cyrilzakka/clinical-trials huggingface dataset:
Polyprenols (Ropren) in Acute Coronary Syndrome

The aim of this study is to determine efficacy and safety of polyprenols (ROPREN) using in patients with acute coronary syndrome

This study is randomized double blind placebo controlled. Patients with acute coronary syndrome taking standard therapy including atorvastatin 40 mg/day were randomized into 2 groups: group 1 takes Ropren 8 drops 3 times per day for 3 week, then 5 drops 3 times per day for 5 weeks; group 2 take placebo in the same dose regimen. The hepatoprotective, hypolipidemic, antiinflammatory, cognitive, antidepression functions evaluates after one and two - month therapy

Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome
* Informed consent received

Exclusion Criteria:

* Patient's incapacity to take accurately drops by oneself
* Cardiogenic shock
SC IL-1Ra in SAH - Phase III Trial (SCIL)

This phase III trial will establish whether IL-1Ra, with sub-cutaneous (SC) administration twice daily for up to 21 days post aneurysmal subarachnoid haemorrhage (aSAH), improves clinical outcome as measured by ordinal shift in mRS at 6 months.

Patients with SAH transferred to a neurosurgical centre will be identified and approached for study participation. Following consent, patients will be randomised to receive either IL-1Ra or placebo for a maximum of 21 days from onset of symptoms. Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment. Blood samples for plasma IL-6 will be obtained prior to randomisation and at day 3-5 post randomisation for IL-6 \& IL-1 measurement. Safety will be measured at 30 days post randomisation and outcome assessed at 6 months post randomisation.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with CT positive spontaneous SAH admitted to a participating neurosurgical centre where written informed consent can be obtained and study drug can be administered within 72 hours of ictus.
2. No concomitant health problems that, in the opinion of the PI or designee, would interfere with participation, administration of study drug or assessment of outcomes including safety.
3. Willing and able to give informed consent or consent available from a patient representative for trial inclusion including agreement in principle to receive study drug and undergo all study assessments.
4. Male or female aged 18 years or above.

Exclusion Criteria:

1. Unconfirmed or uncertain diagnosis of spontaneous SAH.
2. Known active tuberculosis or active hepatitis.
3. Known active malignancy.
4. Known Still's Disease
5. Neutropenia (ANC \<1.5 x 109/L ).
6. Abnormal renal function (creatinine clearance or estimated Glomerular Filtration Rate (eGFR) \< 30 ml/minute) documented in the last 3 months prior to this SAH.
7. Live vaccinations within the last 10 days of this SAH.
8. Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial.
9. Current treatment with TNF antagonists.
10. Known to have participated in a clinical trial of an investigational agent or device in the 30 days prior to ictus.
11. Known to have participated in a clinical trial of an investigational agent or device within 5 half-lives (of the previous agent or device) prior to ictus.
12. Known to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant
13. Clinically significant serious concurrent medical condition, pre morbid illnesses, or concurrent serious infection, at the PI's (or designee's) discretion, which could affect the safety or tolerability of the intervention.
14. Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC
15. Known allergy to other products that are produced by DNA technology using the micro-organism E. coli (e.g. E.coli derived protein).
16. Current treatment with IL-6 or IL-1 inhibitors or drugs affecting the IL-1 axis.
17. History of DRESS syndrome.
Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia

The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care.

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).


Eligibility Criteria:
Key Inclusion Criteria:

* Documented diagnosis of B-cell CLL, with diagnosis established according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL)
* No prior therapy for CLL other than corticosteroids for disease complications
* CLL that warrants treatment
* Presence of measurable lymphadenopathy
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Key Exclusion Criteria:

* Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
* Known presence of myelodysplastic syndrome
* Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
* Ongoing liver injury
* History of non-infectious pneumonitis
* Ongoing inflammatory bowel disease
* History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
* Ongoing immunosuppressive therapy other than corticosteroids
* Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The Effects and Mechanisms of Mindfulness Based Cognitive Therapy (MBCT) on Depressive Symptoms and Depression Relapse

This research proposal is intended to elucidate the efficacy and mechanisms underlying Mindfulness Based Cognitive Therapy (MBCT) in a population in remission from recurrent Major Depressive Disorder (MDD). The first objective of the study is to replicate previous studies' findings of MBCT's effects on decreasing depressive symptoms and depression relapse rates. However, this proposal aims to make a novel contribution to the literature by using a randomized, controlled design, and comparing the effects of MBCT to an active control condition (ACC). The use of a well-designed ACC will enable us to control for confounding variables such as social support and expected outcomes, thus allowing us to determine whether elements specific to MBCT lead to its salutary effects (Aim 1). Previous MBCT studies have largely relied on self-report measurement methodologies, limiting valid conclusions about the nature of MBCT. Further, few studies have examined the mechanisms underlying effects of MBCT on depressive symptoms and relapse. Theoretical considerations and preliminary empirical evidence suggest emotional, physiological, and cognitive functioning to be promising mechanisms of MBCT. Therefore, the investigators propose to assess each of these potential mechanisms of MBCT using self-report, autonomic physiological, and reaction time tasks (Aim 2). Collectively, these aims are expected to strengthen the evidence base for MBCT while cultivating a scientific model for its effects and mechanisms on decreasing depressive symptoms and depression relapse rates.


Eligibility Criteria:
Inclusion Criteria:

* must comprehend English well
* be 18-55 years of age
* meet enhanced DSM-IV criteria for remission of MDD, recurrent and have a history of three or more previous episodes of DSM-IV major depression in the absence of a history of mania or hypomania
* at least one of those episodes was within the past two years
* participant must be in remission and if on antidepressant medication (ADM), they must be on a stable dose with no change in type or amount for past 12 weeks or participants must be off ADM at T1 for at least the preceding 12 weeks
* have, at screening assessment, residual depressive symptoms indicated by a Beck Depression Inventory-II (BDI-II;\[72\]) score between 6-19.

Exclusion Criteria:

* bipolar disorder
* schizophrenia or borderline personality disorder
* current suicidal thoughts and/or suicide attempt in last two months
* current anxiety disorder if it constitutes the predominant aspect of the clinical presentation and requires primary treatment not offered in the project
* substance abuse or dependence within last three months
* dementia or subnormal intellectual potential
* current obsessive-compulsive disorder
* current eating disorder
* history of previous mindfulness training or more than eight lifetime sessions of CBT
* current use of psychotherapy or counseling
Effects of Serious Games for Shoulder Rehabilitation

The aim of this study is to examine the effect of Serious-Game Exercise (SGE) platform on pain, range of motion (ROM), joint position sense, shoulder functions, and approximation force in patients with rotator cuff rupture. In addition, another objective is to evaluate the usage of balance board as a measurement tool for measuring the approximation force in the rotator cuff rupture.

Purpose: To examine the effect of Serious-Game Exercise (SGE) platform on pain, range of motion (ROM), joint position sense, shoulder functions, and approximation force in patients with rotator cuff rupture. In addition, another objective is to evaluate the usage of balance board as a measurement tool for measuring the approximation force in the rotator cuff rupture.

Method: Twenty patients with rotator cuff rupture will be included in the study. They will be divided into two groups as a serious game group (SGG) and a conventional exercise group (CEG) with a randomization method. The Serious game exercise program developed for shoulder rehabilitation will be applied to the SG group and conventional exercise training will be applied to the CEG. Pain severity, flexion, abduction and external rotation ROM, functionality, joint position sense, and approximation force of all individuals will be evaluated pre and post-treatment. SGG and CEG underwent serious games and conventional therapy twice a week for 6 weeks, respectively.

Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 40-60,
* having pain for more than 4 weeks,
* not having had any shoulder surgery

Exclusion Criteria:

* Individuals with cervical-origin neurological findings, uncooperative, different orthopedic problems in the same shoulder,
* neurological, vascular and cardiac problems that limit function
Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX

A comparative trial where all patients will receive daily doses of tacrolimus (TAC) until day +60 when tapering will begin, in the absence of graft-versus-host disease (GVHD), and discontinued by day +180. In addition patients will be randomized to methotrexate (MTX) or mycophenolate mofetil (MMF) and again, in the absence of GVHD, a tapering schedule will begin on day +240 and be completed on day +360. Doses will be adjusted to maintain blood levels.

The randomization for this comparative trial will be stratified by conditioning regimen and, for those patients enrolled on MCC-14178, by busulfan AUC level.

All patients will receive daily doses of TAC beginning day -3 (day 0 being the day of hematopoietic stem cell transplant (HCT)) and will be given until day +60 when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180. Doses will be adjusted to maintain blood levels.

In addition to TAC, patients will be randomized to one of the following additional anti-GVHD medications: MTX or MMF beginning day 0 at least 2 hours after the end of the HCT. In the absence of GVHD a tapering schedule will begin on day +240 and be completed on day +360.

Study participants will be extensively monitored as inpatients and then weekly as outpatients. Some tests will be conducted at least twice weekly (blood tests, toxicity data, GVHD and physical exams) one-month post-transplant and during the tapering off periods for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

- Patient must be going through a T cell-replete allogeneic transplant

Exclusion Criteria:

- A contraindication to the use of tacrolimus, mycophenolate, or methotrexate
Emotional Perception and Production in Facial Palsy: Respiratory, Vocal and Facial Markers.

Respiratory function, phonation and facial expressivity are related to emotional reaction through neurophysiological process. Specific emotional respiratory, vocal and facial patterns had been described in literature. Respiratory cycles variation is modulated by stimulus arousal. Furthermore, inspiratory-to-expiratory time ratio in abdominal area is modulated by emotional valence. Inextricably linked to respiration, vocal production depends on emotional arousal and valence too.

According to embodied cognition, the effector pattern of an emotion initiates the corresponding subjective activation. Facial recognition is influenced by automatic mimicry and facial feedback. Most facial feedback studies included patients with diplegia but few studies dealt with emotional perception in Bell's palsy.

The aim of the present study is to understand production and perception of emotion in Bell's palsy with respiratory, vocal and facial markers. What impact lack of mimicry have on physiological emotional reaction in Bell's palsy? To this end, prospective monocentric study will be conducted with 60 patients with Bell's Palsy from grade II to grade VI of House \& Brackmann's scale. During production and perception of vocal and facial expression, respiratory rate and thoraco-abdominal movements will be analyzed. The investigators hypothesize that severity of facial deficit is negatively correlated with variation of respiratory cycles, lower segmental and suprasegmental changes during vocal expression, and lower facial perception (congruency and arousal).


Eligibility Criteria:
Inclusion Criteria:

* Patients affiliated to the health care system
* Patients must have been diagnosed with unilateral peripheral facial palsy stage III to VI, according to House and Brackmann international classification.
* To be able to read, understand and sign a consent
* To be able to understand French spoken and written

Exclusion Criteria:

* Diplegia or facial graft
* Visual disorders, non corrected
* Respiratory or vocal disorders
* Psychiatric history
* Facial surgery
Evaluation of a Plasma Protein Profile As a Predictive Biomarker for Metastatic Relapse in Triple Negative Breast Cancer Patients

The INSTIGO study aims to assess a plasma protein profile at different stages of patient follow-up as a predictive factor of metastatic recurrence in triple negative breast cancer. It also aims to look at other potential biomarkers of metastatic relapse such as Tumor-infiltrating Lymphocytes, circulating tumor DNA, figurative elements in blood, or a tumor RNA signature.

The investigators propose to carry out a study that measures the concentrations of a set of plasma proteins in order to assess their ability to predict metastatic relapse of triple negative breast cancer. A plasma protein profile could be an interesting biomarker since it is easily accessible and quantifiable.

The investigators also propose to search relation between metastatic relapse in TNBC and other biomarkers or potential biomarkers such as Tumor-infiltrating Lymphocytes (TILs), figurative blood components and circulating tumour DNA (ctDNA).

Finally, they also want to validate a TNBC RNA signature, established at Jean PERRIN Center, by analyzing the RNA expression of 8 genes.

Before treatment begins, the patient will take an initial blood sample. A second blood sample will be taken on the day of the first surgery or the day of the surgery post chemotherapy. A third blood sample will be done on the day of the beginning of the radiotherapy. A 4th and a 5th blood sample will be done at 6 months and 1 year respectively after the end of the radiotherapy. A part of these blood samples will be used for the quantification of circulating proteins, for the determination of the blood's figurative elements and for the quantification of circulating tumour DNA.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age \> 18 years
* Diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer
* Patient able to understand the French language
* Patient affiliated to social security
* Obtaining signed written consent

Exclusion Criteria:

* Persons deprived of their freedom or under guardianship or incapable of giving consent
* Refusal to participate
Evaluate Efficacy, and Safety of Topical Therapy and Etanercept in Subjects With Moderate to Severe Plaque Psoriasis

The primary hypothesis of this trial is that the addition of short courses of clobetasol propionate foam to etanercept monotherapy in subjects with moderate to severe plaque psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by PASI 75 at Week 12.


Eligibility Criteria:
Inclusion Criteria:

* Subject has had stable moderate to severe plaque psoriasis for at least 6 months
* Subject has involved BSA ≥ 10% and PASI ≥ 10 at screening and at baseline.
* Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator

Exclusion Criteria:

* Subject has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
* Subject has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept and/orclobetasol propionate foam on psoriasis.
* Subject diagnosed with medication-induced or medication exacerbated psoriasis
* Subject has any active Common Toxicity Criteria (CTC) grade 2 or higher infection
* Subject has a significant concurrent medical condition or laboratory abnormalities as defined in the study protocol.
* Subject has used any of the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids.
* Subject has used any of the following therapies within 28 days of the first dose: Class I or II topical steriods, UVA therapy (with or without psoralen), or systemic psoriasis therapies
* Subject has used one or more biologic therapies (other than interleukin (IL)12/IL23 inhibitors) within 3 months of the first dose
* Subject has used an IL-12/IL-23 inhibitor within 6 months of the first dose of etanercept
* Subject has ever used efalizumab (Raptiva®).
Laparoscopy and COVID-19 Contamination

The aim of the study is to search the presence of the SARS-COV-2 virus (COVID19) in the pneumoperitoneum of patients with a positive (or suspected) COVID19 status during a routine laparoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patient of legal age
* Indication for laparoscopy
* Positive (past or current) or suspected Covid19 status (cough, fever, suggestive radiological images, etc.)
* Lack of opposition to participating in the study

Exclusion Criteria:

* Patient under legal protection
* Covid19 status negative, (former or current) and not suspected
* Patient unable to object
* Patient with no social security care
Impact of Steroid, Diuretic, and Fluid Use on BPD Outcomes

Assess the impact of steroid, diuretic, and fluid practices on BPD outcomes in extreme premature infants in the Banner - University Medical Center Phoenix (BUMCP) neonatal intensive care unit (NICU).

The investigators propose performing a retrospective analysis of the current respiratory management methods to potentially find a correlation between the number of steroid doses administered, the timing of initiation of steroid therapy and the effect on premature infants at risk for developing BPD. The investigators are also going to explore the number and timing of diuretic medications and average fluid intake.

Eligibility Criteria:
Inclusion Criteria:

* Infants born at \<30 weeks and/or \<1500g
* Admitted to BUMCP between January 1, 2019 and December 31, 2020

Exclusion Criteria:

* Infants that do not survive to 36 weeks CGA, when the determination of BPD is made
* Infants that are transferred to another hospital prior to 36 weeks CGA
* Out born infants
* Infants with life threatening congenital anomalies
* Investigator discretion as to other factors which might impact the study
A Safety and Effectiveness Study of JUVÉDERM VOLUMA® XC Injectable Gel for Chin Augmentation

This is a safety and effectiveness study of JUVÉDERM VOLUMA XC injectable gel for chin augmentation to correct volume deficit in chin retrusion.


Eligibility Criteria:
Inclusion Criteria:

* Chin retrusion
* In good general health

Exclusion Criteria:

* Permanent facial implants on the face and/or neck
* Received fat injections below the nose
* Tattoos, piercings, beard, mustache, and/or scars on the face below the nose
* Received semi-permanent dermal fillers in the chin or jaw line in the last 3 years
* Undergone dermal filler injections or had any surgery in the chin or jaw area in the last 2 years
* Received dermal filler injections in the lips or in the mouth area in the last 12 months
* Undergone mesotherapy or cosmetic treatment (e.g., laser, photomodulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, liposuction, lipolysis, or other ablative procedures) anywhere in the face or neck in the last 6 months
* Received botulinum toxin treatment below the nose in the last 6 months
Non-Invasive Blood Pressure Measurement in Critically Ill PAtients Post Cardiosurgical Therapy

The aim of the present study is to evaluate the accuracy of measuring beat-by-beat diastolic blood pressure from a non-invasive, cuffless and non-obtrusive watch-like optical device worn at the wrist.

Given the prevalence of hypertension in society and the current limitations associated with oscillometric cuffs, the need for a continuous cuffless alternative for blood pressure home monitoring at a global scale is paramount. Such a device would not only improve the global control of blood pressure, but more generally, it could have a larger social impact by improving the comfort and reducing the stress for the clinical management of hypertensive patients.

In the present study the investigators seek to investigate, as a primary purpose, to evaluate the accuracy of non-invasive blood pressure measurements via a watch-like optical sensor and compare these to standard monitoring (arterial line).

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for cardiac or vascular surgery, with presence of a radial arterial line for perioperative management;
* Willing and able to provide Informed Consent.

Exclusion Criteria:

* (Chronic) pace-maker/ defibrillator in situ at study inclusion;
* Known severe aortic stenosis (mean gradient \> 40 mmHg, valve area \< 1 cm2);
* Rhythmogenic heart disease (resting heart rate \> 120/min) at time of study inclusion;
* Emergency patient (i.e. unscheduled OR).