bioihbjkbjnl/mcl2 huggingface dataset:
Persistence of Antibody Levels and Response to Fifth or Third Meningococcal B Recombinant Vaccine in 4-year Old Healthy Children Who Previously Participated in Study V72P12E1
Condition: Meningococcal Disease; Meningococcal Meningitis
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      It is a Phase 3 extension of study V72P12E1 (NCT00944034). The main aim of the second
      extension study is to explore the bactericidal antibody persistence in 4-year-old children
      after a fourth dose boost of rMenB+OMV NZ or after a two-dose catch-up schedule of rMenB+OMV
      NZ administered to toddlers as part of their respective vaccination courses in study
      V72P12E1.

      In addition, this study will characterize the antibody response to a fifth dose boost in all
      children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age
      (in parent study V72P12, NCT00721396), and only in a subset of children who received a
      three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12).
      Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ
      administered at approximately 4 years of age in all children who received a two catch-up
      doses of rMenB+OMV NZ as toddlers in study V72P12E1.

      Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2
      months apart to healthy naïve children at 4 years of age will be assessed.
    


Intervention name(s): 1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine; 2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose; 0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, two doses, two months apart
Other intervention name(s): rMenB+OMV NZ; rMenB+OMV NZ
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal disease, vaccines, children, persistence
Study to Assess the Safety, Tolerability, and Pharmacokinetics (Movement of Drugs Within the Body) of AZD2693 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I, randomised, single-blind, placebo-controlled study has been designed to assess
      the safety, tolerability, and pharmacokinetics (PK) of AZD2693 following subcutaneous (SC)
      administration of AZD2693 in healthy participants
    

Detailed description: 
      The study will be performed at a single study center in Japan.

      The study will comprise of following periods:

        -  Screening Period of maximum 28 days.

        -  An 8-week Treatment Period during which participants will be randomized to receive
           multiple doses of AZD2693 or placebo at the study center.

        -  A Follow-up Period of 15 weeks post last dose of study intervention consisting of 8
           Follow-up Visits.

      Participants will be enrolled in 4 consecutive cohorts of 11 participants where 8
      participants will be randomized to receive AZD2693 and 3 participants will be randomized to
      receive placebo.

      A participant is considered to have completed the study if the participant has completed all
      phases of the study including the last visit.
    

Intervention name(s): AZD2693; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive subcutaneous injection of AZD2693, once per month.; Participants will receive subcutaneous injection of placebo (volume matching to AZD2693 injection [0.9% saline solution]), once per month.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Pharmacokinetics; Healthy Japanese Participants; Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis
Evaluation of a Spatio-behavioral Application
Condition: Physical Activity
Study type: Interventional

Summary: 
      The CIRCUIT program (Centre pédiatrique d'interventions en prévention et en réadaptation
      cardiovasculaire) of the CHU Sainte-Justine is a multidisciplinary, personalized intervention
      for children with cardiovascular risk. This program includes an evaluation of the physical
      activity pattern using wearable sensors (accelerometer, heart rate monitor and GPS), to
      replace the physical activity practice of the patients in their respective real life context.
      The accelerometer will measure physical activity and heart rate, while the GPS will serve to
      obtain precise information about places visited and travels in the neighborhood. The data
      obtained with these tools will serve to develop indicators of the "environmental diagnosis".
      This information will help to personalize the intervention for each patient.
    


Intervention name(s): multi-sensor lifestyle intervention
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart
      (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by
      injection under the skin. The study will assess how fast the active ingredient (insulin
      lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove
      it. A test meal will be given to trial participants to assess the course of the blood sugar
      lowering effect of the investigational products. The safety and tolerability of LY900014 will
      also be assessed. Screening is required within 14 days prior to the lead in. For each
      participant, the study will last up to 91 days.
    


Intervention name(s): LY900014; Insulin Lispro; Insulin Aspart; Insulin Aspart
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered SC; Administered SC
Other intervention name(s): Ultra-Rapid Lispro; Humalog®; LY275585; NovoRapid®; Fiasp®
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications
Condition: Patent Ductus Arteriosus
MeSH terms: Ductus Arteriosus, Patent
Study type: Observational

Summary: 
      This study will evaluate the use of acetaminophen in preterm infants when a patent ductus
      arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational
      studies over a 3 year period. The first will be of infants with clinically significant PDAs
      beyond 14 days of life who are medically treated with acetaminophen as a means to avoid
      surgical ligation, and the second will be of infants who received acetaminophen for a PDA
      closure during the first 2 weeks of life as a result of ibuprofen, the current standard of
      care in our NICU, contraindication due to medical status.
    


Intervention name(s): Acetaminophen
Intervention type(s): Drug
Intervention description(s): Acetaminophen given at discretion of medical team for PDA treatment. Research team to evaluate pre and post laboratory values and echocardiograms.
Intervention MeSH terms: Acetaminophen
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premature infants born between 23 0/7 weeks to 29 6/7 weeks gestational age.
Pediatric Expanded Access Program-Oral Solution (0831-908)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Monitor the safety and tolerability of efavirenz oral solution in combination with
      Antiretroviral Therapy for the treatment of patients age 3 to 16 years who have failed
      therapy or who are intolerant to their current therapy.

      This is an early phase trial and some specific protocol information is in progress and not
      publicly available at this time. (Full information is available to trial participants).
    


Intervention name(s): MK0831
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Treatment Experienced
Effectiveness of Toric Intraocular Lenses for Treating Corneal Astigmatism in Patients With Cataract and Previous DALK
Condition: Corneal Astigmatism in Cataract Patients and Previous DALK
MeSH terms: Cataract; Astigmatism
Study type: Interventional

Summary: 
      the purpose of this study was to assess the efficacy of custom made toric intraocular lens
      implantation in patients with simultaneous post-DALK high corneal astigmatism and cataract.
    

Detailed description: 
      Patients undergoing cataract surgery after DALK for keratoconus were enrolled. Total corneal
      astigmatism (TCA)was assessed by a rotating Scheimpflug camera combined with Placido disk
      corneal topography (Sirius; CSO, Firenze, Italy). A customized toric IOL (FIL 611 T, Soleko)
      was implanted in all eyes. One year postoperatively, refraction was measured, the IOL
      position was recorded, and vectorial and non-vectorial analysis were performed to evaluate
      the correction of astigmatism.
    

Intervention name(s): Customized toric IOL for post-DALK atigmatism
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 60 week study including a double-blind phase followed by an open-label phase.
    


Intervention name(s): Botulinum Toxin Type A; placebo (saline)
Intervention type(s): Biological; Other
Intervention description(s): Two treatment sessions in the double-blind phase and three treatment sessions in the open-label phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.; Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
Other intervention name(s): BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Short-Term Exposure for PTSD
Condition: Chronic Post-Traumatic Stress Disorder; Marijuana Abuse
MeSH terms: Marijuana Abuse; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study examines how marijuana use affects processes related to recovery from chronic
      posttraumatic stress disorder (PTSD). Half the participants will be individuals with chronic
      PTSD and heavy marijuana use and half will be individuals with chronic PTSD and no marijuana
      use. This study will assess how individuals with PTSD with heavy or no marijuana use perform
      on a discriminative conditioning and extinction paradigm designed to measure fear extinction
      learning, and how they respond to a brief daily imaginal exposure treatment in regards to
      PTSD symptom reduction.
    

Detailed description: 
      In this study, 36 patients with chronic PTSD and heavy marijuana use (heavy) and 36 patients
      with chronic PTSD and no marijuana use (no use) will be recruited to examine the effects of
      marijuana use on behavioral (emotional experiencing), physiological (skin conductance,
      acoustic startle) and biological (cortisol, blood pressure) responding on a well-established
      discriminative conditioning and extinction paradigm. To examine real world therapeutic
      implications, we will also examine how individuals with PTSD and heavy or no marijuana use
      differentially respond to a brief (6 session, 50 min) daily imaginal exposure (IE) treatment.
      Throughout treatment, we will monitor level of cannabis metabolites in urine samples of
      marijuana users to correlate effects to outcomes and preliminarily explore how varying levels
      of cannabis metabolites affect extinction processes. Independent evaluators will assess
      patients at baseline, 4 weeks, and 12 weeks following study entry.
    

Intervention name(s): Brief Imaginal Exposure
Intervention type(s): Behavioral
Intervention description(s): Psychoeducation and imaginal exposure components of full prolonged exposure, in which patients relive the trauma vividly and process thoughts and feelings related to it
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of CS1001 in Subjects With Esophageal Squamous Cell Carcinoma
Condition: Unresectable Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase III Study to Investigate the Efficacy and Safety of CS1001 or Placebo in Combination
      with FP as First-Line Therapy in Subjects with Unresectable Locally Advanced, Recurrent or
      Metastatic Esophageal Squamous Cell Carcinoma
    


Intervention name(s): CS1001+ Fluorouracil+Cisplatin; Placebo+ Fluorouracil+Cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): CS1001 1200 mg, intravenous infusion on the first day of each cycle (3 weeks) (Q3W).
Fluorouracil: 800 mg/m2/day, continuous intravenous infusion on Day 1 to Day 4 of each cycle Cisplatin: 80 mg/m2, intravenous infusion on the first day of each cycle.; Placebo 1200 mg, intravenous infusion on the first day of each cycle (3 weeks) (Q3W).
Fluorouracil: 800 mg/m2/day, continuous intravenous infusion on Day 1 to Day 4 of each cycle Cisplatin: 80 mg/m2, intravenous infusion on the first day of each cycle.
Intervention MeSH terms: Cisplatin; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Partnering With Media and Vaccination Program to Improve Infant and Young Child Feeding
Condition: Infant and Young Child Feeding
Study type: Interventional

Summary: 
      Infant and young child feeding (IYCF) is a key determinant of under-nutrition and overweight
      in young children. In Mexico, breastfeeding extends well into the second half of infancy, but
      animal-source foods, cereals, and legumes are not regularly provided to the child by 9 mo.
      This study evaluates whether knowledge and practices about dietary diversity and food
      consistency can be improved using a two-component intervention strategy in semi-urban
      communities in Mexico. The two components will deliver appropriate complementary feeding
      messages using: (a) nurses during the 1st National Vaccination Week (NVW); and (b) radio
      messages and interviews. The intervention is evaluated using a cluster randomized design in
      small semi-urban communities in two states in Mexico with pre- and post-test questionnaires
      designed to assess changes in feeding behaviors.
    


Intervention name(s): Appropriate complementary feeding messages
Intervention type(s): Behavioral
Intervention description(s): Messages delivered through National Vaccine Program and radio
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain
Condition: Low Back Pain; Chronic Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this 52-week open label study is to determine the long-term safety of a new
      opioid molecule, NKTR-181, in patients with moderate to severe chronic low back pain or
      chronic non-cancer pain.
    

Detailed description: 
      This is an open-label safety and tolerability study in which approximately 600 subjects will
      receive NKTR-181 for up to 52 weeks. Subjects may include newly enrolled subjects and
      subjects who have recently completed SUMMIT-07 study.

      This study will also investigate the pharmacokinetics of NKTR-181 in patients with chronic
      low back pain or chronic non-cancer pain.
    

Intervention name(s): NKTR-181 BID tablets
Intervention type(s): Drug
Intervention description(s): NKTR-181 tablets 100-600 mg twice daily (BID)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Use Study With VYVANSE® in Australia for Binge Eating Disorder
Condition: Binge-eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Observational

Summary: 
      This study will check how and to whom Vyvanse is prescribed in Australia by retrospectively
      analyzing a prescription database with additional information provided by a physician survey.
    

Detailed description: 
      This is a drug utilization study (DUS) using cross-sectional database analysis of
      participants who are prescribed lisdexamfetamine dimesylate for treatment of BED. The study
      will combine data from two sources of patient-level drug utilization data for
      lisdexamfetamine dimesylate:

        -  NostraData database: Longitudinal participant level prescription dispensing database

        -  Physician survey: De-identified participant data provided by representative
           psychiatrists and other physicians expected to treat participants with BED in Australia.

      In the NostraData database, actual drug dispensing data are collected, which allows for the
      generation of information on actual drug usage. However, these data do not contain certain
      participant variables, such as age and indication, needed to monitor potential off-label use.
      Therefore, these data must be supplemented with another data source. The physician survey
      will provide the data not included in the NostraData database.

      The DUS will enroll approximately 150 participants.

      This DUS will be conducted in Australia. The overall time for data collection in the study
      will be approximately 36 months after the launch date of lisdexamfetamine dimesylate.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participants who have been prescribed lisdexamfetamine dimesylate at least once during the
        reporting period without evidence of use of lisdexamfetamine dimesylate for ADHD treatment.
A Two-part, Single-dose, Randomized Study to Evaluate the Safety of Supra-therapeutic Doses of RO7033877 and to Investigate the Effect of RO7033877 on the QTc Interval
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part study to evaluate the safety and tolerability of supratherapeutic doses of
      RO7033877 (Part 1) and to investigate the effect of RO7033877 on the QTc interval in healthy
      volunteers (Part 2). Part 1 is a single ascending dose, randomized, observer-blind,
      placebo-controlled study to determine the safety tolerability and pharmacokinetics of a
      supratherapeutic dose to be used in Part 2. Participants will be randomized in up to 8
      cohorts to receive a single dose of either RO7033877 or placebo. Part 2 will be a single
      dose, randomized, double-blind, double dummy, placebo-controlled, positive control, 4-way
      crossover study. Part 2 will evaluate whether a single therapeutic or supratherapeutic dose
      of RO7033877 has a threshold pharmacologic effect on cardiac repolarization, as detected by
      changes in the QT/QTc interval measured by electrocardiogram (ECG). Pharmacokinetic
      parameters will be assessed for Parts 1 and 2, continuous ECG recordings will be evaluated in
      Part 2.
    


Intervention name(s): Part 1: SAD RO7033877; Part 1: SAD placebo; Part 2: Treatment A, RO7033877; Part 2: Treatment B, RO7033877; Part 2: Treatment C, moxifloxacin; Part 2: Treatment D, RO7033877 and moxifloxacin placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose; Single dose; Single dose RO7033877 and moxifloxacin placebo; Single dose RO7033877 and moxifloxacin placebo; Single dose moxifloxacin and RO7033877 placebo; Single dose moxifloxacin placebo and RO7033877 placebo
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Effect of Cheese on Cardiovascular Risk
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      The main objective of the current study is to examine whether a high intake of regular-fat
      cheeses (Danbo and Cheddar) affect blood lipids differently than an isocaloric intake of
      either other fatty animal food products or of starchy carbohydrates. Furthermore, effects on
      fat digestibility, blood pressure, anthropometry, bile acid metabolism and insulin
      sensitivity is investigated.

      To do this, a randomized crossover intervention study with 3x14 days full diet periods
      (cheese diet, meat diet or carb diet)will be conducted in 16 postmenopausal women. Between
      the diet periods there will be at least 14 days of wash-out where the subjects eat their
      habitual diets. Fasting blood samples will be drawn before and after the diet periods, and
      also a non-fasting blood sample will be drawn after the diet periods. Furthermore, total
      feces is collected the last 5 days of each diet period.
    


Intervention name(s): Dietary intervention: CHEESE (High cheese intake); Dietary intervention: MEAT (High Meat intake); Dietary intervention: CARB (High Carbohydrate intake)
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dairy; Cheese; Blood lipid concentrations; Blood lipid sizes; Fecal fat; Fat digestibility; bile acids