Kornimate/medical-research-clean huggingface dataset:
noblestitch el stitch trial is a pfo comparative trial

Conditions: Foramen Ovale, Patent; Stroke, Ischemic

Summary: stitch - prospective multi-center comparative parallel concurrent study of the noblestitch™ el versus fda-approved amplatzer occluder device for closure of patent foramen ovale to prevent recurrent ischemic stroke.

to demonstrate the non-inferiority of the noblestitch™ el with medical management in both safety and effectiveness compared to the fda-approved amplatzer occluder with medical management for pfo closure. to demonstrate that the noblestitch el does not increase the incidence of ischemic stroke compared to published medical management data.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * male or female ages 18 - 60 years old * a pfo and a cryptogenic stroke verified by a neurologist * stroke is defined as an acute focal neurological deficit, presumed to be due to focal ischemia, and either: * symptoms persisting ≥24 hours, or * symptoms persisting \<24 hours with magnetic resonance or ct findings of a new, neuroanatomical relevant infarct * cryptogenic stroke was defined as a stroke of unknown cause * prolonged cardiac rhythm monitoring (recommended 30 days and not less than 24 hours required) * intra and extracranial artery imaging: magnetic resonance angiography, ct angiography, or contrast angiography, or contrast angiography or echocardiography of the carotid arteries to rule out ischemic stroke associated with atherosclerotic plaque, arterial dissection, or other vascular diseases. (the aortic arch may also be evaluated by tee). * hypercoagulable state assessment to rule out an underlying hypercoagulable state exclusion criteria: * female participant who is pregnant, lactating or planning a pregnancy during the course of the study * age \ 60 years of age * previous myocardial infarction or unstable angina within 6 months * clinically significant mitral or aortic valve stenosis or severe regurgitation * left ventricular ejection fraction \<50 percent * progressive neurological dysfunction or reduced life expectancy * contrast allergy * atrial septal defect (baseline left to right shunt assessed by tee or other congenital heart diseases * active endocarditis * perspective participants with known causes of ischemic stroke * arterial dissection * contraindicated or unsuitable for antiplatelet agents or oral anticoagulants * perspective participants with prosthetic heart valves * uncontrolled diabetes mellitus * pulmonary hypertension * uncontrolled systemic hypertension * intracranial pathology * neurological deficits not due to stroke that may affect neurologic assessments * active autoimmune disease * active infection * alcohol and/or drug abuse * a requirement for chronic anticoagulation therapy that cannot be discontinued * anatomic features (inability to achieve vascular access)

Keywords: patent foramen ovale stroke
the validity and reliability of the turkish version of the combined index of severity of fibromyalgia

Conditions: Fibromyalgia

Summary: the aim of the investigator's study is to determine the validity and reliability of the turkish version of the combined index of severity (icaf) in turkish patients with fibromyalgia syndrome (fms).

the original form of the combined index of severity of fibromyalgia (icaf) will be translated into turkish by two turkish mother tongue translators who also speak english in advanced level. then these translations will be combined into one translation and translated back to english. these translations will send to 7 different health professions who had experience working with fms patients. the pre-final version will be composed and tested on a group of patients with fms. if necessary, readjustments will be made, and the final version will be investigated in fms patients. acceptability was assessed in terms of refusal rate, rates of missing responses, and administration time. reliability was assessed using cronbach's alpha and test-retest assessments. re-test assessments will be conducted after one week from first assessment. content validity was assessed by examining the floor and ceiling effects and skew of the distributions. convergent and divergent validity was assessed by examining the pearson's correlation coefficients. in addition, the confirmatory factor analysis will be done to evaluate the validity of icaf. responsiveness was determined by examining effect size (es), standardized response means (srm) and p values generated using wilcoxon's test.

Eligibility criteria:
inclusion criteria: * having a fibromyalgia diagnosis according to wolfe et al. (2016) criteria. * feeling fibromyalgia symptoms last 3 mounts exclusion criteria: * having physical and functional problems with fms * having a diagnosis of chronic pain other than fms, * using medicine other than simple analgesics, * history of cardiovascular or pulmonary diseases * can not read and write in turkish language

Keywords: health statues observational study questionnaire
paravertebral block versus epidural anesthesia for percutaneous nephrolithotomy

Conditions: Kidney Calculi

Summary: this prospective, randomized study is aimed to assess the efficacy and safety of paravertebral block compared to epidural anesthesia for percutaneous nephrolithotomy. the investigators suppose that paravertebral block is not inferior in controlling the perioperative pain for percutaneous nephrolithotomy compared to epidural block.

background: percutaneous nephrolithotomy (pcnl) is generally performed under general or neuraxial anesthesia. the investigators have reported three patients who were at high risk of both general anesthesia and neuraxial anesthesia received percutaneous nephrolithotomy with ultrasound guided paravertebral block. then，the investigators performed ultrasound guided paravertebral block for 45 patients who received percutaneous nephrolithotomy successfully. the investigators' impression is that paravertebral block is as effective as epidural anesthesia for surgical anesthesia of percutaneous nephrolithotomy. objectives:to assess the efficacy and safety of paravertebral block compared to epidural anesthesia for surgical anesthesia of percutaneous nephrolithotomy. methods: fifty adult patients undergoing elective percutaneous nephrolithotomy will be randomized to receive ultrasound guided paravertebral block or epidural anesthesia. the primary outcome will be the pain score 12h postoperation. the secondary outcomes will include: time spent to perform block, dose of intraoperative opioids, rate of hypotension need for vasoconstrictors, muscle power grading of the lower legs at the end of the operation, anus exhaust time, opioid consumption postoperation, postoperative ponv score and the frequency of vomiting , hospitalization duration and patient satisfaction. clinical implications: ultrasound guided paravertebral block could be an equally effective and safe alternative to epidural block for surgical anesthesia of percutaneous nephrolithotomy.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical statusⅰ-ⅲ * undergo first stage percutaneous nephrolithotomy * informed consent exclusion criteria: * bmi\>35 * coagulopathy, on anticoagulants * history of surgery on spine * spine deformity * a known allergy to the drugs being used * tumor or infection at the site of puncture * inability to provide adequate informed consent * refusal to participate in the study

Keywords: paravertebral block ultrasound percutaneous nephrolithotomy postoperative pain
a clinical trial to assess the safety of a measles vaccine (dry powder) administered by two different devices

Conditions: Prophylaxis for the Measles Infection

Summary: this is a phase i, open-label, randomized study in healthy adults. eligible subjects will be given single dose of either dry powdered measles vaccine (pmv) by puffhaler® device, dry pmv by soloventtm device or licensed measles vaccine by subcutaneous route (smv). subjects will be followed for 180 days for safety.

this is a phase i, open-label, randomized study in healthy adults. eligible subjects will be given single dose of either dry powdered measles vaccine (pmv) by puffhaler® device, dry pmv by soloventtm device or licensed measles vaccine by subcutaneous route (smv). solicited reactions will be assessed for first 14 days after vaccination and unsolicited adverse events will be assessed till 84 days after vaccination. subjects will be followed for 180 days for any saes.

Eligibility criteria:
inclusion criteria: * male adults of age of 18-45 years. * measles immune, as determined by igg antibody levels. * healthy as supported by medical history, physical examination and laboratory evaluation on preset parameters. * signed informed consent for participation in trial and for hiv screening. exclusion criteria: * medical history of immunodeficiency/suppression or subject with history of close contact with immunocompromised/ immunosuppressed person. * chronic administration of immunosuppressants or other immune modifying agents * acute febrile illness or suspected measles illness or acute infectious disease * acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, neurological, hepatic or renal functional abnormality which in the opinion of the investigator, might interfere with the study objectives * history of seizure disorders * major congenital defects * thrombocytopenia or known bleeding disorders 8. history of a previous severe allergic reaction * positive serology for hiv antibody, hcv antibody or hepatitis b surface antigen * known hypersensitivity to any component of the study vaccine
microcirculation after map increase in septic shock patients with previous hypertension

Conditions: Septic Shock

Summary: the optimal levels of mean arterial pressure that must be achieved in septic shock are subject of debate. studies tried to correlate blood pressure increase in patients with septic shock with microcirculation. however, there are few studies that specifically assessed septic shock patients with previous arterial hypertension. the main objective of this study is to evaluate the effect of increased blood pressure level in the microcirculation of these patients and compare them with patients without arterial hypertension.

hypothesis: after a rise in mean arterial pressure, microcirculation improvement will occur only in the previously hypertensive patients. study design: prospective clinical trial setting: intensive care units of the anesthesiology department at the federal university of sao paulo and the intensive care unit of kidney hospital. studied population: forty patients will be included, being 20 without known history of systemic arterial hypertension and 20 with this diagnosis for at least 2 years and already with clinical or subclinical organ damage. inclusion criteria: age over than 18 years old, norepinephrine drug use for at least 12 hours and for less than 72 hours, sedation level equal or deeper than ramsay 4, blood pressure stable for the last 30 minutes prior to inclusion, central venous catheter in place and signed informed consent. exclusion criteria: pregnancy, cirrhosis, systemic sclerosis, and need to maintain mean arterial pressure above 65mmhg for others conditions. intervention: noradrenaline dose will be risen to obtain a mean arterial pressure of 85-90 mmhg. assessments and outcome: systemic hemodynamic (central venous oxygen saturation, cardiac output, heart rate, central venous pressure) and sublingual microcirculation variables (microcirculatory flow index, total vascular density, proportion of perfused vessels, perfused vascular density) will be measured before and after the rise in mean arterial pressure. sidestream darkfield will be used to assess microcirculation. the variation between those variables before and after the intervention will be compared.

Eligibility criteria:
inclusion criteria: * age over than 18 years old, * norepinephrine drug use for at least 12 hours and for less than 72 hours, * sedation level equal or deeper than ramsay 4, * blood pressure stable for the last 30 minutes prior to inclusion, * central venous catheter in place and * signed informed consent. exclusion criteria: * pregnancy, * cirrhosis, * systemic sclerosis, and * need to maintain mean arterial pressure above 65mmhg for others conditions
a pharmacokinetic and pharmacodynamic study of mabthera (rituximab) plus methotrexate in patients with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: this single arm study will investigate the pattern of b cell depletion in synovial tissue and peripheral blood of patients with active ra, after mabthera (1000mg iv x 2 on days 1 and 15) + methotrexate (10-25mg/week po) treatment. the clinical efficacy and pharmacokinetic profile of mabthera after treatment and retreatment will also be investigated. the anticipated time on study treatment is 2+ years, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients 18-80 years of age; * ra for \>=3 months; * receiving outpatient treatment; * failed treatment with \>=1 dmard (but not anti tnf or other biologic therapy); * inadequate response to methotrexate, having taken and tolerated it for \>=12 weeks, with a stable dose for \>=4 weeks. exclusion criteria: * rheumatic autoimmune disease other than ra, or significant systemic involvement secondary to ra; * history of, or current, inflammatory joint disease other than ra, or other systemic autoimmune disorder; * diagnosis of ra before the age of 16; * bone/joint surgery within 12 weeks of study; * prior use of anti-tnf or other biologic therapy, an anti-alpha 4 integrin, or any cell-depleting therapies.
dorsal root ganglion thermal radiofrequency versus pulsed radiofrequency for metastatic pain in thoracic vertebral body

Conditions: Bone Neoplasm,Malignant Vertebral Column Thoracic Secondary

Summary: aim of the work to evaluate the effectiveness and safety of pulsed and thermal radiofrequency lesion of the dorsal root ganglion (rf-drg) on a consecutive group of patients presenting with chronic thoracic pain due to vertebral bone metastasis.

study design this is a prospective randomized controlled trial that will be conducted at the national cancer institute. all patients who are eligible for the study will be included and randomized into 3 equal groups. patients and methods after approval from the ethics committee at the national cancer institute, cairo university, and obtaining written informed consent, eighty-one patients with thoracic segmental pain due to metastasis, unresponsive to conventional therapy and meeting the inclusion criteria will be randomly assigned to either one of the two types of treatment, prf or trf lesioning of the drg or the control group. patients will be carefully evaluated for neurologic deficits and side effects. assessment of pain will be done at baseline then at 1, 3, 6 months after the procedure. randomization will be done using randomized permuted block design. randomization list will be generated through random.org online site. patients will be randomly assigned and divided into 3 equal comparable groups. before the procedure, laboratory investigations, dorsal x-ray, ct and mri will be done. all patients will be interviewed and examined by physicians trained in interventional pain management. patients will be carefully assessed on physical exam for sensory, motor, or reflex deficit and carefully documented. patients will be informed about the technique of the blocks, and written informed consents will be obtained. the types of measures used to assess pain relief will include single rating scales; vas, and multiple-dimension composite measures; oswestry low back pain disability questionnaire (odi), the european organisation for research and treatment of cancer (eortc) qlq-c30 and qlq-bm22.

Eligibility criteria:
inclusion criteria: 1. a greater than 6-month history of segmental pain of thoracic vertebral body metastasis origin. 2. unsatisfactory pain control with oral pharmacotherapy including strong opioid with vas \>5 . 3. absence of a chronic or progressive motor deficit. 4. absence of significant sensory deficit. 5. no indication for percutaneous or open surgical intervention. 6. magnetic resonance imaging and computed tomogrophy evidence of thoracic involvement. 7. asa status of ii to iii . 8. age \> 18 . 9. body mass index (bmi) :less than forty and more than twenty . 10. informed consent exclusion criteria: 1. known sensitivity or contraindication to injected materials: local anesthetics. 2. history of psychological disorders. 3. evidence of significant neurological deficit. 4. inability to lie prone. 5. local contraindication to procedure e.g. local sepsis at the site of intervention, coagulopathy. 6. patient refusal.

Keywords: bone metastasis,thoracic secondary, cancer pain,
dual trigger versus booster dose of hcg

Conditions: Infertility

Summary: to salvage the luteal phase and improve pregnancy rate in antagonist ivf/icsi cycles triggered with gnrh agonist. two strategies are compared dual trigger with gnrh agonist plus 1000 iu of hcg or triggering with gnrh and giving a booster dose of hcg (1500 iu) on the day of ovum pickup.


Eligibility criteria:
inclusion criteria: * high responder females undergoing antagonist protocol ivf/icsi cycle * more than 14 mii oocytes * estradiol more than 3500 pg/ml on day of trigger exclusion criteria: * any other protocol * normal or poor responders
evaluation of an innovative smart t-shirt capable to monitor ecg signal and related parameters through the comparison with a holter ecg and a smartwatch

Conditions: Cardiac Arrhythmias

Summary: evaluation of an innovative smart t-shirt capable to monitor ecg signal and related parameters through the comparison with a holter ecg and a smartwatch

the primary purpose of this study is to evaluate the biosignal (ecg) acquisition features of the smart t-shirt, developed by university of bologna in collaboration with accyourate s.p.a., comparing it with a standard holter ecg. secondly, the study wants to compare the parameters related to ecg signal calculated by the smart t-shirt with those calculated by commercial smartwatches.

Eligibility criteria:
inclusion criteria: 1. subjects agree to participate in the study and having dated and signed the informed consent form, 2. subjects who have the capability to communicate, to make themselves understood, and to comply with the study's requirements, 3. male or female aged ≥ 18 years and ≤ 90 years old, 4. subjects with cardiac electrophysiological (heart rhythm) pathologies or under screening for the assessment of possible cardiac electrophysiological pathologies. exclusion criteria: 1. subjects that for different reasons have difficulties to wear the sensorized t-shirt or the alternative sensorized chest band: movement's impairments; dermatological reaction to t-shirt fabric or materials, 2. any medical or surgical condition that would limit the patient adhesion to the study protocol, 3. severe obesity and sever underweight, 4. subject that are not able to understand the scope of the study.

Keywords: smart t-shirt wearable electrocardiogram
an extension study to evaluate casimersen or golodirsen in patients with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: the main objective of this study is to evaluate the safety and tolerability of long-term treatment with casimersen or golodirsen in patients with duchenne muscular dystrophy (dmd).


Eligibility criteria:
inclusion criteria: * completed a clinical trial evaluating casimersen or golodirsen, per protocol. * is between 7 and 23 years of age, inclusive, at enrollment. other inclusion/exclusion criteria apply.

Keywords: duchenne muscular dystrophy exon skipping dmd exon 53 exon 45 duchenne
posterior nasal nerve neurectomy for treatment of intractable allergic rhinitis

Conditions: Intractable Allergic Rhinitis

Summary: this study aims to compare the outcomes of posterior nasal nerve neurectomy in patients with resistant allergic rhinitis by using three different methods ( surgical resection vs radiofrequency ablation vs surface coblation ) through assesment of functional outcomes, postoperative complications, and impacts on quality of life.


Eligibility criteria:
inclusion criteria: * patients aged 16 to 65 years, fit for surgery, diagnosed as moderate to severe persistent allergic rhinitis, as per the aria guidelines having 3 or more of the typical symptoms of allergic rhinitis including nasal discharge, repeated attacks of sneezing, nasal itching and nasal obstruction. exclusion criteria: * • patients with coexisting nasal pathologies that could influence the outcomes of the surgery like: chronic granulomatous diseases of the nose, nasal tumors, chronic sinsitis with or without nasal polyps, etc. * patients who had used topical steroid nasal spray, oral or topical antihistamines, oral leukotriene antagonists, oral or tobical nasal decongestants in the last 2 weeks. * immunocompromised patients, systemic disease affecting prognosis such as diabetes mellitus, hypertension,chronic liver failure or heart failure. * unwillingness for endoscopic surgery. * patients younger than 18 years of age. * patients who are unfit for general anesthesia. * previous history of nasal surgery
controlled release of oxycodone 10 mg in pre-medication for the post operative analgesia in elective laparoscopic bilateral inguinal hernia and elective laparoscopic cholecystectomy

Conditions: Elective Laproscopic Bilateral Inguinal Hernia; Elective Laproscopic Cholecystectomy

Summary: a prospective double blind rct: controlled release oxycodone 10 mg on a 12 h dosing schedule started with the premedication ,placebo controlled study,on post operative analgesia management in laparoscopic cholecystectomy and laparoscopic bilateral inguinal hernia (bih). cro is indicated for the management of moderate to severe pain when a continuous,around the clock analgesic is needed for an extended period of time.its safety and efficacy in the first 12-24 hours post operative has not been established.


Eligibility criteria:
inclusion criteria: * local ethic committee approval * written informed consent * asa physical status i-iii, scheduled for elective laparoscopic cholecystectomy and elective laparoscopic bih exclusion criteria: * difficulty in communication * allergy to oxycodone and/or morphine * allergy to local anesthetic * history of alcohol and substance abuse * treated depression * chronic use of opioid or tramadol or nsaids * pregnancy * obstructive sleep apnea * anticipated fiber optic intubation * severe hepatic or renal impairment * weight \ 100 kg * conversion to laparotomy * patient extubated in pacu. * any prior abdominal surgery
comparison between ex vivo and in vivo injection of blue dye in sentinel lymph node mapping for colon cancer

Conditions: Sentinel Lymph Node Biopsy; Colon Cancer

Summary: the technique of sentinel lymph node mapping in patients with colon cancer varies among reports, and the optimal method remain to be established. the purpose of this study was to determine the optimal injection technique for sentinel lymph node mapping for colon cancer.


Eligibility criteria:
inclusion criteria: * stage i - iii colon cancer patients exclusion criteria: * cancer located at the low rectum which were located within 10 cm of the dentate, recurrent or metastatic colon carcinoma, adjacent organ invasion tumor, prior chemotherapy or radiation, cancer with intestinal obstruction, past intestinal surgery

Keywords: sentinel lymph node-colon cancer