cyrilzakka/clinical-trials huggingface dataset:
Using Liquid Biopsy in Newly Diagnosed Patients With High Grade Adenocarcinoma of Ovarian Origin, Fallopian Tubes or Primary Peritoneal

BOVARY-CE is a monocentric, pilot, longitudinal, real-life study with a total duration of 36 months. The purpose of this study is to assess the feasibility of using liquid biopsy as a substitute for tissue multisampling, in order to describe clonal heterogeneity and tumor evolution in patients with ovarian cancer. The method involves the inclusion of 20 patients with high-grade ovarian adenocarcinoma, fallopian tubes or primary peritoneal origin, not pretreated, newly diagnosed, and eligible for treatment who will participate in the research. These patients will have several samples throughout their treatment for a period of 2 years: blood samples which will be taken at each therapeutic moment of interest.

Tissue samples which will be taken at the time of the diagnostic laparoscopy and at the time of surgery.

The concentration of cfDNA and tumor heterogeneity will be used to predict disease-related events defined as relapse, progression or death.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient with non-treated high grade serous and endometrioid carcinoma of ovarian, fallopian tube, or primary peritoneal origin proven cytologically or histologically at inclusion and eligible for treatment
* Patient eligible for an upfront surgery or pretherapeutic coelioscopy
* Adequate haemoglobin rate ≥ 9 g/dL
* Patient affiliated to a social security scheme
* Ability to provide written informed consent

Exclusion Criteria:

* Age \< 18 years
* Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
* Contraindication to blood samples of 20 mL
* Pregnant or breast-feeding women
* Ongoing treatment for the newly diagnosed cancer or the recurrence
* Other cancers treated within the last 5 years
* Patient under guardianship or curatorship or deprived of liberty
Pre-approval Single-patient Expanded Access for Abrocitinib (PF-04965842)

Provide pre-approval single patient Expanded Access (compassionate use) of abrocitinib for patients with severe uncontrolled atopic dermatitis

In Expanded Access, treating physicians are the Sponsor.

Expanded Access requests from treating physicians may be submitted at www.pfizercares.com ; availability will depend on location/country.

Eligibility Criteria:
Must have severe uncontrolled atopic dermatitis refractory to other available treatments
Phase 2 Study of ABT-869 in Combination With mFOLFOX6 Versus Bevacizumab in Combination With mFOLFOX6 to Treat Advanced Colorectal Cancer

To determine the effect of ABT-869 plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 on disease progression in advanced colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

Subject must be \>/= 18 years of age. Subject (male or female) must be diagnosed with adenocarcinoma of the colon or rectum. Subject must have metastatic disease or locally recurrent disease that is not amenable to surgical resection with curative intent.

Subject must have received one prior chemotherapy regimen containing irinotecan or a fluoropyrimidine for locally recurrent or metastatic colon or rectal cancer.

Subject has experienced progressive disease during or following the previous anti-tumor treatment.

Subject may have received prior adjuvant treatment for colorectal cancer. Subject has measurable disease by RECIST criteria (randomized portion only). Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1. Subject must have adequate bone marrow, renal and hepatic function. Subject must have Partial Thromboplastin Time (PTT) \< 1.5 x Upper Limit of Normal (ULN) and International Normalized Ratio (INR) \< 1.5.

Exclusion Criteria:

Subject has received more than one prior therapy in the metastatic setting. Lead-in Cohort only: The subject may have received more than one prior therapy in the metastatic setting.

Subject has received cytotoxic chemotherapy within 21 days prior to Study Day 1.

Subject has received non-cytotoxic, anti-cancer therapy within 21 days or within a period defined by 5 half lives whichever is shorter, prior to Study Day 1.

Subject has not recovered to less than or equal to Grade 1 clinically significant adverse effects/toxicities of the previous therapy.

Subject has received prior treatment with a tyrosine kinase inhibitor targeting VEGF or PDGF.

Subject has received prior treatment with oxaliplatin in the metastatic setting. Lead-in cohort only: Prior treatment with oxaliplatin will be allowed provided that any neuropathy as a result of the oxaliplatin treatment has resolved to less than or equal to Grade 1.

Subject has had major surgery within 28 days of Study Day 1. Subject has had radiotherapy within 14 days of Study Day 1. Subject has a history of hypersensitivity to recombinant murine monoclonal antibodies, oxaliplatin or other platinum-containing compounds, fluorouracil, or folinic acid.

Subject has a known intolerance to bevacizumab. Subject has untreated brain or meningeal metastases. Subject is receiving therapeutic anticoagulation therapy . Subject has a history of/or currently exhibits clinically significant cancer related events of bleeding.

Subject currently exhibits symptomatic or persistent, uncontrolled hypertension.

Subject has a history of myocardial infarction, stroke, or transient ischemic attack within six months of Study Day 1.

History of another active cancer within the past 5 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous cell or basal cell carcinoma of the skin.
Evolution of Ischemic Stroke Subtypes in Hong Kong

Stroke is the 4th leading cause of mortality in Hong Kong. It also carries considerable socioeconomical consequences due to disability.

Ischemic stroke can be classified by the TOAST classification, which includes large artery atherosclerosis, cardioembolism, small-artery occlusion and other causes (1). Among which, intracranial atherosclerosis (ICAS) had been major cause of acute ischemic stroke (AIS) in the Asia Pacific. It was estimated as high as 24.1% of AIS or transient ischemic attacks (TIAs) were attributed to ICAS in China (2). Management of ICAS related strokes has been challenging owing to its high rate of recurrence despite medical therapy. Recent randomized clinical trial suggested that aggressive medical therapy may result in reduction in recurrence compared with historical cohorts (3).

Our group has previously observed a 2.5-fold increase in atrial fibrillation related stroke over a 15-year period (4). The inverstigator also observed a decline in ICAS related AIS as well as its recurrent stroke risk throughout the recent years. Possible mechanisms include better management of metabolic risk factors and aggressive secondary prevention. Other possible reasons are increased atrial fibrillation (AF), small vessel disease (SVD) or other stroke mechanisms.

This study is aim to find the evolution of different stroke subtypes in relation to the characteristics of our stroke population over a 15-year period. This may influence territorial prevention strategy.

Five time points, i.e. 2004, 2006, 2008, 2010, 2012, 2014, 2016, 2018 are selected for analysis. All consecutive stroke patients included in the Prince of Wales Hospital stroke registry will be recruited.

Patients will be stratified according to their stroke subtypes with reference to the TOAST classification (1), which includes large artery disease, cardioembolism, small vessel occlusion, other determined causes, undetermined cause or incomplete investigations.

Stroke etiology is determined by stroke neurologists with reference to the history, physical signs, imaging including carotid duplex, transcranial doppler, computer tomography (CT), CT angiogram, magnetic resonance imaging (MRI), MR angiogram, electrocardiography (ECG) and echocardiography. Interobserver variability for stroke mechanism determination will be evaluated.

Pre-defined demographic data including age, gender, smoking status, vascular risk factors including hyperlipidaemia, hypertension, diabetes, prior stroke or TIA, etc. will be retrieved from the stroke registry.

The investigator will also compare the use of antiplatelet agents, anticoagulants, lipid-lowering agents, specific antihypertensives in the Shatin territory across the 15-year period using the CDARS.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive Chinese stroke patients included in the Prince of Wales Hospital stroke registry at 2-year intervals, i.e. from 2004 to 2018

Exclusion Criteria:

1. Uncertain diagnosis of stroke
2. Non-Chinese patients
Radiation Therapy With Capecitabine in Rectal Cancer

This study will use an experimental combination of treatment with the drug Capecitabine and radiation therapy prior to an operation for removal of the patient's tumor. The drug Capecitabine is an oral form of a drug called 5-FU which has been widely used to treat rectal cancer.

This is a phase II clinical trial, which means that the physician will be studying the reactions of the patient's body and tumor to treatment with Capecitabine and radiation therapy. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. The study also will see what kind of side effects this experimental treatment causes and see how often these side effects occur.

Preliminary human studies using Capecitabine and radiation therapy have produced encouraging results with acceptable side effects.


Eligibility Criteria:
Eligibility Criteria

1. Histologic confirmation of adenocarcinoma of the rectum.
2. The lesion must be located in the rectum. For purposes of this study, the lesion must be within 12 cm of the anus as measured by sigmoidoscopy.
3. Patients must have indication of a locally advanced lesion defined for this study as tumor through the bowel wall (\> T3) or involving regional lymph nodes (\>N1). Clinical stage determination may be made by physical examination (for T4 lesions only), endoscopic ultrasound or CT scan of pelvis.
4. Patients with metastatic disease are eligible provided operative intervention on primary site is anticipated.
5. Patients must have adequate organ function defined as pretreatment leukocyte count \> 3,000/ul, platelet count \> 100,000/ul, serum creatinine \< 2.0 mg/dl, serum bilirubin \< 2 mg/dl. Note: Capecitabine is contraindicated in patients with severe renal impairment (creatinine clearance \< 30 ml/min). In patients with calculated creatinine clearance of 30-50 ml/min capecitabine will begin at (-)1 level dose reduction (see section 6.3)
6. Patients must be at least 18 years of age and have a Zubrod performance status of \< 2 (see appendix 1.)
7. Patients must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to the initiation of therapy.

Exclusion Criteria:

1. Patients may not have received previous pelvic irradiation for any indication, or previous chemotherapy for cancer therapy within the preceding 6 months.
2. Patients must have no other serious medical or psychiatric illness that would limit the ability of the patient to receive protocol therapy or provide informed consent.
3. Pregnant or lactating women may not participate. Women/men of reproductive potential must agree to use an effective contraceptive method.
4. Patients with lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome are not eligible.
Allogeneic Platelet Lysate Eye Drops for the Treatment of Severe Chronic Ocular Graft-versus-host Disease

The study evaluates the efficacy and safety of allogeneic platelet lysate eye drops in patients with severe ocular graft versus host disease refractory to conventional systemic and local treatments. The corneal staining, conjunctival hyperemia, tear film break up time,Schirmer test and ocular surface disease index will be evaluated before and after allogeneic platelet lysate treatment. The safety of allogeneic platelet lysate treatment will be also assessed.

The corneal staining with fluorescein will be assessed using Oxford grading scale.

Tear film break up time is the time in seconds taken to appear first dry sport after complete blinking. Fluorescein is instilled into the patient tear film, the tear film is observed under cobalt blue illumination.Schirmer test will be performed without anesthesia. Conjunctival hyperemia will be graded from 0 to 2. The OSDI questinnaire will assess the impact of treatment on the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Severe ocular chronic graft-versus-host disease (keratoconjunctivitis sicca) after allo-HSCT
* Schirmer test \< 5mm\\5min
* Tear Film Break-up Time \< 5sec
* Corneal staining \> II Gr (Oxford grading scale)
* Ocular Surface Disease Index (OSDI) \>30
* Resistance to conventional therapy

Exclusion Criteria:

* Karnofsky \<30%
* Other concomitant conditions, which does not allow to adequately assess the condition of the eye surface;
* Acute bacterial, viral or fungal infection of the eyes at the time of screening;
* Somatic or mental pathology that does not allow you to sign an informed consent;
* Keratoconjunctivitis sicca associated with an anomaly of the eyelids.
A Study to Compare the Pharmacokinetics of Two Different Tablets of Sotorasib in Healthy Participants

The primary objective of this study is to compare the pharmacokinetics (PK) of sotorasib dose A administered orally as 3 tablets (test) to sotorasib dose A administered orally as 8 tablets (reference).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 30 kg/m\^2 (inclusive), at the time of Screening.
* Females of nonchildbearing potential.

Exclusion Criteria:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
Additional Autoimmune Diseases With Type 1 Diabetes in Pediatrics at Diabetes Diagnosis and During Follow-up

This study aims to describe the prevalence of additional autoimmune diseases and their specific antibodies at type 1 diabetes (T1D) diagnosis, and their incidence rate during follow-up, for children and adolescents. It also aims to describe the characteristics of the pediatric cohort followed since 2014 for type 1 diabetes by one of France's centers of reference for paediatric diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes diagnosed with the following criteria: (i) Classic symptoms of diabetes or hyperglycemic crisis, with plasma glucose concentration ≥11.1 mmol/L (200 mg/dl), or (ii) fasting plasma glucose ≥7.0 mmol/l (≥126 mg/dl) ; and (iii) presence of diabetes associated autoantibodies : ICA, GAD, IA2, IAA and/or ZnT8
* age \< 18 years old at type 1 diabetes diagnostic
* type 1 diabetes diagnosed between 2014-01-01 and 2021-02-01

Exclusion Criteria:

* type 1 diabetes diagnostic not certain
Multimodal Assessment of Knee Conditions

The purpose of this study is to assess both osteoarthritis and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint.


Eligibility Criteria:
Inclusion Criteria:

* Age 45 - 65

Exclusion Criteria:

* Rheumatoid arthritis
* Weight over 110 kg
* Previous total knee replacement surgery
* Contraindications to MRI
Feasibility of Using Ultrasound to Track Respiration Motion

The purpose of this study is to evaluate the effectiveness of using ultrasound to image and track pancreas/duodenum motion during radiation therapy treatment delivery. Also develop a workflow and process to allow the final ultrasound system to be used routinely by radiation therapists.

1. Acquire 2D and 3D ultrasound images for 5 pancreatic cancer patients using the existing Clarity system with a hand-held probe. The visibility of pancreas, duodenum, and other organs will be evaluated. Based on this image acquisition experience, design and construct stands to hold the ultrasound probe. Issues to be considered in the design include (i) avoiding the stand and probe blocking radiation beams, (ii) avoiding ultrasound going through the ribs, (iii) minimizing the effect of respiration motion. Also explore building the probe into the immobilization device (e.g., Alpha cradle) or using robotic arm.
2. Acquire ultrasound images for 20 patients with pancreatic cancer treated in the Department of Radiation Oncology department using the tools developed in Aim 1. As the standard practice, the 4 dimensional CT (4DCT) and 4 dimensional (4D) morphological and physiological MRI (T1, T2, apparent diffusion coefficient, DWI) will be acquired for treatment planning, and a respiration-gated CT will be acquired immediately before the delivery of each fraction using an in-room CT or cone-beam CT for patient positioning. The ultrasound images may be acquired during initial simulation immediately before or after the planning 4DCT and the daily gated CT, and during the treatment delivery in 2D, 3D and/or 4D modes. All raw ultrasound data will be stored.
3. Process ultrasound data acquired above to evaluate the effectiveness of using ultrasound to image and to track pancreas/duodenum motion during the treatment delivery. The images will be processed to visualize pancreas and/or surrogates, such as the boundary between pancreas and duodenum, infusion catheter. To improve the visible appearance, elastography will be explored by processing the raw data collected in Aim 2. Existing software will be used, and may be modified if necessary, to segment and to register ultrasound with CT. A tool the investigators previous develop for multimodality registration will be used to register ultrasound with MRI. Anatomic markers, such as the boundary between pancreas head and duodenum, stent, infusion catheter, may be used for registration and/or motion tracking.
4. Develop/modify workflow and process to allow the final system to be used routinely by radiation therapists. If necessary, user-friendly software tools will be developed/incorporated in the final system.
5. Explore the use of Doppler mode for tissue characterization and the potential of using it to image radiation effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will receive standard radiation therapy for pancreas cancer

Exclusion Criteria:

* Patients who will receive standard radiation therapy for sites other than pancreas cancer
Stem Cells and Resynchronization Cardiac

Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant with Cardiac Resynchronization Therapy in these patients.

About 120cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution the mononuclear cells are injected into the cardiac muscles with fibroses area through 20 shots.This procedure is indicated for patients with cardiac ischemia and left ventricular dysfunction(desynchrony), on whom all the others known therapies have failed.

Eligibility Criteria:
* Dilated Cardiomyopathy
* Heart Failure
* Optimized Therapeutics
* Ventricular Desynchrony
* Functional Class III or IV
* Ejection Fraction(Echo/ Sympson) \< 35%
Qualitative Analysis of Barriers to Consistent Use of Neuromuscular Monitoring in General Anaesthesia

Monitoring the degree of neuromuscular blockade in general anaesthesia reduces complications and patient discomfort. However, monitoring is not applied consistently by Danish anaesthesia personnel. Surveys show that part of the explanation is that the anaesthetists often experience problems with the equipment used for monitoring, though the problems have not been described in detail.

We hypothesise that the lack of consistent monitoring in general anaesthesia is caused by insecurity in the anaesthesia personnel's set-up and use of the equipment, as well as in interpreting the measurement results.


Eligibility Criteria:
Inclusion Criteria:

* has been working in the field of anaesthesiology for at least 1 year.

Exclusion Criteria:

* none
Clinical, Molecular and Physiopathological Study of Cohen Syndrome and Cohen-like Syndromes

This project will make it possible to better understand the natural history of Cohen Syndrom and the phenotypes associated with mutations in the VPS13B gene, to improve the therapeutic management of patients. It will also provide a better description of Cohen-like syndrome for genetic counselling for the families concerned.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting Cohen syndrome and two VPS13B mutations
* who accept a clinical evaluation, and to provide at least one blood sample
* Patients presenting the diagnostic criteria of Cohen syndrome, but without a VPS13B mutation
* Patients presenting neutropenia or pigmentary retinopathy and at least one of the following signs, after exclusion of any other syndrome: mental retardation, microcephaly, truncal obesity

Exclusion Criteria:

* - Patients who do not meet the clinical and/or molecular criteria
* Patients who do not wish to provide a blood sample for question 1,
* Patients who have not provided written informed consent,
* Pregnant or breast-feeding women,
* Persons not covered by National Health Insurance and persons under guardianship or in prison.
Open-Label Safety Extension Study of Avonex

To collect data on serious adverse events which occur during extended treatment with Avonex in subjects at high risk for developing multiple sclerosis (MS) and in subjects with secondary progressive MS.


Eligibility Criteria:
Inclusion Criteria:

* Must have completed (as defined below) one of the following Biogen AVONEX® clinical studies and meet the other criteria indicated.
* Subjects enrolled from studies C95-812 and C97-830 must have completed their respective study within 12 months prior to enrollment in C98-838. Subjects enrolled from study C96-823 must have completed the study within 24 months prior to enrollment in C98-838.
* have not been diagnosed with any other disease that accounts for their neurologic symptoms.

Exclusion Criteria:

* History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta.
* History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin.
* History of seizure within the 3 months prior to enrollment.
* Abnormal laboratory results at the screening visit:
* History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment into this study.

Other inclusion and exclusion criteria apply as per Biogen Idec Protocol