cyrilzakka/clinical-trials huggingface dataset:
Tools for Health and Resilience Implemented After Violence Exposure (Project THRIVE)

Sexual assault victimization is a common and particularly harmful form of trauma that is associated with increased risk for high-risk drinking and other conditions of public health concern, such as PTSD. Given evidence that sexual assault survivors who have low social support or receive negative social reactions to sexual assault disclosure are more likely to experience PTSD and drinking problems, improving social support is a novel target for intervention. The proposed study will attempt to prevent the onset of high-risk drinking and PTSD in sexual assault survivors by developing and testing a web-based early intervention aimed at increasing contact with social supporters and mitigating the harm of negative social reactions; ultimately, results will contribute to advancing the field's understanding of the potential for social support to mitigate the harm of trauma.

This study involves developing, modifying, and preliminarily testing an intervention to prevent high-risk drinking and PTSD in women who have experienced sexual assault (SA) in the past 10 weeks. In the pilot trial phase of this study, intervention feasibility will be tested in an open trial with N = 40 women with past-10-week SA histories, active drinking, and elevated distress. Participants will complete surveys at baseline, termination, and 3-month follow-up. Participants will be randomized to either the intervention (N = 20) or assessment-only control (N = 20). We hypothesize that (H1) most participants will respond positively on items assessing satisfaction with the intervention, (H2) participants will report above-average usability on a standardized measure, (H3) completion rates for daily activities will be similar to previous web-based interventions, (H4) participants will show significant learning as evidenced by increases in correct responses to knowledge questions from baseline to post, and (H5) participants in the intervention condition will evidence less high-risk drinking and PTSD at 3-month follow-up than participants in the assessment-only condition.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* self-identification as female
* sexual assault, defined as endorsement of unwanted, attempted or completed sexual contact in the past 10 weeks
* age \> 18
* English fluency
* smartphone and internet access at least daily for 3 weeks and at least weekly for 3 months
* consumption of \>1 alcoholic drink in the past month
* \>1 episode of high-risk drinking in past 6 months, defined as either more than 3 drinks on a given day or more than 7 drinks in a given week
* at least 3 symptom clusters endorsed on the PTSD Checklist.

Exclusion Criteria:

* active suicidality
* psychosis
Effect of Kron (Citicoline and Nicotinamide Oral Solution) on Patients With Open-angle Glaucoma

Aim of this study is to investigate the administration effects of the combination of citicoline 40mg/ml and nicotinamide 15mg/ml oral solution (Kron®) on short term improvement in inner retinal function, bioelectrical activity of the visual cortex and visual function.

Prospective, masked, randomized placebo-controlled study to evalute the offect of the oral solution Kron® (citicoline 40mg/ml and nicotinamide 15mg/ml) on patients with a diagnosis of open angle glaucoma and risk of glaucoma progression.

Glaucomatous patients with a diagnosis of open angle glaucoma and risk of glaucoma progression who meet the study criteria will be enrolled and randomly assign to the following two arms:

1. Treatment group (TG): 20 patients will receive Citicoline 40 mg/ml + Nicotinamide 15 mg/ml oral solution for 3 months (10 ml/day)
2. Control group (CG): 10 patients will be evaluated as control

Once recruited, a clinical evaluator will perform a comprehensive ophthalmologic evaluation at baseline, week 6 and week 12. The following examinations will be done in the following sequence:

* Visual acuity
* Slit lamp evaluation
* PERG
* PEV pattern
* Tonometry
* Visual field
* Optical Coherence Tomography
* Dilated Fundus examination

Eligibility Criteria:
Inclusion Criteria:

* glaucomatous patients with moderate visual field loss, MD ranging from -6 dB and -12 dB, and risk of progression
* controlled intraocular pressure
* at least 3 previous visual field examinations.

Exclusion Criteria:

* angle closure glaucoma and secondary open angle glaucoma
* refractive error outside +2D and -6D
* ophthalmic surgery 6 months before the recruitment
* presence of cataract or other conditions that could affect results of perimetry or electroretinography
* treatment with supplements in any form with a demonstrated or presumed neuroprotecting/neuroenhancing effect in the last six months
* presence of other ocular or systemic diseases that could affect results of perimetry or electroretinography.
Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection

The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.

Participants will receive placebo to match SOF/VEL/VOX FDC to assess ability to swallow tablets at screening up to Day 1.

Eligibility Criteria:
Key Inclusion Criteria:

* Consent of parent or legal guardian required
* Chronic HCV infection
* Screening laboratory values within defined thresholds
* Individuals must have a determination of prior treatment status:

  * DAA-naive is defined as either:

    * Treatment naive with no prior exposure to any interferon (IFN), ribavirin (RBV), or approved or experimental HCV-specific DAA
    * Treatment experienced with an IFN-based regimen and no prior exposure to an approved or experimental HCV-specific DAA
  * DAA-experienced is defined as prior exposure to a regimen including any DAA (eg, non-structural protein (NS)3/4A protease inhibitor, NS5A inhibitor, or NS5B nucleotide/nucleoside inhibitor)

Key Exclusion Criteria:

* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
* Co-infection with human immunodeficiency virus (HIV), acute hepatitis A virus (HAV) or hepatitis B virus (HBV)
* Clinical hepatic decompensation (eg, clinical ascites, encephalopathy, and/or variceal hemorrhage)
* Pregnant or nursing females
* Known hypersensitivity to study medication
* Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis

The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with relapsing Multiple Sclerosis (RMS).


Eligibility Criteria:
Inclusion Criteria:

* Participant has diagnosis of relapsing remitting multiple sclerosis (RRMS) or secondary-progressive multiple sclerosis (SPMS) with relapses within the past 24 months.
* Participant has cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with multiple sclerosis (MS).
* Participant has evidence of physical disability according to Expanded Disability Status Scale (EDSS) or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.

Exclusion Criteria:

- Participants must not have experienced or be recovering from a clinical MS relapse within 6 months of Screening.
Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Patients With Primary Hyperoxaluria

The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent (as applicable for the age of the subject).
* Male or female subjects ≥ 2 years of age (Germany \& France) / Male or female subjects ≥ 5 years of age (United Kingdom)
* A diagnosis of PH type I, II or III (as determined by standard diagnostic methods).
* A mean urinary oxalate excretion of \> 1.0 mmol/24h/1.73m2, based on at least three eligible urine collections performed during baseline (weeks 1-4).
* Renal function defined as an estimated GFR ≥ 40 ml/min normalised to 1.73m2 body surface area, or a creatinine clearance of ≥ 40 ml/min normalised to 1.73m2 body surface area.
* Subjects receiving vitamin B6 must be receiving a stable dose for at least 3 months prior to screening and must not change the dose during the study. Subjects not receiving vitamin B6 at study entry must be willing to refrain from initiating pyridoxine during study participation.

Exclusion Criteria:

* Inability to collect complete 24-hour urine samples. Each urine collection will be evaluated for completeness based on urine qualitative criteria.
* Inability to swallow size 4 capsules twice daily for 8 to 10 weeks.
* Subjects that have undergone transplantation (solid organ or bone marrow).
* The existence of secondary hyperoxaluria, e.g. hyperoxaluria due to bariatric surgery or chronic gastrointestinal diseases such as cystic fibrosis, chronic inflammatory bowel disease and short-bowel syndrome.
* Use of antibiotics to which O. formigenes is sensitive, including chronic use, a history of more than two courses of antibiotic use during the past 6 months, current antibiotic use, or antibiotics use within 14 days of initiating study medication.
* Subjects who require immune suppressive therapy.
* Current treatment with ascorbic acid preparation.
* Pregnancy.
* Women of child-bearing potential who are not using adequate contraceptive precautions such as oral, transdermal, injectable, or implanted contraceptives, IUD, complete abstinence, use of a condom by the sexual partner, or sterile sexual partner.
* Presence of a medical condition that the Principal Investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures.
* Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to screening or not willing to forego other forms of investigational treatment during this study.
The Effect of D3 on Selected Cytokines Involved in Cytokine Storm in the Covid-19 Uninfected Jordanian People

The effect of Weekly 50,000 IU vitamin D3 supplements on the serum levels of selected cytokines involved in cytokine storm of Covid-19; A randomized clinical trial in the Covid-19 uninfected people with vitamin D deficiency.

No data are available on the effect of Weekly 50,000 IU vitamin D3 supplements on the serum levels of selected cytokines involved in cytokine storm of Covid-19 in the Covid-19 uninfected Jordanian people with vitamin D deficiency. This study was designed to investigate whether a high dose of vitamin D3 (50,000 IU) / week for 8 weeks supplementation has a potential effect on cytokine storm of Covid-19; such as IL-1 beta, IL-6, and TNF in the Covid-19 uninfected Jordanian people with vitamin D deficiency.

This study aims to assess whether high doses of vitamin D3 may improve immune responses against COVID-19 infection in uninfected Jordanian peoples. We hypothesize that Weekly 50,000 IU vitamin D3 supplements will significantly change immune responses compared with the control group.

Eligibility Criteria:
Inclusion Criteria:

Age ≥30 years old Male and female Jordanian ASU students and employees who live in Amman. Informed written consent from the participant prior to the start of the study. a serum 25(OH)D concentration less than 30 ng/mL.

Exclusion Criteria:

Any eligible subject refuses to apply with informed written consent before the start of the study. Men or women previously diagnosed with chronic diseases, including kidney disease or GIT problems. Who are receiving vitamin D3 supplements (3 months before the start of the study). Pregnant, Breastfeeding females, Females using hormonal contraceptives
Treatment of Newly Diagnosed Elderly Patients With Multiple Myeloma

In multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. We assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.

Trial design This multicenter, randomized, controlled trial is conducted by the French Myeloma Intergroup(IFM) in elderly patients with previously untreated multiple myeloma. The primary objectives of the study are to compare the efficacy and safety of MP with MP-Thalidomide or with MEL100 (intermediate-dose melphalan 100 mg/m2 - based treatment). The secondary objective is to compare the efficacy of MP-Thalidomide vs MEL100.

Eligibility Criteria:
Inclusion Criteria:

* Stage II or III multiple myeloma according to Durie and Salmon criteria.
* Patients between 65 and 75 years of age
* Previously untreated patients

Exclusion Criteria:

* Prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma)
* Primary or associated amyloidosis
* World Health organisation performance index of at least 3
* Significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more
* Cardiac or hepatic dysfunction
* Cerebral circulatory insufficiency
* Absolute contraindication to corticosteroids
* Peripheral neuropathy
* HIV or hepatitis B or C positivity
* Patients who had geographic, social or psychological conditions which might prevent adequate follow-up
Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers

The primary translational research objective of the study is to demonstrate feasibility of using the Transcutaneous Raman Spectroscopy technology in a point-of-care environment. This study represents an initial evaluation of the device in a small cohort of human patients with diabetic foot ulcers. We will be evaluating safety, device design and certain human engineering factors associated with point of care use of the TRS. We anticipate the data we collect in this study will form the basis of later medical device studies.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Diagnosis of diabetes mellitus
* Full thickness or superficial foot and ankle ulcers based on clinical assessment (e.g., University of Texas (UT) grades 1-3, stages A-D). For reference, see Appendix 1 for the UT classification table

Exclusion Criteria:

* Age less than 18 or greater than 80 years old
* Subject has a psychological or sociological condition or an addictive disorder that would preclude informed consent
* Completely epithelialized ulcer based on clinical assessment with no ischemia or infection (UT classification 0A)
* Current or previous use of anti-resorptive bisphosphonate drugs (e.g., risedronate (Actonel) and alendronate (Fosamax))
Diphtheria Vaccination in Adolescents With Inflammatory Bowel Disease

Assessment of the immunogenicity and safety of booster immunization against diphtheria in children with inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria),
* vaccination, as a part of the basic vaccination course, with five doses of diphtheria, tetanus and whole-cell pertussis vaccine, without booster dose after the age of 6,
* written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.

Exclusion Criteria:

* serious exacerbation of inflammatory bowel disease defined as Paediatric Ulcerative Colitis Activity Index (PUCAI) \> 65 points for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) \> 40 points for patients with Crohn's disease.
Cannabidiol in Sickle Cell Disease

Randomized, placebo-controlled, double masked, dose finding study of twice daily cannabidiol given at 3 dose levels, 200mg, 400mg, and 600mg, compared to placebo for 4 weeks.

The researchers will conduct a randomized, double blind, placebo-controlled, study of cannabidiol in an oral formulation. Participants will be enrolled when they are not in pain crisis and have demonstrated a urine toxicology test free from cannabinoids in the past 30 days. The sample size will be 52 participants, aged ≥18, with 1:1:1:1 allocation of placebo to 3 drug doses. This is a dose finding study with a primary outcome of reduction of inflammatory cytokine TNFα.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Clinical diagnosis of SCD (HbSS, HbSC, HbSβ+; Thal, HbSβ0Thal, HbS variants)
* Baseline score of 60 or lower on the ASCQ-Me 7-day pain interference domain
* If on a SCD modifying therapy (hydroxyurea, regular blood transfusions, L-glutamine, voxelotor, crizanlizumab), on stable dose for at least 3 months
* If using opioids for pain at home, on stable dose for at least 3 months
* One urine toxicology negative for cannabinoids within 30 days of randomization
* Willing to abstain from cannabis, medical and illicit, during study weeks 1 through 4 • Not pregnant or nursing
* If a woman capable of becoming pregnant, willing to use a medically accepted form of birth control for the duration of study participation. Accepted forms include oral contraception, medroxyprogesterone, contraceptive implants or patch, surgical sterilization, total abstinence.
* Able to consent for research

Exclusion Criteria:

* No known intolerance to cannabinoids
* No history of psychotic episode, psychosis, or active suicidality
* No contraindication to epidiolex with attention to potential side effects, concurrent medications/substances, and concurrent medical problems, as evaluated by a physician
* Not a daily cannabis user
* No diagnosis of active substance use disorder
* No ALT\>3 times the upper limit of normal
Psychological Impact of Confinement on the Adult

This clinical interview is made to allow a clinical follow-up of the patients followed in psychiatry of the EPS Ville-Evrard establishment in a simple way and in a secure medical framework during the period of the epidemic and the confinement from March 30 to June 30, 2020.


Eligibility Criteria:
Inclusion Criteria:

Adult patient followed in outpatient psychiatry at EPS Ville Evrard and agrees to participate -

Exclusion Criteria:

Adult patient followed in outpatient psychiatry at EPS Ville Evrard and does not wish to participate

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Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Hemophilia A, B or C, or Von Willebrand's disease
* Chronic genotype 1, 2, 3 or 4 HCV infection
* HCV RNA ≥ 1000 IU/mL at screening
* Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male
* Screening laboratory values within defined thresholds
* For HIV-1/HCV co-infected individuals:

  * Suppressed HIV-1 RNA on an antiretroviral (ARV) regimen for at least 6 months prior to screening
  * Stable protocol-approved ARV regimen for \> 8 weeks prior to screening
  * CD4 T-cell count \> 200 cells/mm\^3 at screening

Exclusion Criteria:

* Clinically-significant illness (other than HCV, inherited bleeding disorder or HIV-1) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
* Current or prior history of any of the following:

  * Hepatic decompensation
  * Chronic liver disease of a non-HCV etiology
  * Hepatocellular carcinoma (HCC)
  * Infection with hepatitis B virus (HBV)
* Pregnant or nursing female
* Prior treatment with inhibitors of nonstructural protein 5A (NS5A) or the NS5B polymerase
* Chronic use of systemically administered immunosuppressive agents
* For HIV-1/HCV co-infected individuals:

  * Opportunistic infection within 6 months prior to screening
  * Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline
The Impact of Early Mobilization Protocol in Patients in the ICU

Advances in intensive care and mechanical ventilation (MV) in the past two decades have increased critically ill patient survival. However, some patients require prolonged MV (PMV) and are deconditioned due to respiratory insufficiency caused by underlying disease, adverse effects of medications, and prolonged immobilization. Patients in the intensive care unit (ICU) are often confined to their beds, which results in inactivity, immobility, and severe osteomyoarticular system dysfunction. Our hypothesis is that an early mobilization protocol improves muscle thickness (MT) of the quadriceps femoris, peripheral muscle strength, perceived functional status, gait speed, quality of life, duration of mechanical ventilation, ICU length of stay of the critically ill patient.

The purpose of this study is to evaluate the effects of implementation an early mobilization protocol in critically ill patients in the Intensive Care Unit of the University Hospital of Santa Maria.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years of age or greater)
* Patients in the first 24 hours of mechanical ventilation.
* Patients in the deep sedation will be evaluated by the Richmond Agitation-Sedation Scale (score -4).
* Hemodynamically stable.

Exclusion Criteria:

* Rapidly developing neuromuscular disease
* Evolution of brain death
* Cardiopulmonary arrest
* Elevated intracranial pressure
* Ruptured/leaking aortic aneurysm
* Acute MI before peak troponin has been reached
* Absent lower limb
* Pregnancy
* Unstable fractures contributing to likely immobility
* Hospitalization prior to ICU admission \>5 days
* Enrollment in another clinical trial