cyrilzakka/clinical-trials huggingface dataset:
Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial

This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as local with or without regional recurrence after ≥1 year of radical treatment;
* Not suitable for surgery;
* Histologic diagnosis of NPC (WHO II/III);
* TNM stage rII-IVa (AJCC/UICC 8th);
* ECOG 0-1 point;
* No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
* No contraindications to immunotherapy or chemoradiotherapy;
* Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
* Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
* Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
* Take effective contraceptions during and two months after treatment;
* Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

* Treated with anti-tumor Chinese medicine treatment;
* Have recurrence with local necrosis;
* Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
* Unexplained fever \> 38.5, except for tumor fever;
* Treated with ≥ 5 days antibiotics one month before enrollment;
* Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive; Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
* Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
* Have known allergy to large molecule protein products or any compound of study therapy;
* Pregnant or breastfeeding;
* Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
* Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
* Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
The Relationship Between Body Surface Gastric Mapping and Gastric Emptying Rate

Currently, a new generation of high-resolution electrogastrograms recording technology with 64-channel electrode array is being developed by Alimetry Limited. This BSGM provide a more complete understanding of the origin and propagation of human gastric slow-wave activity non-invasively, such as frequency, amplitude, velocity, and pattern, in high spatiotemporal detail. The system is also capable of providing a novel meal response metric, which might correlate with the gastric emptying time. The system includes an App for tracking patient-reported symptoms throughout the test.The aim of the present study is to assess and compare BSGM and breath-based gastric emptying parameters and to study the relation between BSGM and presence or severity of individual symptoms and clinical features.The investigators will perform a study in 100 subjects to record gastric bioelectrical activity by non-invasive multi-channel body-surface electrode arrays during gastric emptying breathing test.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>18 years old;
* Male or female patients;
* Patients planned GEBT;
* Negative PCR on nasopharyngeal swab 24 or 48 hours prior to the test;
* Signed informed consent.

Exclusion Criteria:

* Females who are pregnant or lactating.
* History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
* Fragile skin vulnerable to skin tears.
* Damaged epigastric skin (open wounds, rash, inflammation)
* Patients unable to remain in a relaxed reclined position for the test duration
Efficacy Study Comparing Topical M518101 and Vitamin D3 in Adult Psoriasis Patients

M5181 - a novel vitamin D3 analogue - is currently under development for the treatment of plaque psoriasis and is being developed as a topical ointment formulation (M518101)

Clinical and non-clinical studies indicate that M5181 is an effective treatment for plaque psoriasis.

Based on the results of previous phase II trials the phase III trial has been designed to evaluate efficacy and safety of an 8-week treatment period with 50 μg/g M518101 in a larger population of patients with stable plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 years or older on the day of signing the informed consent form (ICF)
* Psoriasis patients with up to 20% affected body surface area ( BSA) (not including face or scalp)
* Investigator Global Assessment(IGA) of moderate to severe and who are suitable for topical therapy

Exclusion Criteria:

* Pregnant or lactating females;
* Patients with known allergic reactions, irritations or sensitivity to vitamin D3 derivatives drug hypersensitivity to other components of the investigational products;
* Patients who have been treated with topical steroids, topical immunosuppressive/ immunomodulative drugs, topical vitamin D3 derivative, topical retinoids, anthralin, coal tar (except when used as shampoo) salicylic acid within 14 days of randomization
* Patients, who in the opinion of the investigator, have clinically relevant history or presence of any disease, any other skin disorder, any chronic medical condition which is not well controlled or surgical history which may interfere with the conduct of the trial
* Patients whose calcium test at screening exceed the upper limit of reference range (including serum calcium, albumin, phosphate, parathyroid hormone);
* Patients who have used any study drug (including experimental biologics) and/or participated in any clinical trial within the last 60 days before the day of randomization
* Patients who have been treated with any biologics for their psoriasis within 30 days or 5 half-lives (whichever is longer) of the biologic before the day of randomization the longest documented half-life of the biologic should be used to calculate the 5 half-lives;
* Patients who have been treated with phototherapy (laser, oral steroids, oral retinoid, oral immunosuppressive/immunomodulative drugs, cytostatics, cyclosporine or methotrexate within 30 days of randomization
The Clinical Significance of Peripheral Blood T Lymphocyte PD-1 Expression and T Cell Subset Distribution.

Providing more theoretical basis for the prediction of the efficacy of advanced HCC and helping select better advantaged population of HCC immunotherapy to maximize the benefits of patients By exploring the relationship between the changes of PD-1 expression in peripheral blood T lymphocytes and the clinical efficacy before and after the use of PD-1 / PD-L1 inhibitors.

Exploring the expression of peripheral blood T lymphocyte PD-1 from an immunological perspective as a potential reference marker for selecting immunotherapy in advanced HCC patients, and elucidating the relationship between the level of peripheral blood T lymphocyte PD-1 expression and survival outcomes after receiving immunotherapy. Additionally, investigating whether there is consistency between the expression levels of PD-1 and PD-L1 and their impact on patients. Furthermore, exploring the correlation between the distribution of T cell subsets and the efficacy of immunotherapy to provide new theoretical evidence for the selection of target populations for immunotherapy and new clinical screening indicators for patient prognosis assessment.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the clinical study, fully understand and be informed about the study, and sign the informed consent form;
* Age between 18 and 75 years, male or female;
* Strictly meet the clinical diagnostic criteria for hepatocellular carcinoma (HCC), confirmed by histology or cytology, with at least one lesion meeting the RECIST 1.1 criteria on CT or MRI examination;
* No prior targeted therapy, immunotherapy, or systemic chemotherapy for liver cancer before admission;
* Child-Pugh A liver function; Barcelona Clinic Liver Cancer (BCLC) stage B or C;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
* Normal function of major organs;
* Expected survival time of at least 12 weeks or more.

Exclusion Criteria:

* Patients who have not previously received treatment with Sintilimab or any other PD-L1 or PD-1 antagonist;
* Patients with any active autoimmune disease or a history of autoimmune disease, or a history of immunodeficiency;
* Patients requiring the use of immunosuppressive drugs;
* Known history of allergy to the formulation of Sintilimab or any other component of the antibody formulation;
* Patients with other malignant tumors.
Stepwise Screening for Silent Atrial Fibrillation After Stroke

The main hypothesis of this work is that an approach combining clinical parameters and biomarker assays could improve the understanding and prediction of the occurrence of silent atrial fibrillation (AF) in the acute phase after stroke. In this prospective work, the investigators will rely on the Dijon Stroke Registry, which collects extensive clinical data for each patient hospitalized for a stroke. As part of this registry, patients are seen 6 months after stroke to assess their clinical status. This clinical follow-up will allow us to judge the evolution of the AF diagnosed during the acute episode at a distance.


Eligibility Criteria:
Inclusion Criteria:

* Patient who had an ischemic stroke defined according to WHO criteria and hospitalized in the Stroke Unit at the Dijon University Hospital.
* Patient 18 years of age and older
* Patient who has given oral consent

Exclusion Criteria:

* Person not affiliated to a national health insurance scheme
* Protected adult
* Pregnant or breastfeeding woman
* Patient refusing to participate in the study
* Transfer planned after the stay in the Stroke Unit to a department outside the Dijon University Hospital, not allowing for the long term screening with an external ECG monitor
* History of atrial fibrillation or atrial flutter
* Patient wearing a pacemaker or defibrillator with an atrial lead
Micronutrient Status Involved in Immunity in Elderly Patients With COVID-19

During the ongoing COVID-19 pandemic, age was clearly the major factor of mortality. Increasing age was strongly associated with this risk, with the upper 80 years age group having more than 12-fold increased risk compared with those aged 50-59 years. Male gender was also associated with a doubling of risk.

The elderly subject is particularly exposed to global denutrition with risk of micronutrients deficiencies such as vitamins and trace elements. Those deficits expose to lower immunity. In addition, viral infection as COVID-19 can also worsen these deficits.

In general, low levels or intakes of micronutrients such as Zn, Se and vitamin A have been associated with adverse clinical outcomes during viral infections. This notion has been confirmed in a recent review proposing that besides vitamins A and D also B vitamins, vitamin C, omega-3 polyunsaturated fatty acids, as well as selenium, zinc and iron should be considered in the assessment of micronutrients in COVID-19 patients.

In this context, the MicroCovAging study will evaluate copper, zinc and selenium, vitamin A, D and E status in elderly subjects affected by COVID- 19 and to correlate this status with prognosis of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adult patient ≥ 50 years at the time of admission,
* Suffering from confirmed COVID-19 (positive quantitative PCR for SARS-CoV-2 and/or chest scanner suggestive of COVID-19),
* Informed and non-opposed to the research. Patient will be informed of the study by his medical doctor during hospitalization or by post thanks to a generic information sheet dedicated to COVID-19 researches.

Exclusion Criteria:

* Adult patient \< 50 years at the time of admission
* Negative quantitative PCR for SARS-Cov-2
French Language Validation of Questionnaires for the Evaluation of Problematic Screen Use.

The main objective of this research is to linguistically validate the Smartphone Addiction Scale, Nomophobia Questionnaire, The Problematic Use of Mobile Phones scale, Smartphone Addiction Proneness Scale, Digital Addiction Scale for Children, Gaming Motivation Scale and Problematic Media Use Measure in French so that they are conceptually equivalent to their original version.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for the SAS, NMP-Q, SAPS questionnaires
* University students over 18 years of age Inclusion criteria for the GAMS questionnaire
* University students over 18 years of age
* Video game players (at least one video game session in the past two weeks) Inclusion criteria for the PUMP and DASC questionnaires
* Adolescents (12-17 years old) Inclusion criteria for the PMUM-SF questionnaire
* Parents of adolescents (this can be parents of adolescents who answered the previous questions)
* Adolescents must have access to at least one screen: smartphone, computer, television, etc (even that of a parent)

Exclusion Criteria:

* Difficulties in understanding the French language
* Cognitive disorders
* Subject under guardianship or subject deprived of liberty
* Opposition to participation in the study
Hydroxychloroquine Chemoprophylaxis in Healthcare Personnel in Contact With COVID-19 Patients (PHYDRA Trial)

Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.

Healthcare personnel infection with COVID-19 is a major setback in epidemiological emergencies. Hydroxychloroquine has proven to inhibit coronavirus in-vitro but no data to date has proven in-vivo effects. Nevertheless, hydroxychloroquine is a low cost, limited toxicity and broadly used agent. Since there is currently no treatment for COVID-19 exposure prophylaxis, the investigators will implement a triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) for 60 days.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old upon study start
* Healthcare personnel exposed to patients with COVID-19 respiratory disease: physicians, nurses, chemists, pharmacists, janitors, stretcher-bearer, administrative and respiratory therapists.
* Signed consent for randomization to any study arm.

Exclusion Criteria:

* Known hypersensitivity to hydroxychloroquine manifested as anaphylaxis
* Current treatment to chloroquine or hydroxychloroquine
* Women with last menstruation date farther than a month without negative pregnancy test.
* Women with positive pregnancy test
* Breastfeeding women
* Chronic hepatic disease history (Child-Pugh B or C)
* Chronic renal disease (GFR less or equal to 30)
Atherosclerosis, Plaque and CVD in Communities

To identify new cellular, metabolic, and genomic correlates of atherosclerotic plaque and early pathologic changes in the vascular wall and determine their consequences for coronary heart disease and stroke.

BACKGROUND:

This study draws upon the existing ARIC cohort of 15,792 members aged 45-64 years at baseline in 1987-1989 who have completed four clinic exams three years apart with the last exam in 1998. The longitudinal ARIC cohort study focused on new cardiovascular disease \[CVD\] risk factors and subclinical measures of atherosclerosis through B-mode ultrasound of the carotid arteries. The current study collects new and novel risk factors and performs carotid magnetic resonance imaging (MRI) examinations on a stratified random sample of 1,200 ARIC participants with high (\>85th percentile) carotid intimal-medial thickness \[IMT\] by ultrasound and 800 participants with \<85th percentile IMT.

DESIGN NARRATIVE:

The study examines an informative subset of the bi-ethnic Atherosclerosis Risk in Communities (ARIC) cohort to identify cellular, metabolic and genomic correlates of atherosclerotic plaque characteristics and of early changes in the vascular wall. The longitudinal follow-up and stored DNA in ARIC will allow testing the ability of the genomic correlates of plaque characteristics to predict incident coronary heart disease and stroke. One thousand two hundred individuals with high (\>85th percentile) carotid artery wall thickness documented by B-mode ultrasound and 800 individuals sampled from the remainder of the carotid artery wall thickness distribution (\<85th percentile) will receive a contrast-enhanced carotid MRI examination. Standardized MRI measures will include carotid artery wall thickness, T2 signal intensity changes and percent contrast enhancement indicative of endothelial dysfunction, and for those with plaque, fibrous cap thickness, lipid core volume, and calcification. Novel cellular, metabolic and genomic measures will be collected and will be related to MRI-measurable plaque characteristics. In particular, flow cytometry will be used to measure monocyte and platelet presentation of cytokines, growth factors and adhesion molecules, and cell-cell aggregation. High throughput genotyping methods will be used to measure 5 to 7 polymorphic sites in each of 150 positional, expressional and biologic candidate genes, permitting multilocus and haplotype genomic analyses. The depth and breadth of existing risk factor and lifestyle data, extensive follow-up since 1986-89, and accumulation of clinical outcomes, including coronary heart disease, stroke and arteriosclerosis, contribute additional strengths to the laboratory and MRI investigations. Inferences will be made both cross-sectionally and longitudinally, with a special emphasis on genotype plus environment interaction. The ARIC cohort is in an ideal age range for the research because of the frequent and documented occurrence of plaque and the spectrum of clinically relevant stages from plaque initiation to mature fibrosis, calcification and even erosion and near-rupture.

Eligibility Criteria:
No eligibility criteria
The Surveillance Clinical Study of Rickettsiosis

The purpose of this surveillance (non-interventional) clinical study is to genotype the causative agents of rickettsiosis in biological samples of patients from the Altai Republic, Russian Federation. This is a solely observational study in the patients with diagnosed or suspected tick-borne rickettsioses, with no intervention to the routine treatment and diagnostic process. During the study the medical history, diseases progress and symptoms, as well as treatments are being registered in individual case report forms. The rests of the samples used for standard diagnostics (plasma, or serum, and/or swabs of the tick bite site) are being collected and afterwards will be analyzed for a new rickettsia type. These data will be compared to the medical history and symptoms of the patients in order to identify clinical pattern specific for the new rickettsia type. Informed consents from all patients or their legal representatives are being collecting. The study was approved by the local ethical committee.


Eligibility Criteria:
Inclusion Criteria:

* Written patient's informed concent for study participation;
* Male and female patients of any age with diagnosed or suspected tick-born rickettsioses.

Exclusion Criteria:

- Unwillingness to participate in the study by any reason.
Correlation Between Patient Perception and Findings on Clinical Examination in Chronic Obstructive Pulmonary Disease (COPD) Patients

This is a multi-center, prospective, non-interventional study that aims to evaluate in daily clinical practice the possible correlation between patient perception of the ability to perform morning activities and the physician's assessment during a regular physical exam in patients with Chronic Obstructive Pulmonary Disease (COPD), group C and D.

CorRELation between PatIent PErception of the Ability to Perform Morning Activities and Findings on Clinical Examination in COPD Patients receiving inhaled combined therapy (corticosteroid/long acting ß2-agonist) - RELIEF Study

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), group C and D according to GOLD Guidelines, 2011
* Receive inhaled combined therapy for COPD (inhaled corticosteroid / long acting ß2-agonist); this treatment should have been initiated for at least one month before entering the study
* Current or past smokers, of at least 10 pack years

Exclusion Criteria:

* History of exacerbation of COPD symptoms within the last month before visit 1, inclusive.
* History of asthma or allergic rhinitis.
* History of lung carcinoma or any other respiratory condition that may limit the airflow circulation.
Comparison of Gadobutrol and Gadobenate Dimeglumin for Delayed Enhancement Cardiac MRI

This study aims at evaluating the diagnostic efficacy of Gadobutrol versus Gadobenate dimeglumine at similar dose of 0.1mmol/kg for assessment of myocardial infarction by delayed enhancement cardiac Magnetic Resonance Imaging


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of myocardial infarction
* Age ≥ 18 years and ≤ 80 years
* Informed consent
* Male patients as well as female patients using contraceptives

Exclusion Criteria:

* Patients with a heart pacemaker, with magnetic material or other magnetic implants.
* Renal failure (GFR \<30ml/min)
* Patients with known allergy to a Gadolinium-containing contrast agent
* Drugs or alcohol addiction, dementia