bioihbjkbjnl/mcl2 huggingface dataset:
Schema, Emotion and Behavior-Based Therapy for School Children
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The study is a randomized controlled trial to examine the efficacy of individual cognitive
      behavioral therapy (CBT) relative to a standard community treatment, in youngsters with
      autism spectrum disorder (ASD). The individual CBT program has been tailored over the last
      five years to the clinical needs of high-functioning youth with ASD.
    

Detailed description: 
      Autism spectrum disorder (ASD) is among the most common childhood developmental disorders. A
      key goal in the field is the discovery of methods that reduce core autism symptoms. Core
      autism symptoms include social-cognitive impairments, pragmatic language deficits, and
      repetitive and rigid behaviors. The core symptoms tend to be stable and resistant to
      intervention. Most treatments involve group-based social skills training (SST), with limited
      effects. No treatment for core autism symptoms in school-aged children with ASD meets
      American Psychological Association guidelines for possible efficacy. Cognitive behavioral
      therapy (CBT) offers a novel approach for addressing core autism symptoms in higher
      functioning school-age youngsters. Initial results suggest that individual CBT may also be
      promising for reducing core autism symptoms (Wood et al., 2009b; Drahota, Wood et al., 2011).
      The treatment is based on a contemporary model of memory retrieval competition, employing
      strategies for enhancing the retention of adaptive conceptual and behavioral responses and
      the suppression of idiosyncratic beliefs and behaviors in daily social contexts, emphasizing
      the use of deep semantic processing to enhance memory retrieval. We are proposing a
      randomized controlled trial to examine the efficacy of individual CBT relative to a standard
      community treatment for youngsters with ASD.
    

Intervention name(s): Individual Cognitive Behavioral Therapy; Standard Community Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Therapists will work with families for 32 weekly sessions, each lasting 90 minutes, implementing the CBT manual for children with ASD (Wood et al., 2007).; In this condition, the child meets with a therapist for 32 weekly sessions, each 90 minutes. Therapists use an established manual to provide a standard community therapy treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intervention; Autism; Treatment sensitivity; School aged; Cognitive behavioral therapy; Social Skills Intervention
Biliverdin Reductase A in Chronic Hepatitis C Virus Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis
Study type: Observational

Summary: 
      In this project, the investigators aim to study the role of biliverdin reductase A (BLVRA) in
      HCV infected patients prior and during/after standard antiviral therapy in association with
      viral clearance, disease progression and treatment response and in comparison with healthy
      subjects.
    

Detailed description: 
      1. To analyze biliverdin reductase (BLVRA) expression in the liver of HVC infected patients
           undergoing liver biopsy followed by standard antiviral treatment (peg-interferon plus
           ribavirin combination therapy) and patients with other forms of liver diseases
           undergoing liver biopsy as controls.

        2. To analyze BLVRA expression in peripheral blood leukocytes (PBL) of therapeutically
           naïve HCV patients, during/after standard antiviral therapy and healthy controls.

        3. To analyze BVLRA genetic polymorphisms both in HCV infected patients and healthy
           controls.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Estimated enrollment: BLVRA expression study: 50 - 100 HCV patients 50 healthy volunteers
        Polymorphisms of BLVRA study: 300 HCV patients
      
Biospecimen description: 
      peripheral blood, liver biopsy
    
Keywords: biliverdin reductase; BLVRA; hepatitis C; HCV; peripheral blood mononuclear cells; PBMC; liver; genetic polymorphisms
Memantine Treatment of Compulsive Buying
Condition: Compulsive Buying
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an 8-week, open-labe study of memantine in the treatment of compulsive buying.
    

Detailed description: 
      The goal of the proposed study is to evaluate the efficacy of memantine in the treatment of
      compulsive buying. Sixteen subjects meeting criteria for compulsive buying will receive 8
      weeks of open-label memantine. The hypothesis to be tested is that memantine will be
      effective and well tolerated in patients with compulsive buying. The proposed study will
      provide needed data on the treatment of a disabling disorder that currently lacks a clearly
      effective treatment.
    

Intervention name(s): Memantine
Intervention type(s): Drug
Intervention description(s): 10-30mg, by mouth, daily
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Buying; Shopping; Impulse Control
Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)
Condition: Infantile Spasms
MeSH terms: Spasm; Spasms, Infantile
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase,
      and an open-label extension phase. The pilot phase only will be described in this record. 2
      cohorts of 5 participants will be enrolled sequentially. All participants will receive
      GWP42003-P.
    


Intervention name(s): GWP42003-P
Intervention type(s): Drug
Intervention description(s): Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Other intervention name(s): CBD; Cannabidiol
Intervention MeSH terms: Cannabidiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GWP42003-P; Cannabidiol
Safety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to determine whether the new inactivated polio vaccine that is
      based on attenuated poliovirus strains is safe and to evaluate the immune response in healthy
      adults.
    

Detailed description: 
      The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted
      Sabin-IPV produced with the production process set up for technology transfer by the National
      Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine
      Institute (NVI).

        -  The primary objective is to evaluate safety (local and systemic reactions) of
           intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy adults (first
           in human).

        -  The secondary objective is to evaluate immunogenicity of Sabin-IPV and adjuvanted
           Sabin-IPV in healthy immunized adults.
    

Intervention name(s): IPV; Sabin-IPV; Adjuvanted Sabin-IPV
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Inactivated poliomyelitis vaccine; Inactivated polio vaccine; Inactivated poliovirus vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Vaccination; Inactivated Poliomyelitis Vaccine; Polio; Sabin
Health Improvement Project - Providence
Condition: HIV
Study type: Interventional

Summary: 
      This study will investigate whether phone-delivered mindfulness training is feasible and
      acceptable for persons living with HIV and whether it may help them improve adherence to
      medications and reduce risky sexual behaviors.
    

Detailed description: 
      Two-thirds of people living with HIV show sub-optimal adherence to antiretroviral therapy
      (ART) and one-third engages in risky sex. Both non-adherence and risky sex have been
      associated with emotional distress and impulsivity. In this trial, the investigators will
      examine the utility of phone-delivered mindfulness training (MT) for people living with HIV.
      The primary outcomes comprise feasibility and acceptability of phone-delivery; secondary
      outcomes are estimates of efficacy of MT on adherence to ART and safer sexual practices as
      well as on their hypothesized antecedents.

      Fifty participants will be enrolled in this parallel-group randomized clinical trial (RCT).
      Outpatients recruited from an HIV treatment clinic will be randomized (1:1 ratio) to either
      MT or to health coaching intervention; both interventions will be administered during 8
      weekly phone calls. ART adherence (self-reported measure and unannounced phone pill counts),
      sexual behavior (self-reports and biomarkers), mindfulness, depression, stress, and
      impulsivity will be measured at baseline, post-intervention, and 3 months post-intervention.
    

Intervention name(s): Mindfulness Training (MT); Health Coaching (HC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.; The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: HIV; Mindfulness; Adherence behaviors; Stress; Depression
Low-level Laser Therapy to Prevent Oral Mucositis in Head and Neck Patients
Condition: Squamous Cell Carcinoma of Nasopharynx; Squamous Cell Carcinoma of Oropharynx; Squamous Cell Carcinoma of Hypopharynx
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Nasopharyngeal Carcinoma; Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Oral mucositis remains a limiting factor in in head and neck squamous cell carcinomas
      patients treated with chemoradiation leading to pain, dysphagia, and weight loss. Low-level
      laser therapy emerges as a promising, preventive therapy of chemoradiation-induced OM. This
      study was designed to assess the efficacy of Low Level Laser Therapy (LLLT) in reducing the
      incidence and/or severity of oral mucositis.
    

Detailed description: 
      Assuming oral mucositis grade 3 for placebo 0.4 (P0); laser group 0.15 (P1) ; β=0.2; α=0.05,
      sample size was 94 pts. From Jun 2007 to Dec 2010, 47 laser group and 47 placebo patients
      bearer of head and neck squamous cell carcinomas of nasopharynx, oropharynx and hypopharynx
      entered a prospective, randomized, double blind, placebo-controlled, phase III trial.
      chemoradiotherapy consisted of conventional radiotherapy 70.2 Gray (Gy) (1.8Gy/d, 5 times/wk)
      + concurrent cisplatin 100 mg/m2 every 3 weeks. The primary end point was the incidence of
      grade 3-4 oral mucositis. The Low-level laser therapy used daily, was a diode indium
      phosphide, gallium and aluminum (InGaAlP), 660nm-100 milliwatts (mW)-4 Joules (J)/cm²(DMC,
      São Carlos, São Paulo, Brazil). Oral mucositis evaluation was done by WHO and Oral Mucositis
      Assessment Scale (OMAS) scale.
    

Intervention name(s): Low Level Laser Therapy- (DMC, São Paulo, Brazil); Placebo (DMC, São Paulo, Brazil)
Intervention type(s): Device; Device
Intervention description(s): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.; The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
Other intervention name(s): Low Power Laser Therapy; Low Energy Laser Therapy; Low power laser therapy; Low energy laser therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Oral mucositis; Low Level Laser Therapy; Head and neck cancer
Stepping Up: A Trial of Activity Monitoring Devices in Patients Undergoing Autologous Stem Cell Transplant
Condition: Multiple Myeloma; Lymphoma; Transplant-Related Disorder
MeSH terms: Multiple Myeloma
Study type: Interventional

Summary: 
      The purpose the research is to obtain preliminary data about the change in fitness from
      admission to discharge in patients undergoing an Autologous Stem Cell Transplant (ASCT) ,
      assessed by the 6 minute walk test as the primary objective and the SF-36 as the secondary
      objective. All subjects will wear a Fitbit monitor while admitted for the ASCT to record
      their daily activity.
    

Detailed description: 
      This study will enroll 20 subjects with a diagnosis of multiple myeloma or lymphoma (10 with
      each diagnosis) scheduled to undergo ASCT at Cedars-Sinai Medical Center.

      After signing the informed consent form, intake data will be collected on all subjects will
      include age, diagnosis, Karnofsky performance status, and comorbidity index. Subjects will
      complete an SF-36 questionnaire that assesses their functional and emotional status. Each
      subject will undergo a 6-minute walk test (6MWT) while wearing a Fitbit monitor to record the
      number of steps taken. After admission, subjects will be randomly assigned to either the
      control or intervention group. Subjects in the control arm will receive an activity monitor
      but the physician, nurse, and patient will not receive any feedback from the device. Patients
      will be blinded to any data capture from their activity monitor. Participants in the
      intervention arm will receive an activity monitor and they will receive feedback from the
      activity tracker and the in-room TV screen. Study participants in this arm will engage with
      their physicians and nurses around achievement of daily step goals by viewing the in-room TV
      display of daily step counts on rounds. After discharge, all subjects will again complete the
      SF-36 questionnaire and perform a 6MWT at a routine clinic visit, within 30 days of the
      transplant procedure. Descriptive statistics in the form of mean and standard deviation will
      be used to summarize patient physical activity as measured by 6MWT.
    

Intervention name(s): Feedback
Intervention type(s): Behavioral
Intervention description(s): The system uses Sonifi health (TV content and visualizations) and Fitabase (3rd party server to process Fitbit data and export to Sonifi). The system utilizes the patient's TVs to engage the patient and multidisciplinary team in monitoring ambulation status.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Can Robot-Assisted Gait Training In Addition To Conventional Rehabilitation Provide Better Outcomes In Children With Cerebral Palsy?
Condition: Cerebral Palsy; Robotics
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      A total of 26 patients who were diagnosed with CP [diplegic, with Gross Motor Function
      Classification System (GMFCS) level of 2-5] and who regularly participated in a
      rehabilitation programme were included in the study after obtaining approval from their
      parents. The patients were randomly assigned to two groups. Group 1 (n = 13) received
      conventional therapy (65 min, 2 days/week ×8) and group 2 (n = 13) received 25 minutes of
      robot-assisted gait training (RoboGait®) in addition to conventional therapy (40 min, 2
      days/week ×8).
    

Detailed description: 
      Purpose: This study aimed to investigate the effects of robot-assisted training (RAT) on
      motor functions, spasticity status, balance and functionality in children with cerebral palsy
      (CP).

      Method: A total of 26 patients who were diagnosed with CP [diplegic, with Gross Motor
      Function Classification System (GMFCS) level of 2-5] and who regularly participated in a
      rehabilitation programme were included in the study after obtaining approval from their
      parents. The patients were randomly assigned to two groups. Group 1 (n = 13) received
      conventional therapy (65 min, 2 days/week ×8) and group 2 (n = 13) received 25 minutes of
      robot-assisted gait training (RoboGait®) in addition to conventional therapy (40 min, 2
      days/week ×8).

      Outcome measures: GMFCS was used to evaluate motor functions and Modified Ashworth Scale was
      used to evaluate spasticity. Paediatric Berg Balance Scale, Paediatric Functional
      Independence Measure and timed up and go test were used to assess balance and functional
      status. The evaluations were performed at baseline and after 8 weeks of therapy.
    

Intervention name(s): conventional therapy; RoboGait®
Intervention type(s): Other; Other
Intervention description(s): Conventional therapy sessions that were planned by a physiotherapist for the children were conducted by a physiotherapist experienced in paediatrics. The therapy sessions mainly focused on functions such as the regulation of muscle tone, correction of posture, elimination of stiffness, muscle strengthening, balance/coordination training and mobilisation (Figure 2). The sessions were planned to last 40 minutes.; The RoboGait®-assisted gait system was used for the robot-assisted gait training. In addition to conventional therapy, 16 robot-assisted gait training sessions were conducted, each lasting 25 minutes for 2 days a week (400 minutes in total). Gait speed was 1.5 km/h in all sessions. Considering conditions such as joint limitations and spasticity, gait training was performed with patients bearing 45% to 75% of their weight.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral palsy; Robotics; Functional status
The Effects of Muscles Strength on Physical Performance in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Muscle weakness, which is one of the most common symptoms in patients with MS, limits the
      activities of daily life activities of patients by causing balance and gait disturbance.
      Lower extremity muscle strengths of MS patients are reported to be weaker than healthy
      individuals. Broekmans et al. showed that the weakness of the knee flexor and extensor
      muscles in patients with MS caused a decrease in walking distance and they are important
      determinants of walking capacity.

      The effects of the endurance and strength of core muscles, as well as the extremity muscles,
      are important on physical performance. The weakness of the extremities and core muscles in MS
      patients also affects the sit-to-stand performance negatively as well as a decrease in
      walking speed and capacity.

      In this study, it was aimed to investigate the effects of extremity and core muscle strength
      on walking and sitting-up performance of MS patients.
    

Detailed description: 
      Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS)
      and healthy individuals of similar age and sex to patients will be included in the study. The
      strength of the extremity and core muscles, walking capacity, and sit-to-stand performance
      will be evaluated once.

      Investigators will use descriptive statistics and t-tests to compare variables between
      groups. Investigators will examine the correlations between variables using Pearson bivariate
      correlations. The significance level is set at p<0,05
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        MS patients who are ambulatory
      
Keywords: strength; walking; sit-to-stand
DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with
      epigenetic changes.
    

Detailed description: 
      OBJECTIVE: Recognize the DNA methylation status of the malar melasma and perilesional skin,
      and its change after treatment with 50 SPF sunscreen (S), 4% niacinamide (N), or 0.025%
      retinoic acid (RA). METHODS: Fifty-six lesion of 28 female patients without treatment were
      clinically evaluated, as also the expression of DNA methyl transferases 1 and 3 by real
      time-PCR (polymerase chain reaction amplification), immunohistochemistry and
      immunofluorescence. It was initially quantified and after 8 weeks of treatment with S, RA and
      N. RESULTS: Relative expression of DNA methyl transferases were significantly elevated
      compared with unaffected skin in all subjects indicating hypermethylation of DNA.
      Hypermethylation decreased by S (7 vs 3 times relative expression, p<0.05), RA (7 vs 2 times
      relative expression p<0.05), and N (7 vs 1 relative expression p<0.01) correlated with
      clinical improvement, this was also supported by immunohistochemistry and immunofluorescence.
      CONCLUSIONS: The investigators found hypermethylation of DNA in melasma lesions.
      Environmental factors such as sun radiation may induce DNA hypermethylation triggering
      hyperpigmentation trough the activation of pathways regulated by epigenetic modifications.
      Thus, decreasing methylation by sunscreen protection and the genetic transcription
      modification through N and RA, may allow their clinical improvement regardless its
      depigmenting effect.
    

Intervention name(s): Retinoic acid; colorimetry measurement; sunscreen; Niacinamide
Intervention type(s): Drug; Device; Drug; Drug
Intervention description(s): topical administration in melasma lesions; Measurement of erythema and luminosity through a colorimeter; topical administration in melasma lesions; topical administration in melasma lesions
Other intervention name(s): Niacinamide; Sunscreen
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids; Tretinoin; Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Epigenetics, Malar melasma,