Kornimate/medical-research-clean huggingface dataset:
renal colic fast track pathway in the emergency department.

Conditions: Renal Colic

Summary: validation of a high-resolution, fast track pathway that combines the use of laboratory tests at the point-of-care testing (poct) and point-of-care ultrasound (pocus) versus the classical pathway, in which blood samples are sent to the central laboratory and comprehensive radiological exams ordered, being equally effective, at a lower cost of care and time of stay in the emergency department.


Eligibility criteria:
inclusion criteria: * first renal colic episode * need of analgesia * oral tolerance exclusion criteria: * hemodynamic instability * fever * anuria * abdominal trauma * chronic renal failure * active oncologic disease * kidney transplant or monorenal patient

Keywords: renal colic point-of-care ultrasound point-of-care testing
a prospective natural history study of progression of subjects with duchenne muscular dystrophy.

Conditions: Duchenne Muscular Dystrophy

Summary: to characterize the natural history and progression of duchenne muscular dystrophy (dmd) to help inform the design of future studies, to capture biomarkers of safety and disease progression and to provide comparative data for the development of rare exons for which formal controlled trials are not feasible.

this is a prospective study. all dmd patients that fulfil the inclusion/exclusion criteria are eligible although the study is weighted towards ambulant subjects aged 3 years or older. there will be 7 study visits and subjects will be in the study for a maximum of 3 years. visits will occur every 6 months (+/- 1 month). up to 250 dmd subjects planned in the following categories : * 75 % ambulant subjects aged between 3 and 18 years at study entry * 25% non-ambulant subjects with a maximum age of 18 years at study entry subjects will be asked to perform muscle testing assessment with a clinical evaluator, such as walking for 6 minutes, climb stairs, breathe in a tube, see how they can move their arms and legs. they will be asked questions about how they feel overall and perform daily activities. these measurements will be assessed every 6 months. urine and blood samples will be collected once a year to measure biomarkers that will allow to have a better overview of dmd.

Eligibility criteria:
inclusion criteria: * diagnosis of dmd resulting from a mutation in the dmd gene confirmed by a state of the art dna diagnostic technique covering all dmd gene exons. * age 3 - 18 years * willing and able to comply with protocol requirements * life expectancy of at least 3 years * able to give informed assent and/or consent in writing signed by the subject and/or parent(s)/legal guardian (according to local regulations) exclusion criteria: * current participation in a clinical study with an investigational medicinal product (imp) * participation within the previous 1 month in a clinical study with an imp

Keywords: dmd myopathy natural history muscular dystrophy biomarkers muscle testing
electrical impedance imaging of patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the goal of this feasibility study is to evaluate the ability of electrical impedance tomography (eit) for providing regional and quantitative information about the extent and nature of bronchial obstruction in patients with cystic fibrosis. it is not being conducted to diagnose, treat, prevent, or cure any kind of disease. in electrical impedance tomography low amplitude, low frequency current is applied on electrodes, and the resulting voltage is measured and used to computed the electrical properties of the interior of the chest as they change in time. the computed properties are used to form an image, which can then be used for monitoring and diagnosis.

the goal of this study is to evaluate the ability of electrical impedance tomography (eit) hardware and software in patients with cystic fibrosis (cf) for providing regional and quantitative information for identifying regions of obstruction and consolidation, and determine whether these measures will correlate with improvements seen after hospitalized treatment for a pulmonary exacerbation (pe). in particular, eit will be used to identify regions of obstruction (air trapping) and consolidation comprised of atelectasis and airway occlusion (consequences of mucus plugging) in cf patients, and to determine whether eit can demonstrate the beneficial effects of antibiotic treatment for cf patients with an acute pe by correlating changes in quantitative eit measures with clinical measures known to improve following therapy, with patients serving as their own controls. regional changes in air trapping and consolidation from pre to post treatment as indicated by the eit images will be calculated, with subjects serving as their own control.

Eligibility criteria:
inclusion criteria: * between the ages of 2 and 21 years (groups 1 and 2) * between the ages of 8 and 21 years (group 3) * healthy lungs (group 1) * clinical diagnosis of cystic fibrosis (groups 2 and 3) * clinically indicated for a pulmonary ct scan or will receive one as part of their routine care (group 2) * receiving iv antibiotics for a clinically diagnosed pulmonary exacerbation (group 3) exclusion criteria: * under age 24 months or over age 21. * no informed consent * known congenital heart disease, arrythmia, or history of heart failure, admission to the intensive care unit, wearing a pacemaker or other surgical implant. * pregnant or lactating

Keywords: cystic fibrosis electrical impedance tomography
atrial sensing capability for better detection of atrial fibrillation

Conditions: Implantable Cardioverter Defibrillator; Atrial Fibrillation; Cardiac Event; Cardiac Arrhythmia

Summary: this prospective multi-center randomized controlled study aims to compare atrial fibrillation detection and inappropriate therapy according to activation of atrial sensing capability in patients with implantable cardioverter defibrillator.

implantable cardioverter defibrillators(icd) therapy has been shown to reduce sudden cardiac death and improve survival in cardiac arrest survivors as well as in heart failure patients with left ventricular dysfunction. atrial fibrillation (af) is commonly found in icd implantation patients up to 50%. af is an independent predictor of mortality, inappropriate shock, and embolic events. therefore, early detection of af in patients with icd is essential for improving the quality of life and overall prognosis of the patients. conventional icds consist of a single chamber (sc) icd with a lead only in the right ventricle (rv) and dual chamber (dc) icd with each lead in the right atrium (ra) and rv. sc icd has the advantage of shorter procedure time, lower cost compared to dc icd. in contrast, dc icd has the advantage of being able to monitor atrial arrhythmic events, but complication rates were higher and additional cost and longer procedure time are usually required than sc icd. sixty percent of icd implantation patients who have are sc icd recently, a unique icd lead with atrial sensing ring capable of monitoring the atrial electrical signals has been developed \[intica 7 vr-t dx icd (biotronik., germany)\]. therefore, turning off the atrial sensing function makes it functionally the same as sc icd whereas turning on makes it function similar to dc icd without additional cost and procedure time. therefore, detection of af could be made earlier with vdd icd versus conventional sc icd without atrial sensing capability, providing a better chance to improve the prognosis of icd patients. however, no study exists which shows whether vdd icd is better for detecting atrial tachyarrhythmia than conventional sc icd. therefore, we designed a multicenter prospective randomized study comparing the af diagnostic efficacy of vdd icd (with atrial sensing 'on') against conventional sc icd. as the second phase, we also plan to compare inappropriate therapy rate according to atrial sensing status of vdd icd.

Eligibility criteria:
inclusion criteria: 1. age ≥ 19 years 2. indication for icd implantation according to guidelines 3. atrial fibrillation didn't detect by electrocardiogram or holter test within the past 1 year from the icd implantation, and 4. cha2ds2vasc score ≥1 point in male or ≥ 2 in female exclusion criteria: 1. persistent or permanent atrial fibrillation (af) 2. atrial fibrillation detected by electrocardiogram or holter test within the past 1 year from the icd implantation 3. history of the catheter or surgical ablation of af or taking antiarrhythmic drug 4. scheduled to undergo heart transplant within 1 year 5. life expectancy \< 1 year 6. requiring atrial pacing
study to test an approved product in the early treatment of migraine (0462-066)

Conditions: Migraine

Summary: the purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine.


Eligibility criteria:
inclusion criteria: * six month history of migraine; attacks typically mild when they begin with 1-4 migraine attacks per month. exclusion criteria: * heart disease * high blood pressure
the use of qst to characterize somatosensory functionality

Conditions: Pain

Summary: pain has a significant impact on quality of life and poses an enormous burden on the healthcare system. the subjective nature of pain complicates its mapping and treatment. quantitative sensory testing (qst) aims to characterize the somatosensory phenotype using calibrated stimuli and subjective thresholds. this set of procedures enables quantification of the somatosensory function in small fibers (thinly myelinated aδ and unmyelinated c), as well as large fibers (thickly myelinated aβ). in this way, sensory loss (hypoesthesia, hypoalgesia) or sensory gain (hyperesthesia, hyperalgesia, allodynia) can be detected. in this study, the inter-period reproducibility of thirteen qst parameters will be determined on the dominant hand, right forearm, right flank and lower back of 20 healthy volunteers.


Eligibility criteria:
inclusion criteria: * voluntary written informed consent has been obtained prior to any screening procedures. * subject is ≥ 18 years and ≤ 25 years of age. * subject is a non-smoker for at least 6 months before the start of the study. * subject has a body mass index (bmi) between 18-30 kg/m². * subject is in good general health, based on medical history and vital signs. exclusion criteria: * subject has a history of any illness which, in the investigator's opinion, might confound the results of the study, including conditions which affect the normal somatosensory functionality. * subject has eczema, scleroderma, psoriasis, dermatitis, or any other abnormality on the skin of the dominant hand, right forearm, right flank or lower back which, in the investigator's opinion, might interfere with the study assessments. * subject is unable to refrain from drinking alcohol 24 hours prior to each study visit, is currently a user of drugs, or has a history of alcohol and/or drug abuse. * subject is unable to refrain from drinking caffeinated beverages 24 hours prior to each study visit. * subject has used concomitant drugs and/or treatments that may interfere, in the investigator's opinion, with the study results. * subject is in a situation or has a condition which, in the investigator's opinion, may interfere with safe and optimal participation in the study. * female subject who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and is not using an adequate contraceptive method. * subject is participating in another trial which, in the investigator's opinion, might confound the results of the study.
insomnia in the patient with schizophrenic disorder: evaluation of a cbt and psychoeducational intervention

Conditions: Insomnia; Schizophrenia

Summary: the study aims to evaluate the efficacy of a cognitive behavioural and psychoeducational intervention in patients with insomnia and diagnosed with a schizophrenic disorder.

patients will be recruited by consecutive non-probabilistic sampling at the outpatient mental health centre of nou barris in barcelona and subsequently randomised into 2 groups, control and intervention. presence and severity of insomnia will be assessed through the following measurement instruments: isi for presence and severity, psqi for sleep quality and eq-5d for health-related quality of life. patients in intervention will attend 6 group sessions with cognitive behavioural and psychoeducational intervention and the control group will carry out the usual follow-up. pre-post, 6-month and 9-month assessments will be analysed.

Eligibility criteria:
inclusion criteria: * insomnia disorder (isi scale) * schizophrenic disorder exclusion criteria: * presence of severe psychopathological alteration * inability to understand the spanish language or difficulties writing or reading
gravitas-301: a study of itacitinib or placebo in combination with corticosteroids for treatment of acute graft-versus-host disease

Conditions: Graft-versus-host Disease (GVHD)

Summary: the purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with grade ii to iv acute graft-versus-host disease (agvhd).


Eligibility criteria:
inclusion criteria: * has undergone 1 allo-hsct from any donor (related or unrelated with any degree of hla matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. recipients of myeloablative and reduced-intensity conditioning regimens are eligible. * clinically suspected grade ii to iv agvhd as per magic criteria, occurring after allo-hsct and any gvhd prophylaxis regimen. * evidence of myeloid engraftment. use of growth factor supplementation is allowed. * serum creatinine ≤ 2.0 mg/dl or creatinine clearance ≥ 40 ml/min measured or calculated by cockroft gault equation. * willing to avoid pregnancy or fathering children. * able to give written informed consent and comply with all study visits and procedures. * able to swallow and retain oral medication. exclusion criteria: * has received more than 1 allo-hsct. * has received more than 2 days of systemic corticosteroids for agvhd. * presence of gvhd overlap syndrome. * presence of an active uncontrolled infection. * known human immunodeficiency virus infection. * active hepatitis b virus (hbv) or hepatitis c virus infection that requires treatment or at risk for hbv reactivation. * participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-hsct was performed. * any corticosteroid therapy for indications other than gvhd at doses \> 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization. * severe organ dysfunction unrelated to underlying gvhd, including: * cholestatic disorders or unresolved veno-occlusive disease of the liver. * clinically significant or uncontrolled cardiac disease. * clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen. * currently breast feeding. * received jak inhibitor therapy after allo-hsct for any indication. treatment with a jak inhibitor before allo-hsct is permitted. * treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment. * any medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.

Keywords: acute graft-versus-host disease janus kinase (jak) inhibitor itacitinib corticosteroids allogeneic hematopoietic stem cell transplant (allo-hsct)
serum biomarkers analysis in patients with ar treated with anti-tmf

Conditions: Rheumatoid Arthritis

Summary: multicenter, prospective, observational study for evaluating if circulant rheumatoid factor, cyclic citrullinated anti-peptide anti-bodies and albumin can be used as potential predictors in the response to the treatment with anti-tnf in patients with rheumatoid arthritis after 24 weeks of treatment.


Eligibility criteria:
inclusion criteria: * both genders * over 18 years old * diagnosis of rheumatoid arthritis according to acr criteria * patients that initiate treatment with anti-tnf drugs according to clinical practice, both in naïve anti-tnf patients and patients after first anti-tnf failure * patients able to follow the protocol requirements * patients that signed the informed consent exclusion criteria: * patients with known hypersensitivity to investigational products * patients with tuberculosis, or severe infections like sepsis or opportunistic infections * patients with moderate/severe cardiac insufficiency (nhya classification class iii/iv) * patients that according to the investigator criteria can not participate in the study or complete the study questionnaires * pregnant or fertile woman that does not use a contraception method
predicting response to systemic therapies for hepatocellular carcinoma(hcc)

Conditions: Hepatocellular Carcinoma Non-resectable; Effect of Drug

Summary: as the most common type of primary liver cancer, hepatocellular carcinoma (hcc) has become a big challenge all over the world. most patients are not available to curative resection when first diagnosed. there are a variety of treatment options for advanced hcc. however, due to the heterogeneity of hcc, the overall response rate (orr) is not high for systemic therapies. therefore, appropriate selection of patients who are suitable for individual systemic therapies is important for clinical decision-making.

although major achievements have been acquired in diagnosis and treatment, the prognosis of hepatocellular carcinoma (hcc) is still unsatisfactory. liver resection remains the main curative treatment for hcc, but most patients are at an advanced stage when first diagnosed, leading to be not available to curative therapies. there is a variety of treatment options for advanced hcc, such as transarterial chemoembolization (tace), hepatic artery infusion chemotherapy (haic), targeted therapy (sorafenib and lenvatinib), immunotherapy, and the combination of different therapies. however, due to the heterogeneity of hcc, different patients respond differently to systemic therapies. the the overall response rate (orr) is not satisfactory and most patients can not benefit from the systemic therapies. there is an urgent need to identify patients who are likely to have positive response to systemic therapies at the beginning before treatment. therefore ,we want to collect the clinical information of patients with advanced hcc treated with systemic therapies, including demographic data , laboratory index, histological features, radiomics data. patients are followed-up at a interval of 1 month after treatment, and the orr, overall survival (os), progression-free survival (pfs) are recorded. then the treatment response are evaluated and the relationship between the clinical data and efficacy of systemic therapies are explored by machine learning methods. then models based on clinical features or radiomics features are developed to predict response to different systemic therapies.

Eligibility criteria:
inclusion criteria: * clinically or pathologically diagnosed hcc * eastern cooperative oncology group performance status (ecog-ps) 0-2 * child-pugh score of ≤7 * complete clinical and follow-up information * evaluable efficacy after treatment * age between 18-80 years old exclusion criteria: * with other malignancies * eastern cooperative oncology group performance status (ecog-ps) \>2 * child-pugh score of \>7 * incomplete clinical data * lost to follow up * unevaluable efficacy after treatment * age \ 80 years old

Keywords: hepatocellular carcinoma systemic therapy immunotherapy tyrosine kinase inhibitor treatment response radiomics clinical characteristics machine learning
comparative trial of botox in the management of children with congenital muscular torticollis

Conditions: Torticollis

Summary: the primary purpose is to investigate the effect of botox on the treatment of congenital muscular torticollis (cmt). the investigators' hypothesis is that a botox injection will be an effective treatment when used in conjunction with current treatment procedures.

the babies that require a neck collar for cmt will be randomly placed into two groups. one group will receive standard treatment which includes physiotherapy and occupational therapy. the other group will receive standard treatment plus an injection of botox. the babies will be monitored to determine if one group has a more favorable outcome than the other in terms of range of motion, length of treatment time and number of required surgeries.

Eligibility criteria:
inclusion criteria: * infants diagnosed with cmt and referred by family physician, pediatrician or orthopaedic surgeon * initial assessment and initiation of treatment prior to 4 months of age * cervical spine radiograph, no focal bony abnormality * head tilt greater than 5 degrees at 5 months of age * lateral head righting past neutral in upright suspension * restricted neck range of movement in lateral flexion or rotation or both * signed consent form and willingness to participate in the study * compliance with attending bi-weekly follow-up appointments exclusion criteria: * any other diagnosis affecting tone or muscle function * any condition that would preclude an anesthetic * any vertebral abnormalities identified by radiograph * attending other health practitioners for treatment, i.e., massage therapist, chiropractor * any associated ocular problems as determined by a pediatric ophthalmologist

Keywords: botox torticollis congenital muscular torticollis (cmt)
medsma℞t mobile ed

Conditions: Opiate-Related Disorders; Opiate Use Disorder; Opioid

Summary: the goal of this clinical trial is to learn if a new smartphone-based intervention can help with factors related to opioid misuse in parents and adolescent/early adult children. the main question it aims to answer is: • can this intervention improve knowledge of, and attitudes towards, opioid misuse over traditional opioid-related counseling alone? participants will, in addition to receiving opioid counseling: * join an online meeting with research staff to test the smartphone-based intervention * report demographic information * complete surveys about opioids * complete a family medication safety plan * complete surveys after 3, 6, and 9 months


Eligibility criteria:
inclusion criteria: * adults who receive an opioid prescription from a study emergency department, and * who report having an adolescent, aged 12-18, living at home, and * who speak and understand english * each participant must have the ability to provide informed consent exclusion criteria: * adults who do not receive an opioid prescription from a study emergency department and/or * who do not have an adolescent, aged 12-18, living at home, and/or * who do not speak or understand english * adults and/or adolescents who do not have the ability to provide informed consent

Keywords: opioid education opioid use disorder opiate-related disorders opiate opioid serious game smartphone smartphone game medication safety adolescent health
clinical study of the cardiofocus endoscopic ablation system - adaptive contact (eas-ac) for the treatment of symptomatic atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation

Summary: this is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.


Eligibility criteria:
inclusion criteria: * 18 to 70 years * paroxysmal atrial fibrillation * failure of at least one aad * others exclusion criteria: * overall good health as established by multiple criteria

Keywords: atrial fibrillation paf