cyrilzakka/clinical-trials huggingface dataset:
FRI a Method of Reading Cardiotocography (CTG) in Labor

The objective of the study is to investigate the FRI's ability to identify cases requiring urgent intervention which will present an adverse perinatal outcome (respiratory acidosis, metabolic acidosis, Apgar index, etc.) compared to the classical interpretation of CTG.

Patients whose CTG in labor will be considered non-reassuring will be enrolled and randomized into two groups. The "Fetal Reserve Index" algorithm will be applied to the first group of patients.

The second group of patients will, however, be managed according to the usual protocols internal management.

Patients in active labor and diagnosed with category II CTG will be enrolled and randomized into two groups. Full randomization will be performed by Excel software by generating random numbers using the "Randomise (RAND)" function The "Fetal Reserve Index" algorithm will be applied to the first group of patients. In in these patients the fetal reserve index will be calculated every 10 minutes. At each of the components of the score will be assigned a score of 1 if the variable evaluated is considered normal, 0 if classified as abnormal. The different scores obtained (score from 1 to 8) will be classified into 3 risk categories: Score 5-8: green zone, Score 3-4: zone yellow, Score 1-2: red zone. An FRI of 1-2 (red zone) is to be considered as anomalous. For patients with abnormal FRI a 40 minute timer will be started within which it will be necessary to exit the "red zone". If such patients will not be able to exit the red zone within 40 minutes, an additional timer will be started of 30 minutes within which the birth will be completed. The birth will be completed immediately in case of sentinel events (prolonged bradycardia, detachment of placenta, cord prolapse).

The second group of patients will, however, be managed according to the usual protocols internal management.

Eligibility Criteria:
Inclusion Criteria:

* Women in the active phase of labor who presented when they entered the room I delivered a negative admission test (i.e. a normoreactive CTG according to ACOG) and that subsequently present during labor a diagnosis of category II CTG
* Single term pregnancy
* Signature of informed consent

Exclusion criteria

* Failure to sign the informed consent
* Previous caesarean section (TOLAC)
* Twin pregnancy
* Gestational age \<37 weeks
* Known genetic/chromosomal syndromes and/or malformations, excluding heart disease without contraindication to vaginal birth

Exclusion Criteria:

-
Effects of Light Intensity Physical Activities on Pre-frontal Cortical Activation, Cognitive Function, Sleepiness and Back Pain

The objective of this randomised controlled trial is to examine the acute effects of two novel light intensity exercise (sit-cycling and stand-twisting) on prefrontal cortical blood oxygenation, executive functioning, sleepiness and back pain among inactive university students.

The main questions it aims to answer are:

* What are the changes in oxygenated haemoglobin (O2Hb) and deoxygenated hemoglobin (HHb) levels in the prefrontal cortex from baseline to immediately after and 20 minutes after a 5-min bout of S-C and S-T compared to sitting for the same duration?
* What are the changes in executive functioning, specifically, n-back test and Word Colour Stroop test performance from baseline to immediately after and 20 minutes after a bout of S-C and S-T compared to sitting for the same duration?
* How does participants' self-rated daytime sleepiness and back pain after a bout of S-C and S-T compare to sitting for the same duration?

Participants will:

* Perform sit-cycling or stand-twisting for 5 mins (experimental condition) and sit for 5 mins (control condition)
* Wear the functional near-infrared spectroscopy cap on their head throughout the measurements
* Complete 1-back, 2-back test and Word Colour Stroop before, immediately after and 20 minutes after experimental/ control condition
* Have their blood pressure, heart rate taken by a smartwatch
* Complete a daytime sleepiness questionnaire and a back pain questionnaire


Eligibility Criteria:
Inclusion Criteria:

* NTU-NIE university student, between 21 and 30 years old, do not meet physical activity guidelines (150 mins of weekly MVPA)

Exclusion Criteria:

* taking blood-pressure lowering medication
* physically active (150 mins or more of weekly MVPA)
* deemed not physically fit to participate in physical activity based on responses to Get Active Questionnaire
Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip

The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip


Eligibility Criteria:
Inclusion Criteria:

* Is male or female ≥ 40 years of age
* If a participant in the previous MEL3-12-02 study, completed the study and did not discontinue for lack of efficacy or safety
* Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
* Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain
* If female and of childbearing potential, is nonlactating and nonpregnant

Exclusion Criteria:

* History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam
* Requires continuous use of opioid or opioid combination products to control OA pain of the knee or hip
* Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease
* Significant difficulties swallowing capsules or unable to tolerate oral medication
* Has received any investigational drug (except Meloxicam SoluMatrix Capsules), device, or therapy within 30 days before Screening
Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma

There is no effective treatment for hemangioma regardless of immediate severity. That is in this respect a orphan disease. These hemangiomas, sometimes large, will have a phase of proliferation of several months (very scary for parents) and regression over several years. The natural history is peppered with local complications (ulcers) and aesthetic and psychological sequelae (sometimes major for the child and the family). The effects of acebutolol and propranolol on the proliferative hemangiomas were discovered accidentally by two French teams (Montpellier for acebutolol and Bordeaux for propranolol). Acebutolol and propranolol have been used for many years for the treatment of hypertension and congenital heart disease, including infants, with few side effects. The effects of acebutolol and propranolol were immediately visible with reduced volume and skin whitening of the hemangioma. In a preliminary study, acebutolol was administered to 20 patients in Montpellier with big regression of hemangiomas. The aim of the study was to compare the clinical efficacy of acebutolol (10mg/Kg/jour) and propranolol (3mg/Kg/j) on the proliferative phase of infantile hemangioma in infants.


Eligibility Criteria:
Inclusion Criteria:

* Infants under 6 months
* Presenting a hemangioma with the following characteristics:

  * subcutaneous and / or cutaneous
  * minimum diameter of 1.5cm on face, 5cm outside face and 3cm if it is ulcerated.
  * without functional impairment requiring treatment or vital corticosteroid
* Consent of both parents (or the person having parental authority in families)
* Which at least one parent is a beneficiary of a social security system.

Exclusion Criteria:

* Indication of treatment with corticosteroids for an indication other than hemangioma
* Indication of treatment with beta-blocker for another indication that the hemangioma
* Infant presenting cons-indications for the administration of acebutolol or propranolol:

  * Asthma and chronic obstructive pulmonary disease in their severe forms.
  * Heart failure controlled by treatment.
  * Cardiogenic shock
  * Prinzmetal Angina
  * Bradycardia (\<80 beats / min at rest the first month \<70/minute from 1 to 6 month).
  * Raynaud's phenomenon and peripheral arterial disorders in their severe forms.
  * Pheochromocytoma untreated.
  * Low blood pressure (blood pressure \<60/30 mmHg before 6 months)
  * Hypersensitivity to acebutolol or propranolol
  * History of anaphylactic reaction.
  * Treatment with amiodarone and / or calcium channel blockers.
  * Congenital heart disease outside inter auricular communication (CIA) or inter ventricular communication (CIV) insignificant
Sensory Re-Training Following Facial Surgery for Correction of Facial Skeletal Disharmony

The purpose of this study is to determine whether facial exercises in conjunction with opening exercises routinely provided after facial surgery to correct a facial skeletal disharmony will shorten the time until a patient receives no unpleasant or negative facial sensation.

Abnormal facial sensation has a negative impact on patients' oral behaviors and may adversely affect a patient's quality of life if the altered sensation persists. Many patients with abnormal sensations retain some sensory function and do not develop chronic pain, and for those individuals there are currently no evidence-based noninvasive therapies. The goal of this project is to evaluate sensory re-training, a rehabilitative therapy that offers significant potential for patients who experience impaired sensory function regardless of the cause. This behavioral therapy approach has been used with substantial clinical success with hand injury patients since the 1970s. Re-training appears to enhance central reorganization of impulses from an injured sensory nerve to the cerebral cortex so that the altered sensory signals can be interpreted and translated into functionally meaningful motor functions.

Sensory re-training will be compared to a placebo jaw-opening exercise in a single blind, randomized two-arm parallel group stratified block clinical trial, using orthognathic surgery patients as subjects. Orthognathic surgery patients offer an uncompromised model for the evaluation of new rehabilitative therapies. These healthy individuals, treated to correct dentofacial deformity, present for surgery with no neurosensory impairment, but yet routinely experience substantial alterations in facial sensation following the surgical procedure. The effects of sensory re-training will be evaluated using three types of outcomes: patient-centered measures to assess the magnitude of the negative effect of altered sensation after surgery and the recovery time needed to reach little or no negative effect; neurosensory behavior measures to assess the patient's ability to learn alternate cues for touch perception and discrimination; and a conventional neurosensory contact threshold measure to assess the actual deficit. Our primary focus will be on the patient's perception of the negative impact of altered sensation on daily life.

Eligibility Criteria:
Inclusion Criteria:

* Developmental dentofacial disharmony
* Receives mandibular advancement by mandibular osteotomy with or without a maxillary procedure.

Exclusion Criteria:

* Congenital anomaly or acute trauma affecting the face.
* Previous facial surgery
* Pregnant at baseline
* Inability to follow written English instructions
* Unwilling to sign informed consent.
* No altered sensation at one week post-surgery
* Altered sensation at baseline reported as numbness or unusual feeling.
* Medical condition associated with systemic neuropathy.
Evaluation of Medical and Economic Incidence of Hypnosis

Hypnosis in conization is more and more use to substitute General Anesthesia (GA) in Anesthesia's field.

This study wants to prove that the Hypnosis in conization are cheaper.

Hypnosis in conization is more and more use to substitute General Anesthesia (GA) in Anesthesia's field. There are few studies about this new anesthesia tool. The latter showed that it's possible to substitute GA by hypnosis. This tool could have many positive such as reduced pains, anxiety or post operative vomiting nausea (POVN). Hypnosis in conization also allows time reduction in post operative security monitoring room (SSPI), speedier hospital discharge and greater patient satisfaction. Most studies involves 1 or 2 practitioners and few patients. There is no reliable research which compare Hypnosis in conization costs and GA costs. Since 2010, anesthesia's team of Grenoble Mutualist Hospital group (GHM) realized many Hypnosis in conization surgical procedures. Half of the team had been trained to Hypnosis in conization and use it for several types of surgeries for a lot of surgeons. It's the case for conisations. Currently, the 7 gynaecologists surgeons of the team achieved between 150 and 200 per year , some of this used GA, others used Hypnosis in conization, and unusually they used " rachianesthesia ". Thus, it gives us the opportunity for studying Hypnosis in conization, without practitioner effect, for a relatively cohesive group of patients (vast majority of patients are between 30 and 50 years and they haven't any particular medical history).

Eligibility Criteria:
Inclusion Criteria:

* all women whom need a conization

Exclusion Criteria:

* age\<18 ans
* guardianship
* trusteeship
* not affiliated to the social security
Digital Solutions in Heart Therapy (DIGNITY)

This study aims to assess the safety and effectiveness of telemedicine guided strategy on guideline-directed medical therapy (GDMT) optimization in hospitalized patients with heart failure in comparison to usual care in Switzerland.

Heart failure (HF) is a chronic condition affecting approximately 26 million people worldwide, with acute decompensations leading to frequent hospitalizations and increased mortality. While guideline-directed medical therapy (GDMT) has been shown to improve outcomes in HF with reduced ejection fraction (HFrEF), real-world data indicate suboptimal implementation, with delayed initiation and low adherence to target doses. The STRONG-HF study demonstrated that rapid up-titration of GDMT following hospitalization significantly reduces HF-related mortality and readmission, highlighting the importance of early and structured treatment optimization. However, close monitoring during the vulnerable post-discharge phase remains resource-intensive and difficult to implement in routine care.

The DIGNITY study aims to assess the safety and effectiveness of a telemedicine-guided strategy for optimizing GDMT in patients with HFrEF compared to usual care in Switzerland after discharge. The study hypothesizes that telemedicine-supported management will improve GDMT optimization and clinical outcomes in this high-risk patient population.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years at the time of hospital admission
2. Ability to use a (smart)phone and/or tablet for the follow-up
3. Documented left ventricular ejection fraction (LVEF) \> 40% assessed within preceding 12 months
4. Not treated with optimal doses of oral HF therapies within 2 days before anticipated hospital discharge for acute HF in at least one of the medication categories (for details see Table 1 on page 10)
5. Hospitalized due to acute HF decompensation.
6. Specific measures within 24 hours prior to randomization

   * Systolic blood pressure \> 100 mmHg, and heart rate \> 60bpm
   * Serum potassium \< 5mmol/L

Exclusion Criteria:

1. Inability to use a (smart)phone or tablet
2. Clear intolerance to high doses of betablockers, ACE inhibitors, or ARBs
3. Estimated glomerular filtration rate \<30ml/min/1.73m2 or dialysis
4. Myocardial infarction, unstable angina or cardiac surgery within 3 months, percutaneous transluminal coronary intervention within 1 months prior to screening
5. Cardiac resynchronization therapy device implantation within 3 months prior to screening
6. Presence of significant obstructive lesion of the left ventricular outflow tract
7. Amyloid cardiomyopathy
8. Pregnant or nursing women
Decision Support Workshop for Breast Reconstruction

The purpose of this study is to determine the effectiveness of a pre-consultation decision support workshop for breast reconstruction after breast cancer, in facilitating the decision-making process, compared to routine pre-surgical education.

Postmastectomy breast reconstruction is becoming increasingly utilized in breast cancer patients to provide surgical restoration of the breast mounds. The breast reconstruction discussions can be highly complex, as there are many different techniques, timing, and complications that are unique to each procedure. However ¼ of women report being dissatisfied with some component of their cancer or reconstructive care. Failure of the physician to provide adequate information about treatment options is the most frequent source of cancer patient dissatisfaction and breast reconstruction patients have expressed a need for further information regarding the complex decision to pursue breast reconstruction. In such scenarios of complex medical decision-making, decision support techniques may be an effective solution to information provision and shared decision-making. As a result, the investigators developed a pre-consultation educational group intervention delivered in a group setting for women considering breast reconstruction, with the aims to fill an existing information-gap, promote high-quality decision-making and enhance decision self-efficacy and other decision measures. This pilot study will be the first step in the evaluation of the educational group intervention and the results will be used to determine the feasibility and inform the optimal design for a definitive randomized controlled trial. This study will first examine the feasibility and acceptability of the intervention through implementation in a pilot, mixed-methods, 1:1 allocation parallel-arm randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient age: 18 - 79 years at the time of consultation
* In situ or invasive biopsy confirmed breast adenocarcinoma
* Considered for immediate or delayed breast reconstruction
* First consultation for breast reconstruction

Exclusion Criteria:

* Chest wall or atypical breast malignancy (ex: angiosarcoma) or inflammatory adenocarcinoma of the breast
* Completion any phase of reconstruction, or for revision reconstruction
* Patient cannot read or write in English.
* Cognitive impairment or uncontrolled psychiatric diagnosis
Influence of Adipocytokines in Osteoarthritis

Adipocytokines play an important role in joint inflammation in patients with knee osteoarthritis as measured by ultrasound and high sensitivity protein-C reactive. Adipocytokines could be the link between osteoarthritis and cardiovascular risk factors more prevalent in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 50 years old with symptomatic knee osteoarthritis.

Exclusion Criteria:

* Patients with secondary osteoarthritis of the knee
* Any other rheumatologic condition.
Safety of Herpes Zoster Subunit (HZ/su) Vaccine During Pregnancy in Adult Women With Immunocompromised Conditions

The purpose of this postmarketing commitment safety study is to evaluate the real-world safety of HZ/su vaccine during pregnancy in immunodeficient or immunosuppressed adult pregnant women between 18 and 49 years of age in the United States. The primary outcome of interest is major congenital malformations (MCMs).


Eligibility Criteria:
Inclusion Criteria:

* Participant who is pregnant with a pregnancy start date between July 1, 2021 and June 30, 2026. Live births are to be followed for 1 year.
* Participant is a female aged 18-49 years on the pregnancy start date.
* Participant meets study definition of systemic lupus erythematosus (SLE), multiple sclerosis (MS), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), psoriasis (PsO)/psoriatic arthritis (PsA), solid organ transplant (SOT), stem cell transplant (SCT), hematologic malignancies (HM), solid tumors (ST), or human immunodeficiency virus (HIV). Codes for immunocompromised (IC) conditions will be identified in the health plan claims of the Distributed Research Network (DRN) during the period 273 days prior to the pregnancy start date through the first trimester (98 days after the pregnancy start date). Diagnoses recorded through the first trimester will be included to account for women who may not have frequent visits prior to pregnancy and may have a more complete assessment of medical conditions during the first prenatal care visit.
* Participant has at least 273 days of continuous health plan enrollment with medical and drug benefits prior to the start of pregnancy through the delivery date, with gaps of up to 45 days in coverage being permitted. The 273-day pre-pregnancy period through the first trimester (a period of 98 days after the pregnancy start date) was chosen to allow identification of potential confounders of interest. In Sentinel projects, gaps of 45 days or less in health plan enrolment are typically considered administrative gaps (and not lapses in health plan coverage) and ignored.

Exclusion Criteria:

* Participant was exposed to a medication(s) that presents a known increased risk for fetal malformations.
* Participant delivered an infant identified as having a chromosomal or genetic anomaly.
* Ectopic pregnancies, molar pregnancies or induced abortions.
* Multigestation (e.g., twin) pregnancies.
Pulmonic SAPIEN XT THV

Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up.

The aim of the registry is to document the feasibility and safety of implanting an Edwards SAPIEN XT transcatheter heart valve in the pulmonic position.

A malfunction or dysplasia of the pulmonary valve or the right ventricular outflow tract (RVOT) is one of the major components of the cardiac physiology in many congenital heart defects. Surgical correction of complex heart defects often includes some form of surgical repair or replacement of the native RVOT by biological valves such as homograft, bioprosthesis or Xenografts (i.e., Contegra conduits). Typical examples are tetralogy of Fallot (TOF) or double outlet right ventricle (DORV), pulmonary stenosis (PS), pulmonary atresia (PA), truncus arteriosus (TA), transposition of the great arteries (TGA) with PS (Rastelli's operation), absent pulmonary valve syndrome (Miller-Lev-Paul), Ross surgery for aortic valve disease and others. The repaired or replaced pulmonary valve however often becomes dysfunctional later on and many patients require surgical revisions of the RVOT with pulmonary valve replacement within 10 years of primary intervention.

TPVI provides a less invasive alternative to surgery in patients with right ventricular-to-pulmonary artery (RV-PA) conduit dysfunction. Early results of percutaneous pulmonary valve implantation (PPVI) showed that it is a promising procedure compared to a conventional surgical intervention. Meanwhile, pre-stenting of the RVOT before PPVI is routinely performed, enabling PPVI in various anatomies.

Eligibility Criteria:
Inclusion Criteria:

* Clinical indication and decision for the implantation of an Edwards SAPIEN XT THV made
* Data release form

Exclusion Criteria:

* none