cyrilzakka/clinical-trials huggingface dataset:
Real-Life Study With Nivolumab (BMS-936558) in Advanced NSCLC Patients After Prior Chemotherapy

This study intends to describe the real-life effectiveness and safety of nivolumab in advanced NSCLC patients in Germany, as well as the patient profile, pattern of use and the quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC, Stage IIIB/Stage IV
* Decision to initiate a treatment with Nivolumab for the first time already undertaken by physician
* Males and Females, ≥18 years of age

Exclusion Criteria:

* Current primary diagnosis of a cancer other than advanced NSCLC. Example: A cancer other than NSCLC that requires systemic or other treatment.
* Pre-treatment with Nivolumab and/or Ipilimumab (pre-treatment with checkpoint-inhibitors other than Nivolumab and Ipilimumab, and Tyrosine Kinase Inhibitors(TKIs) is allowed)
* Current participation in an interventional clinical trial for treatment of NSCLC. (Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. For blinded studies, the treatment administered needs to be known)

Other protocol defined inclusion/exclusion criteria could apply
Effects of a Non-nutritive Sweetener Reduction Intervention in Pregnancy and Lactation on Maternal and Infant Outcomes

The effects of consuming non-nutritive sweeteners (NNS) during pregnancy and lactation on infant obesity and cardiometabolic disease risk are not well understood. In this project, pregnant women who frequently consume NNS will be randomly assigned to an NNS-restriction intervention (NNS restriction during pregnancy and lactation or during lactation only) or a control group (no NNS restriction) to determine whether NNS consumption during pregnancy and/or lactation affects infant body composition, maternal blood sugar during pregnancy, and the infants' gut microbiome and metabolome. The results of this study have the potential to shape recommendations around NNS consumption during pregnancy and lactation, thereby potentially improving maternal and infant metabolic health and reducing the global burden of obesity and cardiometabolic disease.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* ≤ 16 weeks\&#39; gestation
* Singleton pregnancy
* Report frequent NNS beverage consumption (≥ 7 servings/week)
* 18-45 years of age
* Able to read English at a 5th grade level; and
* Intend to breastfeed for at least the first 6 months of life.
* For infants: The mother must be enrolled and provide assent for the infant to participate.

Exclusion Criteria:

* Physical or mental concerns preventing study participation;
* Medication (e.g., metformin; GLP-1 agomists) use that may affect body weight, body composition, insulin resistance, or lipid profiles;
* Tobacco or drug use during pregnancy;
* Alcohol consumption (\&gt;1 drink per week) during pregnancy;
* Pre-existing gastrointestinal, inflammatory, or malabsorptive disorders (e.g., - Crohn\&#39;s disease, ulcerative colitis, inflammatory bowel disease) that may impact NNS absorption or gut microbiota;
* Known suspected/confirmed genetic fetal abnormalities or suspected or known congenital birth defects.
Evaluation of the Safety and Effectiveness of ALLEVYN Gentle Border

The clinical study will evaluate the safety and effectiveness of the ALLEVYN Gentle Border. The study is a post-market clinical follow-up to assess clinical performance and safety of ALLEVYN Gentle Border with new wound contact layer to support performance claims.


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent.
2. 18 years of age or older.
3. Willing and able to make all required study visits.
4. Able to follow instructions and deemed capable of completing the CWIS questionnaire, Patient Assessment Scale and Pain Scale.
5. Presence of a moderately to highly exuding wound of at least 3cm2 in size.
6. Presence of a chronic wound of at least 6 weeks duration at the point of enrollment; full-thickness, partial thickness or shallow granulating wounds.

   Chronic wounds include:
   * pressure ulcers or
   * leg ulcers or
   * diabetic foot ulcers

   or

   Presence of an acute wound at the point of enrollment; full thickness, partial thickness or shallow granulating wounds

   Acute wounds include:
   * dehisced surgical or
   * traumatic wounds
7. The patient has a wound size which can be treated with the available sizes and shapes of ALLEVYN Gentle Border. Cutting of the dressing is allowed, if needed. ALLEVYN Gentle Border can be cut and an aseptic technique should be used with cutting the dressing. Ensure any exposed foam areas are covered with an appropriate film dressing taking care not to cover the entire dressing.

Exclusion Criteria:

1. Subjects with confirmed or suspected clinically infected reference wound.
2. Reference wound undergoing treatment with compression therapy.
3. Contraindications or hypersensitivity to the use of the ALLEVYN Gentle Border.
4. Participation in the treatment period of another clinical trial within 30 days of Visit 1 or planned participation overlapping with this study.
5. Subjects with skin features (e.g. tattoos, skin color, pre-existing scarring) which, in the opinion of the Investigator, could interfere with the study assessments.
6. Subjects who have participated previously in this clinical trial.
7. Subjects with a history of poor compliance with medical treatment.
8. Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study
Topical Timolol: a Comparison of Surgical Outcomes

The use of topical beta-blockers, such as 0.25% timolol, in promoting wound healing is currently emerging in the literature. The investigators will enroll 30 participants in a split scar study who have their skin cancer surgically removed resulting in a linear wound equal to or longer than 4cm. The objective of this randomized study is to determine the safety and efficacy of 0.25% timolol in promoting wound healing in wound closed primarily greater than or equal to 1.5 cm.

Topical timolol has shown in case series to improve healing time and cosmetic outcome of ulcerated or non-healing wounds with improved cosmetic outcome when compared to standard wound care. There is currently no research detailing if this improved outcome is applicable when used with wounds approximated with sutures.

Mechanism of action is not fully elucidated but improved keratinocyte migration and suppression of the inflammatory cascade is thought to improve wound healing. Skin cancer surgeries have morbidity for patients as they are often in cosmetically sensitive locations. Improving cosmetic outcomes of surgical scars could improve patient outcomes and overall satisfaction.

The goal of this study is to determine if topical timolol will improve long-term cosmetic outcomes of surgical scars and thereby improve patient outcomes. There is great variability in how a surgical site heals depending on patient factors as well as surgical site location. The investigators will perform a split scar study to allow each patient to be their own control to account for this variability.

To assess the efficacy and safety of topically applied 0.25% timolol in promoting wound healing in surgical primary linear wound greater than or equal to 4cm versus standard of care (SOC) by:

1. Evaluating cosmetic outcomes of surgical wounds in terms of blinded physician and patient assessment at 30 days and 90days following suture removal
2. Evaluating patient discomfort by patient questionnaire.
3. Determining the side effects associated to 0.25% topical timolol versus SOC;

Eligibility Criteria:
Inclusion Criteria:

* skin wounds greater than or equal to 4cm, closed primarily and linearly following standard excision or Mohs

Exclusion Criteria:

* Past medical history of psoriasis
* known history of sensitivity to beta blockers or topical timolol
* pregnant women
Using Ferumoxytol-Enhanced MRI to Measure Inflammation in Patients With Brain Tumors or Other Conditions of the CNS

This pilot clinical trial study will assess the inflammatory response of brain tumors or other central nervous system conditions in pediatric and adult patients using ferumoxytol-enhanced MRI. Imaging features will be correlated with the number of inflammatory cells (macrophages) at histopathology. Determining the extent of inflammation associated with pathologies in the central nervous system may be helpful for diagnostic and prognostic purposes as well as monitoring treatment response of current and future immunotherapies.

In this study, we will establish the MR imaging characteristics of macrophages in malignant brain tumors and other CNS conditions in the pediatric and adult populations using ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle that is approved for the treatment of iron deficiency anemia in patients with chronic kidney disease. The investigators will correlate the MR signal of ferumoxytol uptake with the number of macrophages in surgical specimen at histopathology. This information may potentially offer clinicians a new means for risk stratification and monitoring treatment efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with suspected brain tumor diagnosed by MRI
* Patients undergoing neuro-imaging evaluation by the neurosurgical service for other indications (e.g. vascular malformations, traumatic brain injury, ischemic and hemorrhagic stroke, CNS infections, and neuro-degenerative diseases)

Exclusion Criteria:

* Informed consent cannot be obtained either from the patient or legal representative
* Severe coexisting or terminal systemic disease that limits life expectancy or that may interfere with the conduct of the study
* Contraindication to MRI (metal implants)
* Hemosiderosis/hemochromatosis
* Need for sedation or anesthesia (claustrophobia) that will not otherwise be undertaken as part of routine clinical care (e.g. routine MRI under sedation already planned)
* Known hypersensitivity to Feraheme (ferumoxytol) or any of its components
* Iron overload from any cause (not just hemosiderosis or hemochromatosis), even if secondary to frequent blood transfusions, severe chronic hemolysis, excess dietary or parenteral iron, or any other etiology
A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection

This randomized, multicenter, partially double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effects of treatment with RO6864018 in virologically suppressed participants with chronic HBV infection.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B infection
* Positive test for HBsAg for more than 6 months prior to randomization
* HBsAg titer greater than or equal to (\>/=) 250 international units per milliliter (IU/mL) at Screening
* Treatment with any nucleoside/nucleotide analogue for \>/= 1 year with ongoing entecavir and/or tenofovir treatment at randomization and for at least 3 months prior to randomization
* HBV DNA less than (\<) 90 IU/mL for at least the preceding 6 months
* HBeAg positive at randomization and for at least 6 months prior to randomization

Exclusion Criteria:

* Pregnant or lactating women
* Documented history of HBV genotype D
* History or other evidence of bleeding from esophageal varices
* History of decompensated liver disease, chronic liver disease other than HBV infection, or any evidence of metabolic liver disease
* Positive test for hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
* Documented history of hepatitis D infection
* History of or suspicion of hepatocellular carcinoma
* History of immunologically mediated disease
* History of organ transplantation
* History of thyroid disease
* Significant acute infection
Bolus Versus Continuous Remimazolam for Anesthetic Induction

Remimazolam is a newly introduced intravenous anesthetic, with rapid onset and offset. Although it is known to cause less hemodynamic instability, the incidence hypotension is the one of the most frequent adverse events with its use. For anesthetic induction, remimazolam can be used either as bolus dose or as continuous infusion.

This study is aimed to investigate the incidence of hypotension after anesthetic induction with bolus (0.14-0.33 mg/kg) or continuous (12 mg/kg/hr) remimazolam administration.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective surgery under general anesthesia
* adult patient (over 19 years old)
* American Society of Anesthesiology Physical Status I-III

Exclusion Criteria:

* arrythmia
* liver dysfunction
* kidney dysfunction
* uncontrolled hypertension
* uncontrolled diabetes mellitus
* allergic to benzodiazepines
* heart failure
* drug intoxication
* alcohol intoxication
Native T1 CMR Imaging for Diagnosis of Cardiac Amyloidosis

The study aims to test the diagnostic accuracy of native T1 mapping for the diagnosis of cardiac amyloidosis prospectively. The hypothesis is that native T1 mapping with a cut-off value of 1341ms (3 tesla CMR) in older patients with symptomatic heart failure, increased LV wall thickness and elevated cardiac biomarkers is non-inferior to the reference method to diagnose cardiac amyloidosis (CA).

As secondary measure, a web-based ATTR probability estimator for the diagnosis of CA will be evaluated.

Cardiac amyloidosis (CA) is an important differential diagnosis in older patients with symptomatic heart failure with preserved or mid-range ejection fraction and increased left ventricular wall thickness. The prevalence of CA among patients with heart failure and left ventricular (LV) hypertrophy is approximately 13%. However, diagnosis of CA is challenging because specific clinical signs are often lacking.

Amyloid fibrils deposit in the extracellular space of the myocardium increases myocardial T1 values on cardiac magnetic resonance (CMR). Therefore, native T1 imaging provides a promising non-invasive method to identify CA.

A preliminary retrospective analysis of 128 patients with increased LV wall thickness identified an area under the curve of 0.9954 (p\<0.0001) for native T1 to detect CA. The optimal cut-off value was 1341ms, with a sensitivity of 100% and a specificity of 97%.

The investigators aim to test the diagnostic accuracy of native T1 mapping with the threshold of 1341ms for the diagnosis of CA compared to the reference method prospectively. Moreover, the web-based ATTR probability estimator for the diagnosis of CA will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Symptomatic heart failure (NYHA II-IV) with LVEF ≥40%
* Increased LV wall thickness (≥12mm end-diastolic)
* NT-proBNP ≥1000pg/mL
* Elevated hs-troponin T ≥14ng/L

Exclusion Criteria:

* Contraindications for CMR
* Acute myocarditis
* Acute myocardial infarction \<1 month
* Severe aortic stenosis and RAISE score \< 2 points
Characterization of Immunosuppressive Signing of Cervical Cancer

Infection with Human Papillomavirus high-risk Human (HR-HPV) is the main factor of risk of cancer of the cervix. Recent studies show that cancers linked to infection with HR-HPV are associated with immunosuppression and lack of T cell response Such mechanisms would promote progression to cancer and progression of it . Various factors such as an increase of regulatory T cells, the presence of myeloid cells and suppressor of defects in the signaling pathway Toll Like Receptor (TLR) may have a key role in these immunosuppression mechanisms. At this stage of knowledge, a better characterization of local and systemic immunosuppressive signing of cervical cancer is needed. The results should have a significant medical impact for the identification of new prognostic markers and new therapeutic targets for the treatment of patients with cervical cancer.

The aim of this research project is to define the signing of immunosuppressive cancer cervix and analyze the different mechanisms involved in this immunosuppression.


Eligibility Criteria:
Inclusion Criteria:

* The women presenting for initial therapeutic management of cervical cancer
* Elderly patients over 18 years
* Patients beneficiary of a social security scheme
* Pregnant women can not participate in this study
* Women known to be HIV positive will not participate in this study

Exclusion Criteria:

* Patients with a recurrence of a treaty cervical cancer
* Patients with a history of pelvic radiotherapy
* Patients unable to receive informed about the progress and objectives of the study
* Patients not receiving a social security scheme
* Patients who have not signed informed consent
* Immunocompromised patients and pregnant women
A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ / Influsplit SSW® 2008/2009 in Adults

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2008-2009 season.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female aged 18 years or above at the time of the vaccination.
* Written informed consent obtained from the subject.
* Healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
* Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
* Administration of an influenza vaccine within 1 year preceding the study start.
* Administration of an influenza vaccine other than the study vaccine during the entire study
* Clinically or virologically confirmed influenza infection within 1 year preceding the study start
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Not stabilized or clinically serious chronic underlying disease.
* Lactating female.
* History of chronic alcohol consumption and/or drug abuse.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Any condition which, in the opinion of the investigator, prevents the subject from participation in the study
Microcephaly Genetic Deficiency in Neural Progenitors

The purpose of this study is to:

I. Compare neuroradiological phenotype and cognitive functioning of MCPH patients caused by ASPM mutations already characterized and published (Passemard et al. 2009a) with other MCPH-related patients (patients with MCPH1, WDR62, CDK5RAP2, CEP 152, CENPJ, STIL, or PCNT mutations)

II. Describe the neuro-radiological and cognitive phenotype of microcephalic patients suffering from Fanconi anemia, and compared them to subjects with:

* Fanconi anemia but normal OFC (head circumference)
* MCPH patients
* Healthy control subjects Our hypothesis is that mutations in genes responsible of microcephaly impact differentially cortical brain development and functioning

Phenotyping study on 2 different cohorts of rare disease affected patients:

* Group1: MCPH (including different MCPH subtypes)
* Group2: Fanconi Anemia (with or without microcephaly)

Inclusion criteria:

Common to each group:

* Age \> 3 years
* Access to french "Social Security"
* No contraindication for MRI

Group1:

* Primary microcephaly without gross malformation within or extra nervous central system
* OFC \< -2SD at birth and \< -3 SD after age 6months
* Mutation in one MCPH gene

Group2:

Proven Fanconi Anemia with:

* Positive chromosome breakage blood test
* One of the 3 following elements:

FANCD2 positive test Fibroblast sensitivity to mitomycin Mutation in one FANC gene

Control subjects:

* No antecedent
* Normal education

Aims:

1. Description of neurological, neuropsychological and radiological phenotype for each group
2. Phenotype comparison:

   * groups 1\&2
   * group1 or 2 with control subjects
   * different MCPH subtypes within group1
   * with or without microcephaly within group2
3. Epidemiological data on these rare diseases in our population

Protocol:

Patients from both groups and control subjects will be evaluated in CIC for 1 day ½. They will be examined by a child neurologist and a geneticist. All of them will have cranial MRI (1.5Tesla). Neuropsychological assessment will be performed (Wechsler scales) for patients and control subjects.

Eligibility Criteria:
Inclusion Criteria:

Patients aged ≥ 3 years:

* Microcephalic phenotype consistent with MCPH (recruitment already done as part of a network GIS-Rare Diseases Institute). MCPH patients have already been selected in the cohort "Robert Debré."
* Holders of a Fanconi anemia characterized in terms of cytogenetics, enzyme and/or molecular (patients in the cohort "Saint Louis" followed by the KRC rare aplastic anemia)
* Healthy controls aged ≥ 5 years siblings of patients with Fanconi Anemia

Exclusion Criteria:

Patients with Fanconi anemia:

* bone marrow \< 3 years
* Post-transplantation neurological complications
* developmental, genetic or environmental additional pathology