bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of Two On-Line Interventions for Child Brain Injury
Condition: Traumatic Brain Injury; Depression; Anxiety Disorders
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Depression; Anxiety Disorders
Study type: Interventional

Summary: 
      The primary aims of this project are to examine the feasibility and relative efficacy of two
      models of on-line intervention for families of children with traumatic brain injury: one, a
      model emphasizing cognitive appraisals and problem solving skills; the other, emphasizing
      linking families to resources and providing professionally-moderated peer support.
    

Detailed description: 
      The feasibility of the two interventions will be evaluated by examining family utilization of
      on-line materials and satisfaction with receiving services this way. Previous studies suggest
      the longer-term effects of TBI often create significant stress for both child and family and
      the need for psychological services.
    

Intervention name(s): Case management and problem solving therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Keywords: tbi; intervention; depression; anxiety
A Post-Approval Pharmacokinetic Study of Bortezomib in Participants With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this post marketing study is to determine the plasma concentration of
      bortezomib (unchanged drug) to assess the pharmacokinetic (PK - the study of the way a drug
      enters and leaves the blood and tissues over time) properties in the Taiwanese population. It
      will also provide expanded access (expanded access, sometimes called "compassionate use," is
      the use of an investigational drug outside of a clinical trial to treat a participant with a
      serious or immediately life-threatening disease or condition who has no comparable or
      satisfactory alternative treatment options) to bortezomib for the same group of participants
      with multiple myeloma (cancer of the types of cells normally found in bone marrow).
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-arm,
      multi-center (conducted in more than 1 center) study to assess the PK of bortezomib and to
      provide expanded access to bortezomib for 14 Taiwanese participants with multiple myeloma who
      have received at least 2 previous lines of therapy (medicine or medical care given to a
      participant for a disease or condition) and are refractory (not responding to treatment) to
      or have relapsed (the return of a medical problem) after their last therapy. Eligible
      participants will receive bortezomib 1.3 milligram (mg) per meter square (m^2) on Days 1, 4,
      8, and 11 of each 3-week cycle for up to 8 cycles. Blood samples for PK assessment will be
      collected on specified time points of Day 1, Day 8, and Day 11 of Cycle 1. Efficacy of the
      participants will primarily be evaluated by recording 'response to treatment' and 'Karnofsky
      Performance Status'. Participants' safety will be monitored throughout the study.
    

Intervention name(s): Bortezomib
Intervention type(s): Drug
Intervention description(s): Bortezomib 1.3 mg per (m^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
Other intervention name(s): VELCADE
Intervention MeSH terms: Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Bortezomib; Velcade
Brain Functional Connectivity Changes Following Cognitive Rehabilitation in Multiple Sclerosis: an fMRI Study
Condition: MS (Multiple Sclerosis)
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This trial seeks to investigate brain network changes following cognitive rehabilitation in
      MS patients. The investigators hypothesize that rehabilitation interventions improve
      connectivity in the brain.Novel Magnetic Resonance Imaging technique is performed to
      investigate changes in brain plasticity.
    


Intervention name(s): Cog Rehab
Intervention type(s): Behavioral
Intervention description(s): Cognitive rehab for MS patients
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Keywords: Multiple Sclerosis; MRI Scans
Effects of tDCS and tUS on Pain Perception in OA of the Knee
Condition: Chronic Pain; Osteoarthritis
MeSH terms: Osteoarthritis; Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of transcranial direct current
      stimulation (tDCS) in conjunction with transcranial ultrasound (TUS) on pain perception and
      functional limitations in people with osteoarthritis of the knee. The investigators
      hypothesize that there will be a decrease in pain levels with active stimulation, when
      compared to sham stimulation.
    


Intervention name(s): transcranial direct current stimulation (tDCS); transcranial ultrasound (TUS)
Intervention type(s): Device; Device
Intervention description(s): Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.; Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcranial direct current stimulation; transcranial ultrasound; non-invasive brain stimulation
Objective Markers of Pain Perception in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      Determine objective markers of pain perception remains a major scientific and medical issue.
      Various tools have been proposed to objectify pain, but their adaptability to different
      clinical contexts are limited. Our working hypothesis considers that the research for markers
      of immediate pain perception should be based on an electrophysiological approach, based on
      the combined analysis of EEG and autonomic responses.
    

Detailed description: 
      This project aims to study the cortical and autonomic responses induced by tonic painful
      stimulation compared to those induced by comparable sensory and stressful stimulations, by
      combining high density EEG, cutaneous sympathetic, cardiovascular and pupillary recordings.
    

Intervention name(s): Painful tonic stimuli; non-painful stimuli
Intervention type(s): Other; Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; Pain; EEG
the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy
Condition: Abdominal Myomectomy
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the effectiveness of carbetocin on reducing intraoperative blood loss during
      abdominal myomectomy
    


Intervention name(s): carbetocin 100 mcg; placebo
Intervention type(s): Drug; Drug
Intervention description(s): a 10 cm syringe containing 100 mcg carbetocin just before skin incision of myomectomy.; a 10 cm syringe normal saline IV given just before skin incision of myomectomy.
Intervention MeSH terms: Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of Dexmedetomidine on Nol-Index Guided Remifentanil Analgesia
Condition: Nociceptive Pain; Anesthesia; Opioid Use; Perioperative/Postoperative Complications
MeSH terms: Postoperative Complications; Nociceptive Pain
Study type: Interventional

Summary: 
      Background:

      Analgesia remains to this day a challenge for anesthesiologists. Dexmedetomidine, a potent
      central alpha-2 agonist, has been shown to have analgesic and opioid sparing effects. The
      classic analgesic strategy focuses on opioid administration guided by estimated time of
      elimination and hemodynamic response (increase in blood pressure and heart rate). This
      technique is not sensitive and forces the anesthesiologist to be one step behind nociception,
      the patient's unconscious response to pain.

      PMD-200 (Medasense, Israel) displays the Nociceptive level (NOL)-Index as marker of
      nociception. The NOL-Index ranges from 0 (no nociception) to 100 (intense nociception) and
      the recommended analgesic range during surgery is from 10 to 25 (Medasense recommendations).

      The goal of this study is to compare two analgesia strategies guided by the NOL Index (range
      10-25) using either remifentanil TCI (target controlled infusion) alone or remifentanil TCI
      associated with a continuous dexmedetomidine infusion.

      Methods:

      A total of 100 patients will be included and informed consent will be acquired. This
      bi-center study will take place at Erasme University Hospital (primary center) and
      Saint-Pierre University Hospital. Patients will be randomized into either two groups:
      remifentanil and placebo versus remifentanil and dexmedetomidine. Both groups will be
      monitored using the PMD-200 that will guide the analgesic therapy strategy. Investigators and
      patients will be blinded to dexmedetomidine and placebo administration. The primary outcome
      will be intraoperative remifentanil consumption. Secondary outcomes will include
      postoperative opioid administration, opioid associated complications, hemodynamics, and
      hospital length of stay.
    


Intervention name(s): Dexmedetomidine; sodium chloride; Remifentanil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients in the dexmedetomidine-remifentanil group will receive an infusion of 0.6 mcg/kg in half an hour followed by an infusion of 0.6 mcg/kg/hour.; Patients in the remifentanil group will receive an infusion of 0.9% sodium chloride instead of dexmedetomidine (identical infusion rate); Both groups will have remifentanil analgesia guided by the Nol-Index
Other intervention name(s): Dexdor; normal saline 0.9%; Ultiva
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
Condition: Chronic HBV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis B; Hepatitis B, Chronic; Virus Diseases; Herpesviridae Infections; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety,
      tolerability, and pharmacokinetics of single and multiple orally administered doses of
      EDP-514 in healthy adult subjects.

      Part 2 is randomized, double -blind, placebo-controlled study including subjects with
      Hepatitis B Virus. It will assess the safety, tolerability, pharmacokinetics and antiviral
      activity of 28 Days of orally administered doses of EDP-514 in nucleos(t)ide reverse
      transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection
    

Detailed description: 
      Part 1 consists of two phases planned in healthy subjects:

      The first phase assesses single ascending doses for EDP-514 (active drug or placebo) in
      healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.

      The second phase assesses multiple ascending doses (active drug or placebo) for 14 days in
      healthy subjects.

      Each cohort within each phase will enroll a total of 8 subjects who will be randomized to
      receive EDP-514 or placebo. The cohort assessing food effect will enroll 10 subjects
      randomized to receive EDP-514 or placebo.

      Part 2 assesses multiple ascending doses EDP-514 (active drug or placebo) for 28 days in
      nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic
      Hepatitis B Virus Infection.

      Each cohort in Part 2 will enroll a total of 8 subjects who will be randomized to receive
      EDP-514 or placebo.
    

Intervention name(s): EDP-514; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).; Placebo to match EDP-514
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: "First-in-Human"; Single Ascending Dose; Multiple Ascending Dose; hepatitis B virus; HBV
A Phase IV, Open-label Single-arm Study Investigating the Pharmacokinetics and Pharmacodynamics of the Antiretroviral Combination of Rilpivirine and Ritonavirboosted Darunavir in Therapy-naive HIV-1 Infected Patients.
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      For patients who are starting to take antiretroviral medication (to treat HIV) for the first
      time, there are now a variety of different medicines which may be taken together as a
      combination in order to form an effective treatment which suppresses the virus for prolonged
      periods of time. Currently, national guidelines recommend the use of two different drugs of
      one type (the nucleoside/ nucleotide reverse transcriptase inhibitors, NRTI often known as
      "nukes") with a third drug from one of two other types (either a nonnucleoside reverse
      transcriptase inhibitor, known as an NNRTI or "nonnuke", or a protease inhibitor, known as a
      PI) to form a treatment regime of three active drugs. In the UK and Europe, all PIs are given
      in combination with a small dose of a second PI, ritonavir, which has the effect of boosting
      the levels of the active PI in the bloodstream.

      The investigators know from both research studies and patient experience in clinic that a
      combination of a ritonavirboosted PI with an NNRTI achieves similar results in suppressing
      the HIV virus, compared to the use of either a PI or NNRTI with 2 NRTI as described above. In
      this study, the investigators will observe the combination of two licensed antiretroviral
      medications, ritonavirboosted darunavir(DRV/r) and rilpivirine (RPV), in suppressing virus
      when given to patients who are commencing treatment for HIV infection for the first time.
      Both of these drugs are licensed for treatment of patients with HIV in the UK and Europe, and
      are currently in standard clinical use.

      The study will monitor this treatment over the first 48 weeks. The investigators will also
      examine the levels of both drugs in the bloodstream during the first 4 weeks of starting this
      regimen, to confirm that they remain at levels which the investigators know to be effective
      against the virus.
    


Intervention name(s): Darunavir, Ritonavir and Rilpivirine
Intervention type(s): Drug
Intervention MeSH terms: Ritonavir; Darunavir; Rilpivirine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Meal Composition on the Responses to Meal Ingestion
Condition: Healthy
Study type: Interventional

Summary: 
      Aim: to determine to what extent meal composition influences postprandial sensations
      independently of palatability. The postprandial responses to a low-fat (240 Kcal) versus a
      high-fat (275 Kcal) test meal (150 g humus) with the same physical and organoleptic
      characteristics (taste, smell, colour, texture, consistency, temperature) will be studied on
      a cross-over design. The responses to the meals will be tested on 2 different days.
      Participants (12 non-obese healthy men) will be instructed to eat a standard dinner the day
      before, to consume a standard breakfast at home after overnight fast, and to report to the
      laboratory, where the test meal will be administered 3 h after breakfast. Studies will be
      conducted in a quiet, isolated room with participants sitting on a chair. Perception will be
      measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals
      up to 60 min after the probe meal.
    


Intervention name(s): High-fat meal; Low-fat meal
Intervention type(s): Other; Other
Intervention description(s): High-fat meal; Low-fat meal with the same physical and organoleptic characteristics as the high-calorie meal.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: meal ingestion; meal composition; postprandial responses; hedonic sensations; homeostatic sensations; new composition
Predicting Physical Activity Change: an Epidemiologic Study
Condition: Cardiovascular Diseases; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To conduct a two-year follow up of participants in a cross-sectional study of physical
      activity determinants. Predictors of change in vigorous exercise habits and recreational
      walking habits were identified as were determinants of change in the proportion of the sample
      who initiated, maintained, or discontinued exercise.
    

Detailed description: 
      BACKGROUND:

      In 1988 when the study began, epidemiological studies had shown the health benefits of
      physical activity and that prevalence of physical activity was well below recommended levels.
      Exercise-promotion interventions were typically ineffective, and lack of knowledge of
      exercise determinants inhibited the design of effective interventions.

      DESIGN NARRATIVE:

      Data from the San Diego Health and Exercise Baseline survey conducted in 1986 were used to
      contact participants for the follow-up. The difference in reported activity level from time 1
      to time 2 served as an estimate of change in activity. The follow-up survey elicited a
      two-year history of vigorous exercise and moderate-intensity exercise, both of which have
      substantial health benefits, as well as different determinants. Potential predictors were
      assessed at baseline and included demographic variables and indices based on social learning
      theory. Multiple regression analyses determine the combined and independent relationships of
      such variables as self-efficacy, social support, perceived barriers and benefits and
      environmental factors on both types of physical activity change. A second analysis separated
      subjects into the baseline physical activity groups of low, intermediate, and high activity
      and examined prediction of change versus no-change in each category.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy Adults 18-60
Comparing the Diagnostic Efficiencies of CEUS and EOB-MRI in Patients With High Risk of HCC
Condition: Hepatocellular Cancer; Liver Cirrhoses; Diagnoses Disease
MeSH terms: Liver Neoplasms; Carcinoma, Hepatocellular; Liver Cirrhosis
Study type: Interventional

Summary: 
      HCC is a serious threat to the health of people. Accurate diagnosis of early HCC by imaging
      allows patients to obtain proper treatment. However, for lesions with diameters ≤2 cm, the
      tumor blood supply is not fully established, and there may be no typical manifestation on the
      image. In addition, atypical enhanced patterns caused by liver cirrhosis may also hinder
      imaging diagnosis of HCC. Therefore, early diagnosis of HCC in the context of cirrhosis
      remains a major clinical problem.

      Contrast-enhanced Ultrasound (CEUS) and MRI Contrast-enhanced Magnetic Resonance Imaging
      (CEMRI) are common diagnostic imaging methods. Till now, there is still lack of a detailed
      investigation comparing the diagnostic efficacies of CEUS and EOB-MRI for micro HCC in the
      context of cirrhosis. Therefore, this study aims to analyze the imaging patterns in CEUS and
      EOB-MRI for liver lesions with diameters ≤ 2 cm among patients with high risk of HCC, and to
      compare the diagnostic efficacies of EOB-MRI and CEUS for early-stage HCCs.
    


Intervention name(s): Diagnostic CEUS and EOB-MRI
Intervention type(s): Diagnostic Test
Intervention description(s): Undergo Sonovue-CEUS and EOB-MRI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hepatocellular Cancer; Contrast-enhanced ultrasound; EOB-MRI; Diagnostic Efficacy
Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Alzheimer Disease; Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The aim of this study is to demonstrate the efficacy of timed exposure to bright light for
      the treatment of disturbed nighttime sleep and daytime wake in community-dwelling dementia
      patients and their caregivers, and to determine if there are genetic relationships between
      memory problems and sleep problems
    

Detailed description: 
      1. Efficacy: Up to 4 weeks of morning bright light exposure will be more efficacious than
           morning dim light in consolidating nighttime sleep as assessed by actigraphy.

        2. Predictors of response: We expect the primary predictor of treatment response will be
           initial MMSE score. Secondary predictors include baseline sleep/wake and circadian
           parameters and age.

        3. Effectiveness: Bright light treatment will be more effective than dim light in improving
           quality of life.

        4. An understanding of some of the genetic markers of memory and/or sleep problems.
    

Intervention name(s): Bright light; Control
Intervention type(s): Device; Device
Intervention description(s): Participants uses bright light; Participants uses dim light
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
Condition: Acute Postoperative Pain; Bunionectomy
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute
      postoperative pain
    


Intervention name(s): ACP-044 Dose A; ACP-044 Dose B; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral dose of ACP-044 Dose A; Oral dose of ACP-044 Dose B; Oral dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment