cyrilzakka/clinical-trials huggingface dataset:
Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population

The purpose of this study is to assess the effect of virtual reality on subjective post-operative pain, total inpatient narcotic administration, and mobilization with physical therapy in pediatric patients who have undergone surgical correction for idiopathic scoliosis.

All pediatric patients (ages 13-18) at Connecticut Children's Medical Center undergoing corrective scoliosis surgery for idiopathic scoliosis are eligible and will be approached for consent and inclusion into the study. This is a prospective pilot study, and all enrolled patients will receive a virtual reality (VR) intervention using a commercially available device manufactured by Oculus. The VR software will simulate a low physical load environment, such as an underwater space exploration game. Starting on postoperative day 1, the prospective cohort will undergo a 20-minute VR session 30 minutes prior to each physical therapy session. There will be two physical therapy sessions scheduled daily for the participant. Outcome measures will be assessed before and after the VR session and after the physical therapy session. The following procedures will continue daily until the participant is cleared for hospital discharge. A retrospective chart review will also be performed on patients with idiopathic scoliosis who have undergone corrective surgery to serve as a historical control for the study. The retrospective arm of the study only includes patients who have not received a VR intervention.

Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients (ages 13-18) at Connecticut Children's undergoing surgical correction for idiopathic scoliosis over a span of 12 months

Exclusion Criteria:

* History of seizures
* Cognitive developmental delay precluding participation in VR
* Head or neck surgery that does not allow a head-mounted display to be worn safely
* Chronic pain requiring the daily use of opioids for more than 2 weeks prior to the procedure
* Non-English speakers
* Side effects during screening
* Patients with vagal nerve stimulators, cardiac pacemakers, and/or cochlear implants that may receive interference from the VR device
Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty

The purpose of this study is to determine whether a standardized education and exercise program proposed before a total knee replacement for knee osteoarthritis is effective in functional recovery after surgery.

Knee osteoarthritis leads to deficiencies in muscle strength, knee range of motion and balance, and cardio respiratory deconditioning that contribute to alter abilities to perform activities of daily living. It is the principal indication for total knee arthroplasty (TKA). Patients' functional state and pain level are generally improved after TKA and the physical and functional status pre-TKA are predictive of recovery after surgery. Decreasing length of stay at surgery departments and promoting return at home after TKA are recommended. The recommendations of the Health Authority in France (HAS) and the new law of finance for French clinics contribute to shorter hospital stays and to restrain the conditions of admission to Physical Medicine and Rehabilitation department after TKA.Exercise and education programs conducted before TKA could help better prepare patients for surgery, improve functional outcome and accelerate functional recovery after surgery thus reducing the length of stay in orthopedic departments and facilitate return to home (directly or after a stay in PMR departments). The type of program necessary to achieve those goals remains to be defined.A systematic review of the literature associated with an analysis of practices about the relevance of rehabilitation programs before TKA, concluded that the implementation of such programs before TKA was likely to reduce the length of stay in surgery departments and improve the rate of direct return to home after surgery but that high quality trials were lacking. It also suggested that association of exercise programs with educational ones could be more effective than exercise or education alone, particularly for fragile patients with impaired functional capacity, co-morbidities and/or social problems.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 50 to 85 years
* Patient suffering from knee osteoarthritis according to ACR for which a total knee arthroplasty is scheduled
* Preliminary medical examination whose results will be transmitted to the patient
* Patient giving his informed consent to participate in the study
* Patient affiliated to or beneficiary of social insurance

Exclusion Criteria:

* Patients institutionalized
* Patients who have already received an ipsilateral total knee arthroplasty
* Patients with chronic inflammatory arthritis
* Cognitive or behavioral disorders making assessment impossible
* Inability to speak and write French
* TKA indicated for other reason than osteoarthritis
Avatar-led Acceptance and Commitment Therapy Smoking Cessation

Smoking remains a global concern, especially for youth where developmentally-suited smoking cessation programs are lacking and especially among those not presenting for treatment on their own. We aimed to assess the effectiveness of an avatar-led digitalized smoking cessation intervention (Flexiquit) based on Acceptance and Commitment Therapy (ACT) for young adult smokers at all levels of motivation to quit.

Cigarette smoking is associated with various health problems, particularly certain forms of cancer and early death (Centers for Disease Control and Prevention, 1997). More recently, smoking has become a global problem among youth and it is imperative that research puts an emphasis on prevention and intervention particularly in this age group (World Health Organization, 2009). Over the past few years, research has shown that internet-based interventions are more cost effective, cater to individuals who are unable/unwilling to attend weekly treatment sessions with a therapist, and are promising in terms of improving attrition rates, a major problem with most treatment trials. Moreover, internet-based interventions use technology often utilized to attract youth (interactive games, animation, video clips etc.) and thus may reach and engage a wider range of individuals than traditional face-to-face interventions. ACT is an empirically-based intervention that uses acceptance and mindfulness strategies and has been shown to increase psychological flexibility. The aim of the present study is to investigate the usefulness and effectiveness of an Acceptance and Commitment Therapy (ACT) internet-based smoking cessation intervention program for college, high school and vocational school student smokers. Findings are expected to show that a digitalized program designed to engage youth in smoking cessation can result in quitting smoking and has a high applicability potential especially among the hard-to-reach population of youth.

Eligibility Criteria:
Inclusion Criteria:

* Regular smoker (at least 1 cigarette per day)
* Parental consent for those under 18years of age

Exclusion Criteria:

* Currently enrolled in another smoking cessation program
An Open-Label Trial of Donepezil in Fragile X Syndrome

Fragile X syndrome is the most common known inherited cause of neurodevelopmental disability. Functional magnetic resonance imaging (fMRI) studies from our laboratory indicate that specific brain regions using the neurochemical, acetylcholine, show significantly reduced activation during learning. Since donepezil is a medication that enhances acetylcholine function in the brain, the purpose of this study is to determine if donepezil has any beneficial effect on behavior or cognition in subjects with fragile X syndrome.

Fragile X syndrome is the most common genetically inherited cause of neurodevelopmental disability in humans, affecting approximately 1:2000 to 4000 live births. Affected individuals have significant, long-term problems with learning, and often with behavior as well. The disorder is caused by the presence of a greatly expanded CGG repeat within the FMR1 gene on the long arm of the X chromosome. Abnormal methylation of this repeat, and adjacent areas within the FMR1 gene impedes transcription, ultimately resulting in reduced production of the FMR1 protein (FMRP). This protein is expressed in neurons, with particularly high levels of gene transcription occurring in the nucleus basalis (basal forebrain) and hippocampus. A recent functional imaging study from our group showed girls with fragile X to have greatly reduced levels of brain activation in the basal forebrain and hippocampal activation during a memory task. The nucleus basalis, is a cholinergic nucleus with widespread connections to the neocortex. It is critical to visuospatial attention in rodents and primates and is presumed to play a similar role in humans. The finding of decreased basal forebrain activation in girls with fragile X, considered in light of histological evidence showing high transcription levels of FMR1 in healthy nucleus basalis, suggests the possibility of a functional cholinergic deficit in fragile X syndrome.

Donepezil is an acetylcholinesterase inhibitor which slows the degradation of synaptic acetylcholine thereby increasing its availability. It is approved for the treatment of mild-moderate Alzheimer's disease. It has been studied in several other neurologic disorders--including vascular dementia, Lewy Body dementia, and Down's syndrome (with and without dementia)--where it has shown varying degrees of efficacy but consistently high degrees of safety and tolerability. The goal of the proposed study is to determine if enhancing cholinergic activity with donepezil has beneficial effects on behavior or cognition in subjects with fragile X syndrome.

Eligibility Criteria:
Inclusion Criteria:1. Confirmed genetic diagnosis of fragile X syndrome

2. Age e 14

3. Verbal IQ e 60 Exclusion Criteria:1. Currently taking any anticholinergic medications, tricyclic antidepressant medications, or diphenhydramine.

2. Presence of cardiac disease or bradycardia (\< 60 beats/minute) at initial evaluation.
Berry Components and Blood Sugar & Fat Metabolism

The primary objective of this study is to determine which components of berries improve glucose metabolism and increase fat oxidation in humans.

The aim of this study is to improve understanding of how diet can regulate glucose metabolism and fuel use. Previous human and animal studies have demonstrated that berries can improve gluco-regulation and increase fat oxidation. The aim of this study is to determine which component of berries is conveying this health benefit.

Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoker
* able to understand consent

Exclusion Criteria:

* Body Mass Index less than 25 kg/m2
* pregnant, lactating, having given birth in the past year
* allergy to berries
* blood glucose greater than 125 mg/dL
* history of bariatric surgery or nutrient malabsorption disease
* diagnosis or treatment of cancer in past three years
* type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
Nasal Swab studyComparison of Effectiveness of Povidone-iodine Versus Saline Versus 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP Swabs for Decolonizing Intranasal MSSA/MRSA

To determine if routinely available 10% povidone-iodine swabs are more effective than saline and 3M Skin and Nasal Antiseptic 5% Povidone-Iodine USP for decolonizing MRSA.


Eligibility Criteria:
Inclusion Criteria:

1. All potential total hip and total knee arthroplasty candidates
2. All femoroacetabular osteoplasty patients
3. All pelvic acetabular osteotomy patients
4. All core decompression patients

Exclusion Criteria:

1. Any trauma patients
2. Any tumor patients
3. Any patient with periprosthetic joint infection
4. Any patient with surgical site infection
5. Any patient with known MRSA infection
6. Any patients allergic to povidone-iodine
7. Patients with thyroid disease
A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT)

This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated.


Eligibility Criteria:
Inclusion Criteria:

* Participant is a male or female at least 18 years of age
* Participant is HIV positive
* Participant is naïve to antiretroviral therapy (ART) and has not received any ART

Exclusion Criteria:

* Participant has received approved or experimental antiretroviral agents in the past
* Participant has been treated for a viral infection other than HIV such as hepatitis B virus infection with an agent that is active against HIV including but not limited to adefovir or lamivudine (= 7 days total)
* Participant has documented resistance to tenofovir, emtricitabine, and/or efavirenz
* Participant has used another experimental HIV-integrase inhibitor
* Participant has a current (active) diagnosis of acute hepatitis due to any cause
* Participants with chronic hepatitis including chronic hepatitis B and/or C may enter the study as long as they have stable liver function tests
Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm

Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.

There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest in non shockable rhythm
* Glasgow score ≤ 8

Exclusion Criteria:

* No flow \> 10 min
* Low flow \> 60 min
* Major hemodynamic instability
* Delay between cardiac arrest and inclusion \> 300 min
* Cirrhosis Child C
* Age \< 18 years
* Pregnant women
* Patient with no liberty
* Lack of informed consent
* Prior inclusion in a research protocol involving cardiac arrest with draw, and whose primary endpoint focuses on the evaluation of a neurological score Day 90
Viral Kinetics of SARS-CoV-2 in Patients With COVID-19 in the Intensive Care Unit Undergoing Dental Procedures

The prevalence and clinical relevance of viremia in patients with COVID-19 have not been well investigated. Seeking to understand the need for dentistry to perform bloody procedures in critically ill patients with COVID-19 admitted to the ICU, the quantification of the magnitude of viral replication may play a fundamental role in this scenario. For this, it is necessary to study the viremia kinetics of SARS-CoV-2, seeking to assess whether there is any characteristic pattern that may be associated with a worse clinical outcome of the patient with COVID-19 after undergoing bloody dental procedures, therefore, the objective of this research will be to investigate the occurrence of viral kinetics produced by dental procedures in patients with SARS-CoV-2 in Intensive Care Units, where, in addition to analyzing the oral health condition, the viral kinetics of SARS-CoV-2 will also be investigated by means of reverse transcription polymerase chain reaction (RT-PCR) examination of blood samples from patients with COVID-19 undergoing bloody dental treatment. This research is expected to identify risks and consequences regarding the possibility of performing bloody dental treatment in patients with COVID-19 in serious condition, in addition to verifying the association of the impact of oral infection foci on this profile of patients.


Eligibility Criteria:
Inclusion Criteria: Patients between 16 and 90 years old who describe subgingival scaling of at least one dental sextant or a tooth extraction.

Exclusion Criteria: Patients who cannot perform clinical examination and/or open dental procedure.
CB-839 in Combination With Niraparib in Platinum Resistant BRCA -Wild-type Ovarian Cancer Patients

The purpose of this protocol is to investigate the efficacy of the combination of CB-839 with Niraparib in platinum resistant BRCA wild-type ovarian cancer patients. The primary and secondary objectives are to determine the maximum tolerated dose of CB-839 in combination with Niraparib and to determine the response rate and percentage of participants who remain progression free at 6 months.

Based on the scientific rationale, pre-clinical data, and clinical data available to date, and the need for further treatment options in patients that are platinum resistance that are specifically BRCA wild-type. Only patients carrying wild type BRCA genes will be enrolled in the study. The proposed research tests a new therapeutic strategy for ovarian cancer with a very novel mechanistic target: metabolic dependency of ovarian cancer. Pre-clinical results indicate that both serous and clear cells ovarian cancers have upregulation of Hypoxia Inducible Factors (HIF) HIF1a and Hypoxia Inducible Factors (HIF) HIF2a regulated genes. In addition, cell line models of these tumors display sensitivity to CB-839 in vitro. Ovarian cancers resistant to standard platinum chemotherapy may thus respond to treatment with this glutaminase inhibitor. The majority of patients do not present mutations in BRCA or any other genes of the Fanconi pathway, but their tumors may respond to CB-839, which in turn may lead to genomic instabilities due to nucleotide deprivation; therefore, CB-839 could sensitize the tumors to treatment with Niraparib.

Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Estimated life expectancy of at least 3 months
* Measurable disease; at least one tumor lesion/lymph node that meets the RECIST 1.1 criteria for measurability
* Negative serum or urine pregnancy test within 3 days prior to the first dose
* Serum creatinine \<= 2.0 x upper limit of normal (ULN)
* Adequate hematological function
* Alanine aminotransferase (ALT) \& aspartate aminotransferase (AST) \<3.0 x ULN
* Total bilirubin \<=1.5 x ULN

Exclusion Criteria:

* Prior treatment with CB-839 or a PARP inhibitor
* Receipt of any anticancer therapy within the following windows:
* Small molecule tyrosine kinase inhibitor therapy (including investigational) within 2 weeks or 5 half-lives, whichever is longer
* Any type of anti-cancer antibody within 4 weeks
* Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization
* Subjects with clinically relevant ongoing complications from prior radiation therapy
* Other investigational therapy within 2 weeks or 5 half-lives, whichever is longer
* Any other current or previous malignancy within he past three years except:
* Adequately treated basal cell or squamous cell skin cancer
* Carcinoma in situ of the cervix
* Prostate cancer with stable prostate specific antigen (PSA) levels for \>3 years
* Other neoplasm that, in the opinion of the Principal Investigator, will not interfere with the study-specific endpoints
The Women's Health Study: From Adolescence to Adulthood

In order to learn more about women's health issues that occur over the lifespan, the Women's Health Study: from Adolescence to Adulthood is building a biorepository and database. The biorepository collects, processes and stores samples (such as urine, saliva, blood, cells, tissue and peritoneal fluid) until they are needed for research. The database contains de-identified information about our study participants. The biorepository and database are being created to serve as a resource for researchers from Boston Children's Hospital, Brigham and Women's Hospital and outside institutions.


Eligibility Criteria:
Inclusion Criteria:

* female
* at least 7 years old
* not experiencing natural menopause

Exclusion Criteria:

-
3D Echocardiography and Cardiovascular Prognosis in Mitral Regurgitation

The 3D-PRIME study will analyse whether use of 3D echocardiography can improve risk stratification and cardiovascular outcome in patients with mitral regurgitation of different etiologies.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with primary or secondary mitral regurgitation (MR)
* MR of moderate or severe degree
* 3D echocardiographic examinations of \>= good spatial and temporal resolution

Exclusion Criteria:

* Co-existence of another valve disease of severe degree
* Inability to give informed consent
Information During Maternity

During the pregnancy , it's now compulsary for the doctors to inform pregnant women and the couple about the medical, non medical informations and explain the physiological changes . As usual, medical staff and doctors explain and inform by oral and with a booklet patient.

In order to cluster and make more accessible these informations, the maternity team of GHPSJ has developed an application on smartphone . If this application has been evaluated on his contents and accordance to recommendations, there is no evaluation about the satisfaction of patient.

The aim is to study the impact of this kind of application on pregnant women satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* single pregnancy
* delivery at 37 weeks of amenhorrhea
* age \> 18
* with an email address

Exclusion Criteria:

* refusing participation
* foetal pathology