Kornimate/medical-research-clean huggingface dataset:
safety and electrical performances evaluation of navigo leads equipped with is4 connector

Conditions: Arrythmia, Implatable Cardioverter Defibrillation, Lead

Summary: the primary objective of this study is to assess the safety and electrical performance of left ventricular (lv) navigo 4lv leads, pre-shaped (s-shaped\&u-shaped: navigo 4lv 2d, navigo 4lv arc) and straight (navigo 4lv pilot), with is4 connector

the devices under investigation, navigo 4lv models pilot, 2d , and arc are the new quadripolar coronary venous leads with polyurethane lead body, intended to be used with defibrillators with ventricular resynchronization therapy. the new lead design with the presence of 4 electrodes that allows several combinations in programming pacing vectors, is intended to benefit both the patients by improving response to therapy, overcoming high pacing threshold and avoiding phrenic nerve stimulation, and the investigators by reducing the number of re-interventions needed. this clinical investigation is a pre-market release study intended to analyze safety and electrical performance of navigo 4lv leads pre-shaped (s-shaped \& u-shaped) and straight leads models. the primary endpoint data will be used to support the achievement of the ce mark of navigo 4lv leads. the primary endpoints will be evaluated at 1 month post-implantation; secondary endpoints will be evaluated up to 2 years post-implantation. the duration of patient inclusion will be approximately 10 months for pre-shaped navigo family (s-shaped \&u-shaped) and approximately 21 months for straight ones. the post implant follows-up visits will take place at hospital discharge, weeks 10, 6 months and every 6 months until 2 years.

Eligibility criteria:
inclusion criteria: * any patient presenting a crt-d indication as detailed in the esc guidelines * primary implant of a platinium 4lv crtd or upgrade from an existing icd connected to a rv lead with a df4 connector (df4llhh) to a platinium 4lv crt-d * signed and dated informed consent exclusion criteria: * patients for whom a maximum single dose of 300 µg dexamethasone sodium phosphate (dsp) eluted from the navigo 4lv lead maybe contraindicated * venous anomalies precluding transvenous implant (contraindication of a pacemaker or icd implant) * active myocarditis, pocket and/or lead infection * stroke/myocardiai infarction one month prior to implant * already included in another clinical study that could confound the results of this study. * inability to meet follow-up visits at the implanting centre as defined in the investigational plan. * patient less than 18 years old or under guardianship * known pregnancy, women in lactation period or in childbearing age without an adequate contraceptive method (failure rate \< 1%) * drug addiction or abuse

Keywords: safety , electrical performance
retrospective review of saphenous vein incompetence: venaseal versus endovenous thermal ablation

Conditions: Varicose Veins; Venous Reflux; Venous Insufficiency

Summary: this study is a retrospective, chart review of treatment of patients with symptomatic varicose veins. treated limbs must have the great saphenous vein and/or small saphenous vein treated with either cyanoacrylate closure (venaseal) or endothermal ablation (either radiofrequency ablation or endovenous laser ablation).

this single site, retrospective, comparison study aims to review up to 400 treated limbs with symptomatic varicose veins to compare the need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure in conjunction with either cyanoacrylate closure versus endothermal ablation of incompetent saphenous veins through 6 months of the index procedure. the overall cost of treatment for both groups will be compared. some of the secondary aims of this study include: 1. to assess changes in clinical, etiology, anatomy, and pathology (ceap) clinical class after completion of treatment. 2. to assess changes in revised venous clinical severity score (rvcss) and compare the two groups. 3. to assess the need for adjunctive therapies. 4. to record and compare retrospectively the adverse events between the two groups.

Eligibility criteria:
inclusion criteria: 1. limb with saphenous vein incompetence, treated with one of the following: venaseal ™ endovenous laser ablation radiofrequency ablation 2. ceap clinical class between 2-5 3. limb treated from october 1st, 2015-present 4. at least 2 months of follow-up post index procedure 5. treatment of either the great saphenous vein (gsv), the small saphenous vein (ssv), or both. treatment of accessory saphenous veins (asv) is allowed as long as either the gsv, ssv, or both the gsv and ssv were treated as well in that limb at the index procedure. exclusion criteria: 1. limb treatment of the accessory saphenous vein (asv) without concomitant great saphenous vein (gsv) and/or small saphenous vein (ssv) treatment 2. limb treatment for reasons other than symptomatic varicose veins 3. limbs without follow-up information at least 2 months following the index procedure 4. subjects who participated in another clinical trial as part of their saphenous vein treatment 5. investigator decision (concurrent condition that would make inclusion inappropriate, protected subject population) -

Keywords: venaseal symptomatic varicose veins
effects of pentazocine versus lorazepam on manic symptoms

Conditions: Bipolar Disorder; Schizoaffective Disorder; Manic Disorder; Mania; Manic State

Summary: pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals. to follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind study. we will examine whether pentazocine, an agent with kappa-opiate activity, decreases manic symptoms.

dysregulation of the opioid system may underlie the pathophysiology of mood disorders, such as bipolar disorder. drugs that modulate the opioid system might be effective treatments for bipolar disorder. the profile and actions of the kappa-opioid system make drugs that target this system particularly promising as a treatment modality, with relatively low risk of addictive properties. pentazocine is an approved drug for pain relief with a good side effect profile. it is predominantly a kappa opioid agonist with weaker side effects at mu opioid receptors, at which it is an antagonist. data from our open-label pilot study of pentazocine had promising results. we will follow up on these findings with a double-blind, active-control study of individuals with bipolar disorder or schizoaffective disorder who are currently hospitalized with acute mania. the antimanic effects of pentazocine will be compared with an active control (ativan).

Eligibility criteria:
inclusion criteria: * bipolar or schizoaffective disorder * currently manic * no acute medical issues * no substance withdrawal exclusion criteria: * unable to give informed consent * using opiates for pain management * history of head injury, dementia, or mental retardation * seizure disorder * glaucoma * unstable cardiac condition or arrhythmia * moderate-severe pulmonary disease * pregnancy

Keywords: bipolar disorder bipolar mania schizoaffective disorder schizoaffective mania mania kappa opiates opiates
effect of ultrasound-guided stellate ganglion block combined with facial nerve and glossopharyngeal nerve block on the treatment of sudden deafness

Conditions: Sudden Deafness

Summary: sudden deafness is a sudden, unexplained sensorineural hearing loss of ≥20 dbhl in at least two adjacent frequencies within 72 h. it may be accompanied by tinnitus, a sense of ear congestion, vertigo and other symptoms.stellate ganglion block increases the blood flow and blood velocity in the inner ear, keeping the body's vegetative, endocrine and immune functions normal.the branches of the facial and linguopharyngeal nerves are connected to the inner ear, and local injection can nourish the nerves and improve local circulation.


Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria for sudden deafness established by the editorial board of the chinese journal of otolaryngology, head and neck surgery and the chinese society of otolaryngology, head and neck surgery * age 18 to 80 years * asa classification ⅰ\~ⅲ grade exclusion criteria: * acoustic conductance test, vestibular function test, cranial mri, etc. suggest organic disease * people with coagulation disorders or on anticoagulation therapy * infection at the puncture site * severe systemic diseases that cannot cooperate with treatment

Keywords: sudden deafness stellate ganglion block facial nerve block glossopharyngeal nerve block
safety and efficacy of tauroursodeoxycholic acid versus ursofalk in the treatment of adult primary biliary cirrhosis

Conditions: Primary Biliary Cirrhosis

Summary: though ursodeoxycholate acid (udca) is the wellknown effective therapy for pbc, clinical effectiveness of udca may be limited by its poor absorption and extensive biotransformation. the more hydrophilic bile acid tauroursodeoxycholate (tudca) is the active ingredients of udca, and has been approved by state food and drug administration in china for treatment of cholesterol stones. so it is necessary to verify the efficacy and safety of tudca in the treatment of adult primary biliary cirrhosis. in this randomized, double-blinded, double-dummy, parallel-controlled and multicenter clinical trial, we detect the proportion of patients who had akp decline more than 25% as the primary outcome; decline of akp, total bilirubin, ggt, alt and ast as secondary outcomes after patients were treated with tudca or udca for 24 weeks.


Eligibility criteria:
inclusion criteria: * written informed consent * aged 18-70 years * increase in alkaline phosphatase for 2 folds or more * positive anti-mitochondrial antibody (ama) with presence of antibodies against the pyruvate dehydrogenase complex (ama-m2)；ama-negative patients should be diagnosed as pbc with histologic evidence. exclusion criteria: 1. patients who had been treated with udca, immunosuppressive medications within 3 months. 2. patients who had evidence of extrahepatic biliary obstruction 3. patients coinfection with hbv or hcv 4. patients with one of the followings: 1) hemoglobin(hb): \<11 g/dl in male, \<10 g/dl in female 2) white blood cell count \<3000/mm3 3) neutrophile granulocyte \<1500/mm3 4) platelet \<50000/mm3; 5) serum albumin \<3.3 g/dl 6) alanine aminotransferase(alt)≥10×uln and/or aspartate aminotransferase(alt)≥10×uln; 7) alt≥5×uln and/or ast≥5×uln coexisting with immunoglobulin g (igg) ≥2×uln; 8) total bilirubin ≥4×uln; 9) prothrombin time (pt) prolong 3 seconds or more, or pta ≦60%; 10) creatinine ≥4×uln. 5. patients with evidence of decompensated liver disease(ascites, gastrointestinal bleeding, hepatic encephalopathy et al.) 6. definitely diagnosed as hepatocellular carcinoma(hcc), probable hcc, afp\>100ng/ml.patients with afp\>2×uln while \<100ng/ml should re-test 2 weeks later. 7. body mass index \>28 kg/m2 8. drug or alcohol abuse. 9. patient with severe disease of heart, lung, kidney, alimentary canal, neural system, autoimmune disease or tumor 10. patient had or on the scheduled of organ transplantation; 11. patient for whom the follow-up is considered impossible 12. pregnant or nursing woman

Keywords: tauroursodeoxycholic acid primary biliary cirrhosis safety efficacy
aerobic versus combined exercise and diastolic dysfunction

Conditions: Diastolic Dysfunction; Heart Failure

Summary: thirty-two stable patients with chronic heart failure participated in an exercise rehabilitation program. they randomly assigned to aerobic exercise (aer) or combined aerobic and strength training (com). before and after the program, they underwent a symptom-limited maximal cardiopulmonary exercise testing and serial echocardiography evaluation examining the indices of diastolic dysfunction (dd).

thirty-two stable patients with chronic heart failure (age: 56 ± 10 years, ef: 32 ± 8%, 88 % men) participated in an exercise rehabilitation program. they randomly assigned to aerobic exercise (aer) or combined aerobic and strength training (com), based on age and peak oxygen uptake, as stratified randomization criteria. before and after the program, they underwent a symptom-limited maximal cardiopulmonary exercise testing (cpet) and serial echocardiography assessment to evaluate peak oxygen uptake (vo2peak), peak workload (wpeak), dd grade, right ventricular systolic pressure (rvsp) and ef.

Eligibility criteria:
inclusion criteria: * chronic heart failure exclusion criteria: * atrial fibrillation copd

Keywords: diastolic dysfunction exercise training
a study of psychosocial and behavioral determinants of differential rates of participant compliance in cpcra protocols

Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

Summary: to examine, in patients enrolled in protocols cpcra 006 and/or 007, the relationship between patient compliance and demographic, psychosocial, and lifestyle characteristics and health belief model premises (i.e., patient's perception of susceptibility to and severity of disease and perception of benefits and barriers to a particular treatment) in order to design more effective intervention protocols. patient noncompliance can influence the statistical findings of a clinical study, possibly resulting in an incorrect assessment of the effects of the investigational therapeutic agent. since the special populations targeted by the cpcra for inclusion in hiv-related clinical research do not typify those traditionally included in clinical trials or compliance research, it is necessary to elucidate and examine the special needs of these populations and to determine the extent to which these needs manifest themselves as potential barriers to protocol compliance.

patient noncompliance can influence the statistical findings of a clinical study, possibly resulting in an incorrect assessment of the effects of the investigational therapeutic agent. since the special populations targeted by the cpcra for inclusion in hiv-related clinical research do not typify those traditionally included in clinical trials or compliance research, it is necessary to elucidate and examine the special needs of these populations and to determine the extent to which these needs manifest themselves as potential barriers to protocol compliance. patients who are enrolled on protocols cpcra 006 and/or 007 are given a baseline questionnaire to complete during the enrollment visit for the qualifying treatment protocol. the survey concerns the patient's work, primary language, support systems, residence status, perception of disease and treatments, and substance use. at 4-month follow-up visits, patients are asked to complete a self-report questionnaire, which assesses the patient's perceptions of difficulties in protocol compliance requirements, clinic/office visits, and health beliefs. the duration of patients on this study will be defined by the qualifying protocol requirements.

Eligibility criteria:
patients must meet the following criteria: * new enrollment on cpcra 006 or cpcra 007. * life expectancy of at least 6 months. * willing and able, in clinician's opinion, to comply with treatment and clinical management. * able to read and write english or spanish. * consent of parent of guardian for patients under 18 years.

Keywords: acquired immunodeficiency syndrome aids-related complex
assessment of voiding after sling

Conditions: Post-operative Voiding

Summary: the purpose of this study is to compare the incidence of catheterization from discharge to 6 weeks postoperatively when using two methods of post-operative voiding evaluation after a mid-urethral sling procedure. the investigators' results may lead to a decreased use of indwelling catheters and their associated morbidity after outpatient sling surgery.

minimally invasive slings have demonstrated similar efficacy to earlier abdominal anti-incontinence procedures, but offer the benefit of shorter operating times, less voiding dysfunction, lower morbidity and are usually done as an outpatient procedure. despite the advantages, about 35% of patients are discharged home with indwelling catheters. indwelling catheters are bothersome for patients, costly to the healthcare system and are a source of significant morbidity. the challenge for pelvic surgeons performing anti-incontinence procedures is avoiding postoperative urinary retention while minimizing the use of catheters and their associated risks. a commonly described backfill-assisted voiding trial is used as a means of evaluating bladder function postoperatively. this method uses a low post-void residual as a specific criterion for discharge without a catheter. however, the validity of this method has never been critically evaluated. our recent observational study suggests that patients may be safely discharged without a catheter after a midurethral sling procedure based on their subjective assessment of the force of stream. our proposed study expands on this pilot data using a randomized trial to evaluate two methods of post-operative voiding evaluation. the results may lead to a decreased use of indwelling catheters and their associated morbidity after outpatient sling surgery.

Eligibility criteria:
enrollment: all patients,18-81 year old, undergoing an outpatient midurethral sling surgery will be screened for participation in the study at the preoperative visit. exclusion: 1. women undergoing concomitant urinary tract or pelvic reconstructive procedures 2. women with pelvic organ prolapse beyond the hymen 3. women who have undergone a different or same procedure for urinary incontinence in the past 4. women with neurological conditions, such as multiple sclerosis, spinal cord injury/pathology 5. cases complicated by a cystotomy or other complication necessitating postoperative catheterization 6. non-english speakers

Keywords: voiding trial sling post-operative assessment urinary retention
impact of advanced practical nursing intervention versus usual care on hypertension control : retrospective study

Conditions: Hypertension

Summary: hypertension is the most frequent chronic pathology in france and in the world. it is one of the main modifiable cardiovascular risk factors. in france, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. since 2018, a new profession has entered the french healthcare system: advanced practice nurses (apn). they have many broad skills, at the interface of nursing and medical exercises. the purpose of this interventional study is to assess the impact of apn on blood pressure (bp) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance. the hypothesis formulated is that an individual apn intervention, included in a usual hypertension management, improves bp control.

hypertension is the most frequent chronic pathology in france and in the world. it is one of the main modifiable cardiovascular risk factors. in france, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. since 2018, a new profession has entered the french healthcare system: advanced practice nurses (apn). they have many broad skills, at the interface of nursing and medical exercises. the purpose of this interventional study is to assess the impact of apn on blood pressure (bp) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance. the hypothesis formulated is that an individual apn intervention, included in a usual hypertension management, improves bp control. this study will be a retrospective quasi-experimental study, conducted at the diagnosis and therapeutic center of the hôtel-dieu university hospital, assistance publique - hôpitaux de paris, france. the timeframe of the study should is from september 2020 to july 2023.

Eligibility criteria:
inclusion criteria: * adult patient * being diagnosed with essential hypertension, * being followed by a md of the structure for hypertension management, * having received a proposition to meet an apn for hypertension management between the day hospitalization and the next md consultation, * having received a loaned tensiometer with instructions during the day hospitalization and explanations for hbpm protocol. exclusion criteria: * being diagnosed with secondary hypertension, * having apn follow-up before the day hospitalization, * being lost to follow-up in the twelve months after the md consultation * not having the bp measurement by obpm for the day hospitalization (baseline) and/or the endline (endline), * pregnancy * under guardianship or tutorship * state medical help

Keywords: advanced practice nurse hypertension therapeutic adherence trial
a study of ipatasertib in participants with mild, moderate or severe hepatic impairment compared to healthy participants

Conditions: Hepatic Insufficiency

Summary: this is a phase 1 study evaluating the pharmacokinetics, tolerability and safety of a single dose of ipatasertib in participants with mild, moderate or severe hepatic impairment compared to healthy participants.


Eligibility criteria:
inclusion criteria: * in good health (except for specific inclusion criteria related to hepatic impairment), as determined by the investigator, based on no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram, and vital signs * females will not be pregnant or breastfeeding, and must be either postmenopausal or agree to use a study-approved method of contraception from the time of signing the informed consent until 30 days after discharge * males will either be sterile or agree to use male condom with spermicide from check-in (day -1) until 90 days following the dose of study drug additional inclusion criteria for healthy subjects only: - liver enzyme tests must be less than or equal to the upper limits of normal additional exclusion criteria for hepatic impaired subjects only: - hepatic impairment must have a child-pugh score of 5 to 6 (mild), 7 to 9 (moderate), or 10 to 15 (severe) and have stable hepatic insufficiency within 1 month prior to screening exclusion criteria: * history of ulcerative colitis or stomach or intestinal surgery or resection * history of unstable diabetes mellitus * history of alcoholism or drug addiction within 1 year prior to check-in (day -1) * use of oral, implantable, transdermal, or injectable contraceptives from the time of signing the informed consent (females only) or 10 days prior to check-in through 45 days after the dose administration * poor peripheral venous access * receipt of blood products within 2 months prior to check-in additional exclusion criteria for healthy subjects only: * use of any tobacco- or nicotine-containing products within 6 months prior to check-in and during the entire study * significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder additional exclusion criteria for hepatic impaired subjects only: * any evidence of progressive liver disease that has worsened or is worsening within 1 month prior to the screening visit * participant has shown evidence of hepatorenal syndrome * ascites requiring paracentesis * participant has required treatment for gi bleeding within 12 months prior to check-in * participant has required additional medication for hepatic encephalopathy within the 12 months (6 months for severe hepatic impairment) prior to check-in * total bilirubin levels \>6 mg/dl