bioihbjkbjnl/mcl2 huggingface dataset:
An Intervention for Primary Caregivers to Improve Outcomes in Children With Severe Malnutrition
Condition: Child Malnutrition
MeSH terms: Malnutrition; Child Nutrition Disorders
Study type: Interventional

Summary: 
      This cluster-randomized controlled trial will evaluate the effectiveness of a four-day
      hospital-based intervention program for primary caregivers of children with severe
      malnutrition.
    

Detailed description: 
      Mortality rates remain high in hospitalized children with severe malnutrition and long-term
      impairments in child development exist in children that do survive. Hospitalized children
      with severe malnutrition will be allocated to an intervention or standard of care group in
      each one-week cycle. The intervention package consists of a counseling and support program
      that includes three modules: 1) psychosocial stimulation; 2) nutrition and feeding; and 3)
      water, sanitation and hygiene. Assessments will be done at baseline (t=0) and follow-up (t=6
      months). The primary outcome is child development, which will be assessed using the Malawi
      Developmental Assessment Tool, a validated tool for gross and fine motor, language, and
      social development.
    

Intervention name(s): Counseling Intervention Package; Standard of Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Daily 45 minutes of group teaching for primary caregivers, followed by 45 minutes of supervised play and stimulation with their children for a total of four days. Teaching modules consist of psychosocial stimulation, nutrition and feeding, and water, sanitation and hygiene practices.; Nutrition and water sanitation and hygiene counseling at any point prior to discharge from hospital as per the local nutrition rehabilitation unit standard of care. In addition, primary caregivers will be stimulated to play with their children in a play area.
Other intervention name(s): Kusamala Program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: child malnutrition; child development; counseling
Galiximab in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as galiximab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or carry cancer-killing substances to them.

      PURPOSE: This phase II trial is studying how well galiximab works in treating patients with
      relapsed or refractory Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the response rate (complete and overall response) in patients with relapsed
           or refractory Hodgkin lymphoma (HL) treated with galiximab.

      Secondary

        -  To assess the duration of response, progression-free survival, and overall survival of
           patients with relapsed or refractory HL.

        -  To assess the safety and tolerability of galiximab in patients with relapsed or
           refractory HL.

        -  To determine if FDG-PET correlates with outcome in patients with relapsed or refractory
           HL treated with galiximab.

      OUTLINE: This is a multicenter study.

        -  Induction therapy: Patients receive galiximab IV over 60 minutes on days 1, 8, 15, and
           22 in month 1.

        -  Extended induction therapy: Patients receive galiximab IV over 60 minutes once every
           four weeks in the absence of disease progression or unacceptable toxicity.

      Patients also undergo FDG-PET/CT imaging at baseline and at time of first restaging (within 7
      days prior to week 8 treatment).

      After completion of study treatment, patients are followed periodically for 10 years.
    

Intervention name(s): galiximab
Intervention type(s): Biological
Intervention MeSH terms: Galiximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult Hodgkin lymphoma; adult lymphocyte predominant Hodgkin lymphoma
Personalized Versus Standard Hydration for Prevention of CI-AKI: a Randomized Trial With Bioimpedance Analysis
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to evaluate, in patients with "lower fluid status" defined by
      bioimpedance analysis, whether two different protocol of IV isotonic saline infusion are
      associated with different volume expansion and differing risks for CI-AKI in patients
      undergoing coronary angiographic procedures.
    

Detailed description: 
      Iodinated contrast media are a well-recognized cause of iatrogenic acute kidney injury in
      patients undergoing imaging diagnostic or therapeutic procedures (contrast-induced acute
      kidney injury, CI-AKI).

      Several protocols have been tested for the prevention of CI-AKI, including periprocedural
      hydration with isotonic saline or sodium bicarbonate, antioxidant compounds, use of low- or
      iso-osmolar contrast agents, and hemofiltration or dialysis. The results of these
      interventions and strategies have been often disappointing or inconclusive and intravenous
      volume expansion remains the only therapy of undisputed efficacy.

      Bioimpedance analysis is an inexpensive, rapid, and accurate tool for evaluating a patient's
      hydration status, and can be performed at the bedside within minutes [Maioli, JACC
      1014;63:1387-94]. In this study we defined patients with "lower fluid status" with high risk
      of CI-AKI (Male with resistance/height ratio > 315 Ohm/meter and Female > 380 Ohm/meter).
      BIVA may represent the optimal tool to monitor the adequacy of volume expansion and
      protective strategy delivery.

      However, most hydration protocols rely on a "one size fits all" approach with a fixed volume
      and time of infusion without an assessment of whether adequate hydration was achieved. This
      practice risks either under-hydration without true amelioration of CI-AKI risk or
      over-hydration with risk of adverse outcomes.

      Thus, on the basis of results of BIVA testing a randomized fluid infusion plan is prescribed.
    

Intervention name(s): sodium chloride infusion
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Contrast-induced nephropathy; Contrast-Induced acute kidney injury; Contrast media; Angiography; Coronary percutaneous intervention
A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9
Condition: Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, active-controlled, open-label, sequential dose group, Phase 1b/2 study
      designed to assess the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics
      of weekly and every other week doses of GX-H9 in the treatment of AGHD.
    

Detailed description: 
      The subjects who are adequately eligible to attend this clinical trial via screening will be
      sequentially assigned starting with Group 1. Each group will be comprised of subjects who
      will receive both GX-H9 and Genotropin, and subjects will be randomly assigned to either
      GX-H9 and Genotropin in the ratio of 4:1. The treatment will proceed as the proposed group
      order (Group 1, Group 2, Group 3), and safety and insulin-like growth factor (IGF-1) will be
      reviewed six weeks after each treatment by the safety monitoring committees before proceeding
      to the next group.
    

Intervention name(s): GX-H9; Genotropin
Intervention type(s): Drug; Drug
Intervention description(s): Human growth hormone; Human growth hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Enhancing Attention in Adults With Compulsive Hoarding
Condition: Hoarding Disorder
MeSH terms: Hoarding Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Available data suggest that compulsive hoarders have cognitive deficits, particularly with
      sustaining attention that might contribute their hoarding symptoms.
    

Detailed description: 
      Compulsive hoarders perform significantly worse than healthy controls on standard attention
      tasks. These data suggest that the inability to sustain focus may interfere with hoarders'
      ability to organize, categorize and make decisions about discarding possessions. Stimulants
      are first-line treatments for ADHD, improve CPT performance in people with ADHD and enhance
      school performance in children with ADHD. Extended release formulations, such as
      methylphenidate ER, are associated with better medication compliance. Together, these data
      suggest that adjunctive methylphenidate ER might be a novel way to improve attention in
      compulsive hoarders which might improve hoarding symptoms.

      The investigators hypothesis is that adjunctive methylphenidate ER will improve attention in
      compulsive hoarders aged 18-55. The investigators will also explore the safety of
      methylphenidate ER administration in compulsive hoarders.
    

Intervention name(s): Methylphenidate ER
Intervention type(s): Drug
Intervention description(s): Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Other intervention name(s): Concerta
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hoarding
Short-term Effects of Postural Taping on Pain and Neck Posture
Condition: Neck Pain, Posterior
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effects of a short treatment period with Balance
      Body Tape on the intensity of perceived neck, shoulder and back pain and neck posture.
    

Detailed description: 
      The aim of this study was to investigate the effects of a short treatment period with Balance
      Body Tape on the intensity of perceived neck, shoulder and back pain and neck posture.

      Method 26 subjects who reported being university students or having a sedentary work and
      experiencing pain in neck, back or shoulders were randomized into intervention- (n=12) and
      control group (n=14).

      The intervention group received a three-week treatment with BBT, the control group received
      no treatment. A questionnaire regarding pain, including a Numeric Rating Scale (NRS)
      measuring pain intensity, and a Photographic posture analysis measurement (PPAM) of habitual
      sitting posture were accomplished before and after the intervention for both groups.
      Wilcoxon´s signed rank test and Mann-Whitney U test was used to assess intra- and between
      group differences respectively. The relationship between pain intensity and CV-angle was
      assessed using Spearman's rank-order correlation.
    

Intervention name(s): Balance Body Tape
Intervention type(s): Other
Intervention description(s): The intervention group received a three-week treatment with Balance Body Tape (BBT) (product by Babota AB), the control group received no treatment. A questionnaire regarding pain, including a Numeric Rating Scale (NRS) measuring pain intensity, and a Photographic posture analysis measurement (PPAM) of habitual sitting posture were accomplished before and after the intervention for both groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 26 subjects experiencing pain in neck, back or shoulders were randomized into either an intervention group (n=12) or control group (n=14).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: posture; Balance Body Tape
Healthy Youth Places: A Program to Promote Nutrition and Physical Activity in Adolescents
Condition: Health Behavior
Study type: Interventional
Phase: Phase 4

Summary: 
      To reduce the risk for chronic disease, adolescents should eat at least five servings of
      fruit and vegetables and be physically active daily. This study will implement and evaluate a
      school-based program to encourage adolescents to achieve and maintain a healthy diet and
      exercise regimen.
    

Detailed description: 
      The Healthy Youth Places project will test if an intervention strategy that implements school
      environmental change, with both adult leader and youth participation, will influence and
      maintain adolescent fruit and vegetable consumption and physical activity.

      The study will assess the effects of school environment and curriculum interventions
      promoting fruit and vegetable (F&V) consumption, physical activity (PA), and their
      environmental determinants. The project will involve goal-setting and efficacy-building
      interventions designed to develop the skills and group efficacy of both adult school
      personnel and students. The adult-based interventions are designed to change the school
      environments through a school coalition assisted by a local coordinator. The youth
      interventions involve the participation of students in the processes of building the local
      health behavior environments and target both school lunch and after-school activity
      environments.

      The project encourages adult and youth participation in the process of planning and
      implementing environmental change in targeted adolescent physical and social environments
      (school lunch place, after-school program place). Environmental change is defined as
      implemented practices, programs, and policies that promote critical elements (connection,
      autonomy, skill-building, healthy fruit and vegetable and physical activity norms). These
      critical elements are social environmental processes of behavior change.

      Sixteen schools will be randomly assigned to either the experimental or the control (no
      treatment) condition. The health behavior of adolescents will be assessed during the sixth,
      seventh, eighth, and ninth grades. Measurement of F&V and PA behaviors are the primary
      outcomes and will be assessed by self-report and verified by objective measures of school
      lunch purchases and physical activity monitoring. The impact of the program on personal,
      environmental, and behavioral determinants of F&V and PA will also be measured.
    

Intervention name(s): Healthy Youth Places: a behavior change model
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Physical Activity; Nutrition; Self Efficacy; Middle School; Intervention
A Single Dose Study of Debio 1450 in Healthy Subjects
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The sponsor is trying to develop a medicine for infections that are not cured by regular
      antibiotics. They have an experimental drug called Debio 1450 that may work. They need about
      48 healthy adults to volunteer for this study.

      This study looks at what the body does to the drug. It measures how the amount of drug in
      blood and urine changes over time.

      From the screening visit through the follow-up visit may be up to 40 days. Volunteers go to
      the clinic in Baltimore for a screening visit. The study doctor chooses qualified volunteers
      to participate or serve as alternates. Alternates might not actually complete the study
      procedures.

      The study doctor divides participants into groups of eight. Six receive Debio 1450 and 2
      receive Placebo. The drug each participant receives is decided by chance - like flipping a
      coin.

      Eligible volunteers check into the clinic for testing and those chosen to participate remain
      for a 5-day/ 4-night stay. The clinic serves standard meals, except when fasting is required.
      Participants must stay at the clinic for the length of the study.

      This study is a "dose escalation" study. That means that if no safety concerns come up a new
      group starts. Each new group of eight participants receives more capsules.

      The study product is contained in capsules. Each capsule contains either placebo or 40 mg
      Debio 1450. After fasting overnight, the first two participants in the group receive their
      capsules. One gets Debio 1450 and one gets Placebo. If these participants tolerate side
      effects for 24 hours, the remaining six participants receive their assigned capsules.

      The plan is to increase the dose for the next group. The study doctor reviews the
      measurements collected from each group after three days. He may decide to repeat, increase,
      or lower the dose or even stop the study. The most any participant receives is 800 mg in 20
      capsules.
    


Intervention name(s): Debio 1450; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single sentinel dosing of 40 mg per unit capsules is planned to escalate from 80 mg to 160, 320, 480, 640 and 800 mg, per respective dosing group. Doses may be modified based on review of available safety and pharmacokinetic (PK) data.; Matching single sentinel dosing of placebo capsules is planned to escalate from 2 capsules to 4, 8, 12, 16 and 20 capsules, per respective dosing group. The number of capsules will match those delivering Debio 1450 for the group, as those doses may be modified based on review of available safety and pharmacokinetic (PK) data.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Antibiotic; Antibiotic Resistant Bacterial Infection
Partial Posterior Hyaloidectomy in Macular Surgery
Condition: Retinal Break; Retinal Detachment
MeSH terms: Retinal Detachment; Retinal Perforations
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of partial posterior hyaloidectomy on preventing iatrogenic retinal
      breaks related to induction of a posterior vitreous detachment
    

Detailed description: 
      The induction of a posterior vitreous detachment (IPVD) during vitrectomy have been suggested
      as one of the etiologies of iatrogenic retinal break related to vitrectomy.The iatrogenic
      retinal breaks related to IPVD usually develop near or anterior to the equatorial region.

      Thus, the investigators hypothesized that this complication could be prevented by restricting
      the extent of IPVD, and planned a modified procedure of vitrectomy in which the extent of
      IPVD and removal of vitreous cortex was restricted to about slightly beyond the margin of
      temporal major vascular arcade.

      The investigators have termed this procedure, partial posterior hyaloidectomy. Unlike RRD or
      proliferative diabetic retinopathy, lesions are localized within the major vascular arcade in
      macular disorders so that macular disorders could be an eligible indication for this
      procedure.
    

Intervention name(s): Partial posterior hyaloidectomy (a modified procedure of vitrectomy)
Intervention type(s): Procedure
Intervention description(s): The core vitrectomy entails more extensive removal of vitreous gel, in contrast to the conventional core vitrectomy. IPVD was conducted by engaging the attached posterior cortical vitreous with a 23-gauge needle with angulated tip in the area adjacent to the optic disc followed by gently moving the tip to approximately 3 disc diameters away from the margin of the optic disc. After then, slightly elevating the tip in a posteroanterior direction with slowly proceeding it to the extent that we planned. With IPVD, the surgeon was able to visualize a floating Weiss ring in all of the cases. Active suction to initiate IPVD was not used in any of the cases. In the temporal direction, the extension of a PVD was restricted to approximately 2 disc diameters distance beyond the margin of temporal major vascular arcade
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prevention; retinal break; vitrectomy; partial posterior hyaloidectomy
Reproducibility of Tearfilm Osmolarity Measurements Using TearLab® in Patients With Dry Eye Syndrome and Healthy Subjects
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Interventional

Summary: 
      Dry Eye Syndrome (DES) is a common condition that affects approximately 20% of adults aged 45
      and older. Although several clinical tests for the diagnosis and monitoring of DES are
      available, currently no gold standard for the assessment of DES exists. It has, however, been
      hypothesized that the assessment of tear film osmolarity may be a new and promising approach
      of an objective and non-invasive method for diagnosis and monitoring of treatment success.

      Recently, a new commercially available instrument (TearLab®, OcuSens Inc, San Diego, USA) for
      the assessment of tear film osmolarity has been introduced. This instrument allows for the
      easy and non-invasive determination of tear film osmolarity. Unfortunately, no data about
      reproducibility are yet available. Consequently, the current study sets out to investigate
      the short time reproducibility of tear film osmolarity measurements using the TearLab®
      instrument.
    


Intervention name(s): Measurement of tear film osmolarity with the TearLab® instrument; Schirmer I test; Tear break up time; Optical Quality Analysis System; Ocular Surface Disease Index
Intervention type(s): Device; Other; Other; Device; Other
Intervention description(s): Measurement of the objective scattering index (OSI)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: tear film osmolarity; objective scattering index; tear break up time; Schirmer I test
A Study to Evaluate the Safety and Efficacy of Celgosivir in Patients With Chronic Hepatitis C Genotype 1 Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to evaluate the safety and efficacy of celgosivir for 12 weeks
      in patients with chronic hepatitis C genotype 1 infection.
    


Intervention name(s): Celgosivir
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Celgosivir; HCV; Genotype 1