cyrilzakka/clinical-trials huggingface dataset:
Predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants

The VRS (Respiratory Syncytial Virus) study group in Lyon is a working that aims to understand, predict and prevent the burden of disease caused by human respiratory syncytial virus (RSV) infection in infants. Incidence of RSV-associated hospitalization in the first year of life was estimated at 14.5 (95% CI 13.4-15.6) per 1000 births in a cohort study in Lyon, France. Related direct medical annual costs were estimated for this cohort at 364,269€, mostly attributed to children born during the RSV season (231,959€) and children born premature (108,673€). This study will combine existing hospital specimens and databases to determine the respective role of socio demographic factors, clinical risk factors, level of cord specific antibody at birth, and virus characteristic in the Respiratory Syncytial Virus (RSV) Hospitalization outcome in Infants.

Regarding the introduction of a new RSV vaccine and RSV-specific neutralizing antibodies, these data are of prime importance to guide future vaccine policies.

Objective:

To determine the main predictors of Respiratory Syncytial Virus (RSV) Hospitalizations in Infants

Study design:

Prospective epidemiological, observational, one-center cohort study with sample collection.

Study population:

Birth cohort of infants born in Lyon before and during the RSV circulation period (October to march) with a follow-up until one year old (from birth until the age of 1 year maximum):

* Estimate Birth cohort (n=5,000).
* Estimate number of RSVH case (n=110).
* Estimate number of Blood cordon associated with a RSVH (Respiratory Syncytial Virus Human) case (n=60)

Eligibility Criteria:
Inclusion Criteria:

* Children born alive at participating centers.
* Parents living in the Rhone Alpes Auvergne region

Exclusion Criteria:

* Parents non-willing to participate
* Parents living outside the region
Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women of age 40 to 65 seeking treatment for hot flashes with last natural menstrual period (LNMP) completed at least 12 months prior to screening.
* Minimum of 7 moderate to severe hot flashes per day or 50 per week recorded for 7 consecutive days
* Body Mass Index less than or equal to 34 kg/m2 using the nomograph for BMI.

Exclusion Criteria:

* History, presence, or suspicion of estrogen-dependent neoplasia; Malignancy, or treatment for malignancy, within the previous 2 years.
* Active or recent arterial thromboembolic disease; History of venous thromboembolism
* History of cerebrovascular accident, stroke, or transient ischemic attack -
* Presence of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy
* Persistent elevated blood pressure
Diffusion Tensor Imaging Magnetic Resonance Imaging (DTI MRI) as a Correlate to Pain Relief and Facial Numbness in Patients Following Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia

Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. However, a common side effect of radiosurgery is facial numbness. To better understand how radiosurgery can bring about pain relief and facial numbness, we are conducting a study in which brain MRI scans will be done following stereotactic radiosurgery to learn if there are any changes in the MRI scans that correlate with symptoms.


Eligibility Criteria:
Inclusion Criteria:

* All patients age 18 years and older with typical trigeminal neuralgia, as determined by diagnostic criteria set by the International Headache Society, who are 1) intolerant of or refractory to medical management and 2) not candidates for or refusing a surgical micro-vascular decompression, will be evaluated for treatment with SRS.
* ECOG or Karnofsky Performance Status will not be employed, but patients must be sufficiently healthy to tolerate all study procedures.
* Patient must exhibit the ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Exclusion criteria
* Patients who present with pre-existing facial numbness.
* Patients MRI contraindications (e.g., pacemaker or defibrillator, cochlear implant, brain aneurysm clip, etc.)
* Patients who have previously been treated with MVD.
* Patients who have previously had an ablative treatment, including prior SRS.
* Pediatric patients (age \<18), pregnant women, and patients who are unable to give informed consent will be excluded.
Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

This study is a Phase 1, randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety of and immune response to CodaVax-RSV in healthy children. They will be vaccinated in spring to early autumn 2023 and followed through the 2023-24 RSV season. 18 children aged 2 to 5 years who are RSV-seropositive (have antibodies to RSV) and 33 children aged 6 months to \< 2 years who are RSV-seronegative (do not have antibodies to RSV) will be enrolled in escalating-dose cohorts. A safety committee will review the safety profile of each dosing group before the next dose-escalation. Children will receive 2 doses of the vaccine at one of several dose levels or placebo (saline solution with no active ingredient) as nose drops; doses will be 28 days apart.

A parent/guardian will record temperature and other conditions in a diary daily for 7 days after each dose. The parent/guardian will be contacted by telephone on the day after Dose 1 for safety assessment and review of the diary data. Children will return to the clinic 3, 7, 14, and 28 days after each dose. The parent/guardian will then be contacted by telephone monthly until 1 year after the second dose.

Study procedures include physical examinations, vital signs, and collections of blood and nose/throat swab samples to look at safety of the vaccine and to analyze body's immune response.


Eligibility Criteria:
Inclusion Criteria:

1. Age at the time of informed consent:

   * Part A: 2 to 5 years, inclusive
   * Part B: 6 months to \< 2 years
2. RSV Status at Screening:

   * Part A: RSV-seropositive
   * Part B: RSV-seronegative
3. Good general health status
4. Product of normal full-term pregnancy (36 to 42 weeks gestation)

Exclusion Criteria:

1. Household contact with any of the following groups of individuals for the period up to 14 days after each dose:

   * Pregnant women
   * Infants \< 6 months of age
   * With hospitalization for asthma or other chronic respiratory disease in the past 5 years
   * Immunocompromised individuals, which includes, but is not limited to, those with the following conditions:

     * AIDS
     * Receipt of chemotherapy within the past 6 months
     * Current receipt of immunosuppressive agents
     * Solid organ or bone marrow transplant
2. Enrolled in the same classroom at full-time day care with infants \< 6 months of age for 14 days after each dose
3. Household contact of another child enrolled into the study
4. Inadequate venous access for repeated phlebotomy
5. Height and weight ≤ 5th percentile for age and sex (according to CDC growth charts for children in Part A, according to World Health Organization Child Growth Standards for children in Part B)
Vaccine Hesitancy: A Survey of Pediatric Clinicians

The purpose of this study is to explore the experiences and perceptions of District VI pediatric clinicians on parental vaccine hesitancy and vaccine refusal.

This is a retrospective, convenience sample, descriptive study. Participants will be asked to complete a web-based survey on parental vaccine hesitancy/ vaccine refusal. Survey responses are primarily categorical. Frequencies and averages will be reported using group statistics.

Eligibility Criteria:
Inclusion Criteria:

* Members of District VI American Academy of Pediatrics

Exclusion Criteria:

* Non-English speaking/reading
Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021

This is an open-label study enrolling healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will receive either a single injection of ARCT-021 or no injection and be followed for up to 365 days.

This is a phase 2a, open-label study enrolling up to 106 healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will enter this study approximately 3 months after their final study visit in the Parent Study. Participants that received placebo in the Parent Study or who are seronegative for SARS-CoV-2 neutralizing antibodies at screening will receive a single dose of ARCT-021 and will be followed for 365 days. Participants that received two injections of ARCT-021 in the Parent Study will not receive any further injections of ARCT-021 and will be followed for 281 days.

Eligibility Criteria:
Inclusion Criteria:

Individuals who:

1. are able to give consent
2. must have completed Study ARCT-021-01
3. agree to comply with all study visits and procedures

   Only for subjects that will receive ARCT-021 in this study:
4. are healthy and medically stable
5. are not planning to donate blood or plasma until 28 days after the last dose of ARCT-021.
6. are willing to refrain from strenuous exercise/activity and alcohol for at least 72 hours prior to study visits and until 28 days after the last dose of ARCT-021.
7. are willing to adhere to contraception requirements if sexually active and/or are of child-bearing potential

Exclusion Criteria:

Individuals who:

1. are unable to comply with the study visits or procedures in Study ARCT-021-01
2. received placebo in the Parent Study and who are not willing to receive ARCT-021 in this study.

   Only for subjects that will receive ARCT-021 in this study:
3. have or will receive any of the SARS CoV-2 or another experimental coronavirus during this study.
4. have a diagnosis of new clinically significant abnormalities including but not limited to

   * Respiratory disease requiring daily medications or oxygen currently or any treatment of respiratory disease exacerbations
   * Significant heart conditions
   * Significant neurological conditions
   * Significant blood disorders
   * Newly diagnosed autoimmune disease
   * Major surgery
5. have abnormal screening laboratory results
6. have uncontrolled diabetes
7. use of any prescription or over-the-counter medications within 7 days prior to vaccination
8. have received immunoglobulins and/or any blood or blood products
9. have a bleeding disorder
10. have uncontrolled blood pressure
11. have been treated with another investigational drug, biological agent, or device since completion of the Parent Study
12. have received or plan to receive:

    * A licensed, live vaccine within 4 weeks before or after study vaccination, or
    * A licensed, inactivated vaccine within 2 weeks before or after study vaccination
13. have traveled outside of Singapore within 30 days before the vaccination or plans to travel outside of Singapore within 60 days after vaccination.
14. other restrictions may apply
A SAD and MAD Study of the Safety, Tolerability, and Pharmacokinetics of ATH-1105

The goal of this Phase 1 interventional study is to assess the safety, tolerability and pharmacokinetics of ATH-1105 in healthy male and female participants.

The study is a Phase 1, First-In-Human study consisting of two parts (A and B). Part A will comprise a single-dose, double-blind, placebo-controlled, sequential-group design. Part B will comprise a multiple-dose, placebo-controlled, sequential-group design.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18.0 and 32.0 kg/m2 inclusive.
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and check-in or predose on Day 1
* Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
* Able to comprehend and willing to sign an ICF and to abide by the study restrictions.

Exclusion Criteria:

Medical Conditions:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* Any of the following:

  1. QTcF \>450 ms in males or \>470 ms in females
  2. QRS duration \>110 ms
  3. PR interval \>220 ms
  4. Findings which would make QTc measurements difficult or QTc data uninterpretable.
  5. History of additional risk factors for torsades de pointes
* Confirmed systolic blood pressure \>140 or \<90 mmHg, diastolic blood pressure \>90 or \<50 mmHg, and pulse rate \>100 or \<40 beats per minute.
* Positive hepatitis panel and/or positive human immunodeficiency virus test
* Part B only: Current psychiatric disorder, suicidal ideation in the previous 2 years (as assessed by the Columbia-Suicide Severity Rating Scale \[C-SSRS\]), or a lifetime suicide attempt.

Prior/concomitant therapy:

* Administration of any vaccine in the 30 days prior to dosing.
* Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes
* Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing
* Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in
* Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check-in
Target Versus Standard Human Milk Fortification in Very Low Birth Weight Preterm Infants

The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Standard fortification is the most commonly used supplementation practice but it does not consider the native variability of human milk. Data on efficacy and safety of prolonged target fortification are scarce. The investigators performed a prospective interventional study in VLBW preterm infants, exclusively fed with human milk, to test efficacy and metabolic safety of target fortification in these preterm infants.

The prevention of postnatal growth failure in very low birth weight (VLBW) preterm infants is of utmost importance. Fortified human milk is the goal for preterm infants' nutrition. Standard fortification is the most commonly used and safe supplementation practice but it does not consider the native variability of human milk. Data on efficacy and safety of prolonged target fortification are scarce. Prospective interventional study was conducted in VLBW preterm infants, exclusively fed with human milk. Twenty-four hour collected pools of human milk were analyzed and targeted human milk fortification was performed during hospitalization. Weekly growth and daily growth velocity were compared with that of an historical group of VLBW preterm infants that had received standard fortified human milk. Osmolality, metabolic and gastrointestinal tolerance were monitored.

Eligibility Criteria:
Inclusion criteria:

* Birth weight \< 1500 grams
* Gestational age \< 32 weeks
* Birth weight \> 10th percentile according to Fenton' growth chart
* Exclusively breast feeding during the entire hospital stay

Exclusion criteria:

- Presence of congenital malformations that could affect growth (congenital diseases, chromosomal abnormalities, chronic lung disease, severe brain disease, severe metabolic, cardiac or gastrointestinal diseases)
Impact of Theta Burst Stimulation Over the Left DLPFC on Language Switching

The purpose of this study is to investigate whether theta burst stimulation (TBS) over the left dorsolateral prefrontal cortex (DLPFC) influences language switching and cognitive flexibility. The experimental paradigm will assess the impact of inhibitory and excitatory prefrontal stimulation by TBS versus sham-TBS over the DLPFC in healthy bilinguals.

Background:

Clinical observations and neuroimaging studies seem to confirm the role of executive functions and frontal structures in language processing in bilingual subjects.

Repetitive transcranial magnetic stimulation, such as for example theta burst stimulation (TBS), is increasingly being used as a valuable tool for neuroscientists investigating the underlying mechanisms of cognitive functions. Case studies have shown a change in language switching after bilingual patients received repetitive magnetic stimulation to the left DLPFC. However, there is no study investigating the effect of TBS applied to the DLPFC on language switching in healthy participants.

Procedure:

A planned total of 40 unbalanced bilingual participants will be included. Half of the participants will receive inhibitory theta burst stimulation (continuous TBS), the other half excitatory theta burst stimulation (intermittent TBS). After TBS, different language and nonverbal tasks will be performed while an EEG is measured. Before being stimulated, each subject will conduct the same tasks with a sham-TBS as a baseline measure.

Eligibility Criteria:
Inclusion Criteria:

* L1 (Swiss)German, knowledge of English as a foreign language
* 18-45 years of age
* right-handedness

Exclusion Criteria:

* epilepsy / family history of epilepsy
* brain surgery, traumatic brain injuries
* cardiac pacemaker, metallic objects in the head
* history of neurological diseases or severe psychiatric disorders
* drug use (alcohol, psychoactive medication)
* strong headache
* pregnancy
A Study of RO5185426 in Patients With Metastatic Melanoma

This is an open-label, non-comparative, multicenter, expanded access study of RO5185426 in patients who have received prior systemic therapy for metastatic melanoma and who have no other satisfactory treatment options.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic melanoma with documented BRAF V600E mutation, determined by the cobas BRAF V600 mutation test
* Patients with either measurable or non-measurable disease
* Adequate recovery from most recent systemic or local treatment for metastatic melanoma
* Adequate organ function
* For women of childbearing potential, agreement to the use of two acceptable methods of contraception, including one barrier method, during the study and for 6 months after discontinuation of RO5185426
* For men with female partners of childbearing potential, agreement to use a latex condom, and to advise their female partner to use an additional method of contraception during the study and for 6 months after discontinuation of RO5185426
* Negative serum or urine pregnancy test within 7 days of commencement of treatment in premenopausal women. Women who are either surgically sterile or have been post-menopausal for at least 1 year are eligible to participate in this study
* Agreement not to donate blood or blood products during the study and for at least 6 months after discontinuation of RO5185426; for male patients, agreement not to donate sperm during the study and for at least 6 months after discontinuation of RO5185426

Exclusion Criteria:

* Pregnant or breast-feeding
* Concurrent anti-tumor therapy
* Uncontrolled medical illness
* History of congenital prolonged QT syndrome or patients with a mean QTc interval greater than 470 milliseconds at baseline, or ongoing grade 2 or greater cardiac arrhythmia
Increasing Folate Status of a General Population(FOLSUPP STUDY)

The aim of this study is to determine the best source of folate to raise the folate status of a general population over a 16 week intervention period.

This study is designed to assess whether increasing the consumption of natural food folates from a mixed diet is as effective as supplemental folic acid or supplemental natural folate in raising folate status, reducing biomarkers of cardio vascular disease (CVD) risk, and improving vascular function. Randomised placebo-controlled parallel studies will be undertaken in groups of individuals in Norwich and Sheffield. There will be four treatment arms: a) 200 µg folate per day from folate-rich foods, b) 200 µg folate per day from supplemental folic acid, c) 200 µg folate per day from supplemental Metafolin® (6S 5-methyltetrahydrofolic acid) and d) a placebo group. Results from the two centres will be combined, thus ensuring a wide population is covered. Folate status, biomarkers of CVD risk and vascular function (pulse wave velocity) will be measured before and following the intervention period of 16 weeks, together with possible confounders (such as vitamins B2 \& B12 status, and MTHFR genotype). 7-Day weighed intakes will be used to measure habitual B-vitamin intake during baseline and intervention, to determine changes in folate intake and assist compliance. Additionally, folate content of selected folate-rich foods will be determined for each volunteer. The results will aid the Food Standards Agency (FSA) in formulating public health policy related to improving folate status and reducing CVD risk.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-65 years
* Smokers and non-smokers

Exclusion Criteria:

* Pregnant or has been pregnant within the last 12 months
* Breastfeeding
* Has donated or intends to donate blood within 16 weeks of the first or last study samples
* Fails standard clinical screening of blood and urine for human studies at the Institute of Food Reseach
* BMI above 18 or below 40
* Receiving vascular disease or anti-hypertensive drugs
* Those with diabetes
* Regularly consuming dietary supplements containing B-vitamins and/or folic acid.

\[As the capsules are prepared from gelatin, true vegetarians may not wish to participate\]