cyrilzakka/clinical-trials huggingface dataset:
Early Endoscopic Ultrasound - Based Sphincterotomy or Conservative Treatment in Severe Biliary Pancreatitis

The primary purpose of this trial is to determine whether an early Early Endoscopic Ultrasound (EUS) immediately followed by an endoscopic sphincterotomy (ES) in case of bile duct stones may improve outcomes in patients with predicted severe acute biliary pancreatitis (ABP).

The management of Acute biliary pancreatitis (ABP) remains controversial. Although early decompression of the bile duct is deemed potentially beneficial, previous randomised studies failed to show the benefit of early endoscopic sphincterotomy (ES) except in selected cases. However, those studies did not use recent non invasive diagnostic methods such as EUS.

Methodology: Patients in the study group undergo EUS followed by ES in case of common bile duct stones within 48 hours of the onset pf symptoms; The control group includes patients with predicted severe ABP undergoing conservative treatment or endoscopic sphincterotomy (without EUS) within 72 hours of the onset of symptoms in case of cholangitis or biliary obstruction.

Eligibility Criteria:
Inclusion criteria :

* age \> 18
* predicted severe acute biliary pancreatitis (including age \> 80, BMI \>30, pre-existing organ failure, Modified Glasgow score \> 3)
* timespan between onset and randomization \< 48 hrs
* informed consent signed by patient or liable person in case of emergency

Exclusion criteria :

* non biliary pancreatitis
* non severe pancreatitis
* age \< 18
* timespan between onset and randomization \> 48 hrs
* absence of consent
* ongoing pregnancy
* no social security insurance
Post Cesarian Section Wound Infections At Emergency Room

The goal of this observational study is to compare the incidence of post-cesarean section wound infections between emergency and elective cesarean deliveries at El-hussien Hospital. The main questions it aims to answer are:

Is there a difference in surgical site infection rates between emergency and elective cesarean sections? What are the other outcome measures associated with emergency versus elective cesarean deliveries?

Participants will be 220 patients undergoing cesarean section, divided into two groups:

110 patients undergoing emergency cesarean delivery in the Emergency Unit 110 patients undergoing elective cesarean delivery

Researchers will compare the emergency cesarean group to the elective cesarean group to see if there are differences in surgical site infection rates and other relevant outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Managed with elective CS or Emergency CS
* BMI \< 25 Kg/m2

Exclusion Criteria:

* Immunodeficiency or diabetes.
* Premature rupture of membrane
* Bleeding disorder.
* Previous uterine surgery except previous CS.
* Malignancy.
* Refusal to participate.
Autologous Activated Adipose-derived Stem Cells (RB-ADSC) Injected Directly Into the Brain for Mild to Moderate Alzheimer's Disease

This is a research study to evaluate the safety of an investigational autologous cell product obtained from participant's own adipose tissue as a possible treatment for Alzheimer disease.

This is a Phase 1, Open-Label Safety Study of Escalating Doses of Intracerebroventricular Injections of Ex Vivo Expanded, Autologous Adipose-Derived Stem Cells (ADSCs) in Participants with Mild to Moderate Alzheimer's Disease (AD) whose Treatment is not Addressed Adequately by Available Therapy (i.e., an unmet medical need). The investigational product, which is referred to as RB-ADSC, consists of stem cells obtained from the participant's own adipose tissue by lipoaspirate. After collection, the stem cells are cultured and expanded outside the body, and then reintroduced into the same patient. A soft plastic reservoir (Ommaya reservoir) is implanted under the scalp, communicating with the brain cavities (ventricles). This study will primarily evaluate the safety of RB-ADSC injected in the Ommaya reservoir in a 3 + 3 dose escalation study. The planned enrollment will be 9 participants, 3 participants per escalation Cohort.

The primary objectives will evaluate adverse events, serious adverse events, and dose limiting toxicities to determine a recommended phase 2 clinical trial dose. Secondary objectives will evaluate preliminary efficacy measured by clinical assessments, volumetric MRI (Neuro Quant®), CSF biomarkers (Phospho-Tau, Total Tau, AB-42), and diagnostic imaging comparison (Amyloid PET). Each participant will be followed for 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* ≥45 and ≤80 years of age
* Mild to moderate AD diagnosis
* Adequate cognitive function
* Non-remarkable clinical laboratory
* Ability to voluntarily provide written informed consent
* No tumors or other disease responsible for dementia
* Well-controlled comorbidities, on stable medications for 3 months
* The participant is otherwise in good general health
* The participant must have a relative/caregiver
* Participant must be able to donate adequate amount of lipoaspirate to establish the final product
* Caregiver separately meets the specified inclusion/exclusion criteria for caregivers

Exclusion Criteria:

* Taking other medications for AD, except that donepezil memantine, AChEIs including patches, Vitamin E, fish oil, and/or gingko biloba are allowed if doses have been stable for at least 3 months prior to the Screening visit
* Stem cell implantation of any type within 3 months
* Existing ventriculoperitoneal shunts
* Neurological disorders except AD
* Psychiatric disorders including schizophrenia, bipolar/unipolar depressive disorder, delirium
* Drug or alcohol abuse or dependence within the past 5 years
* Participants with a history of cancer in the past 5 years
* No caregiver available to meet the inclusion criteria for caregivers
NIR Arthroscopic Fluorescence Angiography of Menisci

This trial is an explorative single center, single-arm study to assess whether vascularization of the meniscus can be visualized intraoperatively using arthroscopic near-infrared (NIR) fluorescence using ICG during standard of care meniscal repair treatment.

The meniscal healing process is based on two fundamental principles: a solid primary fixation, and a well-functioning biological process of cicatrization, where the presence of vascularization is thought to play a major role. Intra-operative near infrared fluorescence angiography using Indocyanine Green (ICG) is a widely used method for operative assessment of vascularization. Fluorescence guided detection of the vascularity surrounding a meniscal tear could be of great value to predict meniscal healing after repair.

This pilot study will explore the technical feasibility of intraoperative near-infrared fluorescence angiography of the meniscus in patients undergoing arthroscopic meniscal repair. Technical challenges for NIR fluorescence arthroscopy are the visibility of the vascular perfusion in microvessels in the dense meniscus, motion artifacts encountered with arthroscopy and wash in of ICG using a fluid irrigation system.

The included patients will be subdivided in four equal subgroups in order to evaluate alteration of NIR fluorescence signal during arthroscopy in combination with a tourniquet and/or irrigation pump system.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older;
* Patients with on MRI confirmed Zone 1 meniscal tear
* Patients with a clinical indication for arthroscopic meniscal repair
* Before patient registration, written consent must be given according to ICH/GCP, national and local regulations.

Exclusion Criteria:

* Prior operative treatment of the ruptured meniscus
* Any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient. In specific, these conditions concern smoking, diabetes and being overweight.
* Pregnancy
* allergy to iodine, shellfish or ICG;
* Psychological, familial sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
Safety and Efficacy Study of MIM-D3 Ophthalmic Solution for the Treatment of Dry Eye

The objective of this study is to compare the safety and efficacy of 1% MIM-D3 and 5% MIM-D3 to placebo for the treatment of the signs and symptoms of dry eye.


Eligibility Criteria:
Inclusion Criteria:

1. Be at least 18 years of age
2. Provide written informed consent
3. Have a reported history of dry eye
4. Have a history of use or desire to use eye drops for dry eye

Exclusion Criteria:

1. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1, or have been diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months
2. Have any planned ocular and/or lid surgeries over the study period
3. Have corrected visual acuity greater than or equal to +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1
4. Have an uncontrolled systemic disease
5. Be a woman who is pregnant, nursing or planning a pregnancy
6. Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study
7. Have a known allergy and/or sensitivity to the test article or its components
8. Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
9. Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days of Visit 1
10. Be unable or unwilling to follow instructions, including participation in all study assessments and visits
Exercise in Mental Illness Questionnaire: French Validation

The validation of the French version of the Exercise in Mental Illness Questionnaire - Health Practitioner Version (EMIQ-HP) is a prospective observational case-only study involving: (a) translation to French, (b) an expert consensus meeting with French speaking experts from Canada to reach a first version, (c) back translation to English, (d) evaluation of the back-translation by the original authors of the EMIQ-HP, (e) an expert consensus meeting with French speaking experts from Canada to reach a final version based on comments of the original authors, and (f) test-retest reliability study. Test-retest reliability will be analysed through two points of measurement with an interval of 7 days.

The aim of this study is to cross-culturally validate the French translation of the Exercise in Mental Illness Questionnaire - Health Practitioner version (EMIQ-HP) scale and investigate the test-retest reliability. We hypothesize that the French validated translation of the Exercise in Mental Illness Questionnaire - Health Practitioner version (EMIQ-HP) scale will show and excellent test - retest reliability. National and international experts from Belgium, Canada and Switzerland are requested to join the expert panel and requested to be available on 2 different occasions, i.e. following the first translation and following the feedback of the original authors on the back translation in order to reach consensus on the final version. For the test-retest part of this study, all health care providers of the Centre Hospitalier Psychiatrique Chêne aux Haies (i.e. nurses, psychologists, physiotherapists, somatic medical doctors, psychiatrists) will be invited to participate. Following written informed consent procedure, participants will complete the EMIQ-HP which will be completed a second time exactly one week following the first completion

Eligibility Criteria:
National and international experts from Belgium and Canada will be requested to join the expert panel and requested to be available on 2 different occasions, i.e. following the first translation and following the feedback of the original authors on the back translation in order to reach consensus on the final version. For the test-retest part of this study, all health care providers of the Centre Hospitalier Psychiatrique Chêne aux Haies (i.e. nurses, psychologists, physiotherapists, somatic medical doctors, psychiatrists) will be invited to participate. There are no specific exclusion criteria.
Recurrent Hypoglycemia in Type 1 Diabetes (Aim 1)

This study will explore the cerebral mechanisms of impaired awareness of hypoglycemia (IAH) in type 1 diabetics following exposure to experimental recurrent hypoglycemia (HG). To induce IAH, patients with T1D identified to have normal awareness of hypoglycemia (NAH) will undergo three 2-hour long hypoglycemic clamps. Neurochemical profiles will be measured by high field MRS before and after induction of IAH. Subject glycemic variability for 2 weeks and activity/sleep for 1 week before each study will be monitored as all factors have been shown to alter responses to HG.

The long-term goal of this project is to identify how recurrent hypoglycemia (HG) leads to the clinical syndrome of impaired awareness of hypoglycemia (IAH) in type 1 diabetes (T1D). This study will test the hypothesis that recurrent HG in T1D leads to an upregulation in brain glucose transport and alterations in glutamatergic and GABAergic tone. The investigators will use MRS methodology that permits evaluation of cerebral cortex and hypothalamus in the same session to simultaneously evaluate the cerebral correlates/mediators of impaired awareness and impaired counterregulatory hormone responses (CRR). High MR data quality and reproducibility will be ensured by using high field MR scanners and technical advances (automated voxel placement, real-time voxel position, frequency, shim updates). Continuous glucose monitoring and actigraphy will be used to chronicle glucose variability and activity/exercise/sleep in the weeks before each experiment to assess the impact of these variables on IAH.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes diagnosed on clinical or laboratory grounds
* Diabetes duration 2 - 30 years
* Hemoglobin A1C \<8.5%

Exclusion Criteria:

* Impaired awareness of hypoglycemia as determined by the Cox and Gold questionnaires
* Pregnant or plan to become pregnant during the study period
* Uncontrolled hypertension (blood pressure \> 145/95 mmHg at screening)
* Evidence of autonomic neuropathy (presence of orthostatic hypotension or history of gastroparesis)
* Proliferative retinopathy
* Impaired kidney function (GFR \< 45)
* History of myocardial infarction, stroke, seizures, neurosurgical procedures, major depression requiring hospitalization within the last 5 years, arrhythmias
* Current substance abuse
* Use of drugs that can alter glucose metabolism including but not limited to glucocorticoids and niacin, and excluding insulin and glucose lowering drugs used to treat diabetes, as determined by a clinician
* Inability to undergo MRI scanning, including but not limited to unable to remain still in an MRI scanner for more than 30 minutes, claustrophobia, presence of paramagnetic substances or pacemakers in body, weight over 300 lbs
Pilot Study of Autologous Anti-EGFRvIII CAR T Cells in Recurrent Glioblastoma Multiforme

Chimeric antigen receptor (CAR)-modified T cells can mediate long-term durable remissions in recurrent or refractory CD19+ B cell malignancies, and are a promising therapy to treat glioblastoma, which is the most dangerous and aggressive form of brain cancer. EGFRvIII mutation (epidermal growth factor receptor variant III, EGFRvIII) is the results of tumor specific gene rearrangement naturally happened in about 30% of glioblastoma patients and produces a mutated protein with neo-antigen that is tumor specific and is not expressed in normal human tissues. Therefore, EGFRvIII is an attractive target for CAR T cell therapy. We have constructed a lentiviral vector that contains a chimeric antigen receptor that recognizes the EGFRvIII tumor antigen. A truncated EGFR (tEGFR) which lacks of the ligand binding domain and cytoplasmic kinase domain of wildtype EGFR is incorporated into the CAR vector and is used for in vivo tracking and ablation of CAR T cells in necessary. This pilot study is to determine the safety and efficacy of autologous anti-EGFRvIII CAR T cells in patients with recurrent glioblastoma.


Eligibility Criteria:
Inclusion Criteria:

1. abilities to understand and the willingness to provide written informed consent;
2. patients are ≥ 18 and ≤ 70 years old;
3. recurrent glioblastoma patients with measurable tumors. Patients have received standard care of medication, such as Gross Total Resection with concurrent Radio-chemotherapy (\~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg/day at the time of leukopheresis;
4. Malignant cells are EGFRvIII positive confirmed by IHC, quantitative PCR or sequencing;
5. karnofsky performance score (KPS) ≥ 60;
6. life expectancy \>3 months;
7. satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500/mm\^3; hemoglobin \> 10 g/dL; platelets \> 100000 /mm\^3; Bilirubin \< 1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5×ULN; creatinine \< 1.5×ULN;
8. peripheral blood absolute lymphocyte count must be above 0.8×10\^9/L;
9. satisfactory heart functions;
10. patients must be willing to follow the orders of doctors;
11. women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study.

Exclusion Criteria:

1. a prior history of gliadel implantation 4 weeks before this study start or antibody based therapies;
2. HIV positive;
3. hepatitis B infection or hepatitis C infection;
4. history of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies;
5. history of allergic disease, or allergy to CAR T cells or study product excipients;
6. patients already enrolled in other clinical study;
7. patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of HR+, HER2- breast cancer.
* Relapsed or progressed following endocrine therapy.
* Have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting.
* Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy.
* Have adequate organ function.
* Have negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use highly effective precautions to prevent pregnancy during the study and for 3 weeks following last dose of study treatment.
* Are able to swallow oral medication.

Exclusion Criteria:

* Have clinical evidence or history of central nervous system metastasis.
* Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
* Have active bacterial or fungal infection (that is, requiring intravenous antibiotics at the time of initiating study treatment) and/or detectable viral infection.
* Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6 inhibitor.
* Have a preexisting chronic condition resulting in persistent diarrhea.
* Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years.
Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy

The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Positive lymphoma patients treated with rituximab-based immunochemotherapy.

HBsAg Positive lymphoma patients are treated with entecavir when they receive rituximab-based immunochemotherapy. Entecavir 0.5mg daily is administrated from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* treatment-naive patients with B-cell lymphoma
* HBsAg positive at baseline
* treated with rituximab-based immunochemotherapy
* life expectancy of more than 3 months

Exclusion Criteria:

* younger than 18 years old
* HBsAg negative at baseline
* pregnant or lactating women