Kornimate/medical-research-clean huggingface dataset:
norwegian constraint-induced (ci) therapy multisite trial

Conditions: Cerebrovascular Accident

Summary: the purpose of this study is to determine whether modified ci therapy treatment is suitable and effective in the early rehabilitation after stroke, and to compare early ci intervention with a later ci intervention group.


Eligibility criteria:
inclusion criteria: * stroke at more than 5 and less than 26 days ago.(either first stroke or second stroke without detectable arm weakness after the first stroke). * modified ranking scale 0-2 before admission * persistent unilateral arm or hand paresis (scandinavian strokes scale (sss) arm motor function 2-5 or sss hand motor function 2-4) * able to lift two fingers with the forearm pronated on the table or able to extend the wrist at least 10 degrees from fully flexed position. * able to follow a two step command. * mini mental state examination score of more than 20 (or more than 16 in combination with expressive aphasia) exclusion criteria: * modified rankin scale \> 4 * unable to give informed consent * large hemispatial neglect (more than two cm on the line bisection test) * not expected to survive one year due to other illnesses (eg cardiac, malignancy) * injury or condition in the affected upper extremity that limited use prior to the stroke. * other neurological condition affecting motor function
transcutaneous auricular vagus nerve stimulation prevents postoperative delirium in elderly patients

Conditions: Vagus Nerve Stimulation

Summary: according to the 3d-cam scale, evaluate the incidence of postoperative delirium within 5 days after surgery in elderly patients receiving tavns.the results are expected to provide evidence of the safety and efficacy of perioperative prophylactic use of tavns in the clinical application of improving postoperative brain health in elderly patients, as well as theoretical and practical basis for subsequent studies or clinical applications.

this study aims to conduct a prospective, randomized controlled clinical trial on the preventive use of tavns to improve the incidence of postoperative delirium(pod) in elderly patients undergoing anesthesia surgery. the intervention group will receive "standard-stimulation parameters" of tavns（25hz，250μs）, while the control group will receive "low-stimulation parameters" of tavns(1hz,250μs). the main outcome measure of the study was the incidence of pod within 5 days after surgery. secondary outcome measures include incidence of new mild and severe postoperative neurocognitive impairment during hospitalization and 90 days, all-cause mortality rate at 90 days, incidence of related adverse events, and length of stay.

Eligibility criteria:
inclusion criteria: * age≥65 years * expected operation time≥ 2 hours * postoperative hospital stay≥ 4 days * sign the informed consent form exclusion criteria: * neurosurgery or cardiac surgery * emergency surgery within 6 hours of admission * end-stage disease with an expected survival of \< 3 months * preoperative severe cognitive dysfunction affected perioperative cognitive function assessment * severe sinus bradycardia, avb of degree ii and above, pacemaker placement
epidemiologic, clinical, molecular characteristics of hospital employees with or without covid-19 infection

Conditions: COVID

Summary: the study cohort will be enrolled among all humanitas group employees (including ich, humanitas university and gavazzeni), and two validation cohorts. participants will be asked consent for the research use of blood, pharyngeal swab, and for those hospitalized for covid-19, also for the bronchoalveolar lavage and fecal samples. biological samples will be used to perform cellular, microbial and molecular analyses aimed at better understanding the disease pathogenesis and the individual differences in susceptibility to the disease.

the analysis will include: * study the expression levels of molecules known to mediated viral infection, like the angiotensin converting enzyme 2 (ace2) and genetic variants in these genes, which could be related to susceptibility to the viral infection and/or to the severity of the clinical course of the disease * compare the frequency of genetic variants potentially related with covid-19 susceptibility/severity in different subgroups of patients, ranging from individuals positive for the virus but asymptomatic to individuals affected by covid-19 with ards requiring admission to icu * germline dna analysis to search for genetic factors predisposing or protecting against severe pulmonary affection in covid-19 infected participants. to this aim dna will be analyzed by a gwas (genome wide association study) approach by using the gsa illumina chip. the obtained data will also be used to try to develop a polygenic risk score to stratify individuals with a particularly high or low risk for severe disease course * explore the contribution of rare variants by studying the exome * sepsis and ards biomarkers developed at ich (e.g. ptx3, sil-1r2, msf) analysis to address their prognostic potential in covid-19 patients * pbmc analysis by facs to investigate the immunophenotype and correlate it to the clinical outcome * microbiota analysis of residual bal and pharyngeal swab to evaluate whether different microbial or metabolome profiles are associated to worsen disease or to protection * plasma and saliva/sputum test for anti-sars-cov-2 antibodies (igm, igg, ige and iga) and for microbiota analysis

Eligibility criteria:
inclusion criteria: * 1. individuals aged ≥ 18 years; exclusion criteria: * 1. lack of informed consent according to local procedure per critically ill patients.
milrinone inhaled in cardiac surgery

Conditions: Valvular Stenosis; Valvular Insufficiency; Hypertension, Pulmonary; Coronary Artery Disease

Summary: pulmonary hypertension is an important morbidity factor in patients having to undergo cardiac surgery with cardiopulmonary bypass (ecc). milrinone used in inhalation, shows evidence of being a pulmonary vasodilator able to possibly contribute to the reduction of pressure on the pulmonary artery.

this controlled, randomized, double-blind study will aim at confirming the efficiency as well as the security of milrinone, used in inhalation, to diminish the degree of pulmonary hypertension before the cardiopulmonary bypass (ecc) circulation. in addition, the pharmacokinetic and echo graphic repercussions of administering the medication will be analysed. at the present time, there is no data on the pharmacokinetics of the medication when it's administered through inhalation. for this reason, we would like to study the serous rate of the medication in the minutes following its administration through inhalation.

Eligibility criteria:
inclusion criteria: * adult patients scheduled for elective valvular or complex (2 or more valves or * valve and revascularization) cardiac surgery under cpb with preoperative pht defined as mean pulmonary artery pressure (mpap) over 30 mmhg or * systolic pulmonary artery pressure (spap) over 40 mmhg (using preoperative right-sided catheterization or estimated by echocardiography). exclusion criteria: * cardiac surgery not requiring cpb, contraindication to tee (esophageal pathology or unstable cervical spine) and emergency surgery. * patients will be recruited the day before surgery and randomized using computerized cards by the pharmacy department

Keywords: valvular surgery pulmonary artery pressure
efficacy of liquid versus powder protein supplementation to optimize protein intake after bariatric surgery

Conditions: Body Composition; Obesity; Protein Supplementation; Bariatric Surgery Candidate; Weight Loss

Summary: the goal of this randomized control trial is to compare the effect of a liquid formula rich in nutrients and low in calories (supplement) with the progressive diet with conventional foods that we usually recommend in patients after surgery. the main question it aims to answer is if the addition of a high-protein, volume-controlled nutritional supplement as a fundamental part of the diet during the first two months after surgery will preserve the patient's nutritional status and prevent the appearance of nutritional deficits and associated complications. participants will be evaluated at the beginning, at 1 month and at the end of the study (2m) and the following determinations will be made: * analytical determination * nitrogen balance by determining urea n2 in 24-hour urine * anthropometric determinations * body composition determined by impedanciometry * resting energy expenditure and nutrient oxidation measured by indirect calorimetry. * energy, protein and hydration intake. * gastrointestinal tolerance through self-registration of symptoms. researchers will compare the effect of a complete hypocaloric liquid formula group with the usual progressive diet group to see if they achieve the protein intake goal established for patients after obesity surgery, preservation of nutritional status and lean mass during the rapid phase of weight loss and the gastrointestinal tolerance during the first two months after surgery.


Eligibility criteria:
inclusion criteria: patients of both sexes between 18 and 65 years of age undergoing bariatric surgery in our center with the ability to understand the objectives and proposals of the study that they agree to participate in the study. exclusion criteria: patients who have had perioperative complications and who require an extended hospital stay patients who after the intervention require some type of artificial nutritional support patients who have undergone a surgical technique other than bpg.
teneligliptin versus linagliptin in diabetes mellitus type two patients

Conditions: Type2 Diabetes Mellitus

Summary: to assess the efficacy and safety of teneligliptin and linagliptin in the type 2 diabetes mellitus patients.

a randomized, open label, parallel-group, non-inferiority, active-controlled, phase iv study

Eligibility criteria:
inclusion criteria: * patients who are 19 years or older on screening * patients with type 2 diabetes mellitus * patients with 7.0% ≤ hba1c ≤ 11.0% at the screening visit * patients with fasting plasma glucose \<15mmol/l(270mg/dl) on screening exclusion criteria: -
assessing induction of type ii (m2) monocytes/macrophages in patients receiving gilenya.

Conditions: Multiple Sclerosis

Summary: in this study we wish to test the hypothesis that continuous gilenya treatment alters immune homeostasis in favor of an anti-inflammatory type ii monocyte and macrophage (m2) phenotype in the circulation of patients with relapsing-remitting multiple sclerosis (ms). in this study we will determine the change in ratio of m2 (type ii, alternatively activated) versus m1 (type i, classically activated) monocytes and macrophages in a cohort of patients that have received continuous gilenya treatment for 0, 1, 3, 6 or 12 months. we will also assess changes in cell surface expression of the m1 marker ccr7 and the m2 markers cd206 or cd301 by monocytes and macrophages using facs analysis of whole blood, and assess the tyrosine phosphorylation of the signal transducer and activator of transcription stat-1 (ptyr-stat1), which is critical for the activation of m1 myeloid cells. we will assess correlates with changes in m1 and m2 cytokine expression assessing possible mechanisms of action of gilenya on myeloid lineage cells.


Eligibility criteria:
inclusion criteria: * patients must qualify to receive treatment with gilenya, according to the university of southern california, department of neurology, ms group, gilenya prescribing process. * clinically definite multiple sclerosis defined by the revised mcdonald criteria (polman et al., 2005, polman et al., 2010) of the relapsing-remitting form with an expanded disability status scale (edss) score of 0 to 5.5. * ability to understand and sign this study-specific institutional review board-approved informed consent form. * willing to donate \~50mls of blood for immunological testing on up to five occasions. exclusion criteria: * patient does not qualify to receive treatment with gilenya, according to the usc, department of neurology, ms group, gilenya prescribing process. * inability to understand nature of the study. * treatment with any of the following within 30 days of commencing treatment with gilenya: avonex, betaseron, rebif, copaxone, natalizumab, rituximab, mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate or any other immunomodulatory, immunosuppressant or immune homeostasis altering drug.
elbow outcomes clinical study (welbow)

Conditions: Orthopedic Disorder

Summary: welbow study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, post-market clinical follow-up (pmcf).

welbow study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, post-market clinical follow-up (pmcf). outcome data collected from this study will provide the basis for post-market surveillance (pms) reporting, clinical study report (csr) and clinical evaluation report (cer) on elbow system devices and support peer-reviewed publications on long-term product performance and safety.

Eligibility criteria:
inclusion criteria: * 18 years or older at the time of the informed consent or the non-opposition (when applicable). * informed and willing to sign an informed consent form approved by irb or ec (when applicable). * willing and able to comply with the requirements of the study protocol. * for prospective inclusion: considered for treatment with one wright medical elbow arthroplasty or fracture devices included in this study (primary or revision). * for ambispective inclusion 1. must have undergone an elbow arthroplasty or fracture with one wright medical elbow studied device between the date of the first site initiation visit (siv) and until 4.5 years prior this one in order to have at least the 5 years follow-up visit prospectively. ambispective patients who were explanted prior the date of the first siv will be included. 2. must have complete information available for each completed visit (demographics, preoperative information, surgery information, device details)\*. exclusion criteria: * not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times). * patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a legally authorized representative (lar), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the iso 14155:2011 norm). * patient with previous elbow device(s) which remain(s) implanted.

Keywords: orthopedic surgery elbow trauma arthroplasty osteosynthesis
comparison of biodegradable & metal plates for fixing ankle fracture

Conditions: Distal Fibular Fracture; Bimalleolar Fracture; Trimalleolar Fracture

Summary: a randomised, prospective clinical investigation to compare post-operative fracture healing and complication rate after the fixation of ankle fractures using the inion otps freedomplatetm biodegradable fixation system versus conventional stainless steel metal screws and plates. the objectives of the investigation are * to compare post-operative fracture healing (union rates, time-to-union), and the complication rates (hardware failure, infection) between the two plating systems (biodegradable inion otps freedomplatetm vs. stainless steel 3.5 reconstruction or dcp plate, or 1/3 semitubular plates) at the clinical setting of ankle fractures * to study the safety of the clinical application of the biodegradable plating system of inion otps freedomplatetm at the acute ankle fracture setting.


Eligibility criteria:
inclusion criteria: 1. patient is willing and able to understand, sign and date the study-specific, institutional review board/ethics committee approved patient informed consent and applicable privacy regulations. 2. patient must require surgical treatment of a ankle fracture, with a distal fibular (i.e., lateral malleolus) fracture (isolated, closed, unilateral, non-comminuted) including either instable/dislocated weber class b or any weber class c fracture that cannot be anatomically reconstructed accurately without open procedure, or bimalleolar fracture with lateral malleolus fracture (as described above) and medial malleolus fracture (closed, unilateral, non-comminuted), or trimalleolar fracture with lateral and medial malleolus fractures as described above and posterior malleolus fracture with less than ¼ of the articular surface fractured 3. fresh/acute fractures (seen within seventy-two hours of the injury) 4. aged between 18 to 60 years 5. skeletally mature 6. willingness to accept randomisation either to the test or control group 7. willingness and ability to comply with all investigation procedures pre- and post-operation. exclusion criteria: 1. contraindications of operative internal plate fixations 2. contraindications for the inion otps freedomplatetm biodegradable fixation system: * active or potential infection * patient's conditions, including limited blood supply, insufficient quantity or quality of bone, and where patient cooperation cannot be guaranteed (e.g., alcoholism, drug abuse) * high-load bearing applications 3. multiple trauma, head injury, bilateral lower extremity fractures, upper extremity fractures 4. any concomitant painful or disabling disease of the lower limb that would interfere with evaluation of the affected ankle 5. previous ankle fracture 6. patients who most likely will not learn to walk with crutches (e.g., due to being severely overweight) 7. bone malignancy 8. osteomyelitis

Keywords: retrospective comparison biodegradable implant ankle fracture
establishment and clinical assessment of a prostate cancer (pca) risk model based on the updated circulating tumor cell (ctc) detection technique

Conditions: Prostatic Neoplasms; Prostatic Adenoma

Summary: 1. to elucidate the role of ctc detection in the evaluation of risk level in pca patients, and establish a mathematic model for predicting the pathological status. 2. to explore the possible subtle change in ctc condition after radical prostatectomy.

1. detect and evaluate the ctc status (a total of 3 times: 1 day before sugery, 3/12 months after surgery) for all of the pca patients enrolled. analyze the ctc result with psa level, needle biopsy and radiological imaging information. 2. analyze the difference in ctc amount/epithelial-mesenchymal ratio between patients in different d'amico risk level(low/intermediate/high). 3. establish a mathematic model based on the ctc results and pathological condition observed in operation (oc, organ confined; epe, extraprostatic extension; svi, seminal vesicle invasion; lni, lymph node invasion), and compare this model with the latest version of partin table. 4. detect and compare the ctc and psa level 3/12 months after surgery. evaluate the radiological condition in 12 months after blood draw.

Eligibility criteria:
inclusion criteria: 1. diagnosed with pca by biopsy, for the first time. 2. clinical assessed suitable for radical prostatectomy 3. age ≥ 18 years, able to provide written informed consent 4. no prior systematic or regional treatment for pca. 5. no neuro-endocrine differentiation or small cell pca pattern. 6. ecog status 0-1 7. expected life span ≥ 12 months. 8. multiorgan function (heart, lung, liver, kidney) able to tolerate radical prostatectomy, and meet the standard of this study. exclusion criteria: 1. severe concomitant disease or infection. 2. alt or ast \> 2.5 uln, or total bilirubin \> 1.5 uln; creatinine \>177umol/l(2.5mg/dl)；plt \< 100,000/ul, neutrophil \<1,500/ul. 3. known or suspected brain metastasis or leptomeningeal carcinomatosis. 4. another malignancy in the last 5 years, excluding completely cured melanoma. 5. severe cardiovascular disease, including: myocardial infarct within 6 months; uncontrolled angina pectoris within 3 months; congestive heart failure; ventricular arrhythmia history with clinical significance; morbiz type ⅱ or complete heart block 6. major surgery (general anesthesia) within 4 weeks.

Keywords: circulating tumor cell epithelial to mesenchymal transition prostate specific antigen (psa) partin table
gallium ga 68-labeled psma-11 pet/ct and fluciclovine f18 pet/ct in imaging participants with recurrent prostate cancer after surgery

Conditions: Recurrent Prostate Carcinoma

Summary: this phase ii trial compares how well gallium 68-labeled psma-11 positron emission tomography/computed tomography (pet/ct) works compared to fluciclovine f18 pet/ct in imaging participants with prostate cancer after surgery that has come back. pet is an established imaging technique that uses small amounts of radioactivity and ct images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. diagnostic procedures, such as pet/ct with gallium 68-labeled psma-11, may work better than pet/ct with fluciclovine f18 in helping find out how far the prostate cancer has spread.

primary objectives: i. to compare the detection rates of gallium 68-labeled psma-11 (\[68\]ga-psma-11) pet/ct and fluciclovine f18 (axumin) pet/ct for the identification of tumor location(s), by patient and region based analysis. secondary objectives: i. detection rate on a per-patient basis of (68)ga-psma-11 pet/ct and axumin pet/ct, stratified by prostate-specific antigen (psa) value (0.2 - \< 0.5; 0.5 - \< 1.0; 1.0 - \< 2.0). ii. sensitivity and positive predictive value (ppv) on a per-patient basis, of (68)ga-psma-11 pet/ct and axumin pet/ct for the detection of tumor location(s), confirmed by histopathology/biopsy and/or clinical and conventional imaging follow-up. iii. agreement among the readers, separate for (68)ga-psma-11 pet/ct versus axumin pet/ct. outline: participants receive (68)ga-psma-11 intravenously (iv) and 60-90 minutes later, undergo pet/ct imaging over 3 hours. participants also undergo best standard of care axumin pet/ct within 2 weeks before or after (68)ga-psma-11 pet/ct. after completion of the pet/ct scan, participants are followed up between 1 and 3 days and up to 12 months.

Eligibility criteria:
inclusion criteria: * histopathologically proven prostate cancer (pca) * radical prostatectomy as definitive treatment for pca * proven biochemical recurrence as defined by american urological association (aua) recommendation: psa greater than or equal to 0.2 ng/ml measured more than 6 weeks after radical prostatectomy * psa values ranging from 0.2 ng/ml to 2 ng/ml * no prior salvage therapies (including salvage radiotherapy and/or salvage lymph node dissection) * axumin pet/ct scan already performed or scheduled as best standard of care procedure for suspected disease relapse within 2 weeks before or after intended 68ga-psma-11 pet/ct * karnofsky performance status of ≥ 50 (or eastern cooperative oncology group (ecog)/world health organization \[who\] equivalent) * ability to understand a written informed consent document and the willingness to sign it exclusion criteria: * any change in prostate cancer treatment between axumin and 68ga-psma pet/ct scan * unable to lie flat, still or tolerate a pet scan
awareness of systemic diseases and its dental implications

Conditions: Dental Awareness of the Relation Between Systemic Disease and Oral Health Conditions

Summary: implications of systemic diseases on oral health and their manifestation

systemic diseases have oral manifestations and these oral manifestation may affects the treatment plan and may affect the drugs given after dental treatment hence the study aims to assess the awareness and knowledge of systemic diseases and its implications in the dental field

Eligibility criteria:
inclusion criteria: * dentists working for egyptian ministry of health - cairo. * dental interns of cairo university. exclusion criteria: * those who refused to share information. * candidates who refused to sign consent.