Kornimate/medical-research-clean huggingface dataset:
a skills-based program delivered via secure live video to patients with acute musculoskeletal trauma

Conditions: Musculoskeletal Injury; Fracture

Summary: the aims of this study are to test a manualized mind body skills-building program aimed at preventing the development of chronic pain and disability following acute musculoskeletal injury in at-risk patients.

this is a pilot randomized feasibility trial of the mind body program toolkit for optimal recovery versus usual medical care. the toolkit is delivered via secure live video to patients at risk for chronic pain, at 1-2 months after injury. the primary aim of this study is to determine the feasibility and acceptability of the program, randomization, procedures and outcome measures. secondarily, we report means and standard deviation and explore change in quantitative outcomes in the toolkit compared to usual care.

Eligibility criteria:
inclusion criteria: * diagnosis of musculoskeletal injury in the past 1-2 months * 18 years of age or older * english fluency and literacy * pcs or, pass score above median split exclusion criteria: * major medical comorbidity expected to worsen in the next 6 months * comorbid chronic pain condition * antidepressant medication change in the past 6 months * secondary gains such as litigations or workers compensation procedures * diagnosis of psychosis, bipolar disorder or active substance dependence (by self report) * unwilling or unable to use videoconferencing

Keywords: psychiatry psychology psychosocial mind-body
impact of aripiprazole on postoperative analgesia in laparoscopic hysterectomy

Conditions: Anesthesia; Analgesia; Hysterotomy

Summary: the analgesic effect of perioperative use of aripiprazole has not been fully investigated. so, this study aims to test the effects of aripiprazole versus placebo in reducing postoperative pain following laparoscopic hysterectomy and to explore the potential side effects.


Eligibility criteria:
inclusion criteria: * physical status american society of anesthesiologist (asa) i or ii * electively scheduled for laparoscopic hysterectomy, exclusion criteria: * patients who refuse to participate * body mass index (bmi) \> 30 * asa physical status \> ii * diabetes * major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological) * coagulation abnormalities * pregnancy * known hypersensitivity to aripiprazole or contraindications to its use (a psychiatric illness, patients on antidepressants, dementia-related psychosis) * history of drug addiction or alcohol abuse * mental retardation interfering with the evaluation of pain scores or pca programs .
to evaluate the efficacy and safety of hl151 versus placebo in perennial allergic rhinitis patients

Conditions: Perennial Allergic Rhinitis

Summary: 4week, a multicenter, randomized, double-blinded, parallel, therapeutic confirmatory clinical trial

4week, a multicenter, randomized, double-blinded, parallel, therapeutic confirmatory clinical trial to evaluate the efficacy and safety of hl151 versus placebo in perennial allergic rhinitis patients

Eligibility criteria:
inclusion criteria: 1. both gender, 19 years ≤ age 2. at least two years history of allergic rhinitis prior to participate in clinical trial 3. patients with positive reaction for perennial allergen in tests(prick test or intradermal test or mast(multiple allergen simultaneous test) or immuno cap test) within 12 months 4. in visit 2, patients with over mean 5 points of the total reflective tnss score per day (during the run-in period) (highest value 12 points) 5. patients who can ability to record subject diary 6. patients who agreed to maintain the same environment throughout the entire clinical trial period. 7. written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial exclusion criteria: 1. patients with non-allergic rhinitis 2. patients with asthma due to the following diseases(but patients with mild and intermittent asthma are available to participate in clinical trials) * within four weeks from the date of screening, patients who visit the emergency room or have been hospitalized within 12 weeks or * patients with asthma who need other treatment except short-acting beta-efficient respiratory relaxants inhalation 3. patients with obstructive nasal polyp or severe deviated nasal septum 4. patients who within 12 weeks from the date of screening, had damage or surgery around nasal cavity 5. patients with anamnesis in acute /chronic sinusitis
using the chinese indigenization fs scale in the diagnosis of fibromyalgia： specificity and sensitivity in clinical practice

Conditions: Fibromyalgia

Summary: this study aimed to evaluate the specificity and sensitivity of the diagnostic criteria for fibromyalgia after conducting local validation in china.


Eligibility criteria:
inclusion criteria: * at least 18 years of age; patients with chronic widespread pain; able to complete the questionnaire. exclusion criteria: * terminal patients with severe psychiatric diseases, tumors, systemic lupus erythematosus, systemic sclerosis, or other serious diseases.
combined bio- and neuro- feedback vs. varenicline use for smoking cessation

Conditions: Chronic Obstructive Pulmonary Disease (COPD); Asthma; Smoking

Summary: this study will develop and experimentally test the efficiency of a neurofeedback training protocol vs. varenicline use for smoking cessation.

this study will develop and experimentally test the efficiency of a neurofeedback(nf) training protocol for smoking cessation. as non-pharmacological, non-invasive and painless brainwave technique, nf contributes to teach individuals how they can take the control of their mind through operant conditioning. nf regulates brain function in natural way. studies have reported an 80% rate of reducing or eliminating the need for traditional medication14. therefore, other nicotine substitutes (such as varenicline) which may carry their own toxicity risk factor may become redundant. the protocol will include 5 bio- and 25 neuro-feedback sessions, lasting approximately 36 months. the electrophysiological evaluation of the efficacy of the intervention will include eeg resting state and a multifeature mismatch negativity (mmn) evoked response measurements before and after the participation of human volunteers. these data will be analyzed in terms of cortical activation patterns and cortical connectivity. questionnaires will be used to collect behavioral and psychometric data regarding smoking related behaviors. additionally, a clinical evaluation including spirometry, exhaled carbon monoxide, total antioxidant capacity, vitamine e, and cotinine will be conducted. the data will be collected prior, during, after the completion of the study and after a one-year follow up. the neurofeedback intervention will be compared to a different group of participants that will follow an intervention based on varenicline use for approximately 3 months. the electrophysiological evaluation of the efficacy of the intervention will include eeg resting state and a sleep polysomnography measurement. questionnaires and clinical evaluation include the same measurements as the neurofeedback intervention but only in 3 time points: prior, during, after the completion of the study.

Eligibility criteria:
inclusion criteria: * being continuous tobacco smokers (\>10 cigarettes per day) for at least 6 months * being unemployed for at least 3 months * being diagnosed with asthma * being diagnosed with c.o.p.d. * age \< 35, for the group of young unemployed * age \>35 years, for the groups of asthma and c.o.p.d. patients exclusion criteria: * diagnosed neurological, mental or psychiatric illness * drug-resistance epilepsy
reirradiation with fdg-pet guided dose painting

Conditions: Head and Neck Cancer

Summary: dose-painting may increase the chance of cure at minimised radiation-induced toxicity in intensity-modulated radiotherapy (imrt) for primary head and neck cancer. this could also apply for recurrent and second primary head and neck cancers in previously irradiated volumes. this trial (ridpaint) investigates the feasibility of fdg-pet guided radiotherapy using imrt dose-painting by contours for patients with recurrent and second primary head and neck cancer.

the standard re-irradiation regimen for head and neck cancer patients treated at the oslo university hospital is 1.5 gy twice daily during 4 weeks with a total dose of 60 gy. in this study the radiotherapy is planned using 18f-fdg pet/ct making one experimental "dose-painting by contours" sib (simultaneous integrated boost) plan with a maximum point dose of 75 gy. the participants will be given 65 gy and 70 gy minimum doses to two gtvs inside the conventional gtv (60 gy). gtv_65gy and gtv_70gy are determined from the suv values from the 18f-fdg pet/ct according to the formula proposed by the ghent group (van der straeten et al, r\&o -06). it is expected to keep the level of normal tissue side-effects within or slightly above the level of conventional radiotherapy (i.e. maximum dose of 60 gy). in addition to the routine follow-up, the participants will be examined with 18f-fdg pet/ct 6 months after inclusion (4 1/2 months after end of radiotherapy) and hrql measurements.

Eligibility criteria:
inclusion criteria: * histologically or cytologically verified invasive carcinoma of the head and neck region; icd10: c01, c02.0 - c02.9; c03.0 - c03.9; c04.0 - c04.9; c05.0 - c05.9; c06.0 - c06.9; c09.0 - c09.9; c10.0 - c10.9; c11.0 - c11.9; c12; c13.0 - c13.9; c14.0 - c14.9; c30; c31.0 - c31.9; c32.0 - c32.9 * planned treatment at the norwegian radium hospital or at other participating university hospitals * age ≥18 years * ability to understand and respond to the questionnaires * informed consent received * squamous cell carcinoma in the head and neck region of patients previously irradiated for head and neck cancer * no grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy * minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer * ecog performance status ≤ 2 exclusion criteria: * patients planned for standard curative treatment (radical rt +/-concomitant chemotherapy or postoperative rt of primary disease) * patients who previously have been re-irradiated for overlapping second primary or relapse * other second primary tumors that are not under control * distant metastatic disease

Keywords: dose painting 18f-fdg positron emission tomography radiotherapy
enteral glutamine supplementation for the patient with major torso trauma

Conditions: Trauma; Critical Illness; Shock

Summary: glutamine is considered a conditionally essential amino acid during critical illness. after severe trauma, glutamine supplementation into the gastrointestinal tract may help maintain bowel function. we hypothesize that for the major torso trauma patient, high dose glutamine given enterally during resuscitation from shock and continued during enteral nutrition support is absorbed, available systemically and preserves gut integrity.

in this prospective, randomized, controlled trial of patients with major torso trauma, high-dose enteral glutamine and enteral nutrition will be given to research subjects while controls will receive isocaloric, isonitrogenous enteral support. enteral tolerance, bowel integrity and permeability will be evaluated. the systemic appearance of glutamine will be measured.

Eligibility criteria:
inclusion criteria: * adult trauma patients meeting criteria for shock resuscitation * major torso trauma * admission to the shock/trauma intensive care unit exclusion criteria: * age \<18 years * pregnant * expected survival \< 24 hours * bowel in discontinuity * renal failure: baseline serum creatinine\>3.0 and/or dialysis * admission total bilirubin \>10 mg/dl * history of cirrhosis or cirrhosis apparent on exploratory laparotomy * asystole or cpr required

Keywords: trauma critical illness shock enteral nutrition glutamine
morbidity, mortality and gender differences in patients with pacemakers

Conditions: Pacemaker, Artificial; Cohort Studies; Arrhythmias Requiring Therapy; Cardiac Pacing, Artificial

Summary: previous publications suggest gender difference in outcome parameters after pacemaker implantation. aim of this study is to investigate gender differences in patients with pacemaker. implanted devices, indication for implantation and pacemaker follow up data of patients will be included. survival data including cause of death will be documented. prevalent comorbidities and relevant laboratory data will be recorded.


Eligibility criteria:
inclusion criteria: * all patients registered in the pacemaker database of the department of cardiology at the medical university vienna. patients get registered when clinical follow up of an implanted pacemaker is done. exclusion criteria: * for survival analysis: no valid match of first name and surname and date of birth with patients' insurance data. * for analysis of comorbidities: not a single documented diagnose was found in our electronic clinic-wide patients' information system.

Keywords: pacemaker gender differences survival retrospective
pain neurophysiology education for sport therapy students

Conditions: Knowledge; Attitude; Behavior

Summary: the effect of a 70 minute pain neurophysiology education session on sport therapy students knowledge, attitudes and clinical behaviour towards athletes with chronic pain

this single-blind, randomised control trial aims to investigate the effect of a brief 70 minute pain neurophysiology education session on sport therapy students knowledge, attitudes and clinical behaviour towards athletes with chronic pain. participants will be selected from first year undergraduate and postgraduate sport therapy cohorts. random number generator will assign participants into two subgroups. group 1 will receive a control education on clinical 'red flags'. red flags are questions that are routinely asked by therapists in clinical practice to screen for sinister pathology. group 2 will receive education called 'pain neurophysiology education' (taken from the explain pain publication). this mode of education uses the neurophysiology of pain to explain the experience, and has been used as an educational tool for patient, healthcare practitioners and students alike. data collection (completion of three questionnaires) will take place immediately prior, and immediately after each education session. the change in these outcomes pre and post intervention will subsequently be compared between groups.

Eligibility criteria:
inclusion criteria: * 1st year undergraduate sport therapy students * 1st year postgraduate, pre-registration sport therapy students * enrolled at teesside university, uk. exclusion criteria: * previous detailed pain education on either pne or red flags.
prospective collection of outcome data post poem-tif procedure

Conditions: Achalasia; Gastroesophageal Reflux Disease

Summary: per oral endoscopic myotomy has been established as a safe and effective treatment of achalasia type i and ii; however, it is limited by post-procedure gastroesophageal reflux. transoral incisionless fundoplication (tif) has been introduced as the endoscopic gold standard for anti-reflux procedure. recently, combined poem-tif has been performed successfully as a standard of care treatment for patients with severe ger after poem. we aim to study the safety and feasibility of performing poem-tif (poem and tif in the same endoscopic session). this study will also put the groundwork for a randomized clinical trial to further study the clinical outcome of the poem-tif procedure.


Eligibility criteria:
inclusion criteria: * adult patient age greater than 18 years old * manometrically proven diagnosis of either type i or type ii achalasia. exclusion criteria: * achalasia type iii, or other esophageal dysmotility disorders. * completion of poem with evidence of mucosal injury or compromise * previous surgery of the stomach such as sleeve gastrectomy, gastric bypass, heller myotomy, partial or complete fundoplication, or partial/complete gastrectomy * esophageal lumen diameter greater than 4 cm * sigmoidization of the esophagus * large esophageal diverticula * known active gastroesophageal malignancy * inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy * cirrhosis with portal hypertension, varices, and/or ascites * pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing) * acute gastrointestinal bleeding * uncorrectable coagulopathy defined by international normalized ratio (inr) \> 1.5 or platelet \< 50,000

Keywords: per oral endoscopic myotomy transoral incisionless fundoplication poem tif
pegylated interferon alpha-2b monotherapy versus combination with entecavir in hbeag-negative chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the outcome of treatment of chronic hepatitis b is determined by viral and host interaction, thus the combination therapy of immunomodulator (peg-ifn) and potent antiviral drug (entecavir) should improve the response rate. in addition, the simultaneous assessment of viral and host genetic factors associated with svr may help to identify predictors of treatment outcomes, which will in turn significant reduce the cost/effect of therapy


Eligibility criteria:
inclusion criteria: * men and women 18 to 65 years of age * patients with hbeag-negative chronic hepatitis b * positive for hbsag for at least 6 months, negative for anti-hbs and hbeag * serum hbv dna levels ≥ 2,000 iu/ml at screening * increased alanine aminotransferase (alt) levels \[greater than the upper limit of normal (uln) and less than 10xuln} * no signs or symptoms of advanced liver disease * patient has had a liver biopsy within 1 year of screening exclusion criteria: * patient had previous treatment with ifn, peg-ifn, and/or entecavir * patient has evidence or history of chronic hepatitis not caused by hbv, including but not limited to nonalcoholic steatohepatitis (nash), drug-induced hepatitis, and autoimmune hepatitis * patient has co-infection with hepatitis c virus and/or human immunodeficiency virus * patients with liver cancer * female patient is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential throughout treatment. * patient has any other condition that is contraindicated for treatment with peg-ifn or entecavir * patient has any condition or pre-study laboratory abnormality, or history of any illness, which in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug

Keywords: hepatitis b hbeag pegylated interferon entecavir
short term group therapy for anxiety disorder

Conditions: Anxiety Disorder

Summary: assessing anxiety in patient suffering from anxiety disorders (not ocd or ptsd)before and after group therapy


Eligibility criteria:
inclusion criteria: * anxiety disorder (other than ocd or ptsd) * eligibility to participate in group therapy exclusion criteria: * ocd * ptsd * suicidal thoughts * psychotic state * severe hostile personality disorder
intervention study to control high blood pressure for korean american

Conditions: High Blood Pressure

Summary: the primary objective of the proposed clinical trials is to compare the differential reduction in blood pressure in underserved hypertensive adult korean american. the study is designed to test the effectiveness of a comprehensive self-help intervention program.

cvd is the leading cause of mortality among ka. recent statistics underscoring the high prevalence and impact of uncontrolled hbp upon this population warrant the development and implementation of effective intervention. ka experiences a great deal of social isolation, which makes it more difficult for them to make behavioral changes for health improvement. individual, family, and community behaviors are part of the hbp problem and also constitute major part of the solution. the proposed research is designed to investigate these issues in a ka population and to lay the groundwork for community-based self-help health education interventions to enhance appropriate care and bp control. comparison(s):this community-based self-help intervention approach offers a more culturally appropriate approach to closing the health status gap for ka. incorporating a partnership with community leaders and health and human service care providers, this approach will utilize state-of-the-art health education strategies and a well-trained bilingual nurse from the community.

Eligibility criteria:
inclusion criteria: * self-identified as first-generation korean american * age 40 to 65 years of age * sbp≥140 or dbp≥90mmhg on hbp medication * resident of greater baltimore census tracts * written consent to participate in the screening/eligibility visit * sbp≥140 or dbp≥90mmhg at the krc hbp verification visit * written consent to participate in the clinical trial:agreeing to participate in study data collection procedures, receiving hbp education, using hbpmt, and permitting contact with their own medical care provider. exclusion criteria: * acute and/or terminal condition precluding participation such as terminal cancer or acute myocardial infarction * psychiatric diagnosis precluding participation such as schizophrenia and cognitive impairment measured by self-report, chart review, or clinical assessment.
management of superficial thrombophlebitis

Conditions: Superficial Thrombophlebitis; Upper Extremity Superficial Thrombophlebitis; Lower Extremity Superficial Thrombophlebitis

Summary: the purpose of this study is to test the hypothesis that fragmin (dalteparin sodium) subcutaneously once daily for 7 days is more effective than ibuprofen given orally three times daily for 7 days for the treatment of superficial thrombophlebitis (stp).

superficial thrombophlebitis is a common problem and is thought to affect up to 20% of patients with varicose veins. in the absence of treatment, stp may cause its greatest morbidity with extension of thrombus into the deep venous system and resultant risk of pulmonary embolism. current standard therapy for stp consists of local heat, elevation of the extremity, and non-steroidal anti-inflammatory medication. however, no study to date has adequately evaluated the effectiveness of this therapy despite persistence and recurrence of symptoms of stp in many patients. the purpose of this study is to document the outcome of patients with objectively documented stp who are treated with nsaid therapy (standard care) verses those treated with low-molecular weight heparin (dalteparin sodium) according to a pre-defined treatment regimen. all patients with documented upper or lower stp will be screened. each will have a complete baseline and risk factor assessment. all patients will be randomized in one of two treatment groups: (a) experimental group who will receive fragmin (dalteparin)fixed dose subcutaneously daily for 7 days or (b) control group who will receive ibuprofen 800mg given orally three times daily for 7 days. all patients will receive study drug for a period of 1-2 weeks with reassessment of stp by ultrasound. all patients will participate for a period of 3 months with follow up visits at 7-9, and 14-16 day, and 1,3 months.

Eligibility criteria:
inclusion criteria: * patients with confirmed upper or lower extremity superficial thrombophlebitis by ultrasound imaging exclusion criteria: * active, clinically significant bleeding * known hypersensitivity to nsaids, heparin or derivatives * currently pregnant or \< 1 week post-partum * acquired bleeding diathesis * known inherited bleeding disorder * renal failure * extremes of weight * unable to return for repeat diagnostic testing or follow-up visit * concurrent deep-vein thrombosis

Keywords: superficial thrombophlebitis stp fragmin ibuprofen superficial thrombus superficial phlebitis phlebitis