cyrilzakka/clinical-trials huggingface dataset:
Remote Oximeter Monitoring Post-discharge to Reduce Emergency Room Visits and Rehospitalization

This randomized clinical trial will determine the efficacy of remote patient monitoring using an Owlet OSS 3.0 pulse oximeter for the reduction of emergency room visits and high-acuity rehospitalizations among high-risk infants after NICU discharge.

To determine if among infants being discharged from the neonatal intensive care unit (NICU) without a cardiorespiratory monitor or respiratory support, remote patient monitoring using an Owlet OSS 3.0 pulse oximeter (Owlet, Lehi, UT) decreases emergency room visits and high-acuity rehospitalizations after discharge compared with routine care.

Infants being discharged from the neonatal intensive care unit (NICU) without a cardiorespiratory monitor or respiratory support are eligible for inclusion.

The Investigators will provide remote patient monitoring using an Owlet OSS 3.0 pulse oximeter to infants in the intervention group for a 6 month period. The Investigators will collect monthly outcome measures from caregivers of all infants.

Eligibility Criteria:
Inclusion Criteria:

* Infants being discharged from the NICU
* Off all respiratory support (oxygen, CPAP, ventilator) before discharge home
* Gestational age ≥ 22 0/7 weeks' gestation at birth
* Parents/legal guardians have provided consent for enrollment

Exclusion Criteria:

* a major malformation, a neuromuscular condition that affects respiration or causes apnea, complex congenital heart disease and hemodynamically significant shunts, or terminal illness or decision to withhold or limit support.
* Infants being discharged from the neonatal intensive care unit (NICU) with a cardiorespiratory monitor or respiratory support are not eligible for inclusion.
Trial to Evaluate the Safety and Efficacy of TP-03 for the Treatment of Demodex Blepharitis

The purpose of this study is to compare the safety and efficacy of TP-03, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles.

This Phase 3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03 to vehicle control for the treatment of Demodex blepharitis. The primary objective of the study is to assess the safety and efficacy of TP-03, 0.25% compared to its vehicle from Day 1 to Day 43 in adult participants with mild to severe Demodex blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp biomicroscopy, endothelial cell density, hematology, blood chemistry, and urinalysis.

Eligibility Criteria:
Inclusion Criteria:

* Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
* Meet all of the following criteria in at least one eye: Have more than 10 lashes with collarettes present on the upper lid; have at least mild erythema of the upper eyelid margin; have an average Demodex density, upper and lower eyelids combined, of 1.5 or more mites per lash

Exclusion Criteria:

* Have used lid hygiene products within 14 days of Screening or unwilling to forego the use of lid hygiene products during the study
* Have used a prostaglandin analogue to promote eyelash growth within 30 days of Screening or any plans to initiate treatment during the study
* Have used artificial eyelashes or eyelash extensions within 7 days of Screening or be unwilling to forego their use during the study
* Be pregnant or lactating at the time of Screening
DETERMINE-reduced - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Reduced Ejection Fraction

International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Reduced Ejection Fraction (HFrEF)


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed informed consent prior to any study specific procedures
* Male or female, aged ≥18 years
* Documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 8 weeks
* LVEF≤40%
* Elevated NT-proBNP levels
* Patients should receive background standard of care as described below: All HFrEF patients should be treated according to locally recognised guidelines on standard of care treatment with both drugs and devices, as appropriate. Guideline-recommended medications should be used at recommended doses unless contraindicated or not tolerated. Therapy should have been individually optimised and stable for ≥4 weeks (this does not apply to diuretics) before visit 1 and include (unless contraindicated or not tolerated):

  * an ACE inhibitor, or ARB or sacubitril/valsartan and
  * a beta-blocker and
  * if considered appropriate by the patient's treating physician; a mineral corticoid receptor antagonist
* 6MWD≥100 metres and ≤425 metres at enrolment and randomization.

Exclusion Criteria:

* Presence of any condition that precludes exercise testing
* Participation in a structured exercise training programme in the 1 month prior to screening or planned to start during the trial
* Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
* Type 1 diabetes mellitus
* eGFR \<25 mL/min/1.73 m2 (CKD-EPI formula) at enrolment, unstable or rapidly progressing renal disease at time of randomisation
* Systolic BP \<95 mmHg on 2 consecutive measurements
* Systolic BP ≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements
* Current acute decompensated HF or hospitalisation due to decompensated HF \<4 weeks prior to enrolment
* MI, unstable angina, coronary revascularization ablation of atrial flutter/fibrillation, valve repair/replacement, implantation of a cardiac resynchronization therapy device within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization.
* Stroke or transient ischemic attack within 12 weeks prior to enrolment.
* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD.
* Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization
* HF due to infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, known genetic hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular disease
Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation

Catheter ablation has emerged as an important treatment option for patients with symptomatic atrial fibrillation (AF). Pulmonary vein antral isolation (PVI) is now considered the cornerstone technique of AF ablation and has shown promise in treating paroxysmal atrial fibrillation (PAF). However, there is no unique strategy for ablation of persistent AF (PeAF), whether PVI alone is sufficient to prevent patients from recurrence remains controversial. The PROMPT-AF study is a prospective, multicenter, randomized trial involving a blinded assessment of outcomes, which is designed to compare arrhythmia-free survival between PVI and an ablation strategy termed upgraded '2C3L' for ablation of PeAF.

The PROMPT-AF study will include 498 patients undergoing their first catheter ablation of PeAF. All patients will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1 fashion. The upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM, bilateral circumferential PVI, and three linear ablation lesion sets across the mitral isthmus, left atrial roof, and cavotricuspid isthmus. The follow-up duration is 12 months. The primary endpoint is the rate of documented atrial tachycardia arrhythmias of \>30 seconds, without any antiarrhythmic drugs, in 12 months after the index ablation procedure (excluding a blanking period of 3 months).

Eligibility Criteria:
Inclusion criteria

Patients must meet all the following criteria to be included in the study:

1. age between 18 and 80,
2. patients undergoing a first-time ablation procedure for non-valvular AF,
3. patients with defined as a sustained episode more than 3 months
4. PeAF documented by ECG, Holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within 90 days6 months of the ablation procedure,
5. patients experienced symptoms caused by AF and these symptoms include but are not limited to palpitations, presyncope, syncope, fatigue, and shortness of breath,
6. AF refractory to at least one AAD,
7. willingness, ability and commitment to provide informed consent and participate in follow-up evaluations.

Exclusion criteria Patients are to be excluded if any of the following criteria is met：

1. patients with paroxysmal AF,
2. patients with AF secondary to an obvious reversible cause,
3. patients with left atrial diameter ≥ 60 mm in the parasternal long axis view,
4. left ventricular ejection fraction (LVEF) \< 30%,
5. patients with triple (aspirin, clopidogrel and OAC) or dual (clopidogrel and OAC) antithrombotic therapy which predispose patients to higher risk of periprocedural bleeding. (e.g., Coronary percutaneous transluminal coronary angioplasty (PTCA)/stenting within the previous 90 days),
6. patients with contraindication to anticoagulation,
7. patients with contraindication to right or left sided heart catheterization,
8. pregnancy,
9. life expectancy less than 1 year (advanced malignant tumor, end stage renal disease, etc.),
10. patients cannot be removed from antiarrhythmic drugs for reasons other than AF.
Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy of Colorectal Cancer

The research objectives is to compare vitro 3D drug sensitivity test results of micro tumor (PTC) with the clinical outcomes of patients, evaluate the consistency between the test results of the technology platform and the clinical prognosis, and explore the decision-making value and guiding significance of this technology in assisting the precise treatment of colorectal cancer. The completion of this study will provide real-world data support for the clinical application of micro tumor (PTC) in vitro 3D drug sensitivity detection technology, and provide more valuable reference basis for realizing the individualization and accuracy of colorectal cancer treatment and improving the clinical benefit rate.

The study is a multi agency prospective cohort study in China. The subjects were patients aged 18 \~ 75 years with colorectal cancer diagnosed by histopathology or cytology. They must be colorectal cancer patients who have at least one assessable tumor focus, need adjuvant therapy after radical surgery, and have not received neoadjuvant therapy， ECoG physical condition score ≤ 2 points. And they must be voluntarily participate in and sign informed consent.

The patients were randomly divided into PTC drug sensitivity test group and control group. The PTC drug sensitivity test group selected the adjuvant chemotherapy scheme according to the 3D drug sensitivity test results of micro tumor (PTC) in vitro. The control group made adjuvant chemotherapy strategy according to clinical experience. All exon (WES) data collection was used to predict postoperative survival in both groups.

The primary endpoint was the non inferiority test, and the 3-year disease-free survival rate was T-C \>- Δ

Eligibility Criteria:
Inclusion Criteria:

* Age 18 \~ 75 years old, regardless of gender
* Patients with colorectal cancer diagnosed by histopathology or cytology
* Colorectal cancer patients who need adjuvant therapy after radical surgery and have not received neoadjuvant therapy
* Having at least one assessable tumor focus
* ECoG physical condition score ≤ 2 points
* Voluntarily participate and sign informed consent

Exclusion Criteria:

* Patients diagnosed with metastasis
* Patients who cannot obtain tumor samples
* Pregnant and lactating women
* Patients with poor compliance
* Patients with severe cardiovascular and cerebrovascular complications who cannot receive adjuvant treatment
* Patients with other malignant tumors
* Suffering from serious mental and nervous system diseases
* The researchers believe that patients should not be selected for this study
Taste Stimulation for Post-stroke Dysphagia

The goal of this clinical study is to compare the effect of favourate taste stimulation of oral cavity and tounge, with sour and traditional single thermal stimulation in post-stroke patients with dysphagia. The main questions it aims to answer are:

1. Whether favourate taste stimulation of oral and tounge is better than traditional thermal stimulation in improving swallowing function of patients with dysphagia.
2. It has been reported that taste of sour stimulation can increase the frequency of swallowing. In this study, we want to know which is better for improving swallowing function between favourate taste stimulation and sour taste stimulation.
3. Functional near-infrared spectroscopy (fNIRS) will be applied in this study to understand the neural mechanism of taste stimulation in improving swallowing function.

Participants screened as post-stroke dysphagia will accept swallowing evaluation and fNIRS test before and after treatment. The treatment include taste stimulation and traditional swallowing training.

Researchers will compare favourate taste stimulation with sour-taste stimulation and single thermal stimulation to see if the swallowing function improved faster and better in favourate taste stimulation group.

Taste perception can help to initiate swallow. Different taste has different impact on swallowing function. Patients with post-stroke dysphagia always have taste impairment and initiation delay of swallowing. In this study, patients with dysphagia after stroke will be recruited and treated with favourate taste stimulation or sour taste stimulation or non-taste stimulation for 2 weeks. Traditional swallowing rehabilitation will be applied base on the status of patients. Before and after the treatment, participants completed swallowing assessment, including quantitative measurement of hyoid displacement, functional oral intake scale (FOIS), dysphagia severity rating scale (DSRS), and standardized swallowing assessment (SSA). In order to understand the effect of taste stimulation on brain network, fNIRS will be conducted.The participants have to conduct these examination three to four weeks after the treatment to undertand the long-time effect of taste stimulation.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed as first-ever stroke and diagnosed as dysphagia with modified water swallowing test, duration of dysphagia was more than one month;
2. can complete all the test with MMSE \>15;
3. agree to participate the experiment, and sign the written informed consent.

Exclusion Criteria:

1. have other diseases that could induce dysphagia, such as cranial and neck tumor, history of radiotherapy or chemotherapy, tongue muscle atrophy, myasthenia gravis, parotid tumor and multiple sclerosis, etc;
2. lose of taste perception;
3. combined with other major disease that can not tolerate the examination and swallowing training;
4. surgery of cranial allogeneic plasticity, scalp ulcer or damage that thought as contraindications of fNIRS.
5. with other neurological conditions (eg, Parkinson's disease, dementia).
Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome.

The primary objective of the trial is to assess long-term safety and tolerability of apraglutide in subjects with SBS-IF.

This is an international, multicenter, open label extension trial to collect further safety, tolerability, efficacy, durability, and clinical outcomes of apraglutide once weekly adminstration, for up to 208 weeks or until apraglutide is commercially available in the country, whichever comes first. Eligible subjects would be those who were trial subjects of TA799-007 or TA799-013 trials.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females with a diagnosis of SBS-IF secondary to surgical resection of the small intestine, with Colon-in-Continuity (CIC) or stoma, who were trial subjects of parent trials TA799-007 or TA799-013
2. Able to give informed consent and agree to follow the details of participation as outlined in the protocol.

Exclusion Criteria:

1. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements.
2. Any other reason judged not eligible by the Investigator.
3. Pregnancy or lactation
Radiotherapy and Atrial Fibrillation

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. Current European guidelines recommend catheter ablation of AF in symptomatic patients refractory to antiarrhythmic therapy. Pulmonary vein isolation (PVI) remains the cornerstone of any ablation procedure irrespective of patient characteristics. Recently, stereotactic arrhythmia radioablation (STAR) with precise high-dose of radiation was used to treat ventricular arrhythmias in patients with a high risk of complications during transcatheter ablation.

Exploratory study to investigate the feasibility of STAR for the treatment of paroxysmal AF in elderly patients in which a rhythm control strategy is indicated. Patients will be followed-up for 12 months after STAR treatment for a safety assessment and AF recurrence.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 70 years
2. Symptomatic Paroxysmal AF
3. Antiarrhythmic drugs intolerance or non-response to antiarrhythmic drugs
4. Understands the nature of the study, treatment procedure and provides written informed consent
5. Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
6. Expected to remain available for at least 24 months after enrollment

Exclusion Criteria:

1. Permanent AF
2. Need or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
3. Unstable angina
4. Presence of any disease that is likely to shorten life expectancy to \< 1 year
5. Any cardiac surgery within three months prior to enrolment
6. Awaiting cardiac transplantation or other cardiac surgery within the next year
7. Myocardial infarction (MI) within 60 days prior to enrolment
8. Contraindications to oral anticoagulation
9. Active systemic infection or sepsis
10. Left atrial thrombus (e.g., transesophageal echocardiogram (TEE), CT and ICE)
11. History of a documented thromboembolic event such as stroke or transient ischemic neurological attack (TIA) in the three months prior to enrollment.
12. Currently enrolled in another trial that has not completed the required follow-up period and would conflict with this study.
13. Any other clinical condition that might jeopardize patient safety during participation in this trial or prevent the subject from adhering to the trialprotocol
Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy

American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive methods in gynecological surgery to ensure increased benefits to the patient and reduce potential hospitalization costs.

Laparoscopic hysterectomy has become the standard approach in gynecological benign disorders. During laparoscopic hysterectomy, vaginal cuff can be closed with different sutures, techniques and approaches, which is one of the challenges of this surgery. Data is limited on potential impact of different sutures, techniques and approaches for vaginal cuff closure on female sexual function in relation to vaginal length.

Various studies in the literature evaluated different approaches (abdominal, vaginal, laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures like operation time, cuff healing, complications, cost effectiveness, etc. were usually measured. However, there is no prospective randomized clinical study in the literature that compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual function in relation to vaginal length.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to have total laparoscopic hysterectomy because of benign conditions only

Exclusion Criteria:

* Suspicion of malignancy
* Presence of large adnexal masses (maximum diameter \>10 cm at preoperative ultrasonography)
Absorption, Distribution, Metabolism and Excretion (ADME) Study of TKI258 in Patients With Advanced Solid Malignancies

This is a phase l study to examine Absorption, Distribution, Metabolism and Excretion of TKI258. There are 2 cohorts. Cohort 1 (4 patients) will receive single radio-labeled 500mg dose of TKI258 followed after 15 days by daily dosing of 400mg TKI258. Cohort 2 (9 patients) will receive 400mg TKI258.


Eligibility Criteria:
Inclusion criteria:

1. Aged ≥ 18 years
2. Patients with histologically confirmed solid tumor or lymphoma who are resistant/refractory to approved therapies or for whom no appropriate therapies are available.
3. WHO performance status ≤ 2
4. All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have been resolved
5. Written informed consent to participate in the study

Exclusion criteria:

1. Primary Brain Tumors or symptomatic leptomeningeal metastases
2. Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start
3. Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection Pregnant or lactating women (all women of childbearing potential must have a negative pregnancy test (\> 5 mIU/ml) before inclusion in the study; post-menopausal women must be amenorrheic for at least 12 months). Female patients must use adequate contraceptive protection
4. Centrally located or squamous cell carcinoma of the lung
5. Proteinuria \> 1+ on dipstick testing
6. History of gastrointestinal malabsorption Surgery involving intestinal anastomosis within four weeks of study start.

Other protocol-defined inclusion/exclusion criteria may apply.