cyrilzakka/clinical-trials huggingface dataset:
COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA

In the Care in Rheumatoid Arthritis (CareRA) trial (NCT01172639) about 70% of early RA patients are in remission at the 2 year evaluation point independent of the combination scheme used.

Interesting to see is that the 30% of insufficient responders can be identified in an early stage of the treatment course.

The purpose of the present study is to investigate if, for patients with an insufficient response to a COBRA-Slim regimen, accelerated access to a short course of anti-TNF therapy already early after treatment initiation (from w8 until w32) could improve outcomes compared to a more traditional treat to target sequence.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Diagnosis of RA as defined by the American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) 2010 criteria for early RA
* Early RA defined by a diagnosis made ≤ 1 year ago.
* Use a reliable method of contraception for women of childbearing potential to be evaluated as in daily clinical practice
* Able and willing to give written informed consent and to participate in the study
* Understanding and able to write Dutch or French

Exclusion Criteria:

* Previous treatment with:

  * Methotrexate (MTX) or leflunomide
  * cyclophosphamide, azathioprine or cyclosporine
  * sulphasalazine (SSZ) for more than 3 weeks
  * hydroxychloroquine for more than 6 weeks
  * oral Glucocorticoids (GC) for more than 4 weeks within 4 months before screening
  * oral GC at a daily dosage of more than 10 mg prednisone equivalent within 4 weeks before baseline
  * oral GC at a daily dosage equal to or less than 10 mg prednisone equivalent within 2 weeks before baseline
  * intra-articular GC within 4 weeks before BL
  * an investigational drug for the treatment/prevention of RA
* History of chronic heart failure
* History of severe infections or chronic infection
* History of malignant neoplasm within 5 years
* Contra indications for GC
* Contra indications for TNF blocking agents
* Contra indications for MTX or leflunomide
* Psoriatic Arthritis
* Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
* Pregnancy, breastfeeding or no use of a reliable method of contraception for woman of childbearing potential (as in daily clinical practice)
* Alcohol or drug abuse
* Active tuberculosis (TB)
* Latent TB unless adequate prophylactic treatment is given according to local guidelines
* No access to the Belgian Health Insurance system-
CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy

Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.


Eligibility Criteria:
Inclusion Criteria:

* are aged 18 or above
* diagnosed with type 2 diabetes
* have had a treatment decision made within the normal course of care to initiate either insulin or exenatide for the treatment of type 2 diabetes
* have not previously been treated with either insulin or exenatide
* are not simultaneously participating in another study which includes an investigational drug or procedure at study entry
* have been fully informed and given their written consent for use of their data
* have sufficient understanding of the primary language of their country such that they will be able to complete the questionnaires.
Triathlon® Cruciate Retaining (CR) Total Knee System Outcomes Study

The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Cruciate Retaining (CR) Total Knee System. These outcomes will be evaluated by comparing pre-operative to post-operative scores, as well as to a control group. The control group is the Scorpio® CR Total Knee System.

The Triathlon® Cruciate Retaining (CR) Total Knee System components are for use in cemented total knee arthroplasty for painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis (excluded from this study according to protocol). The components are designed to improve range of motion (ROM) and stability. This study serves to demonstrate that subjects have reduced pain, increased ROM and improved stability following implantation with the Triathlon Cruciate Retaining (CR) Total Knee System as compared to the historical control.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is a male or non-pregnant female between the ages of 21 and 80.
2. The subject requires a primary cemented total knee replacement.
3. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
4. The subject has intact collateral ligaments.
5. The subject has signed the IRB-approved, study specific Informed Patient Consent Form.
6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. Patient has inflammatory arthritis.
2. The subject is morbidly obese, BMI \> 40.
3. The subject has a history of total or unicompartmental reconstruction of the affected joint.
4. Patient has had a high tibial osteotomy or femoral osteotomy.
5. The subject has no obvious charcot (i.e. a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device).
6. The patient has a systemic or metabolic disorder leading to progressive bone deterioration.
7. The subject is immunologically suppressed, or receiving chronic steroids (\> 30 days duration).
8. The subject's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prothesis.
9. The subject has had a knee fusion to the affected joint.
10. The subject has an active or suspected latent infection in or about the knee joint.
11. The subject is a prisoner.
Chronic Beta2-adrenergic Stimulation and Cardiac and Skeletal Muscle Hypertrophy

Studies in animals have shown that beta2-adrenoceptor activation with selective agonists regulates protein metabolism and muscle growth in skeletal and cardiac muscle tissue. These effects may be mediated by cAMP/PKA dependent activation of several downstream sites that modulate protein synthesis and breakdown. While the role of beta2-adrenoceptor signaling is well-described in animals, it is inadequately explored in humans. The purpose of the study is thus to investigate the effect of chronic beta2-adrenergic stimulation (cAMP/PKA-signaling) on muscle hypertrophy.


Eligibility Criteria:
Inclusion Criteria:

* Physical active
* Non-smokers
* Non-asthmatics
* No chronic diseases
* Informed consent

Exclusion Criteria:

* Smoker
* Allergy towards study drug
Safety Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke

The primary purpose of the study is to determine whether carbamylated erythropoietin (CEPO) is a safe treatment for patients who have suffered an acute ischemic stroke.

Acute ischemic stroke is a major cause of death and severe disability. There is only one approved pharmacological treatment, Alteplase, which has to be administered within 3 hours from symptom onset. Consequently, only about 2-3% of patients world wide with ischemic strokes are treated. The naturally occurring hormone, erythropoietin (EPO), is able to protect various neuronal tissues from ischemic injury and is beneficial in animal models of acute ischemic stroke. However, treatment of stroke with EPO is undesirable due to its ability to stimulate production of red blood cells and to promote the blood to coagulate. Lu AA24493 is a modified (carbamylated) version of EPO, neuroprotective but without the haematopoietic side effects. Lu AA24493 is developed for treatment of patients with acute ischemic stroke.

In this safety study of single doses with Lu AA24493, patients will receive Lu AA24493 within 12-48 hours from symptom onset.

Eligibility Criteria:
Inclusion Criteria:

* Age between 50 and 90 years
* Clinical diagnosis of acute ischemic stroke
* Measurable stroke-related deficit
* Patient is stable
* Treatment can be initiated between 12 hours and 48 hours after the onset of stroke
* Expected hospital stay of at least 72 hours after study medication
* If female then not of childbearing potential

Exclusion Criteria:

* Primary intracerebral haemorrhage (ICH), or parenchymal haemorrhagic transformation of infarction (type PHI or PHII as defined in ECASS), subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), cerebral aneurysm, or cerebral neoplasm
* Treated with a thrombolytic \<24 hours (if \>24 hours excluded ICH then eligible)
* Score \>0 on the NIHSS item 1a
* Pre-stroke mRS score \>1
* Uncontrolled hypertension
* Previous treatment with erythropoietin
* Clinically significant abnormal ECG
* Cerebral pathology
* Received or donated blood within previous 3 months
Investigation of Immediate, Short and Long Term Effects of Mulligan Mobilization With Movement Techniques in Nonspesific Chronic Low Back Pain

Introduction: Although the effectiveness of many mobilization methods in chronic low back pain (CLBP) was shown, these effects were not monitored in the long term. The aim of this study was to identify the immediate, short and long-term effects of mulligan mobilization with movement (MWM) in terms of pain, range of motion (ROM), flexibility, endurance, functionality and disabilities in patients with CLBP. Methods: The study was designed in randomized-placebo controlled with 36 people randomly distributed into 2 groups. Sustained natural apophyseal glide (SNAG) was applied to the lumbar region, straight leg raise (SLR) with traction to the hip, and internal rotational mobilization techniques and home exercise program were applied in Group 1 (n=19); and the same techniques were applied as sham mobilization in Group 2 (n=17). The evaluations were made as post-intervention for immediate effect, and were also made at the 5th week, 3rd month, and 6th months for short and long-term effect. Evaluation was also made for pain in 12th month.


Eligibility Criteria:
Inclusion Criteria:

* Having 3 months' continuous or intermittent LBP symptoms, without leg pain above the knee
* Pain at VAS \> 3/10,
* Back pain increased by active lumbar flexion movement

Exclusion Criteria:

* Confirmed nerve root compression
* Neurological symptoms
* Lumbar spine stenosis
* Back surgery history
* Chronic pain syndrome
* LBP from fracture
* Infection
* Visceral disease
* Pregnancy
* Major clinical depression
* Cauda equina syndrome
* Significant osteoporosis.
Use of Radiofrequency Ablation to Eliminate Continuous Atrial Fibrillation in Patients Undergoing Mitral Valve Surgery

The aim of this prospective randomized clinical trial was to evaluate the early and late outcome following left atrial radiofrequency ablation during MV surgery for the treatment of continuous atrial fibrillation and to assess the functional effects of restoration of sinus rhythm.

Atrial fibrillation (AF) is a frequent and important contributor to symptoms and morbidity in patients with mitral valve (MV) disease.Radiofrequency ablation (RFA) of the left atrium (LA) during open- heart surgery has emerged as a novel surgical modality for the treatment of AF. Although RFA therapy of the LA is being increasingly offered to patients with chronic AF undergoing MV surgery, its efficacy has not been tested in the context of an adequately powered randomized study. The aim of this prospective randomized clinical trial was to evaluate the early and late outcome following left atrial RFA during MV surgery for the treatment of continuous AF and to assess the functional effects of restoration of SR.

Patients were randomized to undergo MV surgery or MV surgery plus RFA of the LA. Additional cardiac procedures were performed as required.

The primary outcome endpoint was the presence of SR at 12 months. Secondary endpoints included patient functional status and exercise capacity, LA contractility, and LA and left ventricular (LV) dimension and function and plasma levels of B-Type natriuretic peptide (BNP).

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring MV surgery with at least 6 month history of atrial fibrillation

Exclusion Criteria:

* Patients with sick sinus syndrome
* Hyperthyroidism
* Permanent pacemaker
* Previous cardiac surgery
The Hospice Advanced Dementia Symptom Management and Quality of Life Trial

Alzheimer's Disease and Related Disorders (dementia) are a group of serious life limiting illness that cause significant challenges to our public health system, with significant illness burden for both the person with dementia and the caregiver. At the end of life, over 230,000 persons with dementia annually are cared for in hospice, yet hospice agencies are ill prepared to care for this population and often resort to inappropriate pharmacologic measures such as antipsychotics that reduce quality of life rather than improve it. This study will therefore through its two phases refine and then implement, using a pragmatic stepped wedge trial design, the Dementia Symptom Management at Home Program Hospice Edition, with the goal improving quality of care for the person with dementia and their caregiver, reducing antipsychotic use, and increasing bereaved caregiver satisfaction in the hospice setting.


Eligibility Criteria:
Inclusion Criteria:

* Must have dementia as primary diagnosis for admission to hospice
* Must be newly admitted to a participating hospice
* Must be 50 years or older

Clinicians:

* Must be a skilled clinician or home health aide who provides care through an eligible home health agency
* Must be 18 years or older

Exclusion Criteria:

Persons with Dementia:

* None

Clinicians:

* None
Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia

This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period 2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on allopurinol pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of allopurinol on tranilast PK and PD as measured by reduction in serum uric acid levels.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 21 to 70
* Subjects with hyperuricemia who are otherwise healthy

Exclusion Criteria:

* Pregnant or nursing
* Known history of gout unless approved by the Investigator or Sponsor
* Clinically significant infection at Screening
* Known sensitivity to tranilast or allopurinol
Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG

The present study is aimed to evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.

The non invasive continuous glucose sensing system of Physical Logic is based on a vector network analyzer (VNA), which monitor blood glucose through propriety sensors.Dielectric spectroscopy is an analytical technique whereby the electromagnetic radiation is affected by the electric dipole moment of the sample it interacts with. This method utilizes the change in the impedance of the antenna to measure the change in the relaxation processes of the interrogated medium.

The VNA (vector network analyzer) , which emits non irradiating electromagnetic waves in very low power emission, is connected via standard coaxial cables to propriety sensors that are attached to the patient skin without direct contact.

Study objective:

To evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.The glucose values generated by the investigational non invasive devise will be compared to glucose reading of a reference devise, which measure blood glucose levels at the subcutaneous tissue.

During the study we will evaluate the reliability of the study device under the conditions of alter blood glucose values in the range of 50-400 mg/dl:

Eligibility Criteria:
Inclusion Criteria:

1. Signing an inform consent form
2. Type 1 diabetes diagnosed at least 12 months prior to study inclusion
3. Age \> 18 years old
4. Willing to perform all study related procedures

Exclusion Criteria:

1. Known or suspected allergy to the sensor or one of its components
2. Psychiatric disorder
3. Patients with one or more of the following diseases: malignancy, myocardial insufficiency, nephrologic disease or any other chronic disease
4. Patients who are not willing or are not capable of performing the protocol requirements
5. Participating in another study that includes investigational drug or investigational equipment
6. Pregnancy
Primary Care Based Intervention for the Secondary Prevention of Osteoporotic Fractures

BACKGROUND Recent evidence has been published about the effectiveness for the secondary prevention of osteoporotic fractures (OF) of the hospital-based fracture liaison services.

AIM To assess the effectiveness of a primary care based intervention in the secondary prevention of OF.

METHODOLOGY Prospective study of random clusters, defined at the primary-care trust (PCT) level. Total study follow-up 3 years. Sample size 1800 patients.

DESCRIPTION To launch a defined strategy for the identification of OF. To carry out a primary care based intervention about lifestyle, diet and drug prescription, if needed, with an intensive follow-up in the intervention PCT vs treatment as usual in the control branch.

ANALYSIS As the outcome are the new OF, a survival analysis will be done. Risk factors will be analyzed through Cox proportional hazard regression model stratified by age groups.

Outcomes :

* new OF ratio in intervention vs control areas.
* maintenance of the adherence to the pharmacological and non pharmacological interventions proposed
* assessment of cost-effectivity of the intervention


Eligibility Criteria:
Inclusion Criteria:

* Major OF (distal forearm, vertebral, hip, pelvis and humerus
* Caused by a low impact mechanism

Exclusion Criteria:

* High impact mechanism of impact or secondary to other diseases (cancer, Paget disease ...)
* Patients not residing in the area of the targeted primary care practices
* Patients with an invalidating disease (dementia ...)
Effect of Two Different Surgical Positions on Pulmonary Functions in Laparoscopic Gastrectomies

The primary purpose of the study is to investigate the effect of the 30° reverse trendelenburg position combined with the sunbed position on respiratory parameters in laparoscopic gastrectomies.


Eligibility Criteria:
Inclusion Criteria:

* Patients who can tolerate general anesthesia and pneumoperitoneum.
* Patients who can give informed consent for surgery.
* Patients over 18 years of age
* patients with body mass index (BMI) \> 30 kg/m2
* Patients with American Society of Anesthesiologists (ASA) physical status I and II

Exclusion Criteria:

* Patients with serious underlying cardiovascular disease (e.g. congestive heart failure, conduction disorders and ischemic heart disease).
* Patients with chronic kidney disease stage 3 or greater (creatinine clearance less than 60 mL/min).
* patients with a history of cerebrovascular disease such as intracranial hypertension, cerebral infarction, cerebral hemorrhage, carotid artery stenosis or cerebral ischemia;
* Patients with a history of chronic lung diseases such as chronic obstructive pulmonary disease, asthma, pulmonary bullae or respiratory failure;
* Patients who have had previous abdominal surgery, including resection of the esophagus, stomach, liver and pancreas.
* Surgeries lasting longer than 90 minutes
* Patients with ASA class IV
* patients with psychiatric disorders
* pregnant or breastfeeding patients
* patients with a history of seizures
Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients

The aim of the study is to evaluate the best stress exam to unmask long QT in patient with KCNQ1 or KCNH2 mutation without long QT interval in rest electrocardiogram.

65 patients with KCNQ1 or KCNH2 mutation presenting QTc interval \<470msec and 65 patients without KCNQ1 or KCNH2 mutation presenting QTc interval \<470msec will be included.

All patients will have the 2 tests: exercise test and epinephrine test, in one half day.

At the end of the inclusions, two experts will examine examens results without knowing in which arm (mutated or not) the patient belongs.

Eligibility Criteria:
Inclusion Criteria:

Patients with QTc\<470 msec, and with molecular analysis (KCNQ1 or KCNH2 genes) performed in order to include 65 patients with KCNQ1 or KCNH2 mutation and 65 patients without KCNQ1 or KCNH2 mutation (controls).

Exclusion Criteria:

* QTc interval \>470msec
* Treatment interfering with cardiac repolarisation
* Under 15 years old
* Pregnant women
* Contraindication to exercise or epinephrine tests
* Patients without social coverage
Effects of Electromagnetic Field and Noise on Resting Electroencephalogram of Health Subjects

With the development of science and technology, there are more and more electromagnetic and noise factors in the working and living environment. These two factors often exist together, and their impact on people may interact. Scalp EEG is a classic nerve detection technology, which can reflect the functional state of the brain in a non-invasive and real-time manner. This project intends to use EEG technology to study the effects of electromagnetism and noise on human brain function.


Eligibility Criteria:
Inclusion Criteria:

* Male, 18-30 years old, right-handed, with normal hearing and normal visual or corrected acuity;

Exclusion Criteria:

* Have history of smoking, alcohol abuse, no history of neurological or psychiatric disorders (e.g., epilepsy), no relevant family history, and no recent medication use;
* Have history of surgery for head injury, no metal implants in the body (including braces);
* Sleep-wake time irregular， with sleep disturbance;
* Have history of noise allergy;
* Participate in similar psychological experiments during 2 months.
Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC)

The purpose of this study is to evaluate whether MST-188 can reduce the duration of vaso-occlusive crisis (VOC) in subjects with sickle cell disease. The study will also evaluate whether MST-188 can reduce the frequency of rehospitalization of subjects due to a recurrence of VOC. Additionally, this study will compare the development of acute chest syndrome during VOC in subjects who receive MST-188 to those who do not receive MST-188.


Eligibility Criteria:
Inclusion Criteria:

* Age 4 through 65 years
* Subject has a confirmed diagnosis of HbSS, HbSC, HbSβ+thal, or HbSβ0thal
* Subject is experiencing acute pain typical of vaso-occlusive crisis requiring treatment with parenteral analgesia
* Subject requires hospitalization

Exclusion Criteria:

* Subject has acute chest syndrome
* Subject's laboratory results indicate inadequate organ function
* Subject is pregnant or nursing an infant
* Subject had a painful crisis requiring hospitalization within the preceding 14 days or has experienced \> 5 hospitalizations for VOC in the prior 6 months
* Subject has been transfused within the past 14 days
* Subject is hospitalized for a condition other than VOC
* Subject has complications related to SCD