Kornimate/medical-research-clean huggingface dataset:
a pilot proof of concept, randomized controlled, single-center study of a decision aid tool for older patients considering lhc as treatment for nstemi

Conditions: NSTEMI

Summary: this study will be a single-center, prospective, un-blinded, randomized controlled trial evaluating a decision aid tool for older patients considering left heart catheterization (lhc) as treatment for non-st elevation myocardial infarction (nstemi). the study population is 50 total inpatients (25 per study arm) with nstemi eligible for elective lhc. the first arm is the control group that will receive standard of care, while the second arm will have access to the decision aid and shared-decision making conversation with one of the co-investigators. baseline characteristics and surveys/questionnaire data will be collected after study intervention (as applicable), and prior to final decision regarding lhc. statistical analyses will be conducted on the primary endpoint, decisional conflict score, as well as on various secondary endpoints.

a single-center, prospective, un-blinded, randomized controlled trial. primary objective: to pilot a coronary revascularization decision aid in older adults with nstemi who are candidates for elective lhc in order to determine its effectiveness in lowering decisional conflict by the decisional conflict scale (dcs). secondary objectives: to determine decision aid feasibility by measuring time of administration and percentage of patients agreeing to use. also, to assess efficacy of the decision aid in decreasing patient feelings of anxiety and depression (by the hospital anxiety and depression scale), increasing decision self-efficacy (by the ottawa decision self-efficacy scale), and increasing medical knowledge.

Eligibility criteria:
inclusion criteria: * must be admitted to the hospital, and there must be clinical suspicion for type i nstemi * must be eligible for non-urgent revascularization * must have capacity to consent for the study based on the judgment of the study investigators * must speak english exclusion criteria: * does not meet all of the inclusion criteria listed above * has significant vision or hearing impairment that prohibits use of the decision aid * unable to read * has a clinical diagnosis of dementia and/or severe cognitive impairment documented in the electronic medical record

Keywords: shared decision making left heart catheterization non-st elevation myocardial infarction decisional conflict decision aid
multiple dose study evaluating the safety and tolerability of nsa-789

Conditions: Alzheimer Disease; Healthy Subjects

Summary: this is a multiple dose study of nsa-789, the purpose of which is to assess the safety and tolerability in healthy subjects and subjects with alzheimer's disease


Eligibility criteria:
inclusion criteria * men or women aged 18 - 50 years (healthy subjects) or greater than 55 years old (subjects with alzheimer's disease) * women must be surgically sterile or postmenopausal * subjects with alzheimer's disease must be generally healthy, but may have a stable, chronic illness if well controlled. exclusion criteria * healthy subjects may not be on any prescription or investigation drugs within 30 days of start of study. * subjects with alzheimer's disease may not be on any cholinesterase inhibitors such as donepezil (aricept®) or rivastigmine (exelon®) within 4 weeks of the start of the study.

Keywords: alzheimer's disease schizophrenia
treatment of anterior ligament rupture with internal brace repair - a prospective randomised controlled study.

Conditions: Ligament; Laxity, Knee; Anterior Cruciate Ligament Injury

Summary: the purpose of this study is to determine whether anterior cruciate ligament injury in patients wishing to return to sports activities may be treated with repair supplemented with internal brace compared with a standard operation using a patella tendon autograft.


Eligibility criteria:
inclusion criteria: * anterior cruciate ligament rupture exclusion criteria: * current malignant disease * rheumatoid arthritis * other knee ligament instability * obesity bmi \>30 * morbus bechterew
study of stp938 in advanced solid tumours

Conditions: Solid Tumor

Summary: the phase 1a part of the study is a dose escalation of stp938 as a monotherapy. the phase 1b part of the study is a safety expansion cohort of stp938 as a monotherapy.


Eligibility criteria:
main inclusion criteria: * signed and dated informed consent, and able to comply with the study procedures and any locally required authorization. * male or female aged ≥ 18 years. * advanced disease not curable by available therapies and requires systemic therapy. * histologically confirmed diagnosis of eligible cancer type. * must have tumor tissue available for biomarker testing. * measurable disease (part 1) and measurable disease per recist (part2) * eastern cooperative oncology group (ecog) performance status ≤2. * life expectancy \> 3 months as assessed by the investigator. * adequate organ function (bone marrow, hepatic, renal function and coagulation). * all toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤grade 1 or returned to baseline levels prior to enrollment. main exclusion criteria: * pregnant or breastfeeding females and women of childbearing potential or males unwilling to comply with contraception requirements. * known active or symptomatic cns metastases, carcinomatous meningitis, leptomeningeal disease or a history of spinal cord compression * active malignancy within 2 years of study enrollment * prior radiation within 2 weeks of start of therapy. * systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or \<5 half-lives since completion of previous investigational therapy, whichever is shorter. * uncontrolled intercurrent illness. * immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in the last 12 months. * known active or chronic hepatitis b or active hepatitis c virus (hcv) infection. * subjects with corrected qt interval \>470 msec based on averaged triplicate electrocardiogram (ecg) readings at the screening visit using the qt interval corrected for heart rate using fridericia's method (qtcf).
pneumatic displacement of subretinal hemorrhage with perfluorocarbon gases

Conditions: Subretinal Hemorrhage and Exudative Maculopathy

Summary: subretinal hemorrhage in the macula causes a significant loss of vision. this hemorrhage can be displaced by the use of a small volume of pure perfluorocarbon gas injected into the vitreous, which expands to a 40% gas bubble in the eye. when the patient gazes 40 to 60 degree below the horizontal, the gas bubble covers the hemorrhage and gravity displaces it rapidly. this position of gaze is easier for the patient than the face down position traditionally recommended.a vector of gravity force tangential to the sclera brings about this displacement. the procedure can improve vision quickly, reduce unwanted degenerative changes in the macula because of the persistent macular hemorrhage and improves the chances of treating of the underlying cause for the subretinal hemorrhage by laser or other means.

this protocol was designed to determine the optimum position of the gaze for pneumatic displacement of subretinal hemorrhage (srh) in the macula. a geometrical analysis of the forces that act upon a srh in the presence of an intraocular gas bubble was analyzed and it was concluded that the displacement was due to the effect of gravity on the srh immersed in gas. this was followed by a prospective trial of positions of gaze and volumes of gas calculated to be optimum for displacement. the eyes of consecutive patients with srh in the macula will had an intravitreal injection of pure perfluorocarbon gas sufficient to provide a 40% bubble after expansion. the patients are instructed to gaze down 40° or 60° below the horizontal depending on the volume of gas for 20 minutes every hour. the srh is displaced rapidly in the first week. visual acuity usually improves but recovery can be limited by the presence of sub pigment epithelial hemorrhage, exudate or proliferation. a vector of the gravity force tangential to the sclera is the largest force acting to displace a subretinal hemorrhage within a gas bubble. 79% of the vertical gravity component is obtained at gaze 40° below the horizontal and requires volumes of intraocular gas not requiring prior removal of vitreous. face down positioning in common practice has been an error and succeeds only if the patient has been non compliant. 5- status

Eligibility criteria:
inclusion criteria: * diminished vision secondary to subretinal hemorrhage in the macula or exudative maculopathy. exclusion criteria: * patient unable to maintain gaze position for 20 minutes every waking hour for 7 days. * patient unable to sleep on their side or with head elevated 40 degrees.

Keywords: subretinal hemorrhage, perfluorocarbon gas
prospective, randomized clinical trial comparing early versus delayed postoperative mobilization after arthroscopic rotator cuff tear reapair.

Conditions: Rotator Cuff Tear Repair

Summary: arthroscopic suture for complete and partial \>50% thickness rotator cuff tears (rct) is the gold standard. however, there is no evidence of superiority of delayed postoperative mobilization protocols versus early ones, in terms of rom, pain, quality of life and complications in last review published in 2019 by aaos. although, excessive immobilization can lead into stiffness, neuropathic pain or adhesive capsulitis. all of these are complications which can diminish patient quality of life or prolong their return to work or sports activities. this is an experimental, prospective, non-blind, comparative, randomized clinical trial, between two options of treatment. on one treatment branch, we will continue applying our standard postoperative 4 weeks immobilization rehabilitation program with a sling in adduction and internal rotation. on the other treatment branch, we will start passive mobilization during second week after surgery, including controlled external rotation movements. all recruited patients will be followed-up during 12 months. our main objective is to compare differences in terms of functionality (using ases scale). secondary objectives are to compare differences in terms of rom, functionality (using cms and ucla scales), pain (using vas score), need of analgesic drugs, quality of life (using eq-5d scale), return to previous work and sports activities, patient adhesion to protocol, complications and mri rotator cuff retear ratio at 12 months follow-up. after this study, we hope to develop a new postoperative mobilization protocol for patients. this protocol will be focused on timing, and self-administrated exercises in order to involve patients in their recovery, in the fastest and safest way for them.


Eligibility criteria:
inclusion criteria: * age: less tan 70 years old. * sex: male or female. * treatment: arthroscopic rct suture. * rct type: degenerative, total or partial \>50% thickness, less than 3 cm length tear. * mri tear classification: patté's in coronal view i or ii, goutalier's \<2, fukuda's \<2 and seebauer´s 1a maximum. exclusion criteria: * not meet the inclusion criteria. * previous surgical procedure in affected shoulder. * have been treated with 2 or more glucocorticoid injections in last year. * high anesthetic risk.
prostaglandin e1 in outpatients with intermittent claudication

Conditions: Stage II Peripheral Arterial Occlusive Disease; Intermittent Claudication Fontaine Stage II PAOD

Summary: investigate, under outpatient conditions, both the effect of 4 weeks of daily treatment with prostaglandin e1 and that of 4 weeks of interval treatment (two infusions per week) on the pain-free walking distance in patients with intermittent claudication.


Eligibility criteria:
inclusion criteria: * subjects with peripheral arterial occlusive disease (paod) of the lower extremity in fontaine stage ii * maximum walking distance on the treadmill (12 %, 3 km/h) between 30 and 150 m * stable intermittent claudication of at least 6 months standing with no acute shortening of walking distance over the past 3 months * stenoses or occlusions below the femoral bifurcation (above-knee or below-knee type) confirmed by duplex us or angiography * ankle/brachial index ≤ 0.90 with a decrease in systolic ankle pressure of ≥ 10 % after maximum loading (maximum walking distance on the treadmill at 3 km/h, 12 %) * the patient is physically and mentally capable of participating in the trial * patient age \> 40 years, male and female * patient is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent * patient is willing and able to comply with all trial requirements exclusion criteria: * surgical or other interventional measures performed on the affected extremity and prostaglandin treatment within the 6 months immediately prior to the trial * rest pain and necroses * systolic ankle pressure less than 50 mmhg * change in maximum walking distance during the one-week run-in phase of more than ± 25 % of baseline * successful physical walking training within the 6 months immediately prior to the trial * inflammatory vascular diseases * polyneuropathy in diabetes mellitus * diseases limiting walking distance (arthrosis, inflammatory diseases of the joints, neurological disease, diseases of the vertebral column, cardiopulmonary diseases) * history of pulmonary oedema * myocardial infarction within the past 6 months * pregnancy or nursing * known hypersensitivity to any components of the trial medication or comparative drug * renal insufficiency, compensated retention (creatinine \> 2.0 mg/dl) * severe retinal haemorrhage * massive haemorrhage * known existing malignant diseases * vasoactive concomitant medication (e.g. naftidrofuryl, pentoxifylline, buflomedil, cilostazol), or other prostaglandins * untreated or uncontrolled hypertension (systolic blood pressure ≥ 180 mmhg, diastolic blood pressure ≥ 110 mmhg) * previous participation of the patient in the present trial * participation of the patient in a trial with the same objectives within the past 6 months, or is currently participating in another trial * illness of the patient due to alcohol or drug-abuse within the past 6 months * serious illness of the patient that the investigator considers to compromise his/her participation in the trial

Keywords: alprostadil prostaglandin e1 prostavasin® paod
effects of vsl#3 on metabolic, endocrine, lipidomic and inflammatory parameters of pediatric patients with bmi>90°

Conditions: Obesity

Summary: obesity in children has become a significant social problem considering that nowadays 4 to 5 % of all children are obese in the industrialized countries with increased incidence in europe by 10 to 50% over the past 10 years. obesity is associated with the metabolic syndrome in 30% of the children and is considered as a state of chronic inflammation inducing the production of pro-inflammatory cytokines which determine metabolic and endocrine alterations on the organism. it has been observed that obesity is also linked to a change in the intestinal microflora with a reduction of bacterioides and bifidobacteria and a decrease of firmicutes and staphylococcus aureus. the qualitative and quantitative analysis of the metabolites may provide us with a characterization of the existing phenotypes and variations in relation to the changes of the physiological state, in particular when supplemented or not with a probiotic preparation.


Eligibility criteria:
inclusion criteria: * age 6-12 * parents or tutors able to give the written consent and follow the study procedures value of bmi\>90° exclusion criteria: * - any severe or concomitant clinical or psychiatric condition that, in the investigator's opinion, could affect the treatment, the evaluations and the inclusion in the protocol; * evidence of active liver disease due to other causes; * steroid treatment; immuno suppressive therapies, chemotherapy agents within 2 month from screening; * pregnancy or breastfeeding; * abuse of alcohol and drugs clinically relevant; * diabetes.

Keywords: probiotic, obesity, bmi, metabolic profile, metabolomics
learning and coping with chronic illness

Conditions: Morbid Obesity

Summary: the purpose of this study is to determine whether the participants have improved their scores on health related quality of life (hrql) 1 year after completing a learning and mastery course and whether sociodemographic variables are associated with hrql.

persons with chronic illnesses have to adjust to changes in their life-style. in the last 10 years learning and mastery centres have been established in norwegian hospitals to offer patient education for the chronically ill. it is not known whether these courses impact any changes in hrql 1 year after course completion.

Eligibility criteria:
inclusion criteria: * diagnosis of morbid obesity * attending learning and mastery course for the obese

Keywords: morbid obesity patient education
coronary collaterals and post-reperfusion intramyocardial hemorrhage

Conditions: Acute Myocardial Infarction

Summary: this study examines the relationship between angiographic coronary collaterals (rentrop grades) and post-reperfusion microvascular injury. this study aims to assess the impact of coronary collateral circulation on intramyocardial hemorrhage incidence and extent.


Eligibility criteria:
1. age 18-85 years 2. index stemi 3. coronary angiogram with primary coronary intervention 4. no contraindications for cardiac mri

Keywords: coronary angiography intramyocardial hemorrhage cardiac magnetic resonance
accelerated age-related cognitive decline: impact of exercise on executive function and neuroplasticity

Conditions: Mild Cognitive Impairment; Chronic Kidney Diseases

Summary: the purpose of this study is to see if 6 months of home-based walking will improve memory, and brain structure and function, compared to health education in older adults that have chronic kidney disease and mild cognitive impairment.

following informed consent, participants will undergo tests for heart health, physical function, memory testing, and brain structure and function using imaging (taking pictures of the brain with an mri). following these tests participants are randomized to a home-based walking program or health education for 6 months. participants are given a fitness tracker and gets ongoing telephone coaching during the 6 months. after 6 months the tests are repeated.

Eligibility criteria:
inclusion criteria: * • diagnosed stage 3-4 chronic kidney disease (ckd, estimated glomerular filtration rate (egfr) \<60 to 20 ml/min); * \>55 yrs of age * mild cognitive impairment (18-26 on the moca) * ability to undergo an mr * no history of major head trauma (no head trauma/concussion with loss of consciousness) * speaks, reads, writes english exclusion criteria: * • diagnosed dementia or a clinical dementia rating scale score of \<2, or a moca of \<18 * participating in a supervised exercise program with intent to increase fitness levels 3 days/week, * requires assistive ambulation * limited exercise capacity due to claudication; unstable angina, severe arthritis, extreme dyspnea on exertion, unstable coronary artery disease * class iii-iv heart failure * history of uncontrolled sustained arrhythmias, severe/symptomatic aortic or mitral stenosis, hypertrophic obstructive cardiomyopathy, severe pulmonary hypertension, active myocarditis/pericarditis, thrombophlebitis, and recent systemic/pulmonary embolus * resting systolic bp \>200 mmhg or resting diastolic bp \>110 mmhg * any unforeseen illness or disability that would preclude cognitive testing or exercise training * one or more contraindication for mri; cardiac pacemaker, aneurysm clip, cochlear implants, shrapnel, history of metal fragments in eyes, neurostimulators, diagnosed claustrophobia (mri only) * any self-reported major psychiatric disorders requiring medical therapy (e.g. schizophrenia, bipolar disorder). * self-reported new diagnosis of clinical depression within 3 months of enrollment or unstable clinical depression requiring medication adjustment within 3 months of enrollment

Keywords: mild cognitive impairment chronic kidney disease exercise lifestyle behavior home-based exercise
enteral feeding of premature babies and olive oil supplementation

Conditions: Premature; Olive Oil; Enteral Feeding

Summary: it is a two-arm prospective interventional study. 40 babies in both groups will be enrolment in the study. in the intervention group, babies will take 1 ml/kg/day of the study product (ultra premium) after full enteral feeding. supplementation will continue until discharge or the 36th week. blood samples will be taken for serum total antioxidant capacity and malondialdehyde levels before the intervention and on the 14th day of the control group. at the end of the study, serum will be taken again for control values. daily lipid intake amounts will be recorded through breast milk analysis. lipid profile will be monitored weekly the growth parameters of babies will be monitored daily it will be evaluated at the end of the study in terms of rop, bpd, and nec. at the end of the study, the data of babies in both groups will be compared.


Eligibility criteria:
inclusion criteria: * premature babies born at 32 weeks or less * babies who tolerate full enteral feeding at the before end of the second week * babies given consent by their parents - exclusion criteria: * having a congenital or genetic anomaly
traveler's diarrhea (td) vaccine asia efficacy study

Conditions: Traveler's Diarrhea

Summary: the purpose of this study is to evaluate the efficacy of the td vaccine system to prevent moderate to severe enterotoxin e.coli (etec) disease in travelers to india.


Eligibility criteria:
inclusion criteria: * 18-64 years of age at date of first vaccination * good health as determined by medical history and physical inspection * females of child-bearing potential must have a negative pregnancy test prior to first and second vaccination in the country of origin; females of child-bearing potential must agree not to become pregnant throughout the duration of study * subjects must have planned travel to dc, within 3 hours traveling distance of approved study site(s), for a minimum duration of stay of 7 days (no maximum stay is specified for inclusion). * subject must be able to communicate in english exclusion criteria: * abnormalities as determined by the investigator/clinician during physical inspection; * participated in research involving investigational product within 30 days before planned date of first vaccination; * ever received lt, etec, or cholera vaccine; * history of diarrhea while traveling in a developing country within the last year; * women who are pregnant or breastfeeding; * clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease; * history of irritable bowel syndrome; * seizure disorder within the last year; * current use of immunosuppressive therapy (excluding inhaled steroids) or immunodeficiency; * known or suspected alcohol abuse or illicit drug use within the last year; * medical history of hiv, hbv, or hcv; * an employee of a study site; * known allergies to any component of the vaccine, including adhesives; * planned use of antibiotics with known activity against gram negative facultative anaerobes; * planned use of antacids, antidiarrheals, loperamide, bismuth subsalicylate, diphenoxylate or similar from two weeks prior to randomization through the surveillance phase of the study; * an employee of intercell (global) or an immediate family member.