cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection

The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus (HCV)-infected pediatric participants. The PK Lead-in Phase will also evaluate the safety, tolerability, and antiviral activity of 10 days of dosing of LDV/SOF FDC in HCV-infected pediatric participants.

The Treatment Phase will be initiated by age cohort after confirmation of age-appropriate LDV/SOF FDC dosage levels. Participants from the PK Lead-in Phase will immediately rollover into the Treatment Phase with no interruption of study drug administration. The primary objective of the Treatment Phase is to evaluate the antiviral efficacy, safety, and tolerability of LDV/SOF FDC +/- ribavirin (RBV) for 12 or 24 weeks in pediatric participants with HCV.

During screening, participants will receive placebo to match LDV/SOF FDC to assess ability to swallow tablets.


Eligibility Criteria:
Key Inclusion Criteria:

* Consent of parent or legal guardian required
* Chronic HCV infection
* Screening laboratory values within defined thresholds

Key Exclusion Criteria:

* History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol.
* Co-infection with HIV, acute hepatitis A virus, or hepatitis B virus
* Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
* Pregnant or nursing females
* Known hypersensitivity to study medication
* Use of any prohibited concomitant medications as within 28 days of the Day 1 visit

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
COVID-19 Aerosol in EGD Using a Droplet Reduction Mouthpiece

Measurement of aerosolisation during esophagogastroduodenoscopy (EGD) to compare two types of mouthpieces, conventional versus a new and commercially available one 'the droplet reduction mouthpiece B1'.

This new mouthpiece is considered to reduce droplet spreading during EGD and therefore could be a good option for use in COVID-19 positive patients.

During esophagogastroduodenoscopy (EGD), a hard-plastic mouthpiece is used to protect the endoscope from being bitten and to enable its smooth insertion. In September 2020, the droplet reduction Mouthpiece "B1" (Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable) was launched by Fujifilm Corporation, Tokyo, Japan and imported to Europe by Fujifilm Europe. The droplet reduction mouthpiece is used in the same way as the conventional mouthpiece but differs from current mouthpieces by the inclusion of a sponge rubber incorporated into the mouthpiece orifice, and a drape shield specifically created to catch and reduce the droplets emitted by the patient during upper gastrointestinal endoscopy. This newly developed mouthpiece is considered for application during routine endoscopy at our facility during the COVID-19 pandemic, helping to minimize the risk to health care workers and patients from becoming infected with COVID-19 and various other pathogens. However, there is a lack of scientific evidence on the amount of aerosol reduction with the modified mouthpiece when upper gastrointestinal (GI) endoscopy is being performed.

The aim of the present study is to quantify the generation of aerosols when performing upper GI endoscopy with the modified mouthpiece. The investigators intend to quantify the number of particles in the air near the patient. The duration of therapeutic upper gastrointestinal endoscopies can vary extremely. To avoid risk of imbalance in procedure durations, the investigational team is limiting the protocol to standard diagnostic EGDs. The investigators assume that aerosol generations during short procedures can be extrapolated to longer procedures and hence this should not invalidate the findings

Eligibility Criteria:
Inclusion Criteria:

* Aged \>18 years old;
* Male or female patients;
* Patients undergoing elective standard diagnostic EGD;
* Negative polymerase chain reaction (PCR) test on nasopharyngeal swab 24 or 48 hours prior to the test;
* No anatomical deformity of nose and throat, no known diseases of nose and throat;
* Signed informed consent

Exclusion Criteria:

* Females who are pregnant or lactating.
Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, (CAIV-T) in Healthy Children

- Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of(CAIV-T) in Healthy Children.

- A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III, Multicenter Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A \& B, Live Cold-Adapted (CAIV-T) in Healthy Children

Eligibility Criteria:
Inclusion Criteria:

* •who are aged at least 6 months and less than 36 months of age at the time of first vaccination

  * who are in good health as determined by medical history, physical examination and clinical judgement
  * whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained
  * who, along with their parent(s)/legal guardian(s), will be available for duration of the trial (8 months ±1 month)
  * whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts \[telephone, clinic or home visit\].

Exclusion Criteria:

* whose parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period with any serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease

  * with Down's syndrome or other known cytogenetic disorders
  * with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids (see Section 4.2.1)
  * who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study
  * for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study
  * have an immunosuppressed or an immunocompromised individual living in the same household
  * who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational)
  * with a documented history of hypersensitivity to egg or egg protein or any other component of the assigned study vaccine
  * who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to vaccination or for which use is anticipated during the study
  * with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results. If any of these criteria are met following enrolment, the subject will be excluded from subsequent vaccine dosing.

Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study.
Prognostic Value of Human Papillomavirus (HPV) Detection in Cervical Intra-epithelial Neoplasia (CIN) Recurrence After Conization

CIN2/3 have been increased for many years and mainly concern women aged 25-29 years. They are subsequent to a persistent HPV infection and are classically treated by conization. Recurrences occur in 7 to 18 % of cases, mainly after CIN3 management during the first 2 years of follow-up. Follow-up is crucial to detect and treat recurrence and to select high risk women who might develop cervical cancer. Colposcopy and cytology have been recommended since 1989 by French ANAES, but these methods have poor sensitivity and specificity. However, DNA HPV testing is more sensitive and has demonstrated a very high negative predictive value, while specificity and positive predictive value remain average. Other HPV markers like genotyping, viral load and integration begin to be used in screening but have not been investigated in CIN2/3 follow-up to assess the values of various HPV markers which predict CIN2/3 recurrence after conization. The primary objective is to describe HPV expression (genotyping, viral load, mRNA E6 and E7) at the time of conization and during the follow-up period (6, 12, 24 months) and to assess the prognostic value of HPV 16 expression (viral load, mRNA E6 and E7) to determine the risk of CIN2/3 recurrence after conization, compared to the other clinical and virological risk factors.

Women with CIN3 treated by conization will be consecutively included in this study during 12 months. They will be recruited in the 3 main University Hospitals of South West France (Bordeaux, Toulouse, Limoges) and followed-up for 24 months. Colposcopy (+/- biopsies), cytology, and virology tests will be performed at the time of conization and during the follow-up period (6, 12, 24 months). HPV expression will be assessed by centralized validated marketed tests (Hybrid Capture 2, RLA genotyping, PreTect® HPV-Proofer) and by a real time PCR measuring E2, E6 and E7 viral load of HPV 1.

Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years
* CIN 2 or 3 diagnosis at inclusion confirmed for a CIN3 diagnosis by conization.
* HPV detected by Hybrid Capture 2 or RLA genotyping.
* Informed and signed consent by the patient and the investigator
* Coverage by French social security

Exclusion Criteria:

* Pregnancy at the time of inclusion.
* Previous history conization.
* Atypical endometrial or glandular cells or evidence of carcinoma on conization.
* Previous vaccination with a prophylactic HPV vaccine.
* Active viral infections including HIV.
* Acquired or congenital immunodeficiency.
* Long term treatment by corticosteroids or immunosuppressive drugs.
* Persons under protection of law.
* Patients unable to meet the requirements of the protocol.
* Any condition that, according to the investigator, would prevent participation in the study or interfere with the objectives of the study (refusal of supervision at the University Hospital, expected change of address within 3 years, etc)
Sexual Function Changes in High-Risk Pregnancies

Sexual Function Changes in High-Risk Pregnancies

Background and Aim: Sexual functions generally decrease during pregnancy, and high-risk pregnancies are more severe clinical conditions that cause couples to reduce or abstain entirely from their intimacy. However, the evidence on the sexual functions in high-risk pregnancies is scarce. Therefore, this study aimed to evaluate the sexual function changes in high-risk pregnancies compared to normal pregnancies.

Methods: A total of 200 pregnant women (100 women in high-risk pregnancy and normal pregnancy groups each) were included. Demographic and obstetric data were collected, and participants completed The Female Sexual Function Index (FSFI).

Eligibility Criteria:
Inclusion Criteria:

study grup Pregnant women who ; followed up for HrP in the second trimester (14th to 28th gestational weeks), between 20 to 40 years old, followed up at our perinatology department with a diagnosis of IUGR, cholestasis, diabetes, preeclampsia, fetal anomaly control grup admitted for routine second-trimester ultrasonography assessment but with no risk for pregnancy

Exclusion Criteria:

Pregnant women who ; younger than 20 or older than 40 years of age, gestation in the 1st or 3rd trimester, presence of psychiatric or chronic disorders like rheumatic or heart diseases,

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Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above

Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects (aged 18 years and above) who have signed an informed consent form

Exclusion Criteria:

* Any acute or chronic illness
* Receipt of seasonal influenza vaccine for the current season 2007/2008
* Known or suspected impairment/alteration of immune function
* Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
* Any serious disease
* Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein,neomycin or kanamycin or any other component of the study vaccine
* Receipt of blood, blood products or immunoglobulins 3 months prior to vaccination
ChildObesity180 - Social Marketing Campaign to Encourage Healthful Eating in Restaurants for Children

The purpose of this study is to determine whether a messaging campaign affects the calories ordered for and consumed by children in a quick serve restaurant setting.

ChildObesity180 seeks to develop and implement a messaging campaign informed by evidence-based behavioral theory as well as perspectives from parents, children, and the restaurant industry. The campaign aims to help parents choose healthful options for their children when dining in the quick-serve restaurant setting. Aim 1 is campaign development. Aims 2 and 3 are assessment (i.e., Randomized controlled trial and revenue analysis). Hypotheses are that the messaging campaign will be associated with fewer calories ordered/consumed by children in the quick serve setting; and the campaign will not negatively impact quick serve restaurant revenue.

Eligibility Criteria:
Inclusion Criteria:

* Parent or legal guardian of a 4 - 12 year old child (who is present)
* Have not participated in the study before
* \<\<Intervention community only\>\> live, work, or frequently travel to community

Exclusion Criteria:

-
Testing Non-nutritive Sweetener Labels in Chile

The goal of this experiment is to examine the effects of 2 types of non-nutritive sweetener (NNS) warning labels among a sample of Chilean parents. The main questions this experiment aims to answer are:

Do non-nutritive sweetener warning labels improve consumers' ability to identify when a product contains non-nutritive sweeteners?

Do non-nutritive sweetener warning labels impact on consumers' selection of non-nutritive sweetener-sweetened, unsweetened, and/or sugar-sweetened products for their children?

Participants will be randomly assigned to 1 of 3 types of labels and view their assigned label on 3 sets of products. Each set will display 4 similar products: one unsweetened, one sweetened with sugar, one sweetened with non-nutritive sweeteners, and one sweetened with both sugar and non-nutritive sweeteners. For each set, participants will identify which product(s) contain NNS and select the product that they would purchase for their child. Researchers will compare results across label types.

Participants will complete an online randomized experiment programmed in Qualtrics. After providing informed consent, participants will be randomly assigned to view 1 of 3 types of labels: a neutral control label, a rectangular label stating "contains non-nutritive sweeteners, not recommended for children" (i.e., Chilean NNS label), or an octagonal label stating "contains non-nutritive sweeteners" (i.e., Colombian NNS label).

Participants will view their assigned label on 4 similar products (one unsweetened, one sweetened with sugar, one sweetened with non-nutritive sweeteners, and one sweetened with both sugar and non-nutritive sweeteners) displayed in random order and complete a task where they identify which product(s) contain non-nutritive sweeteners and select one of the products to purchase for their child. During this task, in all arms, products will also display Chile's current nutrient warning labels when applicable. This task will be repeated 3 times, each time with a different product category (i.e., fruit drinks, yogurts, breakfast cereals), with categories displayed in random order.

After the selection/identification tasks, participants will view their assigned labels on 2 products containing non-nutritive sweeteners (i.e., flavored milk and cereal bar). For each product, participants will rate the perceived message effectiveness of the label and perceived product healthfulness. Lastly, after all product exposures, participants will rate their intentions to limit their child's non-nutritive sweetener consumption.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Parent or guardian of child between 2-14 years old who has never been diagnosed with diabetes, high blood sugar, pre-diabetes or insulin resistance
* Residing in Chile

Exclusion Criteria:

* Less than 18 years old
* Not parent or guardian of child between 2-14 years old who has never been diagnosed with diabetes, high blood sugar, pre-diabetes or insulin resistance
* Not residing in Chile
A Study of Nivolumab in Participants With Locally Advanced or Metastatic (Stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) With Squamous and Non-Squamous Histology After Prior Chemotherapy Treated in Real World Settings in Greece and Cyprus

The purpose of this observational study is to estimate the overall survival (OS) rates in the overall study population treated with nivolumab in the second and third line setting in real world clinical practice in Greece and Cyprus. The study is descriptive in nature and is not planned to reject or affirm any formal statistical hypothesis.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male or female adult Greek-speaking patients, of any race (residing in Greece or Cyprus), aged at least 18 years at time of initiation of nivolumab treatment.
* Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic (stage IIIB-IV) Non-Small Cell Lung Cancer (NSCLC) with Squamous Cell Carcinoma (SCC) or Non-Squamous Cell Carcinoma (NSCC) histological subtype
* Initiated on second or third line treatment with nivolumab as monotherapy after prior chemotherapy as per the product's Summary of Product Characteristics (SmPC) prior to informed consent obtainment, and for whom therapy is ongoing and no more than one infusion has been administered from treatment initiation to obtaining the signed informed consent
* Decision to prescribe nivolumab treatment has been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study
* Provided signed informed consent for participating in the study and for collecting and analyzing medical data pertinent to the objectives of this study

Exclusion Criteria:

* Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment
* Previously treated with nivolumab or other non-chemotherapy agents, with the exception of immune checkpoint inhibitors (anti-PD-1(Programmed cell death-1)/anti-PD-L1 (Programmed death-ligand 1) agent, other than nivolumab) administered in combination with chemotherapy
* Currently receiving or are planned to receive treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to nivolumab therapy initiation
TIMCIs: A Hybrid Type 2 Study of Next-generation Pulse Oximeters

This study aims to provide evidence on next-generation clinical measurement tools through a mixed methods diagnostic accuracy and implementation study in Kenya, Senegal, Tanzania, and Uttar Pradesh, India.

Performance and feasibility of photoplethysmograph (PPG)-derived clinical measurement tools (medical device and smartphone-based screening technologies) by primary care providers will be assessed using a type 2 hybrid design to conduct a mixed methods diagnostic accuracy and implementation study.

The diagnostic accuracy study will consist of 3 components to achieve the primary and secondary objectives: 1) a usability assessment of observed user-product interactions and a system usability score, 2) measurement of multimodal PO device performance through comparison against a reference standard, and 3) caregiver/provider acceptability through semi-structured interviews.

The observational implementation (OI) study consists of 3 components to achieve the primary and secondary objectives: 1) a human-centered design workshop, 2) an observational study to evaluate the feasibility of implementing an approved multimodal PO device in clinical care, and 3) semi-structured in-depth interviews to assess provider and caregiver acceptability and adaptation.

The interventions for this study are PPG-derived clinical measurement tools that measure oxygen saturation (SpO2), pulse rate, respiratory rate, and/or temperature. The interventions will also be compared to a reference standard for the different clinical measurements

Eligibility Criteria:
Inclusion Criteria:

* Children 0 - 59 months for whom caregivers provide consent to participate in the research study, following completion of clinical consultation
* Consulting for a respiratory illness, or reported to have a respiratory illness when attending for a routine visit as an outpatient (e.g., vaccination, growth, or chronic disease monitoring)

Exclusion Criteria:

* Children in the immediate post-natal period or first day of life
* Attending for a consultation related to trauma only (including new and follow-up presentations for burns, injuries, wounds)
* Admitted within an inpatient part of the facility (including neonates delivered at the facility admitted with their mother)
* Children who are critically ill, requiring emergency treatment, or received a recommendation of immediate referral during clinical consultation