Kornimate/medical-research-clean huggingface dataset:
international multicenter project comparing radiofrequency ablation versus implantable defibrillator after well-tolerated ventricular tachycardia in ischemic heart disease with minimally impaired ejection fraction

Conditions: Ischemic Heart Disease; Ventricular Tachycardia

Summary: evidence for the usefulness of the defibrillator in cases of preserved left ventricular ejection fraction and well-tolerated ventricular tachycardia (without cardiocirculatory arrest or syncope) is lacking, as no previous trials have included such patients. additionally, sudden death in this particular population is low compared to other subgroups of patients with malignant ventricular arrhythmias. on the other hand, numerous recent retrospective data show that ablation of ventricular tachycardia can reduce mortality, and also clearly reduces the number of recurrences in prospective studies. finally, a very low rate of sudden death was observed in a multicenter european retrospective study that we conducted, including patients with well-tolerated ventricular tachycardia in structural heart disease with minimally impaired ejection fraction and benefiting from ablation without implantation of defibrillator.


Eligibility criteria:
inclusion criteria: * ischemic heart disease with history of infarction - lvef\> 35% (measured by mri) * sustained monomorphic ventricular tachycardia - without history of syncope or cardiac arrest - * having signed informed consent * affiliated to a social security system exclusion criteria: * transient regressive cause of ventricular tachycardia * recent myocardial infarction (\<2 months) * ventricular tachycardia by reentry from branch to branch * serious conduction disturbances (with indication of stimulation) * contraindication to the implantation of a defibrillator or to the performance of an ablation (life expectancy \<1 year, relevant comorbidities) * pregnancy * age \<18 years * patient under legal protection, guardianship or curatorship

Keywords: ablation
evaluation of rc28-e injection in diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: this is a randomized, open-label, multicenter study of the efficacy and safety of rc28-e injection (a chimric decoy receptor trap fusion protein by dual blockage of vegf and fgf-2) in the treatment of patients with moderately severe to severe nonproliferative diabetic retinopathy.


Eligibility criteria:
inclusion criteria: * sign the consent form, willing and able to comply with clinic visits and study-related procedures; * aged 18 years to 80 years, male or female; * diabetes mellitus(type 1 or 2); * moderately severe to severe npdr (drss levels 47 or 53) which was confirmed by the central reading center, and in whom prp can be safely deferred by the investigator's judgement; * bcva score in the study eye of ≥69 letters (approximate snellen equivalent of 20/40 or better) using the etdrs protocol at an initial testing distance of 4 meters; * if both eyes meet the inclusion criterion, one eye with poor bcva is selected as the study eye; exclusion criteria: * presence of dme threatening the center of the macula (within 1,000 microns of the foveal center) in the study eye; * evidence of retinal neovascularization on clinical examination or fa; * any prior focal or grid laser photocoagulation (within 1,000 microns of the foveal center) or prp in the study eye; * current asnv, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involved the macular in the study eye; * history of vitreoretinal surgery in the study eye; * active infectious blepharitis, keratitis, scleritis, conjunctivitis at the screening assessments in either eye ; * previous treatment with anti-angiogenic drugs in either eye or system (ranibizumab, aflibercept, conbercept, etc) within 3 months of the day 0 visit; * previous use of intraocular or periocular corticosteroids (such as triamcinolone acetonide, dexamethasone vitreous implant) in either eye within 6 months of day 0. * uncontrolled clinical disease (such as severe psychiatric, neurological, cardiovascular, respiratory disease or other systemic diseases) and tumors; * pregnant or lactating women, subjects who had family planning throughout the study period; * those who participated in clinical trials for 3 months or 5 half-lives of the investigational product (the longer the time) before theday 0 * those who considered unsuitable for enrollment by investigator.
a study of intramuscular sebacoyl dinalbuphine ester for post-hemorrhoidectomy pain management

Conditions: Analgesia Disorder; Pain

Summary: this is a randomized, double blind, placebo-controlled, single dose study to assess the safety, efficacy and pharmacokinetics of intramuscular sebacoyl dinalbuphine ester (sde) for post-hemorrhoidectomy pain management.


Eligibility criteria:
inclusion criteria: * male or female \>= 20 years of age at screening * scheduled to electively undergo 2 or 3-column excisional hemorrhoidectomy * american society of anesthesiology physical class 1 - 3 * adequate clinical lab values (values of potential clinical concern are detailed in appendix) or, if abnormal, deemed not clinically significant per the investigator. * ability and willingness to provide informed consent, adhere to the study visit schedule and complete all study assessments and language specific questionnaires exclusion criteria: * body weight less than 40 kg. * concurrent fissurectomy. * subject is pregnant or breastfeeding. women of childbearing potential must have a negative urine pregnancy test at baseline. * women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, iud, barrier device or abstinence) throughout the study. * history of hypersensitivity or allergy to amide-type local anesthetics, opioid, or any ingredient of the medications administered in this study. * subject has a resting respiratory rate less than 8 per minute and blood oxygen saturation less than 90 mmhg. * use of any nsaids, selective cox-2 inhibitors, opioid, acetaminophen, selective serotonin reuptake inhibitors (ssri), tricyclic antidepressants (tca), gabapentin, or pregabalin within three days of surgery. * chronic use of opioid medications for more than 14 days in the last 3 months, or non-opioid pain medications more than 5 times per week before screening visit. * use of any long-acting opioid medication within 3 days of surgery or any opioid medication within 24 hours of surgery. * current painful physical condition or concurrent surgery requires analgesic treatment in the postoperative period. * contraindication to epinephrine or any of the pain-control agents planned for postoperative use. * administration of an investigational drug within the longer of 30 days or 5 elimination half-lives of such investigational drug prior to study drug administration. * any psychiatric disorder, psychological, medical, or laboratory condition that may interfere with study assessments or compliance. * significant medical conditions or laboratory results that may indicate an increased vulnerability to study drugs and procedures, and thus expose the subject to an unreasonable risk as a result of participating in this clinical trial. * any clinically significant event or condition may be uncovered during surgery. * history of abuse illicit drugs, prescription medicines or alcohol within the past 2 years. * known history of anti-hiv antibody positive * failure to pass drug and alcohol screen.

Keywords: analgesic opioids pain relief after surgery dinalbuphine sebacoyl dinalbuphine ester sde sdn lt1001
energy conservation technique in copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is characterised by non-reversible bronchial obstruction associated with systemic disorders and comorbid factors. dynamic hyperinflation during an exercise increase dyspnea and can reduce exercise capacity. stair climbing is associated with prolonged dynamic hyperinflation and severe dyspnea in copd patients. the aim of this study is to carry out the effect of an energy conservation technique on dyspnea to facilitate stair climbing.


Eligibility criteria:
inclusion criteria: * a diagnosis of copd * dyspnea in daily living (2-4 on the modified medical research council dyspnea scale) * clinically stable exclusion criteria: * exercise contraindication any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise. * exacerbation during the study * inability to climb 6 floors

Keywords: copd daily activity stair climbing rehabilitation
preoperative frailty assessment with ultrasound in elderly patients

Conditions: Frailty

Summary: in this study, the investigators aim to evaluate the prediction accuracy of the thickness measured with point-of-care ultrasound of the rectus abdominis, biceps brachii muscles of frailty.


Eligibility criteria:
inclusion criteria: * patients 60 years old or older scheduled for total knee arthroplasty exclusion criteria: * unable to communicate with the patient or the patient's guardian * myopathy * history of injury of rectus abdominis, biceps brachii or quadriceps femoris muscle. * history of total knee arthroplasty in the recent 3 months prior to surgery
study of small doses of etoposide as maintenance treatment in small cell lung cancer(sclc)

Conditions: Small Cell Lung Cancer Extensive Stage

Summary: patients with extensive-stage small cell lung cancer receive six cycles of chemotherapy(etoposide plus platinum) as first-line treatment,who achieve complete response(cr)/partial response(pr) will accept small doses of etoposide as maintenance treatment. the objective of this study is to evaluate the progression free survival,overall survival,objective response rate,disease control rate and safety of etoposide as maintenance therapy. based on previous studies on maintenance therapy in small cell lung cancer,the hypothesis of this study is maintenance therapy using etoposide may improve progression free survival,overall survival for selected patients. the investigators will use the peripheral blood to assess circulating tumor cell and cell-free dna,which may help us to screen a subgroup of patients with better response to etoposide maintenance therapy.


Eligibility criteria:
inclusion criteria: * pathological diagnosis of small cell lung cancer * extensive stage according to american veteran staging system * at least one measurable lesion according to response evaluation criteria in solid tumors (recist )1.1 * eastern cooperative oncology group (ecog) scores for performance status of 0 to 2 * age≥18 years * adequate organ function * consent form according with guideline for good clinical practice of the international conference on harmonisation (ich-gcp)guidelines * the expected survival≥2 months exclusion criteria: * pathological diagnosis of mixed small cell lung cancer * limited stage according to american veteran staging system * other preexisting or existing malignant tumors,not including non-melanoma skin cancer with effective treatment,cervical cancer in situ or tumor response has been 3 years which is considered cured by the investigator * known pre-existing interstitial lung disease * pre-existing or uncontrolled gastrointestinal disease which may affect drug absorption or worsen existing disease believed by the investigator * any other medical history or coexisting disease that may affect compliance of patients or the assessment of safety and effectiveness of the drug believed by the investigator * pregnant or lactating women * active phase of hepatitis b virus infection,active phase of hepatitis c virus infection or known hiv carriers
a study to compare the pharmacokinetics of different formulations of pf-04937319 in healthy subjects

Conditions: Healthy

Summary: this study is designed to compare the pharmacokinetics of three different formulations of pf-04937319


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg or clinical laboratory tests. * subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of treatment. * body mass index (bmi) of 23 to 33 kg/m2 and a total body weight \>=50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated seasonal allergies). * any condition possibly affecting drug absorption (eg, gastrectomy). * a positive urine drug screen.

Keywords: pharmacokinetics relative bioavailability formulation comparison
ultrasound-guided mid-point transverse process to pleura block versus thoracic paravertebral block for pain management in patients with multiple rib fractures (a prospective randomized double- blinded, non-inferiority trial )

Conditions: Rib Fractures

Summary: the aim of our study is to investigate whether the analgesic effect of mtpb is non inferior to that of tpvb in trauma patients with multiple rib fractures.

trauma is a major global health problem. in egypt, trauma-related death accounted for 8% of total fatalities and was the eighth leading cause of death in 2010. however.\[1\]rib fractures have an incidence around 10% of all trauma patients and over 30% of chest trauma patients.\[2\] multiple fractured ribs are associated with extreme pain, to avoid intensifying discomfort, patients' breathing becomes shallower and they repress coughing, leading to respiratory insufficiency. which may result in numerous complications, as sputum retention, atelectasis, infection, and respiratory insufficiency. this is associated with increase in intensive care admissions and mortality (25%).\[3\] hence, pain control is the cornerstone of rib fracture management. modalities for pain relief ranges from oral administration of analgesic drugs to regional nerve blocks including \[intrapleural, intercostal ,thoracic paravertebral nerve blockade (tpvb)\]. despite the low rate of technical failure in tpvb execution (6.1%), pulmonary complications, such as inadvertent pleural puncture (0.8%) and pneumothorax (0.5%), are still a recognized risk.\[4\] bedside ed-performed ultrasound-guided anesthesia is gaining in popularity, and early and adequate pain control has shown improved patient outcomes with rare complications. one of the most recently described technique is mid-point transverse process to pleura (mtp) block.\[2\] in mtp block, the local anesthetic drug is deposited at the mid-point between the transverse process and pleura and it reaches the paravertebral space by diffusion. with this technique, even if superior costotransverse ligament (sctl) is not visible, effective block can be achieved. in addition, needle is placed far away from pleura minimizing the rate of pneumothorax.\[5\]

Eligibility criteria:
inclusion criteria: * adult patients aged between 18 and 70 years, from both genders, who had uni lateral traumatic multiple rib fractures (three or more confirmed by a ct chest scan). exclusion criteria: * significant head injury/unconsciousness (gcs less than 15). * patients with pain score \>6. * those having significant trauma outside the chest wall, e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries. * obese patients with body mass index ≥ 35. * coagulopathy. * history of drug allergy to local anesthetics. * patient refusal. * local infection at the injection site. * opioid addiction.
i-interact preterm

Conditions: Pre-Term

Summary: open pilot of a brief online parenting-skills intervention for young children ages 3-8 who were born very preterm (\< 32 weeks gestational age). parent-child interactions, child behavior, parent functioning, and child white matter connectivity will be assessed pre- and post-intervention 10 weeks later.

the investigators will modify i-interact north to reflect united states language and culture and emphasize our focus on neural plasticity and development. the modified intervention will be renamed building better brains and behavior (b4 preterm). then, investigators will conduct a single-arm clinical trial to establish b4 preterm's feasibility, acceptability and preliminary efficacy in improving child and family outcomes. additionally, neuroimaging (mri/dti) will be collected pre- and post-intervention. the primary neuroimaging sequence will allow the investigators to examine associations between white matter injury and treatment response as well as changes in neural activation and connectivity pre- to post-treatment. an exploratory neuroimaging sequence will also be collected pre- and post-intervention. this exploratory sequence will serve as a backup for the primary sequence in case it is affected by significant motion and allow the investigators to test this sequence in young children.

Eligibility criteria:
inclusion criteria: * age at enrollment: ages 3-8, inclusive * born at \< 32 weeks gestational age * total t score of \> 55 on the child behavior checklist total or externalizing behavior scales or total t score of \> 55 on the eyberg child behavior inventory total problem- or total intensity-scale or documented behavioral problems noted in medical chart and parent endorses current concerns about child's behaviors * language: english must be the primary spoken language in the home exclusion criteria: caregiver must be 18 years or older to participate in the intervention. participant will be excluded from the study if the child does not reside with the caregiver at least half-time; the caregiving situation is not stable (i.e., there must be no scheduled custody hearings); english is not the primary language spoken in the home. additionally, caregivers with a psychiatric hospitalization in the past year will be ineligible to participate. children with certain types of metal in their heads will be unable to participate in the mri portion but will be able to participate in the intervention and complete pre- and post-intervention questionnaires.
a study of the laparoscopically-placed adjustable gastric band for the management of obesity in adolescent patients

Conditions: Obesity

Summary: this is a prospective, non-randomized, single center study of a laparoscopically placed, adjustable gastric band medical device for the treatment of adolescent obesity.

study population we plan to enroll 30 subjects between the ages of 14 and 17 years with the lap-band®. the inclusion criteria are in accordance with recent evidence-based indications for the surgical management of severe obesity in the pediatric population (pratt, lenders et al. 2009). the enrollees will be children who have a body-mass index in the 99th percentile, corresponding to a bmi\>= 35 kg/m2, and who exhibit significant comorbidities. this sample size will provide over 90% power to detect a 15% change in body mass index with a standard deviation of 6, two-tailed alpha of 0.05, and allow for 20% loss to follow-up, using a paired design.

Eligibility criteria:
inclusion criteria: * bmi \>= 35 kg/m2 and at least one serious comorbidity (type 2 diabetes mellitus, moderate or severe obstructive sleep apnea, pseudotumor cerebri, and severe steatohepatitis) * bmi =\> 40 kg/m2 and a serious comorbidity (as listed above or at least one other comorbidity (mild obstructive sleep apnea, hypertension, insulin resistance, glucose intolerance, dyslipidemia, impaired quality of life or activities of daily living) * must live in dallas/fort worth area so that necessary follow-up can be ensured. exclusion criteria: * intention to have another surgical procedure for weight reduction within 12 months of lap-band® placement * history of pregnancy, or the intention to become pregnant within the next 12 months * history of substance abuse within one year prior to surgery * obesity caused by medically correctable condition * history of gastric or esophageal surgery, or the presence of an esophageal dysmotility disorder * eating disorder that is untreated * chronic use of aspirin and/or nonsteroidal anti-inflammatory medications and unwillingness to discontinue the use of these medications * history of previous bariatric surgery, intestinal obstruction, or peritonitis * presence of localized or systemic infection at the time of surgery * history of congenital or acquired anomalies of the gastrointestinal tract * history of immunocompromise, or auto-immune, hematologic or dermatologic condition that increases risk of bleeding, breakdown of skin integrity (due to port), or infection. * planning to or having high likelihood of moving out of region within 2 years * portal hypertension or cirrhosis * uncorrectable coagulopathy or severe bleeding disorder * use of weight loss medications within 6 weeks of procedure

Keywords: obesity adolescent pediatric weight loss bariatric surgery gastric banding
effect of intraoperative dexmedetomidine on lung protection following thoracic aorta surgery with hypothermic circulatory arrest: a randomized clinical trial

Conditions: Chronic Dissecting Aneurysm of Thoracic Aorta; Chronic Nontraumatic Dissection of Thoracic Aorta; Dissecting Aneurysm of the Thoracic Aorta

Summary: dexmedetomidine has been known to protect the lung against inflammation and oxidative stress in diverse clinical settings. the investigators aimed to investigate the lung protective effect of dexmedetomidine in patients undergoing thoracic aortic surgery with hypothermic circulatory arrest, which is associated with systemic inflammatory response, and oxidative stress.

patients will be divided into 2 groups; dexmedetomidine group and control group. dexmedetomidine group will receive dexmedetomidine during and after thoracic artery surgery. and control group will receive the same amount of normal saline instead. analyzing patients lung function and serum factors, which indicates the degree of systemic inflammatory responses and oxidative stress, the investigators will investigate the protective effect of dexmedetomidine on lung.

Eligibility criteria:
inclusion criteria: * patients undergoing thoracic aorta surgery with hypothermic circulatory arrest, over 20-of age exclusion criteria: * unstable vital sign before surgery * severe pulmonary disease requiring consistent treatment * illiterate * pregnancy