Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of gsk3196165 versus placebo and tofacitinib in participants with moderately to severely active rheumatoid arthritis who have an inadequate response to conventional synthetic (cs)/biologic (b) disease modifying anti-rheumatic drugs (dmards)

Conditions: Arthritis, Rheumatoid

Summary: this study \[contrast 2 (201791: nct03970837)\] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of gsk3196165 in combination with csdmard(s), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (ra) who have had an inadequate response to csdmard(s) or bdmard(s). the study will consist of a screening phase of up to 6 weeks followed by a 52 week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive gsk3196165 150 milligrams (mg) subcutaneous (sc) weekly, gsk3196165 90 mg sc weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with csdmard(s). participants who, in investigator's judgement will benefit from extended treatment with gsk3196165 may be included in the long-term extension study \[contrast x (209564: nct04333147)\]. for those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.


Eligibility criteria:
key inclusion criteria * \>=18 years of age * has had ra for \>=6 months and was not diagnosed before 16 years of age * has active disease, as defined by having both\* * \>=6/68 tender/painful joint count (tjc), and * \>=6/66 swollen joint count (sjc) * has at least 1 bone erosion present on hand/wrist or foot radiographs * has had an inadequate response to one or two of the csdmards: * methotrexate (mtx) 15-25 mg/week\*\* oral or injected * hydroxychloroquine up to 400 mg/day or chloroquine up to 250 mg/day * sulfasalazine up to 3000 mg/day * leflunomide up to 20 mg/day\*\*\* * bucillamine up to 100 mg/day (or up to 300 mg/day if permitted per local requirement) * iguratimod up to 50 mg/day * if surgical treatment of a joint has been performed, that joint cannot be counted in the tjc or sjc. * a lower dose of 7.5 mg/week is acceptable if reduced for reasons of intolerance to mtx or per local requirement. * concomitant use of leflunomide and methotrexate is not allowed, for safety reasons. key exclusion criteria * history of other inflammatory rheumatologic or systemic autoimmune disorder, other than sjögren's syndrome secondary to ra, that may confound the evaluation of the effect of the study intervention. * has had any active and/or recurrent infections (excluding recurrent fungal infections of the nail bed) or has required management of acute or chronic infections. * has received prior treatment with an antagonist of gm-csf or its receptor or janus kinase (jak) inhibitors (either experimental or approved).

Keywords: rheumatoid arthritis gsk3196165 otilimab tofacitinib placebo dmards
data analysis for drug repurposing for effective alzheimer's medicines (dream)- amiloride vs triamterene

Conditions: Hypertension

Summary: this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

this is a non-randomized, non-interventional study that is part of the dream study of brigham and women's hospital. dream is led by dr. madhav thambisetty, md, phd, chief of the clinical and translational neuroscience section, laboratory of behavioral neuroscience, national institute on aging (nia) intramural research program. this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility criteria:
please see https://docs.google.com/spreadsheets/d/1idolui5-bz_1d_0iflzovjo9e1_3kflc_jlefm030no/edit?usp=sharing or appendix a for full code and algorithm definitions. medicare timeframe: 2008 to 2018 (end of data availability). inclusion criteria: * 1. aged \> 65 years on the index date * 2. enrollment in medicare part a, b, and d with no hmo coverage for 365 days prior to and including cohort entry date * 3. at least two claims with hypertension diagnosis recorded in 365 days prior to cohort entry date exclusion criteria: * 1. prior history of dementia measured anytime prior to cohort entry date * 2. prior use of amiloride or triamterene any time prior to cohort entry date
risk reduction in coronary heart disease

Conditions: Coronary Heart Disease

Summary: study hypothesis: multifactorial risk reduction in coronary heart disease can reduce the risk of new coronary heart disease and death


Eligibility criteria:
inclusion criteria: * acute myocardial infarction, cabg or pci exclusion criteria: * age \ 80 * pregnant * critical illness * drug abuse
trial of prehabilitation in vulnerable patients undergoing cystectomy for bladder cancer

Conditions: Bladder Cancer

Summary: the development of clinically relevant and scalable exercise interventions in older cystectomy patients may have an impact upon: * patients: exercise interventions may improve patient outcomes, including quality of life and avoidance of skilled nursing facilities. * clinicians: proving the safety and feasibility of targeted interventions in older surgical patients may facilitate the development of clinically relevant preoperative interventions suitable for wider study and implementation. * payers: improved surgical outcomes among high risk surgical patients will be associated with significant cost savings. * researchers: targeted and well controlled studies focusing on improving surgical outcomes through exercise may provide insight into relationships between patient factors, surgical stressors and outcomes. ultimately, such work may lead to novel clinical approaches to optimize patients for surgery. the investigators will study the effects of preoperative exercise training on cystectomy patients, specifically targeting increasing functional capacity and muscular strength. prior to conducting a more extensive, multi-center, randomized-controlled trial, the feasibility, safety, and initial efficacy of preoperative exercise in cystectomy patients must be determined. to address this issue, the investigators will complete a trial of rehabilitation in cystectomy patients at the university of michigan.


Eligibility criteria:
inclusion criteria: * patients must have biopsy-proven bladder cancer. * patients age ≥60, diagnosed with bladder cancer with planned cystectomy and urinary diversion, +/- neoadjuvant chemotherapy. * the patient must be able to communicate and understand/complete forms/instructions, and be able to provide informed written consent prior to enrollment. patients may have the assistance of an interpreter or surrogate when completing forms/surveys as needed. * karnofsky performance status ≥70 with the ability to walk unassisted. * sedentary baseline lifestyle, with an average of \<180 minutes/week of moderate-intensity aerobic activity. * attending surgeon clearance to undergo a supervised exercise training program. exclusion criteria: * contraindication to exercise training, such as skeletal metastases, symptomatic coronary artery disease, severe anemia, or any condition limiting their ability to participate in an exercise training program. * patients who require surgery sooner than 28 days from enrollment.
lidocaine injection: a nove block therapy for stroke-related dysphagia

Conditions: Dysphagia

Summary: this was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. besides, the observation group additionally underwent the stellate ganglion block (sgb). at admission and after 20-day treatment, kubota water swallowing test, video fluoroscopic swallowing study (vfss), and rosenbek penetration-aspiration scale (pas) were used to assess swallowing function.

dysphagia is a frequent and potentially serious complication of stroke. however, there is no effective measure for the treatment of pharyngeal dysphagia in stroke patients. this study aims to explore the efficacy of stellate ganglion block in post-stroke pharyngeal dysphagic patients who received comprehensive rehabilitation. this was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. besides, the observation group additionally underwent the stellate ganglion block (sgb). at admission and after 20-day treatment, kubota water swallowing test, video fluoroscopic swallowing study (vfss), and rosenbek penetration-aspiration scale (pas) were used to assess swallowing function.

Eligibility criteria:
inclusion criteria: * diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy. * upper esophageal sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by videofluoroscopic swallow study. * age \>18 years. * first-time stroke. * steady vital signs, * transferred or admitted to the department of rehabilitation medicine within 15d after onset. exclusion criteria: * allergy to lidocaine injection or vitamin b12 injection; * severe cognitive impairment; * coagulation disorders; * severe dysfunction of organs including heart, lungs, kidney, liver, etc.; * complicated with other neurological diseases; * dysphagia caused by other diseases or reasons.
laparoscopic sacrocolpopexy: long term follow-up

Conditions: Vaginal Vault Prolapse

Summary: the purpose of this study is to determine the long term results of laparoscopic sacrocolpopexy regarding anatomical results, recurrences, complications, further surgeries required, patients satisfaction and quality of life.


Eligibility criteria:
inclusion criteria: * patients operated for vaginal vault prolapse at our institution by laparoscopic sacrocolpopexy between 2003 and 2007 * consent exclusion criteria: * no consent
cost effectiveness if primary pci versus thrombolytic therapy in acute stemi in assiut university hospital

Conditions: ST Elevation Myocardial Infarction

Summary: cost effectiveness between ppci and thrombolytic therapy in stemi patients without contraindications

cost effectiveness between ppci and thrombolytic therapy in stemi patients 100 patient each within 90 m for ppci and 6h for thrombolytic

Eligibility criteria:
inclusion criteria: * all ppci patients within 90 minutes door to ballon. * all thrombolytic patient without contraindication ,within 6 golden hours of chest pain. exclusion criteria: * patients don't meet inclusion criteria
bolus insulin card calculator randomised controlled study

Conditions: Type 1 Diabetes

Summary: in pediatric patients with type 1 diabetes using subcutaneous injections; a randomised controlled trial comparing the effects of fixed carbohydrate exchanges and insulin doses to the use of variable size meals and insulin doses determined with a bolus insulin calculation card.


Eligibility criteria:
inclusion criteria: * age 11 - 18 years old * currently using indvidual subcutaneous injections (not csii) exclusion criteria: * hba1c \> 9.5% * serious illness

Keywords: type 1 diabetes youth insulin dose
effects of game-based balance exercise for older adults with fall history

Conditions: Mobility Limitation

Summary: due to the many problems associated with reduced balance and mobility, providing an effective and engaging rehabilitation regimen is essential to progress recovery from impairments and to help prevent further degradation of motor skills. the purpose was to examine effects of physical therapy based on the task-oriented approach delivered in an engaging, interactive video game paradigm. the intervention focused on performing targeted dynamic tasks, which included reactive balance controls and environmental interaction. thirty community dwelling and ambulatory older adults attending the day hospital for balance and mobility limitation treatment participated in this study. participants were randomly assigned to either a control group or experimental group. the control group received the typical rehabilitation program provided at the day hospital, consisting of strengthening and balance exercises. the experimental group received a program of dynamic balance exercises coupled to video game play, using a centre of pressure (cop) position signal as the computer mouse. the tasks were performed while standing on a fixed floor surface with progression to a compliant sponge pad. each group received 16 sessions, scheduled two per week, each lasting 45 minutes. balance performance measures and spatial-temporal gait variables were obtained pre- and post-treatment findings demonstrated significant improvements for both groups in balance performance scores post-treatment, and change scores were significantly greater in the experimental compared to control group. no significant treatment effect was observed in either group for the spatial-temporal gait variables. in conclusion dynamic balance exercises on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based exercise. this in turn resulted in a greater improvement in dynamic standing balance control compared to the typical exercise program. however there was no transfer of effect to gait function. key words: balance, postural; rehabilitation; therapy, computer-assisted; video games; center of pressure.


Eligibility criteria:
inclusion criteria: * age: 65-85 years * mini-mental state examination (mmse) score \> 24 * english-speaking with the ability to understand the nature of the study and provide informed consent * independent in ambulatory functions, with or without an assistive device (cane or walker). exclusion criteria: * any medical condition or disability that prevented participation in an exercise program.

Keywords: balance postural rehabilitation therapy computer-assisted video games center of pressure
efficacy of gut-brain neuromodulators in the treatment of gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease

Summary: gastroesophageal reflux disease (gerd) is a common chronic digestive system disorder with a high prevalence and a notably increasing trend. it imposes significant costs in terms of treatment expenses and impacts patients' quality of life. acid suppression remains the primary treatment for gerd. however, numerous clinical studies have shown that 20-30% of patients still exhibit poor response to proton pump inhibitors (ppis) even after completing a standard course of acid-suppressive therapy. many studies have demonstrated that the incidence of abnormal psychological conditions, such as anxiety, depression, and obsessive-compulsive disorder, is higher in gerd patients compared to the general population. current international consensus acknowledges that the application of psychosomatic medicine principles and the use of neuromodulators can effectively alleviate symptoms in patients with gut-brain interaction disorders. nevertheless, with the growing emphasis on digestive-psychosomatic-holistic medicine in clinical practice and the deepening of research on "gut-brain interactions," recent studies in the field of psycho-gastroenterology have challenged the notion that psychological processes are unique to gut-brain interaction disorders. instead, these processes may play a universal role in symptom generation across the entire spectrum of gerd. previous experiments have confirmed that flupentixol-melitracen (fm) can improve symptoms in gerd patients with a low incidence of adverse reactions. therefore, we aim to verify the efficacy and safety of neuromodulators in patients with gerd, reduce healthcare costs, and provide new insights for optimizing treatment strategies for gerd patients in the future.


Eligibility criteria:
inclusion criteria: - adults aged 18-70 years with gastroesophageal reflux disease (gerd) meeting diagnostic criteria. exclusion criteria: * patients with organic gastrointestinal disorders (e.g., celiac disease, inflammatory bowel disease, history of gastrointestinal malignancies); severe dysfunction of major organs (e.g., class iv cardiac dysfunction, hepatic failure, uremia, respiratory failure) or congenital diseases (e.g., hemophilia, wilson's disease); hypersensitivity to study medications; patients who are pregnant, lactating, or planning pregnancy; use of monoamine oxidase inhibitors (e.g., linezolid or intravenous methylene blue) within the past 5 weeks; severe psychological symptoms or cognitive impairment (gad-7 \>15 or phq-9 ≥15); circulatory failure, central nervous system depression (e.g., acute alcohol, barbiturate, or opioid intoxication), or coma.
a study of subcutaneous mircera in participants with chronic kidney disease not treated with esa or on dialysis

Conditions: Anemia

Summary: this single arm study will assess the efficacy and safety of subcutaneous mircera for correction of anemia in participants with chronic kidney disease who are not treated with erythropoiesis stimulating agent (esa) and not on dialysis. eligible participants will receive mircera by monthly subcutaneous injections. the initial dose, based on body weight, will be 1.2 micrograms/kilogram (mcg/kg). the anticipated time on study treatment is 9-11 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * chronic renal anemia; * hemoglobin value less than or equal to (\<=) 10.5 grams/deciliter (g/dl). exclusion criteria: * prior esa therapy during previous 3 months; * acute or chronic bleeding requiring therapy during previous 2 months; * transfusion of red blood cells during previous 2 months; * active malignant disease (except non-melanoma skin cancer).
patient blood management in the approach to prosthetic surgery [pbm(l4178)]

Conditions: Anemia, Iron Deficiency

Summary: we have been well guided in the "good use of blood" during major surgery for many years, reaching a percentage of 4% of patients transfused after elective prosthetic operations. valid patient blood management must provide for the possibility of limiting/zeroing the transfusion risk dependent on preoperative anemia, and the national guideline on pbm (patient blood management) also underlines this hypothesis and relevance

we want to analyse patients from a diagnostic point of view (occult blood, diverticulitis, gastrorrhagia) and from the point of view of laboratory parameters (blood count, serum iron, transferrinemia, ferritinemia, transferrin saturation) in ordr to be able to suggest the best approach in preparation to the intervention. we want to evaluate the effectiveness of this approach, considering the proposed treatments (ferric carboxymaltose, chelated iron, folic acid, sideremil vita) and the transfusion result (or not) obtained

Eligibility criteria:
inclusion criteria: * candidates for prosthetic surgery * patients of both sexes over 40 years of age * hemoglobin values \<12 g% for females and 13 g% for males * % transferrin saturation \< 10% * willingness and ability to provide informed consent. exclusion criteria: * patients with mediterranean anemia * patients with coagulation disorders * patients who do not sign the consent form * pregnant or breastfeeding women (self-declaration) * minor aged
colchicine for the reduction of dependency and vascular events after an acute intracerebral hemorrhage

Conditions: Colchicine; ICH - Intracerebral Hemorrhage; Stroke; Dependence

Summary: data indicate that patients with intracerebral hemorrhage (ich) are at high risk for thromboembolic events and disability that is not being sufficiently mitigated by current treatment strategies. this is aggravated by the cessation of antithrombotic medications for significant periods after hemorrhage. these findings highlight the need for novel treatments that modify the high risk for major vascular events and functional outcomes in ich survivors. the objective of covasc-ich 2 is to demonstrate that oral colchicine 0.5 mg daily is superior to placebo for improving the outcomes of ich survivors with evidence or risk factors for atherosclerosis, when started within 72 hours from ich onset.


Eligibility criteria:
inclusion criteria: adult patients presenting with spontaneous intraparenchymal hemorrhage within 72 hours of symptom onset and qualifying for at least one of the following categories: i. history of symptomatic coronary, peripheral and/or carotid artery disease (severe atherosclerotic vascular disease), or ii. visualized extracranial cervical/intracranial atherosclerotic disease causing any degree of stenosis/occlusion or presence of aortic arch plaque with maximum thickness ≥1 mm (moderate atherosclerotic vascular disease), or iii. two or more risk factors including: age 60 years or older, hypertension, dyslipidemia, diabetes mellitus, chronic kidney disease (egfr: 15-50ml/min), history of ischemic stroke or current smoking (mild atherosclerotic vascular disease). exclusion criteria: * secondary causes of ich (such as trauma, macrovascular anomalies, neoplasms or bleeding diathesis) * ich volume more than 60ml in the last imaging scan prior to consent * glasgow coma scale (gcs) score less than 7 or being intubated at the time of consent * inflammatory bowel disease or chronic diarrhea * cirrhosis or severe hepatic dysfunction * renal insufficiency (egfr\<15ml/min) * concurrent or planned treatment with strong cyp3a4 inhibitors (atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir) or p-gp inhibitors (cyclosporine, ranolazine) * pregnancy or breast-feeding * known allergy or sensitivity to colchicine * a strong indication for colchicine where assignment to placebo is deemed unacceptable * estimated life expectancy less than 6 months at the time of enrollment, and * inability to adhere to study procedures
geranium oil and its components for the relief of numbness-ob 100

Conditions: Nerve Conduction; Numbness

Summary: this study is designed to evaluate the effectiveness of geranium oil and its components in the relief of numbness and the restoration of sensations.

this is a pilot study to define the time course, the incidence of sensation restoration and the improvement in nerve conduction in people with numbness by using topical geranium oil.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * neuropathy with the inability to feel touch in a standard nylon filament test * signed informed consent exclusion criteria: * pregnant or nursing * known allergies to geranium oil or geranium oil fractions * open sore in the area of numbness * migraine headaches or headaches to strong smells