cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)

This Phase II study will compare the efficacy and safety of obinutuzumab plus mycophenolate mofetil (MMF)/mycophenolic acid (MPA) with placebo plus MMF/MPA in participants with proliferative LN.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Systemic Lupus Erythematosus (SLE), according to current American College of Rheumatology (ACR) criteria
* Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV LN as evidenced by renal biopsy performed within 6 months prior to or during screening. Participants may co-exhibit Class V disease in addition to either Class III or Class IV disease
* Proteinuria (urine protein to creatinine ratio) greater than (\>) 1.0
* For women who are not postmenopausal (greater than or equal to \[\>/=\] 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of less than (\<) 1 percent (%) per year, during the treatment period and for at least 18 months after the last dose of study drug
* For men: agreement to remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \<1% per year during the treatment period and for at least 12 months after the last dose of study drug and agreement to refrain from donating sperm during this same period

Exclusion Criteria:

* Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE
* Presence of rapidly progressive glomerulonephritis
* Severe renal impairment as defined by estimated Glomerular Filtration Rate (GFR) \<30 milliliters per minute (mL/min) or the need for dialysis or renal transplant
* Greater than 50% of glomeruli with sclerosis on renal biopsy
* Treatment with cyclophosphamide or calcineurin inhibitors within the 3 months prior to randomization
* Unstable disease with thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions
* History of severe allergic or anaphylactic reactions to monoclonal antibodies or known hypersensitivity to any component of the obinutuzumab infusion
* Significant or uncontrolled medical disease in any organ system not related to SLE or LN, which, in the investigator's opinion, would preclude participant participation
* Concomitant chronic conditions, excluding SLE, (e.g., asthma, Crohn's disease) that required oral or systemic steroid use in the 52 weeks prior to screening
* Previous treatment with an anti-cluster of differentiation (CD20)-targeted therapy within 12 months
* Previous treatment with a biologic B-cell-targeted therapy (other than anti-CD20) within 6 months of randomization
* Known intolerance to MMF or MPA
RAre, But Not aLone: a Large Italian Network to Empower the Impervious diaGNostic Pathway of Rare cerEbrovascular Diseases (ALIGNED)

Cerebrovascular diseases (CVDs) are one leading cause of morbidity and mortality worldwide. Despite intensive investigations, more than 30% of strokes remain of undetermined origin. Rare Cerebrovascular Diseases (rCVDs), including heritable (i.e., CADASIL, COL4A1 syndrome, Fabry disease) and acquired conditions (i.e., Sneddon syndrome, Moyamoya arteriopathy) account for a proportion of these strokes. However, rCVDs are often misdiagnosed since clinicians are not able to recognize them. Although rare, the identification of these stroke causes is important to establish appropriate management measures, including genetic counselling, and, if available, therapy. The lack of data on phenotype and clinical course of rCVDs, given the paucity of published series, makes the diagnosis and the development of therapies challenging. Furthermore, the molecular characterization of rCVDs is still lacking, despite progresses achieved in common stroke by applying high throughput approaches as multi-omics. Since the diagnosis and care of rCVDs require adequate expertise and instrumental tools, clinical and research activities are usually reserved to few specialized centers, mostly located in the North of Italy, leading patients to expensive trips for consultations. Therefore, the creation of a clinical and research network aimed at improving the diagnostic pathways of rCVDs is highly needed to improve the number of patients with rCVDs to better define the clinical phenotype and to transfer the knowledge on rCVDs in other centers overall Italy filling the geographical gap affecting Southern Italy.


Eligibility Criteria:
Inclusion Criteria:

* patients with a clinical, genetic and/or neuroradiological diagnosis of rCVD (CADASIL, Fabry's disease, COL4A1, Sneddon's syndrome or Moyamoya arteriopathy), who have had at least one brain MRI study;

Exclusion Criteria:

* na
Effect of Head Tilting During Nasotracheal Intubation

The goal of this prospective randomized controlled study is to investigate the effect of head tilting on tracheal tube passing during nasotracheal intubation.

The question which the investigators are trying to answer is: If patient's neck is extented on inserting tracheal tube via nostril, will the E-tube be more easily to pass through nasopharynx to oropharynx without trapping?

For nasotracheal intubation, clinicians do sometimes experience tube trapping at naso/oro-pharyngeal tissue. Application of force to overcome resistance can cause tissue injury leading to bleeding, which can disturb tracheal intubation.

The hypothesis of this study is that the method of 'head tilting' can help easy passing of tracheal tube at naso/oro-pharyngeal pathway without trapping in nasotracheal intubation. The purpose of the present study is to investigate the effect of 'head tilting' on the incidence of trapping of tracheal tube at naso/oro-pharynx when tracheal tube is being advanced into oropharynx via nostril during nasotracheal intubation.

Eligibility Criteria:
Inclusion Criteria:

* The patients who need to nasotracheal intubation for surgery.

Exclusion Criteria:

* Who doesn't agree to enroll
* Who has a problem to head tilting position such as C-spine injury.
1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer

In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab.

Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 ans.
* Metastatic breast cancer or locally advanced
* RE+, HER2-
* Patient receiving paclitaxel-bevacizumab first line chemotherapy

Exclusion Criteria:

* Previous treatment by exemestane (both in adjuvant or metastatic treatment).
* 1st line of chemotherapy different thaan paclitaxel-bevacizumab.
* Treatment by paclitaxel-bevacizumab \> 18 weeks.
* HER2 positifs et/ou récepteurs aux oestrogènes négatifs.
* Previous thrombosis event within the 6 months before inclusion .
* Previous significant surgery within the 28 days before treatment start
* Previuous coagulopathy.
A Phase 2 Open Label Study of BA3021 in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

This is a multi-center, open-label Phase 2 study designed to evaluate the efficacy and safety of BA3021 as monotherapy and combination therapy in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.


Eligibility Criteria:
Inclusion Criteria:

* The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. Patients may not have a primary tumor site of nasopharynx (any histology).
* Neoadjuvant/induction setting (Cohort N1): Patient with newly diagnosed Stage III SCCHN who are eligible for induction therapy with resectable tumors. No prior treatments, including surgery, radiation, or systemic treatment, for SCCHN are allowed.
* Recurrent or metastatic setting: Histologically or cytologically confirmed recurrent or metastatic SCCHN Stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy).
* First-line - Combination Cohorts (C1 and C2): Patients must have NO prior systemic therapy administered in the locally recurrent or metastatic setting. Previous treatments with PD-1/L1 inhibitor or anti-CTLA-4 treatment are not allowed.
* Second-line (Combination Cohort C3) and Second-line+ (Monotherapy Cohorts M1 and M2): Patients must have documented treatment failure of no more than one approved PD-1/L1 inhibitor either administered alone or in combination.

Patients must have measurable disease.

* Age ≥ 18 years
* Adequate renal function
* Adequate liver function
* Adequate hematological function
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
* Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
* Patients must not be women who are pregnant or are breast feeding.
Autologous Fat Grafting Versus Subepithelial Connective Tissue Graft for Volume Augmentation

The aim of this study was to evaluate the effectiveness of autologous fat as a grafting material for soft tissue volume augmentation of localized horizontal ridge defects in humans.

A total of 20 patients having 26 localized horizontal ridge defects were recruited for the study from the patient pool at the dental clinics of the faculty of dentistry, Alexandria University. Ridge defects were divided into two parallel groups:

Test group: localized ridge defects were augmented using autologous fat grafting Control group: localized ridge defects were augmented using conventional subepithelial connective tissue graft.

Eligibility Criteria:
Inclusion Criteria:

1. Patients had at least one localized horizontal ridge defect in a single tooth gap requiring soft tissue volume augmentation.
2. Teeth in the defect area have been extracted at least 3 months prior to enrolment
3. All patients were systemically healthy
4. Patients were non-smokers
5. Patients had abdominal fat accumulation allowing liposuction
6. Ability to understand the nature of the proposed surgery and ability to sign an informed consent form

Exclusion Criteria:

1. General contra-indications to surgical procedures
2. Pregnancy
3. Systemic diseases like Diabetes Mellitus and autoimmune diseases
4. History of malignancy, chemotherapy or radiotherapy within the last 5 years
5. Concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients

The purpose of this study is to determine the maximum tolerated dose of the TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response

The Maximum Tolerated Dose of the combination was determined and the Phase I terminated.

Then, Phase II study started.

Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of soft tissue sarcoma metastatic or recurrent after 6 months from the last chemotherapy
* Age \>/=18 yrs
* PS \</=2
* Disease detectable almost for 1 dimension
* Life expectancy \>/=3 mos
* Minimum 4 wks from last radiotherapy
* Adequate medullary, liver, and renal functions
* Normal LVEF
* Written Informed Consent

Exclusion Criteria:

* Pregnant or breast-feeding patients
* Serious concomitant disease or not controlled infections
Effects of Occupational Therapy in COPD

Chronic obstructive pulmonary disease is a chronic condition involving an impairment in functionality and in the execution of activities of daily life. The hypothesis of this study is that an occupational therapy intervention added to a physiotherapy program and a medical treatment increase the functionality and the quality of life of patients with chronic obstructive pulmonary disease.

The evolution of chronic obstructive pulmonary disease can be aggravated in some periods by an increase of the symptoms (above all, the cough, the dyspnea and the quantity of sputum purulence). This is known as exacerbation, and it is the most frequent reason for hospital stay, urgences services and death in this condition. A physiotherapy program and an occupational therapy intervention are carrying out in patients attending to the Hospital because of an exacerbation.. Participants will be assessed at baseline and again at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic obstructive pulmonary disease with exacerbation.
* No contraindication of physiotherapy.
* Signed written consent.
* Medical approval for inclusion

Exclusion Criteria:

* Heart disease.
* Neurological patients.
* Contraindications of physiotherapy.
* Nursing home residents.
* Cognitive impairments.
Protective Effects of Remote Limb Ischemic Preconditioning on Acute Cerebral Infarction

Stroke is one of the three leading causes of human death, and a major cause of adult disability. Our pre-clinical studies confirmed that ischemic preconditioning can prevent cerebral infarction. Animal studies confirmed that ischemic postconditioning can reduce infarct size of cerebral infarction. Investigators hypothesized that postconditioning would reduce infarct volume of ischemic stroke patients.

This study explored the neuroprotective effects of post-positioning on ischemic stroke patients with randomized, double-blinded and controlled method. Patients are divided into experimental and placebo groups to receive remote ischemic post-conditioning for 30 days. Remote ischemic post-conditioning is performed by the inflating tourniquets to certain extents on bilateral arms with 5 cycles of 5min inflation and 5min relax alternation for the total of 30 consecutive days. It is 200mmHg for RIPC group and 60mmHg for control group. Evaluation parameters include CRP, TNF-α, ICAM-1 and GFAP in blood at 0, 3, 7, 15 and 30 days after treatment; and MRI at 0 and 30 days after treatment.

Eligibility Criteria:
Inclusion Criteria:

1. age between 40 to 80 Years
2. Ischemic cerebrovascular disease within 6 hours
3. National Institutes of Health Stroke Scale(NIHSS) score 0-15,and Modified Rankin Scale(mRS) score 0-4
4. Cranial CT to rule out the the cerebral hemorrhage
5. Written informed consent was

Exclusion Criteria:

1. Cerebral hemorrhage
2. Other parts of the active bleeding disease
3. Atrial fibrillation
4. Moyamoya disease or vasculitis
5. Hereditary disease, such as with CADASIL, FABRY, mitochondrial myopathy
6. Out coagulation disorder
7. Severe lesions of severe liver and kidney disease, malignancy or other systemic
8. Cannot tolerate BLIPC or without informed consent
Prevalence and Economic Burden of Obesity-related Comorbidities in the Gulf Region: A Retrospective, Observational Study

The aim of this study is to assess the annual prevalence of ORCs among adult people with obesity in the real-world clinical setting across the Gulf region. In addition, the study will describe the annual HCRU and associated costs of obesity and ORCs, describe the demographics and clinical characteristics of adult people with obesity, as well as estimate the annual incidence and point prevalence of the ORCs among adult people with obesity.


Eligibility Criteria:
Inclusion Criteria:

1. Local national (male or female) of Arab ethnicity, age above or equal to 18 years at index date
2. Primary or secondary diagnosis of obesity (BMI above or equal to 30 kg/m2) at index date
3. Minimum of 1 visit with BMI recorded between months 1 and 6 following index date, and minimum of 1 visit with BMI recorded between months 7 and 12 following index date.

There should be a minimum time gap of 3 months between the BMI records and the BMI must be above or equal 30 kg/m2 at each visit. If there are multiple visits during the 12-month observation period, then a mean BMI above or equal 30 kg/m2 must be maintained during the observation period.

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having collected data of the participants in this study already.
2. Participation in an interventional trial during the 12-month observation period
3. Conditions associated with unintentional weight change
4. Participants who underwent bariatric surgery within 18 months prior to the index date
5. Participants with non-ambulatory disability diagnosis
Evaluation of the " Tele-follow-up " for the Follow-up of Implantable Defibrillators

The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced "remote monitoring" devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by "tele-follow-up" might reduce the cost of care by avoiding useless visits to the implantation centre.

The aim of our study is to assess the cost-benefit ratio of "tele-follow-up" assisted care as compared with the conventional ICD follow-up.

The implantable cardioverter defibrillator (ICD) has been shown to be effective in preventing mortality in patients with ventricular tachyarrhythmia. However, the expanding indications of this therapy will have an impact on the follow-up policy. Currently, regular follow-up visits are scheduled every 3 months. In this context, the recently-introduced "remote monitoring" devices constitute a promising new technique, allowing to transmit information about the status of the device and ICD therapies, without direct contact between patients and physicians. This monitoring by "tele-follow-up" might reduce the cost of care by avoiding useless visits to the implantation centre.

The aim of our study is to assess the cost-benefit ratio of "tele-follow-up" assisted care as compared with the conventional ICD follow-up. Thanks to an open label, randomized, 2 arms study : one using a telephone follow up, the other a conventional follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adults over 18,
* First implantation of an implantable cardioverter defibrillator device (CRT-D devices being excluded), single or dual-chamber in primary or secondary prevention,
* ICD with data-transmission features,
* GSM mobile phone network at patient home compatible with remote transmission,
* Patient able to use correctly the transmission system,
* Patients having given a written informed consent.

Exclusion Criteria:

* Class IV of NYHA,
* Concomitant pathology leading to a life expectancy inferior to the protocol duration,
* Concomitant participation to another protocol.
Effect of Dexmedetomidine After Thyroidectomy

The purpose of the present study was to compare the effect of dexmedetomidine which is administered during emergence in adult patients undergoing elective thyroidectomy on smooth emergence form general anesthesia (reducing agitation or coughing, signs of hypertension or tachycardia, or etc.) and postoperative outcome (postoperative bleeding and hospital staying).

Smooth emergence from general anaesthesia after surgery is important to prevent potentially dangerous effects such as hypertension, tachycardia, myocardial ischaemia, arrhythmias and increased intracranial and intra-abdominal pressure. After thyroidectomy, activities during emergence such as agitation or coughing, signs of hypertension or tachycardia, or etc. may lead to postoperative bleeding, resulting in acute airway obstruction or reoperation.

The purpose of the present study was to compare the effect of dexmedetomidine which is administered during emergence in adult patients undergoing elective thyroidectomy on smooth emergence form general anesthesia and postoperative outcome.

Eligibility Criteria:
Inclusion Criteria:

* Female patient,
* Aged 20-60 yr,
* ASA physical status 1-2,
* Patients undergoing elective thyroidectomy under general anesthesia

Exclusion Criteria:

* Sighs of difficult airway,
* History of respiratory disease or chronic cough,
* Cardiovascular disease,
* Pregnant or breast-feeding woman
Trans-foraminal Lumbar Epidural Injection of Dexmedetomidine Against Magnesium Sulfate When Combined With Dexamethasone in Uni-lateral Lower Limb Radicular Pain. Multi-centeric Comparative Study

Transforaminal injection of chronic radicular lower limb injection by either dexmedetomdine or magnesuim sulfate


Eligibility Criteria:
Inclusion Criteria:

* Age group. 25-75ys old
* Both sex.
* Lumber disc protrusion at one or two segments on MRI.
* Chronic lumbar radiculer pain for more than 6 weeks refractory to
* medical treatment for at least 4 weeks. .
* Positve leg rising test at 30-70 degrees.

Exclusion Criteria:

* Diabetic candidates ( type Ior II).
* Patient refusal.
* MRI with disc sequestration.
* Neurological examination revealed foot drop, neuropathic ulcers
* Myelopathic or scoliotic patients, .
* Coagulopathic patients ( cirrhotic patients, on anti-coagulation )