bioihbjkbjnl/mcl2 huggingface dataset:
The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care
Condition: Infant, Premature
Study type: Interventional

Summary: 
      NIDCAP based developmental care is a method of looking after preterm infants that is guided
      by the infant's behavioural cues, and that actively involves parents in the care of their
      infant. There is limited evidence that outcomes for infants are improved if they receive
      NIDCAP based care. This study evaluates the effects of introducing NIDCAP based care to a
      level III neonatal intensive care unit, in the post - surfactant era, and also evaluates its
      effects on developmental outcomes at age 18 months.
    

Detailed description: 
      This RCT differs from previous trials in that it is conducted in the post - surfactant era
      [an intervention that has greatly changed clinical neonatology]. The number of infants
      required to demonstrate a clinically relevant outcome [Length of Hospital Stay] has been
      calculated a priori. The infants will be tracked for outcome data after transfer to
      peripheral nurseries [a reality in today's healthcare environment], allowing generalisability
      of results to other high risk, referral Neonatal Intensive Care units. Neurodevelopmental
      outcomes will be evaluated at 18 months; [these data are sparse from previous studies]. This
      RCT will therefore demonstrate whether NIDCAP based care is truly an effective intervention
      for the very low birth weight infant.
    

Intervention name(s): NIDCAP based developmental care
Intervention type(s): Procedure
Intervention description(s): Infants in the intervention arm will receive care in the NICU by nursing staff who have received basic education in NIDCAP - based developmental care. They will also have NIDCAP behavioural observations performed by NIDCAP - Certified staff [this includes 3 of the investigators], at intervals during their stay at the study site NICU. These behavioural observations form the basis for behaviourally guided "baby -friendly" care, so that the timing and pace of caregiving is synchronised to the infant's readiness. Parents are actively encouraged to become the infant's primary caregiver in the NICU.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Preterm Infant; Behaviour; Developmental Care; NIDCAP; Family Centred Care; Neurodevelopmental Outcome, preterm infant
Epirubicin and Docetaxel Combination (ET) or Epirubicin Followed by Docetaxel (E/T) for Node Negative (N0) High Risk Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The combination of taxanes, and especially docetaxel, with an anthracycline seems to be an
      important part of the chemotherapy regimens used in the adjuvant setting of patients with
      early-stage node-positive breast cancer patients. Whether sequential or concurrent
      administration of these drugs is preferable is not yet known, especially in patients with
      node-negative high risk tumors.
    


Intervention name(s): Docetaxel; Epirubicin; Epirubicin; Docetaxel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Docetaxel at the dose of 75 mg/m2 intravenously (IV) every 3 weeks for 4 consecutive cycles; Epirubicin at the dose of 90 mg/m2 IV every 3 weeks for 4 consecutive cycles; Epirubicin at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles; Docetaxel at the dose of 75 mg/m2 IV every 3 weeks for 6 consecutive cycles
Other intervention name(s): Taxotere; Farmorubicin; Farmorubicin; Taxotere
Intervention MeSH terms: Docetaxel; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High risk node negative
Exploratory Study of the Effects of Vortioxetine (Lu AA21004) on Cognition and Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Subjects Remitted From Depression and in Controls
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if Vortioxetine 20 mg/day will lead to changes in
      neural activity (BOLD signal), as measured using fMRI, in brain areas associated with
      executive functioning and memory during cognitive task performances compared to placebo in
      subjects remitted from depression and in controls, and to explore if Vortioxetine will lead
      to improved cognitive performance in the absence of depression.
    


Intervention name(s): Vortioxetine (Lu AA21004); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): encapsulated 20 mg tablets, orally, once daily for 13 to 14 days; capsules, orally, once daily for 13 to 14 days
Other intervention name(s): Brintellix
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Reaction Time, Cognitive Function and Physical Fitness of Children and Adolescent Soccer Players
Condition: Neuroplasticity
Study type: Interventional

Summary: 
      Investigation of the effect of an exercise program with visual stimuli on reaction time,
      cognitive function and physical fitness of children and adolescent soccer players.
    

Detailed description: 
      38 male soccer players aged 10-15 participate in the research voluntarily. A wireless reflex
      measurement system (FITLIGHT Trainer) is used to measure the response time, a cognitive
      function test (Cognitive Function Scanner Mobile) is used to assess cognitive function and an
      interactive virtual reality application (VR game) is used to estimate the visual field.
      Physical fitness is assessed using ALPHA-Fitness and the Eurofit test batteries. The
      screening takes place in the soccer field with portable devices. After the initial check, the
      participants were randomly divided into two equal groups using the program
      http://www.randomizer.org/.

      18 soccer players follow a 6-month exercise program with visual stimuli, 5 times a week and
      lasting 15 minutes each time, which precedes their regular soccer training program. The
      special training program includes training using illuminated units / disks. Each unit is
      activated alternately, and it is deactivated when the trainee passes in front of it or
      touches it with any part of his body as well as with another object / sports accessory. The
      remaining players continue their regular soccer training program. After the end of the 6
      months, the initial measurements will be repeated in both groups.
    

Intervention name(s): FitLight Trainer
Intervention type(s): Device
Intervention description(s): Evaluation of the reaction time before and after special training program using visual stimuli.
Other intervention name(s): Cognitive Function Scanner Mobile; VR game; Eurofit Physical Fitness Test Battery; ALPHA-Fitness test battery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Around half of the participants follow a 6-month exercise program with visual stimuli, 5 times a week and lasting 15 minutes each time, which precedes their regular soccer training program. The other half of the participants will continue their regular soccer training program. After the end of the 6 months, the initial measurements will be repeated in both groups.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Reaction Time; Cognitive Function; Physical Fitness; FITLIGHT Trainer; Visual Field; VR; soccer players
Effect of Raw Milk on the Immune Response Upon Cholera Vaccination
Condition: Infection
MeSH terms: Cholera
Study type: Interventional

Summary: 
      Rationale: Infections are an important worldwide cause of death, both in elderly and young
      children. Therefore, support of immunity could help to reduce the incidence of infections. To
      screen the potential of specific foods or food ingredients to support immunity, oral
      vaccination can serve as a model. In this study, oral cholera vaccination will be applied in
      human adult volunteers, and used as a model to study the support of the immune response by
      raw milk.

      Objective: To investigate whether raw milk is able to enhance the immune response as induced
      by oral cholera vaccination.

      Study design: The study is designed as a single-blind randomized controlled trial of 4 weeks.

      Study population: Healthy subjects of 18-50 years of age.

      Intervention: Raw milk, obtained from farms that comply to the high quality requirements for
      production of raw milk, and that has been screened according to the safety criteria for raw
      milk.
    


Intervention name(s): Cholera vaccination; Raw milk
Intervention type(s): Biological; Other
Intervention description(s): Oral cholera vaccination on day 0 and day 14
Other intervention name(s): Dukoral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: immunity; vaccination; milk
Evaluation of the Gametocytocidal Efficacy and Safety of Primaquine in Uncomplicated Falciparum Malaria in Uganda
Condition: Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of lower doses of primaquine
      compared to the dose recommended by the WHO for reducing P. falciparum gametocytes in the
      infected human host to prevent transmission of falciparum malaria to the anopheles mosquito
      vector.
    

Detailed description: 
      A single dose of 0.75mg/kg primaquine base is recommended by the WHO to block transmission of
      falciparum malaria from infected humans to mosquitoes by clearing gametocytes. However, the
      optimal dose for safety and efficacy has not been evaluated. Dose-finding data is important
      because primaquine has a dose-dependent risk of causing haemolysis (destruction of blood
      cells) in pre-disposed individuals, such as those with G6PD deficiency. G6PD deficiency is
      most prevalent in malaria-endemic areas. Therefore, it is essential that data on primaquine's
      safety is available in such areas.

      The investigators hypothesise that lower doses of primaquine have a lower risk of adverse
      effects compared to the WHO-recommended dose, but retain the transmission-blocking efficacy.

      The investigators propose to test this hypothesis in a four-arm clinical trial with a
      non-inferiority design to evaluate the efficacy and a superiority design to evaluate the
      safety of the WHO dose (0.75mg/kg) and lower doses of primaquine for clearance of P.
      falciparum gametocytes in children in Uganda. The study will include a pharmacokinetic
      analysis.
    

Intervention name(s): Primaquine
Intervention type(s): Drug
Intervention description(s): Single dose of oral primaquine phosphate. Comparator dose is 0.75mg/kg primaquine base. Each experimental arm is a different (reduced) dose of primaquine phosphate. Placebo contains no primaquine phosphate (non-active ingredients only).
Other intervention name(s): primaquine phosphate
Intervention MeSH terms: Primaquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: malaria; uncomplicated malaria; gametocytocidal drug; gametocytocidal; gametocyte; primaquine; transmission blocking; malaria transmission; sexual parasite; sexual stage; Uganda; Africa
Early Pharmacotherapy Aimed at Neuroplasticity in Autism : Safety and Efficacy
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the efficacy, safety, and population
      pharmacokinetics and determinants of drug responses to buspirone in children with autism
      using a randomized, double blind, cross over study in children ages 2 to 6 years.
    

Detailed description: 
      Autism is a neurodevelopmental disorder defined as qualitative impairment in social
      interaction and communication and restrictive stereotype patterns of behavior, interests and
      activities. Pharmacological agents are being increasingly used off label in very young
      autistic children, and there is virtually no data regarding the pharmacokinetics, safety or
      efficacy of these agents in young children.

      The approach in this study differs from pharmacotherapy studies of autism carried out thus
      far in several ways:

        -  the rationale underlying our approach is based upon an attempt to alter synaptic
           plasticity during postnatal development, focusing on very young children

        -  are integrating our drug trial with a PG study evaluating whether buspirone response is
           related to expression of genes involved in serotoninergic neurotransmission

        -  will assess these variables together with in vivo assessment of serotonin synthesis
           capacity with PET.

      This is a prospective, randomized, double blind, crossover study where children will be
      stratified by age into two groups. Treatment will last for 12 weeks with dosing twice a day.
      Parent ratings, cognitive tests and blood sampling will occur throughout the study period.
    

Intervention name(s): Buspirone
Intervention type(s): Drug
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Autism; Neuroplasticity
Bridging Active Heroin Users to Hepatitis C Treatment Using Buprenorphine - 1
Condition: Hepatitis C; Heroin Dependence
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Heroin Dependence
Study type: Interventional

Summary: 
      The purpose of this study is to see whether street-recruited heroin users can be successfully
      treated for hepatitis C after stabilizing them on buprenorphine.
    

Detailed description: 
      This is a prospective pilot safety study based on the hypothesis that active,
      street-recruited heroin users can be successfully treated for hepatitis C after stabilization
      on buprenorphine. Eligible subjects will be actively using heroin and have hepatitis C
      viremia; screening will occur at street-based sites like syringe exchange programs. Those who
      are eligible will sign informed consent, and then be asked to attend 3 weekly educational
      sessions about hepatitis C and addiction as well as undergo an intake interview. After this,
      subjects will be inducted onto buprenorphine/naloxone combination therapy (Suboxone) and
      receive this medication for 12-24 weeks. Once reaching the 12-24 week study time point,
      subjects will have the option of a 12-week Suboxone taper, or instead of undergoing 6-12
      months of hepatitis C treatment with pegylated interferon and ribavirin while being
      maintained on Suboxone. Once completing hepatitis C treatment, subjects will undergo a
      24-week Suboxone taper, or be transitioned to outpatient Suboxone therapy by a medical
      provider.
    

Intervention name(s): Buprenorphine/naloxone; pegInterferon
Intervention type(s): Drug; Drug
Intervention description(s): Human subjects HIV, HCV; intervention drug 1. buprenorphine/naloxone. street-recruited heroin users induced on bup/naloxone for period of 3-6 months, after which the second intervention is offered. intervention drug 2: pegInterferon/ribavirin. subjects interested in initiation treatment for HCV are offered pegInterferon, 180ug SQ/wk and ribavirin, 800-1200 mg daily for the standard duration of HCV treatment as dictated by genotype.
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: heroin addiction
Cryopreserved-thawed Embryo Transfer With or Without Gonadotropin Releasing Hormone Agonist
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Traditionally, the use of GnRH-a suppression was considered essential for adequate
      endometrial hormonal modulation in cryopreserved-thawed embryo transfer cycles. Several
      studies, however, have questioned its necessity for controlled endometrial preparation. Using
      a high dose of estradiol from day 1 of the cycle will suppress the gonadotroph, preventing
      folliculogenesis and excessive secretion of LH, allowing adequate endometrial preparation
      without GnRH-a.
    


Intervention name(s): Embryo transfer; Serum Estradiol and Progesterone levels; GnRH agonist; External Estradiol; Progesterone
Intervention type(s): Procedure; Procedure; Drug; Drug; Drug
Intervention description(s): The transfer of cryopreserved-thawed embryos inside the uterus aiming to achieve pregnancy; Serum estradiol and serum progesterone levels in blood on the day of start of progesterone supplementation; GnRH agonist given on day 21 of the cycle preceding the embryo transfer; Estradiol started on day1 of the cycle for endometrial prepartaion; progesterone as luteal phase support start after endometrium is well prepared
Other intervention name(s): Decapeptyl SR; estradiol valerate of Cycloprogenova tablets; Cyclogest vaginal suppositories
Intervention MeSH terms: Triptorelin Pamoate; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Clopidogrel and Clarithromycin on the Oral Disposition of Sibutramine in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy
      subjects
    

Detailed description: 
      1. Plasma concentrations of sibutramine and its two active metabolites after single oral dose
      of sibutramine were determined in Korean healthy male subjects with different CYP2B6
      genotypes (CYP2B6*1/*1, *1/*6 and *6/*6), either alone or after four-day pretreatment with
      clopidogrel or clarithromycin.
    

Intervention name(s): Sibutramine-clopidogrel; sibutramine-Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Sibutramine-clopidogrel; sibutramine-Clarithromycin
Intervention MeSH terms: Clarithromycin; Sibutramine; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: clarithromycin; sibutramine; clopidogrel
A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
Condition: Seasonal Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to measure the safety and the immune response to 3
      next-generation influenza vaccine candidates (mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1)
      compared with influenza vaccine candidate mRNA-1010 controls in healthy adult participants.
    


Intervention name(s): mRNA-1011.1; mRNA-1011.2; mRNA-1012.1; mRNA-1010; mRNA-1010.2; mRNA-1010.3
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Sterile liquid for injection; Sterile liquid for injection; Sterile liquid for injection; Sterile liquid for injection; Sterile liquid for injection; Sterile liquid for injection
Other intervention name(s): Seasonal influenza vaccine; Seasonal influenza vaccine; Seasonal influenza vaccine; Seasonal influenza vaccine; Seasonal influenza vaccine; Seasonal influenza vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza vaccine; mRNA-1010; mRNA-1011.1; mRNA-1011.2; mRNA-1012.1; Moderna
Comparison of Three Plasmodium Falciparum Isolates in an Experimental Human Malaria Infection
Condition: Plasmodium Falciparum; Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      Plasmodium falciparum isolates display a wide genetic diversity with possibly different
      properties to induce immune responses. These properties could directly influence the ability
      to induce protective efficacy. Since 1998 an experimental human malaria infection model at
      the Radboud University Nijmegen Medical Center (RUNMC) has been very successful in answering
      questions with regards to immunological mechanisms of human Pf infection. To date only the
      NF54 strain of Pf has been deployed in this Nijmegen model. However, investigation of
      heterologous Pf challenge is not only highly informative for our basic understanding of
      induction of immune responses but also provides an essential model for protective capacity
      testing in the clinical development of candidate malaria vaccines. Recently, the parasite
      culture laboratory of the RUNMC has been able to overcome technical hurdles to produce
      infectious mosquitoes of two genetically different isolates from different geographical
      regions to increase the portfolio for Phase IIa trials. These isolates, PfA and PfB will be
      compared with the NF54 strain for parasitic, immunological and clinical features in humans.
    


Intervention name(s): Exposure to Plasmodium falciparum infected mosquitoes
Intervention type(s): Biological
Intervention description(s): Healthy volunteers are exposed to the bites of 5 Plasmodium falciparum infected mosquitoes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Plasmodium falciparum; Malaria