Kornimate/medical-research-clean huggingface dataset:
modified constraint induced movement therapy versus virtual reality training in children with cerebral palsy

Conditions: Hemiplegic Cerebral Palsy

Summary: children with hemiplegic cerebral palsy (cp) are characterized by motor impairments mainly lateralized to one side of the body, with greater upper limb than lower limb involvement; these impairments may further limit the daily activities and school participation of children with hemiplegic cp. for the improvement of activity limitations in hemipelagic cerebral palsy children will take 20 hemiplegic cerebral palsy children with the age of 5-16 year all participants will be randomly assign and use modified constraint induced movement therapy and virtual reality techniques. mcimt and hot pack will be given to group i and unaffected hand will immobilized by a volar resting splint extending from finger tips to the proximal forearm. use splint every day for at least 5 waking hours individualized, 18-hour program of mcimt every other day, 3 times per week during a 4-week period. each modified cimt session continued for 1.5 hours will give to group i on the other hand vr and hot pack will give to group ii and 18-hour vr program, every other day, 3 times per week for 4 weeks will give each vr session continued for 1.5 hours. then evaluate both groups on follow up. all the data will be collected from rising sun institute by using abilhand-kids questionnaire and children's hand-use experience questionnaire. the reliability and validity of tools and mentioned. the duration of study will be 6-months. data will be analyzed with the help of spss 27


Eligibility criteria:
inclusion criteria: * age range between 5 to 16 years of age. * medical diagnosis of spastic hemiparetic cp. * at least 20◦wrist and 10◦ active finger extension from full flexion. * more movement deficits in 1 upper extremity (less than 2.5 on the amount of use scale (aou) on the pediatric motor activity log (pmal)). * muscle tone less than 3 on the modified ashworth scale. * normal or corrected-to-normal vision and hearing. * classified level i, ii, or iii of the manual ability classification system ( macs) for children with cp exclusion criteria: * health problems not associated with cp. * seizure hemispatial neglect. * orthopaedic surgery on the involved upper extremity. * botulinum toxin therapy for the affected upper extremity within the past 6 months or within the study period. * balance problems

Keywords: cerebral palsy hemiplegic modified constraint induced movement therapy spastic virtual reality
comparative study of mitomycin and lobaplatin in advanced colorectal cancer patients with radical surgery combined with hyperthermic intraperitoneal chemotherapy

Conditions: Colorectal Cancer; Chemotherapy Effect; Surgery; Metastasis; Survival

Summary: this study is a prospective, randomized, comparative clinical trial conducted by wuhan union hospital and aim to compare the therapeutic effects of mitomycin and lobaplatin in the treatment of advanced colorectal cancer patients with radical surgery combined with hyperthermic intraperitoneal chemotherapy

hyperthermic intraperitoneal chemotherapy (hipec) is traditionally used to treat peritoneal cancer combined with cytoreductive surgery (crs). further, there have been more than 20 years for crs + hipec applying in treatment of patients with colorectal cancer peritoneal metastasis. while, to date, the kinds, doses, combinations of hipec drugs are not clearly been evaluate a criterion for local advanced colorectal cancer patients. thus, this study aim to compare the efficacy of mitomycin and lobaplatin in the treatment of advanced colorectal cancer patients with radical surgery combined with hipec. we plan to recruit 201 patients and divide into 3 groups, 2 drug groups and 1 control group, radomly. all patients with advanced co cancer receive radical surgery + hipec + mfolfox6/xelox chemotherapy regimen. the mainly experimental variable is hipec drugs and three groups employ mitomycin, lobaplatin and none respectively. the endpoints of study include peritoneal metastasis, overall survival, immune status and perioperative safety assessment.

Eligibility criteria:
inclusion criteria: 1. no chemoradiotherapy or other anti-tumor therapy before clinical trial performed; 2. aged 18-75 years; 3. male or non-pregnant or lactating women; 4. pathological diagnosis of colorectal adenocarcinoma; 5. clinical diagnosis of t3 stage or above without distant metastasis and can be given radical surgery (ajcc version 8, 2018); 6. normal function of major organs; 7. routine blood examinations meeting the following criteria: a. hb ≥ 90 g/l; b. anc ≥ 1.5 x 10 9 /l; c. plt ≥ 125 × 10 9 /l; 8. chemistry indexs meeting the following criteria: a. tbil \ 30 g/l c. serum cr ≤ 1.25 uln or endogenous creatinine clearance \> 50 ml/min (cockcroft-gault formula); 9. ecog score 0-1; exclusion criteria: 1. a history of other malignant tumors within 5 years; 2. distant metastasis found during surgery; 3. allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs; 4. suffering from epilepsy or other mental illness, unable to control behavior; 5. inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease; 6. pregnant or lactating women. 7. receiving anti-cancer drug therapy from other clinical trials.

Keywords: advanced colorectal cancer hyperthermic intraperitoneal chemotherapy mitomycin lobaplatin prognosis
dexmedetomidine versus magnesium sulfate infusion during spinal anesthesia

Conditions: Postoperative Pain

Summary: the aim of this work is to compare the hemodynamic and analgesic properties of dexmedetomidine and magnesium sulphate infusion in lower abdominal surgery.

dexmedetomidine is a relatively new alpha 2 adrenergic receptor agonist with a higher α2/α1 selectivity ratio of 1620:1 that provides analgesic and anesthetic effects . dexmedetomidine has various clinical uses in anesthesia such as sedation, and prolongation of the duration of postoperative analgesia when used as an adjuvant through intrathecal, epidural, or intravenous routes. magnesium sulphate is another commonly used drug in anesthesia. magnesium sulphate suppresses nociceptive impulses through inhibition of voltage-gated calcium channels and through antagonism of the n-methyl d-aspartate (nmda) receptors. although both drugs were reported to prolong the duration of spinal anesthesia, no studies to the best of our knowledge had compared the analgesic and hemodynamic profile of both drugs when used as intravenously during spinal anesthesia.

Eligibility criteria:
inclusion criteria: * adult patients aged between 18 and 65 years. * scheduled for lower abdominal surgery. exclusion criteria: * systolic blood pressure less than 100 mmhg * coagulation disorders * history of heart failure * mitral or aortic stenosis
comparison of gabapentin and pregabalin for radicular pain

Conditions: Radicular; Neuropathic, Lumbar, Lumbosacral; Radicular; Neuropathic, Cervical

Summary: although some studies show improvement of pain and associated effects of pain with off-label use of neuropathic agents for cervical or lumbar radiculopathy, there is limited published evidence so far. we propose to complete a year-long prospective, observational study as a pilot to recruit 400 patients within the year and follow their pain level, function, and qol measures for 16 weeks to determine whether it is feasible to continue studying this group in the future. we expect that pain, function, and quality of life will be improved in the group of patients who are given neuropathic agents as an adjunct to other conservative treatments compared to the expected 65% of patients with similar symptoms who are treated conservatively without neuropathic agents. we do not expect a statistically significant difference between the two neuropathic agents. since these drugs are currently used off-label, there is limited empirical evidence regarding which agent is more efficacious compared to the other, and since their use in treating radicular pain is based mostly on anecdotal evidence so far, prescription of one or the other of these agents has been based on likely compliance (medication needed twice a day, three times a day) or whether or not the patients' insurance will pay for one or the other. this study will be a first step to better assist practitioners in counselling their patients on use of these medications in radiculopathy, examining rates of discontinuation due to side effects and what effects these medications have on perceived pain, function and quality of life.


Eligibility criteria:
inclusion criteria: * cervical or lumbar radicular complaints with clinical diagnosis of radiculopathy or sciatica * aged 18 years and older * able to provide informed consent either with or without a legally authorized representative * patients with vas\> or = 4 (visual analog pain score) exclusion criteria: * under the age of 18 * previously completed epidural injections within 3 weeks of the study * undergone cervical or lumbar surgery * history of renal disease, metastatic disease to the spine, vertebral fractures * individuals with pending litigation, workers compensation claims or disability claims * unable to provide informed consent and no legally authorized representative is available

Keywords: gabapentin pregabalin lyrica neurontin lumbar cervical
mega-choep: conventional chemo vs hd chemo followed by auto sct in younger pts with aggressive non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma (NHL)

Summary: according to amendment 3 this study addresses the question if intensification of administration of rituximab in standard treatment for patients with newly diagnosed aggressive b-non hodgkin lymphoma (b-nhl) and high risk (aaipi 2 or 3) results in a better time to treatment failure (tttf)

this study was primarily designed to compare aggressive conventional chemotherapy with a repetitive high-dose (hd) therapy program using identical, effective drugs at highest possible dose and dose intensity with/without addition of rituximab (initially 4 treatment arms). in 2004 the first amendment had to be added in order to close two treatment arms without rituximab due to recent data revealing a significant advantage for rituximab-treated patients with cd20+lymphoma. a planned interim analysis in 2010 revealed inferiority of the high-dose treatment thus in the 2nd amendment the high-dose arm was closed and additionally the rituximab frequency was raised from 6 to 12 administrations as recent publications gave hint for advantage. the last amendment was added in 2010 to adjust for delayed recruitment mainly due to organisation problems. as the high-dose arm was closed only cd20+ b-lymphoma were included past amendment 2.

Eligibility criteria:
inclusion criteria: * 18-60 years of age * risk group international prognostic index (ipi) 2 and 3 (age adjusted) * performance status: eastern cooperative oncology group (ecog) 0-3 * patient's written informed consent * aggressive non-hodgkin's lymphoma with cd20+ histology exclusion criteria: * already initiated lymphoma therapy * serious accompanying disorder or impaired organ function * bone marrow involvement \> 25% * known hypersensibility to the medications to be used * known hiv-positivity * active hepatitis infection * suspicion that patient compliance will be poor * simultaneous participation in other trials * prior chemo- or radiotherapy for previous disorder * other concomitant tumour disease
a study of arry-502 in patients with persistent asthma

Conditions: Asthma

Summary: this is a phase 2 study, involving a 6-week treatment period, designed to evaluate the effectiveness of investigational study drug arry-502 in treating mild to moderate persistent asthma, and to further evaluate the safety of the drug. approximately 180 patients from the us will be enrolled in this study.


Eligibility criteria:
key inclusion criteria: * documented history of bronchial asthma diagnosed at least 6 months prior to study start and prior to the age of 40 years. * body mass index (bmi) of 18 to 35 inclusive. * an acq score of ≥ 1.5 at specified time points prior to first dose of study drug. * a best prebronchodilator fev1 of 60% to 85% of the predicted normal value and a change in best postbronchodilator fev1 of ≥ 12% and ≥ 200 ml at specified time points prior to first dose of study drug. * additional criteria exist. key exclusion criteria: * evidence of aspirin-sensitive asthma. * pre-existing lung disease other than asthma. * clinically significant dermatologic, hematological, renal, endocrine, pulmonary (other than asthma), gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, musculoskeletal or immunologic disease (excepting allergic disease and asthma) that is uncontrolled despite treatment or is likely in the opinion of the investigator to require a change in therapy during the study. * patients with any current or past history of cancer within 5 years prior to study start except for treated basal cell or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or cervical carcinomas in situ. * any history of serious illness requiring hospitalization within 6 months prior to study start. * known positive serology for the human immunodeficiency virus (hiv), hepatitis b and/or active hepatitis c. * a positive test for drugs or alcohol, unless the positive drug screen is associated with a prescribed medication and is approved by the medical monitor. * smoking (tobacco or marijuana) within 6 months prior to study start and/or a smoking history of \> 10 packs/year. * blood donation of ≥ 1 pint (473 ml) within 8 weeks prior to the first dose of study drug. * previous treatment with arry-502. * additional criteria exist.
capsaicin-evoked pain in patients with crps

Conditions: CRPS (Complex Regional Pain Syndromes)

Summary: to evaluate the effect of capsaicin in patients with complex regional pain syndrome.

primary outcome parameters: capsaicin-induced pain and inflammation. secondary outcome parameters: peripheral sensory and autonomic function.

Eligibility criteria:
inclusion criteria: * age: 18 or older. * pain in arm or hand \> 3 months. * diagnosed with crps acc. to diagnostic research criteria (harder et al., 2005) * inclusion of healthy subjects: age-, gender-, and bmi-matched. exclusion criteria: * other significant disease affecting the parameters measured, including cardiovascular disease. * treatment with anticholinergics, sympathomimetics and parasympathomimetics, and alpha- and beta-adrenergics.
metformin continuation versus interruption following coronary angiography: a pilot randomized controlled trial

Conditions: Acute Coronary Syndrome; Unstable Angina; Diabetes Mellitus; Metformin Adverse Reaction

Summary: this pilot randomized controlled trial aims to evaluate the feasibility for safety examination of continued metformin therapy in patients with type 2 diabetes (t2d) following invasive coronary angiography. metformin will be continued until coronary angiography.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. on metformin therapy 3. angiography for acs or elective non-acs related indications 4. informed consent received exclusion criteria: 1. cardiogenic shock prior to randomization 2. cardiac arrest prior to randomization 3. established severe ckd (egfr\<30, or on dialysis) 4. chronic liver disease 5. need for cabg within 48 hours of hospitalization 6. inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk if the investigational therapy is initiated

Keywords: metformin diabetes pci percutaneous coronary intervention unstable angina acute coronary syndrome
mac project, monitoring of anticoagulant therapies (mac)

Conditions: Anticoagulants and Bleeding Disorders

Summary: mac project is a prospective cohort, multicenter, observational, no-profit study aimed to prospectively collect reliable real-life clinical information in unselected vte or nvaf patients treated with any doac, during a medium-long term follow-up period.

mac project is a prospective cohort, multicenter, observational, no-profit study aimed to prospectively collect reliable real-life clinical information in unselected vte or nvaf patients treated with any doac, during a medium-long term follow-up period. patients will be investigated in italian hospital-based clinical centers, skilled in the management of adult patients with vte or nvaf requiring anticoagulant treatment, and followed-up up to 5 years. the drugs will be prescribed according to current standards of care and regulations and not provided by any sponsor. the primary outcome is to collect and evaluate the safety and efficacy data of doacs in a real-life setting, regardless of the underlying pathology, and the duration of treatment. the secondary outcome is to separately evaluate safety and efficacy of doacs for treatment of cardiovascular diseases, specifically considering treatment duration, as follows: short-term (e.g., superficial venous thrombosis); medium-term (e.g., deep vein thrombosis, pulmonary embolism, etc.); long-term (e.g., atrial fibrillation, prevention of recurrent vte or long-term treatment of recurrent vte, peripheral arterial obstructive disease, etc.).investigators will store event-driven clinical information into a redcap based on-line edc system about management and outcome of all efficacy and safety end-points; treatment compliance/adherence; vte risk factors; thromboembolic and haemorrhagic risk-scores; comorbidities; concomitant treatments; patients' appreciation by a specific score (acts); clinical or adverse events; survival; possible causes of death.

Eligibility criteria:
inclusion criteria: * aged \> 18 years, * mandatory anticoagulant treatment * ability to understand the purposes of the study * ability to express valid informed consent. exclusion criteria: * none

Keywords: anticoagulant doac oac benefit-risk
a clinical study of ono-1110 in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: to evaluate the efficacy and safety of ono-1110 in patients with fibromyalgia


Eligibility criteria:
inclusion criteria: * japanese (both sexes) * outpatient * patients who are considered capable of understanding the study procedures and completing the pain diary and questionnaires appropriately by the investigator (sub-investigator) * patients who meet the american college of rheumatology fibromyalgia criteria exclusion criteria: * patients with inflammatory arthritis, infectious arthritis, or autoimmune disease * patients with pain other than fm that may affect assessments in this study * patients with a past history of or concurrent neurologic diseases that may affect assessments in this study * patients with a past history of or concurrent malignant tumor within 3 years * patients who are pregnant, nursing, or possibly pregnant, or intending to become pregnant during the study period.

Keywords: ono-1110 ono-1110-05 fibromyalgia
meta self-efficacy internet intervention to improve work self-efficacy and occupational well-being in young employees

Conditions: Self Efficacy; Occupational Stress; Well-Being, Psychological; Work Related Stress

Summary: this randomized controlled trial aims to test whether enhancing meta self-efficacy through a self-guided internet intervention improves young employees' work self-efficacy and occupational well-being. the trial will evaluate primary (work self-efficacy) and secondary (three dimensions of occupational well-being) outcomes. it is hypothesized that boosting meta self-efficacy will lead to improvements in outcomes, with effects assessed immediately after the intervention, and at 3- and 6-month follow-ups.

this study investigates the efficacy of a self-guided internet intervention designed to enhance meta self-efficacy in young employees. meta self-efficacy is a psychological resource that encompasses the ability to leverage self-efficacy sources (mastery experiences, vicarious experiences, persuasion, and affective \& physiological states) to boost context-specific self-efficacy. in this two-arm randomized controlled trial, participants (young employees) will be randomly assigned to an experimental group, which will receive internet intervention with activities aimed at enhancing meta self-efficacy, or to a placebo control group, which will receive educational content. primary and secondary outcomes (including work self-efficacy, job stress, job affective well-being, and work capabilities), as well as the manipulation check (meta self-efficacy), will be assessed immediately after the intervention and at 3- and 6-month follow-ups. the trial aims to evaluate the effect of enhancing meta self-efficacy and explore the impact of factors such as adherence and engagement on the intervention's efficacy.

Eligibility criteria:
inclusion criteria: * must be between 18 and 30 years old * must be empolyed (working at least 20 h / week, for at least the prior two months, regardless of the type of contract) exclusion criteria: * none

Keywords: meta self-efficacy self-efficacy job affective well-being sustainable employability work stress work self-efficacy
home-based action observation treatment with virtual-reality for arm rehabilitation in people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: action observation treatment (aot) is a rehabilitative strategy which has been proposed as a promising approach to improve motor performance in neurological conditions, including multiple sclerosis (ms). in this clinical trial, the investigators aim to explore the role of a home-based aot with virtual reality (vr) in improving upper limb motor function in people with ms (pwms). the objectives are: * to compare the effects of home-based vr-aot versus vr-landscape observation (lo) on upper limb motor performance; * to measure brain network functional changes (functional plasticity) and structural variations of gray matter (gm) and white matter (wm) (structural plasticity) using advanced magnetic resonance imaging (mri) techniques following vr-aot and vr-lo; * to study the correlations between mri changes and clinical improvements and the predictors of vr-aot efficacy. all participants will undergo treatment sessions for 3 weeks (5 consecutive days/week, total=15 sessions lasting 30 minutes each). those in the vr-aot group will observe, imagine and execute two upper limb motor tasks in each session. those in the vr-lo group will perform the same tasks, but they will observe inanimate landscapes beforehand instead.


Eligibility criteria:
inclusion criteria: * age 18-65 years; * diagnosis of ms according to 2017 revised mcdonald criteria; * ability to understand the purpose and risks of the study and provide signed informed consent; * ability to remotely perform vr-aot; * right pre-morbid handedness (ehi\>50); * muscle strength deficit involving the right upper limb (≥1 point decrease of mrc scale); * presence of activity limitation of the right hand (need of adaptations, supervision or help by another person for the execution of daily living activities according to items 1-6 of the fim); * edss score 2.0-7.0 (inclusive); * cerebellar functional system score of the edss ≤1; * baseline 9hpt score \>21 seconds and \<180 seconds. exclusion criteria: * mri contraindications; * significant visual deficits not allowing to observe vr stimuli; * moderate to severe pain disturbances (vas≥4); * concomitant neuro-psychiatric or systemic diseases (other than ms); * clinical relapses or steroid treatment in the past 3 months; * modification of symptomatic treatment or botulin toxin injection in the upper limb in the past 3 months; * stable disease-modifying treatment for ms for ≤6 months; * rehabilitation treatment in the past 3 months.