Kornimate/medical-research-clean huggingface dataset:
a multicenter study of pulsed field ablation for paroxysmal supraventricular tachycardia

Conditions: Paroxysmal Supraventricular Tachycardia; Atrioventricular Nodal Reentrant Tachycardia; Atrioventricular Reciprocating Tachycardia

Summary: the purpose of this study was to explore the safety and efficacy of pulsed field ablation（pfa) in the treatment of paroxysmal pupraventricular pachycardia（psvt）with a contact force(cf)-sensing pfa catheter

the primary efficacy endpoints were to evaluate the acute and 6-month follow-up success rate after pfa without the use of antiarrhythmic drugs . the primary safety endpoints were to assess the incidences of serious adverse events (saes) at the end of the procedure , discharge and during the 6-month follow-up period.

Eligibility criteria:
inclusion criteria: 1. age from 18 to 80 years, 2. episode of psvt recorded by a 12-lead surface electrocardiogram (ecg), 24-hour holter monitoring, or esophageal electrophysiologic study (ees) before hospitalization 3. reproducible clinical tachycardia confirmed by the electrophysiological study (eps). exclusion criteria: 1. previous failure or recurrence of radiofrequency ablation 2. left ventricular ejection fraction (lvef) ≤ 40% 3. combined with atrial flutter or atrial fibrillation 4. combination of thromboembolic disease 5. women who are breastfeeding, pregnant or planning to become pregnant during the study period 6. carrying active implants in the body (e.g., pacemakers, icds, etc.) 7. patients with second-degree (type ii) or third-degree atrioventricular block 8. nyha class iii-iv cardiac function \[appendix 1\] 9. patients with congenital heart disease (excluding atrial septal defect and patent foramen ovale) 10. patients with definite acute cerebrovascular disease (including cerebral hemorrhage, stroke, transient ischemic attack) within the last 1 month 11. cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy) 12. acute or severe systemic infection 13. patients with severe liver and kidney diseases, malignant tumors and end-stage diseases 14. patients with significant bleeding tendency, hypercoagulable state and serious hematologic disorders 15. patients who have participated or are participating in other clinical trials within 3 months before enrollment 16. patients who have other conditions that the investigator considers inappropriate for participation in this trial.

Keywords: pfa psvt avnrt avrt
treating the fear of gaining weight in anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the main aim of this study is to develop a virtual reality (vr) embodiment-based exposure technique to improve the treatment of anorexia nervosa (an). a systematic and hierarchical body exposure intervention in which the patient owns a virtual avatar is proposed. at first, the virtual body matches with the real measurements of the patient, then the experimenter will progressively increase body mass index (bmi) values of the virtual body during the exposure sessions until a healthy bmi value is reached (e.g. bmi score of 20). in this study a vr embodiment-based technique that combines visuo-motor and a visuo-tactile stimulation procedures is proposed in order to increase illusory feelings of ownership over the virtual body. it is hypothesised that adding a vr-based body exposure intervention to the classical cognitive behavioral therapy (cbt) will significantly reduce symptomatology in an patients.

in order to evaluate the efficacy of the addition of a vr body exposure component to the usual treatment, a randomized controlled clinical trial will be conducted. 54 patients with a primary diagnosis of anorexia nervosa and a bmi \> 18.5 will be randomly assigned to the experimental group receiving vr body exposure in addition to cognitive behavioral therapy or control group, which receives cognitive behavioral therapy only. data regarding eating disorder symptomatology and body related attention will be collected before and at the end of the intervention, as well as after six months of follow-up. in the systematic and hierarchical vr body exposure intervention, which consists of 5 weekly exposure sessions, patients will gradually be exposed to increases in the bmi of their virtual avatar. each session starts by inducing illusory feelings of ownership over the virtual body by the means of visuo-tactile and visuo-motor stimulation. then patients are exposed to their virtual bodies in order to achieve the habituation or extinction of the anxiety response to their body image and, consequently, reduce the fear of gaining weight. during exposure, patients will be asked to focus on different parts of the virtual body, by asking what they think and feel about them. body ownership illusion, body-related anxiety and fear of gaining weight will be assessed within each session by means of visual analogue scales.

Eligibility criteria:
inclusion criteria: * patients with primary diagnosis of anorexia nervosa (dsm-v) * from the age of 14 years * with bmi \<18.5 exclusion criteria: * visual deficits * epilepsy or neuroleptic medication * psychotic disorder * bipolar disorder * medical complications * pregnancy * clinical cardiac arrhythmia
an exploratory investigation to assess changes in quality of life for individuals with type 2 diabetes after taking a meal-replacement shake.

Conditions: Diabetes Mellitus, Type 2

Summary: this is an open-label single-arm observational trial to study the effectiveness of a commercially available meal-replacement shake and its effect on the quality of life in individuals with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * male or female between 18-75 years old * diagnosed with type 2 diabetes for at least 3 months * hba1c of 7.5 to 10% inclusive * bmi of 27 to 40 kg/m2 * if on any medication, treated with a stable dose for at least 90 days * must be in good health (don't report any medical conditions asked in the screening questionnaire) * willing and able to provide written informed consent * must have a glucometer at home exclusion criteria: * diagnosis of type 1 diabetes * have a history of severe hypoglycemia or hyperglycemia requiring hospitalization within the prior 6 months * use of dietary supplements or meal-replacement shakes targeted at diabetes and unwilling to stop using them for the duration of the study * allergies to any test product ingredients * has any of the following medical conditions: * oncological conditions * psychiatric disease * cardiovascular disease: any hospitalization within the past 3 months * multiple sclerosis * gastrointestinal conditions such as celiac disease, crohn's disease, etc. * any other severe chronic disease * history of drug or alcohol abuse * females who are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding during the course of the study * participation in a clinical research trial within 30 days prior to screening * participating in an investigational health product research study * any disorder, unwillingness, or inability, which in the investigator's opinion, might jeopardize the individual's safety or compliance with the protocol
validation of ultrasound "angle of progression" measurement to decrease the cesarean rate

Conditions: Prolonged Second Stage of Labor

Summary: ultrasound during labor and measurement of angle of progression showed extensive prospective and retrospective publications since 2010. the investigators performed between 2013 and 2016 the only one multicenter, randomized controlled trial comparing digital exam to angle of progression after a prolonged 2-hour second stage of labor with uncertain fetal head. the investigators consider a cut off of 120° to accepted vaginal birth among cephalic occiput anterior position this randomised pilot study showed that measurement of angle of progression in addition to digital exam reduced caesarean delivery from 41% to12% ( n= 33, p=0,06). doi: 10.1016/j.ajog.2022.04.018. the objective of this new study is therefore to validate the results of this pilot study in a more powerful multicenter randomized trial (delivery).


Eligibility criteria:
inclusion criteria: * nulliparous or multiparous women with no history of vaginal delivery, * \> or = 37 weeks amenorrhoea * cephalic presentation in anterior position (occipito-pubic position, left anterior occipito-iliac and right anterior occipito-iliac ) confirmed by ultrasound * uncertain fetal head engagement on digital examination or midline fetal presentation in prolonged second stage of labor (at least 2 hours), exclusion criteria: * multiparous women who were previous vaginal deliveries, * presentation other than cephalic, * twin pregnancies, * posterior or transverse position * transperineal ultrasound for head-perineum distance measurement * fetal heart rate abnormalities requiring rapid delivery, * contraindication to vaginal delivery whether maternal or fetal

Keywords: angle of progression cesarean delivery transperineal ultrasound
buddy taping compared to splint immobilization for displaced paediatric finger fractures

Conditions: Fracture Finger

Summary: fracture immobilization with buddy taping is not inferior to splint immobilization for non-displaced extra-articular paediatric finger fractures. however, whether the same applies for reduced finger fractures is unclear.

displaced fractures will be reduced in the paediatric ed by emergency physicians. after fracture reduction, fracture immobilization will either be done with a splint immobilization or a fingertaping. after 4 and 21 days, clinical and radiographic controls will take place at the hand surgery outpatient clinic.

Eligibility criteria:
inclusion criteria: * extraarticular displaced finger fractures of the proximal or middle phalanges exclusion criteria: * fractures of the thumb * fractures that are open, instable, pathologic or multifragmented * multiple fractures of the hand * phalangeal neck fractures * presentation later than 5 days after the injury
human challenge study to evaluate the efficacy of mv-012-968 vaccine

Conditions: RSV Infection

Summary: the purpose of this research study is to evaluate whether the investigational, live attenuated, intranasally delivered vaccine mv-012-968 ('study vaccine') may have prophylactic efficacy against symptomatic rsv infection when administered to adults 18-45 years of age in the human viral challenge model.


Eligibility criteria:
key inclusion criteria: 1. an informed consent document signed and dated by the participant and the investigator. 2. aged between 18 and 45 years old on the day of signing the consent form. 3. in good general health with no history, or current evidence, of clinically significant medical conditions (including respiratory, cardiac and immunodeficiency), and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination (including vital signs), electrocardiogram (ecg), and routine laboratory tests as determined by the investigator. 4. a documented medical history prior to enrolment. 5. females of child bearing potential must have a negative pregnancy test prior to enrollment. 6. females and males must agree to adhere to the highly effective contraceptive requirements of the study from 2 weeks prior to the first study visit until 90 days after the date of study vaccination. 7. sero-suitable to the challenge virus, as defined in the study analytical plan. exclusion criteria: 1. history of symptoms or signs suggestive of upper or lower respiratory tract infection within 4 weeks prior to the first study visit 2. rhinitis which is clinically active 3. history of moderate to severe rhinitis 4. acute sinusitis during screening 5. use of corticosteroid in respiratory tract (e.g. nasal or inhaled steroid) in the 30 days leading up to study vaccination 6. females who are breastfeeding or have been pregnant within 6 months prior to the study 7. participants who have smoked ≥ 10 pack years at any time \[10 pack years is equivalent to one pack of 20 cigarettes a day for 10 years\]) 8. positive human immunodeficiency virus (hiv), active hepatitis a (hav), b (hbv), or c (hcv) test 9. those employed or immediate relatives of those employed at hvivo or the sponsor 10. participants may not live or work in direct close contact with, or live with anyone whose work brings them into direct close contact with, children under 2 years of age 11. any other finding that, in the opinion of the investigator, deems the participant unsuitable for the study

Keywords: rsv vaccine live attenuated intranasal challenge phase 2 safety efficacy
ethnic differences and the ischemia/bleeding risk of dapt duration

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Dual Antiplatelet Therapy

Summary: this study is an individual patient level meta-analysis of randomized clinical trials, to evaluate the influence of ethnicity, to study whether the relative tradeoff between ischemia and bleeding is distinct by ethnicity.


Eligibility criteria:
inclusion criteria: * patients enrolled in previous rcts related to the duration of dural antiplatelet agent therapy
evaluation of spinal mobility reeducation in patients treated for a lumbar spinal stenosis after epidural infiltration

Conditions: Lumbar Spinal Stenosis

Summary: in actual practice the patients with mild or moderate lumbar spinal stenosis symptoms receive an epidural infiltration and participate in kyphosis reeducation in first intention. yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. the study assume that the spinal mobility reeducation will reduce the incidence of pain recurrences compared with the classic kyphosis reeducation.

the standard treatment of lumbar spinal stenosis is the lumbar canal recalibration surgery which presents co-morbidity factors and risks of post-operative complications. the non-invasive methods are a good alternative compared with the surgery : the patients medically treated present few damages and the results of the postponed surgery are equivalent to the immediate surgery. that is why a non-surgical treatment is proposed in first intention to the patients with mild or moderate symptoms : this treatment associates an epidural infiltration and a kyphosis reeducation. yet the kyphosis reeducation did not show a real profit in the time compared with the natural evolution of the pathology. the benefits of the infiltration are lost three months after this one in 80 % of the cases. a return to physical activity and a restored spinal mobility would improve the duration of the infiltration effect. the objective is then to compare the efficiency of a spinal mobility reeducation program versus a kyphosis reeducation program in patients with acquired and central lumbar spinal stenosis. it is a prospective, monocentric, randomized, superiority and parallel-group study : * group c (control group) : kyphosis reeducation + patient education + auto-reeducation at home, * group m (test group) : spinal mobility reeducation + patient education + auto-reeducation at home.

Eligibility criteria:
inclusion criteria: * age \> 50 years, * central, acquired and multi-staged lumbar spinal stenosis, * pain since at least three months, * radicular pains higher than the lumbar pains, * walking distance \< 1000 m, * oral consent. exclusion criteria: * intercurrent pathology limiting the walking distance (arteriopathy, cardio-respiratory insufficiency, disabling arthrosis affecting the lower limbs...), * history of spinal surgery for lumbar spinal stenosis, * extended lumbar arthrodesis (equal to or greater than 2 levels), * monosegmental and degenerative spondylolisthesis, * foraminal stenosis, * motor deficit of the lower limbs or cauda equina syndrome ("cauda equina" syndrome (ces) is a serious neurologic condition in which damage to the cauda equina causes acute loss of function of the lumbar plexus, (nerve roots) of the spinal canal below the termination (conus medullaris) of the spinal cord), * bleeding disorders or allergies contraindicating the epidural infiltration.

Keywords: lumbar spinal stenosis
anesthesia management of retroperitoneal adrenalectomies

Conditions: Adrenal Tumors

Summary: this study is a prospective, perioperative evaluation of hemodynamic and respiratory parameters in patients undergoing retroperitoneoscopic adrenalectomies.

due to their underlying disease, patients with adrenal tumors are prone to episodes of hyper- and hypotension. furthermore, excessive hypercarbia and an increased arterial-alveolar co2 difference can be seen during these operations.

Eligibility criteria:
inclusion criteria: * patients with an adrenal tumor exclusion criteria: * age below 18 years

Keywords: retroperitoneoscopic adrenalectomy intraoperative arterial-alveolar carbon dioxide difference
methadone-maintained smokers switching to e-cigarettes

Conditions: Nicotine Dependence; Electronic Cigarette Use

Summary: participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ecs). there will be a total of 7 study visits over the course of 6 weeks; each visit includes psychometric assessment and biomarker measurements. after completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of ec use (juul 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (nrt) in the form of nicotine lozenges. ec and nrt use will begin the day after the baseline assessment.

participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ecs). there will be a total of 7 study visits over the course of 6 weeks: baseline, 5 weekly check-in (ci) visits, and a 6-week assessment. baseline assessments will include biomarker measurement, carbon monoxide (co) readings, smoking history and current cigarette use, spirometry, respiratory symptoms, and tobacco demand. after completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of ec use (juul 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (nrt) in the form of nicotine lozenges. ec and nrt use will begin the day after the baseline assessment. all participants will attend weekly brief assessment check-in visits where distribution of either ec or nrt will occur. check-in assessments will include cigarette use, ec use, nrt use, co readings, respiratory symptoms, and tobacco demand. at the 6-week assessment, baseline measurements will be repeated to determine changes in the health effects, biomarkers, and combustible cigarette use associated with 6 weeks of ec use, relative to nrt. this study will be the first to test the potential behavioral and health effects of ecs in smokers with opioid use disorder, a population that is highly dependent on nicotine, highly vulnerable to smoking-related morbidity and mortality, and searching for novel methods to lower smoking-related risks.

Eligibility criteria:
inclusion criteria: * moderate to heavy cigarette smokers (10 cigarettes/day for \> 1 yr; breath co \> 10 ppm) * have been receiving methadone for at least three months * attend at least weekly to receive methadone dose * speak english * have a telephone or access to a telephone * are available over the next 6 weeks * are interested in switching to either electronic cigarettes or nicotine replacement therapy exclusion criteria: * use of ecs on \> 2 of the past 30 days * currently use medications that may reduce smoking (e.g., bupropion, varenicline, nrt) * have unstable psychiatric conditions * have near-daily or daily use of marijuana * are pregnant * had a cardiovascular event in the last month * daily medication for asthma or copd
excision followed by radiofrequency ablation for breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (rfa) of breast cancer lumpectomy sites to extend the "final" negative margin and consequently decrease the rates of re-operation. during the initial breast conservation procedure (lumpectomy), immediately following routine surgical resection of the tumor, radiofrequency energy (rfa) is applied to the wall (bed) of the fresh lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the resected specimen.


Eligibility criteria:
inclusion criteria: * patient is a female, ≥ 50 years of age * the tumor size is ≤ 3 cm (on pre-study radiologic or clinical exam) * the tumor is unicentric and unilateral * the tumor is not involving the skin * pathology confirms ductal in situ (dcis) or infiltrating ductal carcinoma (idc), grade i-iii * if tumor is idc, pathology must be hormone receptor positive (er+ and/or pr+) * patient signs current written informed consent and hipaa forms exclusion criteria: * patient is under 50 years of age * patient is male * tumor \> 3 cm in diameter * bilateral malignancy * clinically positive lymph nodes * tumor involving the skin * pathology confirms invasive lobular carcinoma * breast implants * less than 2 years disease-free survival from previous breast cancer * neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years

Keywords: breast conservation therapy lumpectomy radiofrequency ablation radiation
oral dexamethasone for postoperative nausea and vomiting after laparoscopic cholecystectomy

Conditions: Postoperative Nausea and Vomiting

Summary: postoperative nausea and vomiting (ponv) are common complications after laparoscopic cholecystectomy. this study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone at night before surgery in preventing ponv after elective laparoscopic cholecystectomy.

background: postoperative nausea and vomiting (ponv) are common complications after laparoscopic cholecystectomy. this study aims to evaluate the efficacy of the administration of prophylactic oral dexamethasone 12 hours before induction of anesthesia in preventing ponv after elective laparoscopic cholecystectomy, as it reaches its peak effect at 2-12 hours and lasts for 72 hours after oral administration. methods: this is a parallel, two-arm, randomized (1:1), controlled, single-center non-inferiority trial. adults (≥18 years) with asa physical status i-iii scheduled for elective laparoscopic cholecystectomy will be eligible for inclusion. the participants will be randomized to receive either 8 mg of iv dexamethasone at the time of induction of anesthesia or 8 mg of oral dexamethasone 12 hours before induction of anesthesia. the primary outcome will be the incidence of postoperative nausea and vomiting. a total of 814 patients are intended to be recruited for this non-inferiority trial. discussion: the current randomized trial is exploring the non-inferiority and feasibility of oral dexamethasone at night to reduce the ponv after laparoscopic cholecystectomy when compared to the standard of care - intravenous dexamethasone at the time of induction. additionally, the investigators suppose oral dexamethasone at night is easier to administer, avoids polypharmacy at the time of induction of anesthesia, avoids the unpleasant sensation of intravenous injection, and is at a lower cost for a one-day surgery.

Eligibility criteria:
inclusion criteria: * all consecutive adults (older than 18 years) with asa physical status i-iii undergoing elective laparoscopic cholecystectomy surgery. exclusion criteria: * steroids or antiemetics within 1 week of surgery * chronic opioid therapy * history of allergy to any of the study drug * serum creatinine \> 1.4 mg/dl * liver enzymes \> triple the normal limits * pregnancy * patient refusal * and psychiatric or neurologic diseases or socioeconomic status that would hinder the postoperative quality of recovery questionnaire * laparoscopic surgery is converted to open surgery after enrollment