cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial of the Use of Remote Heart Rhythm Monitoring With a Smartphone After Cardiac Surgery

The objective of the study is to evaluate the clinical consequences following the detection of postoperative atrial fibrillation or flutter (POAF) using a remote heart rhythm monitoring strategy with a photoplethysmography based smartphone technology in the early postoperative period after discharge.

A predefined subgroup analysis of the outcomes described below will be performed in the following subgroups:

* Subjects not on anticoagulation drug therapy (for a planned duration of \>45 days) at discharge.
* Subjects with no history of AF prior to surgery and no POAF lasting \>24h in hospital.
* Subjects with a CHADSVASC score ≥ 4 or a CHADSVASC score ≥ 2 with at least one additional risk factor associated with the risk of developing POAF.

additional risk factors include:

* chronic obstructive pulmonary disease
* sleep apnea
* impaired renal function
* left atrial enlargement
* elevated body mass index
* combined CABG with valve repair or replacement

Eligibility Criteria:
Inclusion Criteria:

* Subject underwent any of (including a combination of) the following surgical procedures during index hospitalization. (coronary artery bypass graft, surgical repair or replacement of a cardiac valve)
* Subject provides informed consent
* Subject understands and agrees to comply with planned study procedures.
* Subject is able to perform heart rhythm measurement using the FibriCheck application at home.

Exclusion Criteria:

* Pacemaker dependent heart rhythm
* Permanent AF/Aflutter or AF/Aflutter present at the time of inclusion
* Insufficient cognitive or comprehensive level of Dutch to participate to the trial.
* No smartphone available at home.
Early Postoperative Blood Glucose Variability and Outcome After TAVI

Stress hyperglycaemia is a well-known risk factor of postoperative morbidity and mortality in cardiac surgery. Recently, several authors have reported that increased blood glucose (BG) variability could worsen the prognosis in this population.The transcatheter aortic valve implantation (TAVI) is a low invasive procedure proposed as an alternative technique to aortic valve replacement surgery in high-risk patients.

The aim of this study is to describe the incidence of stress hyperglycaemia and assess whether BG variability could impact the outcome of patients undergoing TAVI.


Eligibility Criteria:
Inclusion Criteria:

* age\>18 years old
* severe degenerative symptomatic aortic stenosis
* logistic Euroscore ≥ 20% or/and Society of Thoracic Surgeons score (STS) ≥ 10%
* recused for a conventional valve replacement by multidisciplinary team (surgeon, cardiologist) because of surgical contraindication or comorbidities related to the patient.
* written consent before the procedure concerning anonymous data processing.

Exclusion Criteria:

* death per procedure
* postoperative admission in a critical care unit
Natural History of Melody Valve in the Mitral and Tricuspid Position

The Melody valve has historically been used for pulmonary valve replacements; however it has been more recently used in the mitral and tricuspid positions. This multi-center, retrospective, observational study will review the durability of the Melody valve inserted into the mitral or tricuspid positions.

Patients who have undergone Melody valve insertion into either the mitral or tricuspid positions prior to December, 2014 will be eligible for the study. Basic de-identified patient demographics will be collected as well as select clinical data. Ventricular function and valvar function of the affected valve will be retrospectively reviewed both prior to surgery and following, as well as review of operative data. The investigators will also review the most recent follow up data and any subsequent re-interventions on the Melody valve. Data from all sites will be entered into an external REDCap database, using only de-identified data.

Prior to recent advancement in using the Melody valve for atrioventricular valve replacement, there have only been fixed diameter valve options for severe valve disease requiring replacement. This presents numerous obstacles for those pediatric patients who require replacement early in life, as the fixed diameter does not offer options for expansion for somatic growth, and early reoperation will be required.

The Melody valve has been approved for transcatheter implantation into the RVOT (right ventricular outflow tract), and has shown competence within a range of sizes. Recent studies conducted at Boston Children's Hospital of off-label use of the Melody valve into atrioventricular valve positions have shown acceptable short-term valve performance, and that subsequent catheter-based expansion is feasible.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have had a Melody valve inserted into either mitral or tricuspid positions via surgical intervention

Exclusion Criteria:

* There are no exclusion criteria.
Effect of Oral Enteral Nutrition Feeding in Parkinson Disease

The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:

• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.

Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Nasogastric tube feeding has been widely used in patients with Parkinson's disease but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy.

The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:

• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.

Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* Meeting the diagnostic criteria for Parkinson's disease.
* Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
* Water swallow test\> Level 3.
* Stable vital signs, conscious, able to cooperate with assessment and treatment.

Exclusion Criteria:

* Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)

This is a multi-center, open label, randomized pivotal study evaluating the safety and efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug (AAD).

The objective of this randomized pivotal study is to evaluate the safety and efficacy of the AtriCure EPi-Sense®-AF Guided Coagulation System with VisiTrax® for the treatment of symptomatic persistent Atrial Fibrillation (AF) patients, refractory or intolerant to at least one Class I or Class III anti-arrhythmic drug (AAD). 153 subjects from up to 27 US and 3 OUS sites. Randomized 2:1.

The primary efficacy endpoint is success or failure to be AF/AT/AFL free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-month blanking period through the 12-month post procedure follow-up visit.

The primary safety endpoint is the incidence of major adverse events (MAEs) listed in the protocol for subjects undergoing the convergent procedure for the procedural to 30-day post procedure time period.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years; \< 80 years
* Left atrium \< 6.0 cm
* Refractory or intolerant to one AAD (class I and/or III)
* Documentation of persistent AF
* Provided written informed consent

Exclusion Criteria:

* Patients requiring concomitant surgery
* Left ventricular ejection fraction \< 40%
* Pregnant or planning to become pregnant during study
* Co-morbid medical conditions that limit one year life expectancy
* Previous cardiac surgery
* History of pericarditis
* Previous cerebrovascular accident (CVA), excluding fully resolved transient Ischemic attack (TIA)
* Patients who have active infection or sepsis
* Patients with esophageal ulcers strictures and varices
* Patients with renal dysfunction who are not on dialysis
* Patients who are contraindicated for anticoagulants
* Patients who are being treated for ventricular arrhythmias
* Patients who have had a previous left atrial catheter ablation for AF
* Patients with existing Implantable Cardioverter-Defibrillator (ICDs)
* Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
* Not competent to legally represent him or herself
Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).

This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration study. Randomization will be stratified according to the patient's baseline serum sodium concentration (137-144 and \<137 mmol/L). The dose of study drug will be increased to the next level on Day 15, and the total duration of the double-blind treatment period is 120 days.


Eligibility Criteria:
* Men or women with chronic heart failure (NYHA Class IIIB and IV).
* Women must be post-menopausal or surgically sterilized; they cannot be pregnant or nursing.
* Age 21 to 80 years.
* Chronic heart failure of at least 3 months duration. For 2 months prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 50% of the time. For 2 weeks prior to screening, patients must have had symptoms at rest or on minimal exertion for more than 90% of the time.
* Patients must be receiving a diuretic and an ACE inhibitor (or an angiotensin II receptor antagonist) for the treatment of heart failure.
* Patients may be receiving digoxin, a beta-blocker or spironolactone
Willingness to Participate in a Daily Smartphone Well-being Study

This clinical trial aims to compare the effectiveness of financial and social incentives in motivating urban populations to participate in Experience Sampling Method (ESM) wellbeing studies and explore alternative incentive preferences to increase participation.

The goal of this clinical trial is to investigate the comparison of two incentives to determine their effectiveness for motivating an urban population to participate in a Experience Sampling Method wellbeing studies. It will also investigate alternative incentive preferences that can motivate the population. The main questions it aims to answer are:

* Does the provision of a financial incentive or social incentive to neighbourhood research participants increase the willingness of individuals to participate in ESM research compared to offering no incentive?
* What are the reasons for unwillingness to participate in ESM studies?
* What are the alternative incentive preference that could increase willingness to participate in ESM studies?

Researchers will compare monetary incentive (4 x £100 prize draw qualification) to a non-monetary incentive (invitation to end of project social event to engage research findings) to how they influence willingness to participate compared to offering no incentive.

Participants will:

* Receive receive an email describing a future experience sampling study in the neighbourhood for at least two times.
* Complete a survey to indicate their positive or negative interest in the hypothetical study.

Eligibility Criteria:
Inclusion Criteria:

* Registered on the King's Cross community smartphone application.
* App users living, working, or have previously visited King\&#39;s Cross
* Given consent to receive email communications during their smartphone app sign-up.

Exclusion Criteria:

* Users of the King's Cross community smartphone app who have not given consent to receive email communication about the neighbourhood
Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone

This is a non randomized, single arm study, where each patient will undergo imaging with Computed Tomography (CT) and Whole-body magnetic resonance imaging (WB-MRI) at different timepoint. The primary endpoint is time to progression as documented by CT or WB-MRI.

This is a monocentric study. All patients will undergo assessments by CT and WB-MRI at all time points.

* A baseline bone scan or Fluorodeoxyglucose-Position Emission Tomography (FDG-PET) will be performed.
* CT scans and WB--MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in section 7.1.3).
* At the point of disease progression, a repeat bone scan or FDG-PET/CT will be obtained in addition to the CT and WB-MRI. Participation in the trials ends at the point of disease progression.

Patients will be reviewed in outpatient clinic:

* At baseline
* Every 12 weeks until week 96, with the results of their recent scans.
* As with the imaging, the trial visits will change to every 24 weeks after the week 96 visit.

At the week 12 and week 36 visits, the patients will undergo a clinical examination and perform a pain thermometer score and Patient Imaging Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of breast cancer
* Single or multiple bone metastases (additional extraosseous or non-bony metastatic disease permitted)
* Due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted)
* Aged 18 and over
* Life expectancy of over 6 months
* No current active malignancy other than breast cancer

Exclusion Criteria:

* Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis
* Absolute contraindication to MRI studies, CT scans, bone scans or FDG-PET/CT
* Pregnancy
* Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient as part of the informed consent process.
Breath and Air Stacking on Respiratory Mechanics in Tracheostomized Patients

The researchers hypothesized that the aid of the resuscitator by the technique Air Stacking increase lung volume, promoting increased lung compliance and improvement of the ventilatory pattern. In addition, Air Stacking does not depend on patient collaboration. The objective of this study was to compare the effects of breath stacking and air stacking techniques on respiratory mechanics and ventilatory pattern in patients admitted to the ICU


Eligibility Criteria:
Inclusion Criteria:

* Patients without mechanical ventilation for more than 72 hours
* Mucus hypersecretion (defined as the need for suctioning \< 2-h intervals)

Exclusion Criteria:

* bronchospasm.
* Pleural effusion or pneumothorax undrained.
* Bronchopleural or tracheoesophageal fistula.
* Neuromuscular disease.
The Outcome and Influence Factors of Assisted Reproductive Therapy in Patients With Cesarean Scar Uterus.

Mode of delivery affects the success rate of assisted reproductive techniques (ART). In this case study, the investigators will evaluate changes in the bacterial ecology and inflammatory markers of the female uterus with different delivery modes. We will investigate whether the dominate endometrial microflora is interrupted by the Cesarean section in the infertile women undergoing ART, and the potential mechanism will also be further explored prospectively.

The highly prevalence of cesarean section rate in China had drawn great attention world widely. Post-cesarean section scar diverticulum ( PCSD) is a poor healing of the local incision after Cesarean section which happened in19.4%\~88% of patients. The cavity is formed by the original incision connected with the uterine cavity. Patients with diverticulum are often accompanied by prolonged menstruation and uterine effusion, which may accompany with endometrial inflammation and impair embryo implantation rate.

Though Cesarean section plays an important role in the treatment of dystocia and also decreasing perinatal mortality, it may impact natural conception and the success rate of ART in secondary infertile patients. Data from other researchers have revealed that Cesarean scar may related to poor pregnancy outcome during ART treatment. We have retrospectively analyzed the pregnancy outcome of ART treatment in patients who have had live birth previously from January 2014 to May 2018. The biochemical pregnancy rate, embryo implantation rate and clinical pregnancy rate are all lower in patients with Caesarean section compared to patients after natural labour, the clinical data is even worse in patients with PCSD. The results suggest a close correlation between the outcome of assisted reproductive therapy and the uterine condition. Further evaluations are required related to whether the dominate endometrial microflora is interrupted by the Cesarean section in the infertile women undergoing ART, and the potential mechanism will also be explored accordingly. A single-center, prospective, case-control study will be carried out.

Eligibility Criteria:
Inclusion Criteria:

1. Women age ≥20 years and ≤40 years.
2. infertile Women with previously live birth.
3. Previous failed transfer cycle ≤2
4. Didn't participate in other clinical subjects within three months.
5. Written informed consent.

Exclusion Criteria:

1. surgery history including: Ovariectomy, myomectomy, adenomyomectomy.
2. Uterine diseases including: uterine malformation, submucosal uterine fibroids and intrauterine adhesion.
3. One of couple has abnormal karyotype.
4. Recurrent abortion ≥2.
5. Untreated hydrosalpinx.
6. History of tuberculosis (pulmonary tuberculosis, pelvic tuberculosis etc.).
Treatment of Rumination by Biofeedback - a Randomized Controlled Trial

Rumination syndrome is characterized by effortless recurrent regurgitation of recently ingested food into the mouth, with consequent expulsion or re-chewing and swallowing. In a previous study the investigators showed that rumination is produced by an unperceived, somatic response to food ingestion.

After having identified the key mechanisms of rumination, the investigators developed an original EMG guided biofeedback technique with specific targets for correction, based on EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study the investigators showed the potential effectivity of this treatment. The current aim is to validate this previous uncontrolled observation by a formal placebo-controlled, randomized trial.

Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG and the signal displayed on a monitor and front in the patients: in the biofeedback group, patients will be instructed to control muscle activity, whereas in the placebo group patients will receive a pill of placebo. In each patient 3 sessions will be performed over a 10-day period. Physiological (muscular activity by EMG) and clinical outcomes (number of rumination events by questionnaires administered daily for 10 days) will be measured before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Rumination syndrome

Exclusion Criteria:

* Relevant organic disease
Impact of Atrio-ventricular Optimization With His Bundle Pacing on Treatment of Atrio-ventricular Dromotropathy

This study aims to determine the clinical and hemodynamic benefit of atrio-ventricular (AV) resynchronization with His bundle pacing in patients with symptomatic first degree AV block.

The term AV dyssynchrony was introduced by Salden F. and coauthors in 2018. It stands for the adverse effects of AV dyssynchrony due to PR interval prolongation. According to the ESC and ACC guidelines, severe first degree AV block is an IIa indication for permanent pacemaker implantation, yet data on these patients' clinical outcomes are scarce. To independently determine the impact of AV resynchronization, His bundle pacing will be used to avoid intraventricular desynchronization.

Symptomatic patients with severe first-degree AV block and echocardiographically proven AV dyssynchrony will be included in the study.

All patients will receive a dual-chamber pacemaker with an atrial lead positioned in the right atrium and ventricular lead placed on the bundle of His. In a single-blind cross-over design, patients will be randomized to AV sequential His bundle pacing with echo-guided AV optimization or back-up VVI pacing mode. Each study period will last for three months. At the end of both periods, cardiopulmonary exercise testing, complete echocardiographic study, and clinical evaluation will be performed.

Peak oxygen uptake and echocardiography-based hemodynamic parameters in both periods will be compared.

Eligibility Criteria:
Inclusion Criteria:

* First OR second degree Mobitz type 1 atrioventricular block with a PR interval \> 250 ms
* left ventricular ejection fraction \> 50%
* echocardiographic criteria of atrioventricular dyssynchrony (diastolic filling time/RR interval ratio \< 0,4 OR fusion of E and A waves OR diastolic mitral regurgitation)
* symptoms on exertion (dyspnea, palpitations)
* insufficient shortening of PR interval during exercise (PR interval \> 200 ms at heart rate of 100 beats per minute)

Exclusion Criteria:

* left ventricular ejection fraction \< 50%
* third degree atrioventricular block
* atrial fibrillation
* sinus node disease
* left bundle branch block
* right bundle branch block
* ventricular arrhythmia that indicates implantation of cardioverter defibrillator
* consumption of drugs that influence atrioventricular conduction
* active bacterial infection
* inability to undergo cardiopulmonary exercise test
* anaemia (haemoglobin concentration \< 100 g/L)
* pregnancy