cyrilzakka/clinical-trials huggingface dataset:
A Randomized Controlled Trial of VSL#3 for the Prevention of Endoscopic Recurrence Following Surgery for Crohn's Disease.

This randomized placebo-controlled double-blind, multi-centre trial will determine the efficacy of the probiotic VSL#3 in the prevention of Crohn's disease development following surgical resection and re-anastomosis. A total of 120 patients will be randomly assigned in a 1:1 ratio to receive VSL#3 or placebo for 90 days. Patients who respond to study treatment, as defined by the absence of a severe endoscopic recurrence at day 90, will be offered open-label VSL#3 for an additional 9 months.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects 16 years of age or older
2. Diagnosis of Crohn's disease
3. Resection of ileocolonic Crohn's disease and small bowel to colonic anastomosis within 30 days of randomization
4. Able to provide informed written consent
5. Women of child-bearing potential with a negative serum pregnancy test, and/or use of effective contraception

Exclusion Criteria:

1. Use of perioperative steroids in tapering doses and anti-diarrheal agents
2. Treatment with a TNF-antagonist in the 8 weeks prior to resection
3. Clinically significant Crohn's disease elsewhere in the GI tract
4. Clinically documented short bowel syndrome
5. Serious disease other than Crohn's disease
6. Impaired liver or renal function
7. History of cancer with less than 2 years disease-free state
8. Abnormal Laboratory values
9. Alcohol or drug abuse
10. Some psychiatric conditions
11. Patients using other study medications
12. Patients who are unable to attend study visits or comply with study procedures
13. Positive pregnancy test
Validation Study of Linear Quantification of CD3+ Cells in Localized Colorectal Carcinomas

The purpose of this study is to confirm that linear quantification of CD3+ cells is a prognostic biomarker in localized colorectal carcinomas.

Adult patients of both gender who have underwent surgical resection of stage III colorectal carcinoma and randomised to receive a chemotherapy FOLFOX or FOLFOX + Cetuximab in the PETACC8 trial.

Eligibility Criteria:
Inclusion Criteria:

* Patient included in PETACC08 study
* Signed informed consent for translational study
* FFPE tumor sample available for CD3 staining

Exclusion Criteria:

- Patient who have withdrawn their consent for PETACC08 and/or for PETACC08 translational study
Evaluation of Fructans Supplementation on Parameters of Metabolic Syndrome

Obesity is constantly increasing, causing an important risk to develop diseases such as heart disease, diabetes,... Some recent studies have shown that obese people present modifications of colon microflora and a low-grade inflammation.

In our laboratory, we have demonstrated that the intake of fructans lessens dietary intake, body weight gain, adipose tissue accumulation and steatosis in rodents. These effects lead to an improvement of insulin resistance and hyperglycemia in diabetic rats and mice. Fructans are also able to restore the microflora disturbed by a high fat diet and to prevent endotoxemia. Moreover, studies have shown that fructans intake promotes satiety (Cani et al, Diabetes 2007) and or decreases fat mass (Abrams et al, Journal of Pediatrics 2007) in healthy human. An intervention study in obese patients is thus needed to study the effects of fructans in the target population.


Eligibility Criteria:
Inclusion Criteria:

* BMI\>30 kg/m2

Exclusion Criteria:

* acute or chronic evoluting disease
* alcohol consumption \> 30 units/week
* more than 30 minutes of sports 3 times/week
* usual consumption of pre/probiotics or fibers supplement
* recent consumption of antibiotics
* slimming diet or unusual diet
* pregnant women
* anti-diabetics drugs ou slimming drugs
* previous bariatric surgery
* severe oesophagus reflux
Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 Infection

The objectives of this intermediate-size expanded access protocol are to assess the safety and efficacy of remestemcel-L in participants with ARDS due to coronavirus infection 2019 (COVID-19).

This intermediate-size expanded access protocol plans to treat approximately 50 adult participants, male and female, with moderate to severe ARDS due to COVID-19 infection. Participants who are 18 years of age or older will be enrolled at multiple clinical sites across the United States.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older
2. Participant has coronavirus disease COVID-19 confirmed by real-time reverse transcription polymerase chain reaction (RT-PCR) assay or another diagnostic test
3. Moderate to severe ARDS as determined by the following criteria (adapted from the Berlin criteria):

   * Bilateral opacities must be present on a chest radiograph or computed tomographic (CT) scan. These opacities are not fully explained by pleural effusions, lobar collapse, lung collapse, or pulmonary nodules.
   * Respiratory failure not fully explained by cardiac failure or fluid overload. An objective assessment (e.g., echocardiography) to exclude hydrostatic pulmonary edema is required if no risk factors for ARDS are present.
   * Moderate to severe impairment of oxygenation must be present, as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2). The severity of the hypoxemia defines the severity of the ARDS:

     * Moderate ARDS: e PaO2/FiO2 \>100 millimeters of mercury (mmHg) and ≤200 mmHg, on ventilator settings that include positive end-expiratory pressure (PEEP) ≥5 centimeters (cm) of water OR
     * Severe ARDS: PaO2/FiO2 ≤100 mmHg on ventilator settings that include PEEP ≥5 cm of water
4. ≤72 hours post-initiation of ventilation
5. High sensitivity C-reactive protein (hs-CRP) serum level ≥ 4.0 milligrams per deciliter (mg/dL)
6. Acute Physiologic and Chronic Health Evaluation (APACHE II) score ≥5
7. Aspartate aminotransferase/alanine transaminase (AST/ALT) \< 5x upper limit of normal (ULN)
8. Creatinine clearance ≥ 30 milliliters per minute (mL/min)
9. Serum creatinine \<2 mg/dL

Exclusion Criteria:

1. Participant is receiving extracorporeal membrane oxygenation (ECMO)
2. Females who are pregnant or lactating
3. Known hypersensitivity to dimethyl sulfoxide (DMSO) or to porcine or bovine proteins
4. Severe chronic obstructive pulmonary disease (COPD) requiring oxygen therapy prior to becoming ill with ARDS due to COVID-19 infection
5. Any end-stage organ disease which, in the opinion of the treating physician, may possibly affect the safety of the remestemcel-L treatment
Effect of Bosentan in Scleroderma Renal Crisis

Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular phenomena that involves multiple organs. Scleroderma Renal Crisis (SRC) occurs in 5% of patients and mainly with diffuse cutaneous SSc. The routine use of angiotensin-converting enzyme inhibitors (ACEI) has been reported to dramatically improve outcome, with a fall of the 12-month mortality from 76% to less than 15% in the United-States. Despite prognostic improvement, SRC remains a severe manifestation of SSc and functional outcome and survival remains poor. Bosentan is a specific, orally active, dual endothelin receptor antagonist that has recently been approved for the treatment of primary pulmonary arterial hypertension and for the prevention of ischemic digital ulcers. Bosentan could have therapeutic benefits on others vascular injuries and particularly in SRC.

Systemic sclerosis (SSc) is a connective tissue disease characterized by excessive collagen deposition, autoimmunity and by vascular hyper-reactivity and obliterative microvascular phenomena that involves multiple organs. Scleroderma Renal Crisis (SRC) occurs in 5% of patients and mainly with diffuse cutaneous SSc. The routine use of angiotensin-converting enzyme inhibitors (ACEI) has been reported to dramatically improve outcome, with a fall of the 12-month mortality from 76% to less than 15% in the United-States. Despite prognostic improvement, SRC remains a severe manifestation of SSc and functional outcome and survival remains poor. Bosentan is a specific, orally active, dual endothelin receptor antagonist that has recently been approved for the treatment of primary pulmonary arterial hypertension and for the prevention of ischemic digital ulcers. Bosentan could have therapeutic benefits on others vascular injuries and particularly in SRC.

Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥ 18 years
* Patients had to fulfil ACR and/or LEROY et MEDSGER criteria for systemic sclerosis
* Patients had to fulfil criteria for renal systemic sclerosis
* Written informed consent obtained

Exclusion Criteria:

* Scleroderma renal crisis occuring before the age of eighteen
* Patients who are receiving bosentan within one month of inclusion for pulmonary arterial hypertension or digital ulcers prevention
* Other treatment by selective or nonselective antagonist endothelin receptor
* Left ventricle systolic dysfunction (EF \< 40 %)
* Patients with systolic blood pressure \< 85mm Hg
* Progressive cancer or considered cured for less than 5 years
* Patients with a known hypersensitivity to bosentan or any of the excipients
* Patients with HIV, HCV, HBV infection
* Patients with Liver disease Child-Pugh B and C
* Patients who are pregnant or breast-feeding
* Women of child-bearing age who are sexually active without practising reliable methods of contraception
* Patients who do not give informed consent
Dose Dense Chemotherapy With Lipegfilgrastim Support in Early Breast Cancer

This is a prospective, non-interventional, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with lipegfilgrastim support in early breast cancer.

An important advance in the use of dose dense chemotherapy regimens for breast cancer was the development of pegylated form of G-CSF (pegfilgrastim and lipegfilgrastim), which offered the convenience of single subcutaneous injection, rather than multiple daily injections

Lipegfilgrastim is a pegylated long-acting covalent conjugate of filgrastim (G-CSF). In a pivotal randomized phase III study in breast cancer lipegfilgrastim was shown to be non-inferior to pegfilgrastim.

In this prospective observational study the incidence of treatment-related neutropenia following four cycles of dose dense (every 2 week) doxorubicin cyclophosphamide (AC) with lipegfilgrastim support is being investigated.

Data will be collected on 40 consecutive patients treated with AC and lipegfilgrastim in Ireland.

The primary objective of this study is to determine the incidence of treatment-related neutropenia following four cycles of dose dense doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).

Secondary Objectives

1. Determine the incidence of febrile neutropenia during 4 cycles (8 weeks)of dose dense AC with lipegfilgrastim
2. Examine the incidence of treatment-related neutropenia during subsequent intravenous cancer therapy up to 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Stage I-III Breast Cancer
3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1(see below)
4. Adequate Bone Marrow Function as defined by neutrophil count of ≥1.0 and platelet count of ≥ 100
5. Planned chemotherapy with Dose Dense Doxorubicin-Cyclophosphamide (AC) as deemed appropriate by a Consultant Medical Oncologist

General Indications for Dose Dense AC include:

1. T3 or T4 Tumours
2. N1 - N3 (Node Positive) Disease
3. Human Epidermal Growth Factor Receptor 2 (HER2) Positive Tumours.
4. Triple Negative Breast Cancer as evidenced by lack of expression of the estrogen receptor (ER), progesterone receptor (PR) and HER2

Exclusion Criteria:

1. Stage IV Breast Cancer
2. Pregnancy
3. Previous Chemotherapy Exposure
4. Prior Exposure to G-CSF
5. Known positive HIV Status
6. Cardiac or other concurrent illness, which at the investigator's discretion contraindicates the use of AC
3D Interlocking Miniplates in Fixation of Mandibular Fractures in the Mental Foramen Region: A Split-mouth Study

the study aims to compare 3D Interlocking miniplates with conventional miniplates in management of mandibular parasymphyseal fractures both clinically and radiographically.

A total of 12 patients with recent bilateral parasymphyseal mandibular fractures were treated with 3D Interlocking miniplates on one side and with conventional two miniplates in the other side. Clinical evaluations were carried at multiple intervals up to 6 weeks postoperatively, with radiographic assessments performed immediately after surgery and at 12 weeks to measure mean bone density at the fracture line

Eligibility Criteria:
Inclusion Criteria:

* patients with recent bilateral mandibular fracture located in the mental foramina region.
* adults without gender predilection who agreed to follow-up,
* fractures requiring open reduction and internal fixation, and
* those medically fit for general anesthesia were included

Exclusion Criteria:

* medically compromised patients,
* fractures with infection,
* pathological or old fractures,
* completely edentulous patients,
* comminuted fractures
Pembrolizumab in Combination with Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients with Soft Tissue Sarcoma - EFTISARC-NEO Trial

This is a phase II single-arm single-stage study evaluating efficacy and safety of pembrolizumab in combination with a soluble LAG-3 protein, eftilagimod alpha (Efti) and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas. This study will determine the pathologic response rate (defined as percentage of tumor hyalinization/fibrosis) to the combination treatment.

Systemic therapy with pembrolizumab and eftilagimod alpha and radiotherapy are administered concurrently. Systemic treatment lasts for 9 weeks (study week 1-9). Radiation therapy lasts for 5 weeks (5 days per week) in weeks 2-6. Surgery takes place 5-6 weeks after completion of radiation therapy (week 11-12). Any adjuvant treatment (chemotherapy, immunotherapy, radiation therapy) after surgical treatment is not allowed. Patients will be then followed up regularly for a period of 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Primary or locally recurrent deep-seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) soft tissue sarcoma
* Grade 2 or 3 tumors according to Fédération Nationale des Centres de Lutte contre le Cancer (FNCLCC);
* Size of the primary tumor \&gt;5 cm at instrumental staging (CT, MRI), or locally recurrent of any size;
* Measurable disease based on RECIST 1.1;
* Non-metastatic disease;

Exclusion Criteria:

* Ewing sarcoma, Alveolar and embryonal rhabdomyosarcoma
* Previous treatment with eftilagimod alpha, anti-PD-1 or anti-PD-L1;
* Prior radiotherapy to tumor-involved sites;
Stress Adenosine Cardiac Magnetic Resonance (MR) Comparison With Single Photon Emission Computed Tomography (SPECT) Imaging

This study is designed to determine the diagnostic value of adenosine cardiac magnetic resonance (CMR) when compared with SPECT.

The investigators hypothesized that adenosine CMR could detect ischemia and is not inferior to SPECT imaging. In addition stress adenosine cardiac MRI offers a "one stop shop" enabling evaluation of cardiac function, rest and stress perfusion and viability.


Eligibility Criteria:
Inclusion Criteria:

* Suspected ischemia referred to SPECT stress imaging

Exclusion Criteria:

* Standard contraindications to MRI including (pacemaker/defibrillator, metallic clips on brain aneurysms, metal fragment in the eye, etc...)
* Congestive heart failure.
* Hemodynamic instability.
* History of asthma or bronchospastic disease.
* Arrhythmia
* Creatinine \>1.4
* Non compliant patient, not able to lie supine in the MRI scanner for 1 hour.
* Pregnant patients
* Patients for whom the repeat stress might pose a significant risk.
Does Etanercept Influence Tweak Modulation of Inflammation During Inflammatory Rheumatisms (Psoriatic Arthritis and Rheumatoid Arthritis)?

TWEAK (TNF weakly inducer of apoptosis) is a type II-transmembrane protein, member of the TNF ligand superfamily that can be cleaved to function as a soluble cytokine. Depending on target cell type, TWEAK triggers multiple cellular responses ranging from modulation of inflammation to cell death when it binds to its main receptor, Fn 14. Our team has been the first to describe pro-inflammatory effects of TWEAK during central nervous system inflammation. Various data support the possibility that TWEAK produced by synovial macrophages may contribute to chronic synovitis in animal models and in humans. In psoriatic arthritis (PsoA), anti-TNF therapy has been successful concording with the key role of TNF in the pathogenesis of this disease and the generation by psoriatic patients of neutralizing anti-TNF autoantibodies referred as "beneficial autoimmunity to pro-inflammatory mediators". In 2010, Van Kuijk et al. have described a high expression of TWEAK in the inflammatory synovial of PsoA and rheumatoid arthritis (RA) patients before and after anti-TNF therapy. The role of TNF-alpha in the regulation of TWEAK expression remains unclear.


Eligibility Criteria:
Inclusion Criteria:

* · Group RhPso :
* Fill(Perform) the criteria CASPAR of the Rheumatism psoriasic (Taylor W, on 2006)
* rheumatoid Absence of factor and antibody anti-CCP(anti-post office account) (cyclic citrulline peptide) in the serum
* Indication established to begin a treatment with etanercept

  · Group PR
* Fill(Perform) the criteria of the ACR (American College of Rheumatology) for PR (revised in 1987) (Arneth FC, on 1988)
* Presence of antibody anti-CCP(anti-post office account) in the serum
* Indication established to begin a treatment with etanercept

Exclusion Criteria:

* Minors(Miners)
* pregnant or breast-feeding Women
* Adults under guardianship
* Nobody staying in a sanitary or social establishment
* Persons in emergency situation and/or not beneficiaries of a national insurance scheme
* Private persons of freedom
* Arthritis or not labelled polyarthritis
* Contraindication established in the treatment(processing) by etanercept
* PUVAthérapie or cyclosporine or high dose of corticosteroid therapy (except intra-articular infiltration) or other anti-TNF treatment(processing) in two months preceding the inclusion
Safety and Pharmacokinetics of Intravenous and Oral APX001 in Patients With Acute Myeloid Leukemia (AML) and Neutropenia

An open-label, multi-center, Phase Ib study to determine the safety and pharmacokinetics of intravenous and oral APX001 in patients undergoing chemotherapy for Acute Myeloid Leukemia with neutropenia.

A total of 20 patients will be enrolled in this study. 10 patients in Cohort I, intravenous drug dosing and 10 patients will be enrolled in Cohort II, oral drug dosing.

All patients will receive chemotherapy for their AML according to local clinical standard of care as well as antifungal prophylaxis.

APX001 will be administered for 14 consecutive days, beginning on Study Day 3 after onset of chemotherapy


Eligibility Criteria:
Key Inclusion Criteria:

* Provision of written consent
* Ages 18-75 inclusive, male or female
* Diagnosis of Acute Myeloid Leukemia
* Patients entering first induction treatment chemotherapy
* Expected to be neutropenic (\<500 ANC/ul) for \>/= 10 days

Key Exclusion Criteria:

* Patients who received systemic antifungal therapy for proven or probable fungal infections within the last 12 months
* Current fever (\> 38 degrees Celsius)
* Concomitant use of rifampin, rifabutin, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, long acting barbiturates, neostigmine and carbamazepine
The Effect of Cycloserine on Smoking Behavior in Nicotine Dependent Smokers

A total of 20 subjects will participate in this four week, between groups, double-blind, placebo controlled study. Subjects will participate in two experimental sessions separated by approximately one week. Subjects will be randomized to receive either 50 mg cycloserine or placebo combined with cue exposure. Several physiological and subjective outcome measures (e.g., heart rate, blood pressure, galvanic skin response) will be obtained during the sessions. Experimental sessions will last approximately 4.5 hours with follow-up sessions lasting approximately thirty minutes. Our aims are:

1. To examine the effect of cycloserine vs. placebo on extinction of smoking cue reactivity in overnight abstinent smokers. Reactivity to smoking cues will be captured with self-report smoking urges and physiological measures (heart rate, blood pressure, and skin conductance).

   We hypothesize that cycloserine, relative to placebo, will facilitate extinction of smoking cue reactivity.
2. To examine the effect of cycloserine vs. placebo when combined with two 4.5 hour laboratory cue exposure training sessions, on smoking behavior in smokers. Smoking behavior will be measured with self-report smoking and saliva cotinine levels.
3. To examine the effect of cycloserine vs. placebo on memory performance in nicotine dependent smokers. Memory performance will be measured with verbal learning, recognition and recall tasks.

4) To examine the safety and tolerability of cycloserine treatment in smokers. We hypothesize that cycloserine will be well tolerated by smokers.


Eligibility Criteria:
Inclusion Criteria:

* female and male smokers, aged 18 to 55 years;
* history of smoking daily for the past 12 months, at least 10 cigarettes daily;
* CO level \> 10ppm;
* for women: not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods other than OCP;
* Non-treatment seeking nicotine dependent smokers.

Exclusion Criteria:

* history of heart disease, renal or hepatic diseases or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study;
* regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and/or recent psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, schizophrenia and panic disorder within the past year;
* current dependence on alcohol or on drugs other than nicotine;
* regular use of any other tobacco products than cigarettes, including smokeless tobacco and nicotine products;
* allergy to cycloserine;
* subjects with epilepsy or a history of seizures;
* Treatment seeking nicotine dependent smokers.