bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of mFOLFOX-6 Plus Cetuximab for 8 Cycles Followed by mFOLFOX-6 Plus Cetuximab or Single Agent Cetuximab as Maintenance Therapy in Patients With Metastatic Colorectal Cancer and WT KRAS Tumours
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of the combination of
      mFOLFOX-6 plus cetuximab for 8 cycles followed by mFOLFOX-6 plus cetuximab or single agent
      (s/a) cetuximab as maintenance therapy in patients (pts) with metastatic colorectal cancer
      (mCRC).
    


Intervention name(s): mFOLFOX-6 + cetuximab until disease progression or early withdrawal.; 8 cycles of mFOLFOX-6 + cetuximab, followed by cetuximab alone until disease progression or early withdrawal.
Intervention type(s): Drug; Drug
Intervention description(s): Treatment regimen:
mFOLFOX-6, day 1, every two weeks; OXALIPLATIN 85 mg/m2; FOLINIC ACID 400 mg/m2; 5-FU 400 mg/m2 IV bolus; 5-FU 2400 mg/m2 continuous infusion for 46 hours
Cetuximab weekly. Cetuximab 400 mg/m2 the first time the treatment is administered; 250 mg/m2 for subsequent administrations.; Treatment regimen.
mFOLFOX-6. day 1 every two weeks. OXALIPLATIN 85 mg/m2; FOLINIC ACID 400 mg/m2; 5-FU 400 mg/m2 IV bolus; 5-FU 2400 mg/m2 continuous infusion for 46 hours
Cetuximab weekly. Cetuximab 400 mg/m2 the first time the treatment is administered; 250 mg/m2 for subsequent administrations.
Intervention MeSH terms: Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic colorectal cancer; wild-type KRAS tumours; cetuximab; mFOLFOX-6
Guam Healthy Relationships Education Program
Condition: Health Behavior
Study type: Interventional

Summary: 
      The Guam Healthy Marriage Partnership (GHMP), a comprehensive culturally responsive program
      that will foster healthy relationships and marriages on the island of Guam.
    

Detailed description: 
      The proposed Guam Healthy Relationships Education Program will improve the quality of life
      for individuals/couples in Guam by using culturally responsive approaches to foster healthy
      relationships and marriages using an Observational approach as there will be no comparison
      group, only the control group. Project activities include a 6-month education program of
      interactive curriculum-based groups and positive social/recreational activities to achieve
      positive outcomes for individuals/couples, community awareness events, and community and
      parenting skills training. The services offered is entrenched in cultures and traditions that
      are meaningful to the people of Guam, and includes capacity building and community awareness
      activities that will change community, family, and peer normative environments and attitudes.
    

Intervention name(s): PREP 8.0 Curriculum
Intervention type(s): Behavioral
Intervention description(s): The PREP 8.0 curriculum is an experiential curriculum designed to be implemented in a workshop or educational setting. Using techniques of cognitive-behavioral marital therapy and communication-oriented marital enhancement, PREP aims to help couples achieve high levels of relationship functioning and prevent marital problems. The PREP approach is based on research in the field of relational and marital health and success conducted at the University of Denver.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Guam; healthy relationships; non-profit organization; PREP 8.0 curriculum
NSAID Treatment in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Central mechanisms may play a role in pain perception during osteoarthritis (OA).Local
      inflammation (which involves production of pro-inflammatory cytokines such as interleukin
      (IL) 4 TNF-alpha, IL-6 and IL-8) is considered to be a major source of pain.

      Certain therapies that specifically interfere with the expression or actions of
      pro-inflammatory cytokines have been explored. NSAIDs have analgesic, antipyretic and
      anti-inflammatory properties and are extensively prescribed for several musculoskeletal
      disorders. Indeed, the Osteoarthritis Research Society International (OARSI) recently
      recommended the use of NSAIDs for management of knee and hip OA in symptomatic patients.
      These drugs have been shown to influence cytokine metabolism in the synovial fluid of OA
      patients with satisfactory relief of painful osteoarthritic joints.

      The aim of the current study was to explore whether NSAID treatment inhibits TNF-alpha, IL-6,
      IL-8, and VEGF secretion in the synovial fluid of osteoarthritic joints. In particular,
      diclofenac, ibuprofen and celecoxib were studied. Under the hypothesis that relationships
      between proinflammatory cytokines and the clinical status of OA patients are possible, we
      also evaluated the association between the concentration of these molecules in the
      osteoarthritic knee synovial fluid and the pain and functional status of patients with OA.
      The effects of NSAIDS on signal transduction pathways in the synovial membrane were also
      investigated.
    

Detailed description: 
      not desired
    

Intervention name(s): Ibuprofen; Celecoxib; Diclofenac
Intervention type(s): Drug; Drug; Drug
Intervention description(s): time of treatment 14 days; time of treatment 14 days; time of treatment 14 days
Other intervention name(s): Brufen; celebrex; voltaren
Intervention MeSH terms: Ibuprofen; Celecoxib; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee Osteoarthritis
A Study To Observe Safety And Blood Concentrations Of PF-04995274 During And Following the Administration of Multiple Doses Of PF-04995274 In Healthy Adult And Healthy Elderly Volunteers.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to observe the safety and blood concentrations of PF-04995274 during
      and following the administration of multiple doses of PF-04995274 for a duration of 14 days,
      in healthy adult and healthy elderly.
    

Detailed description: 
      To examine the safety and pharmacokinetics of PF-04995274 in healthy adult and healthy
      elderly subjects after multiple doses.
    

Intervention name(s): 0.1 mg PF-04995274; 1 mg PF-04995274; 10 mg PF-04995274; 15 mg PF-04995274; 1.0 mg PF-04995274; 15 mg PF-04995274
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.1 mg PF-04995274, qd, for 14 days or placebo; 1 mg PF-04995274, qd, for 14 days or placebo; 10 mg PF-04995274, qd, for 14 days or placebo; 15 mg PF-04995274, qd, for 14 days or placebo; 1.0 mg PF-04995274, qd, for 14 days or placebo; 15 mg PF-04995274, qd, for 14 days or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: multiple dose; healthy volunteer; healthy elderly volunteer; safety; pharmacokinetic
Effects of Suboptimal CPAP Therapy on Symptoms of Obstructive Sleep Apnoea
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Obstructive sleep apnoea (OSA) is a highly prevalent sleep-related breathing disorder. The
      most effective treatment for OSA is continuous positive airway pressure (CPAP). CPAP therapy
      has been shown to significantly reduce subjective sleepiness and blood pressure in patients
      with symptomatic OSA. Its effectiveness tends to depend on its nightly usage and a commonly
      held view is that CPAP should be used for at least 4h/night. However, previous studies have
      estimated that a considerable proportion of CPAP users fail to achieve this. In addition,
      there is inadequate evidence to support this apparent threshold effect and so it is unclear
      whether such patients actually benefit from treatment or whether they could be withdrawn from
      CPAP, thus substantially reducing health care costs, or encouraged to increase their nightly
      usage of CPAP.

      The aim of the proposed project is to study the effect of CPAP withdrawal on subjective
      sleepiness in OSA patients using CPAP for less than 4h/night on average. We hypothesize that
      two-week CPAP withdrawal in patients with 3-4h/night use will lead to a return of OSA-related
      symptoms. This trial will better establish the minimum level of CPAP adherence which could
      generally be regarded as effective in reducing OSA-related symptoms.
    


Intervention name(s): Continous Positive Air Pressure Device
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Continous Positive Airway Pressure; CPAP; Sham CPAP; CPAP withdrawal; suboptimal CPAP
Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress
Condition: Stress, Emotional; Sleep Disturbance
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      Poor sleep is common among college students and likely contributes to stress. The
      investigators developed a brief, remotely-delivered intervention and tested whether it
      improves sleep hygiene and reduced sleep disturbance and stress among undergraduates.
    

Detailed description: 
      Poor sleep is common among college students and likely contributes to stress. The
      investigators developed a brief, remotely-delivered sleep hygiene intervention, which is
      delivered via the internet, and tested in a randomized controlled trial, whether it improves
      sleep hygiene and reduced sleep disturbance and stress in a sample of undergraduates who
      report wanting to improve their sleep. This study compares the novel sleep hygiene
      intervention to an active, matched control condition--sleep education. Baseline and 2-week
      follow-up questionnaires assess sleep hygiene, sleep disturbance, and stress. ANCOVAs will
      compare conditions at follow-up, and mediation tests will explore whether the intervention
      reduced stress through improved sleep.
    

Intervention name(s): Sleep Hygiene Intervention; Non-behavioral Sleep Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This 1-hour on-line intervention presents three sleep hygiene modules, selected randomly from among these six: establishing a bedtime routine, optimizing sleep environment, implementing a sleep schedule, bedtime relaxation, nutrition choices, and exercise habits.; 1-hour on-line set of three modules that cover non-skill (non-hygiene) educational topics (sleep research, sleep stages, dreams). This control condition equates for engagement rationale.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Efficacy of Oral Mitoquinone (MitoQ) Supplementation for Improving Physiological in Middle-aged and Older Adults
Condition: Aging
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of supplementation with the
      mitochondria-targeted antioxidant, mitoquinone (MitoQ), for improving physiological function
      (vascular, motor, and cognitive) in middle-aged and older adults.
    

Detailed description: 
      Overall, the proposed research project has the long-term potential to influence clinical
      practice by establishing novel therapies for treating multiple domains of age-associated
      physiological dysfunction and thereby reducing the risk of clinical disease and disability.
    

Intervention name(s): MitoQ; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Mitoquinone pill, 20 mg/day; Placebo pill with inert excipient, 1 time/day
Other intervention name(s): mitoquinone; placebo pill
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will be a multi-center, parallel, group, placebo control, double-blind, randomized
      controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged
      10 to 17 years) diagnosed with Bipolar I disorder. The study consists of 4 phases: Screen
      (approximately 2 weeks), Open label phase (up to 18 weeks), Randomized phase (up to 36 weeks)
      and Taper and follow-up phase (up to 4 weeks).
    


Intervention name(s): lamictal
Intervention type(s): Drug
Intervention description(s): Flexible Dosing
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bipolar I pediatric lamictal adolescent
Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in South Africa
Condition: HIV Infections; Tuberculosis
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin
      (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an
      alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic
      induction effect appears to be less important on the associated antiretroviral therapy (ART)
      drugs.

      This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in
      combination with different ART regimens in Vietnamese HIV infected patients with pulmonary
      tuberculosis, in order to define optimal doses that will be further tested in a larger phase
      III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.
    

Detailed description: 
      Patients will be offered to participated in the study after the first 6 weeks of the
      nationally recommended TB treatment. All the enrolled patients will be switched to rifabutin
      and randomized, two weeks later, to one of the three study ARV regimens. The RBT doses will
      be then adapted to the allocated ARV regimen according to a cross over scheme. Three full
      pharmacokinetics profile will be performed at different time point : before initiation of
      ARV, after one month of the first RFB dosage and one month after the second RFB dosage.
    

Intervention name(s): rifabutin in combination with efavirenz; rifabutin in combination with nevirapine; rifabutin in combination with lopinavir/ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ia. arm 1a:
D4T/3TC/EFV(600mg)+INH/Rifabutin(450 mg OD 4 wks switch to 600 mg OD 4 wks);
Ib. arm 1b:
D4T/3TC/EFV(600mg)+INH/Rifabutin(600 mg OD 4 wks switch to 450 mg OD 4 wks);; IIa. arm 2a:
D4T/3TC/NVP(200mg)+INH/Rifabutin(300 mg OD 4 wks switch to 450 mg OD 4 wks);
IIb. arm 2b :
D4T/3TC/NVP(200mg)+INH/Rifabutin(450 mg OD 4 wks switch to 300 mg OD 4 wks);; IIIa. arm 3a :
D4T/3TC/LPV/r(2 tabs BD)+INH/Rifabutin(150 mg TPW 4 wks switch to 150 mg OD 4 wks);
IIIb. arm 3b:
D4T/3TC/LPV/r(2 tabs BD)+INH/Rifabutin(150 mg OD 4 wks switch to 150 mg TPW 4 wks).
Intervention MeSH terms: Ritonavir; Lopinavir; Nevirapine; Efavirenz; Rifabutin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Tuberculosis; Rifabutin; Pharmacokinetics; South Africa
Brain Training in Preterm Children at Risk for Inattention, Hyperactivity, and Executive Function Impairment
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to determine if different forms of child-friendly,
      computer-based puzzles and games ("brain training") targeting executive function (EF) skills
      (i.e., thinking, problem-solving) result in improvements in EF in preschool children at risk
      for EF problems due to premature birth. The investigators hypothesize that children receiving
      active "brain training" will show greater improvements in EF and related skills immediately
      after treatment than children receiving passive "brain training." The investigators are also
      interested in whether any improvements in EF and related skills occur or are maintained at 3
      and 6 months after completion of brain training.
    

Detailed description: 
      Detailed description:

        -  Investigators will talk to you by telephone to determine if your child might be eligible
           for the study.

        -  Children complete two baseline testing sessions to evaluate executive function (EF) and
           related skills

        -  Parents complete a packet of information, including questionnaires about the child's
           behavior, EF, and functional skills.

        -  After completion of the baseline testing, we will inform you of eligibility for the
           "Brain Training" phase.

        -  During "Brain Training" children play online computer games for 25-30 minutes/day (can
           range from 15-45 minutes/day depending on your child's attention, training version
           received, number and length of breaks needed), 5 days a week, for 5-7 weeks to complete
           a total of 25 sessions.

        -  Children return for 3 more time points, immediately after the completion of "Brain
           Training" (1 session), and also at 3 months (1 session) and 6 months (2 sessions) after
           completion of "Brain Training."
    

Intervention name(s): Brain Training (Active); Brain Training (Passive); Brain Training (Active or Passive)
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Online computer games targeting attention, EF, and problem-solving match the child's skill level.; Online computer games targeting attention, EF, and problem solving are set to a consistent level.; Online computer games targeting attention, EF, and problem-solving either match the child's level or are set to a consistent level depending on which version the child has already completed.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: premature birth; executive function; preschool
Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 1
Condition: Pre-diabetes; Diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Interventional

Summary: 
      Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft
      drinks may play a role in the development of diabetes.

      Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence
      metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and
      even modulate incretin release.

      However, it is unclear, if these findings are valid for all kinds of AS, as they are
      chemically different. Furthermore, data on human subjects are sparse and controversial.

      The investigators will therefore conduct 7 consecutive single oral stimulations with glucose
      or AS alone or a combination. Three different AS will be tested.
    

Detailed description: 
      Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft
      drinks may play a role in the development of diabetes.

      Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence
      metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and
      even modulate incretin release.

      However, it is unclear, if these findings are valid for all kinds of AS, as they are
      chemically different. Up to now, no single study has ever compared metabolic responses to
      different AS in the same subjects. Furthermore, data on human subjects are sparse and
      controversial. This is partially explained by different methodical approaches such as
      intragastral/intraduodenal application of AS, rather than conventional oral consumption.

      The investigators will therefore conduct 7 consecutive single oral stimulations with glucose
      or AS alone or a combination. Three different AS will be tested: saccharin, aspartame and
      sucralose.
    

Intervention name(s): oral stimulation glucose; oral stimulation saccharin; oral stimulation aspartame; oral stimulation sucralose
Intervention type(s): Other; Other; Other; Other
Intervention description(s): oral stimulation with glucose, AS or glucose+AS in fasted state, blood samples from fasted state up to 120 min post-ingestion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: incretin release
The Bioavailability of Rifampicin in (FDCs) Widely Used in South Africa to Treat Drug-susceptible (TB)
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      3-way cross-over single dose design evaluating bioavailability of 2 rifampicin-containing
      FDCs vs a single drug comparator in healthy volunteers
    

Detailed description: 
      In this study the 4- and 2-drug FDCs (for intensive and continuation phases respectively)
      widely used within the South African treatment program will be evaluated in a comparative
      bioavailability study against a single drug rifampicin product registered by the South
      African Medicines Control Council. A three-way, single dose, cross-over study will be
      conducted in 24 healthy volunteers
    

Intervention name(s): Rimactane; Rifafour e-275; Rimactazid 150/75
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 mg capsules, Sandoz MCC registration # A/20.2.3/784; Rifampicin/isoniazid/pyrazinamide/ethambutol 150/75/400/275 mg This 4-drug FDC is the most widely used 4-drug FDC in South Africa with an estimated 100% of the SA DOH tender.; Rifampicin/isoniazid 150/75 mg This 2-drug FDC is one of 2 widely used 2-drug FDCs in South Africa, with an estimated 30% of the SA DOH tender. Rifinah® made by Sanofi-Aventis holds about 70% of the tender, however as the Sanofi-Aventis 4-drug FDC will also be evaluated.
Other intervention name(s): Rifampicin; Rifampicin / Isoniazid
Intervention MeSH terms: Rifampin; Isoniazid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other