cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants

The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS. The other objectives of this study are to evaluate the safety and tolerability of dimethyl fumarate and peginterferon beta-1a and to assess the effect of dimethyl fumarate and peginterferon beta-1a, both compared with placebo, on additional clinical and radiological measures of disease activity.

Participants will be randomized in a 1:2:2 ratio to receive the double-blind study treatment (Dimethyl Fumarate, Peginterferon Beta-1a, and placebo). Participants experiencing a confirmed relapse or disability progression or high lesion burden on MRI will have the option to discontinue the blinded study treatment and switch to an alternative therapy or open-label BG00012.

Eligibility Criteria:
Key Inclusion Criteria:

* Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS
* Must have an EDSS score between 0.0 and 5.0.
* Must have a body weight of ≥30 kg
* Must have experienced ≥1 relapse in the 12 months prior to randomization (Day 1), or must have evidence of asymptomatic disease activity seen on MRI in the 6 months prior to randomization, or ≥2 relapses in the 24 months prior to randomization (Day 1). Relapse is defined as the occurrence of a clinical demyelination event regardless of whether the event is a first or subsequent demyelinating event.

Key Exclusion Criteria:

* Participants having primary progressive, secondary progressive, or progressive RMS.
* Disorders mimicking MS, such as other demyelinating disorders, systemic autoimmune disorders, metabolic disorders, and infectious disorders.
* History of clinically significant cardiovascular, pulmonary, GI, hepatic, renal, endocrinologic, hematologic, immunologic, metabolic, dermatologic, growth, developmental, psychiatric (including depression), neurologic (other than MS), and/or other major disease and/or laboratory abnormality indicative thereof, that would preclude participation in a clinical study
* Occurrence of an MS relapse within the 30 days prior to randomization (Day 1) and/or the subject has not stabilized from a previous relapse prior to randomization

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Predictive Role of HRV for PONV in Laparoscopic Cholecystectomy

Postoperative nausea and vomiting (PONV) are among the most common complications following general anesthesia (GA), significantly affecting patient comfort and recovery. Although various risk factors for PONV have been identified-such as female sex, non-smoking status, and history of motion sickness-these predictors are not always sufficient to determine individual risk accurately.

Heart rate variability (HRV) reflects autonomic nervous system (ANS) balance and has been proposed as a potential physiological biomarker for predicting PONV. Reduced HRV is associated with increased vagal imbalance, which may contribute to gastrointestinal (GI) dysregulation and PONV.

This prospective observational study aims to investigate the predictive value of HRV in estimating the incidence and severity of PONV in female patients undergoing elective laparoscopic cholecystectomy (LC). A total of 110 participants will be enrolled, and preoperative and early postoperative HRV measurements will be obtained using a validated chest-strap heart rate monitor (Polar H10). HRV parameters, including the standard deviation of normal-to-normal intervals (SDNN), the root mean square of successive differences (RMSSD), and the low-frequency/high-frequency (LF/HF) ratio, will be analyzed via the Elite HRV application. Standardized anesthesia, analgesia, and antiemetic protocols will be used for all participants. PONV severity will be assessed over the first 24 hours postoperatively using a 4-point scale.

The primary objective is to evaluate whether preoperative HRV can predict PONV occurrence. Secondary outcomes include correlations between HRV parameters and PONV severity.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged 18 to 65 years
* Scheduled for elective laparoscopic cholecystectomy
* American Society of Anesthesiologists (ASA) physical status I-II
* Non-smokers
* Able and willing to provide written informed consent

Exclusion Criteria:

* History of cardiovascular, neurological, or gastrointestinal disease
* Use of medications affecting HRV (e.g., antihypertensives, diuretics, atropine, antidepressants, antipsychotics, steroids)
* Presence of systemic diseases that may affect PONV risk
* Inability to comply with study procedures
Effectiveness of Night Administration of Low Dose Aspirin in Hypertensive Patients

The goal is to investigate in patients with high blood pressure, BP, namely, those with systolic blood pressure and diastolic blood pressure, SBP/DBP higher than or equal to 140/90 mmHg, and high cardiovascular risk, under treatment with low-dose acetylsalicylic acid, ASA, whether changing the time they take the drug (same dose) to bedtime (from taking it at some point during the active part of the day) produces a drop in their blood pressure (mean systolic and diastolic over 24 hours) of at least 2.5 mm Hg; and also whether among non-dippers, under secondary treatment with low-dose ASA, there is be a greater decrease in their night BP when the drug is taken in the evening.


Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients (≥140/90)
* Patients from 18 to 80 years old
* Patients are currently taking low doses of ASA during the day, for secondary prevention of cardiovascular events
* Patients have been stable for at least one month with their current antihypertensive and antiplatelet therapy.

Exclusion Criteria:

* Severe and/or terminal illness
* Moderate/severe congestive heart failure (CHF), New York Heart Association, NYHA stage ≥ III
* Moderate/severe chronic renal failure glomerular filtration rate \<45ml/min.
* Physical or mental illness that prevents the patient´s collaboration
* Being a heavy drinker, consuming more than 280 g of alcohol per week in the case of men or 170 g for women31
* Concomitant treatment with other antiplatelets or anticoagulants
* Taking nonsteroidal antiinflammatory drugs, NSAIDs, on a regular basis
* Treatment with ASA at doses outside those established in the inclusion criteria (above)
* ASA already being taken in the evening
* Being a shift worker or having a very intensive work schedule
* Hospital admission during the clinical trial
* Changes being made in the antihypertensive and antiplatelet therapy taken by the patient during the seven months of the trial
* Patients with unstable treatment or clinical condition requiring frequent adjustments thereof.
* Compliance with less than 90% of the doses, both those for daytime and those for evening administration
Model-informed Dose De-escalation of Infliximab in Patients With Inflammatory Bowel Diseases

This is a monocentric, two-arm, non-randomised, non-blinded, historically controlled, interventional trial. The purpose of this trial is to investigate the effect of model-informed infliximab dose de-escalation on the infliximab exposure and therapeutic outcome as compared to standard dose de-escalation in patients with inflammatory bowel diseases.


Eligibility Criteria:
Inclusion Criteria:

* The subject or, when applicable, the subject's legally acceptable representative signs and dates a written informed consent form and any required privacy authorisation prior to the initiation of any study procedures.
* The subject is aged 18 to 80 years inclusive.
* The subject has a good understanding of the Dutch language.
* The subject is diagnosed with moderately to severely active ulcerative colitis or Crohn's disease, confirmed by clinical, endoscopic, histological, and/or imaging criteria.
* The subject was in maintenance therapy, later lost their response to treatment and subsequently gained steroid-free, clinical and biological remission following infliximab dose escalation (i.e., by increasing the dose and/or shortening the dosing interval) and had an infliximab trough concentration ≥5 mg/L.
* Adequate contraception in female subjects of reproductive age (oral contraception, intra-uterine device, sterilisation or barrier method).

Exclusion Criteria:

* The subject is aged \<18 years or \>80 years.
* The subject receives infliximab prophylactically (e.g. in the immediate postoperative setting).
* The subject has an ostomy or an ileal anal pouch anastomosis.
* If female subjects, when pregnant (based on a positive serum sample) or lactating or intending to become pregnant or nurse before, during or within 15 weeks after the last dose of study drug; or intending to donate ova during such time period.
* The subject is participating in another interventional clinical trial.
Effects of 3 Day Preoperative Immunonutrition in Well-nourished Patients With Gastrointestinal (GI) Cancer Undergoing Surgery

Major surgery is still associated with a high rate of postoperative morbidity despite improved techniques in surgical management. Surgery-induced alterations of the immune system are well described and may play a role in the genesis of postoperative complications. It has been shown by several large scale clinical trials, that the use of immunonutrition in postoperative cancer surgery, trauma and critically ill patients resulted in an improved immunocompetence and/or reduced postoperatively infectious morbidity and/or length of hospital stay.The pre-operative regimen was between 5 to 7 days of treatment. The aim of this trial is to evaluate if a shorter administration of 3 days pre-operatively would be beneficial as well.


Eligibility Criteria:
Inclusion Criteria:

* Patients with GI cancer (stomach, pancreas, small and large bowel and rectum) histologically proven
* Well nourished patients as defined by a total score of \<3 on the nutritional screening tool NRS-2002 (46) (Appendix III)
* Patients who are \>= 18 years of age;
* Patients who have signed a written Informed Consent (Appendix I) prior to admission to the study;
* Patients who have an ECOG performance status of 0, 1 or 2 (Appendix II).
* Patients able to orally consume 750 mL or more of liquid a day prior to surgery

Exclusion Criteria:

* Patients who have co-morbid conditions, uncontrolled metabolic conditions or psychiatric conditions that might make tolerance or evaluation of the feeding formula difficult;
* Patients who are pregnant;
* Patients with cardiac failure as defined by the Goldman classification class\>3
* Patients with respiratory failure (FEV\<0.8l/sec)
* Patients with renal failure (Cr \>= 3mg/dl or dialysis patients)
* Patients with hepatic dysfunction (Child \>A)
* Patients suffering from an intestinal obstruction or ileum
* Patients with an Hb level of \<=8 g/dL experiencing gastrointestinal hemorrhaging
* Patients with HIV, HCV, HBV
* Patients requiring immunosuppression treatments
* Patients undergoing emergency surgery
* Other patients determined by a study investigator to be inappropriate for enrolment in this study
Evaluation of the Effectiveness and Safety of Remote Electrocardiographic Monitoring in Patients with Atrial Fibrillation Following Ablation Therapy

Background:

Atrial fibrillation (AF) is the most common arrhythmia, significantly contributing to complications such as stroke, heart failure, dementia, and increased mortality. Catheter ablation is widely used for treatment, but recurrence rates range from 15-50% within 12 months post-procedure. Conventional intermittent ECG monitoring lacks sufficient sensitivity to detect asymptomatic AF recurrence effectively.

Objective:

To compare the recurrence rates of atrial tachyarrhythmias between a 1-day monitoring group and a 14-day monitoring group using MEMO Patch 2 after catheter ablation in AF patients. The study also evaluates the effectiveness and safety of early recurrence detection via remote monitoring.

Study Population:

Patients diagnosed with AF and treated with catheter ablation.

Intervention:

Participants will undergo three sessions of remote ECG monitoring using MEMO Patch 2 and MEMO Link (first session only), spanning approximately one year after catheter ablation.

Hypothesis:

Long-term monitoring with MEMO Patch 2 will be more effective than 1-day monitoring in detecting the recurrence of atrial tachyarrhythmias (including AF, atrial flutter, and atrial tachycardia) following catheter ablation.


Eligibility Criteria:
Inclusion Criteria:

* 1. Adults aged 19 years or older who have voluntarily provided written informed consent to participate in this clinical trial.

  2. Individuals who have been diagnosed with atrial fibrillation prior to the date of informed consent acquisition.

  3. Individuals who are scheduled to undergo catheter ablation for atrial fibrillation within three months from the date of informed consent acquisition.

Exclusion Criteria:

* 1. Individuals with a history of catheter ablation prior to obtaining informed consent.

  2. Individuals with sensitive skin, allergic skin conditions, skin cancer, rashes, or other dermatological disorders.

  3. Individuals with implanted cardiac devices, such as pacemakers, implantable defibrillators, or other implantable electronic devices.

  4. Individuals deemed by the investigator to be at an increased risk or otherwise unsuitable for participation in the clinical trial.

  5. Individuals with cognitive impairments that make it difficult to understand trial information or voluntarily make an informed decision.

  6. Pregnant or breastfeeding women.
NATional TUnisian REgistry of Atrial Fibrillation

A non-interventional, national longitudinal study of atrial fibrillation performed with 91 cardiologists.

The NATURE-AF study is carried out in Tunisia at cardiology consultations in hospitals and in the liberal sector. A total of 91 cardiologists participate in the selection of patients as investigators. The study is a longitudinal non-interventional registry of atrial fibrillation. The data collected are managed by the DACIMA Clinical Suite® platform, which complies with international standards: FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPPA (Health Insurance Portability and Accountability Act), ICH (International Conference on Harmonisation), MedDRA (Medical Dictionary for Regulatory Activities). The DACIMA Clinical Suite® platform allows to track the data entered, check for inconsistencies and missing data, and schedule monitoring visits. A Steering Committee is set up to monitor patient inclusions, verify data sources, perform audit trails and prepare the statistical analysis plan for the study.

Eligibility Criteria:
Inclusion Criteria:

* At least one episode of atrial fibrillation, documented on a 12-lead ECG and / or a rhythmic holter (duration of the episode: 30 seconds or more)
* Recent atrial fibrillation diagnosed for less than a year
* Regular monitoring every 3 months is ensured
* Informed, read and signed consent

Exclusion Criteria:

* Estimated life expectancy at less than 12 months
* Transient atrial fibrillation due to reversible cause (eg acute myocardial infarction, following cardiac surgery, acute alcohol intoxication, hyperthyroidism, pulmonary embolism or other acute pulmonary disease, pericarditis, myocarditis, hydro-electrolyte disorder, metabolic disorder)
* Cardiac surgery ≤ 3 months
* Atrial flutter isolated without atrial fibrillation
* Mental disorders
* Ongoing anticoagulation for reasons other than atrial fibrillation
Sleep Apnea in Paralympic Ontario-Resident aThletes With Spinal Cord Injury (SPORTS) Study

This single arm clinical trial will assess whether continuous positive airway pressure (CPAP) therapy in the management of moderate-to-severe sleep-related breathing disorders (SRBDs) among para-athletes living with cervical/thoracic, complete or incomplete spinal cord injury (SCI) is effective in improving cognitive impairment, in reducing fatigue, depression, anxiety, and overall quality of life. Further, the study will evaluate the effectiveness of CPAP therapy in improving their performance in sports and the perceived risk of injuries.

Untreated moderate-to-severe SRBDs are associated with an increased risk of stroke, heart attack, diabetes, and kidney problems. For para-athletes living with SCI, it can have a major negative impact on their performance when practicing and playing sports.

CPAP therapy is the treatment of choice for moderate-to-severe SRBD (or sleep apnea) in accordance with current good medical practices.

Therefore, the aim of the study is to determine whether CPAP therapy in para-athletes living with SCI who developed moderate-to-severe SRBDs is effective in improving memory, psychosocial implications, social and work participation, and performance in sports.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a cervical or thoracic, complete or incomplete (AIS A to D), chronic (\> 6 months) SCI;
* English-speaking adults (18 years of age or older); and
* Play a wheelchair sport at a high-performance level.

Exclusion Criteria:

* A previous history of diagnosis and treatment for sleep apnea;
* Concomitant diseases of the central nervous system and other pre-existing diseases of the central nervous system;
* Current substance misuse;
* History of primary hypersomnia, or secondary hypersomnia of any cause except for SRBDs.
* Conditions that might prevent participants to follow the study protocol.
Cell Therapy In Dilated Cardiomyopathy

The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

This protocol describes a double-blind placebo controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart Association.

The primary endpoint of this study is to evaluate the effect of the autologous bone marrow stem cell implant in the increase of the ejection fraction of the left ventricle in comparison with a control group, under optimized therapy for dilated cardiomyopathy. Secondary endpoints will evaluate the alteration in NYHA functional class, mortality rate, physical capacity (by ergoespirometry), life quality (Minnesota questionnaire) and pulmonary congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem cell implant.

Hypothesis: The main hypothesis of this study is that the patients who received the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean 5% increase in absolute left ventricle ejection fraction in comparison with the control group.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of dilated cardiomyopathy according to WHO criteria
* Syndromic heart failure in functional class III or IV of the NYHA
* Enrollment and continuous follow-up in cardiac out-patient clinic
* Adequate medical therapy after optimization therapy
* Echocardiogram with an ejection fraction equal to or less than 35% by Simpson's rule

Exclusion Criteria:

* Valvular diseases, except functional mitral or tricuspid reflow
* Coronariography showing a significant lesion (obstruction of at least 50% of the lumen in the troncus or the main arteries - LAD, CX, RC) in one or more arteries
* Serologic diagnosis for Chagas disease or at least two of the following criteria: epidemiology, right bundle branch block, anterior hemi-block, apical aneurism
* Sustained ventricular tachycardia
* Abusive use of alcohol or illicit drugs
* Pregnancy
* Use of cardio toxic drugs
* Any co-morbidity with impact in life expectancy in 2 years
* Renal function compromised (creatinine above 2 mg/dl)
Efficacy and Safety of HSK16149 Capsule in the Treatment of Moderate and Severe Central Neuropathic Pain in China

To evaluate the efficacy and safety of HSK16149 capsule in the treatment of moderate to severe central neuropathic pain compared with placebo.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign an informed consent form;
2. Able to read and complete survey questionnaires;
3. Male or female patients aged ≥ 18 years old;
4. The subject has a medical history and symptoms related to central neuropathic pain, including spinal cord related neuropathic pain (subject enrollment ≥ 50%), post-stroke central neuropathic pain, Parkinson's disease pain, and multiple sclerosis pain, and must meet the following criteria: a) pain duration ≥ 3 months; b) Characteristics that conform to neuropathic pain: DN4 scale score ≥ 4 points;
5. During screening visits, patients were assessed to have an average pain visual analogue scale (VAS) score of ≥ 40 mm over the past 24 hours.

Exclusion Criteria:

1. The presence of other painful diseases that may affect the evaluation of neuropathic pain;
2. Patients with spinal cord injury or stroke whose condition is unstable and is expected to require surgical treatment;
3. There is a chronic systemic disease that the investigator has assessed may affect the participant's participation in the study；
4. Meet any of the following laboratory test results: a) Hematology: WBC\<3×109/L, N\< 1.5 ×109/L, PLT\< 75 ×109/L, or HB\< 90 g/L; b) Liver function: ALT or AST\> 2.5 × ULN; Or TBIL\> 1.5 × ULN; c) eGFR\< 60 mL/min/1.73 m2; d) Creatine kinase \> 2.0 × ULN;
5. Women who are pregnant, planning to become pregnant during the study period, or breastfeeding; Women who do not wish to use reliable contraceptive methods (including condoms, spermicides, or Iuds) for 28 days after signing up for the ICF from the beginning to the last trial drug administration, or who plan to use progesterone contraceptives during this period;
6. Mechanical operators engaged in high-altitude work, motor vehicle driving and other dangerous activities during the study period;
7. Participated in any other clinical study within 30 days prior to screening;
8. The investigator determined that there were other conditions that were not suitable for study participation.