bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Baby-CIMT in Infants Younger Than 12 Months
Condition: Cerebral Palsy; Hemiplegia; Children
MeSH terms: Cerebral Palsy; Hemiplegia
Study type: Interventional

Summary: 
      A randomized control trial investigating if an early intervention program of modified
      Constraint Induced Movement Therapy for babies, Baby-CIMT, performed before 12 months of age
      will improve hand function in children with risk for developing cerebral palsy.
    

Detailed description: 
      The investigators hypothesis is that Baby-CIMT including intensive specific task oriented
      training is more preferable than general stimulation which is the assumption for baby massage
      used in the control group. The intervention protocol is developed at Astrid Lindgren Children
      hospital, Stockholm Sweden.
    

Intervention name(s): Baby-CIMT; Baby-Massage
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Baby-CIMT is a very much modified model of constraint induced movement therapy for infants. It is developed to suit small children and their needs of stimulation. The infant should wear a comfortable glove on the less affected hand, while stimulating the use of the affected hand 30 minutes per day during 2 periods of 6-weeks training before 12 month. The hand training provides the baby with amusing and easily handled toys.; For baby massage, there will be a special instructional course by a health professional certified for baby massage. Massage should be given every day during 2 periods of 6 weeks. Families will be responsible for the massage.
Other intervention name(s): Constraint Induced Movement therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: infants; unilateral cerebral pares; hand function; early intervention; constraint induced movement therapy
Assessing the Effects of a Neurobehavioral Intervention on Symptoms of Obsessive Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      This experiment will examine if the use of computerized tasks that train individuals to
      control their attention more effectively will predict individual differences in
      obsessive-compulsive symptoms, rumination and BDNF change. After giving consent, filling out
      self-report forms, and giving blood for the BDNF test, 80 participants will be randomized to
      Cognitive Control Training (CCT) or Peripheral Vision Task (PVT) (described below) which will
      be administered three times over a two week period. At the third visit, participants will
      also complete an anagram task and repeat the blood draw for BDNF testing. The investigators
      hypothesize that computerized tasks that train individuals to control their attention more
      effectively will reduce Obsessive Compulsive (OC) symptoms. Additionally, individuals
      training in CCT will show increased ability to disengage from unattainable goals as assessed
      by responses to an unsolvable anagram task. Finally, individuals training in CCT will show a
      greater increase in BDNF levels as compared to individuals training in PVT.
    


Intervention name(s): Cognitive Control Training; Peripheral Vision Task
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Pace Auditory Serial Addition Task (PASAT;(Gronwall, 1977): A computer version of the PASAT will be used to measure sustained attention and working memory. Participants are asked to add serially presented numbers. Attention Control Intervention (Wells, 2000): This task involves training individuals to attend differentially to multiple auditory sources (e.g., by counting tones, discriminating the location of tones, and moving their attention between auditory sources for a prolonged period).; Peripheral Vision Task (PVT; C. Moore, personal communication): This task serves as a non-active control condition which does not target the brain regions influenced by the Wells and PASAT tasks. Participants focus on the placement of dots on a computer screen in this task while listening to a tone.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: High OCI-R scores
Metoclopramide Use in Very Low Birth Weight Newborns
Condition: Infant, Premature
Study type: Interventional
Phase: Phase 4

Summary: 
      During the first 7 days of life very small babies will receive the drug metoclopramide or a
      salt solution through an intravenous line. They will also begin to receive a very small
      amount of breast milk or formula within the first 72 hours of life, in addition toother
      nourishment that is provided by an intravenous line, according to standard hospital
      procedure. We think that the babies who receive the medication may reach full oral feeds than
      babies who receive the salt solution.
    

Detailed description: 
      Clinically stable, premature babies (birth weight between 500 and 1,250g) will be randomized
      to receive metoclopramide (0.1 mg/kg IV q8h)or an equal volume of placebo for 7 days.A
      transition feeding schedule will begin within the first 72 hours of life. The time to full
      feeds for the 2 groups will be analyzed.
    

Intervention name(s): Metoclopramide
Intervention type(s): Drug
Intervention MeSH terms: Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: metoclopramide; feeding; very low birthweightnewborn
DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the visual performance of DACP MF and PROCLEAR 1D MF
      daily disposable contact lenses in an established presbyopic population.
    


Intervention name(s): DACP MF; PROCLEAR 1D MF
Intervention type(s): Device; Device
Intervention description(s): Nelfilcon A multifocal contact lenses; Omafilcon A multifocal contact lenses
Other intervention name(s): DAILIES® AquaComfort Plus® Multifocal (DACP MF); Nelfilcon A; PROCLEAR® 1 DAY MULTIFOCAL (PROCLEAR 1D MF); Omafilcon A
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Visual Performance
Single-photon Emission Computed Tomography (SPECT) to Predict Peritoneal Chemotherapy
Condition: Peritoneal Carcinomatosis
MeSH terms: Carcinoma; Peritoneal Neoplasms
Study type: Observational

Summary: 
      SPECT was performed in 51 patients after cytoreductive surgery in combination with
      intraperitoneal chemotherapy. The detected volume was compared to the number of subsequent
      sequential postoperative intraperitoneal chemotherapy courses that could be performed without
      further surgical intervention. SPECT data was found to predict feasibility of sequential
      postoperative intraperitoneal chemotherapy.
    


Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        Patients who had undergone cytoreductive surgery and intraperitoneal chemotherapy (SPIC) at
        the Dept of Surgical Sciences, Uppsala University Hospital in the time period between May
        1991 and August 2004.
      
Keywords: Intraperitoneal volume; peritoneal carcinomatosis; cytoreductive surgery; SPECT; intraperitoneal chemotherapy
Effectiveness of Kinesio Tape in Morning Stiffness and Functional Capacity in Patients With Rheumatoid Arthritis.
Condition: Wrist Morning Stiffness
Study type: Interventional

Summary: 
      The purpose of this study is to determine how the applications of Kinesio Tape affect the
      morning stiffness in patients with rheumatoid arthritis.
    


Intervention name(s): Kenzo Kase Method; Kinesio Taping
Intervention type(s): Procedure; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Board Game-Based Nutrition Education on Primary School Children
Condition: Nutrition Assessment; Education; Child Behavior
Study type: Interventional

Summary: 
      The purpose of this study to design a board game that will enable primary school children to
      recognize foods by enabling them to distinguish between healthy and unhealthy foods by going
      beyond the traditional education patterns and to compare the effects of this board game-based
      nutrition education intervention on children's behaviors, self-efficacy, and attitudes with
      the control group in which no intervention was made.
    

Detailed description: 
      Nutrition is an important part of health and development. In particular, the gaining of
      healthy eating habits in early childhood promotes growth and development and reduces the risk
      of many non-communicable diseases, especially obesity. In order to create healthy societies
      in the future, nutrition education is one of the effective methods for developing healthy
      eating behaviors and raising awareness starting from childhood. Game-based education
      approaches provide motivation for learning information that is made a part of the game by
      going beyond traditional education methods. Board games are used in nutrition education by
      giving children the opportunity to think interactively and make different choices with their
      immersive stories and designs.
    

Intervention name(s): Board Game
Intervention type(s): Behavioral
Intervention description(s): Food Hunter board game intervention, which includes various nutrient cards and question cards and is played with pawns and dice, will be played with children for approximately 4 weeks, one day a week and one session (40 minutes) with the researcher dietitian. By talking about the nutrients in the game on the game cards, children will be able to recognize the nutrients and important points will be emphasized for the participants with the answers to the cards containing various questions about healthy nutrition.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups with the intervention group in which the game was applied and the control group
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dietary Intake; Behavior; Self Efficacy; Attitude
Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study in patients with moderately to severely active Crohn's disease is designed to
      establish the efficacy and safety of vedolizumab for the induction of clinical response and
      remission.
    

Detailed description: 
      After completing the study, patients were eligible to enroll in a long term safety study with
      continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated,
      and no major surgical intervention for Crohn's disease occurred or was required.

      Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16
      weeks after the last dose of study drug) for a maximum time on study of 22 weeks.
    

Intervention name(s): vedolizumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Vedolizumab for intravenous infusion; Placebo intravenous infusion
Other intervention name(s): Entyvio; MLN0002; MLN02; LDP-02
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Clinical Study to Evaluate Efficacy and Tolerability of a Cosmetic Product for Arm Firming
Condition: Photodamaged Skin; Skin Care
Study type: Interventional

Summary: 
      This single-center, split-body, double-blind, randomized, controlled clinical trial was
      conducted to assess the efficacy and tolerance of a topical firming body moisturizer when
      used over the course of 12 weeks by women with mild to moderate sagging, crepey skin, and
      overall photodamage on the upper arms. A total of 40 subjects completed study participation
      which included 10 subjects in the biopsy subgroup.
    

Detailed description: 
      This single-center, split-body, double-blind, randomized, controlled clinical trial is being
      conducted to assess the efficacy and tolerance of the topical firming body moisturizer when
      used over the course of 12 weeks by women with mild to moderate sagging, crepey skin, and
      overall photodamage on the upper arms.

      Efficacy and tolerance will be assessed through clinical grading at baseline and weeks 4, 8,
      and 12. Efficacy will also be assessed through Corneometer and upper arm circumference
      measurements at baseline and weeks 4, 8, and 12, and Cutometer and Ultrasound measurements at
      baseline and weeks 8 and 12. Self-assessment questionnaires will be completed at baseline and
      week 12. Digital images will be taken at baseline and weeks 4, 8, and 12. Vectra H2 3D images
      will be taken at baseline and weeks 8 and 12. BMI will be measured at baseline and weeks 8
      and 12. Biopsies will be collected from a subgroup of at least 10 subjects at baseline and
      week 12 (two biopsies on each arm at each time point; total of 8 per biopsy subject).

      A total of 40 subjects completed study participation which included 10 subjects in the biopsy
      subgroup.
    

Intervention name(s): Topical Body Firming Moisturizer; Body Cleanser; Sunscreen; Placebo Moisturizer
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Moisturizer composed of a patent-pending blend of botanical extracts, bioavailable peptides, antioxidants, and a prebiotic innovation; Body cleanser to be used by study participants; Sunscreen to be applied after application of moisturizer; Placebo moisturizer is the vehicle control of the topical body firming moisturizer
Other intervention name(s): Dove Sensitive Skin Nourishing Body Wash; Neutrogena® Ultra Sheer® Dry-Touch Sunscreen Broad Spectrum Sunscreen Protection Factor 55
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split Body, randomized, and placebo controlled
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Body; moisturizer; Firming
Encouraging Healthy and Sustainable Dietary Substitutions
Condition: Food Selection
Study type: Interventional

Summary: 
      The aim of this study is to examine emerging adults' responses to dietary substitution
      messages about health, the environment, or both health and the environment.
    

Detailed description: 
      This online study will examine emerging adults' responses to dietary substitution messages
      about 4 different topics. Participants will be randomized to 1 of 4 topic arms: 1) Control
      (neutral topic, not related to health or the environment); 2) Health topic; 3) Environment
      topic; 4) Health and Environment topic. Participants will view messages about each of 4
      dietary substitutions: replacing red meat with chicken or vegetarian options; replacing dairy
      milk with non-dairy milk; replacing juice with whole fruit; and replacing sugar-sweetened
      beverages with water. For each dietary substitution, participants will view 2 messages about
      their assigned topic, with the 2 messages shown in random order. Participants will rate each
      message on perceived message effectiveness (primary outcome).
    

Intervention name(s): Health messages; Environmental messages; Health and environmental messages; Neutral messages
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants view messages about the health impacts of certain dietary substitutions.; Participants view messages about the environmental impacts of certain dietary substitutions.; Participants view messages about the health and environmental impacts of certain dietary substitutions.; Participants view neutral messages unrelated to the health and environmental impacts of certain dietary substitutions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: health; environment; sustainability; food choices; dietary substitutions; diet; emerging adults
A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe
      and works better than taking either saxagliptin or metformin alone
    

Detailed description: 
      All subjects will participate in a lead-in period, and qualifying subjects will continue into
      a short-term randomized treatment period. Subjects who complete the short-term period will be
      eligible to enter the long term extension period. Also, subjects in the short-term period who
      have an elevated blood sugar that requires additional medication for blood sugar control will
      be eligible to enter the long-term treatment extension period where they will receive
      pioglitazone (rescue medication) added onto their blinded study medication
    

Intervention name(s): Saxagliptin; Saxagliptin; Metformin; Placebo; pioglitazone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Coated Tablets, Oral, 10 mg, Daily (6 months ST, 12 months LT); Coated tablets, PO, 5 mg, Daily (6 months ST, 12 months LT); Coated tablets, Oral, 500 mg, Daily (6 months ST, 12 months LT); Coated tablets, Oral, 0 mg, Daily (6 months ST, 12 months LT); Tablets, Oral, 15-45 mg, as needed (12 months LT)
Other intervention name(s): BMS-477118; BMS-477118
Intervention MeSH terms: Metformin; Pioglitazone; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      Visceral hypersensitivity as evidence of central sensory sensitization is evident in many
      patients with functional disorders such as functional dyspepsia (FD) and irritable bowel
      syndrome (IBS). We recently demonstrated both somatic hypersensitivity and abnormal
      endogenous pain modulation in IBS, both of which indicate central sensitization as a crucial
      mechanism in IBS. Endogenous pain mechanisms regulate, fine-tune and integrate sensory and
      homeostatic, including neuroendocrine, immune, motor and autonomic nervous system processes.
      Hitherto, no studies have investigated the role endogenous pain modulation in FD. Abnormal
      modulation could explain several of the symptom complexes associated with FD and provide a
      rationale for exploration of new treatments.

      The current study was designed to

        1. investigate the gastric sensitivity in FD patients and healthy controls during gastric
           capsaicin stimulation

        2. assess the endogenous pain inhibitory modulation system in FD patients and healthy
           controls during heterotopic stimulation
    


Intervention name(s): gastric capsaicin with heterotopic stimulation/ distraction
Intervention type(s): Procedure
Intervention description(s): The subjects are randomized to swallow either a capsaicin 0.50mg capsule or an identical placebo capsule with 100ml of water If after 15 minutes pain scores do not reach a minimum level of 30, a further double-blinded capsule of the same content will be swallowed with 100ml of water. This is repeated to a maximum of 8 capusles until pain with VAS >30 is reported.
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Escitalopram Neuroimaging Supplement
Condition: Body Dysmorphic Disorder
MeSH terms: Body Dysmorphic Disorders
Study type: Observational

Summary: 
      The purpose of this study is to find out more about the brain's response to selective
      serotonin reuptake inhibitor (SSRIs) treatment in people with body dysmorphic disorder (BDD).
      The investigators will use positron emission tomography (PET) and Magnetic Resonance Imaging
      (MRI) scans to look at brain activity in people with BDD before and after treatment with an
      SSRI. The investigators hope that what is learned will allow prediction of whether someone
      will improve with SSRI treatment.
    

Detailed description: 
      The investigators have chosen to focus on five regions of interest, namely ACC, OFC, caudate,
      amygdala and hippocampus. These are brain regions that have been previously associated with
      obsessive-compulsive, affective, and psychotic phenomena. The investigators will test for
      correlations between pre-treatment FDG brain images and subsequent SSRI treatment outcome to
      identify potential predictors of treatment response. Finally, the investigators will compare
      pre-treatment and post-treatment PET FDG studies as well as MRI studies in BDD subjects to
      examine changes in these brain regions following treatment. The goals of the proposed
      research are to use FDG-PET and MRI to identify predictors of treatment response to SSRIs in
      BDD and to determine changes in rCMRglu in BDD subjects following treatment with SSRIs.
    

Intervention name(s): PET scan and MRI scan
Intervention type(s): Procedure
Intervention description(s): PET: The PET Scan is manufactured by Siemens and the model is the Exact HR+ .rCMRglu data will be gathered over a 30 minute resting period using a Siemens HR+ PET camera (4.5 mm in-plane and axial resolution). The total time for an individual PET session, will thus be one hour and a half (30 minutes for serum pregnancy test and 30 minute uptake period followed by 30 minutes of scanning).
MRI: High-resolution scans will be acquired using a Seimens (manufacturer) 1.5T Avonta system at MGH, to be coregistered with subsequently acquired PET images, and used for A) delineation of regions of interest (ROIs), and B) facilitation of optimal transformation to MNI space.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be 24 subjects with BDD newly enrolled, but not yet treated, in a
        multi-site (MGH and Rhode Island Hospital) clinical study of escitalopram for BDD
        (NCT00149799/R01MH072854), Dr. Wilhelm, PI). All BDD subjects will be drawn from this
        clinical study, in order to best ensure that they have all received a comparable regimen of
        SSRI treatment. BDD subjects will have been recruited via the BDD Clinic at Massachusetts
        General Hospital (MGH)/Harvard Medical School and Rhode Island Hospital/Brown Medical
        School.
      
Keywords: BDD