bioihbjkbjnl/mcl2 huggingface dataset:
Virtual Reality Social Cognition Training for Adults With Autism Spectrum Disorders
Condition: Autism Spectrum Disorders
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to predict and explain on the basis of brain function and
      structure the behavioral and brain effects of an evidence-based intervention for adults with
      high-functioning autism, Virtual Reality-Social Cognition Training (Kandalaft et al., 2012;
      Journal of Autism and Developmental Disorders). Adults with autism will be randomly assigned
      to receive either (a) two hours per week of intervention services for five weeks, or (b) a
      treatment as usual control. The intervention will focus on enhancing social skills, social
      cognition, and social functioning. Outcome measures will evaluate changes in these social
      skills, cognition, and functioning using standardized assessments. We will perform structural
      and functional magnetic resonance imaging (MRI) scans at three time points-before, during,
      and after treatment (i.e., Time Point #1, 2, and 3).
    

Detailed description: 
      The purpose of this study is to predict and explain on the basis of brain function and
      structure the behavioral and brain effects of an evidence-based intervention for adults with
      high-functioning autism, Virtual Reality-Social Cognition Training (Kandalaft et al., 2012;
      Journal of Autism and Developmental Disorders). Adults with autism will be randomly assigned
      to receive either (a) two hours per week of intervention services for five weeks, or (b) a
      treatment as usual control. The intervention will focus on enhancing social skills, social
      cognition, and social functioning. Outcome measures will evaluate changes in these social
      skills, cognition, and functioning using standardized assessments. We will perform structural
      and functional magnetic resonance imaging (MRI) scans at three time points-before the
      treatment, after the treatment, and a 3-month follow-up (i.e., Time Point #1, 2, and 3).

      All the recruitment will be taking place at Yale Child Study Center (YCSC), while the
      intervention will be delivered online by therapists located at the Center for BrainHealth at
      the University of Texas at Dallas (UTD). The intervention is called Virtual Reality-Social
      Cognition Training (VR-SCT) and has been approved by the IRB at UTD (approval number #06-54).
    

Intervention name(s): Virtual Reality Social Cognition Training
Intervention type(s): Behavioral
Intervention description(s): Social skills training via virtual reality with trained therapist.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Social Skills; Adults
Bioavailability Study of a Dolutegravir Dispersible Tablet and Effect of Different Types of Water on the Dispersible Tablet in Healthy Volunteers
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Dolutegravir (DTG) is an HIV-1 integrase inhibitor approved in the United States, Canada,
      Australia and EU. A dispersible tablet has been developed for pediatric use as an alternative
      to the granule formulation, already in development, and the approved film-coated tablet. This
      is a single-center, randomized, open-label, 5-way crossover study in healthy adult subjects.
      The study will evaluate the relative bioavailability of five dosing regimens: 20 mg DTG
      pediatric granules (Treatment A) and of DTG 20 mg dispersible tablets (DTG 20 mg DT) after
      dispersed in: low mineral content(LMC) water (Treatment B); dispersed in CONTREX™ mineral
      water (Treatment C); dispersed in low mineral content water and consumed after standing for
      30 minutes (Treatment D) and dispersed in CONTREX mineral water and consumed after standing
      for 30 minutes (Treatment E). Safety evaluations and serial PK samples will be collected
      during each treatment period. A follow-up visit will occur 7-14 days after the last dose of
      study drug. CONTREX is a trademark of Nestlé Waters Corporation.
    


Intervention name(s): Dolutegravir Pediatric Granules; Dolutegravir Dispersible Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Dolutegravir pediatric granules are supplied as 40 grams bulk bottles containing 0.4% weight by weight of dolutegravir to be reconstituted with 73 mL of purified water to yield a dolutegravir concentration of 1.6 milligram / millilitre. 12.5 mL of reconstituted granules contain 20 mg DTG; Dolutegravir is available as 5mg dispersible tablets and can be administered as 4 tablets dispersed in 12.5 mL LMC water and consumed immediately or 4 tablets dispersed in 12.5 mL CONTREX mineral water and consumed immediately or 4 tablets dispersed in 12.5 mL LMC water, allow to stand at room temperature for 30 mins, re-suspend mixture and consumed or 4 tablets dispersed in 12.5 mL CONTREX mineral water, allow to stand at room temperature for 30 mins, re-suspend mixture and consumed
Intervention MeSH terms: Dolutegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: GSK1349572; granule; pediatric; CONTREX mineral water; free-acid; chelating; cations; divalent; dolutegravir; dispersible tablet; relative bioavailability
Emotional Effects of Methylphenidate and MDMA in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares the interactive emotional/subjective effects of single doses of
      3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") and methylphenidate, a dopamine (DA) and
      norepinephrine (NE) transporter blocker, in healthy subjects. The primary goal is to
      determine the role of transporter mediated DA and NE release in the subjective response to
      MDMA in humans. The investigators hypothesize that methylphenidate will attenuate the
      subjective response to MDMA.
    

Detailed description: 
      3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its
      euphoric effects. MDMA releases serotonin (5-HT), dopamine (DA), and norepinephrine (NE).
      5-HT release mainly contributes to the subjective effects of MDMA whereas NE release is
      involved in the cardiovascular and psychostimulant effects of MDMA. DA is also likely to be
      involved in the rewarding and reinforcing effects of drugs of abuse. However, the functional
      role of DA in the subjective effects of MDMA in humans is largely unclear. To determine the
      role of the DA transporter (DAT) in the response to MDMA in humans the investigators test the
      effects of the DA and NE transporter blocker methylphenidate on the subjective effects of
      MDMA. The investigators use a randomized double-blind placebo-controlled cross-over design
      with four experimental sessions. methylphenidate or placebo will be administered before MDMA
      or placebo to 16 healthy volunteers. Subjective and cardiovascular responses will be
      repeatedly assessed throughout the experiments and plasma samples are collected for
      pharmacokinetics. The primary hypothesis is that methylphenidate will significantly reduce
      the subjective effects of MDMA.
    

Intervention name(s): 3,4-Methylenedioxymethamphetamine; Methylphenidate; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 125 mg per os, single dose; 1 hour before MDMA/placebo 60 mg methylphenidate per os, single dose; capsules identical to MDMA or methylphenidate
Other intervention name(s): MDMA; ecstasy; Ritalin; Concerta
Intervention MeSH terms: Methylphenidate; N-Methyl-3,4-methylenedioxyamphetamine
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: MDMA; pharmacokinetics; pharmacodynamics; emotions; Mechanism of action of MDMA; Interaction study; Effect of MDMA and methylphenidate on emotions
A Study of Anthrax Vaccines Px563L and RPA563 in Healthy Adult Subjects
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial investigates Px563L and RPA563, two formulations of a novel anthrax vaccine.
    

Detailed description: 
      This is a Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety,
      tolerability, and immunogenicity of Px563L or RPA563 administered intramuscularly. All
      subjects will be followed for safety and tolerability for 393 days after the initial
      vaccination. Immunogenicity analyses will be performed for up to 182 days, including an
      interim analysis based on Day 70 results, after the initial vaccination.
    

Intervention name(s): Px563L, RPA563, or placebo
Intervention type(s): Biological
Intervention description(s): Two intramuscular injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
MK-0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus (0431-043)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A clinical study to determine the safety and efficacy of MK-0431 in patients with Type 2
      diabetes mellitus who have inadequate glycemic control on diet/exercise therapy
    


Intervention name(s): MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks; Comparator : placebo (unspecified) / Duration of Treatment: 12 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
UHR-OCT and HD-OCT for Preretinal Membranes: ICG Versus Membrane Blue
Condition: Retinal Diseases
MeSH terms: Retinal Diseases; Epiretinal Membrane
Study type: Interventional

Summary: 
      Using the UHR-OCT and HD-OCT to evaluate early postoperative changes in patients with
      diagnosis preretinal membrane after successfully performed pars-plana vitrectomy and membrane
      peeling with two different types of dyes.
    

Detailed description: 
      Surgical procedures performed are pars-plana vitrectomy and membrane peeling with or without
      cataract extraction and IOL implantation. The type of the dyes is randomized. The study is
      designed to include a total of tweny cases (10 cases with ICG and 10 cases with Membrane
      blue)

      Main outcome measures are:

      UHR-OCT, HD-OCT distance and near visual acuity and contrast sensitivity amsler grid
      secondary outcome measures are: OCT Stratus 3000 and visual field. Clinical examinations:
      preoperative, and follow-up examinations after 1 week, 1 months, 3 months, 6 months and 12
      months.
    

Intervention name(s): ppVE, MP, ICG; ppVE, MP, MB
Intervention type(s): Procedure; Procedure
Intervention description(s): surgery with ILM staining; Surgery with ERM staining
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: preretinal membrane; vitrectomy; uhr-oct; hd-oct
The Optimum Time for Preoxygenation Based on Body Mass Index
Condition: Body Weight; Obesity
MeSH terms: Body Weight
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the relationship between the time needed to raise
      the oxygen concentration in patient's blood to 90% and his/or her body mass index. The
      prevalence of obesity in our society continues to rise. No studies have shown the time
      required for preoxygenation (oxygen given) in relation to body mass index (body weight in
      kg/height in meter2).
    

Detailed description: 
      100% oxygen given to patient before induction of anesthesia (asleep) is the standard clinical
      care. However, studies using various methods have shown differences in terms of the optimal
      time, technique and number of breaths needed for efficient oxygenation. The only difference
      to the standard pre-anesthesia care is that we will record the time to raise patient oxygen
      to 90%. Age is recorded to ensure that the subjects fall within our inclusion criteria. The
      weight (W) in kilograms and height (H) in meters will be used to calculate the body mass
      index (BMI): BMI = W/H2. Alveolar oxygen uptake is dependent on respiratory rate, heart rate,
      blood pressure, temperature and hemoglobin level. These parameters are measured in order to
      identify factors that may affect the accuracy of the study. We will record the pulse oximetry
      value to note the initial oxygen saturation on room air and after the oxygenation.

      Facial hair and mask fit are recorded to assess possible failure of an optimal facemask seal.
      End-tidal carbon dioxide (FE'CO2) is also measured to ensure an adequate facemask seal.
      Anxiety can increase the respiratory rate, heart rate and affect patient compliance with a
      fitted facemask. All of the aforementioned values are recorded to assess reasons for possible
      failure of the preoxygenation technique and inaccurate results.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of 100 subjects between the ages of 18-50 classified as
        ASA 1 or 2 with no limitations as to gender or race that are scheduled for elective surgery
        at Cedars-Sinai Medical Center. There are changes to lung functioning as functional
        residual capacity (FRC), closing capacity, and lung volume after age 50; therefore, the age
        limitation is set to age 50. Changes in lung and chest wall compliance necessitate the
        exclusion of anyone over the age of 50. Minors are also excluded as there is difficulty
        fitting the face mask due to a smaller physiology.
      
Keywords: pre-oxygenation; body mass index; end-tidal O2; anesthesia induction
The Effect of Kinesiological Taping Applied to the Tibialis Anterior Muscle on Gait Parameter in Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The effect of kinesiological taping applied to the tibialis anterior muscle on gait parameter
      in stroke patients: Sham controlled study
    

Detailed description: 
      Objective: The aim of this study was to compare the immediate effect of kinesiological and /
      or sham taping to the tibialis anterior muscle on walking parameters in stroke individuals.

      Methods: The study included 28 adults stroke patients . The subjects who received scores of 7
      or more in the Hodkinson Mental Test and 3 and above in the Functional Ambulation
      Classification with subjects who gastrocnemius muscle spasticity 2 and below points according
      to Modified Ashworth Scale were included in the study. The walking parameters of the
      participants were evaluated with the BTS G-Walk Spatio-Temporal Walking Analysis System. The
      walking parameters of the participants who were selected by randomization method were
      evaluated separately by applying kinesiological taping and sham taping or without any taping
      or interference on a 10 meter track.
    

Intervention name(s): kinesiological taping
Intervention type(s): Other
Intervention description(s): The kinesiological banding applied to the tibialis anterior muscle was applied to improve walking parameters and compared to sham control.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sham Controlled Study
Masking: Single (Participant)
Primary purpose: Other
Keywords: Stroke; Kinesiological Taping; Walking; Tibialis Anterior
The Antidepressant Effects Of The NMDA Antagonist, CP-101,606, In Patients With MDD
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine if the NMDA antagonist, CP-101,606, is effective for depression
    


Intervention name(s): NMDA Antagonist, CP-101,606 (traxoprodil)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Ibuprofen, Acetaminophen and Dipyrone to Fever Control in Children
Condition: Fever
MeSH terms: Fever
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to compare the efficacy and tolerability of acetaminophen,
      dipyrone and ibuprofen to fever control in children.

      For the efficacy asses were compared:

        -  the time to start the action;

        -  the action duration;

        -  the difference between the basal temperature and the lower temperature in the study
           period.

      For the tolerability asses all adverse events were recorded, as well as your intensity and
      the relation to the treatment.
    


Intervention name(s): ibuprofen, dipyrone, acetaminophen
Intervention type(s): Drug
Intervention description(s): The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration
Intervention MeSH terms: Acetaminophen; Dipyrone; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fever; Ibuprofen; Acetaminophen; Dipyrone
AV-101 as Adjunct Antidepressant Therapy in Patients With Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the safety and efficacy of AV-101.
    


Intervention name(s): AV-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant); Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Other intervention name(s): L-4-chlorokynurenine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Subtenon's Block With Olive Tipped Cannula
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the efficacy of olive tip cannula to the standard
      Steven's cannula in performing subtenon's anesthesia for patients undergoing cataract
      surgery.
    


Intervention name(s): subtenon block; subtenon block
Intervention type(s): Device; Device
Intervention description(s): subtenon block with stevens cannula; subtenon block with Olive tip cannula cannula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Keywords: subtenon block
Cast Versus Splint in Children With Acceptably Angulated Wrist Fractures
Condition: Distal Radius Fractures
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will compare the effectiveness of a prefabricated wrist splint with thermoplast
      reinforcements versus a short arm cast in skeletally immature children.

      The hypothesis is that the commercially available wrist splint is at least as effective as
      traditional casting with respect to recovery of physical function.
    

Detailed description: 
      Acceptability angulated wrist bone fractures in children carry an excellent long-term
      prognosis because of the unique capacity of skeletally immature bones to heal via remodeling.
      Their management varies widely and there is virtually no scientific evidence supporting one
      treatment modality over another. Importantly, the most common treatment modality of cast
      application for four to six weeks is associated with many inconveniences. There are
      commercially available wrist splints that offer a more convenient alternative. Wrist splints
      likely have comparable immobilization and symptom relief, while simultaneously allowing for
      easier bathing and less reliance on subspeciality care. Preliminary adult evidence suggests
      that, in a comparable adult fracture, splinting may offer a safe alternative to casting, with
      earlier resumption of the usual activities. However, this treatment modality needs to be
      compared to the traditional casting management in the pediatric population before it can be
      recommended for clinical practice.

      This study will be the first to challenge the current practice of routine casting and compare
      it to a commercially available wrist splint with respect to recovery of physical function in
      children with acceptably angulated wrist fractures. In addition, standardized treatment of
      these fractures with a splint may be associated with lower morbidity, reduced use of health
      care resources, and have the potential for cost savings.

      This study will compare, in skeletally immature children, the functional outcomes that result
      from treatment with a prefabricated wrist splint versus a short arm cast in acceptably
      angulated distal radius fractures. Secondly, the cost-effectiveness of the splint relative to
      the cast will be evaluated.
    

Intervention name(s): Fiberglass short arm cast; Prefabricated wrist splint
Intervention type(s): Device; Device
Intervention description(s): Cast will be applied for a 4-week period; Splint will be applied for a 4-week period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatrics; wrist fractures; casting; wrist splint
Investigating the Absorption, Metabolism and Excretion (AME) of Idalopirdine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigating the absorption, metabolism and excretion of
      radio labelled single doses of idalopirdine in healthy men.
    


Intervention name(s): [ethyl-1-14C]-idalopirdine; [benzyl-7-14C]-idalopirdine
Intervention type(s): Drug; Drug
Intervention description(s): 120 mg/2.40 MBq Lu AF67708 ([ethyl-1-14C]-idalopirdine) in one capsule for oral administration, single dose; 120 mg/2.40 MBq Lu AF67709 ([benzyl-7-14C]-idalopirdine) in one capsule for oral administration, single dose
Other intervention name(s): Lu AF67708; Lu AF67709
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY3015014 in Otherwise Healthy Participants With High Low-density Lipoprotein (LDL) Cholesterol
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study in otherwise healthy participants with high LDL cholesterol.
      Following multiple doses of LY3015014, the safety and tolerability of the drug, how the body
      handles the drug, and the drug's effect on the body will be evaluated. Participants will
      participate in the study for approximately 3 months not including screening. Screening is
      required within 42 days prior to the start of the study.
    


Intervention name(s): LY3015014; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science