology network that can recapitulate the complexity of processes underlying differential sars-cov-2 phenotypic responses through exploitation of clinical -omics data. identifying key determinants and mechanisms of biological variability responsible for phenotypic differences will lead to a better management of patients through the application of precision medicine.

hygieia is a multicentric prospective interventional study. the study has two parts, part 1 with prospective data and sampling, and part 2 based on samples that were previously collected and stored within cobisa study (2020/11mai/269). i. in part 1, patients acutely infected with sars-cov-2 will be proposed inclusion. included patients will be sampled at two different time points (acute infection and convalescent phase, i.e. 8-12 weeks later). samples will be analysed using cutting edge -omics technologies in order to characterize the genotypic, proteomic, transcriptomic, metabolomic and respiratory microbiota/virome profile through explorative approaches. clinical and routine biological data will be prospectively collected either as outpatients or during the acute hospitalization and convalescent phase. ii. in part 2, samples collected and biobanked during the cobisa study (2020/11mai/269) will be analysed similarly to the samples collected during the prospective part. clinical and routine biological data will be retrospectively collected using the patients electronic medical record (emr). generated data will be integrated using a systems biology approach with algorithms developed by a biostatistics team.

Eligibility criteria:
inclusion criteria: * 18 years or over * patient or legal representative have provided informed consent * cases: reverse-transcriptase polymerase chain reaction (rt-pcr) confirmed symptomatic sars-cov-2 infection. * controls : (1) patient presenting with hypoxemic respiratory failure diagnosed by the treating physician as being from infectious origin; (2) sars-cov-2 infection excluded by rt-pcr and deemed non-probable by the treating physician. * healthy controls : patients presenting without acute respiratory failure (ie. spo2 \>93%); (2) no rt-pcr or antigen rapid test proven sars-cov-2 infection within the last 6 months; (3) no active respiratory tract infection. exclusion criteria: * for all: (1) \<18 years old ; (2)unwilling to provide informed consent; (3) pregnancy at the time of inclusion * for cases: asymptomatic infection * for controls: covid-19 diagnosed by rt-pcr or suspect according to the treating physician at the time of inclusion, * for health controls: acute or chronic respiratory failure.
thromboprophylaxis in individuals undergoing superficial endovenous treatment (thrive)

Conditions: Venous Thromboembolism; Varicose Veins

Summary: endovenous interventions are keyhole operations for varicose veins that are carried out from within the vein itself. varicose veins are enlarged veins close to the surface of the skin. they are connected to the bigger deeper veins in the leg (known as deep veins). because of this, operations to close the varicose veins can increase the chance of a blood clot forming in the deep veins. blood clots in the deep veins happen in around 1 in 50 people after endovenous operations. a clot in the leg can cause swelling, pain, and other long-term problems. if a clot in the leg breaks off and travels to the lungs, it can cause problems with the lung' ability to move oxygen from the air into the blood and may, in rare cases, be life threatening. varicose vein procedures may carry a slightly higher risk of blood clot formation, and we are currently unsure if current clot reducing medicines are beneficial in preventing blood clots in people having varicose vein procedures. this study will investigate if it is worthwhile prescribing medicines to reduce blood clots after varicose vein procedures.


Eligibility criteria:
inclusion criteria: * adults (\>18 years) * scheduled to undergo endovenous intervention of truncal varicose veins under local anaesthesia * treatment technologies including radiofrequency, laser, mechanochemical, foam sclerotherapy and cyanoacrylate glue exclusion criteria: * clinical indication for therapeutic anticoagulation e.g., atrial fibrillation * previous personal or first-degree relative history of vte * thrombophilia * female patients of childbearing potential who have a positive pregnancy test * a history of allergy to heparins or direct oral anticoagulants * a history of heparin-induced thrombocytopenia * inherited and acquired bleeding disorders * evidence of active bleeding * concomitant major health problems such as active cancer and chronic renal and/or liver impairment * known thrombocytopenia (platelets known to be less than 50 x 109 /l) * surgery or major trauma in the previous 90 days * recent ischemic stroke in the previous 90 days * inability to provide consent
does axillary nerve and inferior capsule release add extra benefit in treating patients with adhesive capsulitis

Conditions: Adhesive Capsulitis of Shoulder

Summary: this study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus hydrodilatation with steroid with axillary nerve injection for treating patients with adhesive capsulitis.

adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. this study was conducted to compare the efficacy of rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis. design: a prospective, single-blinded, randomized, clinical trial patient and methods: patients with adhesive capsulitis were enrolled and randomly allocated into group 1 ( ultrasound guided hydrodilatation with steroid via posterior approach) and group 2 (ultrasound guided hydrodilatation with steroid via posterior approach as well as axillary nerve injection). the patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. outcomes measures included a pain scale (visual analog scale), range of motion, and shoulder pain and disability index.

Eligibility criteria:
inclusion criteria: 1. age 35-65 years (to prevent the inclusion of patients with secondary ac), 2. onset of shoulder stiffness since over a month 3. limitation in the passive range of motion (rom) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation. exclusion criteria: 1. ultrasound findings of rotator cuff tears 2. plain radiography findings of significant glenohumeral joint arthritis 3. accompanying cervical radiculopathy 4. systemic inflammatory joint disease 5. intra-articular injection into the glenohumeral joint within the past 3 months 6. history of surgery on the affected shoulders 7. regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids 8. allergy to corticosteroid or lidocaine. -
substudy of change in cardiometabolic disease (cmd) risk factors during an interactive fitness program

Conditions: Insulin Resistance

Summary: substudy examining cardiovascular and metabolic risk factor change in children at high risk for future atherosclerosis who are enrolled in a pilot intervention using novel gaming and exercise activities to increase physical activity.

childhood obesity is increasingly common and is predictive of adult type 2 diabetes and cardiovascular disease (cvd). recent pediatric studies suggest exercise reduces cardiometabolic risk factors. despite evidence of its benefits, exercise training prescribed by pediatricians is traditionally vague, developmentally inappropriate, and/or fraught with psychological, financial and practical barriers. there has been recent interest in the use of interactive technologies, also termed "exer-gaming" as a way to translate known positive benefits of exercise into increased physical activity in youth. initial adult studies demonstrate benefits, yet there are few studies of exer-gaming involving children at increased cvd risk. this project involves a partnership between children's hospital boston and the gokids boston youth fitness research and training center at umass boston, featuring an interdisciplinary team of researchers and clinicians from pediatric cardiology, prevention, nursing, exercise physiology, and behavior change. participants are eligible for this substudy based on enrollment in a pilot project evaluating the effects of a state-of-the-art exercise training facility incorporating the latest technology-based exercise games ("exer-games") in boston public school elementary children. effects on cvd risk factor levels including lipids, blood pressure, body composition vascular reactivity, insulin resistance pre and post intervention will be compared to an advice-only condition and correlated with activity level. eligible participants will be identified as part of the baseline measurements of that study and will be offered the chance to participate in the chb sub-study, a two visit observational design.

Eligibility criteria:
inclusion criteria: * participation in main intervention study exclusion criteria: * unwillingness to comply with study requirements including two visits and data collection procedures

Keywords: insulin resistance cardiovascular risk physical activity child
management of cytomegalovirus (cmv) infection in lung transplant recipients (ltr)

Conditions: Lung Transplant; Complications

Summary: background: lung transplant recipients (ltr) have the highest risk of cmv infection. cmv pneumonitis, lymphocytic bronchitis, and detection of cmv dna in bronchoalveolar lavage fluid are independent risk factors for the development of chronic lung allograft dysfunction (clad). however, to demonstrate the clinical impact of the indirect effects of cmv, it is necessary to conduct studies with a very large sample size. hypothesis: the different current preventive strategies for cmv infection in ltr and their clinical application on a daily basis impact on the development of direct and indirect effects of cmv in this population. objectives: to study the effect of cmv infection on ltr in relation to current preventive strategies in terms of: * the incidence of acute and chronic rejection * the incidence of other opportunistic infections * the incidence of neoplastic disease, especially, post-transplant lymphoproliferative disease * patient and graft survival methods: multicenter, retrospective, cohort study. consecutive inclusion of all adult lung transplant recipients from 2013 to 2017 with 2 years of follow-up. the investigators will collect and analyze the main clinical and microbiological variables in order to respond to the objectives of the study. relevance: knowing in detail the current epidemiology of cmv infection in ltr and its subsequent influence on both mortality and the presence of different complications, could allow improving the management of these patients in the future.


Eligibility criteria:
inclusion criteria: · survival \> 1 month post-transplant • high to moderate risk patients to develop cmv disease by means of pre-transplant cmv serology: * donor positive to recipient negative * recipient positive independently of donor serology exclusion criteria: * survival \< 1 month after procedure * low risk serology to develop cmv disease: both donor and recipient seronegative

Keywords: cytomegalovirus
measuring and predicting glycemic response to food in patients with type 1 diabetes

Conditions: Personalized Medicine in Type 1 Diabetes

Summary: personalized medicine methods in the management of type 1 diabetes

this proposal joins together clinical practitioners, biologists, and computer scientists to set up the infrastructure for research that will facilitate, for the first time, the use of big-data, machine-learning approaches in the application of personalized medicine methods in the management of type 1 diabetes mellitus. we will model the clinical, microbial, and nutritional factors underlying the variability in glycemic response to food in this population; develop algorithms for prediction of this response and for the accurate administration of insulin, assisting the clinical management of the disease and discover intervention targets in the gut microbiome aimed at improving glycemic control.

Eligibility criteria:
inclusion criteria: over one year of diagnostic with t1dm. exclusion criteria: drug related diabetes. genetical diabetes.