cyrilzakka/clinical-trials huggingface dataset:
VACcination In Methotrexate Treated Rheumatoid Arthritis Patients

To estimate the rate of immunological answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffered from rheumatoid polyarthritis and who begin a treatement by methotrexate either in the same time, either 1 month later.

Patients suffering from rheumatoid polyarthritis have an increased risk to develop an infection compared to general population, with a more important mortality risk because pneumococcus is considered as one of the major pathogenic agents. Antipneumcoccal vaccination is recommended to patients suffering from chronic inflammatory rheumatism treated with immunosuppressants. Methotrexate is a long term treatment used in first intention for rheumatoid polyarthritis. A recent study shows a decrease of efficacity of antipneumoccal vaccination for patients suffering from rheumatoid polyarthritis treated by methotrexate. The tested hypothesis will be the presence of better vaccinal protection for patients suffered from rheumatoid polyarthritis after 1 month between antipneumococcal vaccination and the initiation of methotrexate. The objective is to compare immunologic response for antipneumococcal vaccination between patients who are vaccinated in the same time of initiation of methotrexate and patients who are vaccinated 1 month before the beginning of the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 yeas old) suffers from rheumatoid arthritis considering ACR/EULAR 2010 criteria
* Rheumatoid arthritis considering 3,2\<DAS\<5,1
* Patient did not treat by long term treatment or has stopped a treatment by sulfasalazine, hydroxychloroquine or methotrexate for at least 3 months
* Patient has never treated by biotherapy
* Patient has never vaccinated against pneumococcal
* Patient has signed study consent form

Exclusion Criteria:

* Patient has ever treated by leflunomide or has treated previously by leflunomide (last 3 months)
* Patient is currently treated by methotrexate or has treated previously by methotrexate (last 3 months)
* Contraindication to methotrexate: renal insuffisance, alcoolic, chronic hepatisis, infectious condition, AIDS, hematological failure (cytopeny), pregnancy, obesity, diabet, respiratory disease, gastric ulcer
* Contraindication to corticotherapy
* Pregnancy or pregancy wish
* Nursing
* Absence of oral contraception for women of childbearing age
* Patient of age protected by law et deprived of liberty
* Subject who refuses to be vaccinated against pneumococcis agent
* Previous history of vaccination allergy (anaphylactic shok, Quincke oedema...)
* Gluten hypersensivity or intolerance
* Other vaccination during the last month before inclusion
* Ig perfusion during the last 3 months period before the study inclusion or during the study duration
* Patient currently treated by anticoagulant or has not been stopped for at least 48h before the study inclusion or hemostasis failure which is contraindicated with muscular injection
* Participation with an other clinical trial
Effects of Cognitive-Behavioral Therapy on Sleep Disturbance in Peritoneal Dialysis Patients

Sleep disturbance is prevalent in chronic dialysis patients and there is a negative correlation between the quality of life and overall survival and sleep disturbance in them. Cognitive-behavioral therapy is an effective behavioral therapy for insomnia clinically. In previous studies, cognitive-behavioral therapy can redress anxiety in chronic hemodialysis patients. This study tries to elucidate its therapeutic effect on the sleep disturbance in chronic peritoneal dialysis patients.

Sleep disturbance is prevalent in chronic dialysis patients and there is a negative correlation between the quality of life and overall survival and sleep disturbance in them. So many factors interfering the sleep of these patients, however, there is no effective therapy for them except some drugs, such as hypnotics or anxiolytics. Cognitive-behavioral therapy is an effective behavioral therapy for insomnia clinically and it contains three therapeutic domains including stimulus control, sleep restriction therapy, and relaxation training. It has been proven to be beneficial in improving sleep pattern in chronic insomnia and cancer patients and alcoholism. In previous studies, cognitive-behavioral therapy can redress anxiety in chronic hemodialysis patients, however, there is no clinical evidence revealing its effectiveness upon sleep disorders in hemodialysis and peritoneal dialysis patients. Our study tries to elucidate the therapeutic effect of cognitive-behavioral therapy on the sleep disturbance in chronic peritoneal dialysis patients.

We will perform cognitive-behavioral therapy to eligible peritoneal dialysis patients and evaluate the sleep condition before and after the therapy. Moreover, clinical conditions, biochemical and hematological parameters, inflammatory mediators in blood will be measured at baseline, before and after therapy.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing peritoneal dialysis (PD) for at least 3 months
* Older than 18 years
* Have sleep disturbance subjectively

Exclusion Criteria:

* Unstable clinical conditions or evidence of malignancy
* Pregnancy
* Participation in another study that would interfere with the outcome of this study
Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment

This interventional study aims to evaluate the efficacy of oral administration of Lactobacillus Rhamnosus GG in preventing relapses of ocular inflammation in Vernal Keratoconjunctivitis (VKC) patients.

Vernal keratoconjunctivitis (VKC) is a chronic allergic disease, characterised by ocular surface inflammation lasting all year with seasonal relapses. Active phases of VKC are characterised by intense ocular symptoms and require treatment with topical steroids to control inflammation and corneal damage. To date, safe and effective therapies in preventing relapses of VKC are not available. Recently, the use of oral administration of probiotics for allergic diseases have been proposed. No data are available on the effects of probiotics on ocular allergies. This multicenter, double-masked, randomised, controlled clinical trial will allow to obtain more data on the efficacy of oral treatment with Lactobacillus Rhamnosus GG in patients affected by VKC. Patients with VKC will be treated with Lactobacillus Rhamnosus GG or placebo in addition to ketotifen fumarate 0.025% eye drops (standard treatment). The number of relapses per year, signs and symptoms of the disease, total symptom score (TSyS), total sign score (TSS), biochemical and molecular parameters will be evaluated at different time points.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of VKC performed on the basis of personal and family history of systemic allergic diseases, clinical examination (presence of conjunctival tarsal and/or limbal papillae) and presence of eosinophils in the conjunctival scraping.

Exclusion Criteria:

* Contact lens wearers,
* Patients affected by other ocular diseases,
* Patients subjected to ocular surgery in the preceding 6 months,
* Patients under eye drop or systemic treatments for other diseases,
* Patients enrolled in experimental trials in the preceding 6 months.
BIS Monitoring to Detect Deep Sedation

Studies have shown that prolonged deep sedation is associated with adverse clinical outcomes in adult intensive care unit (ICU) patients. The revised guidelines for management of pain, agitation and delirium by the Society of Critical Care Medicine in 2013 also recommended that adult ICU patients should be maintained at a light level of sedation. The key point in light sedation strategy is the assessment of depth of sedation. At present, sedation is monitored mainly by the subjective clinical score systems, such as the Ramsay Scale, the Riker's Sedation-Agitation Scale (SAS) and the Richmond Agitation-Sedation Scale (RASS). However, the subjective and intermittent nature of these scales instruments has limited their application in light sedation algorithm. Consequently, objective and continuous measurement of the level of sedation would be more desirable in clinical practice. In recent years, objective measures of brain function have been of great interests in the evaluation of sedation level, and bispectral index (BIS) has been the most investigated instrument.

Several studies compared BIS with subjective sedation scales in adult ICU patients, and yielded conflicting results. The different approaches to select BIS value may be the most important reason for these inconsistent agreements between BIS and subjective sedation scales. A formal scheme of subjective assessment of the depth of sedation and level of consciousness should incorporate exerting verbal and physical stimuli and observation of the patient's subsequent responses. Our primary aim is to clarify the diagnostic accuracy of BIS in detecting early deep sedation against the reference standard of subjective scale instrument. We hypothesize that BIS monitoring will provide accurate, subjective and continuous evaluation of deepen sedation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients are intubated and ventilated within the previous 24 hours, are administered with continuous or intermittent intravenous sedatives and/or analgesics, and are expected to receive mechanical ventilation and sedation for longer than 24 hours

Exclusion Criteria:

* Age under 18 or over 65 years;
* Continuously infusion of muscle relaxants;
* Diagnosed or suspected brain diseases, which including brain trauma, intracranial hemorrhage, stroke, brain tumors, hypoxic-ischemic encephalopathy, epilepsy and meningitis;
* Diagnosed conditions that resulted in a decrease level of consciousness, which including hypoxemia with partial pressure of oxygen in arterial blood less than 60 mmHg, hypotension with systolic blood pressure less than 90 mmHg, hypoglycemia with blood glucose concentration less than 4.1 mmol/L, anemia with hemoglobin concentration less than 70 g/L, and body temperature below 36 °C.
Neovascular Age Related Macular Degeneration (AMD), Periocular Corticosteroids, and Photodynamic Therapy (PDT)

Randomized controlled clinical trial of periocular corticosteroids as adjunctive therapy to photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration (AMD). Patients undergoing PDT are randomized to either a periocular corticosteroid injection with 40 mg of triamcinolone acetonide or observation just prior to PDT. Patients are followed for 6 months. Primary outcome is leakage from choroidal neovascularization (CNV) at 3 months on fluorescein angiography.


Eligibility Criteria:
Inclusion Criteria:

* Active choroidal neovascularization
* Age related macular degeneration
* Visual acuity 20/20 to 20/400

Exclusion Criteria:

* Neovascular lesion \>6500 microns is greatest linear diameter
* More than one prior photodynamic therapy treatment
* Receiving systemic corticosteroids
* Intraocular pressure \> 21 mm Hg or glaucoma medication use
* History of glaucoma or history of ocular hypertension
ICG Angiogram as a Predictor of Postoperative Visual Function After EEA Surgery

Endonasal endoscopic approaches are an established treatment for suprasellar lesions compromising the optic nerves (ON). Surgery often involves dissecting tumors from the optic nerves and its blood supply, which can result in nerve damage and visual loss after surgery. To date, there are no reliable methods to monitor the optic nerve function during surgery and thus, post-surgical visual outcomes is unknown until the patients are fully awake after surgery for a visual exam. This delay in diagnosis prevents early therapeutic measures and can result in further harm to the ON. We have recently recognized that when ICG is routinely injected during these cases to check for patency of the big arteries the sub millimetric superior hypophyseal arteries supplying (SHA) the ON are also visible and that lack of visualization of these vessels is associated with worse visual deficits after surgery. Thus, ICG may be a tool to intraoperative predict visual outcomes after endonasal approach for suprasellar lesions and fill the nondiagnostic gap. This study will assess whether endoscopic ICG angiography before and after resection of suprasellar lesions can predict post-operative visual deficits. Successful completion will provide surgeons a novel tool to assess visual function during surgery. The ICG endoscopic angiograms suggested in this study are noninvasive and currently routinely performed at the end of surgery to check for patency of big brain arteries.


Eligibility Criteria:
Inclusion Criteria:

* The study will enroll adult (18 y.o. and older) participants undergoing endonasal endoscopic surgery for suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas.

Exclusion Criteria:

* Underage patients (younger than 18 y.o).
An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst

Digital myxoid cysts arise from degeneration in the connective tissue of the digit joint, usually the last joint of the finger or toe, often due to underlying joint arthritis. They may connect with the joint. Pressure from the cyst can result in deformity of the digit's nail and trauma to the cyst results in leakage of the fluid, representing a potential source of entry for infection. Cysts can be tender and interfere with the digit's function. A variety of treatments are available, from simple extrusion which is rarely successful, to more destructive cryotherapy, infra-red coagulation and formal excision under local anaesthetic. These latter three approaches can result in considerable scarring. Sclerosant injection of polidocanol in one small non-randomised trial has been reported to be a well tolerated efficacious treatment with minimal scarring and long-term resolution. Following a pilot study, the investigators aim to trial this treatment to assess efficacy in a larger population.


Eligibility Criteria:
Inclusion Criteria:

* All patients referred to dermatology in NHS Lothian or NHS Fife who have a visible Digital Myxoid Cyst affective the dital phalynx of the toes or fingers.
* The patient must have the ability to give informed consent

Exclusion Criteria:

* History of sensitivity to polidocanol or other sclerosants
* Age less than 18
* Inability to give informed consent
* Inability to report side effects experienced
* Cyst not clearly visible
* Cyst not fluid-filled
Reshaping Exercise Habits and Beliefs (REHAB)

Regular exercise has been demonstrated to improve muscle strength, balance, coordination as well as improve cardiovascular fitness levels and overall quality of life in stroke survivors. This study is designed to test the feasibility and effectiveness of a 12-week intervention to education and encourage stroke survivors to exercise following discharge from rehabilitation settings using a walking program and targeted functional activity homework.


Eligibility Criteria:
Inclusion Criteria:

1. 40-85 years old ischemic Stroke patients,
2. Stroke onset \<90 days at enrollment,
3. Hemiparetic gait disorder,
4. Patients able to walk 30ft with or w/out assistive device,
5. Sufficient English comprehension to understand instructions, provide consent, and answer questions,
6. Lives within 30 miles of the Greater Baltimore area.

Exclusion Criteria:

1. Dementia (extended MMSE \<85 or \<80 if education level below 9th grade),
2. Untreated major clinical depression (CES-D\>16) and confirmed with clinical interview,
3. Heavy alcohol use (\<3 oz liquor, 3, 4-oz glasses of wine, or 3, 12- oz beers daily),
4. Active cancer, or any illness with a life expectancy of less than 6 months,
5. Any condition in which exercise activity would be contraindicated including, but not limited to: unstable angina, cardiac ischemic event within the past 6 months, congestive heart failure (Stage III or IV), major orthopedic chronic pain or non-stroke neuromuscular disorders restricting exercise, oxygen-dependent COPD or peripheral neuropathy.
Auditory Intranerve Stimulation Study

This feasibility clinical investigation is designed to answer the question of whether auditory brainstem responses can be safely elicited by acute electrical stimulation within the human auditory nerve.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Patients who will undergo an acoustic neuroma removal surgery and are functional deaf
3. Age ≥ 18 years
4. Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gyncecologists

Exclusion Criteria:

1. Disabilities in addition to hearing impairment which might interfere with the study procedure
2. Pregnant and breast feeding woman or other vulnerable population
Prediction of Rehospitalization Following a Sepsis Admission Using a Wearable Biopatch

The goal of this observational study is to learn about the utility of biopatches predicting 30-day readmissions in patients discharged from the hospital with sepsis.

The main question\[s\] it aims to answer are:

• Does the application of a biopatch provide data that can improve prediction of an unplanned 30-day readmission following a hospitalization for sepsis.

Participants will be asked to wear a biopatch on their chest for 30-days following hospital discharge or until readmission to the hospital.

Study Design: Longitudinal cohort study with repeated measure of outcomes and predictors.

The BioIntelliSense patch is an FDA approved wearable device that is applied to the chest with a 30-day battery lifespan and allows for real-time monitoring of heart rate, respiratory rate, skin temperature, general activity, severe cough episodes, and sedentary body position, among others.

Outcomes of Interest: Hospital readmission within 30 days of discharge following an index admission with a diagnosis of sepsis is the primary outcome of interest for this study. We will calculate the positive predictive value (PPV) of readmission prediction as the the primary outcome of interest from the following approaches: analytic score plus biopatch, analytic score alone, LACE+ score. Secondary outcomes include area under the curve of the receiver operator characteristic (AUCroc) of predictive scores (analytic score and biopatch, analytic score alone, LACE+ score) and number of patients readmitted to the hospital within 30 days of discharge.

Protocol for Patient Selection and Application of Biopatch: Patients who meet "Sepsis 3" definition will be identified with institutional review board (IRB)-approved screening protocols. Our previously derived and validated machine-learning algorithm to predict unplanned 30-day readmissions will then generate daily predictions about 30-day readmission probability which will be recorded, as well as LACE+ scores. As a patient approaches discharge, the treatment team and patient (or legally authorized representative) will be approached about potential enrollment. If there is agreement to enroll in this prospective study, then we will apply the patch at the time of discharge. Patients will then be followed with the BioIntellisence patch with augmented and real-time risk predictions based on data obtained from this. For this proposal, we will use data from the BioIntelliSense patch and are not providing clinicians with data on risk of readmission.

Eligibility Criteria:
Inclusion Criteria:

Age \>= 18 years Development of sepsis, defined by recent international guidelines (Suspected infection AND 2-point change in sequential organ failure assessment (SOFA) score), in emergency department or hospital Admission to hospital from emergency department

Exclusion Criteria:

Transition to comfort measures within 6 hours of time of sepsis Discharge from the emergency department Admission to bone marrow transplant service Severe burn or other dermatologic condition that will prevent application to skin
Surgical Intervention on the Body-mind-spirit of Patients With Cervical Spine Surgery

The study aimed to evaluate if surgical intervention in patients with degenerative cervical diseases improves quality of life (QOL), lowers pain-induced mental impairment, improves psychologic health, and promotes spiritual well-being.

Degenerative cervical disease induces cervical radiculopathy and myelopathy, which have a significant impact on the patients' health. The study aimed to evaluate if surgical intervention in patients with degenerative cervical diseases improves quality of life (QOL), lowers pain-induced mental impairment, improves psychologic health, and promotes spiritual well-being.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 20 who were diagnosed with degenerative cervical diseases, including herniation of the intervertebral disc, ossification of the posterior longitudinal ligament, and spinal stenosis, resulting in cervical radiculopathy, or degenerative cervical myelopathy, and were scheduled to undergo anterior discectomy with fusion surgery.

Exclusion Criteria:

* Patients who were unable to attend follow-up visits or complete the questionnaires, and those patients who expressed doubts or were unable to provide satisfactory responses regarding the trial.
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.

To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis

This was a randomized, double-blind, double-dummy, active comparatorcontrolled, parallel-group, multi-center study with variable treatment duration in approximately 900 patients with relapsing multiple sclorosis (RMS). The maximal treatment duration in the study for an individual patient was 2.5 years. Eligible patients were randomized to receive either experimental ofatumumab subcutaneous (s.c.) injections every 4 weeks or active comparator teriflunomide orally once daily. The dose regimen for ofatumumab for this study was a loading dose regimen of 20 mg at Day 1, Day 7 and Day 14, followed by a maintenance dose regimen of 20 mg administered every 4 weeks starting at Week 4. In order to blind for the different formulations, double-dummy masking was used, i.e., all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo).

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 to 55 years at Screening
* Diagnosis of multiple sclerosis (MS)
* Relapsing MS: relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS) with disease activity
* Documentation of at least: 1 relapse during the previous 1 year OR 2 relapses during the previous 2 years OR a positive gadolinium-enhancing MRI scan during the year prior to randomization
* Disability status at Screening with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5
* Neurologically stable within 1 month prior to randomization

Exclusion Criteria:

* Patients with primary progressive MS or SPMS without disease activity
* Disease duration of more than 10 years in patients with an EDSS score of 2 or less
* Patients with an active chronic disease of the immune system other than MS
* Patients at risk of developing or having reactivation of hepatitis
* Patients with active systemic infections or with neurological findings consistent with PML