Kornimate/medical-research-clean huggingface dataset:
a device for rapid, painless, bedside muscle evaluation of children

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of this protocol is to perform electrical impedance myography (eim) testing on healthy children and children with duchenne muscular dystrophy so as to develop a new, convenient tool for the office based assessment of children with a wide variety of neuromuscular conditions.


Eligibility criteria:
duchenne muscular dystrophy: inclusion criteria: * 1. age 0-18 * 2. male * 3. genetic or histopathologic diagnosis of duchenne muscular dystrophy, or signs and symptoms of dmd and genetic or histopathologic diagnosis in a family member. exclusion criteria: * 1. age over 18 * 2. female * 3. presence of a superimposed neuromuscular or other medical condition that substantially impacts the individual's health or ability to cooperate.

Keywords: dmd duchenne muscular dystrophy eim
loco/regional anaesthesia evaluation in laparoscopic hernioplasty

Conditions: Postoperative Pain

Summary: laparoscopic hernioplasty is associated with lesser postoperative pain and quick return to work. tap block is the gold standard technique in this type of hernioplasty. our aim is to compare tap block with a novel local infiltration technique that uses direct laparoscopical vision.

laparoscopic hernioplasty is associated with lesser postoperative pain and quick return to work. tap block is the gold standard technique in this type of hernioplasty. our aim is to compare tap block with a novel local infiltration technique that uses direct laparoscopical vision. patients will be randomized into two arms of intervention that will be compared by a blind analysis. primary outcomes will be postoperative pain evaluated systematically until 30 days postoperative, and analgesic consumption.

Eligibility criteria:
inclusion criteria: * 18 years or more. * programmed inguinal laparoscopic hernioplasty exclusion criteria: * allergic to medication prescribed * story of mesh rejection

Keywords: postoperative pain laparoscopic inguinal hernioplasty tap block
correlation between tils and blood cell counts in triple negative breast cancer patients

Conditions: Triple Negative Breast Cancer

Summary: the perception study aims to assess the correlation between blood cell counts (leucocytes, neutrophils, lymphocytes, platelets, nlr (neutrophil-to-lymphocyte ratio) and plr (platelet-to-lymphocyte ratio)) and tumor infiltrating lymphocytes (tils), at baseline and after surgery, for patients diagnosed with triple negative breast cancer. it also aims to assess these circulating elements and circulating tumor dna as predictive factor of metastatic recurrence in triple negative breast cancer.

triple negative breast cancer (tnbc) is the most aggressive type of breast cancer. because of the limited therapeutical strategies, early tnbc relapses are quite common during the five years following treatment. it has been shown that the presence of tumor infiltrating lymphocytes (tils) at baseline is related to good pathological response to neoadjuvant chemotherapy. in addition, the presence of a high quantity of tils in the residual tumor after neoadjuvant chemotherapy is related to better survival rates. blood circulating elements, such as peripheral blood cells or circulating tumor dna, could be of interest in predicting response to treatment and in the prediction of metastatic recurrences in different types of cancer, including breast cancer. however, the correlation of these markers in triple negative breast cancer has not yet been thoroughly studied. the perception study aims to assess the correlation between blood cell counts (leucocytes, neutrophils, lymphocytes, platelets, nlr (neutrophil-to-lymphocyte ratio) and plr (platelet-to-lymphocyte ratio)) and tumor infiltrating lymphocytes (tils), at baseline and after surgery, for patients diagnosed with triple negative breast cancer. it also aims to assess these circulating elements and circulating tumor dna as predictive factor of metastatic recurrence in triple negative breast cancer.

Eligibility criteria:
inclusion criteria: * female * age \> 18 years * diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer * patient treated with chemotherapy, surgery and radiation therapy * patient able to understand the french language * patient affiliated to social security * obtaining signed written consent exclusion criteria: * male * unavailable tumoral samples before inclusion * unavailable blood test results at baseline, before inclusion

Keywords: triple negative breast cancer nlr (neutrophil-to-lymphocyte ratio) tils (tumor infiltrating lymphocytes) peripheral blood cells
analysis of cardiac biomarkers, ecg and cpet results in children with cardiomyopathies

Conditions: Cardiomyopathies

Summary: the aim of the study is to analyze cardiac biomarkers, electrocardiograms and cardio-pulmonary exercise test (cpet) results in children with cardiomyopathies.

the study group will consist of children that have been diagnosed with dcm, hcm or lvnc. the control group will be composed of healthy children. examination of cardiac biomarkers (in the study group), ecg, 24-hour- ecg monitoring, cpet will be performed. patients in the study group will be invited for 2 consecutive visits (in 6-10 months intervals). during the first and the last visit cpet will be performed. the control group will not be invited for consecutive visits.

Eligibility criteria:
inclusion criteria: * children with hcm, dcm, lvnc diagnosed in 2d echo. * healthy children with no congenital heart disease (chd) in 2d echo. * patients who signed consent form. exclusion criteria: * patients with coexisting chd, kidney and liver disfunction, taking anti-psychotic and anti-depressant medication, or patients with bundle bunch blocks in ecg. * no consent form signed.
evaluation of the effects of duloxetine on norepinephrine

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate how taking duloxetine 60mg every day affects the transfer of two normal body chemicals, 3,4-dihydroxyphenylglycol (dhpg) and norepinephrine (ne), across cells in blood and cerebrospinal fluid.


Eligibility criteria:
healthy subjects between the ages of 18-65 years are nonsmokers or are willing to refrain from smoking and are not taking concomitant medications which may inhibit or induce cyp1a2 or cypd6 or is an maoi.
efficacy and safety of biphasic insulin aspart 30 in type 1 or type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart 30 in subjects with type 1 or type 2 diabetes.


Eligibility criteria:
inclusion criteria: * subjects with insulin requiring type 1 or type 2 diabetes for at least 24 months * current treatment with human insulin (either premix of short and long/intermediate acting insulin) in a twice daily treatment regimen preparation and/or self-mix for at least 12 months * body mass index (bmi) below or equal to 35.0 kg/m\^2 * hba1c below or equal to 11.0% exclusion criteria: * total daily insulin dose at least 1.4 iu/kg * treatment with oral hypoglycaemic agents within the month prior to inclusion * recurrent severe hypoglycaemia (as judged by the investigator) * active proliferative retinopathy * impaired renal function with creatinine at least 150 mcmol/l (1.7 mg/dl) * history of pancreatitis
clinical and radiologic follow up of subchondral fractures of the glenoid

Conditions: Subchondral Fractures of the Glenoid

Summary: in this study the investigators will call patients who had subchondral fractures and treated in our department over the last 20 years. the investigators will evaluate their shoulder function by a questionary, constant score and radiologic evaluation.

patient evaluation by: - physical examination, questionary constant score: pain (severe, moderate, mild, non), activity level (sleep affected/sport limitations/daily living limitations/arm positioning) and range of motion (forward flexion/lateral elevation, internal and external rotation). - radiologic examination: axial view, axillary view and anterior posterior view- to evaluate the level of osteoarthritis by kellgren lawrence score and samilson score.

Eligibility criteria:
inclusion criteria: * any man or women who had subchondral fractures of the glenoid exclusion criteria: * pregnant women * children
clinical validation of a microfluidic device for isolation and molecular characterization of circulating tumor cells

Conditions: Cancer

Summary: to evaluate the efficiency of a microdevice for circulating tumor cells isolation and to correlate the circulating titre with response and progression.

* validate the clinical use of a mircofluidic device to capture circulating timor cells from a broad range of tumor types * characterize and identify these circulating tumor cells and demostrate cell viability with this capture method * apply this technology in clinically relevant settings and correlate to response to treatment and disease progression * elucidate predictive and pharmacodynamic biomarkers in the context of early phase trials of novel therapeutics

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed metastatic disease planned for palliative chemotherapy * tumor types as specified: non smokers with lung adenocarcinoma, undifferentiated ebv-ish positive nasopharyneal carcinoma, breast cancer, colorectal cancer, prostate cancer, gastric cancer * informed consent given for the purposes of blood sampling for this study * measurable disease by recist criteria of at least 1cm is preferred but not a sine qua non for study accrual exclusion criteria: * n/a

Keywords: circulating tumor cells metastasis cancer cell isolation mircofludics cell detection
comparing the performance of a categorical loudness scaling based fitting with a behavioural fitting in adults with a nucleus cochlear implant 3 months post-activation

Conditions: Hearing Loss

Summary: this study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.

firstly, it aims to collect data to investigate if the new fitting method gives a good fit of map for newly implanted ci-recipients in terms of performance outcomes, compared to the standard streamlined behavioural fitting after 3 months of use. secondly, it aims to collect data to further refine the new fitting method beyond what is evaluated within this study.

Eligibility criteria:
inclusion criteria: 1. aged 18 years or older (no upper age limit). 2. post-lingually deafened defined as severe or greater sensorineural hearing loss onset after the age of 2 years as reported by the subject 3. unilaterally implanted with the ci600 series (ci612, ci622, ci632) or ci500 series (ci512, ci522, ci532) cochlear implant. 4. fluent speaker in the language used to assess speech perception performance, as determined by the investigator. 5. willingness to participate in and comply with all requirements of the protocol. 6. willing and able to provide written informed consent exclusion criteria: 1. score below 3 on the screening subset of questions from the mobile device proficiency questionnaire. 2. subject who will be programmed with an acoustic component in the implanted ear. 3. pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 khz) less than or equal to 30 db hl and aided word score of more than 80% in the contralateral ear. 4. diagnosis of auditory neuropathy. 5. additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues. 6. unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator. 7. investigator site personnel directly affiliated with this study and/or their immediate families: immediate family is defined as a spouse, parent, child, or sibling. 8. cochlear employees or employees of contract research organizations or contractors engaged by cochlear for the purposes of this investigation. 9. current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a cochlear sponsored investigation and determined by the investigator or sponsor to not impact this investigation). -
upper limb robotic rehabilitation after stroke

Conditions: Stroke

Summary: this is a single arm study aimed at evaluating the acute effects induced by a single session of robot-assisted passive hand mobilization on local perfusion and upper limb function in post-stroke hemiparetic patients. twenty-three participants with subacute or chronic stroke received 20 min passive mobilization of the paretic hand with robotic assistance. after the intervention, significant improvements were found in forearm perfusion, muscle tone significantly decreased and subjects reported decreased upper limb heaviness, stiffness and pain. this study supports novel evidence that hand robotic assistance promotes local forearm circulation, may help in the management of spasticity and acutely alleviates reported symptoms of heaviness, stiffness and pain in subjects with post-stroke hemiparesis.


Eligibility criteria:
inclusion criteria: * first event of cerebrovascular stroke; unilateral paresis; ability to remain in sitting position exclusion criteria: * bilateral impairment; cognitive or behaviorql dysfunctions; finger flexion contracture; degenerative or non degenerative neurological conditions; refusal or inability to provide informed consent.
clinical trial comparing devices used for cardioversion of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the goal of this single center, investigator initiated, open label prospective randomized controlled trial is to compare the efficacy of a single 200j rbw shock and a single 360j bte shock. the secondary objective of the study is to compare the frequency of adverse events after one or two 200j rbw or 360j bte shocks

data will be derived from approximately 560 patients arriving to inova sites of care in atrial fibrillation (af) scheduled to undergo either atrial fibrillation ablation with expected direct current cardioversion (dccv) or elective stand-alone af dccv. patients will be included if they are in af prior to their procedure and are willing to sign the information sheet and comply with the research procedures. participants will be excluded if they are in a rhythm other than af on arrival, have not been appropriately anticoagulated with warfarin or direct oral anticoagulant, or have known left atrial appendage thrombus prior to their procedure.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. in af on presentation with plan for dccv in either the electrophysiology lab or dccv procedure area exclusion criteria: 1. participants who are receiving any other investigational agents. 2. parents/guardians or participants who, in the opinion of the investigator, may be non-compliant with study schedules or procedures. 3. patients with arrhythmias other than af 4. patients with hemodynamically unstable af 5. patients with untreated hyperthyroidism 6. patients with known or suspected pregnancy 7. patients without sufficient anticoagulation or a transesophageal echocardiogram or computed tomography scan documenting the absence of intracardiac thrombi
platelet reactivity and treatment with prostacyclin analogues in pulmonary arterial hypertension

Conditions: Pulmonary Hypertension

Summary: background: prostacyclin analogues (epoprostenol, treprostinil and iloprost) induce vasodilation in advanced pulmonary arterial hypertension (pah) but also inhibit platelets, increasing patients' bleeding risk. the antiplatelet effects of different prostacyclin analogues have never been compared head-to-head. the goal of the papaya (platelet reactivity and treatment with prostacyclin analogues in pulmonary arterial hypertension) trial is(i) to compare platelet function (platelet reactivity, extracellular vesicles concentration and thrombus formation) in patients with pah treated with prostacyclin analogues on top of endothelin receptor antagonists (era) and/or phosphodiesterase type 5 inhibitors (pde5i) and patients treated only with era and pde5i, and (ii) to compare the antiplatelet effect of different prostacyclin analogues. venous blood will be collected from patients treated with prostacyclin analogues (study group; n=40) and patients treated with era or pde5i (control group; n=40). platelet reactivity will be analysed in whole blood by impedance aggregometry using arachidonic acid, adenosine diphosphate and thrombin receptor-activating peptide as agonists. concentrations of extracellular vesicles from all platelets (cd61+), activated platelets (cd62p+), leukocytes (cd45+) and endothelial cells (cd146+) will be analysed in platelet-depleted plasma using flow cytometry (a-60 micro). platelet-rich thrombus formation will be measured using whole blood perfusion system. the study will determine the antiplatelet effect of prostacyclin analogues and compare different prostacyclin analogues head-to-head to identify the best drugs to use in case of thrombosis or bleeding.


Eligibility criteria:
inclusion criteria: * informed consent to participate in the study * pulmonary arterial hypertension confirmed with right heart catheterization * treatment with prostacyclin analogues (epoprostenol, treprostinil, iloprost) - study group * treatment with endothelin receptor antagonists and phosphodiesterase type 5 inhibitors - control group exclusion criteria: * known coagulopathy * active pathological bleeding * known history of bleeding disorder * severe thrombocytopenia (platelet count \< 50,000/μl ) * need for antiplatelet therapy with acetylsalicylic acid or p2y12 antagonists * severe chronic renal failure (estimated glomerular filtration rate \< 30 ml/min) * severe liver insufficiency (child-pugh class c) * known pregnancy, breast-feeding, or intention to become pregnant during the study period * study drug intolerance * participation in any previous study with prostacyclin analogues

Keywords: prostacyclin analogues pulmonary arterial hypertension platelet reactivity extracellular vesicles thrombus formation
overcoming chemoresistance in advanced ovarian cancer via targeting hypoxia

Conditions: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Carcinoma; Hypoxia

Summary: the goal of this non-randomized prospective study is to use 18f-ef5-pet/ct imaging to identify and locate intraabdominal hypoxic ovarian cancer lesions. with targeted surgical sampling, precisely obtain hypoxic and potentially chemoresistant cancer tissue for our analyses and identify key molecular differences between hypoxic and non-hypoxic tumors within the same patient. a portion of advanced stage eoc are inoperable at diagnosis and can be treated with neoadjuvant chemotherapy (nact) before surgery. this approach offers a unique opportunity to study how hypoxic tumor areas respond to treatment.

more specific aims 1. to validate the feasibility of pet-tracer ef5 in eoc imaging. * quantify the amount and exact locations of hypoxic tumors in eoc patients using herein developed protocol and tracers (18f-ef5 and 18f-fdg) in diagnostic and neoadjuvant settings. * measure the non-cancer related ef5 accumulation spots and establish the potential pitfalls in abdominal ef5 imaging * establish a method to verify hypoxic locations with 18f-ef5-pet/ct information during the operation. * develop and validate a model that predicts chemotherapy response based on functional imaging information. 2. to reveal hypoxia related alterations in collected tissue samples (i.e. altered dna damage repair, altered mitochondrial respiratory functioning, overexpression of hypoxia response elements etc)

Eligibility criteria:
inclusion criteria: * newly diagnosed advanced epithelial ovarian, primary peritoneal or fallopian tube cancer. * age 18-79 years * informed concent exclusion criteria: * previous cancer * pregnancy or nursing

Keywords: advanced ovarian cancer ef5-pet/ct hypoxia
clinical study to evaluate the efficacy and safety of dapagliflozin in patients with refractory cirrhotic ascites

Conditions: Refractory Ascites

Summary: the aim of this clinical trial is to evaluate the safety and efficacy of low dose dapagliflozin use along with standard care versus the standard care alone in improving the clinical outcomes of patients with cirrhotic refractory ascites. the main question it aims to answer is the difference in ascites control between the two groups at the end of treatment defined as: complete response: disappearance of ascites. partial response: presence of ascites not requiring lvp. no response: presence of ascites requiring lvp. researchers will compare intervention group receiving dapagliflozin 5m once daily for 3 months along with standard care versus standard care group to evaluate the effectiveness and safety of dapagliflozin in refractory ascites patients.


Eligibility criteria:
inclusion criteria: * adults \>18 years diagnosed with decompensated liver cirrhosis complicated with ascites grade 2. * refractory ascites defined as one of the following: 1. ascites cannot be mobilized despite adherence to low sodium diet of ≤88 mmol/day for ≥1 week and maximum diuretic treatment dose (spironolactone 400 mg/day or furosemide (160 mg/day). 2. recurrence can't be prevented by medical therapy, re-appearance of grade 2 or moderate ascites with moderate symmetrical abdominal distention, or grade 3 with massive ascites with marked abdominal distention within 4 weeks of initial mobilization. exclusion criteria: * presenting blood pressure below 90/60 or history of hypotension requires vasopressor treatment. * history of recurrent urinary tract infections, defined by the occurrence of 2 or more acute utis within months or 3 within a year. * history of hypersensitivity to sglt2 inhibitors. * history of diabetic ketoacidosis or presence of risk factors for dka (i.e alcohol consumption, type 1 diabetes). * pregnant or lactating women. * history of recurrent episodes of hypoglycemia defined as plasma glucose concentration \<70mg/dl. * severe renal dysfunction defined as, egfr \<20 ml/min/1.73m2.

Keywords: refractory ascites dapagliflozin
post marketing surveillance of menopur

Conditions: Infertility

Summary: the purpose of this study is to evaluate the safety and efficacy of highly purified (hp) menotrophine to korean women.


Eligibility criteria:
inclusion criteria: * anovulation in women (who group ii) * controlled ovarian hyperstimulation cases for art exclusion criteria: * hypersensitivity to menopur * pregnancy, lactation or contraindication to pregnancy * ovarian cysts not related to polycystic ovarian syndrome * abnormal uterine bleeding * tumors in uterus, ovaries and breasts * ovarian hyperstimulation syndrome * thromboembolism or history of it * infertile due to other reason than anovulation * high fsh level indication primary ovarian failure
determine central 5-ht1b receptor occupancy of zomig® rapimelt (zolmitriptan) in healthy male volunteers

Conditions: Migraine

Summary: the purpose of this study is to determine the central 5-ht1b receptor occupancy of zomig® rapimelt (zolmitriptan) in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * body mass index between ≥19 and ≤30 kg/m2. exclusion criteria: * a history or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic, pulmonary, renal disease * use of drugs that induce the liver drug metabolising enzymes within 4 weeks before first pet

Keywords: migraine zomig® rapimelt