cyrilzakka/clinical-trials huggingface dataset:
MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study)

In the MOVING study should be examined, whether early therapeutic intervention with fingolimod (Gilenya ®) after optic neuritis(ON) has a favorable visual outcome as a comparative therapie with Interferon beta-1b (Extavia®), as measured by multifocal visual evoked potentials (mVEP) after 6 month compared to baseline.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsing-remitting multiple sclerosis (RRMS)
* ability to consent and a written approval
* First acute ON attack to the fit eye within 30 days before screening
* Age 18 - 55 years at screening
* EDSS ≤ 6.0
* No MS Attack except for ON in the last 30 days before screening
* No immunomodulatory therapy for at least three Months (before randomization), or
* strong immunomodulatory therapy with interferon beta or glatiramer acetate for at least 6 months
* visus in the affected eye at least 0.1
* latency of Conventional VEP in the affected eye

  * = 115 ms or difference\> = 15 ms to the opposite side at a Study at least 4 but no more than 6 weeks after Onset of clinical symptoms
* At least 2 T2 lesions typical of MS in a previous MRI

Exclusion Criteria:

* other MS course than RRMS
* any condition which could interfere or prevent the MRI study or other investigations
* known allergy or intolerance, or other contraindication against Gd-DTPA
* Patients with known contraindications to treatment with fingolimod (Gilenya ®) or interferon beta-1b Extavia ®
* Competing diseases which could affect visual functions such as diabetic, retinopathy, glaucoma, retinal detachment
Early Nutrition Impact on Post Abdominal Surgery Outcome

Introduction: Nutritional support is a vital therapy of most surgical patients. Early initiation via the enteral route has a significant effect on postoperative recovery. The prognostic role of CRP and albumin can be explained by their abilities to reflect inflammation in the acute phase in critical settings and assess the nutritional status of critically ill patients, respectively. This indicates the prognostic value of the CRP/ALB ratio in postoperative patients admitted to the ICU.

Aim of work: Determine the effect of early enteral \& parenteral nutrition on ICU outcome \& nutritional status in postoperative abdominal surgical patients and investigate the effect of enteral \& parenteral nutrition on CRP/albumin ratio as an inflammatory marker \& its correlation with SOFA score.

Methods: A prospective cohort non randomized study included 80 postoperative abdominal surgical patients at Critical Care Department, Cairo University over one year duration. Forty patients (50%) received enteral nutrition 6 hours after surgical procedures and 40 patients (50%) received parenteral nutrition 6 hours after surgical procedures. Nutritional status and inflammatory markers were screened. All patients were followed up during the ICU stay \& up to 3 months. SOFA scoring was done every 48 hours.


Eligibility Criteria:
Inclusion Criteria:

* postoperative abdominal surgical patients at Critical Care Department, Cairo University over one year duration.
* age between 18-80 years

Exclusion Criteria:

* renal failure
* liver failure
* extensive burns
* hemodynamic instability.
Viaskin® Peanut (DBV712) Expanded Access Protocol

This is an open label expanded access program for male and female patients ≥ 4 years old.

This study is an open-label Intermediate-size EAP designed to provide treatment access for eligible Peanut-Allergic Children. This EAP entails visits every three months to assess patient status, safety, and to provide drug supply. Viaskin® Peanut treatment will continue until, in the clinical judgment of the Investigator, the patient is no longer benefiting from continuation of the treatment, the drug becomes approved and available by prescription, or the study is terminated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 4 years of age
* Prior participation in a Viaskin® Peanut REALISE or PEOPLE clinical study for peanut-allergic patients

Exclusion Criteria:

* Pregnancy or lactation or planning a pregnancy.
* Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back with no intact zones to apply the Viaskin® patches.
* Patients who developed hypersensitivity to excipients of the Viaskin® patches.
* Received or planning to receive anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy.
* Receiving or planning to receive any other type of immunotherapy to any food (for example, EPIT, OIT, or SLIT or specific oral tolerance induction) or any aeroallergen or venom immunotherapy during their participation in the study.
* Use of cyclosporine or other immunosuppressive agents within 3 months before entering the study. Topical calcineurin inhibitors are permitted.
* A history of important non-compliance during the REALISE or PEOPLE studies. Important non-compliance includes patients not applying the patches for 60 or more days in total and/or for 30 or more consecutive days during the REALISE or PEOPLE studies.
Effect of Probiotic on Rhinovirus Induced Colds

This is a randomized, double-blind placebo controlled trial to evaluate the effect of a probiotic (Bl-04) on the occurrence of rhinovirus-associated common cold illness in the experimental rhinovirus challenge model. A previous study documented that Bl-04 has significant effects on the innate immune response in the nose and this study will be powered to assess whether these effects translate into a demonstrable clinical benefit. Volunteers will be given Bl-04 or placebo for 28 days then challenged with rhinovirus. The primary analysis will be on the proportion of volunteers who develop a rhinovirus associated illness in the two treatment groups.


Eligibility Criteria:
Inclusion Criteria:

INCLUSION CRITERIA AT ENROLLMENT:

* Subject must be 18-60 years of age.
* Subject must read and sign a copy of the approved Consent Form
* Subject must have a serum neutralizing antibody titer of less than or equal to 1:4 to rhinovirus type 39

INCLUSION CRITERIA AT DAY -28

• Female subjects must be using an effective birth control method.

INCLUSION CRITERIA AT CHALLENGE:

* Female subjects must be using an effective birth control method.

Exclusion Criteria:

* Antibiotic use within 3 months prior to day -28

  * Female subjects with a positive urine pregnancy screen
  * History of use of probiotics in the preceding two weeks
  * Current cancer diagnosis or immunosuppressive therapy in the last 6 months
  * Any clinically significant abnormalities of the upper respiratory tract
  * Any clinically significant acute or chronic respiratory illness
  * Any clinically significant bleeding tendency by history
  * Hypertension that requires treatment with antihypertensive medications
  * History of angina or other clinically significant cardiac disease
  * Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study
  * History of regular use (more than 3 days in 7) of tobacco products within the preceding two weeks
  * History of drug or alcohol abuse in the 6 months preceding the study

EXCLUSION CRITERIA AT CHALLENGE:

* Any upper respiratory infection or allergic rhinitis in the two weeks prior to the challenge
* Female subjects with positive pregnancy screen prior to challenge
* Any medical condition that in the opinion of the Principal Investigator is cause for exclusion from the study
* Use of any anti-inflammatory (steroids or NSAIDs) or cough/cold or allergy preparation in the two weeks prior to the challenge
Metabolic Effects of Eccentric Endurance Training

The purpose of this study is to evaluate metabolic parameters in previously sedentary individuals before and after eccentric endurance training (hiking downwards). Study participants will regularly hike downwards over a difference in altitude of 540 meters during 8 weeks. For the opposite way, a cable car will be used. Metabolic profiles will be obtained at baseline and after the 8 weeks period of eccentric endurance exercise.


Eligibility Criteria:
Inclusion Criteria:

* men and women
* age over 18 years

Exclusion Criteria:

* previous systematic endurance training (\>3 times per week \>30 min)
* body mass index \> 35 kg/m²
* heavy smoking (\>20 cigarettes per day)
* regular alcohol consumption \>60g per day
* history of cardiovascular disease
* established musculoskeletal disease
* unwillingness to stay in the area for the whole period
Study of MDX-1411 Given Every 14 Days With Pre-medications to Subjects With Clear Cell Kidney Cancer.

To determine the highest and safest tolerated dose of MDX-1411 for the treatment of clear cell renal cell carcinoma (Kidney cancer).

Subjects will be assigned one dose upon enrollment and will continue with the same dose throughout the study. The maximum duration for the study is two and a half years for a total of 17 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of RCC with clear cell component
* Measurable disease
* Treated with up to 6 prior systemic therapies for advanced/recurrent disease or have become intolerant to a systemic therapy
* Subjects with treated brain metastases must be without magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks and off steroids for at least 4 weeks to be eligible
* At least 28 days since the last chemotherapy
* At least 28 days before the first dose of MDX 1411 since any major surgery
* ECOG performance status 0-2
* No known positivity for human immunodeficiency virus (HIV), Hep B or C

Exclusion Criteria:

* Previous treatment with any other anti-CD70 antibody
* Active infection requiring i.v systemic therapy within 28 days before first dose
* Evidence of bleeding diathesis or coagulopathy
* Active autoimmune disease requiring immunosuppressive therapy
* Known current drug or alcohol abuse
* Any underlying medical condition which will make the administration of MDX 1411 hazardous
* Psychiatric illness or social situation that would preclude study compliance
Trans Thoracic Ultrasound to Assess Diaphragmatic Function in Stable COPD Versus Bronchial Asthma.

* Assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in COPD and bronchial asthma patients.
* Assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function.
* Assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator.

* Assessment of diaphragmatic function (excursion, thickness variation, thickness ratio) in COPD and bronchial asthma patients.
* Assessment of presence of correlation between diaphragmatic dysfunction and pulmonary function (FEV1/FVC).
* Assessment of possible association between diaphragmatic dysfunction and presence of reversibility in pulmonary function post bronchodilator (short acting B2 agonist)

Eligibility Criteria:
Inclusion Criteria:

Stable patients (not in exacerbation).

Exclusion Criteria:

* Patients with comorbidities as cardiac, renal or hepatic diseases.
* Patients who have combined COPD and bronchial asthma.
Effectiveness of Mobile Application Intervention in Day Surgery

In Finland about 50% of surgical operations for all under 16 years of age are made as day surgery which means that the patient comes to the hospital and is discharged on the day of the operation. Day surgery will continue to grow in the next few years. Its benefits include shorter hospitalization, family reunion and rapid recovery. The preschool children and their parents who come in for day surgery feel fear, anxiety and stress, which depend on the amount of knowledge and its quality. By developing the preparation of preschool children and their parents for day surgery, and by testing new methods more attention can be paid to the special features of day surgery, supporting the families, and increasing family involvement in the whole process.

The purpose of this study is to describe and evaluate the effectiveness of a new mobile application intervention compared to the effectiveness of the traditional preparing method when measuring preschool children's fear and pain and their parents' anxiety and stress. The aim is to produce new information and to develop day surgery of preschool children.

The study consist of two phases. The first phase of the research is a systematic literature review and meta-analysis. The purpose of the review is to assess and describe the methods previously used in the preparation of parental day surgery and their effectiveness for preschool children fear and pain and parents' anxiety and stress. The second phase of the study is carried out as a randomized controlled trial (=RCT). The parents of the preschool children are randomized to the mobile application group (n = 50-60) and the control group (n = 50-60). The sample size is based on power-analysis, with anxiety as the primary outcome. The material for the second phase of the study is collected at the day surgery department of the Oulu University Hospital. The study group is prepared for day surgery with a new mobile application and the control group according to the traditional preparing method. The study examines the effectiveness of a new intervention compared to the effectiveness of the traditional preparing method when measuring preschool children's fear and pain and their parents' anxiety and stress. The collected data are analyzed using the Mann-Whitney, t-test, Khi square test, and Fisher's accurate test.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 or 2
* ELECTIVE DAY SURGIGAL PROCEDURE IN 3-4 WEEKS
* PARENT ABLE TO USE MOBILE INTERVENTION, UNDERSTANDS FINNISH AND WILLING TO PARTICIPATE IN PREPARING CHILD FOR DAY SURGERY
* GENERAL ANAESTHESIA

Exclusion Criteria:

* INCLUSION CRITERIA NOT MET
Sjogrens Syndrome Measured by Ultrasound

Ultrasound study focused on salivary gland outcomes in Sjogren's subjects

A 32 week ultrasound study for subject diagnosed with Sjogren's Syndrome. Subjects will receive Orencia (Abatacept) as intervention therapy during this trial.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with Sjogren's Syndrome

Exclusion Criteria:

* Subjects previously diagnosed with Sarcoidsis
* Subjects with positive for Hepatitis B, Hepatitis C, HIV
* Subjects diagnosed with Cancer within 5 years of screening
Thermal Imaging in Liver Disease.

This is a feasibility study, to assess if thermal imaging and/or near infrared imaging will be useful in identifying changes in the peripheral circulation in patients with different stages of liver disease.

The aim of this study is to use new and advanced thermal imaging techniques to identify changes in the peripheral circulation and hand temperature in patients with liver disease. These changes could be used as a non-invasive marker of the severity and progression of liver disease. Thermal imaging will also be used to assess the changes in the peripheral vasculature with the use of terlipressin, a drug used as treatment for specific complications of liver disease.

Patients with acute or chronic liver disease from any aetiology will be recruited, along with patients without liver disease as healthy controls. Patients with disease or on drugs known to affect the peripheral vasculature will be excluded.

All studies will be performed in a ward setting in the Royal Infirmary of Edinburgh. The subjects will be required for up to three sessions, each lasting 30 minutes. The session will involve static thermal images being taken, and video images of the hands warming up after being cooled for 30 seconds in water at a temperature of 7 degrees Celsius. If the patient is receiving terlipressin therapy, static images will be taken before, during and after terlipressin therapy.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of chronic liver disease (any stage)
* diagnosis of acute liver disease (any aetiology)

Exclusion Criteria:

* on drugs known to affect peripheral circulation
* conditions known to affect peripheral circulation e.g. Raynauds
A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers

This single-center, open-label study will investigate the pharmacokinetics and elimination of a radiolabelled dose of RO4602522 in healthy male volunteers. The healthy male volunteers will receive a single oral dose of RO4602522.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, 35 to 55 years of age, inclusive
* Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
* A body mass index (BMI) between 18 to 30 kg/m2 inclusive
* Male volunteers and their partners of childbearing potential must use 2 methods of contraception, one of which must be a barrier method for the duration of the study and for 90 days after the last dose.
* Able to participate and willing to give written informed consent and to comply with the study restrictions.
* Non-smokers or have not smoked since at least 3 months prior to screening

Exclusion Criteria:

* If capable of reproduction, unwilling to use an effective form of contraception
* Suspicion of regular consumption of drug of abuse and/or positive drug or alcohol screen
* Infection with hepatitis B, hepatitis C, or human immunodeficiency virus 1 and 2
* Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 90 or less than 50 mm Hg
* Resting pulse rate greater than 90 or less than 45 beats per minute
* Clinically significant abnormalities in laboratory test results
* Participation in an investigational drug or device study within 90 days prior to screening
* Donation of blood within 3 months prior to screening
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
iChoose Decision Kidney Aid for End-Stage Renal Disease Patients

The investigators developed iChoose Kidney -- a shared decision-making support tool accessible through iPad, iPhone, or the web -- to provide ESRD patients and their providers with a simple, standardized, easily accessible, statistically robust tool for use in the clinic to guide patient education and healthcare decision-making about treatment options of dialysis or kidney transplantation. The iChoose Kidney decision aid provides patients with estimates of their individualized 1 and 3-year risks of mortality on dialysis vs. transplantation, based on previous national data. The tool has the potential to improve communication and decision-making between patients and their healthcare providers and improve access to kidney transplantation among patients with ESRD.

This will be a two-arm, randomized study, and will be conducted at 3 large transplant centers with diverse patient populations. One group of patients will receive standard education alone during their scheduled transplant evaluation. The second group will receive the standard education as well have the provider use the iChoose Kidney aid with them. The project timeline will be a total of 24 months inclusive of enrollment, follow-up, data analysis, and outcome evaluation.

This study will assess how well the iChoose decision aid works in improving patient knowledge, preferences for treatment, and patient access to transplant. The study will also assess whether providers find the tool useful for providing ways to share information with patients about ways to treat their kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of end-stage renal disease (ESRD) and on dialysis for \< 1 year
* English-speaking
* Subjects coming in for transplant medical evaluation
* Age \> 18 years

Exclusion Criteria:

* Severe cognitive or visual impairment
Primary Hyperoxaluria Mutation Genotyping

This study will help us determine whether certain genetic mutations, more than others, are a cause of more severe disease in Primary Hyperoxaluria.

During your study visit, we will draw one tube, about two teaspoonfuls (1 to 1 ½ teaspoons for children), of blood from your arm to obtain white blood cells. These white blood cells will be used as a source of DNA for genetic testing. We will use the isolated DNA to try to identify the gene that is defective in Primary Hyperoxaluria by comparing it with the structure of genes in normal individuals, patients with Primary Hyperoxaluria, and family members of Primary Hyperoxaluria patients. In family members of primary hyperoxaluria patients, a 24 hour urine test may also be collected.

Eligibility Criteria:
Inclusion Criteria:

* You have been diagnosed, or you are in the process of being diagnosed Primary Hyperoxaluria
* You have a family member diagnosed with Primary Hyperoxaluria
Monitoring Drug-induced Myocarditis (CardiTOX)

Several drugs and chemotherapies seem to induce myocarditis. This study investigates reports of myocarditis, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Several drugs and chemotherapies seem to have an impact on the myocardium and are responsible of myocarditis. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by myocarditis side effect imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the WHO's pharmacovigilance database till 25/02/2019

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
DZD8586 in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (TAI-SHAN9)

This study will treat patients with DLBCL whose disease comes back or is not responding to prior therapy. This study will assess the anti-tumor activity of DZD8586 as monotherapy. It will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body.


Eligibility Criteria:
Inclusion Criteria:

Participants who meet all the following criteria:

1. Male and female ≥ 18 years of age.
2. ECOG performance status 0-2.
3. Histologically confirmed recurrent or refractory DLBCL.
4. Adequate bone marrow reserve and organ system functions.
5. Willing to comply with contraceptive restrictions

Exclusion Criteria:

Participants who meet any of the following criteria:

1. CNS involvement
2. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives. Monoclonal antibodies and antibody-drug conjugates within 28 days.
3. Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks.
4. Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers.
5. Active infection.
6. Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.
7. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption.
8. Another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer.
9. Women who are breast feeding.
10. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.