Kornimate/medical-research-clean huggingface dataset:
imatinib and bl-8040 (novel anti cxcr4 antagonist) for improving molecular response in chronic myelogenous leukemia

Conditions: Chronic Myeloid Leukemia

Summary: the aim of the study is to test the safety and efficacy of bl-8040 (a cxcr4 antagonist) in improving the response to imatinib in cml patients not achieving an optimal response with imatinib alone.

to improve cytogenetic and molecular response of cml patients receiving imatinib, who have not achieved an optimal response according to european leukemianet (eln) definitions , or mr4 after 24 months with imatinib. this will be achieved by addition of the cxcr4 antagonist bl-8040, mobilizing cml leukemia stem cells from their protective bone marrow niche and exposing them to imatinib and bl-8040-mediated apoptosis.

Eligibility criteria:
inclusion criteria: 1. adult men and women subjects aged 18 to 70, inclusive. 2. confirmed diagnosis of chronic phase cml according to the who criteria (who 2008) 3. cml patients with sub-optimal response to tyrosine kinase inhibitors, defined as "warning" in the eln recommendations: following 3 months: bcr-abl1 \> 10%, and/or ph+ 36-95% following 6 months: bcr-abl1 1-10%, and/or ph + 1-35% following 12 months: bcr-abl1 0.1-1 % following 24 months: less than mr4 4. clinical laboratory values should be as follows: white blood cell count \< 30 x 10\*9/l creatinine \< 1.5 uln 5. women of childbearing potential and all men must agree to use approved form of contraception 6. subject is able and willing to comply with the requirements of the protocol. 7. subject is able to voluntarily provide written informed consent. exclusion criteria: 1. cml patients not in chronic phase. 2. cml patients receiving tyrosine kinase inhibitors other than imatinib. 3. cml patients receiving imatinib \> 400 mg/day. 4. patients not able to sign informed consent. 5. known allergy or hypersensitivity to any of the test compounds or materials or contraindication to test product. 6. low performance status (ecog \> 2). 7. abnormal liver function tests: 1. serum aspartate transaminase (ast/sgot) or alanine transaminase (alt/sgpt) 2 x upper limit of normal (uln). 2. serum bilirubin. total bilirubin \> 2.0 mg/dl (34 µmol/l), conjugated bilirubin \> 0.8 mg/dl 8. abnormal left ventricular ejection fraction, \< 40 %. 9. subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to: 1. subject has been diagnosed or treated for another malignancy within 3 years of enrolment, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy 2. a co-morbid condition which, in the view of the investigators, renders the subject at high risk from treatment complications. 10. women subjects who are pregnant or breastfeeding.

Keywords: chronic myeloid leukemia imatinib cxcr4 antagonist bl-8040
botulinum toxin type a block of the sphenopalatine ganglion in trigeminal neuralgia. safety issues.

Conditions: Trigeminal Neuralgia; Headache Disorders

Summary: trigeminal neuralgia is one of the strongest pains known to humans. some patients do not have enough effect with the available pharmaceutical treatments and are offered surgery. there are different types of procedures and most of them are complex with a risk for complications. the researchers want to start a pilot study on 10 patients with a new surgical technique using neuronavigation. the target will be a neural structure (sphenopalatine ganglion) which has an important role in facial pain. there have been a few trials trying to block this structure in trigeminal neuralgia, but none using this new approach with botulinum toxin. the researchers technique requires local anesthesia only (awake patient). the researchers believe that this treatment can become a "low threshold"-treatment for patients who do not have enough effect with pharmacological treatment and a better alternative to other complex surgical approaches. using this new neuronavigation system the researchers can reach this neural structure with high precision.


Eligibility criteria:
inclusion criteria: * informed and written consent * trigeminal neuralgia defined in international classification of headache disorders (ichd)-3 criteria * unsatisfactory effect of pharmacological treatment exclusion criteria: * microvascular decompression is seen as a better alternative * heart or lung disease * any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection * psychiatric illness that hinders participation in the study * known pregnancy or breast feeding * inadequate use of contraceptives * overuse or abuse of opioids * abuse of medications, narcotics or alcohol * anomalies which hinder or impede the used method of injection * allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type a, botox or any of it's constituents or any other related medication * treatment with medication that can interact with botulinum toxin type a

Keywords: nerve block sphenopalatine ganglion block botulinum toxins, type a
resonance breathing training for long covid-related myocardial injury

Conditions: Long COVID; Myocardial Injury

Summary: an investigation of the efficacy of resonance breathing training in the rehabilitation of patients with long covid-related myocardial injury


Eligibility criteria:
inclusion criteria: 1. age between 18 and 60 years; 2. according to the who definition: one or more systemic involvement present 3 months after the diagnosis of a new crown infection, and at least 2 of these months cannot be explained by other diseases 3. 2d-ste suggestive of glsavg: -17% ≤ men ≤ -10%, -18% ≤ women ≤ -10%; 4. consent for enrollment based on the degree of myocardial injury, as diagnosed by a clinician; 5. signing the informed consent form with the consent of the patient or his/her family members exclusion criteria: * (1) previous history of coronary atherosclerotic heart disease and heart failure; (2) combination of severe arrhythmia or cardiogenic shock; (3) combination of severe hypertension, hypertrophic cardiomyopathy, valvular disease of moderate or higher grade, acute myocarditis or pericarditis; (4) combination of any disease that severely affects limb movement, such as musculoskeletal system disease or severe hepatic or renal insufficiency; (5) combination of progressive malignant tumors, infectious diseases, bleeding disorders, autoimmune diseases, etc; those who have serious mental illness and are unable to cooperate

Keywords: 2d-ste resonance breathing myocardial injury long covid-19
recap total hip resurfacing prospective data collection

Conditions: Arthritis

Summary: prospective data collection on survivorship of recap total hip resurfacing

detailed protocol not available

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hip joint arthritis exclusion criteria: - less than 18 years of age
study on diagnosis value of mngs technology among diabetic patients with pulmonary infections

Conditions: Diabetes Mellitus; Pulmonary Infection

Summary: focusing on patients with diabetes complicated with pulmonary infection, the purpose of this study is: 1) to identify the epidemiology, etiologic spectrum and status of diagnosis and treatment; 2) to explore the lower respiratory microenvironment and host immune response and then make an application in clinic.

investigators perform a cross-sectional multicenter study on patients with pulmonary infection. all patients receive clinical questionnaires, laboratory examinations and treatment monitoring. routine clinical pathogen culture and mngs are both carried out on pathogen detection. among participants in idseq ultratm group, 1:2 nested case-control study is carried out involving 77 cases from pulmonary-infected group paired with 154 control cases and peripheral blood rna-seq is carried out between pneumonia patients with diabetes and pneumonia patients without diabetes matched for gender, age and fasting blood-glucose. the final purpose is to find out the difference in etiologic spectrum and host immune on lower respiratory infection between diabetes patients and controls. now investigators wish to register this study to do a further research, in order to improve the diagnosis value of diabetes complicated with pulmonary infection and to reduce the mortality.

Eligibility criteria:
inclusion criteria: * diagnosis by pathogen examination: positive * diagnosis through x-ray or ct: characteristic features of pulmonary infection * age older than 18 years exclusion criteria: * irregular follow-up and lost follow-up * withdraw from the study for any reason

Keywords: pulmonary infection diabetes mellitus mngs host immune response
use of echocardiography in the evaluation of chest pain in the emergency department

Conditions: Chest Pain

Summary: chest pain is one of the most common complaints that brings a patient to the emergency department (ed). the differential diagnosis of chest pain is broad and includes cardiac as well as non-cardiac diseases. one of the initial goals in the ed evaluation of a patient presenting with chest pain is to rapidly and accurately diagnose the presence or absence of acute coronary syndrome. the diagnostic accuracy of the initial routine evaluation is often limited and results in frequent admissions for patients presenting with chest pain for further diagnostic testing. echocardiography has a high sensitivity and specificity for the diagnosis of acute myocardial infarction. tissue doppler imaging with strain and strain rate (sr) measurement is a new echocardiographic technique, which enables accurate assessment of regional left ventricular systolic and diastolic function. prior studies have shown that abnormal strain and sr are highly sensitive markers of ischemia. acute ischemia induces early systolic thinning and a delay in the onset of systolic thickening, a progressive decrease in the rate and degree of maximal systolic thickening, and an abnormal ischemia-related thickening which occurs after aortic valve closure. a major obstacle to the routine use of echocardiography in the ed is the need for portable studies, using heavy, bulky portable echo machines. there are currently available portable hand-held echo machines (ge-vivid i) that produce high quality images and offer an opportunity to incorporate echocardiography into routine practice in the ed. this study will use of early, portable echocardiography, with detailed assessment of wall motion and left ventricular function by strain and strain rate measurements, for the evaluation of chest pain in the ed. it is hypothesized that an early with detailed left ventricular function assessment will be highly sensitive and specific for the diagnosis of myocardial ischemia, and will enable rapid triage of patients who present to the ed with chest pain.


Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. chief complaint on presentation to ed: chest pain 3. differential diagnosis includes acute coronary syndrome as determined by the emergency physician or admitting attending. 4. admission to the hospital required for further cardiac work up. exclusion criteria: 1. obvious noncardiac cause of the chest pain 2. patient requires urgent intervention before echo can be obtained 3. failure to obtain informed consent

Keywords: chest pain echocardiography strain imaging
pulmonary rehabilitation in copd: effects of two aerobic exercise intensity in patient-centered outcomes

Conditions: Chronic Obstructive Pulmonary Disease

Summary: trial design: an equivalence/non-inferiority randomized controlled trial with parallel group design studied the effect of two aerobic exercise-training intensities in copd patient-centered outcomes. methods: thirty-four copd clinically stable patients stratified from mild to very severe gold stages, were blinded to 60 or 80%wmax aerobic exercise training intensity in an outpatient pulmonary rehabilitation program, between 2009-2010. outcomes were assessed with st.george's respiratory questionnaire (primary outcome), mahler dyspnea index, london chest activity of daily living scale, 6-minute walk, constant load and incremental exercise tests. patient's allocation sequence was computer-generated, with consignment in a safe deposit box.


Eligibility criteria:
inclusion criteria: * clinically stable copd * fev1/fvc \< 70% * exercise training medical referral exclusion criteria: * unable to attend 3-times/week program * infectious disease * metastatic cancer * unstable heart disease * neuromusculoskeletal disorder * cognitive or psychiatric disorder

Keywords: chronic obstructive pulmonary disease copd pulmonary rehabilitation aerobic exercise cedoc fcm unl nova medical school
single dose cefepime versus cefuroxime plus metronidazole as a prophylactic antibiotic during emergency intrapartum cesarean section

Conditions: Emergency Cesarean Section; Infection Wound

Summary: compare between cefepime versus routine antibiotics as a prophylactic antibiotic during emergency cesarean section in a tertiary center of obstetric care

this is a randomized double blinded study which compare between single dose cefepime versus cefuroxime plus metronidazole during emergency intrapartum cesarean section. outcomes will include fever, wound infection, and urinary tract infection.

Eligibility criteria:
inclusion criteria: * intrapartum caesarean section exclusion criteria: * evidence of infection

Keywords: cefepime, cefuroxime, metronidazole, cesarean, intrapartum
evaluation of the autonomic nervous system during first-dosing with 0.5mg of fingolimod (gilenya) in patients with relapsing-remitting ms

Conditions: Multiple Sclerosis; Autonomic Nervous System Dysfunction

Summary: this study is designed to primarily evaluate the impact of gilenya (fingolimod) on the autonomic nervous system in patients being treated for the first time with gilenya (fingolimod). effects on the cardiovascular system will be studied as well. the study is conducted to answer the question, if, and if yes, what impact the treatment with gilenya (fingolimod) has on the autonomic nervous system. to our knowledge little is known about the effects of gilenya (fingolimod) on the autonomic nervous system. we do know of rare, but potentially clinically and therapeutically relevant cardiovascular adverse events of gilenya (fingolimod). from a scientific point of view the mechanisms by which this is mediated are of interest. maybe a better understanding of these mechanisms might even be of clinical relevance (e.g. risk stratification). the impact of gilenya (fingolimod) on the autonomic nervous system is quantitavely measured, using a state-of-the-art technique. non-invasive blood pressure measurement is performed with the finometer pro (finapres medical systems, nl) under different paradigms (breathing at rest, deep breath, valsalva maneuver, active standing). in addition the sympathetic skin reaction is performed. the non-invasive blood pressure measurements are done by continuous, plethysmographic blood pressure measurement at the index finger, while the patient is performing the tasks mentioned above. by interpreting the blood pressure curve, heart rate and blood pressure variability are calculated. the sympathetic skin reaction consists of measuring the change of electric conductibility of the skin (palms and soles) after an electric stimulus of a peripheral nerve. these parameters allow to assess the functionality of four important autonomic functional systems (orthostasis, sympathetic adrenergic, sympathetic cholinergic, parasympathetic cholinergic). normative data has been acquired in our lab. our hypothethis is, that there will be a change of heart rate variability at t4,5h compared to baseline (t0) for the parameter "rmssd" under "normal breathing".


Eligibility criteria:
inclusion criteria: * indication for treatment with gilenya according label * treatment with gilenya intended * no contraindications for the treatment with gilanya * all safety-aspects have been fullfilled * age between 18 and 60 years * written consent is given exclusion criteria: * relapse during the last 30 days befor randomization * steroids within 30 days before randomization * heart rhythm disturbance * new or currently changed dose (last 4 weeks) of bata-blockers, calcium antagonists, antidepressants or antiarrhythmics * diabetes mellitus * polyneuropathy * missing consent * pregnancy * lactation period

Keywords: relapsing remitting multiple sclerosis fingolimod gilenya autonomic nervous system
optimal duration of olanzapine add-on therapy in major depression

Conditions: Relapse Rate of a Major Depressive Episode; Safety of Olanzapine in Subjects With Major Depression

Summary: evaluation of olanzapine versus placebo in the continuation therapy of subjects with major depression who had a response with additional olanzapine to an antidepressant.


Eligibility criteria:
inclusion criteria: * informed consent * age 18 - 80 * diagnosis of major depression according dsm-iv, unipolar course * hamilton-depression-rating-scale (17 item score) \> 18 prior to inclusion * response towards therapy with antidepressant and olanzapine as defined \> 50 % reduction of hamdd score * negative pregancy test * highly effective contraceptive method in women * no participation in other trial according to german drug laq * normal liver function exclusion criteria: * pregnancy, lactation * depressive episode secondary to somatic disease or substance dependency * contraindication for olanzapine * treatment with interacting substances (cyp1a2 inhibitors or inductors) * comorbidity according to dsm-iv, axis i * denail of consent * hospital treatment by legal order * hepatic insufficiency * severe neurological or medical disease * adipositas permagna * hiv-infection * active viral hapatitis

Keywords: major depression olanzapine add-on therapy antidepressant atypical antipsychotic
assessment of patients' pain and anxiety during a hysterosalpingography narratified by a virtual reality helmet (daphné)

Conditions: Salpingography; Virtual Reality Exposure Therapy; Virtual Reality; Pain; Anxiety

Summary: compare the maximum pain and anxiety experienced between the group using a virtual reality headset and the control group in an adult woman during a hysterosalpingography examination

in france, 1 couples out of 5 consults for suspected infertility. hysterosalpingography is the first line diagnostic examination in this course and can sometimes be therapeutic. this gynecological examination is invasive in nature, this exam requires an administration of iodinated contrast product by the endocavitary route. hysterosalpingography is the most painful examination in this treatment path and pain's assessment is classified as strong by the french national authority for health (haute autérité de santé) and anxiety-inducing. for these patients, drug analgesic treatments remain ineffective or contraindicated in outpatient mode. ionizing irradiation is a constraint that makes hypnosis unsuitable. several studies show the contribution of a virtual reality headset in reducing pain and anxiety by inducing patients in an hypnotic environment. this tool standardizes interventions based on changes in consciousness. it is an easy-to-use, non-drug analgesia with few side effects and inexpensive. the environment offered by this medical device is based on evidence to peacefully escort patients on a journey of natural elements. calm music is made up of key elements of musical therapy. a medical anesthesiologist and hypnotherapist wrote the hypnotic induction. and, the voice is the one of an experienced sociologist in practice. a simple meditation modeled on heart synchronization sets a persistent goal during this immersion.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * patients with a prescription for hysterosalpingography * patients able to answer the questionnaire independently (french-speaking or understanding french) * informed consent, signed by the patient * patients benefiting from a social security scheme or benefiting through a third party exclusion criteria: * patients with a contraindication to virtual reality headset. * refusal to participate in the study * contraindication to the realization of hysterosalpingography (pregnancy / lactation or infection) * patient under guardianship, curatorship or subordination
measuring intraabdominal pressure, lactic acid, and urine output

Conditions: Intra-Abdominal Hypertension; Inguinal Hernia

Summary: this study serves as a pilot study with the intention to to measure intraabdominal pressure, lactic acid, and urine output in obese individuals undergoing laparoscopic inguinal hernia repair. by measuring these values, the investigators aim to look for correlations between metrics and determine an accurate and precise measurement of iap during laparoscopic hernia surgery using the accuryn monitoring system. by obtaining accurate and precise measurements of iap during surgery the investigators will be to compare measurements to previous iap data obtained during daily activities and strenuous movements and any associations with inguinal hernia recurrence.


Eligibility criteria:
inclusion criteria: * obese with bmi \> 30 * diagnosis of inguinal hernia * qualify for laparoscopic inguinal hernia repair exclusion criteria: * previous bowel resections resulting in short bowel * extensive abdominal scarring * bmi \< 30 * fail to qualify for laparoscopic inguinal hernia repair