cyrilzakka/clinical-trials huggingface dataset:
A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious uveitis


Eligibility Criteria:
Inclusion Criteria:

* Documented history of non-infectious intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis
* Current uveitis therapy must conform to one of the following:

  1. Prednisone monotherapy at a dose of ≥ 10 mg/day (or equivalent) for ≥ 2 weeks prior to randomization
  2. Have received ≥ 2 injections of corticosteroid (intravitreal or periocular) for control of disease within the past 8 months, but not within 2 weeks of randomization; subjects may also be receiving systemic corticosteroid therapy
  3. Receiving monotherapy with azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate for at least 2 weeks prior to randomization
  4. Receiving prednisone in addition to one immunomodulatory agent from among cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid and methotrexate for at least 2 weeks prior to randomization
  5. Subjects for whom corticosteroid therapy (systemic or local) is medically inappropriate or who refuse corticosteroid therapy
* Grade of 2+ or higher for vitreous haze at time of enrollment
* Considered by the investigator to require immunomodulatory therapy.
* Not planning to undergo elective ocular surgery during the study

Exclusion Criteria:

* Uveitis of infectious etiology
* Clinically suspected or confirmed central nervous system or ocular lymphoma
* Primary diagnosis of anterior uveitis
Lidocaine on Manifestations of Fibromyalgia

Background and Objectives: Fibromyalgia is a pain syndrome characterized by numerous manifestations. The objective of this study was to evaluate the effect of the combination of intravenous lidocaine and amitriptyline on the manifestations of fibromyalgia. Methods: A prospective, randomized, double-blind, comparative study was conducted. All patient received 25 mg amitriptyline. Patients of group 1 (n = 15) received 125 mL 0.9% saline, and patients of group 2 (n = 15) received 240 mg lidocaine in 125 mL 0.9% saline once a week for 4 weeks. Manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on a verbal numerical scale.

Amitriptyline was chosen in the present study because it is the most widely used antidepressant with proven analgesic efficacy for the treatment of a variety of chronic pain syndromes. Amitriptyline also promotes improvement of sleep, an effect observed in the present study.

Lidocaine has been widely applied by the intravenous route and patients with a variety of pain syndromes, including fibromyalgia, have reported pain relief with this technique.The dose of lidocaine employed by various investigators ranges from 1 to 5 mg/kg administered over a period of 30-60 min. The minimum effective dose is 1.5 mL/L, which is achieved with 2-5 mg/kg infused over 30-60 min. In these study, 240 mg lidocaine was administered, corresponding to about 3 mg/kg.

Eligibility Criteria:
Inclusion Criteria:

* pain in the four quadrants of the body for at least 3 months
* sleep disorders
* fatigue
* subjective edema
* depression
* paresthesia.

Exclusion Criteria:

* alterations in thyroid
* rheumatological
* renal and hepatic function
* trauma
* rheumatic, neuromuscular or psychiatric disease
* infectious arthropathy
* other pain syndromes
* drug hypersensitivity
* pregnancy
MIL62 Plus Lenalidomide for Patients With Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (FL and MZL)

This phase 1b/2 trial studies the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).

The Aim of this phase 1b/2 trial (MIL62 Plus Lenalidomide) is to find the safety and best dose of lenalidomide when given together with MIL62 and how well this combination works in treating patients with Relapsed/Refractory low-grade Follicular Lymphoma(FL) and Marginal Zone Lymphoma(MZL). Giving MIL62 plus lenalidomide may work better in indolent Non-Hodgkin Lymphoma(NHL).

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients, \>=18 years of age;
2. Patients with either histologically documented CD20-positive MZL or FL, WHO grade 1, 2 or 3a
3. Evidence of progression or lack of response following at least 1 prior treatment
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
5. At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter \> 1.5 cm and a short axis ≥ 10mm
6. Adequate hematologic function (unless abnormalities are related to NHL)
7. Life expectancy \>6 months
8. Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria:

1. Evidence ongoing transformation into aggressive NHL
2. Central nervous system lymphoma
3. Patients with progressive multifocalleukoencephalopathy (PML)
4. Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start
5. Prior use of any anti-cancer vaccine
6. Prior administration of radiotherapy 42 days prior to study entry
7. Prior administration of chemotherapy 28 days prior to study entry
8. History of prior malignancy within the last 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
9. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
10. Known hypersensitivity to thalidomide or lenalidomide
11. Regular treatment with corticosteroids prior to the start of cycle 1, unless administered for indications other than NHL at a dose equivalent to \< 20 mg/day prednisone
12. Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)
13. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
14. Pregnant or lactating females
ELIGIBLE (Efficacy of Left atrIal Appendage Closure After GastroIntestinal BLEeding)

Patients with atrial fibrillation requiring anticoagulation treatment are at high risk of gastrointestinal bleeding. The investigators propose the percutaneous stop the oral anticoagulation and closure of the left atrial appendage with the Amplatzer ® system in patients receiving anticoagulant therapy for atrial fibrillation without associated valvular heart disease, to reduce significantly the risk of stroke while minimizing the risk of bleeding in a group of patients with high risk for both events.

ELIGIBLE trial(Left atrial appendage Efficacy of GastroIntestinal Bleeding after closure) is a prospective, multicentric and randomized (2 to 1) trial, comparing percutaneous closure of atrial appendage left versus standard treatment with oral anticoagulants in patients with history of gastrointestinal bleeding and high embolic risk.


Eligibility Criteria:
Inclusion Criteria:

* documented atrial fibrilation (paroxysmal or permanent) without significant heart valve disease
* \> 18 years
* Classic oral anticoagulation(INR at therapeutic levels: 2-3) or New oral anticoagulants
* CHA2-DS2-VASC score ≥ 3
* prior digestive bleeding without any treatable cause
* Informed consent.

Exclusion Criteria:

* POF
* contraindication to further treatment with dual antiplatelet therapy (aspirin + clopidogrel)
* Intracardiac thrombus
* significant carotid disease
* Cardioversion scheduled within 30 days following the implantation
* AF not controlled by FVM\> 100 bpm
* AF secondary to surgery or ablation
* thrombosis in patients \<40 years
* chronic renal insufficiency with Cr clearance \<30 ml 2
* left appendage sizeappendage with inlet \<12.6 mm or \> 28.5 (ETE)
* depth of the appendage \<10mm in the TEE
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.

This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18-65 years of age
* HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve
* Detectable hepatitis B virus (HBV) DNA (\>100,000 copies/mL)

Exclusion Criteria:

* Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)
* Evidence of decompensated liver disease
* A medical condition associated with chronic liver disease other than viral hepatitis
Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1

The study is designed to investigate the effect of adjuvant therapy by Sorafenib, Oxaliplatin and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver transplantation


Eligibility Criteria:
Inclusion Criteria:

* hepatocellular carcinoma after liver transplantation
* Major organ (heart, lung and brain) function was normal

Exclusion Criteria:

* Any active infectious process
* The presence of clinically confirmed extrahepatic metastasis
* Postoperative dysfunction of any organ
Monitoring of Implant Diseases: Diagnosis and Monitoring with AMMP-8 Test Technology

68 patients underwent the aMMP-8 chair-side test as well as clinical traditional measurement methods. Those who had one or more implants in their mouth were selected as patients. The condition of the attachment tissues of these implants is monitored at a control visit after five years.

Patients who arrive for maintenance follow-up are included in the study. The trational measurement technique is used to follow the health of peri-implant tissues.

Eligibility Criteria:
Inclusion Criteria:

* the participation previously study implant patient

Exclusion Criteria:

* has not received antibiotic treatment within 6 months
Simplified Medical Abortion Follow-Up

The purpose of this operations research study is to evaluate women's interest in and compliance with using a semiquantitative multi-level dipstick pregnancy test at home for medical abortion follow-up.


Eligibility Criteria:
Inclusion Criteria:

* She has been determined by the site investigator or designee to be fully eligible for medical abortion with mifepristone followed by misoprostol according to the site's standard criteria;
* She is willing to use the semiquantitative pregnancy test at home;
* She is wiling and able to comply with the study procedures;
* She speaks and reads English;
* She has signed the study informed consent form.
Effects of Chewing Gum Against Postoperative Ileus

The purpose of this study is to determine whether the use of chewing gum effects postoperative ileus after pancreaticoduodenectomy.

Postoperative ileus is common after surgery. One non-pharmacological intervention that has shown promising results in reducing the duration of postoperative ileus is chewing gum after surgery. However, this has not been investigated in upper gastrointestinal surgery such as pancreatic surgery. Hence the aim of this study was to investigate the effects of chewing gum treatment on patients undergoing pancreaticoduodenectomy due to pancreatic or periampullary cancer.

This study was conducted as a phase-III trial. Patients diagnosed with pancreatic tumours scheduled for pancreaticoduodenectomy were included. The treatment group received chewing gum postoperatively and standard care. Controls received glucose solution and standard care.

Participants were included on the day of admission, which was the day prior to surgery. Randomization to the two groups (1:1) was done when patients returned from the intensive care unit (ICU) to the ward. This procedure was chosen in order to avoid perioperative drop-outs due to inoperable tumors. With a power of 80% and a level of significance of 0.05, 18 patients were needed in each group.Comparisons between the groups were analyzed with non-parametric tests; the Mann Whitney U test and Chi 2 test.

Controls received standard care and sips of glucose, in total 3.6g/day in a 12-ml mixture per day, the same amount of glucose per day as the treatment group received via the chewing gum. The chewing gum used was ChiczaTM, a natural organic gum whose main ingredients are latex, glucose and natural flavors (lime or spearmint). Patients started to chew after they returned from the ICU the day after surgery. Chewing gum was administered every fourth hour (08.00-12.00, 12.00-16.00 and 16.00-20.00). During each four-hour period, patients chewed two pieces of gum for 30 minutes each. Chewing gum was used during the whole hospital stay. The time to the first postoperative flatulence and defecation was recorded, in addition to standard clinical data.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with pancreatic or periampullary cancer and scheduled to undergo pancreaticoduodenectomy.
* Understand and speak swedish
* No diagnosed neurological injuries or diseases affecting the ability to swallow or gastric function
* No ongoing treatment for mental disease
* No ongoing abuse of alcohol or other drugs
* No previously known allergies to the content of chewing gum

Exclusion Criteria:

* Additional surgery after primary surgery.
* No radical curative surgery
* Previous abdominal surgery.
The Clinical Performance of Two Dentine Replacement Materials in Deep Occlusal Cavities (Randomized)

Higher mechanical properties are needed to restore structurally compromised posterior teeth, short fiber reinforced resin composite and injectable bioactive resin composites provide superior properties to flowable composites that were traditionally used to improve adaptation in deep cavities below the packable resin composite restorations. Thus, this study was designed to assess the clinical outcome of high strength dentine substitute materials.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients aged (20-50)
2. Medically free
3. Good oral hygiene (Plaque index ≤2 (Moderate accumulation with plaque in the sulcus))
4. Patients accepting to participate in the study.
5. Teeth of normal appearance and morphology
6. Maxillary and mandibular molar teeth with deep class Ⅰ carious lesions extending into the inner third of dentin.

Exclusion Criteria:

1. Patients \<20 and \>50.
2. Teeth with proximal lesions.
3. Patients with bad oral hygiene (Plaque index \>2).
4. Systematic disease that may interfere with the study.
5. Patients with xerostomia.
6. Presence of any abnormal occlusal habits (bruxism, nail biting, clenching).
7. Patients undergoing or will start orthodontic treatment.
8. Pregnancy.
9. Teeth with signs or symptoms of irreversible pulpitis.
10. Non-vital, fractured or cracked teeth.
11. Teeth with secondary caries.
12. Periodontally compromised teeth.
Over Active Bladder Patients Having Sling Surgery

The purpose of this study is to determine whether treatment with anti-muscarinic medications following sub-urethral sling procedures improves overall subjective and objective outcomes in women with mixed incontinence with primary stress symptoms.

Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18
* Patient is appropriate for sub-urethral sling procedure
* Mixed urinary incontinence
* No antimuscarinic therapy for previous 30 days

Exclusion Criteria:

* Uncontrolled narrow angle glaucoma
* Acute cystitis
* Unevaluated hematuria
* Currently using anti-muscarinic therapy
* Unable to complete pre-operative urodynamics
* Contraindication to anti-cholinergic therapy
* Unable or unwilling to complete diaries or quality of life questionaire
* Significant (exteriorized) Pelvic Organ Prolapse
Screening of NASH in Oupatients Followed in Various Hospital Specialty Clinics at the University Hospital of Strasbourg

The aim of the present study is to assess, by using a simple algorithm combining FIB-4 and Fibroscan, the prevalence of NASH with advanced fibrosis in outpatients followed in various hospital specialty clinics other than hepato/gastroenterology and to examine risk factors associated with this condition. The prevalence of NASH will be investigated among 6 cohorts of outpatients followed in different hospital specialty clinics at Hôpitaux Universitaires de Strasbourg.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* outpatients followed at specialty clinics in HUS and at risk of NAFLD: with at least one metabolic risk factor (overweight, diabetes mellitus, hypertension, hypertriglyceridemia) and/or elevated transaminases and/or liver steatosis on US.
* endocrinology cohort : type 2 diabetes patients
* infectious disease cohort : HIV positive patients
* rheumatology cohort : patients with psoriasis, gout or rheumatoid arthritis
* nephrology cohort : patients with chronic kidney disease such as diabetic nephropathy or hypertensive nephropathy, including those receiving hemodialysis.
* cardiology cohorts: patients with history of angina, myocardial infarction, stroke or arteritis of lower limbs.
* internal medicine cohort: patients with auto immune systemic diseases such as lupus, sclerosis or rheumatoid arthritis.
* subjects who have given their informed consent
* Subjects affiliated to a social security system

Exclusion Criteria:

* alcohol consumption \> 30g/d in male or \> 20g/d in female in the past 6 months
* history of chronic viral hepatitis
* history of liver auto immune disease, genetic hemochromatosis, Wilson disease
* biliary disease, bile duct obstruction
* drug-induced liver injury
* secondary liver cancer or other active cancer
* organ graft
* use of medications associated with secondary NAFLD (corticosteroids, tamoxifen, amiodarone, methotrexate).
* congestive heart failure
* AIDS
* pregnancy, breastfeeding
* no information could be given to the patient (subject faces emergency situation, comprehension difficulties, etc.)
* patient under guardianship
* patients under judicial protection
Impact of Diabetes Continuing Education on Primary Health Care Physicians' Knowledge, Attitudes and Practice

The main objective is to evaluate the effectiveness of a continuing education program on the Knowledge, Attitudes and Practices of primary health care physicians towards a high quality of diabetes care in Aseer region, Saudi Arabia.

Background:

Diabetes is one of the rapidly growing chronic health conditions across the world. Healthcare providers still continue to face difficulties in delivering optimal care and education worldwide. Thus, continuing education is needed to improve Knowledge, Attitudes and Practices of physicians.

Objective: To evaluate the effectiveness of a continuing education (CE) program on the Knowledge, Attitudes and Practices of primary health care physicians (HCPs) towards a high quality of diabetes care.

Design and Methods:

This is a quasi-experimental design composed of pre-test post-test uncontrolled experimental design. The study will include all PHC physicians registered in health sectors of Abha and Khamis Musheet cities, Aseer Region. The physicians will be invited to attend a CE program. All participants will fill out a questionnaire before and after the intervention. The change in knowledge and attitudes of the participants will be measured at the end of the program. After 4 months, the practice of physicians will be assessed through retrospective review of patient's files.

Impact:

Education programs could positively influence the knowledge, beliefs and attitudes of healthcare workers toward a high quality of diabetes care, which in turn plays a major role in improving clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* all PHC physicians registered in health sectors of Abha and Khamis musheet cities, Aseer Region
* willing to provide informed consent to participate in the study

Exclusion Criteria:

* physicians worked at hospital
* other health care professional (non-physicians)
Intrapartum Glycemic Control in GDMA2

This is a randomized, parallel, controlled, non-inferiority trial to assess the impact of a tight versus a more liberalized intrapartum glycemic control in gestational diabetic mothers on neonatal glycemia. National guidelines for the management of intrapartum glucose in women with GDM are lacking. This is likely due to the scarcity of high-quality data on the topic.

Gestational diabetes mellitus (GDM) remains a common pregnancy complication, affecting 6-15% of pregnancies worldwide. The incidence of GDM is expected to continue its global upward trend in light of the growing obesity epidemic and delayed childbearing. GDM is associated with adverse short- and long-term maternal and offspring outcomes. Neonatal hypoglycemia, as a result of fetal hyperinsulinemia, occurs in up to 35% of pregnancies complicated by GDM with potential long-term neurodevelopmental sequelae. In that regard, significant emphasis has been placed on the prevention of neonatal hypoglycemia through optimal maternal glycemic control. Available data are conflicting as to the contribution of intrapartum glycemia to neonatal glycemia.

Moreover, national guidelines for the management of intrapartum glucose in women with GDM are lacking. This is likely due to a lack of high-quality data on the topic. As far as we are aware, only one single center randomized controlled trial has been published on the topic. That study's findings suggest that an approach to a more liberalized intrapartum glycemic management was not associated with a higher rate of neonatal hypoglycemia compared to a tight glycemic control regimen. We propose to replicate these findings in a different population at our institution. If this more relaxed approach to intrapartum glycemic management is confirmed to be safe to women and their babies, its clinical application has the potential to decrease the inconvenience of frequent finger pricks for our patients during labor and allow more efficient allocation of resources for the nursing staff on an already labor-intensive unit.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years or older
* Non-anomalous singleton gestation
* Gestational diabetes type A2 diagnosed at 24 weeks' gestation or beyond
* Planned vaginal delivery at term at Inova Fairfax Women's Hospital

Exclusion Criteria:

* Women \< 18 years
* Fetus with major congenital malformations
* Twin or higher order gestation
* Pre-existing diabetes mellitus
* Exposure to antenatal or any systemic steroids 14 days or less prior to delivery
* Preterm delivery
* Scheduled cesarean birth
* Intrapartum cesarean birth prior to 4-5 cm of cervical dilatation