Kornimate/medical-research-clean huggingface dataset:
rapid agitation control with ketamine in the emergency department

Conditions: Violent Aggressive Behavior; Ketamine

Summary: compare intramuscular (im) ketamine to a combination of im midazolam and haloperidol with regards to the time required for adequate behavioral control, in minutes, in patients presenting to the emergency department with psychomotor agitation and violent behavior.


Eligibility criteria:
inclusion criteria: 1. age 19 - 60 years inclusively; 2. patients presenting to the emergency department with psychomotor agitation or violent behaviour (rass score \> +3). exclusion criteria: 1. less than 19 years of age; 2. greater than 60 years of age; 3. previous participation in this study; 4. women suspected or known to be pregnant or breastfeeding; 5. previous known hypersensitivity, intolerance or allergy to ketamine, midazolam or haloperidol or their components. 6. subjects who are in comatose states or have cns depression due to alcohol or are taking other depressant drugs. 7. subjects with severe depressive states, spastic diseases and in parkinson's syndrome, except in the case of dyskinesias due to levodopa treatment. 8. senile patients with pre-existing parkinson-like symptoms. 9. subjects with a history of cerebrovascular accident 10. subjects in whom a significant elevation of blood pressure would constitute a serious hazard, such as patients with significant hypertension 11. subjects with severe cardiac decompensation 12. subjects who intend to have surgery of the pharynx, larynx, or bronchial tree unless adequate muscle relaxants are used 13. subjects with acute pulmonary insufficiency 14. subjects with severe chronic obstructive pulmonary disease 15. subjects with acute narrow angle glaucoma

Keywords: ketamine aggressive behaviour midazolam haloperidol emergency department
pharmacokinetics of yimitasvir phosphate capsule in subjects with normal renal function and esrd

Conditions: Renal Impairment

Summary: this study is to evaluate the single-dose pharmacokinetics (pk) and safety of yimitasvir phosphate capsule in participants with end-stage renal disease without hemodialysis using matched healthy participants as a control group.


Eligibility criteria:
inclusion criteria: 1. male or female, age 18 to 70 years of age, inclusive; 2. must have a calculated body mass index (bmi) from 18 to 28 kg/m2 at study screening; 3. glomerular filtration rate must be \< 15 ml/min /1.73 m2 for end-stage renal disease without hemodialysis group, and ≥ 90 ml/min for normal renal function group(using mdrd method); 4. matched for age (±5 years) ,gender and bmi(±15%) with a subject in the end-stage renal disease without hemodialysis group; exclusion criteria: 1. allergies constitution ( multiple drug and food allergies); 2. use of \>5 cigarettes per day during the past 3 months; 3. a positive test results for hbsag, hepatitis c antibody, hiv-1 antibody, or treponema pallidum antibody； 4. history of alcohol abuse； 5. donation or loss of blood over 400 ml within 3 months prior to the first dose of study drug； 6. subjects deemed unsuitable by the investigator for any other reason.
effects of an intervention on improving midlife women's menopause-related symptoms

Conditions: Genitourinary Symptoms

Summary: this study was an experimental study with repeated measures. study aims were to examine the effects of pelvic floor muscles training (pfmt) combined with yoga on improving genitourinary/climacteric symptoms, the pelvic floor muscles strength, and health-related quality of life (hrql). study participants were assigned to the intervention group or comparison group. data analyses were based on the information obtained from 91 midlife women with a mean age of 56.6 years. information related o the pelvic floor muscles strength was only obtained from 45 women. descriptive statistics were used to represent study participants' individual characteristics, genitourinary/climacteric symptoms, the pelvic floor muscles strength, and hrql. paired t tests, independent t tests, and generalized estimating equation (gee) procedures were used to examine the intervention effects.

this study was an experimental study with repeated measures. study aims were to examine the effects of pfmt combined with yoga on improving genitourinary/climacteric symptoms, the pelvic floor muscles strength, and hrql. study participants were randomly assigned to the intervention group or comparison group. all study participants received an educational section (a discussion section and an abbreviated practice section) and related educational materials. the intervention group attended on-site group practice sessions and performed individual home-based practice. the comparison group performed individual home-based practice only. data analyses were based on the information obtained from a sample of midlife women with a mean age of 56.6 years. relevant information was mainly collected by a structured questionnaire. information related to the pelvic floor muscles strength was only obtained from 45 women in the intervention group by using the femiscan pelvic floor therapy system. descriptive statistics were used to represent study participants' individual characteristics, genitourinary/climacteric symptoms, the pelvic floor muscles strength, and hrql. paired t tests, independent t tests, and gee procedures were used to examine the intervention effects.

Eligibility criteria:
inclusion criteria: * women who experienced ≥1 genitourinary symptoms. exclusion criteria: * being pregnancy or breastfeeding, experiencing iatrogenic menopause (e.g., surgery, chemotherapy or radiation related), maintaining regular pfmt and/or yoga practices, using oral contraceptive or psychiatric medications, and having physical weakness/limitation or major cognitive impairment.
a study of pegasys (peginterferon alfa-2a (40kd)) plus entecavir in treatment-naive patients with hbeag-positive chronic hepatitis b.

Conditions: Hepatitis B, Chronic

Summary: this 3 arm study will assess the efficacy and safety of pegasys + entecavir combination therapy in treatment-naive patients with hbeag positive chronic hepatitis b. patients will be randomized to receive 1)pegasys 180 micrograms s.c./week for 48 weeks, 2)pegasys 180 micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36 or 3) entecavir 0.5mg p.o. once daily for 24 weeks + pegasys 180 micrograms s.c./week from week 21 to 68. treatment will be followed by 24 weeks treatment-free follow up. the anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for group 3, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-65 years of age; * hbsag positive, hbeag positive and anti-hbe negative for at least 6 months, anti-hbs negative; * absence of cirrhosis confirmed by liver biopsy in previous 12 months. exclusion criteria: * previous treatment for chronic hepatitis b within previous 6 months; * antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months; * co-infection with active hepatitis a, hepatitis c, hepatitis d or hiv; * history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis.
reduction in symptomatic esophageal stricture formation

Conditions: Esophageal Stenosis

Summary: complete endoscopic resection of early neoplastic barrett's esophagus (be) is a curative procedure. however, a significant proportion of patients develop symptomatic esophageal strictures following complete barrett's eradication (cbe), and this limits the technique, particularly for circumferential and longer segment disease. oral steroid therapy may reduce stricture formation; thereby allowing cbe to be performed with minimal associated morbidity.

the main objective of the proposed randomized trial is to compare the rate of symptomatic oesophageal strictures in patients receiving placebo versus oral prednisone.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed barretts mucosa with high grade dysplasia or early esophageal adenocarcinoma (t1a, intramucosal adenocarcinoma). 2. barretts segment ≥ 30% circumference, ≤c3 and ≤m5. 3. the general health condition of the patient permits anesthesia for endoscopy. 4. patient is 18 years of age or older. 5. informed consent is obtained exclusion criteria: 1. previous (referral) biopsies show low grade dysplasia only, or invasive adenocarcinoma. 2. barretts segment \ c3 or \>m5. 3. during initial gastroscopy there are highly suspicious areas for submucosal invasive cancer (kudo pit pattern type v; excavated/depressed type morphology; large smooth or ulcerated nodule). in cases of significant doubt, initial resection is of the highly suspicious area only, and urgent histology processing requested. if submucosal invasion is excluded, the patient is rebooked for 1st stage complete barrett's excision (60% circumferential resection) and randomization after a 4-6 weeks interval. 4. presence of a tight peptic oesophageal stricture that impedes safe and effective endoscopic mucosal resection using a cap (cook medical). 5. active malignancy, uncontrolled diabetes mellitus, active or untreated major psychiatric disorder, uncontrolled infection, uncontrolled hypertension, uncontrolled or severe congestive cardiac failure, non-correctable coagulopathy (inr\>2, or platelet count \<60 x 109/l), osteoporosis, recent peptic ulcer disease, moderate-to-severe glaucoma or untreated glaucoma, or pregnancy. 6. unable to provide informed consent 7. allergy to compound used in tablet formulation
a study to evaluate whether losartan protects the kidney in hypertensive diabetic participants with microalbuminuria (mk0954-365 am1)

Conditions: Hypertension

Summary: this study will evaluate whether losartan protects the kidney in hypertensive type ii diabetic participants with microalbuminuria.


Eligibility criteria:
inclusion criteria: * diabetes mellitus * hypertension and has received losartan 50 mg or losartan 100 mg for at least 6 months * microalbuminuria (defined as microalbuminuria \> 30 mg/g and \< 300 mg/g by spot urine test) * serum creatinine ≤1.5 mg/dl for men and ≤1.4mg/dl for women * urinalysis with white blood cells (wbc) \<5 cells per high power field * results of hemoglobin a1c (hba1c), fasting blood glucose, serum creatinine, urine albumin/urine creatinine ratio and urinary analysis tests at baseline and 6 months after initiating the losartan therapy are available * medical history and co-morbidities (if available) listed in medical records * prescription information of antihypertensive regimen of losartan 50 mg or 100 mg available exclusion criteria: * treated with angiotensin-converting enzyme (ace) inhibitors or angiotensin-receptor blockers (arb) before initiated treatment with losartan 50 mg or losartan 100 mg * enrollment in another clinical trial
14729-d9831c00002- 1 month biopsy study

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to study histological changes, cellularity, clinical efficacy and safety of azd1981 in patients with chronic obstructive pulmonary disease


Eligibility criteria:
inclusion criteria: * men or women 40 years or above * fev1 between 40 and 80% of predicted normal value post-bronchodilator * clinical diagnosis of copd exclusion criteria: * other clinically relevant disease or disorders * exacerbation of copd within 30 days

Keywords: copd moderate to severe copd
intravenous lidocaine for pain associated with pancreatic cancer and chronic pancreatitis

Conditions: Pancreatic Cancer; Chronic Pancreatitis

Summary: pain is a major clinical problem for many patients with pancreatic cancer and chronic pancreatitis (cp).in pancreatic cancer, nearly 75% of patients suffer from pain at the time of diagnosis, with over 90% of patients in advanced stages. in cp, pain occurs in 80-90% of patients and strongly affects quality of life. for both conditions, the majority of pain is addressed using the who analgesic ladder. however, more invasive pain therapies are often necessary. currently, in several centers in the netherlands, treatment with iv lidocaine is already used in clinical practice in patients with pancreatic cancer and cp. based on practical experience, the majority of patients benefit from this therapy, however, its efficacy in terms of duration of pain relief, decrease in pain scores, increase in patient satisfaction and adverse events is unknown. therefore, the aim of this study is to investigate the efficacy of monitored single intravenous infusion in patients with pancreatic cancer and cp.


Eligibility criteria:
inclusion criteria: * age 18 years or older; * nrs score ≥4 despite previous pain treatment with non-opioid analgesics, opioids or tcas. or pain treatment with non-opioid analgesics, opioids or tcas with adequate effect on pain, but unable to reduce the opioids; * for cp: * diagnosis of cp based on the m-annheim diagnostic criteria;17 * for pancreatic cancer: * diagnosis of pancreatic cancer (all stages) * eastern cooperative oncology group (ecog) performance status 0-2; * life expectancy ≥ 3 months; * consensus of surgeon/gastroenterologist and anesthesiologist for suitability for treatment exclusion criteria: * patients with contra-indications for intravenous lidocaine i.e. medical history of non-adequate liver function, hypersensitivity to local anesthetics, new york heart association class iii or iv cardiac disease or myocardial infarction within the past 12 months, shock, and conduction abnormalities (defined as second and third degree atrioventricular (av) blocks, or atrial fibrillation); * patients who underwent invasive pain therapies: such as endoscopic treatment or surgery for chronic pancreatitis, and splanchnic nerves or coeliac plexus blocks, neurolysis, or prf for pancreatic cancer.
effect of sensorimotor training on upper extremity in parkinson's patients

Conditions: Parkinson Disease

Summary: there are many factors affecting the upper extremity such as tremor, bradykinesia, rigidity, and postural instability in parkinson's patients. according to the international classification of functioning, disability and health (icf) model, there are restrictions on people's activities and participation in life due to structural and functional disorders affecting the upper extremity in pd. in pd, integrating and using proprioceptive feedback, sensorimotor integration and peripheral sensory functions are reported to be impaired. numerous studies show that the main source of motor problems in pd is dysfunction of sensorimotor integration. since the cervical region contains a dense concentration of proprioceptive organs such as muscle spindles, it plays an important role in providing afferent proprioceptive information for postural control. therefore, sensorimotor training targeting the cervical region gains importance. in this study, we aim to reduce pd-specific upper extremity disorders and related activity and participation limitations by increasing motor control in the cervical region with sensorimotor training. patients with parkinson's disease will be included in the study and randomly divided into 2 groups. while the general physiotherapy program will be applied to the control group, sensorimotor training will be given in addition to the exercise group.


Eligibility criteria:
inclusion criteria: * having idiopathic parkinson's disease over the age of 40 * meets the diagnostic criteria of the united kingdom parkinson's disease society brain bank * hoehn-yahr staging \<3 * mini mental test score of 24 and above * in the "on" period * receiving oral therapy only exclusion criteria: * patients receiving device-assisted therapy * patients receiving apomorphine therapy * patients with mini mental test scores below 24 * patients who use drugs (antidepressants, etc.) that will affect cognitive functions * patients with hearing and speech problems * patients with orthopedic, neurological and vestibular problems other than parkinson's that may prevent them from completing the tests and treatment

Keywords: parkinson upper extremity sensorimotor training icf function
the efficacy and safety of prc-4016 in hypertriglyceridemic subjects

Conditions: Dyslipidemia

Summary: the objectives of this study is * to evaluate the efficacy of prc-4016 by assessment of the percentage change in blood lipids and lipoprotein parameters from baseline after 12 weeks of treatment. * to evaluate the safety of prc-4016 as assessed by adverse events and other safety parameters

6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification

Eligibility criteria:
main inclusion criteria: * fasting triglycerides 500-1500 mg/dl * not on other lipid altering therapy, or on stable lipid altering therapy main exclusion criteria: * type i diabetes or uncontrolled type ii diabetes * recent cardiovascular or coronary event * history of pancreatitis * history or evidence of major and clinically significant diseases that would interfere with the conduct of the study or interpretation of data * uncontrolled hypertension
an observational study to investigate the efficacy, safety, tolerability and the effect on quality of life of telmisartan (micardis) and telmisartan with hctz (micardis plus) in patients with hypertension

Conditions: Hypertension

Summary: an observational study to investigate the efficacy, safety, tolerability and the effect on quality of life of telmisartan (micardis) and telmisartan with hctz (micardis plus) in patients with hypertension


Eligibility criteria:
inclusion criteria: 1. ability to provide written/verbal informed consent in accordance with gcp (good clinical practice) and local legislation 2. patients aged 18 \~ under 80 3. hypertension as described below: * newly diagnosed patients with hypertension * patients with current antihypertensive therapy exclusion criteria: 1. female subjects who are breastfeeding, pregnant or who plan to be pregnant during the study 2. known or suspected secondary hypertension(e.g. pheochromocytoma) 3. patients who have been treated with telmisartan prior to the acquisition of informed consent (including verbal informed consent)
a study of the mind diet for persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study will assess the impact of a mind (mediterranean-dash intervention for neurodegenerative delay) diet on brain health and ms symptoms. participants will be randomly assigned to one of two arms: the diet intervention arm or the "continue current diet"/control arm. participants randomized to the dietary intervention arm will change their diet to follow a mind dietary pattern for one year; diet-related education and programming is provided to support this change. participants randomized to the continue/control arm will be asked to continue their current dietary habits, without major change for one year; multiple sclerosis (ms) ms-related related education and programming (unrelated to diet) is provided. all participants will be asked to provide blood \& stool samples and to complete online questionnaires \& three in-person assessments.

the goal of this study is to evaluate the effects of a mediterranean-style dietary intervention on neuroprotection and symptom management in ms with an early phase ii, randomized, controlled clinical trial. participants will be randomized-stratified by ms phenotype and treatment type-to the diet intervention arm (change current diet to a mind diet) or the continue/control arm (no major change in current dietary habits). all patients will participate in a baseline visit, and 6 month visit, a 12 month (end of study visit), and meet with small support groups between study visits. participants will also complete online questionnaires, undergo functional \& cognitive assessments, and contribute blood \& stool samples while on protocol. the diet intervention arm will receive mind diet-related education and support from the study dietitian and the principal investigator; virtual small group environments will facilitate discussion about participants' experience and potential challenges with mind diet adherence and ways to overcome them. virtual groups will meet weekly for the first month, then monthly through month 12. the continue current dietary habits /control arm will receive ms-related education and support unrelated to diet from members of the study team and the principal investigator. group meeting topics and schedules will be provided in advance to offer flexibility; participants are required to attend 6 virtual small group meetings but are invited to join as many as desired.

Eligibility criteria:
inclusion criteria: * ages 18-70 years, inclusive * ms diagnosis, on any treatment (including no treatment) * mind diet score of ≤8 at baseline * nfl parameters determined by age exclusion criteria: * diagnosis of an additional neurodegenerative disease (e.g. alzheimer's) or other serious neurological condition (e.g. stroke) * current serious medical condition that could impact the ability to participate or influence study results (e.g. cancer, hiv) * pregnancy/planning during study period

Keywords: multiple sclerosis diet
infraclavicular brachial plexus block with bupivacaine alone or with both dexmedetomidine and dexamethasone

Conditions: Upper Extremity Injury

Summary: upper-extremity regional anesthetic techniques, using brachial plexus blockade, have been shown to reduce adverse effects related to opioid administration, improve patient satisfaction, and provide significantly improved analgesia immediately following these surgeries. many medications have been investigated to extend and enhance long-acting local anesthetics' (la) analgesic effects. currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal long-lasting single-shot nerve block. in general, adjuvants have been used in peripheral nerve blocks to accelerate onset, decrease plasmatic absorption and secondary toxic effects, and prolong the block effects.

brachial plexus blockade-based upper-extremity regional anesthetic approaches have been demonstrated to lessen opioid administration side effects, increase patient satisfaction, and offer noticeably better analgesia right after these surgeries. a lot of drugs have been tested to prolong and improve the analgesic effect of long-acting local anesthetics (la). currently, dexamethasone and dexmedetomidine have been studied, looking for an optimal, long-lasting single-shot nerve block. adjuvants have generally been employed in peripheral nerve blocks to lengthen the block effects, limit secondary toxic effects and plasmatic absorption, and speed the onset of the block. objectives: to compare the effects of adding dexmedetomidine and dexamethasone to bupivacaine on the start of sensory blockade in an infraclavicular brachial plexus block. patients and methods: a prospective, randomized controlled trial will be conducted on patients who are undergoing hand or forearm surgeries. patients who will be eligible for the study will be divided into 2 groups. the first group will receive dexmedetomidine and dexamethasone as adjuvants to bupivacaine, while the second group will receive bupivacaine alone. expected results: the success rate, onset time, duration of the block, and possible adverse events.

Eligibility criteria:
inclusion criteria: * age 18-65 years * american society of anesthesiologists physical status i-ii * body mass index between 18 and 35 kg/ m2 * scheduled for forearm and hand surgeries exclusion criteria: * inability to consent to the study * coagulopathy * sepsis * decompensated chronic hepatic or renal illnesses * allergy to any of the used drugs * pre-existing musculocutaneous/median/radial/ ulnar neuropathy * prior surgery in the infraclavicular fossa