Kornimate/medical-research-clean huggingface dataset:
a web-based healthy living training for promotores

Conditions: Obesity Prevention

Summary: the goal of this clinical trial is to test a new web-based promotora de salud/ community health worker (chw) training. this training is designed to provide chws with the knowledge and skills to effectively implement a healthy living intervention for latinas. the main question it aims to answer is: o do chws who complete the web-based healthy living training have higher self-efficacy in implementing core lifestyle intervention learning components for obesity interventions in hispanics than chws who do not? participants will: * complete a baseline survey asking about self-efficacy related to implementing core lifestyle intervention learning components, knowledge, health behaviors, and skill mastery. * be randomized to receive the new web-based training or to a standard chw training designed by health and human services. the new web-based training provides promotores with the self-efficacy, knowledge, and skills required to effectively implement an obesity intervention for hispanic women. promotores will build their skillset through interactive quizzes, exercises, video role-playing scenarios, and interactive tools. * complete follow-up surveys at 3 months and 6 months after the baseline survey. this survey will ask the same questions as the baseline survey and will include additional questions regarding satisfaction with training and behavior application. researchers will compare participants who receive the new web-based training to participants who utilize the hhs training. the goal is to see whether the new web-based training increases self-efficacy among chws to effectively implement core lifestyle learning components for obesity interventions in hispanics.


Eligibility criteria:
inclusion criteria: * 18 years of age and old * comfortable speaking, reading, and writing english or spanish * female * access to a computer that has internet * not pregnant * have a community health worker certification through the state of tx or have worked over 6 moths as a community health worker and meets core competencies for chws * provides services to hispanic populations exclusion criteria: * less than 18 years of age and old * not comfortable speaking, reading, and writing english or spanish * male * does not have access to a computer that has internet * pregnant * does not have a community health worker certification through the state of tx or have not worked over 6 moths as a community health worker and does not meet core competencies for chws * does not provide services to hispanic populations

Keywords: obesity latina
predictors of motor progression in parkinson's disease

Conditions: Parkinson's Disease

Summary: treatment resistant motor features, such as postural instability and freezing of gait are common in people with parkinson's disease and major contributors to morbidity and mortality. this project will use sleep studies, quantitative motor assessments and magnetic resonance imaging to examine the relationship between abnormally increased muscle activity during rapid eye movement sleep and the development and progression of treatment-resistant postural instability and gait disturbances. specifically, the investigators will test the hypothesis that anticipatory postural adjustments (weight and pressure shifts) during gait initiation are significantly reduced in people with parkinson's disease who have abnormally elevated muscle activity during rapid eye movement (rem) sleep compared to individuals will parkinson's disease whose rem sleep muscle activity is normal. in addition, the investigators will test the hypothesis that the level of rswa at baseline is predictive of measures of motor decline (postural stability and gait) and alterations in the structure and function of locomotor brainstem networks. since sleep disorders can emerge years before a diagnosis of parkinson's disease, establishment of a link between sleep and treatment-resistant posture and gait disorders will help identify individuals at risk of developing these disabling motor features of disease.


Eligibility criteria:
inclusion criteria: 1. diagnosis of idiopathic parkinson's disease (pd). 2. age 21-75 years 3. able to ambulate independently without the use of an assistive device (e.g. cane) exclusion criteria: 1. history of dementia 2. history of musculoskeletal disorders that adversely affects walking and/or balance 3. other significant neurological disorders 4. implanted deep brain stimulator(s) (dbs) or other neurosurgeries to treat pd 5. mri exclusion for 7 tesla scans: presence of any metallic clips or implantable medical devices 6. pregnant women
primary prevention of major adverse cardiac events (mace) with standard and intensive statin treatment in patients with diabetes: survival and cardiovascular event assessments

Conditions: Hypercholesterolemia; Type 2 Diabetes; Hypertension

Summary: the study is being conducted to compare the effect of standard treatment (target ldl-c level: \<120 mg/dl (jasgl 2007 target level)) and intensive treatment (target ldl-c level: \<70 mg/dl) in the prevention of major adverse cardiac events (mace) in hypercholesterolemia patients with concomitant type 2 diabetes and hypertension.


Eligibility criteria:
inclusion criteria: patients meeting the following inclusion criteria will be included in the study: 1. patients giving voluntary written consent to participate in the study 2. male or female patients 50 years of age or older (at informed consent) 3. hypercholesterolemia patients (untreated patients: ldl-c level ≥140 mg/dl; treated patients: ldl-c level ≥120 mg/dl) 4. type 2 diabetes patients (hba1c level ≥6.1% (jds criteria), with or without history of drug therapy) 5. hypertension patients (sbp ≥130 mmhg or dbp ≥80 mmhg, with or without history of drug therapy) 6. patients with two or more of the following risk factors * male * 65 years of age or older * smoker * l/h ratio: ≥3.0 •hba1c level: ≥8.0% * left ventricular hypertrophy * first- or second-degree family history of mace * microalbuminuria (quantitative testing: ≥30 mg/dl), proteinuria (qualitative testing: + or higher) or egfr (\<60 ml/min/1.73 m2) exclusion criteria: patients meeting the following criteria will be excluded from the study: 1. patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent 2. patients judged to have familial hypercholesterolemia 3. patients with a serum triglyceride level of ≥400 mg/dl 4. patients with a history of myocardial infarction 5. patients with a history of coronary revascularization (pci or cabg) 6. patients with a history of treatment of unstable angina 7. patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction) 8. heart failure patients 9. patients with a history of hypersensitivity to statins 10. patients with a history of drug-induced myopathy 11. patients with poorly controlled arrhythmia 12. patients with severe liver or kidney disease 13. patients with serious concurrent disease, such as malignancy, or patients with severely limited lifespan 14. patients who are or may be pregnant 15. patients judged by the investigators to be ineligible for participation in the study for any other reason

Keywords: hypercholesterolemia with concomitant type 2 diabetes and hypertension
infliximab biosimilar "pfizer" drug use investigation (crohn's disease or ulcerative colitis)

Conditions: Crohn's Disease; Ulcerative Colitis

Summary: to collect information on the safety and effectiveness of infliximab bs for intravenous drip infusion 100 mg "pfizer" against crohn's disease or ulcerative colitis under actual status of use.

this study will be conducted with all-case investigation system in patients with crohn's disease or ulcerative colitis. this study will be conducted in patients who used this drug after the day of approval of dosage and administration for crohn's disease or ulcerative colitis at contracted medical institutions. patients who used this drug before conclusion of the contract with the medical institution will also be included in this study (retrospective patients will be included). therefore, time perspective is retrospective and prospective.

Eligibility criteria:
inclusion criteria: * patients with crohn's disease or ulcerative colitis who started treatment with this drug * patients who received this drug for the first time at the medical institution after the day of launch of this drug.

Keywords: crohn's disease ulcerative colitis infliximab biosimilar
mannitol vs hs to treat icht after severe tbi : comparison on ptio2 and microdialysis values

Conditions: Traumatic Brain Injury

Summary: the purpose of this study is to determine whether hypertonic saline is as much effective as mannitol to treat intracranial hypertension after traumatic brain injury and has at least the same effects on ptio2 and cerebral metabolism studied through microdialysis.

mannitol is frequently used to treat intracranial hypertension after tbi. however, it can be deleterious, particularly through hyperdiuresis and risks of hypovolemia. it also needs volume compensation and induces logistical problem because of needs of high infused volume to achieve osmolar load and avoid hypotension. finally, some recent studies tend to prove superiority of hypertonic saline versus mannitol on the prognosis of tbi. especially through modulation of inflammatory reactions mechanisms and apoptosis. we would like to prove non inferiority of hypertonic saline versus mannitol after tbi to allow its large utilization, especially by field military doctors with specific logistical problems. for that, more than the single intracranial pressure, we want to study effects of hs vs mannitol not only on ptio2 but also on cerebral microdialysis which gives informations on focal metabolism with profiles of ischemia, metabolic crisis, hyperglycolysis (possible reflect of neuronal restoration) and normality.

Eligibility criteria:
inclusion criteria: * severe traumatic brain injury monitored with icp, ptio2 and cerebral microdialysis * and icp\> 20 mm hg needing osmotherapy * and approval of the next of kind exclusion criteria: * bilateral fixed dilated pupils * contra-indication to multimodal neuromonitoring * previous cns disease * contra-indication to hs (cardiac insufficiency,...) * natremia \> 155 mmol/l or osmolarity \> 320 mosm/l

Keywords: traumatic brain injury ptio2 cerebral microdialysis osmotherapy hypertonic saline mannitol
systemic steroids plus antibiotics in sleep apnea syndrome in children

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the purpose of this study is to investigate the effect of treatment with a steroid and antibiotic on the size of the tonsils and symptoms of children with osas.

we will enroll children between 18 months and 12 years of age with mild sleep apnea and treat them with 5 days of prednisolone and 10 days of amoxicillin/clavulanate. we will obtain a questionnaire pre and post treatment and ask the parents to tell us if they think the child has improved enough after treatment to forego surgery. if not, they will undergo an adenotonsillectomy to relieve their sleep apnea and if yes, we will repeat the sleep study to make sure that the apnea has resolved.

Eligibility criteria:
inclusion criteria: * polysomnogram results showing mild obstructive sleep apnea. exclusion criteria: * significant medical problems * chronic medication intake (except bronchodilators and inhaled steroids) * allergy to penicillin or its derivatives.

Keywords: obstructive sleep apnea syndrome (osas) in children
evaluation of pharmacokinetics, safety, and tolerability of ertugliflozin (pf-04971729, mk-8835) in japanese and western healthy participants (mk-8835-041)

Conditions: Diabetes Mellitus, Type 2

Summary: this study is to characterize the pharmacokinetics, safety, tolerability, and pharmacodynamics of single and multiple oral doses (sd, md) of ertugliflozin (pf-04971729, mk-8835) in japanese healthy participants. the secondary objective is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of ertugliflozin in western healthy participants as compared to japanese healthy participants.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects of non-childbearing potential, between the ages of 18 and 55 years, inclusive * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * japanese subjects must have four japanese grandparents who were born in japan. * mean body weight and the body weight range of western subjects are similar to those of japanese subjects with a 10% plus and minus error. * an informed consent document signed and dated by the subject. * subjects who are willing and able to comply with scheduled visits, treatment plan,laboratory tests, and other study procedures. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease * asian or polynesian subjects in western subject groups. * any condition possibly affecting drug absorption (eg, gastrectomy). * a positive urine drug screen. * history of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males within 6 months of screening. * history or evidence of habitual use of tobacco or nicotine containing products within 3 months of screening, with the exception of light smoking (up to 5 cigarettes per day or the equivalent). * treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication. * 12-lead ecg demonstrating qtc \>450 msec at screening. * subjects with any of the following abnormalities on safety laboratory tests): * evidence of glycosuria, as defined by a positive urine dipstick test; * fasting serum triglyceride \>300 mg/dl; * fasting ldl-cholesterol \> than or equal to 190 mg/dl. * fasting serum glucose \>125 mg/dl.

Keywords: ertugliflozin japanese and western population pharmacokinetics pharmacodynamics
diagnostic accuracy of the vegetative and minimally conscious state

Conditions: Disorder of Consciousness; Minimally Conscious State

Summary: the aim of this study was to investigate diagnostic accuracy of the vegetative and minimally conscious state: clinical consensus versus standardized neurobehavioral assessment

in this study, doc patients with clinical consensus of doc were enrolled. the investigators used coma recovery scale-revision (crs-r) to assess consciousness levels for all doc patients during ten days.

Eligibility criteria:
inclusion 1. at least 18 years old; 2. acquired brain injury; 3. no neuromuscular blockers or sedatives were used within 48 hours of enrollment. exclusion criteria: 1. there are functional disorders caused by progressive mental diseases; 2. persistent seizures; 3. unstable vital signs; 4. double upper limb frustration, fracture.

Keywords: disorders of consciousness coma recovery scale-revision diagnostic accuracy
vestibular innovation in pain

Conditions: Pain; Fatigue; Quality of Life

Summary: the vip trial will assess the effectiveness, tolerability, and durability of effect of vestibulocortical stimulation (vcs) - a safe \& cost-effective bedside technique - in treating pain, fatigue \& related symptoms using validated patient-reported outcomes. data from this trial will be used to guide optimized treatment protocols in future randomized controlled trials and help inform the implementation of vcs into standard clinical practice.

vcs is a form of non-invasive neuromodulation whereby cold water is irrigated into the external ear canal.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * age equal to or \>18 years old * stated interest in and willingness to receive vcs and to complete the online patient reported outcomes before and after the procedure. * owns or has access to a smart phone or computer to complete outcome measures * diagnosis of one of the following: * fibromyalgia (fm), with at least a 4/10 average baseline pain on the numeric rating scale at the time of inclusion. * myalgic encephalomyelitis/chronic fatigue syndrome (me/cfs) * long-covid * post treatment lyme disease syndrome (ptlds) exclusion criteria: an individual with any of the following criteria will be excluded from participation in this study: * history of tympanic membrane injury, rupture, or surgery * including tympanostomy, or "ear tubes," and/or cochlear implant. * ear infection within the last 3 months, or current ear pain. * current pregnancy * bipolar disorder * history of seizures (including non-epileptiform seizures) * history of syncope * inability to lay supine for 30 minutes * clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study * not fluent in english * history of or current meniere's disease * history of myocardial infarction (mi), stroke or tia, or coronary artery bypass graft (cabg) in the last three months * history of hospitalization for severe hypertension * history of vestibular schwannoma or meningioma resection.
comparing pericapsular nerve group block with lumbar erector spinae plain block in total hip arthroplasty surgery

Conditions: Postoperative Pain; Total Hip Arthroplasty

Summary: total hip arthroplasty is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. despite being a frequently performed procedure, there is high variability in the peri-operative anaesthetic and analgesic management for total hip arthroplasty. beyond the immediate postoperative period, regional anesthesia and analgesia can have potentially beneficial effects on long-term outcomes, especially on postoperative pain, functional rehabilitation and morbidity . the primary implication of this study is to compare postoperative opioid consumption of patients' after total hip arthroplasty using pericapsular nerve group (peng) block with lumbar erector spinae plain block.

total hip arthroplasty is a common surgical procedure aiming to improve mobility and quality of life in patients suffering from hip pain. despite being a frequently performed procedure, there is high variability in the peri-operative anaesthetic and analgesic management for total hip arthroplasty. beyond the immediate postoperative period, regional anesthesia and analgesia can have potentially beneficial effects on long-term outcomes, especially on postoperative pain, functional rehabilitation and morbidity . the primary implication of this study is to compare postoperative opioid consumption of patients' after total hip arthroplasty using pericapsular nerve group (peng) block with lumbar erector spinae plain block.

Eligibility criteria:
inclusion criteria: * patients over 18 years old, undergoing total hip arthroplasty surgery exclusion criteria: * patients with solid organ dysfunction, chronic opioid or corticosteroid use, bleeding diathesis, patients receiving inpatient medication, patients with psychiatric disorders and patients who cannot be contacted after surgery.

Keywords: total hip arthroplasty peng block lumbar erector spinae plain block postoperative opioid consumption
study of drug-drug interaction of the effects of gemfibrozil and rifampicin on sar442168 in healthy adult subjects

Conditions: Multiple Sclerosis

Summary: this is a phase 1, single-center, open-label, non-randomized study to assess the effects of cyp2c8 inhibition using gemfibrozil, and cyp3a4 and cyp2c8 induction using rifampicin on the pharmacokinetics of sar442168 in healthy male participants aged 18 to 45 years.

study duration per participant approximately 16 days for cohort 1 and approximately 18 days for cohort 2.

Eligibility criteria:
inclusion criteria: * male participant, between 18 and 45 years of age, inclusive. * body weight between 50.0 and 100.0 kg, inclusive, body mass index (bmi) between 18.0 and 30.0 kg/m2, inclusive. * having given written informed consent prior to undertaking any study-related procedure. exclusion criteria: * any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness. * presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician. participants with known hypersensitivity to any component of the imp formulation or allergic disease diagnosed and treated by a physician. * any medication (including st john's wort and ginseng) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication, any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion. * any contraindications to gemfibrozil or rifampicin, according to the applicable labelling. * any subject who, in the judgment of the investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
comparative pharmacokinetic study of two different strengths of bay14-2222

Conditions: Hemophilia A

Summary: this is a single dose, open-label, randomized, crossover study in subjects with severe hemophilia a to compare the bioavailability of 2 different strengths of kogenate fs (bay 14-2222).


Eligibility criteria:
inclusion criteria: * males, age 18 to 65 years * subjects with severe hemophilia a with a documented plasma fviii level of \<1% * \>/= 150 ed (exposure days) with fviii concentrates(s) as supported by medical records exclusion criteria: * evidence of current or past inhibitor antibody * history of any congenital or acquired coagulation disorders other than hemophilia a * platelet count \<75,000/mm3 * abnormal renal function (serum creatinine \>2 times the upper limit of the normal range) * active liver disease verified by medical history or persistently elevated alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>5x the upper limit of normal or severe liver disease as evidenced by, but not limited to any of the following: international normalized ratio (inr) \>1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices

Keywords: bay14-2222 pharmacokinetics