Kornimate/medical-research-clean huggingface dataset:
head to head study of anti-vegf treatment.

Conditions: Age-related Macular Degeneration

Summary: an exploratory single site, open label, randomized, controlled study evaluated plasma vascular endothelial growth factor levels after intravitreal injection of ranibizumab (lucentis) and conbercept (langmu) for neovascular age-related macular degeneration

this prospective, randomized, open label study enrolled patients with neovascular amd who were naïve to anti-vegf therapy or have not received intravitreal anti-vegf therapy for the previous 3 months. patients were randomized in two treatment arms for 3 months: * study arm 1: three monthly injections of 0.5mg ranibizumab * study arm 2: three monthly injections of 0.5mg conbercept blood sample (plasma/serum) was collected at baseline (pre-dose), 3h post-injections and days 1, 3, 7 and 28, following doses 1 and 3 for pk and systemic vegf analysis. the lab staff was blinded for treatment allocation. plasma vegf concentration was measured by a blinded laboratory using quantikine® elisa kits. serum ranibizumab and conbercept concentration will be determined using validated elisa assay. the study was divided into 2 stages: the 1st initial feasibility stage with 6 patients per arm (12 patients in total) to verify sd for sample size justification and 2nd stage to confirm the findings with justified sample size.

Eligibility criteria:
inclusion criteria: 1. written informed consent must be obtained before any assessment is performed. 2. male or female patient ≥ 50 years of age. 3. subfoveal cnv secondary to namd. 4. bcva score must be between 73 and 24 letters as measured by etdrs chart exclusion criteria: for both eyes 1. any active periocular or ocular infection or inflammation 2. uncontrolled glaucoma 3. neovascularization of the iris or neovascular glaucoma. for study eye 4. choroidal neovascularization of any other cause than wet amd 5. ocular disorders present that may confound interpretation of study results, 6. previous treatment with verteporfin pdt (visudyne®), external-beam radiation therapy, focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy. 7. structural damage within 0.5 disc diameter of the center of the macula 8. atrophy or fibrosis involving the center of the fovea. 9. inability of obtaining required lab report. ocular medical history 10. history of intravitreal injection with any anti-vegf drugs within 3 months. exclusion criteria for systemic medical conditions and treatment 11. any type of systemic disease or its treatment 12. any patients diagnosed with tumor. 13. stroke or myocardial infarction less than 3 months. 14. known hypersensitivity to indocyanine green, fluorescein, or any component of the investigational drug formulation. 15. use of any systemic anti-vegf drugs within 6 months. exclusion criteria for patient 16. patients who have participated in other investigational drug study within 60 days. 17. pregnant or nursing (lactating) women. 18. inability to comply with study or follow-up procedures.

Keywords: age-related macular degeneration, ranibizumab, conbercept, plasma vegf pk
optimization of desflurane in elderly patients

Conditions: Postoperative Cognitive Dysfunction

Summary: various issues had been pointed out when undergoing the anesthesia for elderly patients with sevoflurane, such as delayed emergence, post-operative trouble with swallowing. desflurane, which has a lower blood/gas partition coefficient, is expected to contribute the better emergence, along with the recent progress on optimization of delivered amount of anesthesia. the purpose of this study is to compare the time to emergence in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system "aisys®" (ge healthcare japan).

the objectives of this study is to compare the time to emergence and quality of recovery in long elderly patient cases with desflurane or sevoflurane, with the recently developed drug-delivery optimization system "aisys®" (ge healthcare japan). inclusion criteria: - elderly patients (\>= 65 yr-old), long operation (\> 4hours), abdominal surgery patients exclusion criteria: - liver dysfunction, renal dysfunction, preoperative dementia neurosurgery patients, cardiac surgery patients, obese patients(bmi\>35)

Eligibility criteria:
inclusion criteria: - elderly patients (\>= 65 yr-old), long operation (\> 4hours), abdominal surgery patients exclusion criteria: - liver dysfunction, renal dysfunction, preoperative dementia neurosurgery patients, cardiac surgery patients, obese patients(bmi\>35)

Keywords: postoperative cognitive dysfunction elderly patients long surgery
fatty liver in inflammatory bowel disease (ibd) patients

Conditions: Inflammatory Bowel Disease; Fatty Liver

Summary: fatty liver is known to be one of the most frequent liver pathologies in ibd patients (35-40%). despite this fact, there are only few publications that evaluated the prevalence of fatty liver in ibd patients. moreover, the pathogenesis of this phenomenon in ibd has not been widely investigated. the paradox of lean patients and fatty liver can be explained by high use of steroids, by rapid weight loss, and by the abundance of tnfα cytokine in ibd patients that causes insulin resistance. the aim of the study: to evaluate the frequency of fatty liver in a cohort of ibd patients and to learn its risk factors. methods: one hundred consecutive ibd patients treated at the tel aviv sourasky medical center will be recruited. patients will fill up a questionnaire regarding their disease, demographic data, other co-morbidities and medications and risk factors for metabolic syndrome. each patient will undergo blood examinations in order to assess inflammation, and metabolic status. fatty liver will be assessed by liver ultra-sonography.


Eligibility criteria:
inclusion criteria: * ibd patients above the age of 18 years old, suffering from the disease for at least one year. exclusion criteria: * pregnant women, * patients suffering from ulcerative colitis after total colectomy, * hiv patients, * patients suffering from other chronic liver disease, * patients suffering from cancer currently or in the past, or * patients suffering from any other chronic severe diseases.

Keywords: ibd inflammatory bowel disease fatty liver
management of proximal interphalangeal (pip) joint injuries

Conditions: Interphalangeal Joint Injury

Summary: this project seeks to compare the treatment efficacy of two different approaches to treating interphalangeal joint (pip) joint injuries. the investigators will compare two participant groups undergoing treatment using the current treatment standard (coban wrap) as well as an innovative treatment approach (neoprene sleeve) in treating the pip joint injury.

hand injuries, specifically those involving the proximal interphalangeal joint (pip) can be difficult to treat. these stubborn injuries leave patients with pain, edema, and limitation in function and changes in the aesthetics of the hand. this project would randomize patients with pip joint injuries including dislocation, volar plate, intra-articular fracture and chip avulsion fracture with ligamentous injury into two groups. the first group will receive the usual treatment including active range motion, edema control - contrast bath and coban. the second group would receive similar treatment except a custom neoprene sleeve will be used in place coban. outcome measures would include: numeric pain rating scale (nprs), measure of patient satisfaction and compliance with the coban vs a custom neoprene sleeve and a measure of hand function (patient rated wrist/hand evaluation) as well as a range of motion and edema.

Eligibility criteria:
inclusion criteria * read/write and speak/understand english * capable of understanding the various questionnaires that will be employed to collect outcome measures exclusion criteria: * participants who do not meet all of the aforementioned criteria * participants with any injuries specific to the treatment finger, or if there is any underlying disease affecting the pip joint

Keywords: pip injury coban wrap neoprene sleeve interphalangeal joint
effectiveness of exercise programs following total hip and knee joint arthroplasty

Conditions: Hip and Knee Joint Osteoarthritis; Hip and Knee Joint Arthroplasty

Summary: the purpose of the study was to evaluate the effectiveness of balance exercises added to typical joint range of motion and muscle strengthening exercises on balance in patients following total hip or knee joint arthroplasty

rehabilitation program following total hip and knee joint arthroplasty typically focus on joint range of motion and muscle strengthening exercises. although the balance ability of these patients tends to be reduced, leading to limitations in mobility and activities of daily living, clinicians often assume that strength and joint range of motion exercises will ultimately lead to improvement in balance, making the typical exercise programs appropriate. however, the feasibility and effectiveness of introducing balance specific exercises during the post-operative period is unclear.

Eligibility criteria:
inclusion criteria: * patients with primary unilateral total hip or knee joint arthroplasty. * patients who had been advised to weight bear as tolerated following surgery. exclusion criteria: * patients who had been advised by their surgeon to remain non-weight bearing or partial weight bearing on the operated leg or unoperated leg. * patients with neurological conditions such as hemiplegia, peripheral neuropathy, parkinsons disease, multiple sclerosis, or spinal cord compression that might affect balance.

Keywords: total hip arthroplasty total knee arthroplasty balance exercises force plate berg balance scale timed up and go test
dry eye syndrome, healthy control, sjögren's syndrome and other inflammation disease in taiwan biobank

Conditions: Dry Eye Syndrome; Sjogren's Syndrome; Healthy Control; Inflammation

Summary: the comprehensive analysis of health records, tcm constitution, biomarker, and whole-genome sequencing among dry eye syndrome, healthy control, sjögren's syndrome and other inflammation disease in taiwan: an integrated analysis between taiwan biobank and sjögren's syndrome database

method: this study wants to apply the dataset of health records, physical examination indicators, blood biomarker, urine biomarker, biochemical biomarker, gene sequence, and metabolome from taiwan biobank database to explore the difference among dry eye syndrome (des), healthy control (hc), and other inflammation disease (id). in addition, we want to investigate the difference among the demographics, personal health behavior, living environment, dietary status, family history, traditional chinese medicine (tcm) body constitution, hematology test, serum biochemical test, virus test, and urine test. we also want to use the whole-genome genotyping, whole-genome sequencing, dna methylation, hla typing, and metabolome to investigate the difference among the genetic variant, gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences. it could find the pathogenesis-associated candidate genes and sites, and could apply to clinical diagnosis and drug development after verification and confirmation of efficacy. integrated the sjögren's syndrome (sjs) database, we could explore the comprehensive analysis among des, hc, sjs, and id. it would provide the evidence-base medicine in tcm in the future. expected results: 1. to evaluate the difference among questionnaire, physical examination indicators, blood biomarker, urine biomarker and biochemical biomarker for the des, hc, and id. 2. to evaluate the difference among gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences for the des, hc, and id. 3. to evaluate the difference among gene variation and tcm body constitution for the des, hc, and id. 4. to evaluate the difference among gene variation for the des, hc, sjs, and id. 5. to establish predicting modal and biomarker among des.

Eligibility criteria:
sjögren's syndrome inclusion criteria: 1. aged between 20 and 75 years 2. fulfilled the 2002 american-european consensus criteria for ss (aecg) exclusion criteria: na dry eye syndrome inclusion criteria: 1. aged between 20 and 75 years 2. schirmer's test less than 10 mm/5 min exclusion criteria: na inflammation disease inclusion criteria: 1. aged between 20 and 75 years 2. disease diagnosed with inflammation exclusion criteria: na

Keywords: dry eye syndrome sjögren's syndrome gene modulation xerophthalmia tcm pattern inflammation healthy control
long-term safety study of mt-2412 in japanese patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the safety and efficacy of co-administration of teneligliptin (mp-513) and canagliflozin (ta-7284) once daily for 52 weeks in japanese patients with type 2 diabetes mellitus who are receiving treatment with teneligliptin and have inadequate glycemic control.


Eligibility criteria:
inclusion criteria: * men or women age ≥20 years old * hba1c of ≥7.0% and \<10.5% * fpg of ≤ 270 mg/dl * patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before treatment period exclusion criteria: * patients with type i diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes * patients with serious diabetic complications * patients with hereditary glucose-galactose malabsorption or primary renal glucosuria * patients with class iii/iv heart failure symptoms according to new york heart association (nyha) functional classification * patients with severe hepatic disorder or severe renal disorder.

Keywords: mt-2412 mp-513 ta-7284 teneligliptin canagliflozin
assessing the impact of pioglitazone on skin barrier function in atopic dermatitis patients

Conditions: Atopic Dermatitis

Summary: many patients with eczema (atopic dermatitis) have an inherent defect in their skin barrier as demonstrated by high water loss. in laboratory conditions, studies have shown that pioglitazone restores the skin barrier function in skin from eczema patients. the purpose of this study is to determine if taking pioglitazone improves the skin barrier function in people with eczema.

enrolled patients will be randomized to either placebo or pioglitazone. each randomized subject will have a skin biopsy and skin irritancy assay performed prior to treatment and at the end of 12 weeks of treatment. noninvasive barrier measurements including transepidermal water loss will be recorded at all study visits.

Eligibility criteria:
inclusion criteria: * i. moderate to severe ad: easi ≥ 10 ii. active atopic dermatitis: subjects must have within the last 3 months according to medical records or by medical exam of the investigator: * pruritus * eczema (acute, subacute, chronic) i. typical morphology and age-specific patterns - patterns include (1) facial, neck, and extensor involvement in infants and children, (2) current or prior flexural lesions in any age group, (3) sparing groin and axillary regions. ii. chronic or relapsing history iii. extrinsic they must also meet both of the following: serum total ige ≥ 1.5 s.d. greater than the age-matched norms and positive multi-allergen rast (phadiatop). additionally, subjects must have tewl of nonlesional skin of upper arm that is ≥ 8 gm/m2/h at screening visit. this is to ensure that we are in fact studying the subset of ad subjects who have a skin barrier defect. exclusion criteria: * unwillingness or inability to complete the informed consent process * subjects with a history of keloid formation * history of lidocaine or novocain allergy * subjects with a systemic infection requiring a course of systemic antibiotics or antivirals within the last 2 weeks * subjects with md diagnosed type 1 or 2 diabetes mellitus * subjects with nyha class iii or iv cardiac status * subjects with a history of liver disease (etoh, viral hepatitis, drug-induced hepatitis or other) * subjects with evidence of an underlying systemic disease based on history and physical (other than the above diagnostic categories (and associated allergic disorders), or well-controlled hypertension, or hyperlipidemia). * history of cancer other than nonmelanomatous skin cancer or cervical dysplasia * participants enrolled while on a systemic treatment for their atopic dermatitis (e.g. cyclosporine, mycophenolate mofetil) must remain on a stable dose for the duration of the study

Keywords: atopic dermatitis eczema
postprandial hemodynamics

Conditions: Heart Disease

Summary: to study the postprandial alterations in hemodynamics and blood pressure in relation to gastric emptying rate, postprandial blood glucose, plasma concentrations of insulin, satiety in healthy subjects.

ingestion of a meal increase blood flow to the gastrointestinal organs and affects the heart rate, blood pressure, and cardiac output. it is not known through wich mechanisms the heart function changes affects after a meal.

Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * history of gastrointestinal disease, abdominal surgery or diabetes mellitus
effect of pelvic floor muscle electrophysiologic therapy on enhanced recovery after gynecologic surgery

Conditions: Pelvic Floor Muscle Electrophysiologic Therapy; Fast-Track Surgery

Summary: this study is to evaluate the effect of pelvic floor muscle electrophysiologic therapy on enhanced recovery after gynecologic surgery,to solve muscle soreness and retention of urine after laparoscopy, and endometrial repair after electrosurgical resection of intrauterine adhesions.

pelvic floor muscle electrophysiologic therapy is widely used in the treatment of pelvic floor dysfunction diseases at home and abroad. electrical stimulation can also relieve depression and anxiety and play a sedative effect. in recent years, some studies have shown that pelvic floor electrophysiological therapy can improve the intimal blood flow resistance index of thin endometrium. therefore, whether or not the pelvic floor electrophysiological therapy can relieve the muscle soreness caused by carbon dioxide retention after endoscopic surgery, reduce the postoperative urinary retention, shorten the postoperative anus exhaust time, and repair the endometrium after the intrauterine adhesion. we expect this electrophysiologic therapy can solve some common postoperative complications and difficult problems, such solve muscle soreness and retention of urine after laparoscopy, and endometrial repair after electrosurgical resection of intrauterine adhesions. hope to help patients recover quickly after surgery.

Eligibility criteria:
inclusion criteria: .after electrocision of intrauterine adhesions; .or after common gynecologic laparoscopic surgery，patients occurred muscle pain or patients occurred urinary retention. exclusion criteria: * pregnancy; * suspected acute inflammation of the genitourinary system; * postoperative persistent vaginal bleeding; * patients have vaginal stenosis; * patients have implantation of a pacemaker with a cardiac pacemaker; * patients have a malignant pelvic organ tumor; .patients have nervous system disease (dementia or unstable seizures),who cannot actively cooperate with the treatment.

Keywords: pelvic floor muscle electrophysiologic therapy enhanced recovery muscle soreness postoperative retention of urine intrauterine adhesions enhanced recovery after gynecologic surgery
prevention of stroke and systemic embolic events in patients with atrial fibrillation

Conditions: Nonvalvular Atrial Fibrillation

Summary: the main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (er) formulation of azd0837 compared with well-controlled, dose-adjusted vitamin-k antagonists (vka) (aiming for an international normalized ratio (inr) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (af) with one or more additional risk factors for stroke.


Eligibility criteria:
inclusion criteria: * nonvalvular af (nvaf) verified by at least two ecgs in the last year separated by at least one week. * previous cerebral ischemic attack (stroke or tia, \>30 days prior to randomization) * previous systemic embolism. * symptomatic congestive heart failure (chf) * impaired left ventricular systolic function * diabetes mellitus * hypertension requiring anti-hypertensive treatment. exclusion criteria: * af secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism * known contraindication to vka treatment * presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than af requiring chronic anticoagulation treatment * conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization

Keywords: anticoagulant treatment risk factors for stroke
a double-blind study evaluating duvelisib in subjects with moderate to severe rheumatoid arthritis and an inadequate response to methotrexate alone

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to investigate the safety and efficacy of multiple dose levels of the investigational product (study drug), ipi-145, in combination with methotrexate compared to methotrexate alone in subjects with active moderate-to-severe rheumatoid arthritis.

this phase 2 study is designed to examine the efficacy and safety of multiple dose levels of ipi-145 in subjects with active moderate-to-severe rheumatoid arthritis receiving a background stable dose of methotrexate. the study will employ a randomized, double-blind, placebo-controlled, parallel design. approximately 316 adult subjects who meet all eligibility criteria at screening will be randomized at baseline in a 1:1:1:1 ratio to one of 4 dose groups. all treatments will be administered twice a day (bid). after randomization, subjects will enter a 12-week treatment period, where study drug (ipi-145 or placebo) will be self-administered bid as an outpatient. during the treatment period, subjects will return to the clinic for efficacy and safety assessments every 2 weeks. following treatment period completion at week 12, subjects will enter a 3-week follow-up period which includes one clinic visit approximately 3 weeks after the last dose of study drug.

Eligibility criteria:
inclusion criteria: * documented diagnosis of rheumatoid arthritis for at least 6 months * active disease, based on screening clinical and laboratory criteria, despite taking methotrexate for at least 3 months exclusion criteria: * pregnant or lactating females * previous failure or inadequate response to \>2 biologic disease-modifying anti-rheumatic drugs (dmards) * concurrent dmard treatment other than methotrexate, sulfasalazine, chloroquine, or hydroxychloroquine * treatment with \> 10 mg daily prednisone (or equivalent) or more than one non-steroidal anti-inflammatory drug