cyrilzakka/clinical-trials huggingface dataset:
The Pilot Study of Chikungunya Virus Infections in Southern Taiwan

This test is to be collected during the dengue outbreak samples, including samples back in the past and forward to close the case, investigating the prevalence of serum Chikungunya virus infection, and against those suspected dengue fever, Chikungunya disease-related tests conducted to clarify dengue and Chikungunya disease of clinical judgment, rapid method to detect Chikungunya virus and then develop.

During the execution of this project was ended March 1, 2012 to December 31, 2015, is expected to gather 300 suspected dengue infection, of whom 150 dengue-negative test results, test results of 150 dengue positive. And closed the case into prospective and retrospective analysis of the last sample into two parts.

Case closed after part of a prospective analysis of the study, subjects were required to complete consent forms and collect 20 ml blood samples, blood samples will be checked to identify dengue and Chikungunya disease associated serum antigen-antibody reaction , PCR (polymerase chain reaction) test and sequence analysis and pathogen identification and separation, in order to identify the source of infection difference. In addition, retrospective analysis of the last part of the specimen, sucked "after the health of the host track dengue infection, host immune regulation changes, and possible interactions with viral hepatitis" (KMUH-IRB-960195) collected by the inspection plan body, the number of samples included in the plan to close the case, and contact with the subjects, changes to inform the content of the plan to re-sign the consent form.

Eligibility Criteria:
Inclusion Criteria:

* Suspected of being infected with dengue fever

Exclusion Criteria:

* none
Clinical Trial Evaluating Methotrexate or Leflunomide + Targeted Therapy Versus Methotrexate or Leflunomide + Sulfasalazine + Hydroxychloroquine in Patients with Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide

Approximately, 40 to 50% of patients with rheumatoid arthritis (RA), the most frequent inflammatory arthritide, are non responders to the consensual 1st line of treatment : methotrexate. In these patients, it is well demonstrated that the addition of other immunomodulatory drug(s) often results in a significant improvement. However, the best option regarding the drug(s) to add remains unclear. Rheumatologists are currently used to adding a targeted therapy, such as anti-TNFα, and more recently abatacept or tocilizumab. Triple therapy using 3 conventional disease-modifying drugs (DMARDs), methotrexate or leflunomide+salazopyrine+hydroxychloroquine could be an alternative option to targeted therapies, all the more as they have a more favorable safety profile and a much lower cost. Uncertainty remains regarding the superiority of targeted therapies on triple therapy in methotrexate or leflunomide insufficient responders (IR). Investigators decided to address this issue by performing a randomized controlled pragmatic trial.


Eligibility Criteria:
Inclusion Criteria:

* Patient with rheumatoid arthritis according to EULAR/ACR 2010 criteria
* DAS28-CRP\>3.2
* Insufficient response to methotrexate at a weekly dose≥15mg after at least 3 months or to leflunomide at a dose of 10 (in case 20 mg are not well tolerated) to 20 mg per day after 3 months of treatment
* RA radiographic erosions and/or serum rheumatoid factor associated to anti-Cyclic Citrullinated Peptide (Anti-CCP)
* Age greater or equal to 18 years
* Written informed consent, dated and signed before initiating any trial-related procedure
* Affiliation to a social insurance system
* Women of child bearing potential, negative β-HCG assay (Human chorionic gonadotropin)
* Effective method of birth control during the study and continuing after the discontinuation of the investigational drug or study. The duration will depend on the drug used (referred to the summary product characteristic).

Exclusion Criteria:

* Previous treatment with or contraindication to targeted therapies (biologic or JAK/STAT inhibitor)
* Previous treatment with triple therapy
* Other inflammatory arthritis except RA associated with Sjögren's syndrome
* Contraindication to all biologics/ JAK/STAT inhibitors or to methotrexate, leflunomide, sulfasalazine and hydroxychloroquine
* Corticosteroids at a dose \>15 mg/d of equivalent prednisone for at least 4 weeks before the inclusion
* Absence of tuberculosis screening
* Patient who cannot be followed during 12 months
* Pregnancy, breastfeeding, desire of pregnancy in the 12 months
* Drug addiction, addiction to alcohol
* Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment
* Women of child bearing potential, unless they are using an effective method of birth control
* Patient under law protection
* Prisoners
Efficacy and Tolerance of Formula 609613 37 in Acneic Patients

Acne affects most adolescents and young adults with varying severity and presentation. For early or localized forms, the first-line treatment is usually local. The available treatments often lead to local irritation, particularly during the first few weeks of use. This is why creams containing exfoliating agents have long been used in acne, as they are considered to allow a faster disappearance of superficial lesions.

The objective of this 6-month double-blind study is to demonstrate in 100 acneic patients the interest of an anti-acne face cream as an adjunct to and in addition to a 5% benzoyl peroxide gel.

The study is conducted in accordance with the protocol and the legislative and regulatory provisions in force (after obtaining authorization of the French health authorities and the favorable opinion of the ethics committee).

Regarding the statistical analysis, two different analysis are performed:

* Descriptive analysis: quantitative variables are described by the mean and standard deviation and qualitative variables by the raw number of each modality and the corresponding percentage.
* Comparative analysis: for quantitative variables, inter-group comparisons are made by a Student's T-test or a non parametric Mann-Whitney test if necessary. For qualitative variables, comparisons are made using a Chi-square test, if the expected number of participants is less than 5, Fischer's exact test on a 4-box contingency tables is used.

A significant level of p \<0.05 is considered as significant. A double-data entry is carried out then a comparison of the two databases is performed. Finally internal and external consistency tests are planned. Missing data are described and possibly analyzed.

Eligibility Criteria:
Inclusion Criteria:

* acneic facial skin
* between 20 and 50 non-inflammatory lesions on the face
* between 10 and 40 superficial inflammatory lesions on the face
* no local acneic treatment in the previous 15 days
* no treatment with isotretinoin in the previous 3 months
* agreeing to apply only the study products

Exclusion Criteria:

* less than 20 or more than 50 non-inflammatory lesions on the face
* less than 10 or more than 40 superficial inflammatory lesions on the face
* prescription of a local acne treatment for less than 15 days
* prescription of an antibiotic treatment for less than 1 month
* prescription of an isotretinoin treatment for less than 3 months
* changing toiletries and hygiene products regularly
Study of Cobimetinib in Participants With Solid Tumors

This non-randomized, open-label, study will determine the highest safe dose of cobimetinib, how often it should be taken, how well participants with cancer tolerate cobimetinib and will assess the pharmacokinetic effect of midazolam and dextromethorphan on the study drug.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival
* Disease that is measurable according to Response Evaluation Criteria in Solid Tumors (RECIST)
* Adequate organ and marrow function
* Sexually active participants must use medically acceptable methods of contraception during the course of the study and at least 11 days after the last dose of study treatment
* Female participants of childbearing potential must have a negative serum pregnancy test at screening
* No other history of/or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assays

Exclusion Criteria:

* Anticancer treatment (e.g., chemotherapy, radiotherapy, cytokines, or hormones) within 28 days (6 weeks for nitrosoureas or mitomycin C, or 14 days for hormonal therapy or kinase inhibitors) before the first dose of study drug
* The participant has not recovered to Grade \</=1 from adverse events (AEs) or to within 10% of baseline values due to investigational or other agents administered more than 28 days prior to study enrollment
* The participant has received another investigational agent within 28 days of the first dose of study drug
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, diabetes, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
* The participant is pregnant or breastfeeding
* The participant is known to be positive for the human immunodeficiency virus (HIV)
* Allergy or hypersensitivity to components of the cobimetinib formulation
Resume Walking by an Interactive Mobile Robot of Rehabilitation After Vascular Stroke (Cerebral Vascular Stroke) in Combination With Traditional Reeducation

The recovery of a balance and gait is a primary objective for geriatric, neurological or orthopedic rehabilitation. Since the 80s, many walking robots were proposed. Despite encouraging results, the use of robotic equipment for gait training remains limited, even if they meet a strong social demand. The reasons for this situation are economic, but also related to the non consideration of the context of utilization . This project aimed at developping a mobile and interactive robot, dedicated to the rehabilitation of balance and gait at an early stage. It was intended for patients with impaired walking vascular neurological, traumatic or associated with chronic neurological disease. The aim of the study is to study the effectiveness of the prototype (interactive walking mobile robot).


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, aged at least 18 years and at most 80 years old

  -Size at least equal to 150 cm and less than or equal to 190 cm (robot design)
* Having signed free informed consent in writing,
* Personal history of stroke with ischemic or hemorrhagic cause, right or left hemispherical, localized in addition or under tentorial
* Single or multiple stroke.
* Post stroke period: acute sub (2 weeks 6 months)
* Left or right hemiparesis resulting from stroke
* Gait or balance disorders related to the consequences of stroke
* Minimum Berg Score: 3
* Hospitalization in a CPR service in complete hospitalization, week or day
* Medical stability, ie not presenting a cardiovascular, biological or other imbalance against the rehabilitation of walking
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Patient with a pacemaker

  * Patient with a very open wound
  * Weight less than 40 kg
* Weight greater than 105 kg (total maximum weight supported by the robot: 120 kg)

  - FAC \> 4 and lack of technical aids for walking (e.g., single cane, tripod cane, rollator).
* Major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty
* Patients currently included in another research protocol with an influence on balance and walking
* Refusal of the patient to participate in the study
* Pregnant and lactating women,
* with major cognitive or mood disorders, - Being unable to give their consent.
Apelin Levels and G212A Polymorphism of Apelin Receptor (APJ)

The aim of this study is to investigate serum apelin levels as well as their possible association with G212A polymorphism of the apelin receptor in obese children and adolescents.

So far apelin has been reported to be involved in the pathophysiology of various heart diseases such as cardiomyopathies and heart failure. According to recent reports in adults apelin seems to be associated with impaired glucose metabolism, particularly in newly diagnosed diabetes type 2 patients. Obesity is associated with insulin resistance and compensatory hyperinsulinemia leading to diabetes mellitus type 2 even in youngsters. The researchers will try to investigate the role of this new adipokine in order to early detect and to prevent similar entities in childhood obesity.


Eligibility Criteria:
Inclusion Criteria:

* Obese children and adolescents (aged 2-16 years old)

Exclusion Criteria:

* Chronic diseases
* Hypothyroidism
* Medication
High-dose Intravenous Vitamin C for the Treatment of Severe Acute Pancreatitis

This study is a prospective, randomized, double-blinded, parallel-controlled, multi-central clinical trial for patients with severe acute pancreatitis (SAP). Patients with SAP in the early stage (within 7 days of onset) and over the age of 18, based on the routine treatment, will be randomly divided into a high-dose intravenous vitamin C group (HDIVC, 500mg/kg/24h, administered by iv. pump at a rate of 2g/h for 7 days) and a control group (an equal volume of normal saline). The primary endpoint is mortality rate in ICU, and secondary endpoints include free organ support duration (FOSD) within 14 days after enrollment, changes in inflammatory response and severity, disease severity scores and changes, fluid retention, incidence of infectious pancreatic necrosis (IPN), ICU mortality, pancreatic necrosis scores, monitoring of vitamin C plasma concentrations before and after HDIVC use, composition of gut microbiota, observation of vitamin C-related adverse reactions. The study hypothesis is that HDIVC can reduce mortality rate in ICU, significantly decrease the FOSD within 14 days and significantly reduce inflammatory response, decrease fluid retention, and improve disease severity.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Time from onset of illness to enrollment is less than 7 days
* Meet the 2012 Atlanta Guidelines SAP diagnostic criteria

Exclusion Criteria:

* SAP caused by tumors or ERCP
* Pregnant or breastfeeding
* Allergic to vitamin C
* Use of other experimental drugs within the timeframe of this study
* Chronic organs failure such as heart, liver, lung, or kidney before admission, with specific indicators being (chronic cardiovascular dysfunction requiring long-term mechanical hemodynamic support or inotropic drug support; chronic obstructive pulmonary disease requiring home oxygen therapy; chronic liver dysfunction at Child-Pugh Class C; chronic kidney disease with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m² or serum creatinine greater than 150 μmol/L)
* Immunosuppressed state, including malignant tumors, post-transplant status, long-term use of immunosuppressor (for at least 1 month before enrollment), AIDS, etc.
* The patient and family are unwilling to sign the informed consent form
* Body weight greater than 100kg
* Urinary system stones
The Correlation and Relationship Between Chromaticity Parameters and Treatment Satisfaction Before and After Tooth Bleaching

Explore the correlation and specific relationship between chromaticity parameters and treatment satisfaction before and after tooth bleaching, compare the curative effect of different tooth bleaching programs.


Eligibility Criteria:
Inclusion Criteria:

* age around 20\~28 years,
* at least six anterior teeth without restorations,
* good general and oral health (no dental caries and periodontal disease).

Exclusion Criteria:

* tooth sensitivity,
* any condition that could cause tooth sensitivity (non-carious cervical lesions, dentin exposure),
* participants under orthodontic treatment,
* smokers.
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single and Multiple Doses of LEO 142397 in Healthy People, Including Japanese

This is the first clinical trial with LEO 142397. The purpose of the trial is to assess the safety and tolerability of LEO 142397, along with the pharmacokinetics (what the body does to the drug) and the pharmacodynamics (what the drug does to the body) in healthy people.

The trial consists of 2 parts:

* In Part 1, participants will receive a single dose of LEO 142397. There will be up to 8 different dose groups.
* In Part 2, participants will receive a daily dose of LEO 142397 for 14 days. There will be up to 6 different dose groups.

Each participant will be enrolled into 1 dose group in either Part 1 or Part 2.


Eligibility Criteria:
Key inclusion Criteria:

* Body mass index of 18.0-32.0 kg/m2, inclusive.
* In good health at screening and check-in as judged by the investigator based on medical history, physical examination, vital signs assessment, 12-lead electrocardiogram, and clinical laboratory evaluations:

  * Aspartate aminotransferase and alanine aminotransferase values ≤1.5 times the upper limit of normal.
  * Congenital nonhaemolytic hyperbilirubinaemia (including suspicion of Gilbert's syndrome) is not acceptable.
  * Haemoglobin value, neutrophil count, and lymphocyte count ≥ the lower limit of normal.
* Female subjects of childbearing potential must use a highly effective form of birth control, in conjunction with adequate barrier contraception, from randomisation until 90 days after the follow-up visit.
* Male subjects with female partner of childbearing potential must use adequate male barrier contraception, in conjunction with a highly effective form of female contraception for the partner, from randomisation until 90 days after the follow-up visit.

Key exclusion criteria:

* Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
* Any medication, including St. John's wort, known to chronically alter drug absorption or elimination processes within 30 days prior to the first dose.
* History of any significant infectious disease, as assessed by the investigator, within 2 weeks prior to the first dose.
* Current active tuberculosis based on QuantiFERON-TB Gold test.
* Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibodies at screening.
* Electrocardiogram abnormalities at screening or check-in.
* Smoking of \>10 cigarettes per day, on average, within the last 3 months.
Comparaison Between Digital and Drug Induced Sedation in Veinous Access Device Implantation

The goal of this clinical trial is to compare in patients who need an implantation of a veinous access device the sedation with anesthesiologic drugs and with hypnosis using virtual reality material. The main question it aims to answer is:

• is hypnosis using virtual reality as safe and powerfull than usual anesthesiologic drugs.

Participants will complete a preoperative and postoperative questionnaire. They will be contacted by phone pre and postoperatively.

If there is a comparison group: Researchers will compare drug induced sedation and hypnosis induced by virtual reality to see if they are similar in efficacy and sides effects.

This study has two arms. All patients has the same preparation to surgery. They had lorazepam 2.5 mg 30 minutes before the surgery. In operative theater, they are randomly chosen between anesthetic protocol (sufentanyl 5mg intravenous) or digital sedation (Sedakit(R) ) with hypnosis induced by virtual reality.

Patients complete an anxiety test (hamilton scale) 2 days before the surgery and 2 days after the surgery. They are called by an external psychiatrist 1 day before the surgery and 3 days after to evaluate the anxiety link to the procedure.

Eligibility Criteria:
Inclusion Criteria:

* need for a venous device implantation

Exclusion Criteria:

* need for a general anaesthesia
* unability to give oral consent
* under 18 years
Diaphragmatic Movement Before and After Stellate Ganglion Block : A Ultrasonographic Study

The temporary diaphrgmatic dysfunction will occur after stellate ganglion block(SGB) and will be easily detected by M-mode ultrasonography


Eligibility Criteria:
Inclusion Criteria:

* ASA class I-II patients who have head and neck pain or shoulder pain or sudden sensory neural hearing loss

Exclusion Criteria:

* coagulopathy, pulmonary disease, neuropathy
SafeTy and Efficacy of Preventative CoVID Vaccines

The STOPCoV study is a decentralized study comparing COVID-19 vaccine specific antibody levels at 24 weeks after final vaccine dose. We plan to study the safety and immunogenicity of COVID-19 vaccine(s) in community dwelling persons 70 years and over relative to a younger group (aged 30 - 50 years).

This is a prospective observational study of a cohort of individuals aged 30-50 years and a cohort of individuals aged 70 years and over receiving the COVID-19 vaccine.

Participants will complete a questionnaire to determine eligibility. Eligible participants will complete and sign an e-consent and then be provided with a participant ID, log in information and password to the database portal, and then be enrolled into the study.

Participants will complete the study assessments (baseline questionnaire, post vaccine symptom e-diary monthly, check-in questionnaire and dried blood spot specimens)

Eligibility Criteria:
Inclusion Criteria:

* Must be a resident of Ontario

Arm A:

* Individuals aged 70 and over
* Speak, read and understand English (or have a trusted individual to help with study procedures)
* Will receive a first or second dose of a COVID-19 vaccine at an Ontario vaccine distribution center. Individuals reaching the minimum age requirement by end of the recruitment calendar year are allowed to participate.

Arm B:

* Individuals between age 30-50 years
* Speak, read and understand English (or have a trusted individual to help with study procedures)
* Receive a first or second dose of a COVID-19 vaccine at an Ontario vaccine distribution center.

Exclusion Criteria:

* Not a resident of Ontario
* Individuals who are \< 30 years or those 51-69 years.
* Those who are unable to complete the study protocols in English either alone or with the assistance of a trusted individual with an electronic device.
* Participants who do not receive any dose of the vaccine
* Participants who have already received both doses of the vaccine prior to enrolment.