Kornimate/medical-research-clean huggingface dataset:
transform cv risk in diabetes

Conditions: Type 2 Diabetes

Summary: this initiative supports a real-world study of practice and physician prescribing patterns and a quality improvement initiative evaluating best practices (including clinical decision support, facilitated referral to cardiometabolic team-based care model, and general educational tools/resources) to im-prove use of guideline-directed therapeutics known to lower cardiovascular risk (cv) in patients with type 2 diabetes (t2d).


Eligibility criteria:
inclusion criteria: * t2d diagnosis in the medical record * ascvd, defined as follows: 1. known coronary artery disease (cad), prior acute coronary syndrome (acs), or coronary artery revascularization 2. prior tia/ischemic stroke or known carotid or intracerebral atherosclerosis, or prior carotid revascularization 3. prior peripheral artery disease (pad) including symptomatic claudication or pe-ripheral revascularization exclusion criteria: * current participation in an interventional clinical assessment of an investigational drug/device (excluding assessments related to covid-19) * currently receiving any sglt2i or glp-1ra * known allergy/hypersensitivity/intolerance/contraindication to sglt2i or glp-1ra * currently receiving comfort care or enrolled in hospice * life expectancy \<1 year * history of or plan for heart transplantation or ventricular assist device * current or planned hemodialysis * decompensated end stage liver disease * history of fournier's gangrene * type 1 diabetes * prior history of diabetic ketoacidosis * pregnancy or active breastfeeding * history of pancreatitis or pancreatic cancer * history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (men-2)
early pelvic floor muscle training improves pelvic floor muscle strength in patient after low anterior resection

Conditions: Cancer of Rectum

Summary: the aim of study is to investigate the difference in maximum squeeze pressure in patients with and without pelvic floor muscle training in low anterior resection in peri-operative period

the functional outcome after low anterior resection varies greatly. proportion of patient suffers from urgency and incontinence. pelvic muscle disuse with atrophy and fibrosis may be a cause for the poor function. peri-operative pelvic floor muscle training may preserve pelvic floor muscle bulk and function and thus improve functional outcome after surgery.

Eligibility criteria:
inclusion criteria: * patients who will undergo low anterior resection of rectum * patient consented for study exclusion criteria: * patient unable to understand pelvic floor exercise * patient who underwent alternative procedure * patient who suffers anastomotic complications after surgery * patient who ileostomy not closed

Keywords: cancer of rectum physiotherapy
pulmonary arterial hypertension secondary to idiopathic pulmonary fibrosis and treatment with bosentan

Conditions: Pulmonary Arterial Hypertension; Idiopathic Pulmonary Fibrosis

Summary: pulmonary arterial hypertension (pah) in the setting of idiopathic pulmonary fibrosis(ipf)is a risk factor for morbidity and mortality in the peri-lung transplant(lt) setting. currently there is no significant data to support the use of pulmonary vasodilators for pah in the setting of interstitial lung disease such as ipf. the majority of ipf patients have pah either at rest or during exercise. the study hypothesis is that bosentan may improve morbidity and mortality in the peri-lt setting in both ipf cohorts with either resting or exercise pah.

the purpose of this study was to evaluate bosentan in the setting of exercise or resting pulmonary hypertension in patients with underlying pulmonary fibrosis.

Eligibility criteria:
inclusion criteria: * idiopathic pulmonary fibrosis referred for lung transplantation * minimum 50 meter 6 minute walk distance * no significant underlying liver disease exclusion criteria: * significant liver disease or cirrhosis * non ambulatory * previous adverse reaction/allergy to bosentan

Keywords: pulmonary arterial hypertension idiopathic pulmonary fibrosis bosentan
relation between the increase of peripheral edema by fluid therapy and the decrease in microcirculatory vesseldensity

Conditions: Edema; Sepsis

Summary: can videomicroscopy of the sublingual microcirculation detect the increase in edema before peripheral edema will appear? by measuring the decrease in vesseldensity after strong positive fluid balances within septic patients versus euvolemic post-cardiac surgery patients. measuring reactance and resistance (biva method) to determine volume status. primary outcome: - total vessel density (tvd) secondary outcome: * fluid balance * biva measurements (reactance \& resistance)

there are a lot of methods to determine if a patient is fluid-responsive, however a moment to stop fluid therapy is lacking. so the purpose of this study is to find a 'stop' moment for fluid therapy before peripheral edema will be present. with sublingual measurements of the vessel density with the cytocam-idf, comparing the septic patients with fluid overload , euvolemic post-cardiac surgery patients at the arrival on the icu and healthy volunteers we can determine if there is a decrease in vessel density during fluid loading. to give a accurate view on fluid overload we include a bio-impedance measurement of reactance and resistance. fluid balances are recorded very accurate by our electronic patient record.

Eligibility criteria:
inclusion criteria: * after cardiac surgery * septic patient with a fluid balance of 4l + exclusion criteria: * recent maxillofacial surgery
implementing an intervention to reduce heat stress and chemical exposures

Conditions: Dehydration; Heat Stress

Summary: the investigators are studying the dangers that farmworkers face while working in the fields and at home. the investigators goals are: 1. measure how much heat and chemicals farmworkers in imperial county are exposed to. the investigators will ask the participants to wear a special belt under their clothes during work to measure heat. the investigators will also put two small temperature monitors in the participant's home for a day. the investigators will collect a urine sample to check hydration, and also measure the participants height, weight, blood pressure, and some blood markers for diseases using a simple finger-prick test. to measure chemicals, the investigators will give the participants a wristband to wear for a week and hang another in the participants home. the investigators will also collect dust from each participant's home with a vacuum. then, the investigators will analyze everything at san diego state university. after collecting samples, a trained community health worker will ask the participants a few questions about their work, lifestyle, health symptoms, and any hazards they face. the investigators will meet the participants twice at their homes to distribute the tools which will later be collected. once the tools are collected, the investigators will have the chance to follow up with the participants if they have any questions. 2. provide help to lower heat and chemical exposure with the help of community health workers. 3. measure heat and chemicals again using the same methods to see if the project made a difference. 4. talk to participants about what they liked and how the investigators can make future projects better.


Eligibility criteria:
inclusion criteria: * currently living in imperial county, california, usa * currently work in agriculture * plan on living in imperial valley for the next 6 months exclusion criteria: * not currently living in imperial county, california, usa * not currently working in agriculture * not planning to live in imperial valley for the next 6 months

Keywords: farm worker heat exposure chemical exposure agricultural worker take-home exposure
visionaire™ value study

Conditions: Osteoarthritis of the Knee

Summary: this is a single center randomized observational study that evaluates the cost benefit ratio between the use of two types of instrumentation in tka: standard instrumentation vs. visionaire™ patient matched technology. this study does not involve treatment or investigational products, as all components are fda approved and are commercially available.

the objective of the current observational study is to assess value of surgical instrumentation following analysis of health economic data. it is hypothesized that patient matched cutting block technology visionaire™ may reduce tka operative time, blood loss, surgical error and adverse event risk as well as providing improved mechanical alignment. in order to test this hypothesis, subjects will be randomized to either visionaire™ or standard tka instrumentation groups. one site will enroll a total of 38 patients; 19 patients per group. all patients meeting the inclusion/exclusion criteria specified in this protocol will be asked to participate in the study. if the patient consents to participate, they will be enrolled in the study and randomized to one of the two study arms. patients requiring tka will be implanted with legion, genesis ii or journey bcs (smith \& nephew) total knee implant systems. standard instrumentation will be used to assist the surgeon in placing the implant in the control group. in the visionaire™ group, standard instrumentation will not be used in the surgery. patients randomized to the visionaire™ arm will have an mri preoperatively that will be used to create the customized cutting blocks. all patients will have an x-ray at each postoperative interval.

Eligibility criteria:
inclusion criteria: patients must meet all of the inclusion criteria. 1. patient is diagnosed with degenerative joint disease of the knee requiring a unilateral tka. 2. patient is of legal age to consent, and is skeletally mature. 3. patient is willing to sign and date an irb/iec approved consent form. exclusion criteria: patients must not meet any of the exclusion criteria. 1. patient has poor bone stock making a tka unjustifiable. 2. patient has active, local infection or previous intra-articular infections. 3. patient has neuropathic (charcot) joint. 4. patient is pregnant or may become pregnant during the course of the study. 5. patient is severely overweight (bmi \>40). 6. patient is a prisoner.
efficacy and safety of ivermectin against dengue infection

Conditions: Dengue Fever

Summary: this is a phase ii/iii, randomized, double-blind, placebo-controlled study of efficacy and safety of ivermectin in children and adult patients with dengue infection.

patients with confirmed dengue infection who meet all inclusion and exclusion criteria will be enrolled in the study and admitted in the hospital. patients will be randomly assigned in a pre-specified ratio of 1:1:1 to one of the following study groups: ivermectin 200-400 µg/kg single daily dose for 2 days, ivermectin 200-400 µg/kg single daily dose for 3 days, or placebo. tablets of ivermectin or placebo will be administered for 3 days. clinical exam will be performed daily during hospitalization and blood samples will be collected for hematology, clinical chemistry, serology, viral load and quantitative nonstructural 1 (ns1) antigen. safety assessment will be conducted during admission. patients will be discharged one day after fever subsidence and will be asked to return 2 weeks after first dose of study medication for safety assessment and blood sampling.

Eligibility criteria:
inclusion criteria: * adults ages of 15 or greater. * history or presence of fever (temperature \> 38°c) of ≤ 72 hr duration. * clinical suspicion of dengue infection such as high fever without an evidence or suspected focus of infection on clinical examination. * positive ns 1 strip assay exclusion criteria: * clinically significant abnormal laboratory results which are deemed to be unassociated with dengue infection * clinical evidence or a history of significant respiratory, metabolic, renal, hepatic, hematologic or chronic diseases * history of autoimmune, immune dysfunction disorder or taking warfarin * clinical suspicion of any bacterial infection * pregnancy and lactating women
remote ischemic preconditioning in septic patients

Conditions: Critically Ill; Acute Kidney Injury; Sepsis

Summary: acute kidney injury is a well-recognized complication in critically ill patients. up to date there is no clinically established method to reduce the incidence or the severity of acute kidney injury. remote ischemic preconditioning (ripc) will be induced by three cycles of upper limb ischemia. the aim of the study is to reduce the incidence of aki by implementing remote ischemic preconditioning (identified by the urinary biomarkers tissue inhibitor of metalloproteinases-2 (timp-2) and insulin-like growth factor-binding protein 7(igfbp7)

acute kidney injury (aki) is a common complication in critically ill patients with sepsis. to date, there is no pharmacological option to treat or prevent aki. ischemic conditioning is an innate tissue adaptation elicited by ischemia that mediates local and remote organ protection against subsequent exposure to the same or other injury. the aim of this trial is to evaluate the effects of remote ischemic conditioning in critically ill patients on acute kidney injury.

Eligibility criteria:
inclusion criteria: * adult patients (age ≥18 years) * critically ill patients with sepsis \< 12 hours * invasive ventilation for at least 24 hours (propofol-free-sedation) and/or vasopressor therapy * unrestricted intensive care for at least 72 hours * written informed consent exclusion criteria: * pre-existing aki * (glomerulo-)nephritis, interstitial nephritis, vasculitis * chronic kidney disease with estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73m² * chronic dialysis dependency * kidney transplant in the last 12 months * oral antidiabetics, sulfonamides or nicorandil * pregnancy or breastfeeding * do-not-reanimate order * participation in another interventional trial involving kidney outcomes within the last 3 months * dependency on the investigator or center
comparison of outpatient and inpatient spa therapy

Conditions: Osteoarthritis, Knee

Summary: in this study, we aimed to compare the effectiveness of inpatient and outpatient physical therapy modalities and spa combination treatments on pain and functional status in patients with knee osteoarthritis.

osteoarthritis (oa) has an important place in musculoskeletal diseases and is the most common rheumatic joint disorder characterized by progressive cartilage degeneration. osteoarthritis of the knee is the most common symptomatic osteoarthritis characterized by chronic knee pain, joint stiffness, limited daily activities, and decreased quality of life. in this study, it was aimed to compare the effects of inpatient and outpatient applications of hp, us, tens, spa combination treatments on pain and functional status in patients with knee osteoarthritis.

Eligibility criteria:
inclusion criteria: * patients diagnosed with primary knee osteoarthritis exclusion criteria: * patients who have secondary knee osteoarthritis due to various diseases * patients with pronounced pathology in the waist, hip and ankle joint, patients with active tumors * patients with febrile infectious disease * having had serious surgical operations in the last 6 months * patients who have undergone and/or have been injected with intraarticular steroid and hyaluronic acid into the knee joint * patients who have received balneotherapy and peloidotherapy in the last one year * patients with decompensated organ failure, those with inflammatory disease, those with pregnancy and breastfeeding * people with neurological diseases such as epilepsy, inner ear hearing aids, pacemakers and other individuals with a small metallic implant

Keywords: spa therapy electrotherapy ultrasound hotpack
study of cryopreserved aurn001 in subjects with corneal edema secondary to corneal endothelial dysfunction

Conditions: Corneal Edema

Summary: the purpose of this study is to assess the safety and efficacy of cryopreserved aurn001 in patients with corneal edema secondary to endothelial dysfunction.


Eligibility criteria:
inclusion criteria: * have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty) * bcva no worse than 5 etdrs letters (i.e., 1.6 logmar or approximate 20/800 snellen equivalent). exclusion criteria: * have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye * have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments
evaluation of the effect of prosthetic management for congenital cleft lip and palate infants on the middle ear function

Conditions: Cleft Lip and Palate

Summary: aim of the study was to evaluate the effect of feeding appliance for congenital cleft lip and palate infants on the middle ear function


Eligibility criteria:
inclusion criteria: * infants with bilateral cleft lip and palate. * centralized pre-maxilla that does not need active appliance. * normal inner ear and auditory nerve function. exclusion criteria: * infant with unilateral cleft lip and palate or cleft palate only. * deviated pre-maxilla that needs active appliance. * congenital hearing problems or sensorineural hearing loss/
safety study of bms-986202 in healthy subjects and to treat psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to establish if bms-986202 is safe and effective at treating autoimmune diseases such as psoriasis. bms-986202 which has shown some promise in preclinical studies for inhibiting autoimmune conditions such as psoriasis. this study will be the first time this drug is given to humans.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * healthy male and female participants * 18 to 50 years of age (parts a-d) * 18 to 70 years of age (part e) * diagnosed with plaque psoriasis (part e) exclusion criteria: * participants that had recent infections * participants with low blood pressure * participants with any heart related problems * participants with cancer * participants with any other major medical illness other protocol defined inclusion/exclusion criteria could apply
improving effects of fish oil combined with pine bark extract on cognitive decline

Conditions: Mild Cognitive Impairment

Summary: the purpose of this study is to evaluate the improving effects of ω-3 fatty acid from fish oil combined with polyphenolic extract from pine bark (pe) on cognitive functions and biological parameters in healthy people aged 55 to 75.

sixty participants who meet the inclusion criteria will be randomly divided into two groups. participants in fo group will be provided one capsule of fish oil (350mg epa + 250mg dha) per day for 6 months. moreover, participants in fope group will be provided one capsule of fish oil (350mg epa + 250mg dha) combined with pe (100mg oligopin) per day for 6 months. a cognitive function evaluation, blood biological analysis and antioxidative status will be carried out at the baseline, 3 th month and the end of the supplementation period. on the other hand, blood fatty acid composition will be measured at the baseline and the end of the supplementation period. all participants will come to laboratory and receive the supplements every month. at the same time, they will accept the measurement of body weight and blood pressure, also be interviewed with 24 hours dietary recall questionnaire.

Eligibility criteria:
inclusion criteria: * i. 55\~75 years old * ii. no severe diseases, such as hyperlipidemia, diabetes, heart diseases, cancer etc. * iii. mini-mental state examination (mmse) score is more than 26 * iv. clinical dementia rating scale (cdrs) score is less than 0.5 exclusion criteria: * liver disease, kidney disease, hypertension, hyperlipidemia, anemia, cancer
efficacy and safety of medi3506 in adult subjects with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this is a research study to determine the efficacy and safety of investigational drug medi3506 for the treatment of adult subjects with atopic dermatitis.

this is a research study to determine the efficacy and safety of investigational drug medi3506 for the treatment of adult subjects with atopic dermatitis. each participant will be assigned randomly to a treatment arm, which could be different strengths of the active treatment or a placebo which does not contain active treatment. both participants and investigators will be masked to the treatment assignment. approximately 152 participants will take part in this study. there is a 4 weeks screening period to determine eligibility. after eligibility is confirmed, participants will receive investigational drug or placebo during the 16 weeks treatment period. this is then followed by an 8-week follow-up period.

Eligibility criteria:
inclusion criteria: * age 18 to 65 years inclusive at the time of consent. * body mass index between 19.0 and 40.0 kg/m2 inclusive. * documented history of chronic ad, for at least 1 year prior to screening visit 1. * meets at minimum 1 of the criteria, as follows: * history of inadequate response to topical medications for ad * subject intolerance to treatment with topical medications for ad, or * topical medications are otherwise medically inadvisable * ad that affects ≥ 10% of the body surface area (bsa). * an easi score of ≥ 12 at visit 1 and ≥ 16 at visit 3 (day 1). * an iga score of ≥ 3. exclusion criteria: * any active medical or psychiatric condition, or other reason, that would interfere with evaluation of the investigational product or interpretation of subject safety or study results. * any other clinically relevant abnormal findings from physical examination (including vital signs and electrocardiogram \[ecg\]) or from safety laboratory analysis. * active dermatologic conditions that might confound the diagnosis of ad or would interfere with the assessment of the skin. * known active allergic or irritant contact dermatitis.

Keywords: medi3506 safety efficacy atopic dermatitis eczema
imaging nsclc treatment response to immunotherapy

Conditions: Cancer

Summary: this feasibility study will aim to assess the potential for functional imaging biomarkers (18fdg pet-ct and dw-mri) to differentiate immunotherapy induced inflammation, indicative of response from non-response in patients with stage iv non-small cell lung cancer (nsclc).

30 patients, recruited from within the pear study (phase 1 dose escalation of palliative radiotherapy with anti-pd1 antibody pembrolizumab in thoracic tumours) will be scanned both before and after receiving immunotherapy for nsclc. immunotherapy induced changes in tumour adc on dw-mri (a surrogate of apoptotic tumour cell death) will be compared with changes in near contemporaneous, anatomically co-registered 18fdg pet-ct suv (a non-specific marker for glut expression and hence metabolic activity in both tumour and tumour infiltrating lymphocytes). for treatment response, an increase in adc (reflecting apoptosis within the tumour) is expected, while 18fdg uptake is expected to decrease compared with baseline tumour uptake. in the presence of significant inflammatory cell recruitment, the investigators hypothesise a similar increase in adc on dw-mri but without associated reduction in 18fdg pet-ct suv. thus the relationship between the adc change on dw-mri and the 18fdg change should distinguish between response and non-response in the presence of inflammation.

Eligibility criteria:
inclusion criteria: * recruited to pear: phase 1 dose escalation of palliative radiotherapy with anti-pd1 antibody pembrolizumab in thoracic tumours study exclusion criteria: * mri incompatible metal implants * claustrophobia

Keywords: magnetic resonance imaging pet/ct non-small cell lung cancer