Kornimate/medical-research-clean huggingface dataset:
setting families on a positive path to recovery after pediatric tbi: road-to-recovery

Conditions: Traumatic Brain Injury; Head Injury; Head Injuries, Closed; Brain Hemorrhage, Traumatic; Brain Edema; Intracranial Edema

Summary: this study has two main goals: 1) to refine and enhance the r2r-tbi intervention; and 2) to examine the efficacy of the r2r-tbi intervention in a randomized control trial. to achieve the second goal, we will employ a between-groups randomized treatment design with repeated measures at baseline, one-month post-randomization, and at a six-month follow-up. the two conditions will be: a) usual medical care plus access to internet resources regarding pediatric brain injury (internet resources comparison group, irc), and b) usual medical care plus the r2r-tbi intervention (road-to-recovery group, r2r-tbi).

the early recovery period constitutes a critical window to set families on a positive road-to-recovery by supporting parental self-care, positive parent-child interactions, and awareness of potential longer-term concerns. the latter would facilitate parental recognition of behavioral and psychosocial needs that might otherwise go unmet. recognizing that (1) caregivers of children who have sustained tbi are at risk of worsening psychological health and that (2) caregiver functioning and parenting behaviors have a direct impact on child recovery and outcomes; intervening and supporting caregivers in the acute phase following injury may set children and families on a positive path to recovery. intervening at the acute phase may reduce the cascading effects of parental burden/distress and concomitant negative parent-child interactions on child recovery and functioning over time. because families of children with tbi and other chronic health conditions may have difficulty accessing services due to transportation and cost issues, particularly lower income families, the r2r-tbi program is designed to be accessed via any web-enabled device (e.g., smartphone, computer, tablet) with any form of internet connection. we will also offer the intervention (via tablet) to parents while they wait for their child to complete outpatient therapies (e.g., speech, physical, and occupational therapy). delivery of web-based behavioral health interventions may reduce barriers to help-seeking and promote evidence-based interventions that are both accessible and efficient.

Eligibility criteria:
inclusion criteria: caregivers will be eligible if they are over 18 years of age, and if their child meets all of the following criteria: * ages 3 months to 18 years at time of discharge from hospital * sustained a complicated mild to severe tbi as defined by a glasgow coma scale (gcs) of 13-15 with imagining abnormalities or gcs 3-12 with or without imaging abnormalities * admitted overnight to the hospital * 0-3 months post-discharge exclusion criteria: the caregiver will be excluded from participation if any of the following occur: * child did not survive the injury * child sustained a non-blunt head trauma (e.g. gunshot wound) * child does not reside with parent/caregiver for study duration * english is not primary language spoken in the home
congrong runtong oral liquid in the treatment of functional constipation (yang-deficiency type)

Conditions: Functional Constipation

Summary: using a placebo as a control, this study aims to preliminarily evaluate the clinical efficacy of congrong runtong oral liquid for the treatment of functional constipation (yang-deficiency type), explore the optimal dosage of congrong runtong oral liquid for functional constipation (yang-deficiency type) to provide a basis for dosage selection in phase iii clinical trials, and observe the safety of clinical use of congrong runtong oral liquid.


Eligibility criteria:
inclusion criteria: 1. meets the rome iv diagnostic criteria for functional constipation; 2. meets the tcm diagnostic criteria for yang-deficiency type constipation; 3. aged between 18 and 70 years (inclusive); 4. has undergone colonoscopy and has been diagnosed with either no abnormalities or non-adenomatous polyps (size not exceeding 0.5 cm, no more than 3) or has undergone polypectomy for more than 1 month and the pathological examination confirms no high-grade intraepithelial neoplasia within 12 months of colonoscopy examination in a tertiary grade a hospital 5. less than 3 complete spontaneous bowel movements per week during the 2-week run-in period; 6. voluntarily participates in the trial and signs an informed consent form. exclusion criteria: 1. patients with constipation caused by organic lesions of the rectum or colon (such as tumors, inflammatory bowel disease, anal fissure, intestinal adhesions, intestinal tuberculosis) leading to intestinal stenosis; 2. patients with constipation caused by other systemic organic diseases, such as congenital megacolon, neurological disorders (such as autonomic neuropathy, cerebrovascular disease, etc.), mental disorders, metabolic endocrine disorders (such as hypothyroidism, diabetes mellitus with fasting blood glucose \> 8.6mmol/l or with complications), muscular diseases (such as amyloidosis, dermatomyositis), etc.; 3. patients whose drug-induced constipation cannot be ruled out by the investigators； 4. patients with alarm signs judged by the investigator and unable to exclude malignant lesions by colonoscopy in the past three months; 5. alt or ast ≥ 1.5 times the upper limit of the normal value, or scr \> upper limit of the normal value; 6. patients allergic to the composition of the ingredients of the cenruong runtong oral solution or bisacodyl; 7. pregnant or breastfeeding women, or women planning to become pregnant; 8. patients who have participated in other clinical trials in the past 3 months; 9. other situations judged by the investigator as inappropriate for participation in this trial.
dietary supplements for covid-19

Conditions: Covid19

Summary: this is a double blind, placebo controlled, phase iii randomized controlled trial evaluating the effects of the dietary supplements vitamin c, vitamin d, vitamin k, and zinc versus placebo on the overall health, symptom severity, and symptom duration of outpatients diagnosed with sars-cov-2.

this study proposed is a double-blind, placebo-controlled, phase iii randomized controlled trial powered to detect meaningful differences in the overall health and symptom severity of people with covid-19 between the treatment and control arms. eligible participants will be randomly assigned, using a web randomization system, in a ratio of 1:1 to one of the following groups: (1) nutrient therapy with vitamin d, vitamin c, vitamin k2, and zinc or (2) placebo. total trial duration will be 12 weeks. nutrients or placebo will be given for a period of 21 days following enrolment and randomization. total trial duration will be 12 weeks. adverse events will be collected during the treatment phase plus one additional week (maximum 4 weeks). with respect to the primary outcome of participant-reported overall health, power calculations were conducted based on between-group differences at a single time point (21 days) and cohen's guideline for a small effect size of 0.3. a sample size of 176 (88 per arm) provides 80% power to detect a difference at an α of 0.05. to account for an approximate 10-15% lost to follow-up we will enrol 200 participants (100 per arm).

Eligibility criteria:
inclusion criteria: 1. adults (≥18) who test positive for sars-cov-2 in an outpatient setting 2. access to internet exclusion criteria: 1. symptom onset greater than 4 days prior to enrolment 2. supplementing regularly with \>500 mg vitamin c, \>1000 units vitamin d, \>120 mcg vitamin k (any form), or \>15 mg zinc taken daily within the past month 3. currently taking warfarin or an equivalent vitamin k antagonist anticoagulant 4. end stage chronic kidney disease 5. history of calcium oxalate kidney stones 6. active granulomatosis (sarcoidosis, tuberculosis, lymphoma) 7. known hypercalcemia or hypervitaminosis d 8. currently taking either of the following antibiotics: cephalexin, tetracyclines 9. participating in an investigational study or participation in an investigational study within the past 30 days 10. any reason which, under the discretion of the qualified investigator or delegate, would preclude the patient from participating.

Keywords: natural health products nhp dietary supplements vitamin c vitamin d vitamin k zinc covid-19 sars-cov-2
estimation of cpr chest compression depth

Conditions: Cardiac Arrest

Summary: optimal chest compression depth during cpr is 4.56cm which is at variance with the current guidelines of 5.0-6.0cm. a change in guidelines is only worthwhile if healthcare professionals can accurately judge a subtle reduction in chest compression depth during cpr by a relatively small amount.

chest compression depth and rate during cardiopulmonary resuscitation (cpr) are important predictors of return of spontaneous circulation and survival following cardiac arrest. stiell et al (2014) found optimal survival at a compression depth of 4.56cm, which is at variance with the current guidelines of 5.0-6.0cm. a change in guidelines is only likely to improve survival rates if healthcare professionals can accurately implement these subtle depth modifications into the basic life support (bls) algorithm. this study aims to determine if healthcare professionals can accurately judge compression depth without real-time feedback.

Eligibility criteria:
inclusion criteria: * nhs professionals (staff or students), who have successfully completed a hospital-accredited basic life support (bls) course, including a practical cpr component. exclusion criteria: * pregnancy, significant medical illness or injury that would impair delivery of chest compressions

Keywords: cpr basic life support
using saline for myofascial pain syndromes (usamps)

Conditions: Myofascial Pain Syndrome

Summary: this study involves adult patients diagnosed with myofascial pain syndromes (mps). the purpose of this research study is to determine if there is a therapeutic difference between trigger point injection (tpi) of normal saline and conventional drug mix (local anesthesic + steroid) in treating mps.


Eligibility criteria:
inclusion criteria: * adult patients diagnosed with mps of the trapezius, gluteus medius/minimus, iliocostalis thoracis-lumborum, quadratus lumborum, or paraspinal muscles in the emergency department. exclusion criteria: * patients allergic to lidocaine and/or steroids. * pregnant women. * prisoners. * patients who are cognitively impaired and/or unable to consent for the study. * age \< 18. * signs of localized infection or skin breakdown at the injection site.

Keywords: myofascial pain syndrome trigger point injection
computational medical imaging and prediction of diffusion/flair mismatch in stroke patients

Conditions: Stroke

Summary: stroke is a public health issue and a priority for our institution. mri plays an essential role in the management of stroke. in this context, the contribution of mri is diagnostic, etiological and prognostic. among the mri parameters evaluated in the acute phase of the stroke, the evaluation of the mismatch between the diffusion and flair sequences is crucial as it will directly contribute to the therapeutic decision. a flair-diffusion mismatch, i.e., a lesion with a diffusion but not a flair hypersignal, identifies patients whose time of onset of symptoms is probably less than 4.5 hours. it is therefore understandable that the main arterial recanalization techniques performed in the acute phase are primarily reserved for patients with a positive mismatch. in current practice, mismatch assessment is performed subjectively, by visually comparing the two sequences, which is known to be the cause of a lack of reproducibility and diagnostic performance. computational medical imaging techniques ("radiomics") have recently gained momentum and offer the prospect of automated and therefore more reproducible analysis of medical imaging data. in stroke patients, radiomics extracted from flair imaging could thus contribute to describe the "diffusion flair" mismatch in a continuous and objective way. for the time being, data analysis cannot be performed in real time due to technical constraints. if it is proven that radiomics can reliably analyze the mismatch on the flair sequence alone, the next step will be to make the analysis feasible in clinical routine (i.e. in a time frame adapted to the therapeutic management).


Eligibility criteria:
inclusion criteria: * patient with age ≥ 18 years * patient with supra-tentorial stroke treated by mechanical thrombectomy and who had mri imaging on admission before endovascular treatment at paris saint-joseph hospital * complete mri protocol including diffusion and flair sequences * french-speaking patient exclusion criteria: * patient under guardianship or curatorship * patient deprived of liberty * patient under court protection * patient objecting to the use of his data for this research
safety & efficacy study of orgn001 (formerly alxn1101) in pediatric patients with mocd type a currently treated with rcpmp

Conditions: Molybdenum Cofactor Deficiency, Type A

Summary: this study will include a screening period, a 6-month treatment period, followed by long-term extension period expected to last approximately 72 months.

patients will receive daily iv infusions of orgn001 (formerly alxn1101) starting on day 1. after a prescribed period, dosing will increase monthly based on defined patient safety measures. after month 6, patients will continue daily dosing at their last tolerated dose.

Eligibility criteria:
inclusion criteria: * male or female patients with a genetically confirmed diagnosis of mocd type a (mocs1 mutation) * currently treated with rcpmp infusions exclusion criteria: - current or planned treatment with another investigational drug or device, with the exception rcpmp treatment through day -1.

Keywords: molybdenum cofactor deficiency (mocd) molybdenum cofactor (moco) biosynthesis sulfite oxidase (so) xanthine dehydrogenase aldehyde oxidase s sulfocysteine (ssc)
assessment of ocrelizumab (ocr) treatment effects on functional impairment of ms patients enrolled in the phase iii orchestra programme using multimodal evoked potentials (ep) and highresolution electroencephalography (eeg)

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is not only an 'inflammatory' demyelinating disease, but also includes axonal and neuronal injury in the grey matter . neurodegenerative processes are partly independent of lesion formation and relapse activity , but represent the direct driver of clinical long-term disability and cognitive decline. multimodal evoked potentials (ep), i.e. the combination of visual, somato-sensory and motor ep (vep, ssep, mep) have been shown prospectively to provide objective, monovectorial, and numerical data which are closely correlated to the edss. as ep capture the functional integrity of the examined systems they represent a method unbiased for directional changes, while remaining specific for the neuronal function, and hence can measure deterioration, as well as improvement, a germane advantage to capture drug response. high-resolution electroencephalography (eeg) allow for explorative analysis of potential surrogate markers for cognitive decline. ocrelizumab (ocr), a humanized anti-cd20 monoclonal antibody has shown strong treatment effects on number of t1gd-enhancing lesions , on new t1gd-enhancing and new t2-hyperintense lesions as well as on the annualized relapse rate in a recent phase ii trial in relapsing-remitting ms. the present study will investigate the effects of ocr on multimodal evoked potentials (ep), furthermore, quantitative eeg as a potential correlate of cognitive dysfunction and fatigue will be explored.


Eligibility criteria:
inclusion criteria: * definitive inclusion in one of the phase iii trials on ocr: relapsing remitting multiple sclerosis (rrms) patients in "opera i" (wa21092b) or "opera ii" (wa21093), primary progressive multiple sclerosis (ppms) patients in "oratorio" (wa25046b) and fulfilling the respective inclusion criteria * stable clinical state (at least 4 weeks after treatment with corticoids, when there was a relapse) * provision of written informed consent and ability to be compliant with the schedule of assessments of the present study exclusion criteria: * exclusion criteria of both phase iii trials on ocr also apply to the present study * additionally patients with movable metal implants, e.g. pace-maker, stents, deep brain stimulators are excluded; (patients with jaw- or bone-fixed metal implants can be included)
mikrobe management of infected knee replacements-obtaining best evidence

Conditions: Arthroplasty, Replacement, Knee

Summary: following a prosthetic knee joint infection, two types of operative approach can be undertaken to treat the infection: a one-stage or two-stage revision operation. both approaches are widely used and are good at treating infection but we don't know which has the best long-term outcomes for patients. this trial aims to assess the feasibility of conducting a randomised controlled trial to evaluate whether treating a prosthetic knee infection with one-stage revision surgery gives a better outcome than two-stage revision surgery in terms of patient function and pain, and cost-effectiveness.


Eligibility criteria:
inclusion criteria: * adults with prosthetic knee infection suitable for either one-stage or two-stage revision surgery * intra-operatively, all cases must have adequate soft-tissue coverage post debridement to allow single or two stage revision surgery. * case meets the international consensus meeting criteria for infection * patients having had a debridement, anti-biotic and implant retained procedure previously or washout/biopsy only of an infected tkr are suitable exclusion criteria: * unable or unwilling to undergo either treatment * lacking capacity to consent to research * refusal to consent to study for any reason * re-revision of prosthetic knee infection if first revision was for infection * presence of tuberculosis infection

Keywords: arthropathy arthropathy related to infection arthropathy of knee joint one-stage two-stage infection prosthetic joint infection
iron deficiency anemia can be an indication for treatment of subclinical hypothyroidism

Conditions: Iron Deficiency Anemia; Subclinical Hypothyroidism

Summary: to determine whether iron deficiency anemia can be an indication for the treatment of subclinical hypothyroidism.

51 patients presented to our university outpatient internal medicine clinic who are found to have iron deficiency anemia coexisting with subclinical hypothyroidism have been included in this study. patients were randomly assigned to oral iron or oral iron plus levothyroxin therapy. the physician and the patients did not know who received oral iron only or oral iron plus levothyroxine treatment. hematologic parameters as well as serum iron, ferritin and iron binding capacity were being measured at the beginning and 3 months after treatment in both groups.

Eligibility criteria:
inclusion criteria: * clinical diagnosis and laboratory confirmation of iron deficiency anemia and subclinical hypothyroidism * must be able to swallow tablets exclusion criteria: * multifactorial anemia or anemia due to other reasons * iron deficiency anemia requiring urgent intervention- cardiac ischemia, severe anemia, gi or gu losses due to malignancy and or acute/subacute big loses by respiratory, gi̇, gu, etc. system * prior thyroid disorder and/or treatment history * presence of any other co-morbid disease like renal insufficiency/ failure, coronary heart disease, hypertension, diabetes mellitus, any endocrine system disease other than subclinical hypothyroidism

Keywords: iron deficiency anemia anemia hypothyroidism subclinical hypothyroidism
benefits of empagliflozin in patients with heart failure and reduced ejection fraction without diabetes mellitus

Conditions: Heart Failure With Reduced Ejection Fraction

Summary: the study is a short to mid-term randomized single-blind placebo controlled study that aimed to detect the effects of empagliflozin (a sodium-glucose cotransporter-2 inhibitor) compared to placebo on lv end-diastolic and end-systolic volumes, lv ejection fraction, n-terminal pro-b-type natriuretic peptide (nt-probnp), functional capacity and quality of life (qol) among non-diabetic patients with hfref.


Eligibility criteria:
inclusion criteria: * ambulatory non-diabetic adult male and non-pregnant female patients with established diagnosis of heart failure (hf) new york heart association functional class ii-iv and left ventricular ejection fraction (lvef) ≤ 40% (calculated by echocardiography within the previous 6 months before randomization). * patients should have stable symptoms and stable guideline-directed medical therapy for hf within the last 3 months before randomization. it was mandatory that all patients have reached the maximum tolerated doses of guideline-directed medical therapy for hf and are regular on them for at least 3 months before participation. * patients were not known to be diabetic and have no history of diabetes remission and their baseline glycosylated hemoglobin (hba1c) should have been \< 5.7%. * patients have never been on sglt2 inhibitor therapy before. * estimated glomerular filtration rate (egfr) should have been ≥ 45 ml/min/1.73 m² using the chronic kidney disease epidemiology collaboration (ckd-epi) creatinine equation (2009) exclusion criteria: * women who were pregnant at time of selection, possibly pregnant, breast-feeding, or planning to become pregnant during the study period. * patients who had acute coronary syndrome, cardiac surgery, stroke or transient ischemic attack (tia) within the last 3 months before randomization. * patients who had infiltrative cardiomyopathy, muscular dystrophies, hypertrophic cardiomyopathy, peripartum cardiomyopathy, pericardial restriction or chemotherapy induced cardiomyopathy within 12 months before randomization. * patients with severe valvular heart disease. * patients who had acute decompensated hf or were on continuous parenteral inotropic agents with 3 months before randomization. * patients who had cardiac resynchronization therapy (crt) implantation within 3 months before randomization. * history of recurrent urinary tract infection, cancer or any life threatening condition or psychiatric disease incompatible with being in the study.