bioihbjkbjnl/mcl2 huggingface dataset:
Schema, Emotion, and Behavior Therapy for 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 in 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 (45 minutes with the child and 45 minutes with the family/parents), 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 administer a standard community treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intervention; Autism; Treatment sensitivity; School aged; Cognitive behavioral therapy
Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Powered exoskeletons have emerged recently, promising to offer walking to individuals with
      severe spinal cord injury who are unable to walk. We will use the ReWalk exoskeleton to train
      walking in individuals with chronic, severe spinal cord injury (SCI). We will determine the
      characteristics of individuals who most benefit from such training, and identify the
      neuroplasticity induced by the training. We will further determine the feasibility of the
      ReWalk for home and community ambulation.
    

Detailed description: 
      A prospective, pilot, cohort study design will recruit participants to train intensively for
      a 3 month period. The training sessions will be documented in detail, including number of
      steps taken, speed of walking, distance of walking. Once walking speed has plateaued, we will
      evaluate the feasibility of using the device in a home-like environment and in the community.

      At the end of this study, we will have a good idea of the capability of the ReWalk to assist
      walking in those with severe spinal cord injury. We will better understand which individuals
      are most likely to benefit from the ReWalk. We will know how training in the ReWalk changes
      the neural connections between the brain and the spinal cord so that we can better guide the
      training protocol. Finally, we will identify limitations of the ReWalk for home and community
      use, so that exoskeletons can be improved in the future to maximize their benefit to people
      with spinal cord injury.
    

Intervention name(s): ReWalk
Intervention type(s): Device
Intervention description(s): Intensive training with the ReWalk to negotiate smooth ground, rough terrain indoors and outdoors, ascending and descending slopes and steps, in a home setting and in the community.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: walking; locomotion; rehabilitation
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions
Condition: Breast Diseases
MeSH terms: Breast Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multicenter, Open-label, Parallel, Phase 2 Clinical Trial in 6 weeks for
      screening, once Investigational product injection, Follow up visit.
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy and safety of LuminoMark inj. (Conc.
      for fluorescence) localization in patients with nonpalpable breast lesions.
    

Intervention name(s): LuminoMark inj. 0.1mL; LuminoMark inj. 0.2mL; Charcotrace Inj.
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Injection LuminoMark inj. (Conc. for fluorescence) 0.1mL once in this study.; Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.; Injection Charcotrace Inj. about 0.3~1mL once in this study.
Other intervention name(s): LuminoMark inj.(Conc. for fluorescence) 0.1mL; LuminoMark inj.(Conc. for fluorescence) 0.2mL; Charcotrace Injection(Activated Charcoal 40mg/1ml)
Intervention MeSH terms: Charcoal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nonpalpable Breast Lesions
Impact of Periodontal Bacteria on the Effectiveness of Periodontal Therapy
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      In light of the controversy that are already approved but that however still exists regarding
      the efficacy and influence of the protocols for the management of periodontitis, the aim of
      this study was to evaluate, at 6 months follow-up, the post-treatment clinical parameters and
      immunological and gingival microbial profiles in patients with periodontitis, treated by
      either SRP in addition to full mouth periodontal debridement.
    

Detailed description: 
      This trial was conducted in accordance with the World Medical Association's Declaration of
      Helsinki of 1975, and reviewed in 2008. Patients were enrolled from January 2020 to December
      2022. The local ethical committee of approved the study protocol (125/PO) and each patient
      was carefully informed about the possible inherent risks of the study and provided their
      informed written consent 88 patients, aged 27 to 65 (mean age 57) were assessed for
      eligibility. In all subjects, subgingival plaque will acquired from 4 separate proximal
      periodontal sites.
    

Intervention name(s): Scaling and root planing
Intervention type(s): Procedure
Intervention description(s): Full mouth or quadrant SRP
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients undergo non-surgical quadrant scaling and root planing
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Periodontitis
Efficacy of Preoperative Autologous Blood Donation and Tranexamic Acid in Revision Total Hip Arthroplasty
Condition: Revision Total Hip Arthroplasty (RTHA)
Study type: Interventional
Phase: Phase 4

Summary: 
      Sixty patients aged between 60 and 75 years old of both sex of ASA physical status I and II
      were included in this randomized study who were divided into the study group of 30 patients
      who had been transfused autologous blood and the control group of 30 patients who had been
      transfused only allogeneic blood. Parenteral iron preparation was given to all patients of
      the study group after each donation. Intraoperatively all patients of the study group
      received 2 grams of intravenous tranexamic acid. This study was conducted through the
      laboratory analysis of the hemoglobin and the hematocrit values during blood donation and for
      both groups in the pre-operative and the post-operative period and the assessment of the
      amount of transfused blood units in both groups.
    

Detailed description: 
      A total of 60 patients were included in this randomized study that were divided into a study
      group of 30 patients, who had been transfused autologous blood and a control group of 30
      patients who had been transfused only allogeneic blood. Parenteral iron preparation was given
      to all patients of the study group after each donation. Intraoperatively all patients of the
      study group received 2 g of intravenous TXA.

      This study was conducted through laboratory analysis of hemoglobin and hematocrit values
      during blood donation and for both groups in the preoperative and the postoperative period
      and the assessment of the amount of transfused blood units in both groups.
    

Intervention name(s): transfused pre-operatively donated autologous blood.; intravenous tranexamic acid (TXA) infusion; transfused only allogeneic blood.
Intervention type(s): Other; Drug; Other
Intervention description(s): Pre-operative autologous donation for minimising perioperative allogeneic blood transfusion; Intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopedic surgery.
Other intervention name(s): Pre-operative autologous donation; Kapron®
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Autologous blood donation, allogeneic blood transfusion
Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      Double-blind phase: The objective of the study was to evaluate the efficacy and safety of
      Bilastine 20 mg, compared to Cetirizine and placebo for the treatment of perennial allergic
      rhinitis.

      Open-label Phase: The objective of this extension was to evaluate the long-term safety of
      Bilastine 20 mg during one year in the symptomatic treatment of perennial allergic rhinitis
    

Detailed description: 
      Double-blind, randomized, placebo-controlled, parallel-group, international, multicenter
      study followed by an open label extension. Duration of the double-blind period was 28 days
      and the duration of the open label period was 12 additional months.

      The primary efficacy variable of the double-blind period was the area under curve (AUC) of
      total symptoms scale (TSS) from baseline (defined as the mean of 6 last points of the
      patients' diary before randomization) to D28 visit according to the patient's assessment on
      reflective symptoms. 650 patients were included in the study and 614 completed the
      double-blind phase. Out of the 614 patients who completed the double blind period, a total of
      513 patients started the open label period with Bilastine 20 mg (83.6%)
    

Intervention name(s): Bilastine; Cetirizine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg encapsulated tablets; 10 mg encapsulated tablets; encapsulated tablets
Other intervention name(s): Zyrtec
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic Rhinoconjunctivitis; Persistent allergic rhinitis; Hay fever; Allergic Rhinitis; Sneezing; Nasal congestion; Rhinorrhea; Nasal itching; Ocular itching; Ocular tearing; Antihistamine
Air Pollution and Cardiometabolic Study
Condition: Cardiovascular Outcomes
Study type: Observational

Summary: 
      The study mainly focuse on examining the subjects living in traffic polluted area and
      assessing the popuation health risk using disease and risk assessment models.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Living in PU community neighborhood,Beijing, China
      
Biospecimen description: 
      Whole blood and urine
Comparison of Effectiveness of Pre-cooling With Ethyl Chloride Versus Honey
Condition: Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      Comparing Pre-cooling with Ethyl Chloride versus Honey in Alleviating Intra-oral injection
      pain in Adult patients
    


Intervention name(s): Ethyl chloride; Honey
Intervention type(s): Drug; Other
Intervention description(s): Ethyl chloride is an agent that is widely used in dental practice as the standard modality for pulp vitality tests .; Honey is a natural dietary product
Intervention MeSH terms: Ethyl Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Telementoring for Identifying the Appendix Using Telesonography
Condition: Appendix, Ultrasonography
Study type: Interventional

Summary: 
      The investigators investigated the feasibility of the clinical application of
      novice-practitioner-performed/offsite-mentor-guided ultrasonography for identifying the
      appendix.
    

Detailed description: 
      A randomized cross-over study was conducted using a telesonography system that can transmit
      the ultrasound images displayed on the ultrasound monitor(ultrasound sequence video) and
      images showing the practitioner's operations(background video) to a smartphone without any
      interruption in motion over a Long Term Evolution (LTE) network. Thirty novice practitioners
      were randomly assigned to two groups. The subjects in group A (n=15) performed
      ultrasonography for the identification of the appendix under mentoring by an onsite expert,
      whereas those in group B (n=15) performed the same procedure under mentoring by an offsite
      expert.

      Each subject performed the procedure on three simulated patients. After a four-week interval,
      they performed the procedure again under the other type of mentoring. A total of 90
      ultrasound examinations were performed in each scenario. The primary outcomes were the
      success rate for identifying the appendix and the time required to identify the appendix.
    

Intervention name(s): Smartphone-based Telesonography
Intervention type(s): Device
Intervention description(s): The 30 participating examiners were randomly divided into two groups. In phase one, group A performed ultrasonography under onsite mentoring and group B performed the same procedure under remote mentoring. Each examiner was randomly assigned one expert and three SPs for phase one. Four weeks later, they were partnered with the same expert and SPs to whom they had been assigned in phase one and performed the procedure under the other type of mentoring (phase two). The examination order of the SPs was randomly assigned by choosing a number between one and six (1: A-B-C, 2: A-C-B, 3: B-A-C, 4: B-C-A, 5: C-A-B, 6: C-B-A) in each phase.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Telesonography, Appendix
Extended Follow-Up After Islet Transplantation in T1D
Condition: Type 1 Diabetes (T1D); Islet Transplantation
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of this study is to provide patients who have received at least one islet
      transplant as a previous participant in a Clinical Islet Transplantation Consortium (CIT)
      clinical trial with maintenance immunosuppressive medications and to collect information
      about the safety of the medications and islet function.
    

Detailed description: 
      After islet-cell transplantation in the CIT studies*, each subject receives maintenance
      immunosuppressive medications.

      The purpose of this protocol is to collect additional follow-up for safety and efficacy from
      CIT subjects with graft function after their completion in their CIT parent study. It is
      expected that most subjects will retain measurable islet function and, in the islet-alone
      studies, continue to receive immunosuppressive medications at the time of completing their
      CIT parent study.

      *CIT parent studies: CIT02 (NCT00464555), CIT03 (NCT00434850), CIT04 (NCT00468403), CIT05
      (NCT00468442), CIT06 (NCT00468117), and CIT07 (NCT00434811)
    

Intervention name(s): Maintenance Immunosuppressive Treatment
Intervention type(s): Drug
Intervention description(s): All immunosuppressive and immunomodulatory therapies are used presently to prevent rejection of transplanted islet cells. The agents listed are those used in the parent trials and continued in this trial, CIT08.
Other intervention name(s): tacrolimus; Prograf®; FK506; sirolimus; rapamycin; Rapamune®; cyclosporine; Neoral®; mycophenolate mofetil (MMF); CellCept®; mycophenolic sodium; Myfortic®
Intervention MeSH terms: Cyclosporine; Sirolimus; Mycophenolic Acid; Tacrolimus; Cyclosporins; Immunosuppressive Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Cohort from Clinical Islet Transplantation (CIT) parent studies (refer to inclusion
        criteria) who continue:

          -  to have islet graft function and

          -  are on prescribed immunosuppression medications to prevent rejection of their
             transplant.
      
Biospecimen description: 
      Participants are given the option to provide consent for:

        1. the collection and storage of blood samples for future research studies

        2. the collection and storage of blood samples for future genetic (i.e., DNA) testing.
    
Keywords: islet allograft function; c-peptide production; maintenance immunosuppressive medications
Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Cocaine dependence is a major public health problem; an effective primary treatment for
      cocaine dependent individuals has yet to be found. The purpose of this study is to examine
      the effects of d-amphetamine and modafinil, when given alone and in combination, in treating
      cocaine dependent individuals.
    

Detailed description: 
      Cocaine is a strong central nervous system stimulant that is widely abused throughout the
      United Sates. Due to its widespread use, it is important to develop an effective treatment
      for cocaine dependence. Modafinil is a glutamate-enhancing agent. D-amphetamine is a central
      nervous system stimulant that is approved to treat individuals with narcolepsy and attention
      deficit disorder. Both modafinil and d-amphetamine may be effective treatments for cocaine
      dependence. The purpose of this study is to examine the effectiveness of modafinil and
      d-amphetamine, alone and in combination, in treating cocaine dependent individuals.

      This study will last 16 weeks. Participants will be randomly assigned to one of four groups:
      1) 60 mg dose of d-amphetamine; 2) 400 mg dose of modafinil; 3) 30 mg dose of d-amphetamine
      combined with 200 mg dose of modafinil; and 4) placebo. All participants will receive 200 mg
      of modafinil over 4 days.
    

Intervention name(s): D-Amphetamine 30mg; D-Amphetamine 60mg; Modafinil 200mg; Modafinil 400mg; Therapy; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Behavioral; Drug
Intervention description(s): Manual-based, cognitive-behavioral therapy was provided for 1 hour each week by master's-level therapists. The cognitive-behavioral therapy emphasized relapse prevention and coping skills.
Intervention MeSH terms: Modafinil; Amphetamine; Dextroamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Brief Alcohol Intervention for School-to-Work Transitions
Condition: Binge Drinking
MeSH terms: Binge Drinking
Study type: Interventional

Summary: 
      This is a 2-year research project to test the efficacy of brief motivational intervention for
      reducing heavy alcohol use in young adults transitioning out of high school. Participation
      occurs within 3 months prior to graduation or within 1 year following graduation or dropout
      from high school. Heavy drinkers ages 17-20 will be randomly assigned to receive one session
      of BMI or one session of relaxation training. All participants complete identical assessments
      at baseline and immediately post-intervention (during session 1). Participants also complete
      in-person 6-week and 3-month follow up assessments to evaluate intervention effects. Study
      aims involve: a) testing the comparative efficacy of BMI; b) identifying moderators
      (person-level predictors) of intervention response; and c) identifying mediators (mechanisms)
      of intervention effects, that is, how BMI exerts its effect on outcomes.
    


Intervention name(s): Brief Motivational Counseling; Relaxation training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): One hour session of brief motivational counseling focused on reduction of heavy drinking.; One hour training in relaxation techniques
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment