bioihbjkbjnl/mcl2 huggingface dataset:
Brassica Intake and Isothiocyanate Absorption
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Healthy individuals (n=18) will participate in 2 controlled-feeding study periods that are 3
      weeks each in length: 1) Control diet 2) Brassica diet. The control diet will consist of
      typical American foods and will be free of Brassica vegetables and free of glucosinolates and
      isothiocyanates. The Brassica diet will contain the control diet plus
      glucosinolate/isothiocyanate treatment foods. There will be a break of 3 weeks in between
      study periods. Blood, urine, and fecal samples will be collected at the end of each study
      period. Eligible participants will be selected based on genotype for glutathione
      S-transferase (GST), which has been shown to influence the potential protective role of
      dietary Brassicas. Half the participants (n=9) will be GSTM1-positive individuals and half
      (n=9) will have the GSTM1-null genotype.
    


Intervention name(s): Controlled diet without brassica vegetables; Controlled diet with brassica vegetables
Intervention type(s): Other; Other
Intervention description(s): Participants will be fed a controlled diet containing foods of a typical American diet.; Participants will be fed a controlled diet containing foods of a typical American diet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients
Condition: Relapsing Remitting Multiple Sclerosis (RRMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to evaluate the evolution of walking capacity as
      measured by the timed 100-meter walk test (T100T), timed 25-foot walk test (T25FW), maximum
      walking distance (MWD), and Expanded Disability Status Scale (EDSS) during the first year of
      therapy with natalizumab. The secondary objectives of this study are as follows:

        -  To evaluate the correlation between the MWD and EDSS and both walking tests, the T100T
           and the T25FW at Baseline, at Week 24 and at Week 48 of therapy.

        -  To determine how well each of the walking tests, T100T or T25FW, predicts walking
           limitations in all participants and in the subgroups of participants stratified by
           baseline EDSS.
    


Intervention name(s): BG00002 (natalizumab)
Intervention type(s): Drug
Other intervention name(s): Tysabri®
Intervention MeSH terms: Natalizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TYSABRI naive; Relapsing-remitting multiple sclerosis (RRMS)
Clinical Endpoint Bioequivalence Study of Fluticasone Propionate & Salmeterol Xinafoate (100μg/50μg)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      A Randomized, Parallel-Group, Placebo-Controlled, Clinical Endpoint Bioequivalence Study of
      Generic Fluticasone Propionate 100 μg and Salmeterol Xinafoate 50 μg Inhalation Powder
      Compared with Advair Diskus® 100/50 in Subjects with Asthma
    

Detailed description: 
      The primary objective of this study is to evaluate the clinical bioequivalence of generic
      fluticasone propionate 100 μg and salmeterol xinafoate 50 μg inhalation powder (test) to
      Advair Diskus ("Advair") 100/50 (reference) for the treatment of asthma.

      The secondary objectives of the study are:

        -  To demonstrate statistical superiority of generic fluticasone propionate 100 μg and
           salmeterol xinafoate 50 μg inhalation powder to placebo.

        -  To demonstrate statistical superiority of Advair 100/50 to placebo.

        -  To investigate the safety and tolerability of fluticasone propionate 100 μg and
           salmeterol xinafoate 50 μg inhalation powder compared with Advair 100/50 in the target
           population
    

Intervention name(s): Fluticasone propionate/salmeterol; Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the LOMI inhaler device; Advair (Fixed dose combination of fluticasone propionate and salmeterol xinafoate administered via the Diskus inhaler device); placebo dry powder administered via the LOMI inhaler device
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
China Betaferon Adherence, Coping and Nurse Support Study
Condition: Multiple Sclerosis, Chronic Progressive
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Observational

Summary: 
      Non-adherence reduces treatment benefit and can bias the assessment of treatment efficacy
      thereby involving safety risks for the patient and influencing health cost-effectiveness.
      This observational study will concentrate upon the role of MS nurses in influencing
      adherence. This study will examine the influence of initial and subsequent periodic nurse
      interviews which aim to improve adherence to Betaferon® treatment.
    


Intervention name(s): Interferon beta-1b (Betaseron, BAY86-5046)
Intervention type(s): Drug
Intervention description(s): All patients will be prescribed with Betaseron and be instructed on treatment by their phisicians
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        MS center located in general hospital
      
Keywords: Relapsing-Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis
Run Daddy Run! A Lifestyle Intervention Focusing on Fathers and Their Children
Condition: Father-Child Relations
Study type: Interventional

Summary: 
      The aim of this study is to develop and implement a multicomponent eHealth lifestyle
      intervention (focusing on (co-) physical activity and screen time) for fathers and their
      children, aiming to prevent childhood overweight and obesity.
    

Detailed description: 
      The Run Daddy Run project aims to develop an effective lifestyle intervention for Belgian
      fathers and their primary school-aged children, to prevent overweight and obesity. There is
      focused on increasing (co-) physical activity and limiting individual and joint screen time.
      The project specifically targets fathers and their children because the literature shows that
      now often only mothers participate in lifestyle interventions, and fathers are
      underrepresented and difficult to involve. However, fathers play an important and unique
      role, independently of the mother, in shaping the child's behavior.

      The Run Daddy Run intervention was developed based on the Intervention Mapping Protocol, a
      theoretical framework that is often used to develop interventions in a systematic way using
      empirical evidence and theoretical insights. A co-creation approach was also used for the
      intervention development, which is a bottom-up approach in which the target group (fathers in
      this case) is actively involved in the development of the intervention. The result of this
      approach is contextually appropriate intervention and intervention strategies.
    

Intervention name(s): Interactive father-child sessions and website
Intervention type(s): Behavioral
Intervention description(s): The Run Daddy Run intervention will consist of 5 (inter)active sessions for fathers and their children + 1 follow-up session, each session lasting 90 minutes. These sessions will be given to 8 groups of +- 13 families (fathers and their children), guided by 2 facilitators and will take place every 2 weeks, at a location in the neighborhood of fathers and children (e.g. school of the children). Additionally, a website will be available for the fathers and their children, with additional information about the project, tips and information about being active together (e.g. movement breaks, fundamental movement skills, etc.) and limiting screen time. In addition, fathers and their children will also log their goals on this website, and between two sessions (= a period of 2 weeks) they will be asked to keep track of their co-PA on this website, aiming to reach their goal.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Non-Randomized Controlled Trial with Intervention and Control Group
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Obesity; Fathers; Children; Primary school; Intervention; Physical activity; Screen time; Sedentary Behaviour
Internet-delivered Strengths Use Intervention
Condition: Burnout, Professional; Mental Health Wellness 1
MeSH terms: Burnout, Professional; Burnout, Psychological
Study type: Interventional

Summary: 
      The aim of the study will be to test the feasibility and acceptability of a novel
      online-delivered gamification-based intervention for the identification, development, and use
      of strengths in the organization. The program will be addressed to employees at the beginning
      of their careers and will have the aim of boosting their well-being and performance.
    


Intervention name(s): Internet-delivered strengths use intervention
Intervention type(s): Behavioral
Intervention description(s): The online strengths use intervention program, will be based on Miglianico et al.'s (2020) general framework, following the theorized five stages: (1) preparation and commitment, (2) identification, (3) integration, (4) action, and (5) evaluation.
As to increase participant engagement and motivation, gamification components will be embedded in several of these stages.
The entire intervention will be delivered online via an LMS software solution.
Intervention model: Single Group Assignment
Intervention model description: One-armed study with baseline and post-intervention measurements.
Masking: None (Open Label)
Primary purpose: Other
Keywords: work engagement; burnout; employee wellbeing
Paracetamol in Patent Ductus Arteriosus
Condition: Ductus Arteriosus, Patent
MeSH terms: Ductus Arteriosus, Patent
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the efficacy and safety of paracetamol in comparison to
      ibuprofen in the treatment of patent ductus arteriosus (PDA) in preterm infants.
    

Detailed description: 
      Although patency of the ductus arteriosus is essential for fetal circulation, the postnatal
      ductal closure is critical for postnatal circulatory adaptation. In premature infants the
      circulating prostaglandin levels are higher than at term, and respiratory difficulties may
      lead to a state of hypoxia, which contribute to the failure of the ductus closure. Recently,
      an incidental finding in one preterm infant led to look at paracetamol, one of the most
      common drugs available, as an alternative therapeutic approach to ductal closure. If
      paracetamol is proven to be effective, it could become the treatment of choice for the
      management of PDA, mainly due to its more favorable safety profile.

      Although the recent results available in the literature demonstrates an highly success rate
      in ductal closure with paracetamol, all case studies are not powered to show efficacy of
      paracetamol for PDA closure. Further prospective randomized-controlled trials are needed to
      evaluate the efficacy of paracetamol versus ibuprofen for the closure of PDA.

      If paracetamol is indeed proven to be effective, it could become the treatment of choice for
      the management of PDA, mainly due to its more favorable side effect profile. In order to test
      this hypothesis, a randomized, open label, parallel groups, comparator controlled,
      multicentre, prospective study is proposed.
    

Intervention name(s): Paracetamol; Ibuprofen
Intervention type(s): Drug; Drug
Other intervention name(s): Acetaminophen
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neurocognitive Function After Carotid Thrombendarterectomy
Condition: Carotid Stenosis; Postoperative Cognitive Dysfunction; Neurological Impairment
MeSH terms: Carotid Stenosis; Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional

Summary: 
      Previous studies did not reach a consensus on the influence of the type of anesthesiologic
      procedure and monitoring, during carotid thrombendarterectomy, on perioperative complications
      and cognitive outcomes. The aim of this study is the optimization of brain perfusion during
      the vascular carotid clamp using multimodal monitoring. We assume that standardized
      monitoring techniques and a better selection of cognitive tests will allow a more accurate
      assessment of subclinical cognitive deficits.
    

Detailed description: 
      ABSTRACT:

      AIM OF THE STUDY: Effect of perioperative multimodal monitoring with transcranial doppler
      (TCD), near-infrared spectroscopy (NIRS), and Electroencephalography (EEG) in patients for
      carotid thrombendarterectomy (CEA) on perioperative complications and cognitive functions.

      PATIENTS AND METHODS: The prospective study will analyze 80 consecutive patients with an
      asymptomatic and symptomatic (transitory ischemic attack, TIA, in anamnesis) stenosis of the
      internal carotid artery in which CEA is indicated in general anesthesia. Cognitive tests will
      be analyzed for all patients preoperatively, first and eighth day postoperatively, and after
      8 weeks. Breath-holding index (BHI) will be measured preoperatively and postoperatively. The
      first group of patients (n = 40) will have expanded intraoperative monitoring involving TCD,
      NIRS, and EEG, and the control group (n = 40) will have only standard anesthetic monitoring.

      EXPECTED CONTRIBUTION OF THE STUDY: Previous studies did not agree on the influence of the
      type of anesthesiologic procedure and monitoring of perioperative complications and cognitive
      outcomes. We assume that standardized monitoring techniques and a better selection of
      cognitive tests will allow a more accurate assessment of the effect.
    

Intervention name(s): NIRS, EEG
Intervention type(s): Device
Intervention description(s): During the carotic clamp, if cerebral oxygenation decreased for more than 12 % on the operating side from the baseline value, simple interventions as, increasing arterial blood pressure, increasing arterial carbon dioxide tension or increasing oxygen inspiration concentration will be performed.
Other intervention name(s): cerebral oximetry
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: CEA ACI; cognitive tests; BHI; NIRS; TCD; EEG
Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV Virus
Condition: Hepatitis C, Genotype 1
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir
      plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients
      coinfected with HIV
    


Intervention name(s): Daclatasvir; Ribavirin; PEG-Interferon alfa 2a
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks; Tablets; oral; for patients weighing <75 kg, the total dose is 1000 mg per day (2 200-mg tablets in the morning and 3 200-mg tablets in the evening); for patients weighing >75 kg, the total dose is 1200 mg per day (3 200-mg tablets in morning and 3 200-mg tablets in evening); twice daily with food; 24 or 48 weeks depending on response; Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response
Other intervention name(s): BMS-790052; Copegus®; Pegasys®; Pegylated interferon
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vitamin D and Sexual Health
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial
Study type: Interventional

Summary: 
      Bacterial vaginosis (BV) develops when the concentration of healthy Lactobacillus species in
      the vagina declines and is replaced by other bacterial species. BV is the most common vaginal
      infection worldwide, but the etiology of this complex condition is not clear. BV is
      associated with a 60% increased risk of HIV acquisition as well as numerous other detrimental
      reproductive outcomes. A profound racial disparity exists in BV prevalence in women in the
      United States (US): 23% of white women versus. 52% of black women have BV. The investigators
      hypothesize that inadequate vitamin D contributes to BV development and/or recurrence.
      Vitamin D is essential to immune function, serving both to stimulate mechanisms associated
      with pathogen elimination and to regulate immune response. According to
      nationally-representative data, 90% of US blacks have insufficient vitamin D levels. In two
      recent analyses, low vitamin D was associated with higher BV prevalence in pregnant
      African-Americans; a third replicated this finding in pregnant African-American and white
      women. The investigators wish to conduct a small, pilot randomized controlled trial (RCT) to
      assess the effect of vitamin D supplementation among non-pregnant, BV-positive women at a
      public sexually transmitted disease (STD) clinic. This small (n=150), two-arm,
      placebo-controlled, masked, 24-week RCT of high-dose vitamin D supplementation will inform
      the development of future large-scale RCT design and implementation.
    


Intervention name(s): Vitamin D3 (cholecalciferol); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Women in the vitamin D arm take 50,000 international units (IU) of vitamin D3 (cholecalciferol) weekly for four weeks (end of week 1, week 2, week 3 and week 4), then every 4 weeks through 24 weeks of follow-up (end of week 8, week 12, week 16, week 20 and week 24) for a total of 9 treatments; Women in the placebo arm will take their matching supplement weekly for four weeks (end of week 1, week 2, week 3 and week 4), then every 4 weeks through 24 weeks of follow-up (end of week 8, week 12, week 16, week 20 and week 24) for a total of 9 treatments
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prospective Memory in Children With Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      Prospective memory (PM) is memory to complete future tasks, such as recalling to give a note
      to someone when you next see them, pick up milk on the way home, or remembering to keep an
      appointment. This study will evaluate PM in children with traumatic brain injury (TBI).
    

Detailed description: 
      While much has been learned about how children with TBIs learn and recall stories, word
      lists, and pictures, little is known about how they perform PM tasks. Impairment in PM could
      have serious implications for academic and vocational pursuits. This study will investigate
      PM in children with mild or severe TBI. The study will focus on three major themes: 1)
      strategies that may help children with TBI overcome or minimize their PM deficits; 2) how
      specific areas of cognition can be impaired following TBI and in turn impair PM; and 3) the
      impact of PM deficits on a child's daily functioning, both at school and at home. The study
      will also evaluate children without TBI (control group).

      Each child will participate in one study evaluation. The evaluation will last approximately 4
      hours, with a lunch break and other rest breaks as necessary. Assessments will include
      neuropsychological tests of attention, memory, and general intellectual functioning.
      Experimental tasks will include measures of metacognition for prospective memory, elucidation
      of strategic versus automatic processes involved in PM, and the effect of motivation
      manipulations in overcoming PM deficits with varying working memory loads. The child's parent
      or guardian will also be asked to complete some tests to measure the impact of PM deficits on
      the child's daily home life.
    

Time perspective: Prospective
Keywords: TBI; Prospective memory
18349-Human Photoallergy Test
Condition: Sunscreening Agents
MeSH terms: Dermatitis, Photoallergic
Study type: Interventional

Summary: 
      To evaluate the potential of a test material to produce a photoallergic response.
    


Intervention name(s): Sunscreen Lotion , BAY 987521; Untreated skin
Intervention type(s): Other; Other
Intervention description(s): 50 μl/ cm2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. Formulation A: Y49-103, Formulation B: Y71-150.; One site is patched without treatment as control
Intervention MeSH terms: Sunscreening Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to compare the efficacy and safety of ABP 501 and
      adalimumab (HUMIRA®) in adults with plaque psoriasis.
    


Intervention name(s): Adalimumab; ABP 501
Intervention type(s): Biological; Biological
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): HUMIRA®; Adalimumab-atto; AMJEVITA™
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Plaque Psoriasis