cyrilzakka/clinical-trials huggingface dataset:
TDI Preejection Velocities and Myocardial Viability

The purpose of the study is to test accuracy of positive preejection velocity to predict left ventricular remodeling and long-term prognosis after revascularization in 200 patients with chronically dysfunctional myocardium. Patients will be followed for 3 years.

Our hypothesis is that tissue-Doppler-derived analysis of positive preejection velocity allows to select optimal responders to revascularization; it means individuals with the greatest benefit in terms of LV remodeling and long-term prognosis.

The objective of the project is to study clinical and prognostic value of new echocardiographic technique, so called positive preejection velocity (+VIC), in patients with chronic ischemic left ventricular (LV) dysfunction indicated for revascularization. Pilot studies has shown high accuracy of pulsed Tissue Doppler imaging (TDI)-derived resting pattern of +VIC to detect viable myocardium in patients with both acute myocardial infarction and chronically dysfunctional myocardium. The aim of the project is to test accuracy of +VIC to predict LV remodeling and long-term prognosis after revascularization in patients with chronically dysfunctional myocardium. Study population will consist of two groups of patients with stable ischemic LV dysfunction: group A- patients indicated for revascularization (n=200), group B- matched control group treated conservatively (case-control design) (n=100). All patients will be followed for 3 years. Endpoints include: 1) LV remodeling at 6 and 24 months and 2) MACE at 6, 12 and 36 months follow-up. Our hypothesis is that TDI-derived analysis of +VIC allows to select optimal responders to revascularization; it means individuals with the greatest benefit in terms of LV remodeling and long-term prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. occluded or suboccluded left anterior descending coronary artery (LAD) at recent coronary angiography (\< 3 months);
2. LV ejection fraction \< 40%;
3. 3 and more akinetic or severely hypokinetic segments in the LAD perfusion territory at resting echocardiography.

Exclusion Criteria:

- Patients with recent acute coronary syndrome, atrial fibrillation, bundle branch block, LV hypertrophy or aneurysm, significant valvular disease, pacemakers or internal defibrillators, poor echocardiographic image quality and contraindications for MRI are excluded.
Effect of IL17 Inhibitor in Comparison With Anti-TNF in Patients With Ankylosing Spondylitis

Ankylosing spondylitis (AS) is a chronic, inflammatory autoimmune disease characterized by axial bone inflammation. The main clinical manifestations include back pain and progressive spinal rigidity, as well as inflammation of the hips, shoulders, and peripheral joints. Also, extra-articular manifestations, such as psoriasis, uveitis, and inflammatory bowel disease (IBD).

Indicators of inflammation such as erythrocyte sedimentation rate (ESR) and Creactive protein (CRP), which are typically elevated in AS patients, particularly when peripheral joints are involved, these tests ultimately do not reflect the disease process and have limited sensitivity and specificity. Disease activity in AS has been measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), which includes only patient-reported measures. The assessment of Spondyloarthritis International society (ASAS) developed a new AS disease activity score (ASDAS) that combines patient-reported assessments with erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). Although platelets play important functions in hemostasis and thrombosis, their functions in controlling immunity and inflammation have drawn more attention recently. Platelets are known to have a key role in controlling inflammatory processes in a variety of pathological states. Overactivated platelets can induce inflammation, which in turn can increase the risk of the development of atherosclerosis, thrombosis, and cardiovascular disorders. Inflammatory diseases, including inflammatory bowel disease (IBD), have platelets play a crucial role in their development. The first-line recommended treatment for active AS is NSAIDs.

Tumor necrosis factor (TNF) inhibitors have completely changed the therapy options for patients who have not improved despite receiving standard NSAID treatment. TNF inhibitors can, however, cause tolerability problems in certain patients or inadequate responses in others, and their effectiveness may gradually diminish. Interleukin (IL)-17 inhibitors are among the new therapeutic alternatives that are currently accessible for these individuals.


Eligibility Criteria:
Inclusion Criteria:

* Patients fulfill the Assessment in Spondyloarthritis International Society (ASAS) classification criteria for Axial Spondyloarthritis.
* Patients with disease duration more than 6 months.
* Patients who failed conventional treatment and on bDMARDs (IL17 or Anti-TNF-α).
* Age above 16 years old.
* Patient cooperative and can answer questions.
* Patients who are able and willing to give written informed consent.

Exclusion Criteria:

* Other rheumatologic or collagen diseases.
* Age below 16 years and above 60 years.
* Uncooperative patients.
* Patient not able and willing to give written informed consent.
* Patient with other causes of platelet dysfunction, count irregularity.
Immune Response in the SAPHO Syndrome

The aetiology of SAPHO syndrome seems to involve genetic, infectious and immunological components. The investigators examined innate and adaptative immune responses in SAPHO syndrome as compared with psoriatic arthritis and rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of SAPHO syndrome
* Must have bone lesions

Exclusion Criteria:

* Infliximab treatment
Study to Evaluate the Efficacy of Rituximab in Combination With Low-dose Radiotherapy in Patients With Relapsed Non-Hodgkin's Lymphoma

This study aims to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

Rituximab and low-dose total-nodal irradiation both have shown promising activity in patients with NHL. Moreover, the radiolabelled antibody Zevalin has been approved for the treatment of relapsed NHL. The patients in this study have a poor prognosis. The treatment strategy aims to control the disease and to ameliorate disease related symptoms with minimal toxicity. Both, rituximab and low-dose radiotherapy are associated with minor toxicity if applied alone.

The primary objective of the study is therefore to assess the short term efficacy of a combination of rituximab and low-dose radiotherapy in patients with non-Hodgkin's lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* B-cell non-Hodgkin's lymphoma
* At least one prior antitumor therapy
* ECOG performance status 0-2
* No major organ dysfunction
* Written informed consent

Exclusion Criteria:

* The following histologies are excluded: Burkitt's lymphoma, mantle-cell lymphoma, primary CNS-lymphoma, HIV-associated lymphoma
Effect of Inspiratory Muscle Training During Pulmonary Rehabilitation on Balance in COPD Patients

Chronic obstructive pulmonary disease (COPD) is a respiratory disease that results in progressive airflow limitation and respiratory distress. Physiopathological features of COPD suggest that people who suffer from this disease have many risk factors for falls that have been identified in older individuals.

The benefit of inspiratory muscle training (IMT) combined with a pulmonary rehabilitation programme (PRP) is uncertain. The investigators aimed to demonstrate that,in chronic obstructive pulmonary disease (COPD) patients, IMT performed during a PRP is associated with an improvement of Balance.

Chronic obstructive pulmonary disease COPD is a preventable and treatable disease(GOLD, 2017). According to the WHO, COPD would be the third leading cause of death by 2030 (WHO, 2017). This disease is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases(GOLD, 2017). However, emerging data showed that COPD patients demonstrate important deficits in balance and control which associated to a high risk of fall ( Butcher et al, 2004 ; Smith et al, 2009 ; Beauchamp et al, 2009 ; Beauchamp et al, 2010). Inspiratory muscle training (IMT) has been shown to be an effective modality for COPD patients for improving the maximal inspiratory muscle strength, the dyspnea and health-related quality of life (GI COPD, 2016). However, the effect of inspiratory muscle training on balance is not studying. The purpose of this study is to evaluate the effect of the inspiratory muscles training on balance in COPD patients.

Eligibility Criteria:
Inclusion Criteria:

* Were COPD diagnosed by pulmonary function testing
* clinically stable
* abscence of other obstructive diseases
* signed written consert.

Exclusion Criteria:

* Were previous pneumonectomy or lobectomy in the past 6 months
* spontaneous risk of pneumothorax or rib fracture
* incapacity to follow a standard rehabilitation programme (locomotor deficits, acute cardiac failure and acute exacerbation of COPD at the beginning of the programme)
* the absence of written informed consent.
Anastomotic Leakage After Anterior Resection of Rectal Cancer

Anastomotic leakage (AL) is one of the most-feared postoperative complications after anterior resection of rectal cancer. This complication compromises both short term and long term outcome of patients. The incidence of AL after anterior resection was approximately 6-11%. Although several risk factors for AL such as male sex, smoking, tumor location, longer operative time, intraoperative blood loss had been reported in previous studies, the incidence of AL did not meet a significant decrease. So far there is no multi-site observational study on incidence and risk factors of AL after anterior resection in China, therefore this study aims to work on this issue and provide evidence for clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* adenocarcinoma of the rectum by biopsy
* single lesion
* anterior resection was performed
* anastomosis using circular stapler

Exclusion Criteria:

* history of colorectal cancer surgery
* emergency surgery because of bowel obstruction, bleeding or perforation
* colo-anal anastomosis
* subtotal colectomy
* total colectomy
* abdominal perineal resection
* Hartmann procedure
* pull out anastomosis
Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Macular Atrophy Secondary to Stargardt Disease

This is a pharmacodynamics study of emixustat hydrochloride in subjects with macular atrophy secondary to Stargardt disease.

This is a multicenter, randomized, masked study to characterize the pharmacodynamics, safety and tolerability of emixustat in subjects with macular atrophy secondary to Stargardt disease.

Eligibility Criteria:
Inclusion Criteria, including, but not limited to:

* Clinical diagnosis of macular atrophy (MA) secondary to Stargardt disease (STGD) in one or both eyes
* At least 2 pathogenic mutations of the ABCA4 gene
* Early Treatment Diabetic Retinopathy Study BCVA of ≥ 20 letters (approximately ≥ 20/400 Snellen) in the study eye
* Adequate clarity of ocular media and adequate pupillary dilation to permit good quality imaging of MA in the study eye
* Able and willing to provide written informed consent before undergoing any study-related procedures
* Able to reliably administer oral medication by self or with available assistance

Exclusion Criteria, including, but not limited to:

* Macular atrophy associated with a condition other than STGD in either eye.
* Presence in either eye of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function.
* History of any intraocular or ocular surface surgery in either eye within 3 months of screening.
* Current or previous participation in an interventional study to treat STGD using gene therapy or stem cell therapy at any time, or participation in an interventional study of a vitamin A derivative ≤3 months prior to screening.
* Pre-specified laboratory abnormalities at screening
* Presence of other medical or ophthalmic disease, physical examination finding, or clinical laboratory finding that in the opinion of the Investigator may contraindicate the use of an investigational drug and place the subject at risk
* Current or history of cancer (except for adequately treated basal cell or squamous cell carcinoma of the skin) within 1 year of screening
* History of myocardial infarction, stroke, unstable ischemic heart disease, uncontrolled cardiac arrhythmia, or hospitalization for congestive heart failure within 6 months of screening.
* Anticipated hospitalization for a medical/surgical procedure(s) that could result in interruption/premature cessation of study treatment or participation.
* Electrocardiogram with a clinically significant abnormal finding
* Female subjects who are pregnant or lactating
* Female subjects of childbearing potential or male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control with their sexual partner from screening through 30 days after the final dose of study drug
Air Barrier System for the Reduction of Airborne Colony Forming Units During Total Knee Arthroplasty

This objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total knee arthroplasty surgeries.

The Air Barrier System (ABS) is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the ABS can reduce the presence of airborne CFU at the surgery site during total knee arthroplasty surgery.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for total knee arthroplasty

Exclusion Criteria:

* Prior history of infection
* Revision surgery
* Screens positive for MRSA
Video Capsule Endoscopy to Investigate the Safety and Tolerability of Lumiracoxib in the Small Bowel

This study is designed to investigate the potential differences in GI safety and tolerability in the small bowel between lumiracoxib, conventional non-selective NSAID (naproxen) with a proton pump inhibitor (omeprazole), or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects

Exclusion Criteria:

* Evidence of cardiovascular, hepatic, gastrointestinal or renal disorders
* Hereditary problems of galactose intolerance, a severe lactase deficiency or glucose-galactose malabsorption syndrome
* Smokers

Other protocol-defined inclusion/exclusion criteria may apply
A Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent

The success of stent implantation has led to the increasingly widespread use of them in the treatment of coronary artery disease (Sigwart, Serruys, Fischman)and although stent restenosis is still a limit for this therapeutic mode (Serruys, Rodriguez) the new generation of stents with improved coating materials and the development of polymers that release different kinds of drugs that prevent the activation and/or proliferation of smooth muscle cells (ultimate cause of restenosis) (Grube, Rodriguez). shows major improvements on this matter. The new generation of stents with biodegradable polymers and short time of drug release gives new advantages to this therapeutic, multiple studies and registries challenge this new devices (Taxus I and II, RAVEL, SIRIUS, ERACI II and III).

For this reason the present study aims to compare a stainless steel stent with a drug eluting stent with coated of biodegradable polymer matrix hemoparin and paclitaxel.

Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina were randomized to treat with a stainless steel stent ("euca STS Flex") or a drug-eluting stent (" euca STS Flex DE") with a coating of a biodegradable polymer matrix of hemoparin and paclitaxel.

Eligibility Criteria:
Inclusion Criteria:

* Patient signing informed consent after receiving extensive written and oral information about the trial,
* Older than 18 years,
* Agreement to have a control examination done after six months,
* Patients with angina pectoris symptoms (CCS stages i-IV, unstable angina pectoris Braunwald B and C) and patients with documented silent ischemia;
* Patients with one or more de novo lesions which all are to be dilated in the same session;
* Target vessel diameter of 2.5 to 4.0 mm

Exclusion Criteria:

* Female patients of child bearing age with pregnancy suspicion(a pregnancy test will be done in this cases)
* Acute myocardial infarction (Q wave or non Q wave ) with documented CK levels more than 2 fold higher than the normal values in the preceding 72 hours ,
* Substantially calcified lesion precluding successful pre dilatation,
* Ejection Fraction less than 35%,
* Patient with previous PCI with one DES,
* Target lesion \< 2.5 mm
* Coagulopathy or clotting disorders, leucopenia anemia or thrombocytopenia,
* Allergy, hypersensitivity or adverse reaction to paclitaxel,
* Intolerance to the clopidogrel, Ticlopidine or Aspirin or unable to receive clopidogrel for one year,
* Active duodenal or gastric ulcer,
* Life Expectancy less than 1 year,
* Patient with LM disease (\>50%)
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy

Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis made at more than two years and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
* left ventricular ejection fraction (LVEF) less than 35%, by echocardiogram
* age below 60 years
* absence of neoplasm
* absence of hematologic disease or systemic disease
* no previous cardiac intervention

Exclusion Criteria:

* episodes of tachycardia or ventricular fibrillation
* severe or moderated mitral insufficiency
* any other valvulopathies
18F-FMISO PET Guided Dose Escalation in Nasopharyngeal Carcinoma - a Feasibility and Planning Study

This study aims to investigate the use of 18F-FMISO PET in identifying hypoxic subvolume for dose escalation radiotherapy in nasopharyngeal cancer and thus improve local control without significant increase in toxicities.

The specific aims of this study are:

1. To establish hypoxia imaging in NPC patients
2. Investigate the dynamics of tumor hypoxia before and during chemoradiation
3. Integrate hypoxia imaging into radiation treatment planning protocols
4. Design hypoxia adapted radiation schedules
5. Identify candidate hypoxia biomarkers

Eligibility Criteria:
Inclusion Criteria:

* T3-T4 disease with no evidence of distant metastasis.
* Histological diagnosis of WHO Type II or III NPC
* No evidence of distant metastases in staging work up (including lung, liver and bone imaging).
* Planned for upfront radiotherapy and/or chemotherapy.
* Cross sectional imaging of the primary and neck disease (MRI preferred)
* Performance status of ECOG grade 0 or 1
* No prior tumour therapy
* At least 21 years of age, of either sex.
* Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential;
* Adequate bone marrow, renal and hepatic function defined as follows:

Bone marrow: WBC \> 3000 / mm3 (ANC \> 1500 / mm3 ) Platelets \> 100 000 / mm3. Hb \> 10 gm/dl Renal: serum creatinine within institutional normal range(or) lower than the lower limit of institutional normal range : calculated creatinine clearance \> 50 ml / min Hepatic: enzymes (SAP, SGOT) \< 2x normal: bilirubin \< 24 mol / l.

Exclusion Criteria:

* Allergic to 18F-fluoromisonidazole or Nitroimidazoles
* Planned for neoadjuvant chemotherapy
* Uncontrolled hypercalcaemia: calcium 2.7 mmol/L (10.8 mg/dL).
* Other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
* Have serious active infection.
* Pregnant or lactating female subjects and subjects with reproductive potential not implementing adequate contraceptive measures
Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy

The specific aim is to determine if there are patterns of temperature differences in the abdominal and back regions of individuals with partial/focal onset epilepsy as compared to a non-epileptic control group. The hypothesis is that individuals with partial/focal onset epilepsy will have colder recorded temperatures in the abdominal area than individuals in a matched control group.

The concept of "Abdominal Epilepsy" has been described in the neurology literature. The present study seeks to amplify understanding of this clinical entity by measuring abdominal area and low back skin temperature changes which may be affected through the function of the abdominal ganglia, specifically the Celiac, Superior Mesenteric and Inferior Mesenteric Ganglia.

This not an intervention study. It is study comparing abdominal area and low back skin temperature in individuals with the Partial/Focal Onset Epilepsy with a match control group of individuals with no epilepsy history. The implications of the outcome of the finding any significant temperature changes between the experimental and control groups is great enough to warrant the highest level of scientific scrutiny that this registration permits.

Eligibility Criteria:
Inclusion Criteria Experimental Group:

1. Diagnosis of Partial/Focal Onset Epilepsy (ICD9-CM 345.4 and 345.5)
2. Ages 18-70

Exclusion Criteria Experimental Group:

1. Pregnancy
2. Recent trauma such as motor vehicle accident or injury to the musculoskeletal system
3. Currently on medication, other than for epilepsy which may affect autonomic nervous system function, e.g. Glaucoma medication
4. If diagnosed with a condition which could affect abdominal area neurophysiologic functions.

   1. Irritable bowel syndrome
   2. Crohn's disease
   3. Ulcerative colitis
   4. Migraine headache with abdominal manifestation

Inclusion criteria Control group:

1. No history or diagnosis of any seizure disorder
2. Ages 18-70

Exclusion Criteria Control group:

1. Pregnancy
2. Recent trauma such as motor vehicle accident or injury to the musculoskeletal system
3. Currently on medication, other than for epilepsy which may affect autonomic nervous system function, e.g. Glaucoma medication
4. If diagnosed with a condition which could affect abdominal area neurophysiologic functions.

   1. Irritable bowel syndrome
   2. Crohn's disease
   3. Ulcerative colitis
   4. Migraine headache with abdominal manifestation