cyrilzakka/clinical-trials huggingface dataset:
Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants

Background: Despite widespread phototherapy usage, many newborn infants remain in need of other lines of invasive therapy such as intravenous immunoglobulins and exchange transfusions.

Objective: To assess the efficacy and the safety of adding fenofibrate to phototherapy for treatment of pathological jaundice in full term infants.

Design/Methods: We conducted a double blinded randomized control study on 180 full-term infants with pathological unconjugated hyperbilirubinemia admitted to the NICU of Mansoura University Children's Hospital. They were randomly assigned to receive either oral fenofibrate 10 mg /kg /day for one day or two days or placebo. Primary outcome was total serum bilirubin values after 12, 24, 36, 48 hours from intervention. Secondary outcomes were total duration of treatment, need for exchange transfusions and intravenous immunoglobulin, exclusive breast-feeding on discharge, and adverse effects of fenofibrate.


Eligibility Criteria:
Inclusion Criteria:

* we included appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinemia who are candidate for phototherapy according to American academy of pediatrics guidelines

Exclusion Criteria:

* Full term infants with intrauterine growth restriction, congenital malformations, conjugated hyperbilirubinemia, severe jaundice initially required exchange transfusion, skin abrasions or infection, and preterm infants were excluded
Effect of Myofunctional Therapy on OSA

The primary medical therapies for patients with Obstructive Sleep Apnea syndrome (OSA) require the use of medical devices on a nightly basis to help control breathing during sleep, which can be difficult for patients with mild-to-moderate disease. Because many patients use these therapies on a limited basis, or stop using them altogether, they continue to be at increased risk of the consequences of untreated OSA. Untreated and undertreated OSA compounds the risk of OSA consequences over time, particularly with increasing age and weight. Orofacial Myofunctional Therapy (OMT) takes a rehabilitative approach to OSA and is comprised of isotonic and isometric exercises that target the oral (e.g., tongue) and oropharyngeal (e.g., soft palate, lateral pharyngeal wall) to help restore normal breathing and airway patency at night while asleep. Should the study have positive findings, OMT could become an important alternative therapy for patients with mild-to-moderate disease because patients could utilize a therapy that improves their nighttime breathing through daytime exercises and without the need for a burdensome medical device.

The purpose of this study is to examine the effect of Orofacial Myofunctional Therapy in Veterans with mild-to-moderate sleep apnea. The main question to be answered is whether OMT improves measures of OSA severity, patient functional status, and OSA symptoms when compared to sham OMT.

Eligibility Criteria:
Inclusion Criteria:

* Mild-to-moderate OSA
* Entry criteria are as inclusive as possible and operationalized as follows: age\>18 years old
* Confirmed diagnosis of OSA
* Having chronic symptoms per screening symptom checklist
* Fluency in English
* Must be getting care the VA San Diego Healthcare System

Exclusion Criteria:

* Cognitive impairment sufficient to cause inability to complete the protocol (per medical chart review)
* Low health literacy
* Residence in a geographical area outside of San Diego County
* Fatal comorbidity (life expectancy \<6 months as indicated by treating physician)
* Significant documented substance/chemical abuse
Analgesia Nociception Index to Explore Autonomic Nervous System in Patients With Continuous Renal Replacement Therapy

The Analgesia Nociception Index (ANI) reflects the balance between sympathetic and parasympathetic tone. It is based on a specific interpretation of the R-R interval variation. During fluid removal by net ultrafiltration in patients with fluid overload and continuous renal replacement therapy, some data suggest that haemodynamic variation could be induced by the autonomic nervous system. The study aims to investigate ANI variations in this context and their association with the haemodynamic variations observed.


Eligibility Criteria:
Inclusion Criteria:

* Continuous renal replacement therapy in intensive care unit
* Initiation of net ultrafiltration according to the protocol of the department or to EARLYDRY study (NCT 05817539) (3 criteria required):

  * Fluid overload \> 5% or peripheral oedema
  * Noradrenaline equivalent \<0.5μg/kg/min
  * No peripheral hypoperfusion
* Invasive blood pressure monitoring
* Central venous line in superior vena cava territory
* Regular sinus rhythm
* Patient awake or Richmond Agitation and Sedation Scale \> -3

Exclusion Criteria:

* Ongoing administration of inotropes
* Ongoing administration of beta blockers
* Current administration of alpha-2 agonists
* History of dysautonomia
* Pregnant or breast-feeding woman
* Mechanical circulatory assistance
* Opposition to participate
* Adults under legal protection
* Persons deprived of their liberty by judicial or administrative decision
Greater Occipital Nerve Pulsed Radiofrequency for the Treatment of Combined Migraine and Cervicogenic Headache (New Approach)

Combined migraine and cervicogenic headache present significant challenges in clinical management due to their complex and overlapping pathophysiologies. Both conditions involve the trigeminocervical complex, suggesting a potential shared anatomical and neurobiological basis

Traditional treatment approaches for these headaches often include pharmacological interventions, but in cases of refractory or inadequate response, interventional techniques targeting the greater occipital nerve (GON) have gained attention.

Radiofrequency ablation (RFA) has gained recognition as a potential therapeutic option for patients with refractory combined migraine and cervicogenic headaches. The proximal and distal ultrasound-guided approaches are widely utilized for GON RFA. These approaches aim to disrupt pain signals transmitted by the GON and provide relief of pain for these headache disorders

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with combined migraine and cervicogenic headache according to The International Classification of Headache Disorders (ICHD)
* Age between 18 and 65 years.
* Willingness to participate and provide informed consent

Exclusion Criteria:

* Previous neurosurgical procedures for headache management.
* Patients with contraindications for the RF technique
* Pregnancy or lactation
* History of psychiatric disorders or substance abuse
Analysis of Donor-derived Cell Free DNA in Liver Transplant Patients

Determine the levels of Donor-derived (dd)cell-free DNA(cfDNA )in liver transplant recipients with normal liver function tests (LFTs) indicating stable immunosuppression status (IS). Based on this range use the dd-cfDNA levels to determine over or under IS in liver transplant patients to make changes to their IS medication regimen.

dd-cfDNA is a non-invasive method to measure graft function stability in liver transplant patients. Liver biopsy is the standard to determine liver rejection and graft function, but no tests exist currently to be able to help guide the IS regimen in these patients. LFTs are not as specific to determine graft function hence testing dd-cfDNA levels can help guide the Immunosuppression (IS )medications dosing and help identify rejection early.

Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥18 years
2. The patient underwent a liver transplant.
3. The patient at least has one level of dd-cfDNA documented

Exclusion Criteria:

* Patient not meeting the inclusion criteria will be excluded.
Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the treatment of fever or pain in the hospital setting.


Eligibility Criteria:
Inclusion Criteria:

* Pain: Patients with baseline Visual Analog Scale assessment \>3, -and/or- Fever: Patients with temperature \>101°F.

Exclusion Criteria:

1. Patients with inadequate IV access
2. Patients \<18 years of age
3. History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
4. Active hemorrhage or clinically significant bleeding
5. Pregnant or nursing
6. Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
7. Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions
8. Refusal to provide written authorization for use and disclosure of protected health information
MRI-Eye Tracking Pairing, a Tool for Assessing Social Cognition in Children With ASD

Most studies use static visual percepts that are less representative of joint attention versus an ecological environment. This has the consequence of decreasing the perception of an interaction with a social partner, which is an essential step in achieving joint attention. The originality of this study is to improve the design of visual percepts (in the form of video) in order to mimic an ecological environment as much as possible by using MRI-ET coupling. The second originality of this study is the longitudinal exploration of the neurodevelopment of social cognition in autistic children. Studies by the Redcay and Oberwelland teams observe different activations at different ages. The hypothesis is that the perception of joint attention varies over time in people with ASD. To date, there are no studies to determine the influence of childhood neurodevelopment in autistic people on the perception of joint attention. It would be unprecedented to use the MRI-ET pairing as a tool for assessing social cognition as a function of the development of children with ASD.


Eligibility Criteria:
Inclusion Criteria:

For the group of people with Autism Spectrum Disorders (experimental group):

* Age between 10 to 20 years old
* Diagnosis of ASD (CARS) ≥ 30 performed at inclusion
* IQ test evaluation (regardless of the result) performed by a trained psychologist
* Obtaining informed oral and written consent after appropriate information
* Obtaining informed oral and written consent from the legal guardian after information
* Be affiliated with social security
* No contraindication to magnetic resonance imaging

For the TD (Typical Development) group of people (control group):

* Age between 10 to 20 years old
* Diagnosis of ASD (CARS) \<30 performed at inclusion
* IQ test evaluation (regardless of the result) performed by a trained psychologist
* Obtaining informed oral and written consent after appropriate information
* Obtaining informed oral and written consent from the legal guardian after information
* Be affiliated with social security
* No contraindication to magnetic resonance imaging

Exclusion Criteria:

For all groups:

* Age outside the range 10 to 20 years
* Person with a contraindication to MRI (including claustrophobia, pace maker, neurosurgical clips, vascular clips, heart valves, ventriculoperitoneal valves, cochlear implant, neurostimulator, intraocular metal shards, joint prosthesis, etc.)
* Person suffering from major obesity (\> 140 kg) not allowing him to enter the tunnel of the MRI machine (diameter \<70cm)
* Pregnant or breastfeeding woman
* Person under guardianship or guardianship or deprived of liberty by a judicial or administrative decision

For TD people (control group):

* Person with psychiatric disorders such as attention disorder with or without hyperactivity, depression, bipolar disorder and schizophrenia.
* Person with a neurological history such as epilepsy and / or neurovascular accident.
AMPLATZER Cardiac Plug (ACP) Latin American Post Market Observational

The ACP device will be clinically evaluated through a prospective, open-label, nonrandomized, multi-center post market clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation (documentation may include an electrocardiogram (ECG), Holter, or event recorder)
* Subject must have a LAA closure procedure that has already been planned or scheduled by his/her attending physician before entry in the study
* Subject must be greater than or equal to 18 years of age

Exclusion Criteria:

* Subject with an implanted atrial septal defect (ASD) device or patent foramen ovale (PFO) device
* Subject underwent LAA closure procedure prior to study entry (i.e. before signing informed consent
* Subject who has a history of surgical ASD or PFO repair
* Subject with a history of stroke and unrepaired PFO
* Subject who has moderate to severe aortic or mitral valve stenosis or regurgitation requiring surgical or percutaneous intervention as assessed by the Investigator
* Subject who has a mitral or aortic prosthetic valve
* Subject with NYHA grade 4
* Subject with evidence of moderate pericardial effusion at baseline evaluation
* Subject who has complex atheroma with mobile plaque of the descending aorta and/or aortic arch
* Subject who has an intracardiac thrombus
* Subject who has carotid disease as assessed by the Investigator, requiring treatment, which includes revascularization and/or medical treatment
* Subject with active infection or active endocarditis
* Subject who has an acute or recent myocardial infarction (MI) or unstable angina (recent is defined as within 3 months of implant date)
* Subject who has had recent major cardiac surgical procedure (recent is defined as within 6 months of implant date)
* Subject with malignancy or other illness where life expectancy is less than one year
* Subject who is pregnant, breastfeeding, or desires to become pregnant during their first six months of follow-up
* Subject or legally authorized representative who is unable to provide informed consent
* Subject who will not be able to be followed for the duration of the clinical study
* Subject with any medical disorder or severe disability that would interfere with completion or evaluation of clinical study results (for example uncontrolled hypertension, uncontrolled diabetes, blood disorder, renal failure, in situ IVC filter)
Trial Evaluating Hedonic vs Cash Incentives

This study aims to determine, using a randomized trial with two parallel arms, whether hedonic rewards (Arm 1) can be more effective than their cash equivalent (Arm 2) in motivating participants to meet step goals.

The evidence is overwhelming that sustained physical activity reduces risks for non-communicable diseases, increases longevity, and reduces medical costs. Yet, the rates of physical activity have been steadily decreasing such that physical inactivity is now the fourth leading cause of death worldwide. In Singapore, 33% of adults are insufficiently active despite Singapore being a highly walkable city with numerous subsidized community-based physical activity programs. A review of the literature shows that, to date, no study has directly compared cash versus hedonic rewards for health behavior change despite theory suggesting hedonic rewards may work better. Furthermore, hedonic rewards can often be purchased at lower cost than their cash equivalent. This makes hedonic rewards potentially more cost-effective if they are proven to be at least as effective at increasing positive behavior change compared to giving the same value in cash.

Thus, we aim to determine, using a randomized trial with two parallel arms, whether hedonic rewards (Arm 1) can be more effective than their cash equivalent (Arm 2) in promoting increases in physical activity, assessed via step counts measured by a Fitbit physical activity tracker, during a 4-calendar month intervention. We hypothesize that the average proportion of months meeting the incentivized step target across participants will be greater for those in the hedonic incentive arm as compared to those in the cash incentive arm (primary outcome).

Eligibility Criteria:
Inclusion Criteria:

* Aged between 21 to 70 years inclusive.
* Singapore resident (residing in Singapore during the study period \[up to 5 months\])
* English-speaking and English literate
* Smartphone-literate

Exclusion Criteria:

* Pregnant or lactating
* Unable to walk up 10 steps (individual steps, not floors) without stopping
* Currently on doctor's advice against engaging in moderate-to-vigorous physical activity (i.e., brisk walking or more intense).
* Currently have a condition(s) that restricts engaging in moderate-to-vigorous physical activity (i.e., brisk walking or more intense).
* Unwilling to be randomized into study arms
* Unwilling to use a Fitbit for the study period (up to 5 calendar months)
* Unwilling to pay the $20 enrolment fee
* Does not complete the Consent Form
* Refuses to give consent to participate in the study
Iron Long-Term Labelling Study Benin

Conventional indirect indicators of iron status, using serum and red blood cell biomarkers, are confounded by inflammation from common infections in sub-Saharan Africa, a region with a high prevalence of iron deficiency, making the assessment of iron balance and efficiency of iron intervention difficult. A potential reference method to quantify iron absorption and requirements using isotope dilution measurements in women living in areas with high burden of infection should be developed and validated within this project. The new method will allow accurate measurement of long term oral iron absorption and the estimation of iron requirements, potentially providing fundamental guidance for supplementation and fortification programs in sub-Saharan Africa. In a case series with four months' preventative iron supplementation intervention imbedded between a four months' control period prior intervention and a four months' control period after intervention, we will follow a group of 63 women. During the intervention period, the women will receive 50 mg Fe as ferrous sulfate tablets every day for 120 d. In total, the women will give 9 blood samples (day 1, 60 120, 150, 180, 210, 240, 300 and 360) for the de-termination of the isotopic composition and iron status biomarkers and 5 stool samples (day 1, 120, 180, 240 and 360) for the detection of soil transmitted helminths and gut inflammation. This design will allow the measurement of the isotopic iron dilution to assess the total oral iron absorption during the intervention period in comparison with the control periods without the administration of additional iron isotopes.


Eligibility Criteria:
Inclusion Criteria

* Have participated in one of the original absorption studies
* Signed written informed consent to participate in the study

Exclusion Criteria

* Long-term medication \[except contraceptives\]
* Any severe metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases according to the participants own statement or examination of study doctor
* Blood losses \[surgery, accident\], donations or transfusions during the past 4 months before study start.
* Residence too far away \[1 hour or more by motorbike\] from study locations; Natitingou or Cotonou
A New Modified Suture Bridge Technique

We aimed to introduce a new modified suture bridge technique and report the clinical outcomes and radiological assessments of modified suture bridge technique for medium rotator cuff tears.

Purpose: We aimed to introduce a new modified suture bridge technique and report the clinical outcomes and radiological assessments of modified suture bridge technique for medium rotator cuff tears.

Methods: We prospectively followed 50 consecutive patients with medium rotator cuff tears treated with the modified suture bridge (MSB) or traditional suture bridge technique (TSB) from December 2018 and December 2019. On the basis of preoperative findings and MRI performance, 26 patients underwent MSB repair whereas 24 underwent TSB repair. Range of shoulder motion, visual analog scale score (VAS score), University of California-Los Angeles score (UCLA score), Constant-Murley shoulder score (Constant score), American Shoulder and Elbow Surgeons score (ASES score) were assessed. Magnetic resonance imaging were performed preoperatively and at 12 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* (1) full-thickness medium tears (1-3cm) of primary supraspinatus (SSP) tendon was identified on preoperative MRI and intraoperative arthroscopy, (2) undesirable conservative treatment for 3 months, (3)completed follow-up of 12 months postoperatively and patients who adhered to the rehabilitation plan.

Exclusion Criteria:

* (1) previous shoulder surgery, (2) Other pathological changes that would need to be addressed at the time of arthroscopic surgery, such as rotator cuff tear involving the subscapular (SSC) tendon，biceps tendon injury, (3) failure to follow our postoperative rehabilitation protocol and patients without regular follow-up.
Phase III Study of Topical Gel for Treatment and Prevention of Raynaud's Phenomenon

The purpose of this study is to investigate the efficacy and safety of a topical gel formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate to severe primary Raynaud's phenomenon or patients with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Raynaud's phenomenon
* 2 or more Raynaud's events on a typical winter day
* Agree to discontinue current treatments for Raynaud's
* Negative pregnancy test and agree to use effective contraception during study

Exclusion Criteria:

* Current use of nitrate medications or medications known to interact with nitroglycerin
* Patients who currently use medications, like calcium channel blockers, that might interfere with study medication
* Patients with a known allergy to nitroglycerin or common topical ingredients
* Patients with a history of migraine headaches
* Patients with a history of unstable medical problems
* Patients with cognitive or language difficulties that would impair completion of assessment instruments
* Patients with lab screening values more than 20% outside normal range
* Patients with non-epithelialized skin lesions, in the area where the gel is to be applied, at the time of screening
* Pregnant or nursing women
* Women of child-bearing potential who are unwilling to comply with the contraceptive requirements