bioihbjkbjnl/mcl2 huggingface dataset:
Mindfulness Based Relapse Prevention for Stimulant Users
Condition: Stimulant Dependence
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      The broad, long-term objective of the current research is to improve treatment for stimulant
      use disorders by augmenting traditional relapse prevention therapy with innovative
      meditation-based strategies to promote affect regulation skills. Based on Mindfulness-Based
      Cognitive Therapy for depression (Segal, Teasdale, & Williams, 2002), Marlatt and colleagues
      recently developed a manualized intervention for the treatment of substance using
      populations: Mindfulness Based Relapse Prevention (MBRP). The specific aims of this research
      are 1) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting
      and retaining individuals for a large scale study and to determine the effect size of MBRP
      relative to a health education (ED) control group in stimulant users receiving contingency
      management (CM).
    

Detailed description: 
      Both MBRP and ED participants will be assessed at baseline, treatment-end, and 1 month
      post-treatment. 2) To test the impact of MBRP compared to ED on negative affect, stimulant
      use, and health care outcomes. 3) To evaluate the differential effects of MBRP versus ED on
      HIV-risk behavior of participants, and 4) To examine potential mechanisms of action of MBRP,
      including reductions in stress reactivity and biological indicators of arousal such as blood
      pressure and heart rate. The investigators hypothesize that MBRP will be more efficacious
      than ED in reducing negative affect and stimulant use. Further, the investigators expect that
      MBRP will produce greater reductions in HIV-risk behaviors, stress reactivity, and arousal,
      and these changes will be associated with substance use outcomes. MBRP incorporates specific
      substance-focused cognitive therapy techniques with an additional emphasis on mindfulness
      skills. By providing coping skills to address affect regulation and stress reactivity, two
      important factors in stimulant relapse, MBRP may provide a promising augmenting strategy for
      the treatment of stimulant users.
    

Intervention name(s): Mindfulness Based Relapse Prevention; Health Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Meditation based therapy group incorporating relapse prevention skills training; Psychoeducation group focused on various topics pertaining to physical health
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stimulant; Addiction; Mindfulness; Treatment
Detection of Subclinical Atrial Fibrillation in High Risk Patients Using Implantable Loop Recorder
Condition: Arterial Hypertension; Diabetes Mellitus
MeSH terms: Hypertension; Atrial Fibrillation; Diabetes Mellitus
Study type: Interventional

Summary: 
      Using implantable loop recorder the investigators wish to detect atrial fibrillation in high
      risk patients and compare it to the results using conventional Holter monitoring. The
      hypothesis is that 10-15% of high risk patients have subclinical atrial fibrillation. The
      investigators want to detect those people so they can receive appropriate anticoagulation
      treatment. The patients will get a comprehensive workup including ecg, echocardiography and
      blood tests.
    


Intervention name(s): Conventional Holter monitoring; Implantable loop recorder
Intervention type(s): Other; Device
Intervention description(s): Patients undergo 72h Holter monitoring; Implantation of loop recorder with follow-up by remote monitoring
Other intervention name(s): REVEAL XT
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Assessment of Growth of Infants Fed a New Formula
Condition: Infant Nutrition
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to assess growth (rate of weight gain in grams per day)
      of infants fed an infant formula with a whey isolate enriched with lactoferrin, during the
      first four months of life as compared to infants fed a standard infant formula.
    


Intervention name(s): standard infant formula; Test formula
Intervention type(s): Other; Other
Intervention description(s): Standard infant formula given during the first 9 months of life, as per standard requirement; Test formula enriched in lactoferrin given during the first 9 months of life, as per standard requirement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: infant formula; growth; weight
Nasal Poly-ICLC (Hiltonol®) in Healthy COVID-19 Vaccinated Adults
Condition: COVID - 19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized (4:1) Phase 1 b safety trial in adults who have completed their full
      COVID-19 vaccination schedule at least 30 days prior to study entry.
    

Detailed description: 
      An initial cohort of 13 participants will receive 2 cycles of drug or placebo per the
      schedule below under carefully monitored conditions, including examinations to observe and
      document administration site reaction following consecutive administration cycles of the
      drug. 10 participants will receive drug and 3 will receive placebo. The safety stopping rule
      is to implement an enrollment pause if 2 dose limiting toxicity (DLT, see section 5.1) out of
      the first six or 3 DLTs out of the first 10 participants receiving drug are observed in
      either cycle 1 or cycle 2. The independent DSMB will conduct a review of the safety data to
      determine the relatedness of the DLTs to the drug exposure and provide a recommendation to
      continue. Thus, if safety events are determined to be not (or unlikely) related to drug
      exposure the trial may resume. The independent DSMB will review safety and tolerance data
      before the study can continue.

      If at most 2 DLTs out of the 10 participants receiving drug are observed, then a Phase Ib
      expansion cohort will open. The expansion cohort will receive 3 cycles of therapy. A total of
      30 participants will be accrued and randomized 4:1 to receive drug (N=24) or placebo (N=6).
      There will be extensive assessment of toxicity and an early stopping rule to implement an
      enrollment pause and independent DSMB review of safety data to determine relatedness to drug
      exposure for recommendation of trial continuation, will be employed as above. Safety and
      tolerability will be the primary endpoint but secondary endpoints include changes in
      immunological parameters.
    

Intervention name(s): Poly-ICLC (Hiltonol®) or Placebo; Poly-ICLC (Hiltonol®) or Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The safety cohort (Cohort A) consists of 13 patients who will be randomized to receive 2 cycles of the study drug (N10) or 2 placebo cycles (N3).; The expansion cohort will receive 3 cycles of therapy. A total of 30 patients will be accrued and randomized 4:1 to receive drug (N=24) or placebo (N=6).
Other intervention name(s): Safety; Expansion
Intervention MeSH terms: Poly I-C; Carboxymethylcellulose Sodium; Poly ICLC
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Intranasal Poly-ICLC (Hiltonol®) or Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: SARS CoV-2; COVID; Prevention; Poly-ICLC; Viral Infection
Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Sealing Root Perforations
Condition: Root Perforation at the Bifurcation Area
Study type: Interventional

Summary: 
      This is a study aimed to compare two materials: (1) Biodentine and (2) MTA. These two
      materials are going to be tested in sealing accidental root perforations at the bifurcation
      areas. The study is going to be conducted as a randomized controlled trial.
    


Intervention name(s): Biodentine; MTA
Intervention type(s): Drug; Drug
Intervention description(s): Biodentine is going to be used as the sealing agent for the perforation.; MTA is going to be used as the sealing agent for the perforation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Reducing Attention Deficit Hyperactivity Disorder in Kindergarten and Pre-Kindergarten Children
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study will determine the effectiveness of an intervention for preventing at-risk
      kindergarten and pre-kindergarten children from developing attention deficit hyperactivity
      disorder.
    

Detailed description: 
      Attention deficit hyperactivity disorder (ADHD) is characterized by inattention,
      impulsiveness, and hyperactivity. ADHD is not commonly diagnosed until a child has entered
      formal schooling and shown academic and behavioral adjustment difficulties, but developmental
      research suggests that risk factors for developing ADHD are evident earlier. A significant
      number of children start school with high levels of disorganized and inattentive behaviors,
      which are symptoms of emerging ADHD. This study will test an intervention aimed at preventing
      the development of ADHD by identifying those at risk for developing ADHD in kindergarten and
      pre-kindergarten and teaching them self-regulation skills through socialization. These skills
      have been associated with school success, and they may reduce the likelihood of children
      developing ADHD.

      Participation in this study will last for 4 months, with a follow-up assessment after 1 year.
      To enroll, child participants will undergo a screening process that will include assessments
      by their teachers and parents. Eligible child participants will also be assessed by
      researchers in a classroom setting. They will then be randomly assigned to receive either a
      play-based intervention, called the Friendship Group, or an individual pre-academic tutoring
      intervention. Both groups will meet at school. The Friendship Group, which will focus on
      strengthening attention and self-regulation through social skills, will involve 30 sessions
      twice a week for 15 weeks. The tutoring intervention, which will focus on strengthening
      academic skills, will involve one or two sessions a week for 4 months. Participants will be
      assessed at three time points: pre-intervention, post-intervention, and after 1 year.
      Assessments will include teacher ratings and direct testing of child attention, language, and
      pre-academic skills.
    

Intervention name(s): Friendship Group; Academic tutoring
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Social skills training for 30 sessions, held twice per week over 4 to 5 months; Tutoring to support emergent literacy skills, held 1 to 2 times per week over 4 months
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison of social skill training intervention with active attention control group (academic tutoring)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ADHD; Psychosocial Intervention; Social Skills Training
Feasibility Trial of ValenTx Endo Bypass System
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of the study is to provide initial clinical data to support the feasibility of
      use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in
      morbidly obese patients.
    

Detailed description: 
      This is a single center open label feasibility study to evaluate the safety, efficacy and
      performance of the ValenTx Endo Bypass system.
    

Intervention name(s): ValenTx Endo Bypass System
Intervention type(s): Device
Intervention description(s): Patient is implanted with device and followed for 12 weeks
Other intervention name(s): ValenTx; Endo Bypass System; EBS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity
Correction for Kyphotic Posture for Improving Balance in Cerebral Palsy
Condition: Kyphosis
MeSH terms: Kyphosis; Cerebral Palsy
Study type: Interventional

Summary: 
      Children with spastic diplegia are at an increased risk of spinal deformities. The most
      common types of these spinal deformities are scoliosis and kyphosis. Thoracic hyper-kyphosis
      may adversely affect balance in children with cerebral palsy . The treatment approaches for
      hyper-kyphosis involved both conservative and surgical treatments. The Conservative approach
      includes corrective exercises, positioning, and spinal braces. This study aimed to evaluate
      the effect of conservative orthotic management for kyphotic posture on balance control, and
      fall risk in cerebral palsied children of spastic diplegia.
    

Detailed description: 
      Kyphosis is a posterior convexity of the spine. Children with cerebral palsy show a higher
      probability of progression of the kyphotic curve. If it is not adequately treated, it becomes
      fixed where it requires surgical management. Children with cerebral palsy have more
      probability to balance impairment and falls than normal children and the consequences of that
      fall are great. The current studies do not properly examine the effectiveness of conservative
      orthoses on the therapeutic management of kyphosis in children with cerebral palsy. Also,
      there is a shortage of studies that evaluate how correction of the thoracic kyphosis
      influences the balance performance and fall risk in children with cerebral palsy. TheraTogs
      orthosis which consists of an orthotic undergarment and external strapping system has been
      designed to provide a soft and passive body compression to maintain a typical body postural
      alignment and to improve posture control. Therefore, the objective of this study was to
      investigate how the correction of dorsal hyper-kyphotic posture by the TheraTogs orthotic
      system could influence balance control, and fall risk in cerebral palsied children of spastic
      diplegia.
    

Intervention name(s): Conventional Physical Therapy Protocol; TheraTog orthotic undergarment with its strapping system
Intervention type(s): Other; Other
Intervention description(s): The conventional physical therapy protocol was prescribed to correct the kyphotic posture of the dorsal spine, and improve postural balance stability during standing and walking. The conventional therapeutic protocol for every child was three sessions per week for 12 successive weeks. Every treatment session was applied for two hours with a few minutes rest in between them.; TheraTog orthotic undergarment with its strapping system was conducted for 8 hours daily for 12 successive weeks. It is made to be fitted directly on the skin as undergarments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kyphosis; Balance; Fall Risk
A Trial Study of SGN-00101 in Treating Pediatric Patients With Recurrent Respiratory Papillomatosis
Condition: Papilloma; Recurrent Respiratory Papillomatosis
MeSH terms: Respiratory Tract Infections; Papillomavirus Infections; Papilloma; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Recurrent Respiratory Papillomatosis (RRP) causes wart-like lesions along the throat area and
      can obstruct the airway or become malignant. The cause has been related to specific types of
      Human Papillomavirus (HPV). The purpose of the study is to assess the clinical effectiveness
      of a trial drug, SGN-00101, in children with RRP and also assess its safety.
    


Intervention name(s): SGN-00101
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HPV; Papilloma
Effectiveness of Melatonin for Sleep Disturbances in Children With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dyssomnias; Parasomnias; Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Sleep disturbance is a common complaint among patients with atopic dermatitis(AD). Melatonin
      may aid sleep and also has anti-inflammatory properties, and has been suggested in managing
      sleep disturbance in AD patients. However, there has been no large randomized controlled
      trials. Hence the objective of this double-blind randomized controlled study is to determine
      whether supplementing melatonin is effective in improving sleep problems in children with AD.
    


Intervention name(s): Melatonin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): melatonin 3 mg tab 1 tab po hs for 4 weeks; starch pill
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atopic dermatitis; eczema
A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.
Condition: Meningococcal Vaccine; rLP2086; Repevax; N Meningitidis Serogroup B; Meningitis
MeSH terms: Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to look at a new vaccine that might prevent meningococcal disease, and to look
      at the safety of the new vaccine as well as how it is tolerated when given together with
      Repevax. The study will be done in healthy adolescents.
    


Intervention name(s): rLP2086; Repevax; Saline; Repevax
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL dose, given at 0, 2 and 6 months.; 0.5 mL dose, given at 0 months.; 0.5 mL dose, given at 0, 2 and 6 months.; 0.5 mL dose, given at 0 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Healthy adolescents
Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis
Condition: Acute Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      This is a randomized, double-blind, controlled trial in the Pediatric Emergency Department.
      The primary objective is to determine whether nebulized 3% hypertonic saline is more
      effective than nebulized 0.9% saline in the treatment of bronchiolitis in the emergency
      department.
    


Intervention name(s): 3% Hypertonic Saline; 0.9 % normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments may be started immediately upon discretion of the treating physician. If the patient is discharged home study PI and/or research assistant will call the parents 7 days from the ED visit to check the number of visits to their primary doctor and/or EDs due to same illness.; Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments may be started immediately upon discretion of the treating physician. If the patient is discharged home study PI and/or research assistant will call the parents 7 days from the ED visit to check the number of visits to their primary doctor and/or EDs due to same illness.
Other intervention name(s): Experimental; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bronchiolitis; Hypertonic saline; Emergency Department
Comparative Study of Cycloplegic Refraction and Subjective Refraction With Fogging in School Age Children
Condition: Myopia; Refractive Error
MeSH terms: Refractive Errors
Study type: Observational

Summary: 
      A thorough ophthalmic examination of a child must include a refraction and this is often done
      with cycloplegia. In our study, we aim to determine at which age group a non-cycloplegic
      refraction technique closely correlates with a cycloplegic refraction and hence, would
      obviate the need for cycloplegic refraction in our routine clinical practice.
    

Detailed description: 
      The accommodative response in young phakic patients has been known to result in
      over-estimation of myopia and subsequently inappropriate prescriptions. Therefore, the
      rationale for cycloplegia is to inhibit the accommodative response in order to obtain a true
      measurement of the refractive error.

      Different cycloplegic agents have been in common use for the last five decades.
      Cyclopentolate is widely used and is commercially available in concentrations of 0.5% and 1%.
      Tropicamide is another widely used cycloplegic agent and is available in 0.5% and 1%
      concentrations.

      The advantages of a non-cycloplegic technique would be firstly, the avoidance of any possible
      harmful effects from the cycloplegic agents used. Secondly, it would vastly reduce waiting
      times for parents and children and allow for a much more efficient clinical service. Finally,
      there may be a significant cost-saving feature involved if these cycloplegic agents are no
      longer required.

      This will be a prospective clinical audit/survey involving children between the ages of 4
      years and 13 years who attend the paediatric ophthalmology clinics in KK Women's and
      Children's Hospital as well as the Singapore National Eye Centre.

      All eligible children will have had a cycloplegic refraction and a non-cycloplegic refraction
      with fogging. A survey of children between the ages of 4 and 13 years who have had refraction
      with both these techniques will be undertaken and the difference in spherical error between
      the 2 techniques will be recorded for each child. We aim to accumulate 15 children from each
      age group.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 4-13 years old.
PVI for Prediction of Spinal Induced Hypotension
Condition: Spinal Induced Hypotension
MeSH terms: Hypotension
Study type: Observational

Summary: 
      The hypothesis is that plethysmography variability index can predict the occurrence of
      hypotension after spinal anesthesia for cesarean delivery
    


Intervention name(s): PVI
Intervention type(s): Other
Intervention description(s): Measurement of PVI (plethysmography variability index)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing cesarean delivery under spinal anesthesia