cyrilzakka/clinical-trials huggingface dataset:
Identification of Predictors for Coronary Plaque Erosion in Patients With Acute Coronary Syndrome

The purpose of this study is to perform pooled analysis with data collected from 5 previously published studies and 8 unpublished datasets collected from international sites. The main goal of this study is to identify the predictors of plaque erosion.

Plaque erosion is reported to be responsible for about one third of patients with acute coronary syndrome (ACS). In the EROSION study, we reported that antithrombotic therapy without stenting achieved a reduction in thrombus volume greater than 50% in over 70% of patients diagnosed with ACS caused by plaque erosion. This result suggests that the conservative approach of anti-thrombotic therapy without stenting may be an option for patients diagnosed with ACS caused by plaque erosion, which may be the paradigm shift in treatment of ACS patients. However, at present, the only way to make an in vivo diagnosis of plaque erosion is intra-coronary optical coherence tomography (OCT). If we can identify clinical factors associated with plaque erosion, we may be able to narrow down a sub-population of patients with a higher likelihood of plaque erosion. This group of patients may be stabilized with pharmacologic therapy and avoid invasive procedures, thereby preventing related complications and reducing health care burden. However, specific demographic characteristics of the ACS patients with plaque erosion are not known. Our group has the world's largest dataset of patients with plaque erosion and several published reports on plaque erosion. However, the study population of each study is still small and unbalanced to identify the demographic characteristics associated with plaque erosion. Therefore, we propose to pool data from a large number of institutions around the world. This will provide an opportunity to identify factors associated with plaque erosion.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with ACS upon admission to hospital, including patients with ST-elevation myocardial infarction (STEMI), non-ST elevation myocardial infarction (NSTEMI), and unstable angina pectoris (UAP).
2. Intra-vascular OCT imaging of culprit vessel.

Exclusion Criteria:

* None
Tolerance of nHFPV Versus nCPAP in Neonatal Respiratory Distress

Respiratory distress is the main cause of morbimortality in preterm and term neonates. In most of the case, these babies required the use of positive end expiratory pressure (PEEP) delivered by a non invasive device. Nasal continuous airway positive pressure (nCPAP) is widely used in neonatal intensive care unit. Nasal high frequency percussive ventilation (nHFPV) can be used as non invasive device to deliver PEEP, and improved lung clearance.

We hypothesized that nHFPV can be used to deliver PEEP in preterm and term newborn with respiratory distress with the same tolerance as nCPAP. To compare the tolerance of these devices we used cerebral tissue oxygenation (rSO2c) measured by near infrared spectroscopy (NIRS).

The objective is to compare nHFPV versus nCPAP tolerance for providing PEEP in newborn respiratory distress.

High frequency percussive ventilation (HFPV) is a pressure limited, time-cycled, high-frequency mode of ventilation that delivers subphysiologic tidal volumes at rapid rates and that can be used via an endotracheal tube, a nasal probe or a face mask. In burned children, it has been shown to provide the same or improved oxygenation and ventilation at lower peak pressure when compared with conventional ventilation. In neonates, HFPV has been described in hyaline membrane disease and acute respiratory failure ventilation with improvement in oxygenation, significant decrease in PaCO2 and no change in central hemodynamics and we recently shown that nasal HFPV is more effective than nasal continuous positive airway pressure in transient tachypnea of the newborn. This stud is a cross-over clinical trial. For each patient enrolled, the 2 respiratory devices (nHFPV and nCPAP) were used one after the other for 15 minutes each. Randomization determines which device to use in first (group A nCPAP then nHFPV, group B (nHFPV then nCPAP). During the experiment, rSO2c is continuously recorded by NIRS, and oxygenation and capnia are monitored in a non invasive way by transcutaneous oxygen saturation and transcutaneous capnia measurement. Ventilators' setting (PEEP, FiO2) will be modified to achieve oxygen and capnia targets (SpO2 \> 90%, and under 95% if FiO2\>0.21, Capnia between 5 to 7 kPa). Duration of patient follow up is 30 minutes. After these 30 minutes, if PEEP is always needed, patients undergo nCPAP. If needed during the experiment, patients can receive mechanical ventilation (the criteria for mechanical ventilation are the same as those used in clinical practice).

Eligibility Criteria:
Inclusion Criteria:

* Inborn neonate.
* Delivered by vaginal delivery or caesarean section.
* Gestational age greater than or equal to 33 weeks of gestation.
* Birth weight \> 1kg.
* Respiratory distress with a Silverman score greater than or equal to 4 after 10 minutes of life.
* Signed parental informed consent.

Exclusion Criteria:

* Meconium aspiration syndrome.
* Congenital anomalies such as heart anomalies, congenital cystic adenomatoid malformation, diaphragmatic hernia...
Phase 2a Study of VX-147 in Adults With APOL1-mediated Focal Segmental Glomerulosclerosis

This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-147 in participants with apolipoprotein L1 (APOL1)-mediated focal segmental glomerulosclerosis (FSGS).


Eligibility Criteria:
Key Inclusion Criteria:

* APOL1 genotype of G1/G1, G2/G2, or G1/G2
* FSGS diagnosed by kidney biopsy

Key Exclusion Criteria:

* Evidence of non-APOL1-mediated FSGS
* Participants with known sickle cell disease
* Solid organ or Bone marrow transplant

Other protocol defined Inclusion/Exclusion criteria may apply.
IRB-HSR# 14145 R,S Methadone: Analgesia and Pharmacokinetics in Adolescents Undergoing Scoliosis Correction

This is a pilot study to determine the pharmacokinetics of (R,S) methadone in adolescents. A total of approximately 15 patients will be required. The purpose is to determine the levels of R, S methadone at various time intervals after drug administration. Patients will receive methadone 0.25 mg/kg IV at induction and a standardized anesthetic of remifentanil and propofol. At the conclusion of surgery (45 minutes prior to the completion), the patients will receive a loading dose of morphine based on respiratory rate. A morphine PCA will be utilized for postoperative analgesia. Pharmacokinetic data will be collected in addition to VAS scores, patient and parental satisfaction with analgesia, and a functional pain assessment.

Study Procedures Following Surgery:

* VAS scores will be recorded at intervals of 1,2,3,4,5,6,8,12,16,20,24, 36, 48 , 72 hrs (after extubation).
* Blood samples for PK will require 5ml per sample and may be obtained from an existing IV or direct phlebotomy and will be obtained at 0min, 5min, 10 min, 15min, 20 min, 40 min, 1hr, 2hrs, 3hrs, 4hrs, 5hrs, 6hrs, 8hrs, 10 hrs, 12hrs, 24hrs, 48 hrs, 72hrs, and 96hrs after study drug administration.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric scoliosis surgery secondary idiopathic scoliosis, congenital scoliosis,
* Age 12 - 19 inclusive
* ASA class I-II.

Exclusion Criteria:

* Preoperative opioid therapy in previous 2 weeks
* Known hepatic or renal impairment
* Inability to assess pain score due to neurological impairment, hearing impairment
* Allergy to methadone, morphine, fentanyl, propofol or remifentanil
* Pregnant or nursing
* Taking SSRI's, MAOI,anticonvulsants, gabapentin or lyrica
* ASA III or greater patients are excluded
* pre-existing chronic pain
Phase 1: Randomized Evaluation of a System to Deliver Mobile Cognitive Behavioral Therapy

The clinical study described in this Clinical Investigation Plan (CIP) will be completed in two stages, Phase I and Phase II. The results of Phase I will confirm patient use of InCaveo's EOA system with integrated mobile CBT but without tapering to improve The Pain Catastrophizing Scale (PCS) scores, and secondarily scores on the VNS pain scale, the Tampa Scale of Kinesiophobia (TSK), and patient satisfaction scores in the subacute period (defined as 2 weeks to 3 months post TKR). Statistically significant positive results on the Pain Catastrophizing Scale (PCS) will trigger phase 2. Phase 1 will also inform the detailed conditions and patient management algorithms for Phase II.

The InCaveo End Opioid Addiction (EOA) System is an integrated pain management therapeutic and opioid tapering system providing alternate treatment options via self-service Cognitive Behavior Therapy (CBT) built into a mobile software app, patient medication usage, and tracking of patient PROs. It is designed to be used alongside Usual Standard of Care using Pill Bottles or to simplify, Usual Care with Pill Bottles (UCPB) treatment practices. The InCaveo EOA System is designed to improve a set of patient outcome measures, primarily Pain Catastrophizing Scale (PCS) and secondarily the Visual Numeric Pain (VNS), Kinesiophobia (TSK) and satisfaction scores while facilitating the ability of patients to taper off their pain medication faster than through the use of USPB in the management of post-operative pain. In order to reduce confounding variables, the study will focus on pain management following a single surgical procedure: Total Knee Replacement (TKR) surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has a Pain Catastrophizing Score \>16
2. 55 years of age and older.
3. English speaking.
4. Has a smartphone (iPhone).
5. Able to swallow oral medications.
6. No continuous daily opioid as defined as more than 15 days in the 30 days before surgery.
7. Undergoing TKR surgery.
8. Patients who are willing and able to comply with scheduled visits and study procedures.

Exclusion Criteria:

1. Diagnosed with Opioid Use Disorder (OUD).
2. Actively using illicit drugs.
3. Allergy to opioids
4. Older than 85 years
Study With Healthy Japanese and Non-Asian Participants With BMS-986231

The purpose of this Phase 1 study is to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of BMS-986231 in healthy Japanese and Non-Asian participants. There is no formal hypothesis to be statistically tested.


Eligibility Criteria:
Inclusion Criteria:

* Ancestry

  * First generation Japanese
  * Non-Asian with grandparents and parents of non-Asian descent
* Body weight greater than or equal to 45kg and less than or equal to 110kg
* Women of childbearing potential have specific birthcontrol methods
* Males sexually active with women of childbearing potential have specific birthcontrol methods

Exclusion Criteria:

* History of chronic illness
* Chronic headaches
* Recurrent dizziness
* Personal or family history of heart disease
* Personal history of bleeding diathesis
REward SYSTem in Autism Spectrum Disorder and Addictive Disorder

An MRI Study in Subjects with Autism Spectrum Disorder and Subjects with Food Addictive Disorder compared to healthy volunteers.

An MRI Study in Subjects with Autism Spectrum Disorder and Subjects with Food Addictive Disorder compared to healthy volunteers, where pathophysiology common to both disorders, based on a dysfunction of the reward system. The project we propose aims to explore the neural networks underlying these alterations in patients suffering from autism or addictive disorder.

Eligibility Criteria:
Inclusion Criteria:

Arm A ˗ Concerning ASD patients: Adult carrying the diagnosis of ASD (DSM-5, ADOS, ADI-R criteria)

Arm B ˗ Concerning FAD patients: Adult diagnosed with FA presenting with food addiction (DSM-5, YFAS 2.0, BES \>= 18 criteria).

Arm C ˗ Concerning healthy volunteers : Adult with no neurological and psychiatric history , absence of progressive somatic pathologies or with vital risk.

For all participants:

* Age greater than or equal to 18 years old
* Without intellectual delay (IQ \> 70).
* Able to understand and apply the instruction when an active task is proposed, according to the estimate of the investigator.
* Free, express, informed and written consent of the participant.
* Participant affiliated to a social security scheme

Exclusion Criteria:

* Neuromotor disorders.
* Visual disturbances not corrected or incompatible with MRI.
* Known epilepsy.
* Current substance use disorder with emotional distress/significant impact on functional outcome
* Rare genetic syndrome.
* Contraindications to MRI (other than body circumference)
* For women of childbearing age: negative urine or blood pregnancy test
* Person subject to a measure of judicial protection (safeguard of justice, curatorship, guardianship or family authorization)
Phosphate in Blood Pressure Regulation

High dietary phosphate intake in the general population is associated with a higher risk for developing kidney disease and cardiovascular disease with an increased overall mortality. Whereas the effects of high phosphate intake on general health become clearer, almost nothing is known about underlying mechanisms. More recently, the investigators and others found in animal models that FGF23 stimulates the renal NaCl cotransporter NCC, the target of thiazide diuretics, and that increased NCC activity may increase blood pressure. The investigators could also show that increasing dietary phosphate intake in mice, increases FGF23 and NCC activity within 3 days. Thus, the objective of this single-centre observational cross-over study including 20-45 year old healthy male probands is to elucidate the role of dietary phosphate on blood pressure regulation and renal handling of sodium chloride in healthy subjects. Further the impact of dietary phosphate intake on the regulation of phosphaturic hormones and other factors regulation blood pressure will be investigated. In addition, the investigators will examine whether phosphate intake modulates gut microbiome composition. The primary outcome in this study is the change in blood pressure in healthy subjects on low-phosphate diet compared to healthy subjects on high-phosphate diet. In addition, to assess changes in NCC activity as the main mechanism of phosphate-sensitive blood pressure regulation, renal sodium chloride excretion after administration of hydrochlorothiazide will be measured. The secondary outcomes of this study are: changes in renal phosphate, calcium and potassium excretion, changes in phosphate regulation hormones such as 25-OH-Vit. D, 1,25-(OH)2-Vit. D, PTH, FGF23, dopamine in plasma and urine, changes in plasma and urinary aldosterone levels, changes in sodium/chloride-cotransporter NCC and NaPi-IIa assessed from urinary exosomes, and changes in stool phosphate excretion and gut microbiome composition.


Eligibility Criteria:
Inclusion Criteria:

* 20-45 year old healthy male subjects

Exclusion Criteria:

* - Kidney disease (defined by eGFR \< 90 ml/min or microalbuminuria (\> 30mg/d))
* Diabetes mellitus
* Hypertension (RR \> 140/85 mmHg)
* Hypotension (RR \< 90/60 mmHg)
* any regular medication
* non-Western type diet e.g. vegetarian, vegan etc.
* History of kidney stones
* Allergy to sulphonamides or penicillins
* Hereditary fructose intolerance
* known hypersensitivity or allergy to class of drugs used in this study
* Glaucoma
* Vitamin D deficiency (\< 20 ng/ml)
* Hyper- or Hypoparathyroidism
* Hypo- or hyperaldosteronism
* Participation in any other study
Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes

A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes

This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for better sleep, (2) indicate a willingness to refrain from taking cannabinoids during the study period, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver disease, heavy drinkers, and those who are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking medications that warn against grapefruit consumption will be excluded.

Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age and older
* Resides in the United States
* Endorses a desire for better sleep
* Selects sleep as a primary reason for taking a cannabinoid product
* Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e. CBD, CBG, CBC, CBN, THC) for the duration of participant engagement (5 weeks)
* Expresses an interest in taking a study product and not knowing the product identity until the end of the study

Exclusion Criteria:

* Pregnant, trying to become pregnant, or breastfeeding
* Reports a diagnosis of liver disease
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English
* Lack of reliable daily access to the internet
* Reports taking any medication that warns against grapefruit consumption
Nirogacestat in Ovarian Granulosa Cell Tumors

This phase 2 clinical trial will study the effectiveness of nirogacestat in ovarian granulosa cell tumors (OvGCTs). Nirogacestat is a gamma secretase inhibitor (GSI) which is hypothesized to decrease the growth and activity of ovarian granulosa tumors.

Ovarian granulosa cell tumors (OvGCTs) represent 5-7% of all ovarian cancers (\~1.5 to 2k newly diagnosed patients/year in the United States) and are the most common subtype of ovarian sex cord tumors (70%). Treatment of granulosa cell tumors with nirogacestat is expected to inhibit Notch-induced granulosa cell proliferation.

This is a multi-center, single-arm, Phase 2 open label treatment study to determine the efficacy, safety, tolerability, and pharmacokinetics of nirogacestat in adult participants with relapsed/refractory OvGCT. The participants will continue treatment until disease progression as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (unless the participants meet criteria for continued treatment) or unacceptable toxicity.

Eligibility Criteria:
Key Inclusion Criteria:

* Has histologically confirmed recurrent adult-type granulosa cell tumor of the ovary prior to first dose of study treatment
* Have documented radiological evidence of relapse after at least one systemic therapy that is not amenable to surgery, or radiation and have measurable disease by RECIST v1.1 criteria
* Have adequate bone marrow, renal and hepatic function as defined by screening visit laboratory values

Key Exclusion Criteria:

* Has signs of bowel obstruction requiring parenteral nutrition, malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat
* Has had a major cardiac or thrombo-embolic event within 6 months of signing informed consent
* Has abnormal QT interval at Screening, or has congenital or acquired long QT syndrome or a history of additional risk factors for Torsades de Pointes
* Has current or chronic history of liver disease or known hepatic or biliary abnormalities
* Has received bevacizumab treatment or other monoclonal antibody therapy with targeted anti-angiogenic activity for OvGCT within 28 days (or 5 half-lives, whichever is shorter) prior to the first dose of study treatment;
* Has received treatment for OvGCT including but not limited to the following within 28 days (or 5 half-lives, whichever is longer) prior to the first dose of study treatment: hormonal therapy, chemotherapy, immunotherapy, targeted therapy or any investigational treatment
Prospective Pecutaneous Coronary Intervention Registry

Coronary artery disease is the most important cause of death worldwide. Treatment option for coronary artery disease is medical treatment, percutaneous coronary intervention, or coronary artery bypass surgery. Among them, the field of percutaneous coronary intervention is rapidly developing with regard to the improvement of devices, techniques, or medical treatment, leading to reduce mortality or morbidity. Until now, numerous previous studies related to the risk factors of coronary artery disease and the prognosis of patients have been conducted. However, the field of percutaneous coronary intervention is rapidly evolving, and treatment strategies are constantly being updated. Therefore, the current study sought to identify the long-term prognosis and related risk factors of patients with coronary artery disease who underwent percutaneous coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

* patients who have undergone or are scheduled to undergo coronary angiography and percutaneous coronary intervention.

Exclusion Criteria:

* patients who did not consent to the research
Self Reduction of Shoulder Dislocation

Anterior dislocation of the shoulder (glenohumeral joint) is one of the most prevalent dislocations. Following a first dislocation recurrence rates of up to 80% have been reported. Many patients will seek medical assistance for reduction of the shoulder after each of these recurrent dislocations. The investigators describe the results of reduction of anterior glenohumeral dislocation using a modified self manipulated Milch technique that can be performed by the patients themselves after simple guidance and demonstration. This method is directed to patients who are not willing or cannot have surgical stabilization and may be in a place where medical assistance is not available.


Eligibility Criteria:
Inclusion Criteria:

* anterior shoulder dislocation
* acute (24 hours) shoulder dislocation

Exclusion Criteria:

* shoulder fracture
* non-cooperative patient