Kornimate/medical-research-clean huggingface dataset:
comparative effectiveness of acute low back pain management

Conditions: Low Back Pain

Summary: current practice guidelines for patients with acute low back pain (lbp) recommend a stepped care approach with initial treatment of education and advice to remain active. referral to physical therapy is considered only when patients fail to recover after a few weeks. recent research has led to the identification a subgroup of patients likely to experience rapid, pronounced, and sustained decreases in disability and pain with a brief manipulation and exercise intervention, suggesting it may be more cost-effective to manage this sub-group with early referral to physical therapy instead of the usual care approach. the integration of this evidence into routine practice has not been evaluated. we will assess the outcomes of integrating this evidence into the management of patients with low back pain. the study is a randomized trial, comparing management with early manipulation with the current care process model. patients fitting the inclusion criteria will be randomized into one of two groups. one group will be managed with the current care process model. the other group will be managed consistent with the decision rule recommending early referral for a brief manipulation and exercise intervention during the first 4 weeks. patients will be followed over 1 year. outcomes will include measures of disability, pain, satisfaction, and direct medical costs. the study will examine the costs and effectiveness of integrating the alternative care model into practice.


Eligibility criteria:
inclusion criteria: * symptoms of pain and/or numbness between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the primary care provider, are originating from tissues of the lumbar region. * age 18 - 60 years * oswestry disability score \> 20% * both of the following clinical decision rule criteria: a)duration of current symptoms \< 16 days; and b)patient report of no symptoms (pain, numbness, etc.) distal to the knee in past 72 hours. exclusion criteria: * prior surgery to the lumbosacral spine * any treatment for low back pain in past 6 months * current pregnancy * currently receiving treatment for lbp from another healthcare provider (e.g., chiropractic, massage therapy, injections, etc.) * presence of neurogenic lbp defined as the presence of either of the following: a) positive ipsilateral or contralateral straight leg raise (reproduction of symptoms at \<45 degrees); or b)reflex, sensory, or strength deficits in a pattern consistent with lumbar nerve root compression * judgment of the primary care provider of "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, cancer, infection or systemic disease

Keywords: low back pain primary care physical therapy
ventavis® registry protocol

Conditions: Pulmonary Arterial Hypertension

Summary: the ventavis® (iloprost) registry is a multicenter, observational, u.s.-based study that longitudinally follows patients with pulmonary arterial hypertension (pah) who have been receiving therapy with ventavis® for at least 3 months. patients diagnosed with who group i pah who are on a stable regimen of commercial ventavis® will be followed for a maximum of 2 years from the time of enrollment. data will be collected via patient interview and review of the medical record. quarterly data collection will include capture of medications and ventavis® adherence data.

the ventavis® (iloprost) registry is a multicenter, observational, u.s.-based study that longitudinally follows patients with pulmonary arterial hypertension (pah) who have been receiving therapy with ventavis® for at least 3 months. patients diagnosed with who group i pah and who are on a stable regimen of commercial ventavis® will be followed for a maximum of 2 years from the time of enrollment. all data will be collected via patient interview and/or review of the medical record, as well as from i-neb® downloads using insight software. adherence with ventavis® will be compared before and after targeted instruction on inhalation techniques by a respiratory therapist or designee, as well as before and after participation in pah patient support groups (if applicable). quarterly data collection will include capture of pah and non-pah medications and ventavis® adherence data; ventavis® adherence data will also be collected one month after study entry.

Eligibility criteria:
inclusion criteria: 1. have a current diagnosis of who group i pah 2. have initiated therapy with commercial ventavis® administered via portable nebulizer at least 3 months prior to study enrollment, either with commercial product or from participation in actelion's clinical study ac-063a302 3. age \> or = 18 years old at the time of enrollment exclusion criteria: 1. meet the criteria for inclusion into who groups ii, iii, iv or v pah 2. are not currently on commercial ventavis® 3. have initiated therapy with commercial ventavis® administered via portable nebulizer less than 3 months prior to study enrollment

Keywords: pulmonary arterial hypertension ventavis® iloprost
md1003-amn md1003 in adrenomyeloneuropathy

Conditions: Adrenomyeloneuropathy; Adrenoleukodystrophy; AMN

Summary: the primary objective of the trial is to demonstrate the superiority of biotin at 300 mg/day over placebo in the clinical improvement (walking tests) of patients with adrenomyeloneuropathy

amn and progressive multiple sclerosis share some similarities including progressive spastic paraparesis and secondary energy failure leading to progressive axonal degeneration. therefore, it was hypothesized that high doses of biotin might be efficient in patients with amn.

Eligibility criteria:
inclusion criteria: * abcd1 gene mutation identified * elevated plasma vlcfa * clinical signs of amn with at least pyramidal signs in the lower limbs and difficulties to walk * edss score ≥ 3.5 and ≤ 6.5 * normal brain mri or brain mri showing : * abnormalities that can be observed in amn patients without cerebral demyelination with a maximum loes score of 4 * and/or stable (≥6 months) cerebral demyelination without gadolinium enhancement with a loes score ≤12. * appropriate steroid replacement if adrenal insufficiency is present * likely to be able to participate in all scheduled evaluation visits and complete all required study procedures * signed and dated written informed consent to participate in the study in accordance with local regulations * affiliated to a health insurance exclusion criteria: * brain mri abnormalities with a loes score \> 12 or with gadolinium enhancement * any progressive neurological disease other than amn * impossibility to perform the walk tests and the tug test * patients with uncontrolled hepatic disorder, renal or cardiovascular disease, or any progressive malignancy * any new medication for amn including fampridine initiated less than 1 month prior to inclusion * contra-indications for mri procedure such as subjects with paramagnetic materials in the body, such as aneurysm clips, pacemakers, intraocular metal or cochlear implants. * inclusion in another therapeutic clinical trial for ald * not easily contactable by the investigator in case of emergency or not capable to call the investigator

Keywords: amn md1003 adrenomyeloneuropathy ald adrenoleukodystrophy biotin 2mwt two-minute walk test tw25 timed 25-foot walk
a study evaluating the safety, efficacy, and pharmacokinetics of miricorilant in obese adult patients with schizophrenia while taking antipsychotic medications (gratitude ii)

Conditions: Antipsychotic-induced Weight Gain (AIWG)

Summary: this phase 2, double-blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (pk) of miricorilant (cort118335) in obese patients with schizophrenia treated with antipsychotic medications.

this is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and pk of miricorilant in obese patients with schizophrenia who are currently taking olanzapine, risperidone, paliperidone, or quetiapine. patients who meet the criteria for the study cort118335-877 will be randomized on day 1 to receive 600 mg miricorilant, 900 mg miricorilant, or placebo for 26 weeks.

Eligibility criteria:
inclusion criteria: * have a diagnosis of schizophrenia * are currently taking olanzapine, risperidone, paliperidone, or quetiapine and have gained weight from treatment while on these medications * must be on a stable dose of medication for 1 month prior to screening * have a bmi ≥30 kg/m\^2. exclusion criteria: * have a history of a medical condition affecting body weight (eg, poorly controlled hyper- or hypothyroidism; eating disorder such as anorexia, bulimia, or binge eating; or polycystic ovary syndrome) * have poorly controlled diabetes mellitus * have poorly controlled hypertension * have a history of symptomatic hypotension * have a history of orthostatic hypotension * have a history of a seizure disorder.

Keywords: antipsychotic-induced weight gain (aiwg) obesity weight gain mental disorders schizophrenia risperidone paliperidone quetiapine olanzapine
early mobilisation in the surgical robot assisted spinal surgery

Conditions: Degenerative Disease; Fracture

Summary: in this study, patients who underwent lumbar spine surgery in our hospital were included. a prospective study was conducted to investigate the effects of early mobilisation on postoperative complications, functual outcomes and patient satisfaction after robotic assisted lumbar spinal surgery.


Eligibility criteria:
inclusion criteria: * diagnosis of degenerative diseases or spinal fracture * single level instrumentation sugery * sign informed consent exclusion criteria: * multilevel instrumentaion surgery * diagnosis of severe osteoperosis (bmd \< 60mg/cm3) by qct * coagulant function abnormality * severe internal disease * not suitable for inclusion

Keywords: early mobilisation robot spine enhanced recovery
study on effect of robotic versus laparoscopic surgical technology on genitourinary function after total mesorectal excision for rectal cancer

Conditions: Colorectal Cancer

Summary: intraoperative pelvic autonomic nerve (pan) injury is the dominant reason for genitourinary malfunction after total mesorectal excision (tme), particularly in low rectal tumours. tme necessitates meticulous, sharp dissection with an awareness of the pan pathway. in particular, laparoscopic tme (l-tme) is technically difficult and requires advanced laparoscopic surgical skills. comparing with the conventional laparoscopic approach, 3d vision, surgeon-manipulated camera systems, and multi-degree-of-freedom robotic instruments facilitate identification and preservation of the pan during robotic-assisted tme (r-tme), theoretically facilitating favourable recovery of postoperative genitourinary function. previous studies have mostly focused on the impact of advanced robotic technologies on postoperative functions. however, in addition to robotic surgical technology, postoperative function is impacted by multiple other intricate factors, such as oncology, comorbidities, postoperative complications, and adjuvant chemoradiotherapy. consequently, the superiority of robotic surgery in terms of recovery of postoperative genitourinary function has been controversial in previous studies. hence, to comprehensively evaluate the effect of robotic technology on postoperative genitourinary function, we conducted a prospective controlled study comparing the conventional approach and robotic surgery.


Eligibility criteria:
inclusion criteria: (i) lesions that were determined by histopathological examination and were staged preoperatively using pelvic mri and ct scans; (ii) patients aged ≥18 and ≤ 75 years; and (iii) american society of anesthesiology (asa) class ≤3 exclusion criteria: benign prostate hyperplasia, previous bladder or prostate surgery, severe sexual dysfunction (international index of erectile function (iief) score \<10 or female sexual function index (fsfi) score ≤26.55), urgent operation, simultaneous or heterochronous multiple primary rectal tumours, distant metastasis, or other severe cardiopulmonary complications.
evaluation of btv100 in subjects with dry eye disease

Conditions: Dry Eye

Summary: this study will be a randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study to evaluate the efficacy, safety and tolerability of repeat dosing of cevimeline ophthalmic solution compared to the vehicle in subjects with dry eye disease (ded).

at the screening visit/visit 1 (day 1 minus 14 days), subjects who are eligible according to the inclusion and exclusion criteria will begin a 14-day run-in period during which they will self-administer 1 drop of single-masked vehicle to each eye twice daily (bid), morning and evening (at least 6-hour interval). at the time of the screening visit/visit 1, subjects will be instructed to discontinue all over the counter (otc) and prescription topical ophthalmic medications except for the vehicle or study drug throughout the study. at baseline/visit 2 (day 1), subjects who continue fulfilling inclusion/exclusion criteria will be randomized to study drug or vehicle. approximately120 subjects will be randomized. subjects will be randomized to one of the following 4 treatment groups. following randomization, subjects being masked to treatment assignments will be instructed to self-administer 1 drop of investigational product (ip) into each eye twice daily, morning and evening (at least 6-hour interval). subjects will be instructed to return to the clinic to be evaluated at day 15 (visit 3), day 29 (visit 4), day 57 (visit 5), and day 85 (visit 6).

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older (regardless of gender). 2. provide written informed consent. 3. willing and able to follow instructions and be available for required study visits during the study. 4. best corrected visual acuity (bcva) of 20/100 or better in both eyes. 5. ongoing moderate to severe dry eye disease (ded) supported by a previous clinical diagnosis or a self-reported history of subjective complaints for at least 6 months prior to the screening visit, and meet all the following criteria in at least one eye (the same eye) at visit 1 and visit 2: exclusion criteria: 1. known hypersensitivity or contraindication to the study drug or its components. 2. within 28 days prior to the screening visit (visit 1), have taken or used: topical ophthalmic, dermatologic or systemic calcineurin inhibitor (e.g. cyclosporine and tacrolimus), including restasis® (cyclosporine) and cequa® (cyclosporine) 3. current use of contact lenses or anticipated use during the study.
biologic tapering study of tnf inhibitors in axial spondyloarthritis

Conditions: Axial Spondyloarthritis

Summary: current evidence on tapering of tumor necrosis factor inhibitors (tnfi) in axial spondyloarthritis (axspa) is still hampered by heterogeneity in tapering regimens, selection and performance biases, and lack of data on optimized treatment dosing strategies especially in real-world clinical settings. this study aims to contribute to the ongoing investigation of disease-activity-guided tapering of tnfi in axspa in the form of a prospective, randomized controlled trial.

this is a 48-week randomized, controlled, open-label, non-inferiority trial of patients with radiographic or non-radiographic axial spondyloarthritis. the study will include 156 patients with inactive disease or low disease activity (lda) for at least 6 months on a tnfi at the time of randomization. participants will be randomized using a 1:1 ratio to either the tapered-dose arm or the standard-dose arm of tnfi. progressive tapering of tnfi according to a predefined protocol will be allowed as long as the patient is able to maintain inactive disease or lda during the study period. we hypothesize that, in patients with 6 months or more of inactive or low-activity axial spondyloarthritis, tapered-dose tnfi are non-inferior to standard-dose tnfi in sustaining the disease state for at least 1 year.

Eligibility criteria:
inclusion criteria: * adult axspa patients satisfying the 2009 assessment of spondyloarthritis international society (asas) classification criteria * currently enrolled in the sparcc program with successful completion of standard data collection protocol in the spondylitis clinic of uhn-toronto western hospital * have sustained inactive disease or lda with an asdas of \<2.1 or basdai \<4 for at least 6 months * on a stable dose of a tnfi (infliximab, etanercept, adalimumab, certolizumab pegol, or golimumab) * must not be pregnant exclusion criteria: * adults axspa patients with active extra-articular manifestations such as inflammatory bowel disease, psoriasis, and/or uveitis * have comorbidities that may preclude clinical assessment (i.e. fibromyalgia or other chronic pain syndromes; chronic inflammatory diseases other than axspa) * have diagnosed psychiatric or personality disorders * pregnant * not enrolled in the spondyloarthritis research consortium of canada (sparcc) program

Keywords: spondyloarthritis tnf inhibitors tapering
ability of mayo clinic high-performance liquid chromatography (hplc) method to measure fecal bile acids

Conditions: Diarrhea Predominant Irritable Bowel Syndrome

Summary: the investigators' hypothesis is that therapy with colesevelam, reduces fecal bile acid excretion in patients with irritable bowel syndrome (ibs)-diarrhea with prior evidence of increased fecal 48 hour total bile acid excretion. the investigators aim to study the ability of the hplc assay for fecal bile acids to demonstrate responsiveness after treatment with colesevelam.

this study will evaluate whether colesevelam, a bile acid sequestrant, is able to reduce fecal bile acids and improve bowel function in patients with ibs-diarrhea and mayo's hplc method can demonstrate a response to the colesevelam. the study design will be a single center, unblinded, single dose trial to study the ability to identify the effect of taking 1875 mg (3 tablets \[625 mg/tablet\]) of colesevelam orally twice daily for ten days on fasting serum 7alphac4 and total 48 hour fecal bile acid excretion. stool and fasting serum samples will be collected predose and during final 48 hours' dosing for assessment. participants will also fill out an 8-day stool diary assessing frequency, consistency, ease of passage of bowel movements before and during treatment with colesevelam.

Eligibility criteria:
patients with ibs-diarrhea with prior evidence of increased fecal 48 hour total bile acid and increased fasting serum 7alphac4 who meet the following: inclusion criteria * bowel disease questionnaire (bdq) - ibs symptoms: positive by rome lll criteria * no restrictions on hospital anxiety/depression score (hads). * gender: men or women. women of childbearing potential will have a negative pregnancy test before initiation of medication. exclusion criteria * use of drugs or agents within the past 1 week or planned use in the subsequent 2 weeks during the study period (birth control pill, estrogen replacement therapy, and thyroxine replacement are permissible exceptions): * agents that alter gi transit including opioids, narcotics, anticholinergics, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (snri) antidepressants. * analgesic drugs including opiates, nonsteroidal anti-inflammatory drugs (nsaid), cyclooxygenase-2 (cox 2) inhibitors * intake of medication that could interfere with the interpretation of the study. * female subjects who are pregnant or breast-feeding. females must be either surgically sterilized, postmenopausal (\>12 months since last menses), or, if of childbearing potential, using reliable methods of contraception as determined by the physician. * abdominal surgery (except appendectomy) * patients with known chronic liver disease or history of elevated aspartate aminotransferase (ast)/ alanine transaminase (alt) 2.0 x upper limit of normal. * bile acid (ba) synthesis and possible false positive or negative fecal bile acid or serum 7alpha-hydroxy-4-cholesten-3-one (7alphac4) result. if there is no ast or alt values in the medical record, the study physicians will determine if the tests need to be run.
longitudinal prospective study of neurocognition & neuroimaging in primary bt patients

Conditions: Primary Brain Tumor; Glioma; Meningioma; Schwannoma

Summary: in this proposal, the investigators introduce a novel, translational study to prospectively examine primary brain tumor patients undergoing fractionated radiation therapy to the brain. quantitative neuroimaging, radiation dose information, and directed neurocognitive testing will be acquired through this study to improve understanding of cognitive changes associated with radiation dosage to non-targeted tissue, and will provide the basis for evidence-based cognitive- sparing brain radiotherapy.

background: fractionated radiation therapy (rt) is a mainstay in the treatment of primary and metastatic brain tumors. however, rt to the brain is associated with an inevitable decline in neurocognitive function in up to 90% of patients who survive more than 6 months after irradiation. radiation to the brain results in an inevitable decline in neurocognitive function, mediated by tissue injury to white matter, cortex and subcortical areas. with quantitative magnetic resonance imaging (mri) techniques, investigators can directly and non-invasively measure such changes. objective/hypothesis: the purpose of this study is to examine radiation-induced imaging changes in normal brain tissue over time in primary brain tumor patients, and correlate these with neurocognitive outcomes. the overarching goal is to better identify sensitive brain regions so that future radiation techniques can be optimally designed to mitigate collateral damage. specific aims: 1. to identify microstructural changes in subcortical white matter, hippocampus, and cortex associated with quantified regional exposure to fractionated brain radiotherapy using advanced quantitative neuroimaging imaging 2. to identify changes in neurocognitive functioning in primary brain tumor patients after brain radiotherapy study design: the investigators will prospectively enroll primary brain tumor patients undergoing fractionated partial brain radiation therapy. patients will undergo volumetric and diffusion brain mri (per clinical standard-of-care) and a neurocognitive battery of tests at baseline (pre-treatment), 3 months, 6 months, and 12 months post-treatment. clinical data including age, gender, educational status, tumor size and histology, steroid use, antiepileptic drug use and chemotherapy will be recorded.

Eligibility criteria:
inclusion criteria: 1. patients 18 years or older 2. karnofsky performance status (kps) ≥70 3. life expectancy of ≥1 year 4. primary brain tumor patients who will receive fractionated partial brain rt 5. able to complete neurocognitive assessments exclusion criteria: 1. inability to undergo mri with contrast 2. prior brain rt