Kornimate/medical-research-clean huggingface dataset:
multilevel lifestyle intervention to improve physical function in older adults with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to explore strategies to effectively implement senior-center-based multilevel lifestyle interventions adapted from evidence-based lifestyle interventions to promote physical function and quality of life in diverse older adults with type 2 diabetes (t2d).

aim 1: work with community stakeholders including individuals with t2d, family members, and senior center staff to adapt evidence-based lifestyle interventions, and develop implementation strategies. aim 2: conduct a senior-center-based 6-month pre- and post-pilot study and collect recruitment, enrollment, retention rate, fidelity, program satisfaction and experience, and stakeholder acceptance using quantitative and qualitative data. aim 3: assess the preliminary health-related responses to the intervention in older adults with t2d in the 6-month trial.

Eligibility criteria:
inclusion criteria: 1. adults aged ≥60 years 2. self-reported t2d diagnosis with verification from a health report 3. live within the census tract of the selected senior center, or a member of the senior center 4. no significant cognitive impairment as defined by mmse (score≥20) (46) which may influence diabetes self-management 5. can speak and understand either english or spanish 6. agree to participate in the study procedures exclusion criteria: 1. severe chronic conditions without physician's permission to participate (e.g., severe heart disease and end-stage renal disease); 2. unwillingness to sign the consent form; and 3. enrollment in other diabetes management programs

Keywords: evidence based lifestyle intervention older adults physical function glycemic control
phase 2, multiple ascending dose proof of concept study

Conditions: Infectious Disease

Summary: this is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of cmx157 at increasing dose levels.

this is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of cmx157 at increasing dose levels in hepatitis b virus(hbv) infected subjects.

Eligibility criteria:
inclusion criteria: * capable of giving written informed consent. * capable of completing study requirements. * chronic hepatitis b positive. * hbv treatment naïve. exclusion criteria: * positive result for hcv(hepatitis c virus), hdv(hepatitis d virus) or hiv(human immunodeficiency virus). * history or medical condition that could impact patient safety. * current or past abuse of alcohol or illicit drugs. * abnormal laboratory value or ecg. * pregnant or breastfeeding. * clinical, histologic or laboratory evidence of significant liver fibrosis or cirrhosis. * systemic immunosuppression. * received an investigational drug or investigational vaccine within the 90 days prior to the first dose of study drug.

Keywords: chronic hepatitis b(chb)
whole body vibration in chronic stroke

Conditions: Stroke

Summary: this study is a randomized controlled trial aimed to assess the efficacy of a 10-week whole body vibration training program on physical functioning, societal participation and quality of life in individuals with chronic stroke. it is hypothesized that the whole body vibration program will induce significantly more gain in physical functioning, societal participation, and quality of life in chronic stroke patients, compared with the control group.


Eligibility criteria:
inclusion criteria: * diagnosis of a hemispheric stroke * chronic stroke (onset of 6 months or more) * aged 18 years or older * medically stable * able to stand for at least 1 minute with hand support * abbreviated mental test score at 6 or more * chedoke mcmaster stroke assessment leg or foot score less than 7 points exclusion criteria: * recurrent stroke * brainstem or cerebellar stroke * other neurological conditions * significant musculoskeletal conditions (e.g. amputations) * vestibular disorders * peripheral vascular disease * other serious illnesses * other contraindications to exercise.

Keywords: stroke exercise rehabilitation vibration
screening for advanced heart failure treatment (see-hf)

Conditions: Advanced Heart Failure; CRT and/or ICD

Summary: advanced heart failure therapy (heart transplantation or lvad) is underutilized and patients are underserved. the purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with crt and/or icd who are candidates for advanced heart failure treatment and obtain insights into patient and physician decisions regarding referral for advanced heart failure therapy.


Eligibility criteria:
inclusion criteria: * crt and or icd device in place. * nyha class iii - iv heart failure * ef \</= 40% * patient is an out-patient * patient is on optimal medical management as tolerated and as defined by primary care physician. * patient has signed an informed consent for data collection. exclusion criteria: * age \ 80 years * crt device that has been implanted \< 3 months prior to enrollment * coronary revascularization within 3 months prior to enrollment * patient only has icd but has crt planned * non-cardiac disease resulting in life expectancy \< 2 yrs * patient is hospitalized or will be hospitalized at this time * known diagnosis of dementia * patient is currently on dialysis * oxygen dependent lung disease * previously or currently treated with lvad or heart transplantation

Keywords: thoratec corporation
safety, tolerability, pharmacokinetics and pharmacodynamics of amg 181 in healthy subjects and subjects with mild to moderate ulcerative colitis

Conditions: Ulcerative Colitis

Summary: to assess the safety and tolerability of single subcutaneous (sc) and intravenous (iv) doses of amg 181 in healthy subjects and of a single sc dose in subjects with mild to moderate ulcerative colitis (uc)


Eligibility criteria:
inclusion criteria: healthy volunteers * healthy male or female subjects of non-reproductive potential between 18 to 45 year-of -age * body mass index (bmi) between 18 and 34 kg/m2 * normal physical and neurological examination, clinical laboratory values and ecg * additional inclusion criteria apply inclusion criteria: subjects with mild to moderate ulcerative colitis * male or female subjects between 18 to 55 year-of -age * body mass index (bmi) between 18 and 34 kg/m2 * diagnosis of ulcerative colitis for at least 2 months * active, mild to moderate disease as defined by an ulcerative colitis disease activity index (ucdai, aka mayo score) score of 4 to 9 (inclusive), with a minimum sigmoidoscopy score of 1 * additional inclusion criteria apply exclusion criteria: healthy volunteers * history or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluations, procedures or completion * history of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers within the past 5 years * recent or on-going infection(s) * underlying condition(s) that predisposes the subject to infections * additional exclusion criteria apply exclusion criteria: subjects with mild to moderate ulcerative colitis * disease limited to the rectum, i.e. within 20 cm of the anal verge * any prior gastrointestinal surgery * evidence of severe disease (as evidenced by an hb concentration \<11g/dl; toxic megacolon, or an ucdai score≥10) * immunosuppressive therapy with either azathioprine, methotrexate, or mercaptopurine, within the past 3 months * prior exposure to a biologic agent or cyclosporine a * use of antibiotics within the past 2 weeks of screening and during screening period * use of topical (e.g. suppository or enema) mesalamine or steroids within two weeks prior to day 1 * additional exclusion criteria apply

Keywords: inflammatory bowel disease amgen
the diabetes patient-reported outcome measures trial

Conditions: Diabetes Mellitus, Type 1

Summary: the study aim to evaluate the use of patient-reported outcome measures in clinical diabetes consultations.

the psychological and emotional impact of living with diabetes is greatly underreported in clinical diabetes care, and diabetes distress is found to be associated with decreased glycemic control. therefore, regular assessment of diabetes distress is recommended. the integration of assessments with patient-reported outcome measures (proms) in clinical practice has the potential to enhance care for people with diabetes by identifying problems and improving patient-clinician communication. the overall aim of the diaprom trial is to develop, test and evaluate the effectiveness of a structured empowerment-based intervention with the use of a prom regarding diabetes distress as a tool for needs assessment and dialogue support in clinical diabetes consultations among adults with type 1 diabetes. the investigator's hypothesis is that the intervention primarily will reduce diabetes distress and secondarily improve overall well-being, improve the perceived competence for diabetes management, improve glycemic control, and improve satisfaction with the diabetes follow-up.

Eligibility criteria:
1. inclusion criteria: * type 1 diabetes for more than one year 2. exclusion criteria: 1. not being able to read and complete questionnaires on the computer because of * language problems * reading problems * cognitive problems 2. pregnancy 3. severe somatic and psychiatric co-morbidities

Keywords: diabetes-related distress living with diabetes patient-reported outcome measures (proms)
the impact of a technology-enabled decision aid, for patients with hip and knee osteoarthritis on decision quality, level of shared decision-making, patient satisfaction and magnitude of limitations

Conditions: Osteoarthritis, Knee

Summary: this study evaluates a technology-enabled decision aid that provides evidence-based education (i.e. on understanding the condition, treatment options and comparisons, patient values and question \& answer quiz) and personalized, quantifiable benefit-risk ratio alongside the level of potential benefit in relation to joint stiffness, joint pain and quality of life. the study will be performed in the setting of an integrated care system providing patient-centered care for hip and knee osteoarthritis over the full cycle of care. the impact of a technology-enabled decision aid incorporating predictive analytics with machine learning capabilities on decision quality, activation, experience \& limitations of patients in this setting is relatively unknown.


Eligibility criteria:
inclusion criteria: * all patients with a presumptive diagnosis of knee oa aged between 45 and 89 (in-line with the decision aid algorithm) * radiographic evidence of moderate to severe osteoarthritis (kellgren and lawrence grade 3-4) * koos jr scores between 0-85 (in-line with the decision-aid algorithm) * participant able to give informed consent for participation in the study exclusion criteria: * kellgren and lawrence scale for classification of osteoarthritis grade 0-2 * patients with a prior experience of total joint replacement * patient with experience with the pilot form of the decision aid * patients undergoing consideration for revision joint replacement * patients seeking care for trauma condition or psoriatic/rheumatoid arthritis * non-english or non-spanish speakers * patients with bmi below 20 or above 46 (in-line with the decision-aid algorithm)

Keywords: shared decision making osteoarthritis
clinical decision rule validation study to predict low recurrent risk in patients with unprovoked venous thromboembolism

Conditions: Idiopathic Venous Thromboembolism

Summary: the main objective of this study is to verify whether a new clinical decision rule identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence can safely stop oral anticoagulant therapy after 5-7 months of treatment.

up to 50% of patients with a first episode of venous thromboembolism (vte) have no identifiable cause (i.e. are unprovoked vtes). the risk of recurrent vte in this large group of patients with unprovoked vte after 3-6 months of anticoagulant therapy is 5-10.8% in the year following discontinuation of oral anticoagulant therapy. one in six to one in twenty recurrences of a new vte are fatal. given the intermediate risks of recurrence in unselected unprovoked vte patients, clinicians do not have clear guidance on whether to continue or discontinue anticoagulants in patients with unprovoked vte. recently attention has turned to the concept of risk stratification to identify subgroups of patients with unprovoked vte who could safely discontinue oral anticoagulation therapy (oat). in the reverse i study, a clinical decision rule derivation study conducted from 2001 to 2006, we developed and internally validated the clinical decision rule "men continue and her doo2" that identifies patients with a first unprovoked vte who likely have a low risk of recurrent vte and could safely discontinue oat subsequent to 5-7 months of oat. the present study will evaluate if the "men continue and her doo2" rule (comprised of gender, elevated d-dimer levels, post-thrombotic signs, obesity, and older age) is safe, clinically useful, and reproducible when prospectively implemented in multiple centers and a variety of settings. if this clinical decision rule is validated, it will provide physicians with important information to allow them to more confidently identify unprovoked vte patients at low risk of vte recurrence who may not need to continue oat.

Eligibility criteria:
inclusion criteria: * first episode of major unprovoked vte * vte objectively proven * vte treated for 5-12 months with anticoagulant therapy authorized for the reverse ii study (initial or ongoing therapy) * absence of recurrent vte during the treatment period exclusion criteria: * less than 18 years of age * patients who have already discontinued anticoagulant therapy * patients requiring ongoing anticoagulation for reasons other than vte * being treated for a recurrent unprovoked vte * patients with high risk thrombophilia * patients who plan on using exogenous estrogen(ocp,hrt)if anticoagulant therapy is discontinued * patients with pregnancy associated vte * geographically inaccessible for follow-up * patients unable or unwilling to provide informed consent

Keywords: unprovoked venous thromboembolism clinical decision rule anticoagulants recurrence prognostic risk stratification
study of the risk factors and outcomes after gastrointestinal bleeding

Conditions: Gastrointestinal Hemorrhage; Cardiovascular Diseases

Summary: the purpose of this multicenter, two component observational and standardized case-control study is to evaluate risk factors of gastrointestinal (gi) bleeding with a prospective 3-month and 12-month follow-up to examine outcomes and their possible causes.

antithrombotic therapies are effective for prevention of cardiovascular (cv) events but cause bleeding. emerging evidence indicates that extra-cranial bleeding is just as important as myocardial infarction as a marker of risk for subsequent non-fatal and fatal cv events, but this issue has not been prospectively studied. if the association between bleeding and cv events is causal, prevention of bleeding, by targeting the risk factors, and prevention of the complications of bleeding, by targeting the causal pathways, could substantially reduce the burden of bleeding-related cv events. progress in developing these approaches has been limited by a knowledge gap. known risk factors do not fully explain bleeding risk and the investigators do not understand the mechanisms linking bleeding with adverse outcome and whether the association is causal. one-half of bleeds that lead to cv events in patients receiving antithrombotic therapy arise in the gi tract. interbleed plans to explore risk factors for gi bleeding, and outcomes after gi bleeding, in this well-circumscribed and important group using a case-control design with prospective 3 month and 12 month follow-up. specific objectives are to: (1) identify risk factors for gi bleeding and estimate their population attributable risk; (2) determine the risk of non-fatal and fatal cv events and functional outcomes after gi bleeding; and (3) explore the possible mechanisms linking gi bleeding with cv outcome. interbleed will recruit 2500 case-control pairs from centres in argentina, belgium, brazil, china, ireland and the netherlands. data will be collected on patient characteristics, medical history and, in cases, the work-up, management and outcomes after bleeding. the interbleed results will help to develop new approaches to reducing the burden of bleeding-related cv events.

Eligibility criteria:
inclusion criteria: cases * age ≥ 18 years at enrollment * written informed consent * confirmed cardiovascular disease * present to the hospital with gi tract bleed or develop gi tract bleed in hospital controls * age ≥ 18 years at enrollment * written informed consent * confirmed cardiovascular disease
post-marketing surveillance (pms) use-result surveillance with spikevax bivalent and spikevax x injection.

Conditions: SARS-CoV-2

Summary: the main objective of the surveillance is to evaluate the incidence of the adverse events (aes), and other safety related information in south-korean population.


Eligibility criteria:
inclusion criteria: * participants should be 18 years or older for spikevax bivalent ba.1, spikevax bivalent ba.4/5 vaccine, and 12 years or older for spikevax xbb.1.5 injection. * participants of any age which is approved for the use of spikevax bivalent ba.1, spikevax bivalent ba.4/5 or spikevax xbb.1.5 for active immunization to prevent covid-19 caused by sars-cov-2. * participant who will be vaccinated with spikevax bivalent ba.1, spikevax bivalent ba.4/5 or spikevax xbb.1.5 following local label approved by ministry of food and drug safety (mfds). * participant who will be vaccinated with at least one dose of spikevax bivalent ba.1, spikevax bivalent ba.4/5 or spikevax xbb.1.5. exclusion criteria: * participant whose participation is deemed inappropriate at the investigator's discretion. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: mrna-1273 mrna-1273 vaccine sars-cov-2 sars-cov-2 vaccine coronavirus virus diseases messenger rna covid-19 covid-19 vaccine moderna
benefits of hysteroscopy prior to performing a cycle of in vitro fertilization/intracytoplasmic sperm injection

Conditions: Sterility

Summary: this is a prospective randomized open-label trial. women scheduled for their first or second in-vitro fertilization/intracytoplasmatic sperm injection (ivf/icsi) cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. in the first group (group i) 31 patients underwent hysteroscopy examination before ivf cycle while in the second group (group ii) 37 patients underwent direct cycle without previous hysteroscopy

this is a prospective randomized open-label trial. women scheduled for their first or second ivf/icsi cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. in the first group (group i) 31 patients underwent hysteroscopy examination before ivf cycle while in the second group (group ii) 37 patients underwent direct cycle without previous hysteroscopy. then ivf cycle was performed with habitual protocol. beta corionic gonatropic hormone (bhcg) test two weeks after embryo transfer was done. if test was positive, patients were followed up for detection pregnancy by transvaginal ultrasound two weeks later. another transvaginal ultrasound at 12 weeks of gestation was done to confirm ongoing pregnancy. biochemical pregnancy, implantation, on-going pregnancy and livebirth rates were compared in both groups. miscarriage, complications rate and hysteroscopy tolerability were also analyzed.

Eligibility criteria:
inclusion criteria: * women with infertility / primary infertility. * women who are about to start an ivf/icsi cycle with their own eggs. * age greater than or equal to 18 years and less than or equal to 40 years. * women in whom a multiple follicular development will be developed with a short protocol with antagonists or long with agonists, and starting dose of gonadotropins according to clinical criteria. * women with uterine ultrasound without endometrial pathology exclusion criteria: * ovarian reserve: antimullerian hormone \<0.5 ng / dl or count of antral follicles \<5 between both ovaries. * myomatous uterus: presence of\> 2 myomas\> 4cm or that deform uterine cavity. * uterine malformations. * body mass index (bmi) \ 30. * polycystic ovarian syndrome: according to european society of human reproduction and embryology (esrhe)/rotterdam 2003 criteria. * moderate-severe endometriosis. * background or presence of pelvic inflammatory disease. * hydrosalpinx not excised or occluded. * hyperprolactinemia, defined as prolactin levels greater than 50 ng / ml. * diagnostic history of endometrial hyperplasia. * severe male factor: severe oligoasthenoteratozoospermia with a sperm cell count (rem) \<100,000 spermatozoa / ml. * impossibility to apply the treatments provided by the study in the terms established by the protocol. * contraindication for the use of any of the treatments provided in the study.
thoracic surgery by the medtronic hugo™ robotic system

Conditions: Thoracic Cancer

Summary: the introduction of robot-assisted surgery is one of the biggest breakthroughs in surgery, and represents the most significant advancement in minimally invasive surgery of recent decades. one of the first surgical uses of the robot was in orthopaedics, neurosurgery and cardiac surgery. however, it's use has now been well recognized in thoracic surgical procedures ranging from mediastinal tumour resection to complex major lung resections. robotic surgery by the da vinci surgical system (intuitive surgical, inc) has been one of the most commonly used robotic systems in surgery. the robotic system overcomes the limitations of the standard thoracoscopic approach and allows for precise dissection in a confined space. these advantages include stable operator-controlled camera, high- definition 3d magnified view of 10 to 12 times, articulating instruments with seven degrees of freedom, motion scaling, and tremor filtration. recently the medtronic hugo™ surgical robotic system has passed the ce mark. this robotic platform, made up of modular surgical arms on wheeled carts, has started its operation in human in latin america, europe and the asia-pacific region. the hugo™ system is designed to provide a lower barrier to entry for hospitals looking to expand their reach in robotic surgery. compared to the platform by intuitive surgical, hugo™can be customized with up to four independent arms, and rolled to different locations in a hospital when needed. the investigator's centre is the first robotic surgical centre in hong kong since 2005. over the years, the investigator have established the centre to be one of the leading centre in hong kong and the region, with involvement in various new development in thoracic robotic procedures, publications and books, and more recently in robotic endo-lumenal procedures. in this study, the investigator evaluate the early surgical outcome and objective functional outcome of patients undergoing robotic thoracic surgery by the medtronic hugo™ surgical robotic system.


Eligibility criteria:
inclusion criteria: 1. age between 18 - 80 years 2. body mass index \<35 kg/m2 3. suitable for minimally invasive surgery 4. willingness to participate as demonstrated by giving informed consent exclusion criteria: 1. contraindication to general anaesthesia 2. severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention 3. untreated active infection 4. non-correctable coagulopathy 5. emergency surgery 6. vulnerable population (e.g. mentally disabled, pregnancy)

Keywords: robotic assisted thoracic surgery minimally invasive surgery lung cancer mediastinal tumour