cyrilzakka/clinical-trials huggingface dataset:
An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST)

This observational study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis. Data will be collected from patients for the 12 months following the first infusion of RoActemra/Actemra.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria
* Initiated on RoActemra/Actemra treatment according to the Summary of Product Characteristics not more than 6 months before opening of study center

Exclusion Criteria:

* Current serious infection
* Hypersensitivity to the active component or any of the excipients
* Pregnant women
Study of the Mechanisms of Metabolic Adaptations to Overfeeding

Obesity results from complex interactions between genetic and environmental factors, and are strongly associated with metabolic complications such as type 2 diabetes mellitus. Obesity is defined as an excessive fat accumulation that presents a risk to health, a risk that is highly dependent upon the type of adipose tissue accumulation, whether visceral or sub-cutaneous, but also upon the characteristics of the fat tissue, especially inflammatory cells accumulation. Because of the well known sexual difference in fat accretion, this obesity-associated risk may also be very different for men and for women. In addition, recent data indicate that various factors such as the intestinal microbiota, but also the dietary intake of protective nutrients might be important determinants of the metabolic complications of obesity.

Here we propose to: 1) study the metabolic adaptations and the mechanisms of adipose tissue accumulation during a period of controlled caloric over-nutrition, both in men and in women; 2) evaluate the potential protective effects of a supplementation with polyphenols on insulin resistance and other metabolic adaptations.

To achieve these goals, healthy male and female volunteers will be enrolled into a one month longitudinal, prospective study on the influence of hypercaloric overfeeding (+50% of daily caloric needs) on different tissues (adipose tissue, muscle and blood).

They will be separated into two different groups: hypercaloric nutrition and placebo, and hypercaloric nutrition and polyphenols (2g/day), where polyphenols administration will be randomized and administered in a double blind fashion. Whole body and hepatic insulin sensitivity, total energy expenditure, glucose hepatic production, protein and gene expression in muscle, adipose tissue and blood as well as intestinal microbiota will be assessed at base line, and after one month of overfeeding.

Eligibility Criteria:
Inclusion Criteria:

* normal healthy male and female volunteer

Exclusion Criteria:

* Diabetes mellitus
* High blood pressure
* Liver disease
* Kidney disease
Phenytoin and Multidose Activated Charcoal

Phenytoin is a medicine used to treat seizures. If too much is taken, patients have ill effects including sleepiness, unsteady gait, and eye problems. The amount of drug in their system can be measured in their blood. Charcoal is a medicine that can absorb phenytoin. We want to see if giving multiple doses of charcoal will quicken the removal of phenytoin from the blood. This is theorized to occur as charcoal absorbs phenytoin from across the intestines and then is secreted in the stool. Patients will be selected to receive either charcoal in multiple doses or no charcoal and their serum levels will be drawn repeatedly to follow their level. The different groups will then be compared to see if multidose charcoal does indeed increase the elimination of phenytoin from the body.

See above

Eligibility Criteria:
Inclusion Criteria:

* Phenytoin level \> 30 mg/L

Exclusion Criteria:

* Age \< 18
* Known allergy to Activated Charcoal
* Pregnant
* Inability to take PO drugs
* Non English speaking
* Inability to give consent
* Any prisoners
Effect of RT3D-TEE-guided Mitral Valve Repair on Outcomes in Patients With Degenerative Mitral Valve Disease

The aim of this randomized controlled trial to investigate the effects of Real-time 3D transesophageal echocardiography (RT3D-TEE)-guided mitral valve repair on surgical failure and 1-year reoccurrence of mitral valve regurgitation in patients with degenerative mitral value disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic primary degenerative mitral regurgitation by the preoperative echocardiogram.
* Informed consent was obtained

Exclusion Criteria:

* Re-operation of mitral regurgitation
* Concurrent surgical plan for congenital heart disease, coronary artery bypass grafting, aortic valve surgery, radiofrequency ablation of atrial fibrillation and other cardiac surgeries.
* Mitral valve replacement
* Unable to undergo TEE
Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis

The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or placebo for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gMG \[Myasthenia Gravis Foundation of America (MGFA) Class II-IV\] at Screening
* Positive serology for acetylcholine receptor (AChR) autoantibodies
* MG-ADL Score of ≥ 6 at Screening and Baseline
* QMG score ≥ 12 at Screening and Baseline
* No change in corticosteroid dose for at least 30 days prior to Baseline or anticipated to occur during the 12-week Treatment Period
* No change in immunosuppressive therapy, including dose, for at least 30 days prior to Baseline or anticipated to occur during the 12-week Treatment Period

Exclusion Criteria:

* Thymectomy within 12 months prior to Baseline or scheduled to occur during the 12 week Treatment Period
* History of meningococcal disease
* Current or recent systemic infection within 2 weeks prior to Baseline or injection requiring intravenous (IV) antibiotics within 4 weeks prior to Baseline
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for Hepatitis B Envelope Antigen (HBeAg) & Hepatitis B Surface Antigen (HBsAg)

This study is performed to evaluate the persistence of anti-hepatitis B surface antigen (HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up study.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

The primary study was to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine administered according to a 0, 1, 2, 12 month schedule in newborns of anti-hepatitis B envelope antigen positive (HBeAg+) and anti-hepatitis B surface antigen positive (HBsAg+) mothers. Results from the primary study have shown that the vaccine was immunogenic and protected neonates of HBeAg positive mothers against hepatitis B chronic carriage. The present study is carried out to evaluate the anti-HBs persistence and the prevalence and incidence of other hepatitis B markers (HBsAg, anti-hepatitis B core antigen {anti-HBc}, HBeAg, Alanine aminotransferase/Aspartate aminotransferase {ALT/AST}), and the clinical significance of the HBsAg and anti-HBc positive cases observed during the long-term from year 16-20. No vaccine will be administered during the long term follow up period.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who had participated in the primary study.
* Written informed consent obtained from the subject.
Assessment of Therapeutic Education About Non Invasive Ventilation in Patients With Chronic Respiratory Failure (QoVNI)

The purpose of the study is to assess the therapeutic education of patients with chronic respiratory failure who start to be treated with non invasive ventilation and during the first six months of ventilation.

Therapeutic education about non invasive ventilation in patients with chronic respiratory failure and alveolar hypoventilation is assessed during the first six months of ventilation thanks to a questionnaire. Moreover, the impact of this therapeutic education on non invasive ventilation compliance, blood gas, dyspnea and nocturnal desaturation is assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic respiratory failure
* with alveolar hypoventilation required non invasive ventilation
* Adults and non-vulnerable subject
* Fluency in French

Exclusion Criteria:

* Age under eighteen years old
* Patient with guardianship
* No french-speaking
* Severe cognitive abnormalities
* No criteria to introduce non invasive ventilation
Active Injury Management (AIM) After Pediatric Concussion

The proposed interventions of this study will determine the ideal discharge recommendations related to activity

The investigators will conduct a phase II factorial clinical trial . The clinical trial will determine the benefit of prescribed low-intensity physical activity, behavioral management, or both, versus standard rest in acute (24-48 hrs) (Moderate Traumatic Brain Injury (mTBI) patients presenting to the pediatric Emergency Department (ED). Low-intensity physical activity (i.e.10,000 steps/day) will be prescribed and monitored in the first week post-injury with an actigraph (Fitbit®). Behavioral management will be prescribed using a phone app referred to as mHealth (mobile Health, specifically SuperBetter©) that promotes mental, physical, social, and emotional resilience. This randomized clinical trial will have four treatment groups: 1) activity, 2) mHealth, 3) activity+mHealth, 4) rest. The primary study outcomes will be symptoms and recovery by 14 days. All subjects will be assessed via phone at 3-5 days and in person at 14 days. The secondary outcomes will be to determine the influence of interventions on comprehensive aspects of physiologic recovery and patient-centered outcomes; including symptoms at 3 days, neurocognitive, vestibular/ocular motor impairment at 14 days, pediatric quality of life measures, time to symptom resolution, and return to normal activity via phone survey at 1 and 2 months. The investigators will assess symptom, quality of life, and recovery outcomes based on treatment group assignment for all subjects and high-risk subjects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mTBI in the past 72 hours

Exclusion Criteria:

* Patients having conditions otherwise which limit physical activity or neurocognitive assessment
* Do not have a smart phone
* History of brain surgery or past moderate/severe TBI within the last 6 months,
* Substance abuse,
* Major psychiatric condition under ongoing treatment with medications,
* Vestibular disorder,
* Cardiac condition,
* Unable to provide consent/assent
* Previous enrollment in the study
Music for Anxiety Management in Cesarean Delivery

A randomized controlled trial will be conducted to determine examine the effects of music played during cesarean delivery on maternal anxiety and vital signs.

It will tested the hypotheses that there is no difference between the intervention and control groups of pregnant women after the intervention in terms of anxiety and vita lsymptoms.

Eligibility Criteria:
Inclusion Criteria:

- Aged between 18-35 years,

* Undergoing cesarean section under spinal anesthesia,
* Experiencing spontaneous and singleton pregnancy,
* With a gestational age greater than 37 weeks,
* Pregnant individuals who have had at least 4 routine check-ups during pregnancy conducted by a member of the research team,
* Scheduled for cesarean section (regardless of the number of previous cesarean sections).

Exclusion Criteria:

* Having high-risk pregnancies such as preeclampsia, early membrane rupture, and placental abruption, • Being scheduled for emergency cesarean section for any reason
Open Label Trial of Fluoxetine for the Treatment of Depression in Patients With End Stage Renal Disease

The purpose of this study is to test whether once-weekly prozac therapy leads to reduction in depression in patients requiring kidney dialysis.

Once-weekly Prozac is a psychiatric medicine, approved by the FDA for the use in treatment of psychiatric disorders. This study will test whether once-weekly Prozac leads to reduced symptoms of depression. Patients requiring dialysis often report symptoms of depression either due to the presence of major depression, a relatively common psychiatric disorder, or due to depression secondary to kidney failure.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic renal failure and end stage renal disease
* Ongoing need for regular dialysis treatment
* Diagnosis of depression based on DSMIV
* Age tween 19-65 years

Exclusion Criteria:

* Inability to provide informed consent
* Medically or psychiatrically unstable, as defined by requiring inpatient treatment
* Pregnancy, nursing or refusal to use a reliable method of birth control in women
* Patients with known allergy to fluoxetine, or previous treatment failure of fluoxetine
Pharmacological Treatment of Comorbid Alcohol and Marijuana Withdrawal and Dependence

The primary aim of the supplemental study is to provide POC testing of aprepitant as a treatment for comorbid alcohol and cannabis dependence. The data analysis plan specified in the parent grant will likewise be applied to the supplemental project to test for effects of aprepitant vs placebo on measures of alcohol and cannabis use and protracted withdrawal. The primary hypothesis is that subjects treated with aprepitant will have significantly less alcohol and marijuana use than subjects treated with placebo.

Consistent with the scope and methods of the parent grant, this was a randomized, double-blind, placebo-controlled, parallel groups, Phase II, single-site, 8-week clinical trial of aprepitant 125 mg/d or placebo. Participants were 20 outpatients seeking treatment for concurrent alcohol and cannabis dependence. All participants received weekly protocol-specific counseling. Research assessments occurred weekly through the treatment phase of the 8-week study. Post treatment follow-up assessments occurred at Weeks 9 and 12.

Eligibility Criteria:
Inclusion Criteria:

* Males or females from 18-70 years of age
* Meets DSM IV criteria for current alcohol and cannabis dependence
* Seeking research-based outpatient treatment for alcohol and cannabis dependence that involves daily oral medication
* Negative BAC and a CIWA score \< 9 at randomization

Exclusion Criteria:

* Significant medical disorders or use of medications that will increase potential risk or influence study outcomes
* Females who are pregnant, nursing or who are sexually active with child-bearing potential and refuse to use an effective, non hormonal method of birth control during the study and for up to 4 weeks after study termination• Treatment with an investigational drug during the previous month
* Prior treatment with NK1 antagonists
* Participants for whom treatment is being mandated by a legal authority• Inability to understand and/or comply with the provisions of the protocol and consent form
TMS in Preclinical and Prodromal AD: Modulation of Brain Networks and Memory

The purpose of this study is to assess the effects of non-invasive brain stimulation on memory in cognitively unimpaired older adults and in patients amnestic mild cognitive impairment (aMCI) due to Alzheimer's disease (AD). This study will use repetitive Transcranial Magnetic Stimulation (rTMS) to stimulate nodes of the Default Mode Network (DMN)- which is thought to support episodic memory and to be affected by Alzheimer's pathology.

We will use functional connectivity MRI (fcMRI) to assess changes in functional network architecture following the stimulation. We will also assess putative cognitive improvements resulting from the stimulation by in-depth memory testing.


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 60-85
2. All participants will be native English speakers
3. Willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points
4. Participants with aMCI will be asked to bring a study partner to all visits
5. Only patients with very mild or mild cognitive impairment (CDR 0.5 or CDR 1) will be included in the prodromal AD cohort

Exclusion Criteria:

1. History of head trauma involving loss of consciousness or alteration in consciousness
2. Another major neurologic or psychiatric condition
3. Known presence of a structural brain lesion (e.g. tumor, cortical infarct)
4. Any contraindication to MRI, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
5. Longstanding premorbid history (i.e. longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed
6. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol.
7. Unwilling to return for follow-up, undergo neuropsychological testing, TMS, and MR imaging
Indego Exoskeleton After SCI

The purpose of this study is to assess the use of Indego as a gait training tool for subjects with complete or incomplete paraplegia as a result of spinal cord injury (SCI) who have preserved lower extremity function. It is hypothesized that subjects with complete or incomplete paraplegia who have preserved their lower extremity function will experience functional improvements after gait training with the Indego exoskeleton.

Subjects will complete a total of fifteen (15) sessions which include a combination of the following; Physical Therapy Evaluation, Indego Training, Mid-Way Assessment, and Post-Assessment.

The aim of this study is to measure the impact of gait training with the Indego device on body structure, function, and participation. Additionally it will assess the perceptions of physical therapists and subjects with SCI on the effectiveness of gait training with the Indego exoskeleton in subjects with preserved limited function.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Height 5'1" to 6'3" (Acceptable height may vary by a few inches depending on femur length)
* Weight 250 lbs or less
* Present with paraplegia resulting from a complete or incomplete (AIS A, B, C, or D) Spinal Cord Injury (\>1 year post-injury), with preserved LE function
* Uses wheelchair as primary means of mobility in the community
* Able to ambulate 14 meters with assist of 2 people and no orthostasis. Subjects may use any combination of stability aids and/or bracing.
* Medical clearance for weight bearing and locomotor training

  * Bone density exams will be at the discretion of each sites' Principle Investigator
* Passive range of motion (PROM) at shoulders, trunk, hips, knees and ankles within functional limits for safe gait and use of appropriate assistive device/stability aid
* Skin intact where interfaces with the Indego device
* Modified Ashworth Scale 3 or less in bilateral LEs
* Blood pressure and heart rate within Locomotor Training Guidelines

  * At rest: Systolic 150 or less Diastolic 90 or less and Heart rate 105 or less
  * Exercise: Systolic 180 or less Diastolic 105 or less and Heart Rate 145 or less

Exclusion Criteria:

* Inability to meet ALL inclusion criteria
* Currently participating in physical therapy for gait training
* Joint contractures of the shoulders, trunk, hips knees or ankles deemed unsafe for locomotor training by PT and or MD
* Edema that would put skin at risk for breakdown
* Modified Ashworth Spasticity of 4
* Inability to achieve adequate fit of the Indego device
* Pregnancy
* Colostomy bag
Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease

Hypoxaemic patients with exacerbations of chronic obstructive pulmonary disease (COPD) are at some risk of carbon dioxide (CO2) retention during oxygen therapy. Main mechanism of CO2 retention is believed to be reversal of preexisting regional hypoxic pulmonary vasoconstriction, resulting in a greater dead space. Risk of CO2 retention during mechanical ventilation remains controversial. Thus recent study suggested limited risk of CO2 retention with controlled oxygen supplementation during mechanical ventilation. Conversely, controlled oxygen supplementation might decrease dyspnea and respiratory workload, increase comfort and improve both urinary output and renal function.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Acute hypercapnic COPD exacerbation
* Respiratory acidosis
* Intensive care unit admission
* Non-Invasive mechanical ventilation for less than 24 hours
* Patients or proxy consent
* Patients affiliated with the General Social Security Health System

Exclusion Criteria:

* Pregnancy
* Sickle cells disease
* Acute coronary syndrome
* Restrictive respiratory disease
* Stage 4 or 5 chronic kidney disease
* COPD exacerbation following a first episode of conventional mechanical ventilation
* Contraindications to non-invasive ventilation
Interactive Virtual Assistance for Self-Care Management and Mental Health Promotion in Type 2 Diabetes

BACKGROUD: Health technology is an important tool in the aging process, which may improve the health condition and self-esteem of the elderly, in addition to offering new opportunities and challenges. In this scenario, the use of virtual interaction systems emerge as promising alternatives for the old adults, which often deals with the lack of social interaction, cognitive decline and decline in functional capacity, making the control of chronic diseases, such as diabetes, a challenge.

OBJECTIVES: This project aims to evaluate the effectiveness of using an interactive virtual assistance system in mental health parameters, glycemic profile and diabetes selfcare behavior in elderly people with diabetes.

METHODS: A randomized clinical trial is proposed, for an intervention that includes 3 months of use of the Smart Speaker Echo Dot system, programmed to provide reminders, stimulate treatment records and maintain healthy habits. Outcomes assessed will include parameters of mental health and diabetes control.


Eligibility Criteria:
Inclusion:

* Being 65 years of age or older;
* Having a diagnosis of type 2 diabetes;
* Residing in Porto Alegre or metropolitan region;
* Presenting availability of Wi-Fi connection at home; and
* Presenting availability to participate in the proposed face-to-face evaluation and accept receiving one visit for installation of the device.

Exclusion:

* Having an interactive virtual home assistance device at the time of enrollment;
* Having cognitive impairments or severe hearing impairments that prevent adequate interaction with outcome assessors and the application of follow-up questionnaires; or
* Residing in regions of difficult access.

Recruitment:

Study subjects will be recruited through two different strategies:

* Screening of records of the outpatients clinics of Hospital São Lucas (HSL)
* Social media advertising, specially in Instagram®
Cardiac Function in Severe Aneurysmal Subarachnoid Haemorrhage Patients

Cardiac dysfunction can occur in aneurysmal subarachnoid haemorrhage and might impact patient's neurologic outcome Condition Aneurysmal subarachnoid haemorrhage World Neurosurgeon Federation Score ≥ III

Trans-thoracic echocardiography on day 1, day 3 and day 7 Speckle-Tracking of echocardiographic loops by a cardiologist blinded to the patient's management and outcome

Eligibility Criteria:
Inclusion Criteria:

* Aneurysmal subarachnoid haemorrhage
* World Neurosurgeon Federation Score ≥ III
* Written information to next-of-kin and patients when possible

Exclusion Criteria:

* History of myocardial infarction, chronic heart failure with NYHA ≥ 2, major heart surgery
* Lack of acoustic window to perform trans-thoracic echocardiography