Kornimate/medical-research-clean huggingface dataset:
peri-operative slow-paced breathing to reduce anxiety in breast cancer surgery patients

Conditions: Anxiety

Summary: the purpose of this single-center trial is to examine the effects of a slow-breathing technique performed at induction of anesthesia in patients undergoing surgery for breast cancer on anxiety, scored by spielberger's state-trait anxiety inventory, state scale (stai-s),13 compared to usual care.

rationale: in the perioperative period anxiety for anesthesia and the surgical procedure is common. breast cancer surgery patients have a higher level of anxiety compared to other patients undergoing (cancer) surgery. relaxation techniques, like breath focus with deep belly breathing are easy to learn and can have a beneficial effect on postoperative anxiety, pain, and postoperative nausea and vomiting (ponv), but the quality of evidence is low. slow paced breathing at a frequency of 6 breaths per minute can possibly increase vagal activation, decrease anxiety, reduce mean blood pressure, and postoperative pain. the investigators aim to apply a pre-trained slow paced breathing technique at induction of anesthesia for surgery, to reduce perioperative anxiety and to explore effects on pre-operative blood pressure, per-operative need of hypnotics, postoperative pain and opioid use, ponv and patient satisfaction. objective: this study aims to examine the effects of guided slow paced breathing performed at induction of anesthesia in patients undergoing surgery for breast cancer on anxiety, scored by spielberger's state-trait anxiety inventory, state scale (stai-s), compared to usual care. study design: single center, two-group, prospective, randomized controlled trial study population: patients scheduled for surgery for breast cancer in the antoni van leeuwenhoek hospital. intervention: performance of pre-trained guided slow paced breathing by the patient at induction of anesthesia for breast surgery. main study parameters: anxiety scored by spielberger's state anxiety inventory (stai-s) nature and extent of the burden and risks associated with participation, benefit and group relatedness: there are no risks related to the intervention. participants randomized in the intervention group are trained in slow paced breathing after inclusion and asked to practice the technique daily until the day of surgery. all participants are asked to complete three questionnaires at baseline, and two short questionnaires on the day of surgery and at day 1.

Eligibility criteria:
inclusion criteria: * female * undergoing surgery for breast cancer in the antoni van leeuwenhoekziekenhuis exclusion criteria: * age \< 18 years * asa ≥ 4 * history of severe pulmonary illness: severe asthma or severe chronic obstructive pulmonary disease (copd) gold iii or iv * known or suspected severe psychiatric disorder * unable to give written or oral informed consent * patient refusal * not able to understand dutch * no internet access * visual or hearing impairments interfering with reading and listening to the online material
online yoga for individuals with mood disorders

Conditions: Mood Disorders; Bipolar Disorder; Depression

Summary: we are seeking to understand the acceptability of an online yoga class for individuals with mood disorders. moodnetwork members who are 18 years old or over who have experienced depression, mania, or hypomania are invited to participate. about 200 moodnetwork participants will take part in this study.

yoga practitioners view yoga as a way to promote good physical and mental health, rather than as a treatment for poor health. this world view may be appealing to patients, especially those concerned with the stigma of conventional mental health treatment, or with the narrow focus on decreasing symptoms (instead of a broader focus on living to one's full potential) that defines much of conventional mental health treatment. yoga classes are widely available and relatively inexpensive compared to other depression treatments. yoga can be practiced at home with the aid of video recordings or books. we propose to examine the acceptability and feasibility of online yoga practice for individuals with depression, mania, or hypomania.

Eligibility criteria:
inclusion criteria: * fluent in english * over age 18 * self-report of having experienced depression, mania, or hypomania in their lifetime exclusion criteria: * any contraindication to exercise (e.g., pregnant, physical injuries or any other reason prohibiting exercise).
detection of anastomotic leakage after esophageal surgery

Conditions: Esophageal Cancer; Anastomotic Leakage

Summary: anastomotic leakage is a major complication in esophageal surgery. although contrast swallow is the current standard to exclude anastomotic leakage postoperatively, endoscopy may be superior. this is the first study to compare radiographic contrast study and endoscopy for the identification of local complications after subtotal esophagectomy.

this prospective, blinded, intraindividual controlled study will be conducted with patients with transthoracic esophagectomy due to esophageal cancer. a radiographic contrast study will be performed prior to endoscopy at the 5th to 7th postoperative day. the investigators will not be aware of the results of the corresponding examination. sensitivity, specificity and feasibility of the radiologic and endoscopic evaluation of the esophageal substitute will be compared.

Eligibility criteria:
inclusion criteria: * patients with primary esophageal cancer undergoing transthoracic esophagectomy. exclusion criteria: * no transthoracic resection * no primary anastomosis * recurrent disease * refusal to participate

Keywords: detection of anastomotic leakage esophageal resection diagnostic safety
ct for pulmonary thromboembolic disease

Conditions: Pulmonary Embolism

Summary: examine the feasibility and efficacy of individually optimized uniform contrast enhancement in ct pulmonary angiography (ctpa) for the diagnosis of pulmonary thromboembolic disease.

patient characteristics, qualitative image quality scores, and quantitative contrast enhancement and cnr will be described using mean values and standard deviations for continuous variables, and frequencies and percent for categorical variables. difference between the two patient groups will be compared using wilcoxon signed rank tests and chi-square statistics for continuous and categorical variables, respectively. all statistical tests will be performed at a significance level of 0.05.

Eligibility criteria:
inclusion criteria: * patients 18 years old or older * patients who have been recommended for ctpa scan for the diagnosis of pulmonary; thromboembolic disease (pe) in the department of diagnostic radiology and nuclear medicine at the university of maryland-patients whose body mass index (bmi) is greater than 30 kg/m2. * patients whose body mass index (bmi) is greater than 30 kg/m2 * patients who signed the university of maryland medical center consent for intravenous contrast administration exclusion criteria: * pregnant or breast-feeding women; female participants of childbearing age (10 - 60 years) will be screened for their pregnancy status prior to study registration, by following the department of diagnostic radiology and nuclear medicine clinical standard procedure di-aop-003 "pregnancy screening documentation"; - patients with decreased renal function34-36. this is evaluated by blood work checked within 30 days prior to the ctpa scan with contrast. patients cannot receive contrast if their bun index is not within \[7-20\] or creatinine is not within \[0.5 - 1.4\] mg/dl * patients with decreased renal function34-36. this is evaluated by blood work checked within current admission for inpatients or within 30 days for outpatients prior to the ctpa scan with contrast. patients cannot receive contrast if their serum creatinine level exceeds 2.0 mg/dl * patients with known moderate or severe allergic reactions to contrast, including but not limited to: shortness of breath, a change in baseline vital signs, such as a change in blood pressure, tachycardia, increased respirations that can progress to major respiratory distress, laryngeal edema, bronchospasm, arrhythmias, convulsions, and cardiopulmonary arrest.

Keywords: pulmonary thromboembolic lung
comparing a patient self-assessment software to treatment as usual in opioid prescriber and patient opioid outcomes

Conditions: Opioid-use Disorder; Opioid Misuse; Opioid Use; Chronic Pain

Summary: the care continuity program (ccp), a product of sure med compliance, is a novel, online patient self-assessment used by prescribers of opioids to better identify patient risk factors and therapy benefit. this tool is completed by the patient, outside of the office, using an internet enabled device and follows a compliance driven protocol developed by analyzing case law against physicians in mis-prescribing opioid cases. results, in the form of a date and time stamped legal report, are instantly transmitted to the prescriber's electronic health records, mitigating the prescriber's civil and criminal risk. a brief of findings is displayed within the software through a dashboard and on the summary page of the report. this software offering includes a mobile and standard web-based application. the objective of the proposed research is to validate the protocols and delivery system of the ccp by measuring patient outcomes, prescriber confidence, and completeness of documentation in the patient chart in primary care and pain management settings, pre and post implementation of the ccp.


Eligibility criteria:
inclusion criteria: * prescribed an opioid at a participating clinic * completed a baseline ccp assessment * report functional impairment due to chronic pain * report at least a 4 out of 10 on pain intensity * have no psychiatric, mental, or physical limitation that precludes participation in the trial exclusion criteria: * current cancer diagnosis * palliative or end of life care

Keywords: pain pain management patient risk patient-focused outcomes outcomes research patient care self assessment digital opioid epidemic opioid misuse patient safety prescription opioid software development opioid prescriber documentation legitimate medical purpose computer software electronic health record laws monitor medication compliance intervention chart documentation prescriber confidence nih heal initiative
evaluation of horizontal bone gain in the lower posterior partially edentulous patient comparing the stabilization of membranes with and without tacs

Conditions: Guided Bone Regeneration

Summary: to address the gap of knowledge in comparing between the bone augmentation outcomes with or without tacks for membrane stabilization


Eligibility criteria:
inclusion criteria: * patients with at least 1 missing tooth in the posterior mandibular area patients with an age above 18 years systemically healthy patients healed alveolar ridge for implant placement with: * deficient buccolingual dimension ( ≤5mm) * sufficient vertical height (≥ 10 mm) * sufficient mesio-distal width (≥ 6.5 mm) inter-arch space ≥ 7 mm to allow space for implant-supported crown presence of neighboring and opposing dentition soft tissue phenotype with keratinized tissue width (ktw) (≥2 mm) and gingival thickness (≥2 mm) good oral hygiene cooperative patients who accepted the trial follow up period and sign the informed consen exclusion criteria: * systemic diseases or medications that might affect bone metabolism, increase surgical risk or complicate post-operative healing untreated periodontal diseases history of radiation therapy to the head and neck heavy smokers (≥ 10 cigarettes per day) pregnant or lactating females alcoholism or drug abuse psychiatric problems patients with signs of acute infection related to the area of interest

Keywords: gbr tacs
vtx958 versus placebo for the treatment of active psoriatic arthritis (tranquility-psa)

Conditions: Psoriatic Arthritis

Summary: the objective of this study is to evaluate if vtx958 is safe and effective in adult participants with active psoriatic arthritis. approximately 195 eligible participants will take vtx958 dose a, vtx958 dose b, or matching placebo (no active drug) for 16 weeks and then move on to a 36 week long term extension (lte). the study will include 16 weeks of treatment, 36 weeks of lte, and a 30-day follow-up period.

this is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two doses of vtx958 tablets, dose a and dose b, in adults with active psoriatic arthritis. approximately 195 participants will be assigned in a 1:1:1 ratio to one of three groups, vtx958 dose a, vtx958 dose b, or placebo, for 16 weeks and then move on to a 36 week long term extension (lte). the study consists of a 30-day screening period, a 16 week double-blind treatment period, 36 weeks of lte, and a 30 day follow-up period.

Eligibility criteria:
inclusion criteria: * diagnosed with psoriatic arthritis for 6 months or more prior to screening * documented history or active signs of at least 1 confirmed lesion of plaque psoriasis and/or nail changes attributed to psoriasis * active psa as defined by 3 or more swollen joints and 3 or more tender joints at screening and day 1 * women must not be of childbearing potential or must agree to use a highly effective contraception during the study and for 30 days after the last dose of the study product * men with a partner who is of childbearing potential must agree to use condoms during the study and for 90 days after the last dose of study product exclusion criteria: * has non-plaque psoriasis at screening or day 1 * has inflammatory bowel disease or active uveitis * has a history of chronic or recurrent infectious disease * has a known immune deficiency or is immunocompromised * has hepatitis b or hepatitis c infection, human immunodeficiency virus (hiv), acquired immunodeficiency syndrome (aids), or active tuberculosis (tb) at screening

Keywords: tyk2 inhibitor psoriatic arthritis ventyx vtx958 tranquility
blinded user study for the evaluation of the acceptability and efficacy of one medical device in venous return in comparison with a control group

Conditions: Venous Disease; Quality of Life; Symptoms and Signs

Summary: the primary goal of this study is to assess in vivo the efficacy of the insoles, in improving venous return in subjects affected by this problem after 14 days of the initial measurements, by self-assessment, filling-in questions regarding quality of life, in comparison with a control group. the secondary goal of this study is to assess in vivo the acceptability of the subjects regarding the same medical device, after 14 days of using the medical device, by selfassessment, filling-in subjective evaluation questions.


Eligibility criteria:
inclusion criteria: * gender: female/male; * age: with 18 years old and older; * having signed an informed consent form (icf); * willingness, ability and likeliness to comply with all the study procedures and restrictions; * ability to give informed consent; * available during the entire study period; * understanding portuguese language: portuguese-speaking subjects capable of reading the documents; * affected by a symptomatic venous return problem; * with a score \>14 from the question 1 to 11 of the adapted civiq questionnaire; * with shoes suitable for insoles (with heel \<2.5cm); * having a size of 36 to 44; * is taking a venotonic as a regular therapy with a daily dosage; exclusion criteria: * known allergy or known history of hypersensitivity to the components of the investigational device and related compounds; * currently participating in another clinical study that may interfere with the study; * diagnosed skin diseases and/or cutaneous alterations on the test region (under the feet) that may impair the study (for example tattoos, marks, burns, scars, etc.); * diagnosed diseases that may impair the study (including but not limited to: diabetes, arteritis, phlebitis, etc); * under pharmacological treatments on the 30 days previous to the beginning of the study and during the entire period of the study that may impair it (including but not limited to: inflammatory drugs, any drug that might cover the signs and symptoms, drugs with arterial or venous indications, etc.); * having applied any type of topical product (pharmaceutical, cosmetic or other) with similar effect of the medical device under study, on the test region (feet) during the study, besides the investigational device; * having a stage of cvd c3 on the ceap classification; * having had a traumatic or neurological history in the last 6 months; * wearing an orthopaedic insole made by a health professional; * having a significant and disabling lower limb pain; * having a significant and disabling back pain; * having a contraindication to wearing insoles; * pregnancy or intention to conceive during the study; * breast-feeding.

Keywords: chronic venous disease, insoles, quality of life, symptoms, relief, venotonic
clinical value of heart rate variability indexes to predict outcomes after exercise training in chronic heart failure

Conditions: Heart Failure; Systolic Heart Failure

Summary: controlled exercise training is a valuable therapeutic addition to pharmacological treatment in most patients with chronic heart failure, reducing long-term mortality, preventing cardiac remodeling and improving functional capacity. despite the mechanism underlying its benefits might be multifactorial, a sustained improvement in autonomic balance is usually attributed as a major effect. nevertheless, not all eligible subjects show the same response to exercise, probably due to several differences in the subpopulations enrolled. the investigators hypothesize that some heart rate variability indexes could be valid tools to optimize the selection and follow-up of chronic heart failure patients to training

forty subjects followed in a university heart failure management program were prospectively included. all patients were evaluated before the randomization and after 24 weeks from enrollment. the investigators performed a detailed anamnesis and complete physical examination, doppler echocardiography, stress testing, 6-minute walk test, heart rate variability analysis, and quality of life test. patients were randomized either to a training group: performing a supervised training program, or a control group receiving usual care. all patients received an optimal pharmacologic treatment including diuretics, angiotensin converting enzyme inhibitors or angiotensin receptor blockers and beta-adrenergic blocking agents. all patients included in the training group attended a supervised program 3-days/week during 24 weeks (68-74 sessions). physical aerobic training appears to impart beneficial changes in autonomic control of patients with chronic heart failure through both parasympathetic and sympathetic control of hear rate. these effects produce changes in several heart rate variability indices as hf and rmssd related with parasympathetic tone.

Eligibility criteria:
inclusion criteria: * subjects followed in a university heart failure management program * maintained sinus rhythm * new york heart association functional class (nyha) i to iii and * lvef≤40% documented by echocardiogram * optimal pharmacologic treatment exclusion criteria: * history of stroke, myocardial infarction or extended anterior myocardial scar * revascularization procedures or recurrent angina within previous 3 months * orthopedic impairment * alcohol or drug abuse; * implant of pacemaker or cardioverter-defibrillator (aicd); * frequently ventricular dysrhythmias, * atrial flutter or fibrillation * insulin-dependent diabetes mellitus; * severe chronic obstructive pulmonary disease or renal dysfunction * comorbid non-cardiac disease limiting short term survival * previous enrollment in an et program * subjects at great propensity for noncompliance

Keywords: heart rate variability systolic heart failure physical exercise parasympathetic indexes
short term outcomes of tricuspid valve annuloplasty using a flexible band

Conditions: Valvular Heart Disease; Tricuspid Valve Regurgitation

Summary: functional tricuspid regurgitation (ftr) remains a common finding in patients with left-sided valvular heart diseases especially mitral valve regurgitation or stenosis. it is mainly caused by dilatation and flattening of the tricuspid valve (tv) annulus as a result of right ventricular (rv) enlargement and is inevitably affected by the rv function. multiple studies support the better outcome of using rigid ring annuloplasty over suture repair for treating ftr in concern with the durability and freedom from residual regurgitation. these studies refer the superiority of rigid ring annloplasty to the three-dimensional configuration achieved by such rings which matches the normal tricuspid annulus and, at the same time, to the rigid support of the annulus. on the other hand, other studies support the use of flexible prosthetic bands like dacron or polytetrafluroethilin (ptfe), especially over suture techniques, due to their easy applicability and availability with good postoperative results. therefore, suture annyloplasty became nowadays less convenient for ftr repair since both flexible bands and rigid rings appeared to offer good midterm outcomes in recent meta-analysis studies. however, the ideal annuloplasty method for repairing ftr is still debatable between the three-dimensional (3d) rigid rings versus flexible prosthetic bands. in this retrospective comparative study, we share our experience with flexible fashioned bands in ftr.


Eligibility criteria:
inclusion criteria: * all patients presented at assiut university hospital with tricuspid valve regurgitation exclusion criteria: * age less than 18 years old. * tricuspid valve stenosis. * organic tricuspid valve disease. * infective endocarditis on tricuspid valve.

Keywords: tricuspid valve tricuspid valve regurgitation tricuspid valve annuloplasty
effect of the mobiushd® in renal hemodialysis subjects with uncontrolled hypertension

Conditions: Uncontrolled Hypertension

Summary: this is a prospective, multi-center, open-label clinical trial intended to evaluate the safety and benefit of the mobiushd® system in renal hemodialysis subjects with uncontrolled hypertension.

renal hemodialysis patients with uncontrolled hypertension will be considered for the study. subjects who meet initial screening requirements will undergo non-invasive imaging of the carotid anatomy to assess adequacy of the anatomy to allow placement of the mobiushd® device. eligible subjects will receive an implant placed in the internal carotid artery. following implantation of the device, subjects will be followed for 60 months.

Eligibility criteria:
inclusion criteria: 1. age 21 years or above 2. end stage renal disease subjects receiving renal hemodialysis at least 3 months prior to procedure 3. hypertension that is unresponsive to medical therapy of at least 3 anti-hypertensive medication classes 4. deemed an acceptable candidate for the implant procedure by the investigator 5. adequacy of the carotid anatomy for treatment with the mobiushd implant based on non-invasive carotid duplex and cta imaging, and invasive carotid angiography exclusion criteria: 1. known or clinically suspected baroreflex failure or autonomic neuropathy 2. history of intradialytic hypotension within the past 3 months 3. secondary cause of hypertension except treated obstructive sleep apnea syndrome 4. bmi ≥ 45 kg/m2 5. presence of atherosclerotic plaque in the intended side for implantation as determined by carotid duplex

Keywords: uncontrolled hypertension end stage renal disease mobiushd