Kornimate/medical-research-clean huggingface dataset:
ibuprofen plus metaxolone, tizanidine, or baclofen for low back pain

Conditions: Low Back Pain

Summary: this is a randomized study, based in emergency departments, in which the investigators determine the utility of adding various skeletal muscle relaxants to standard therapy, which consists of ibuprofen and an educational session. patients will be enrolled at the time of an emergency visit and followed for three months to determine outcomes.


Eligibility criteria:
inclusion criteria: * present to ed primary for management of lbp, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included. * musculoskeletal etiology of low back. patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. the primary clinical diagnosis, at the conclusion of the ed visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal lbp. * patient is to be discharged home. patients admitted to the hospital are more likely to be treated with parenteral medication and therefore are not appropriate for this study. * age 18-64 enrollment will be limited to adults younger than 65 years because of the increased risk of adverse medication effects in the elderly. * non-radicular pain. patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern. * pain duration \<2 weeks (336 hours). patients with more than two weeks of pain are at increased risk of poor pain and functional outcomes.(9) * prior to the acute attack of lbp, back pain cannot occur more frequently than once per month. patients with more frequent back pain are at increased risk of poor pain and functional outcomes.(9) * non-traumatic lbp: no substantial and direct trauma to the back within the previous month * functionally impairing back pain: a baseline score of \> 5 on the roland-morris disability questionnaire exclusion criteria: * not available for follow-up * pregnant or breast-feeding * chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis * allergic to or intolerant of investigational medications * contra-indications to non-steroidal anti-inflammatory drugs: 1) history of hypersensitivity to nsaids or aspirin 2) active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed 3) severe heart failure (nyha 2 or worse) 4) hypertension (jnc7 stage 2 or worse) 5) chronic kidney disease 3 or worse 6) current use of anti-coagulants 7) hepatitis 8) alcoholism * contra-indications to muscle relaxants: 1) concurrent use of centrally acting opioids; 2) renal impairment; 3) liver abnormality including cirrhosis or elevated enzymes 4) use of any of the following medications: fluvoxamine, fluoroquinolones, amiodarone, mexiletine, propafenone, verapamil, cimetidine, famotidine, acyclovir, ticlopidine, oral contraceptive pills
unstable dorsally displaced fractures of the distal radius in the elderly

Conditions: Fracture of the Distal Radius; Wrist Fracture

Summary: the purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.

we will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. secondary outcomes are objective physical measurements.

Eligibility criteria:
inclusion criteria: * unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°). exclusion criteria: * previous displaced fracture of the distal radius. * additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (spmsq\<5), psychiatric illness, alcohol abuse).

Keywords: elderly wrist fracture fracture of the distal radius volar plate plaster cast
endocuff adenoma detection rate pilot study

Conditions: Colorectal Adenoma; Colorectal Cancer

Summary: colorectal cancer is the second leading cause of cancer deaths in the uk(1) . detection of cancer at an early stage, as well as detection and removal of polyps through gold standard colonoscopy examination decreases mortality from the disease. however colonoscopy has a well documented miss rate, with some areas of the bowel difficult to visualise and neoplastic lesions potentially hidden behind folds in the colon. the endocuff© is a disposable polymer sleeve with hinged lateral arms. the arms flatten mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled withdrawal and improving mucosal visualization. the cap easily attaches to the tip of current colonoscopes without modification. in this single centre, randomised controlled trial, the investigators aim to assess the performance of the current gold standard colonoscopic examination against the current gold standard colonoscopic examination with the endocuff© attached to the colonoscope. the investigators aim to recruit 300 patients (150 in each group) who have previously been identified to have colonic polyps or cancers undergoing surveillance colonoscopy following nice guidelines(2). colonoscopy will be performed by joint advisory group on gastro-intestinal endoscopy (jag) certified colonoscopists following quality indicator guidance. all patients undertaking follow up surveillance colonoscopy for previous polyps or cancer will be invited to participate and those agreeing will be randomly allocated to one or other technique.


Eligibility criteria:
inclusion criteria: * patients undergoing surveillance colonoscopy test as part of the colonic adenoma and cancer surveillance programme. * ability to understand the nature and requirements of the study and to provide written informed consent. exclusion criteria: * contraindication to undergo standard colonoscopy. * severe active colitis. * known colonic stricture

Keywords: adenoma, polyp, colonoscopy.
mindmate: a study of a reminder system for people with dementia

Conditions: Dementia

Summary: a study to investigate the effectiveness of a reminder tool application at increasing performance on memory tasks in people with mild dementia

background memory difficulties are a core feature of dementia. these include difficulties remembering to do something at a specific time and place in the future (prospective memory). although a range of electronic prospective memory aids currently exist (e.g. "neuropage"), the evidence supporting their use among the dementia population remains limited. "mindmate" is a recently developed mobile application that aims to support individuals with a diagnosis of dementia, improving self-management skills and quality of life. aims this study will explore the effectiveness of "mindmate" reminder alerts delivered to a smart phone or tablet computer as a memory aid for people with a diagnosis of mild dementia. method three participants with a diagnosis of dementia, who are considered to be in the early stages and who report everyday prospective memory difficulties, will be recruited from older people community mental health teams within greater glasgow and clyde. the participants will own a smart phone or tablet and will be living with a partner or family member who will also participate in the study. during the initial baseline phase, the partner or family member will monitor the number of pre defined tasks the participant remembered and forgot. the partner or family member will record this information on a weekly monitoring form and this phase will last between five to seven weeks. this will be followed by a five-week intervention phase where "mindmate" reminder alerts will be sent to the participant's phone or tablet. again, tasks that require remembering will be identified prior to the intervention phase, and family members or carers will monitor their success on a form. results will be analysed using visual inspection and tau-u analysis. applications this study will provide information on the effectiveness of a form of assistive technology at supporting people with a dementia, which could improve quality of life of those with a diagnosis.

Eligibility criteria:
inclusion criteria: * has a diagnosis of mild dementia, according to international classification of diseases (icd) 10 criteria * has received the diagnosis from a psychiatrist * owns a smart phone or tablet * has a family member/partner/carer who is willing to monitor memory aid use * has capacity to consent to being involved in the research * is reporting memory difficulties that are affecting them in daily life exclusion criteria: * visual or auditory difficulties which cannot be corrected through the use of appropriate aids * has a pre-existing neurological or severe psychiatric problem (e.g. bipolar disorder, psychosis) * has a diagnosis of dementia that is considered to be in the moderate to severe stages * those whose first language is not english * those with a diagnosed or suspected developmental learning disability * those who are currently using online or electronic memory aids
primary prevention of cardiovascular disease among female hospital employees: the heart smart for women intervention

Conditions: Cardiovascular Risk Factor

Summary: this study aims to show that a 6-week program designed specifically for women can lead to sustainable behavior change and improvement in heart disease risk factors over one year among a cohort of 46 female employees recruited from within the heart hospital at north shore university hospital (nsuh). the program is adapted from book "heart smart for women: six s. t. e. p. s in six weeks to heart-healthy living," written by northwell cardiologists dr. jennifer h. mieres and dr. stacey e. rosen. the 6-week intervention will include a weekly didactic session, with each week devoted to a different theme (food, exercise, etc). the intervention will follow the program outlined in the book. we will also be using yammer, an online discussion group part of the office 365 suite, to distribute materials and encourage conversations surrounding the theme of the week.

heart disease is the leading cause of death in women in the united state. nine out of ten women have one or more risk factors for heart disease and one in three women will die of heart disease. however, most women are unaware of these statistics. as a result, women are less likely than men to recognize the symptoms of a heart attack and are more likely than men to delay in seeking help. the best ways to educate women about heart disease and change their behavior to prevent heart disease are unknown. more than 80% of heart disease is preventable but requires both knowledge of risk factors and adherence to lifestyle changes. this program is designed to address these challenges in women, where this is a particular unmet need. some prior community and workplace-based studies have demonstrated short term improvements in modifiable risk factors for cardiovascular disease. a community based primary prevention program among disadvantaged women decreased the rate of metabolic syndrome, anxiety, depression and stress. the economic burden of heart disease on employers is significant although workplace employee wellness programs have not been shown to decrease employer costs. the impact of employee wellness programs on clinical outcome measures have been inconsistent. this program is designed to educate female employees about their heart disease risk factors and provide tactical support to improve their heart health. once validated, the program can be rolled out to other employees and to the community.

Eligibility criteria:
inclusion criteria: * one or more of the following modifiable risk factors for cardiovascular disease \[as defined by the american heart association\]: 1. cigarette smoking 2. high blood pressure 3. high cholesterol 4. abnormal blood sugar 5. sedentary lifestyle 6. overweight/obese * must be an employee of the heart hospital at north shore university hospital exclusion criteria: * prior history of heart attack or stroke * pregnancy
a study to assess the safety, tolerability, efficacy, and drug levels of bms-986369 (golcadomide) in participants with relapsed or refractory t-cell lymphomas in japan (golseek-3)

Conditions: Relapsed or Refractory T-cell Lymphomas

Summary: the purpose of this study is to test the safety, tolerability, efficacy, and drug levels of bms-986369 (golcadomide) in participants with relapsed or refractory t-cell lymphomas in japan (golseek-3).


Eligibility criteria:
inclusion criteria - have one of the following subtypes of t-cell lymphoma (tcl) with relapsed or refractory disease, as assessed by the investigator:. i) adult t-cell leukemia-lymphoma (atl). ii) peripheral t-cell lymphoma not otherwise specified (ptcl-nos). iii) angioimmunoblastic t-cell lymphoma (aitl) and other nodal lymphomas of t follicular helper phenotype (tfh) cell origin. iv) anaplastic large cell lymphoma (alcl), anaplastic lymphoma kinase-positive (alk+). v) alcl, anaplastic lymphoma kinase-negative (alk-). vi) breast implant-associated alcl. vii) extranodal nk/t-cell lymphoma, nasal type (enkl). viii) mycosis fungoides (mf) with advanced stage (stage iib-ivb). * phase 1 participants must not be responsive, intolerant, or ineligible to standard therapies that may prolong life or provide symptomatic relief, or for whom no standard therapeutic option is available in the clinical practice guidelines in the opinion of the investigator. * phase 2 participants must have been treated by at least 1 prior line of systemic therapy. * have an eastern cooperative oncology group performance status of 0, 1 or 2. exclusion criteria * have any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participants from participating in the study. * have any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, which places the participants at unacceptable risk if he/she were to participate in the study. * have a life expectancy ≤ 3 months. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: relapsed or refractory peripheral t-cell lymphoma (r/r ptcl) relapsed or refractory adult t-cell leukemia/lymphoma (r/r atl) golcadomide bms-986369 cc-99282 adult t-cell leukemia/lymphoma (atl) peripheral t-cell lymphoma, not otherwise specified (ptcl-nos) angioimmunoblastic t-cell lymphoma and other nodal lymphomas of t follicular helper (tfh) cell origin angioimmunoblastic t-cell lymphoma (aitl) follicular t-cell lymphoma (ftcl) nodal peripheral t-cell lymphoma with tfh phenotype anaplastic large cell lymphoma, alk-positive (alcl, alk+) anaplastic large cell lymphoma, alk-negative (alcl, alk-) breast implant-associated anaplastic large cell lymphoma (bia-alcl) extranodal nk/t-cell lymphoma, nasal type (enkl) mycosis fungoides (mf)
comparing brief relaxation period to virtual reality period in reducing dental anxiety prior to root canal treatment

Conditions: Dental Anxiety

Summary: the goal of this study is to evaluate non-drug approaches to reducing dental anxiety prior to non-surgical root canal treatment. this will be done by comparing two relaxation methods which will be performed immediately prior to scheduled, clinical non-surgical root canal treatment. measures of anxiety will be evaluated prior to, and after, the relaxation intervention, as well as after the non-surgical root canal treatment is completed. participation in the study is completed in a single study visit.

fifty-eight participants who needed non-surgical root canal treatment were randomly assigned into 2 groups of abr and vrr. one group received earphones to listen to a guided brief relaxation recording, focusing on a body scan of tense points with diaphragmatic breathing. the other group received meta 2 virtual reality headsets to listen and watch a 360 inclusive and integrative experience of ambient music, high resolution graphic illustrations and immersive scenery. participants self-reported levels of anxiety were assessed prior to and post treatment by conducting evaluations using the state trait anxiety indicator (stai-state \& trait) and the use of both a self-reported visual analog scale (vas) as well as by assessing objective secondary biometrics of anxiety of heart rate (hr) and blood pressure (bp) pre intervention, post intervention and following treatment completion.

Eligibility criteria:
inclusion criteria: * requires non-surgical root canal treatment * is able to independently provide informed consent for root canal treatment * proficient in english exclusion criteria: * history of vertigo or severe motion sickness * history of severe psychiatric disease * history of seizures, concussions, or severe neurological conditions * visual or hearing impairments * cardiac pacemaker or defibrillator * will require nitrous oxide sedation, nor pharmacologic anxiolytics or sedatives for dental treatment
a study of comparing rates of dementia and alzheimer's disease in participants initiating methotrexate versus those initiating anti-tumor necrosis factor (tnf)-alpha therapy

Conditions: Dementia; Alzheimer Disease

Summary: the purpose of the study is to compare the risk of dementia in participants diagnosed with rheumatoid arthritis (ra) exposed to anti-tumor necrosis factor (tnf) therapy versus those exposed to methotrexate.


Eligibility criteria:
inclusion criteria: * at least one claim for methotrexate or anti-tnf therapy during the study period. first medication received is the index medication, and date of first receipt is the index date * 365 days of continuous pre-index observation immediately prior to the index date * participants have at least two occurrences of a diagnosis of rheumatoid arthritis within 365 days before and including the index date * no prior use of methotrexate or an anti- tumor necrosis factor (tnf) therapy at any time prior to the index date * cohort follow-up persists until end of continuous observation or filling the comparator drug
a prospective, randomized trial of early versus late tracheostomy in trauma patients with severe brain injury

Conditions: Respiratory Failure; Traumatic Brain Injury

Summary: the purpose of this study is to evaluate the efficacy of early conversion tracheostomy from endotracheal intubation (et) to percutaneous, dilatational tracheostomy (pdt) in traumatic brain-injured patients requiring prolonged mechanical ventilation.

this is a prospective, randomized trial to evaluate the efficacy of early (less than or equal to 72 hours) versus late (10 to 14 days) conversion from endotracheal intubation to percutaneous, dilatational, translaryngeal tracheostomy for mechanical ventilation of traumatic brain injured patients. the primary efficacy parameter will be the number of days on mechanical ventilation. secondary objectives include: * number of days in the hospital * to assess the incidence of ventilator-acquired pneumonia in each group * to assess the incidence of accidental extubation in each group * to assess the incidence of death in each group

Eligibility criteria:
inclusion criteria: * 18 years of age or older * tbi defined as penetrating or blunt brain injury including 1)subarachnoid hemorrhage, 2)subdural hemorrhage, 3) epidural hemorrhage, 4)brain contusion, 5)diffuse axonal injury * mechanically ventilated by endotracheal intubation * projected to need ventilation support for more than 14 days according to: gcs measured in field less than or equal to 8 and a gcs on day 3 which remains less than or equal to 8 * informed consent obtained from patient or legal representative exclusion criteria: * less than 18 years of age * projected to need ventilation support for less than 14 days * anatomical deformity of the neck, including thyromegaly and cervical tumors * previous tracheostomy * uncontrolled coagulopathy * existence of platelet count less than 50,000/mm2 * anti-platelet agents * clinical evidence of ongoing infection at the proposed tracheostomy site as per physician * mechanical ventilation with a positive end-expiratory pressure greater than 12 cm h20 * intubated more than 72 hours * patient has undergone cricothyroidotomy * cricoid cartilage, trachea, or sternal notch not palpable with neck in position

Keywords: respiratory failure tracheostomy percutaneous dilatation tracheostomy endotracheal conversion traumatic brain injury
interventional study on pentostatin, cyclophosphamide and rituximab in indolent b-cell non-hodgkin-lymphoma (b-nhl)

Conditions: Immunocytoma/Morbus Waldenström; B-Cell Non-Hodgkin's Lymphoma; B-Cell Chronic Lymphocytic Leukemia

Summary: the combination of fludarabine and cyclophosphamide have yielded overall response rates of over 80% in previously untreated patients with indolent non-hodgkin-lymphoma. however, hematotoxicity rates were high with grade 3 and 4 toxicities of over 50%. several studies have indicated that the treatment with pentostatin and cyclophosphamide causes lower hematotoxicity rates than the combination of fludarabine and cyclophosphamide. to evaluate the efficacy and safety of treatment with pentostatin/cyclophosphamide immuno-chemotherapy for patients with newly diagnosed or relapsed immunocytoma/morbus waldenström, b-cell chronic lymphocytic leukemia (b-cll) and other indolent cd20-positive b-nhl, an open, non-randomized, multi-center prospective phase ii-study to evaluate the efficacy and safety of treatment with immuno-chemotherapy is conducted. treatment consists of 6 courses of pentostatin (4mg/m² on day 1), cyclophosphamide (600mg/m² on day 1) and rituximab (375mg/m² on day 0) administered every three weeks. patients achieving complete or partial remission undergo maintenance therapy consisting of 8 courses of rituximab (375mg/m²) administered every three months over a period of 2 years.


Eligibility criteria:
inclusion criteria: * confirmed first diagnosis of or relapsed cd20-positive immunocytoma, b-cll or other indolent b-nhl * therapy-requiring cll defined as: binet stage c or binet b combined with occurence of b-symptoms, rapidly progressing disease, risk of organ compression by lymphoma mass * therapy-requiring immunocytoma as defined by the consensus panel recommendations from the second international workshop on waldenström´s macroglobulinemia, 2003) * age \> 18 years * anticipated life expectancy \> 6 months * ecog 0-3 * no significant comorbidities * signed informed consent * efficient method of contraception during time of therapy (men and women) exclusion criteria: * age \< 18 years * cd20 negativity * significant comorbidities interfering with therapy as required by the protocol * history of hiv infection or active hepatitis

Keywords: immunochemotherapy pentostatin cyclophosphamide rituximab maintenance indolent b-nhl b-cll b-nhl