cyrilzakka/clinical-trials huggingface dataset:
Metabolic and Infectious Diseases in La Réunion (the REUNION Population-based Study)

The aim of the present study is to determine the prevalence of cardiometabolic and infectious disease in La Reunion (french oversea department and region of France).

Known or suspected risk factor for these diseases will also be assessed, such as microbiota, cognitive impairement, social inequalities, and genetics.

Overall, 2000 men and women will be recruited during two years for an extensive clinical examination including a microbiota, blood, hair and DNA collection, cognitive tests, autonomous nervous system assessment, spirometry, pulse wave velocity measurement, a carotid doppler echo tracking.

Eligibility Criteria:
Inclusion Criteria:

* 18-67 years
* given consent for genetic analysis,
* written consent for participating in the study

Exclusion Criteria:

* judicial protection or guardianship
Efficacy and Safety of Semaglutide Once-weekly Versus Placebo in Drug-naïve Subjects With Type 2 Diabetes

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes. (SUSTAIN™ 1-Monotherapy).


Eligibility Criteria:
Inclusion Criteria: - For Japan only: Male or female, age above or equal to 20 years at the time of signing inform consent - Subjects diagnosed with type 2 diabetes and treated with diet and exercise for at least 30 days before screening - HbA1c 7.0 - 10.0 % (53 - 86 mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with any glucose lowering agent(s) in a period of 90 days prior to screening. An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as eGFR (estimated glomerular filtration rate ) below 30 mL/min/1.73 m\^2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association class IV
Use of UC-MSCs for COVID-19 Patients

The purpose of this research study is to learn about the safety and efficacy of human umbilical cord derived Mesenchymal Stem Cells (UC-MSC) for treatment of COVID-19 Patients with Severe Complications of Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS).


Eligibility Criteria:
Inclusion Criteria:

Patients \>/= 18 years old diagnosed with COVID-19 (as evaluated by PCR test confirming infection with SARS-CoV-2) will be eligible for inclusion if they meet all of the below criteria. Inclusion criteria must all be present within a 24-hour time period at the time of enrollment:

1. Patient currently hospitalized
2. Aged ≥ 18 years
3. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
4. Peripheral capillary oxygen saturation (SpO2) ≤ 94% at room air, or requiring supplemental oxygen at screening
5. PaO2/FiO2 ratio \< 300 mmHg
6. Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan
7. Hypoxemia requiring an increase in the fraction of inspired oxygen (FiO2) of ≥ 20% AND an increase in positive end-expiratory airway pressure (PEEP) level of 5 cm H2O or more to maintain transcutaneous oxygen saturations in the target range of 88-95%, or requirement for escalation from oxygen therapy to invasive mechanical ventilation

Exclusion Criteria:

1. PaO2/FiO2 ≥ 300 at the time of enrollment
2. A previous MSC infusion not related to this trial
3. History of Pulmonary Hypertension (WHO Class III/IV)
4. History of left atrial hypertension or decompensated left heart failure.
5. Pregnant or lactating patient
6. Unstable arrhythmia
7. Patients with previous lung transplant
8. Patients currently receiving chronic dialysis
9. Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO)
10. Presence of any active malignancy (except non-melanoma skin cancer)
11. Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
12. Moderate to severe liver disease (AST and ALT \>5 X ULN)
13. Severe chronic respiratory disease with a PaCO2 \> 50 mm Hg or the use of home oxygen
14. Baseline QT prolongation
15. Moribund patient not expected to survive \> 24 hours
A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy


Eligibility Criteria:
Inclusion Criteria:

* ≥18 and ≤65 years of age at the time of consent.
* Patients with Atopic Dermatitis
* Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit
* Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit
* static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit

Exclusion Criteria:

* Serological evidence of hepatitis B virus or hepatitis C virus infection
* Known human immunodeficiency virus infection
* Ongoing treatment with specific or non-specific hyposensitization therapy for AD
* Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week prior to randomization
* History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization.
* Evidence of tuberculosis (TB) infection as defined by a positive purified protein derivative (PPD) and/or positive interferon-gamma release assay.
* Pregnant or lactating women.
Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA

A case-control study to evaluate the diagnostic accuracy of FDG uptake in cranial arteries by FDG PET/CT in the diagnosis of giant cell arteritis.

Although older studies argue that FDG PET/CT cannot demonstrate inflammation in cranial arteries, e.g. temporal and maxillary arteries, the resolution of modern PET systems may have improved, making a case for FDG PET/CT. FDG PET/CT is increasingly used in giant cell arteritis (GCA) diagnosis due to its excellent diagnostic accuracy considering large-vessel involvement. In case of uncommon distribution of vessel involvement or marginally increased large-vessel FDG uptake, FDG PET/CT-specificity may be compromised. Hence, recognising FDG uptake in cranial arteries potentially adds to FDG PET/CTs diagnostic accuracy.

Objectives To evaluate the diagnostic accuracy of conventional FDG PET/CT of the cranial arteries in the diagnosis of GCA.

Methods In a cohort of consecutively included glucocorticoid-naïve patients suspected of new-onset GCA, patients with a clinical GCA diagnosis will be identified. Conventional FDG PET/CT and vascular ultrasound(US) was performed before treatment. Patients were referred for a temporal artery biopsy (TAB).

Controls are age-(+/- 3 years) and sex-matched malignant melanoma (MM) patients who had a follow-up metastatic-disease-free FDG PET/CT ≥6 months after MM resection.

Images will be assessed by 5 nuclear medicine physicians blinded to clinical symptoms and findings. Temporal (TA), maxillary (MA) and vertebral (VA) arteries will be visually assessed. Arterial FDG uptake more than FDG uptake in surrounding tissue is considered positive. Sensitivity, specificity and interreader agreement will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

Cases:

* 1) age ≥50 years, 2) CRP\>15mg/l or ESR\>40mm/h, 3) either a) cranial symptoms, b) new-onset extremity claudication or c) weight loss \>5 kilograms or fever\>38oC for \>3 weeks and a clinical diagnosis of giant cell arteritis judged by expert rheumatologist.

Controls:

* age-(+/-3 years) and sex-matched malignant melanoma (MM) patients
* follow-up metastatic-disease-free FDG PET/CT ≥6 months after MM resection

Exclusion Criteria:

* Previous diagnosis of polymyalgia or giant cell arteritis
* immunosuppresive treatment within last month
Chemoprevention of Esophageal Squamous Cell Carcinoma (ESCC) With Aspirin and Tea Polyphenols

Evidence from laboratory studies suggests that aspirin and tea polyphenols may have an antineoplastic effect in esophageal squamous cell carcinoma (ESCC). To assess the safety and efficacy of aspirin and tea polyphenols for preventing ESCC, the investigators designed this double-blind, randomized controlled clinical trial. Research project is planned to recruit 10,000 participants with the ages of 40-60 years in Fengfeng city, Hebei province, China, which has been known as a high incidence region of ESCC. All the participants receive endoscopic examination. Lugol's chromoendoscopy is used to identify esophageal unstained lesions (USLs). The location and size of each USL will be recorded followed by collecting biopsy samples from each USL. Participants with USL are randomly assigned to receive 100 mg/d of aspirin (n=200), 100 mg/d of tea polyphenols (n=200), or placebo (n=200) for six months. Follow-up consists of 2 endoscopic surveillance cycles (the first interval will be at six months and the second at 3 or 5 years later). The primary outcome measure was occurrence of high grade dysplasia and invasive ESCC. Secondary outcome was the mortality of the participants and adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. age 40 to 60 years;
2. Lugol's chromoendoscopy showing at least one USL 1 cm or larger containing mild to moderate dysplasia and chronic inflammation;
3. subject neither pregnant nor intending to become pregnant during the study.

Exclusion Criteria:

1. current non-steroidal anti-inflammatory drugs (NSAID) therapy;
2. major intercurrent illness;
3. pregnancy;
4. invasive carcinoma;
5. any condition that could be worsened by aspirin or tea polyphenols.
Assessment of Asymptomatic Heart Disease in Children With HIV

The purpose of this study is to perform cardiac evaluation in HIV-1 (predominantly clade C)infected children by history, physical examination, echocardiogram and plasma N-terminal pro-B-type natriuretic peptide (N-BNP)measurement in order to determine asymptomatic abnormalities.

Human immunodeficiency virus (HIV) infection affects nearly 40 million adults and children worldwide. Recently introduced new antiviral drugs have significantly improved survival of patients with HIV infection. As mortality declines, morbidity becomes a concern. Heart disease is present in 20% of children and adults with HIV. The cardiac diseases include left ventricular dysfunction, hypertrophy and dilation, pericardial effusion and intracardiac masses. Cardiac disease is an independent risk factor for death in these children. The reported two-year survival of children with congestive heart failure is zero compared to 17% when no heart failure is present. It is thus indicated to perform periodic cardiac examinations in these patients, and early recognition of cardiac disease is paramount.

In addition to the traditional tools to assess cardiac status which include history, physical examination, ECG, chest X-ray and echocardiography, we propose to check biochemical markers. Brain natriuretic peptide has been shown to be a very sensitive marker for symptomatic and asymptomatic cardiac dysfunction, prognosis, severity of the disease and response to therapy in adults. Troponin-T is a very good marker for cardiac ischemia. Recently, we have found troponin-T to be a good marker for acute cardiac insult in infants and children.

The aim of this study is to perform screening of children with HIV predominantly clade C for cardiac disease using the above mentioned means.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children congenitally infected with HIV-1
SATIN WP4 Acute Effect on Appetite of Pineapple Juice With Viscofiber and Red Ginseng

The objective of the study is to establish whether a Pineapple juice with Viscofiber and Red ginseng can enhance satiety and reduce appetite and/or accelerate satiation in the short-term.

A double-blind, randomised crossover design will be employed with an experimental (active) condition and a control condition at least one week apart. After having successfully completed screening procedures eligible participants will be invited for two separate test days, at least 7 days apart. On the two test days, the products will be provided in a randomized order as part of a fixed breakfast meal, and subjective appetite ratings will be measured every 30 min for the following 8 hours. Satiety and satiation will be measured through administration of test meals in the laboratory supplied with controlled food intake under free-living conditions

Eligibility Criteria:
Inclusion Criteria:

* Participants who have provided written informed consent
* Healthy men and women
* Ages between 18 and 55 years
* BMI between 25.0-31.9 kg/m2
* Regular breakfast eaters (eating breakfast ≥ 4 times a week)
* Regular menstrual periods (women only)

Exclusion Criteria:

* Significant health problems as judged by the investigator
* Taking any medication or supplements known to affect appetite or body weight within the past month and/or during the study as judged by the investigator
* Pregnant, planning to become pregnant within the next 4 weeks or breastfeeding (women only)
* History of anaphylaxis to food
* Any known food allergies or food intolerance
* Smoking, smoking cessation within the past 3 months or nicotine use (electronic cigarettes)
* Self-reporting currently dieting or having lost/gained significant amount of weight (±3 kg) in the previous 3 months
* Significant changes in physical activity patterns in the past 4 weeks or intention to change during the study as judged by the investigator
* Significant change in diet in the past 4 weeks or intention to change the diet during the study as judged by the investigator
* Use of systemic or local treatment likely to interfere with evaluation of the study parameters as judged by the investigator
* Participants who work in appetite or feeding related areas
* Participants not able to comply with the study protocol
* Post-menopausal (women only)
Antibiotic Misuse During COVID-19 Pandemic

Evaluating the important role of the community pharmacists in pandemics like covid-19 and to find whether there was a misuse of antibiotics during the pandemic or not and to define the reasons behind this misuse if any present.

Community pharmacy in Egypt is considered as the frontline health care system that is easily and freely accessible by the patients, in this pandemic and due to the current circumstances from closing most general hospitals in front of the public, and with the government applying curfew long hours, community pharmacists were the only healthcare providers available for most patients. Their role will not be restricted to delivering medication but expands to monitoring patient conditions especially those with chronic diseases and patient counseling and education clarifying any misunderstanding concerning covid1-19 medication. The present study includes a questionnaire (with detailed questions including how/when/which/for how long antibiotics are prescribed) that is addressed for community pharmacists who dealt with covid-19 patients during the pandemic.

Eligibility Criteria:
Inclusion Criteria:

* All community pharmacists worked during the pandemic and dealt with covid-19 patients inside their pharmacies are welcomed to participate

Exclusion Criteria:

* Clinical and hospital pharmacists- other medical staff- pharmacist assistant
Cannabis, HIV and Mental Processing Systems

This study employs novel methods to identify key determinants and consequences of concurrent HIV infection and regular cannabis use. This study will acquire extensive phenotype data from peripheral and brain markers of immune activation, brain structure, and neuropsychological performance (NP) in persons living with HIV (PLWH) receiving combination anti-retroviral therapy (cART) (80 regular cannabis users and 80 non-users) and HIV uninfected (HIV-) controls (80 regular cannabis users and 80 non-users). This study will provide key insights into the effects of regular cannabis and HIV on peripheral and brain markers of immune function and NP in PLWH and HIV- controls. These insights are critical for cure strategies and ongoing HIV treatment initiatives.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be 18-70 years old.
2. PLWH must have documented HIV infection for approximately 1 year, be on a cART regimen for approximately ≥3 months, and be virally well-controlled (\< 200 copies/mL).
3. HIV- controls must have confirmed HIV- serostatus.
4. Participants must complete at least 9 years of education.
5. Participants must be able to provide informed consent.
6. Female participants must have a negative pregnancy test or written documentation of tubal ligation, hysterectomy, post-menopausal status, etc. and cannot be breastfeeding.
7. Participants should have no contraindications to an MRI scan.
8. Participants should be willing to have cannabis use history confirmed via clinical interview and urine analysis .
9. All inclusion criteria at PI discretion.

Exclusion Criteria:

1. History of neurological disorder (e.g., stroke, head injury with loss of consciousness for \>5 minutes, developmental learning disability, etc.).
2. Uncontrolled major affective disorder; history of bipolar disorder or schizophrenia. Major depression controlled with no hospitalizations or suicidal ideation in the past year is allowed.
3. Current substance use disorder (SUD) as defined by DSM-5 criteria besides cannabis use disorder (CUD) (though a past SUD \> 1 year before the time of study enrolment will be allowed).
4. currently prescribed anti-coagulants (only exclusionary if participant will engage in optional LP).
5. an allergy to lidocaine or similar anesthetic (only exclusionary if participant will engage in optional LP).
6. a history of a bleeding disorder (only exclusionary if participant will engage in optional LP).
7. claustrophobia or a pacemaker that would prevent magnetic resonance imaging (MRI) scanning.
8. all exclusion criteria at PI discretion.
Observational Study of the Analgesic Effect of Treatment With rTMS in Patients With Chronic Neuropathic Pain

For ten years, rTMS, repetitive transcranial magnetic stimulation of the motor cortex, has found its place in the treatment of drug-resistant neuropathic pain. Patients relieved by some sessions may thereafter receive a chronic invasive stimulation via electrodes implanted through a neurosurgical procedure. This is common practice at the University Hospital of Caen and in different CHU with the proper equipment rTMS. It seems permissible to provide in our center only a non-invasive technique for patients challenged with brain surgery, since according to the various meta-analyzes the analgesic efficacy of rTMS seems to be correlated to the repetition of sessions.

Assessment centers and the treatment of pain allow a multidimensional assessment, bio-psycho-social of patients in order to optimize their management and experience efficiently analgesics first- and second-line.

We propose a study evaluating the analgesic efficacy of rTMS, in relevant stimulation parameters reproduced according to a literature review, during 3 months after 5 active sessions separated by one week apart, in 15 patients with neuropathic pain chronic refractory to treatment of first and second line, followed by multidisciplinary center specializing in chronic pain Lower Normandy. The quality of life will also be assessed by validated scales, and the results will be compared to the literature data.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 to 70 years with:

  1. Pain lasting for more than six months;
  2. Monitoring in CETD in Normandy;
  3. Having had a bio-psycho-social assessment and have been the subject of a multidisciplinary discussions recorded in the medical record;
  4. Presenting unilateral neuropathic pain, central or peripheral origin:

     * may affect the face,
     * upper limb,
     * or hémicorps but including at least the upper limb;
  5. With neuropathic pain screening test positive (≥ DN4 4/10);
  6. etiology objectified by further examinations (MRI, scanner, or EMG, PES MEP);
  7. Resistant to usual treatments: less than 50% improvement compared to the initial pain (EN or EVA) in patients who received an effective dose for treatment of first and a second intention.

Exclusion Criteria:

* Contraindications of rTMS:

  1. Brain implanted ferromagnetic material,
  2. Implanted neurostimulator (cortical and deep brain, spinal cord)
  3. Cochlear Implants
  4. Active epilepsy (seizures despite existence of a current treatment)
  5. Pacemakers
  6. Hearing loss or current taking ototoxic drugs (aminoglycosides, cisplatin)
* Pregnancy, breastfeeding, lack of effective contraception for patients of childbearing age
* Psychiatric illness decompensated
* Cancer pain and post-chemotherapy
* severe cognitive disorders