bioihbjkbjnl/mcl2 huggingface dataset:
Bortezomib and Dexamethasone Followed by ASCT Compared With ASCT Alone in Treating Patients With AL Amyloidosis
Condition: Amyloidosis
MeSH terms: Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized phase III trial is studying the side effects and how well giving induction
      therapy with bortezomib and dexamethasone followed by autologous stem cell transplantation
      (ASCT) compared with ASCT alone in treating patients with newly diagnosed renal AL
      amyloidosis. In this prospective, randomized control study, patients with newly diagnosed AL
      amyloidosis who met the criteria for ASCT were randomized to receive 2 cycles of BD as
      induction therapy followed by ASCT (BD+ASCT) (arm 1) or to receive ASCT alone as an initial
      treatment (arm 2). Hematologic and organ responses were evaluated every 3 months after ASCT.
      All the patients should be followed up for 12 months.
    

Detailed description: 
      Arm 1: The BD regimen included bortezomib 1.3 mg/m2 i.v. and dexamethasone 40 mg p.o. on days
      1, 4, 8 and 11 of the 21 day cycle. This process was repeated for 2 cycles. After two cycles
      of BD therapy, the collection of peripheral blood stem cells (PBSC) should be completed
      within 4 weeks. Recommended dose of drug is as follows: granulocyte colony-stimulating factor
      (G-CSF) 5-10ug/kg on days 1-5 will be given, then peripheral blood stem cells will be
      collected on days 5-6 for 2×10^6 CD34+ cells /kg. Patients will receive ASCT therapy in 8
      weeks after collection of PBSC (Recorded as day 0), while melphalan (day -2) with a dose of
      140 or 200 mg/m2 (choosing a dose according to the degree of risk for patients). Melphalan
      will be administered by central venous catheter.

      Arm 2: the patients who assigned to arm 2 will receive ASCT alone as an initial treatment.
      The process of ASCT is as same as arm 1.
    

Intervention name(s): Bortezomib; dexamethasone; filgrastim; autologous hematopoietic stem cell transplantation (ASCT); Melphalan
Intervention type(s): Drug; Drug; Biological; Procedure; Drug
Intervention description(s): Given orally; Given subcutaneous; Given on day 0
Other intervention name(s): Velcade
Intervention MeSH terms: Dexamethasone; Bortezomib; Melphalan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AL amyloidosis; bortezomib; autologous stem cell transplantation
Group-Based Online Virtual Reality Gaming to Improve Mental Health Among Children With Physical Disabilities
Condition: Disability Physical
Study type: Interventional
Phase: Phase 1

Summary: 
      COVID-19 has had a negative impact on the mental health of many children with physical
      disabilities. This project aims to test the potential effects of an online multiplayer
      virtual reality group-based, active video game program on social isolation and depression and
      will include a total of 12 children with physical disabilities.
    

Detailed description: 
      This pilot feasibility study will investigate the potential effects of a revised multiplayer
      virtual reality exergaming program on depression, socialization, and loneliness among
      children with physical disabilities. This proposed study will use both quantitative and
      qualitative research methods, to gain a deep understanding of program benefits and
      implementation procedures that can be refined for a large clinical trial. The active video
      game program will last 1-month and include 2 supervised 1-hour sessions per week of
      group-based gaming. Game sessions will be supervised by 2 research staff who will act as
      gaming and mindfulness coaches. Outcomes will be measured by self-report questionnaires
      before and after the program. The program will be completed in two waves (6 people per wave).
      After the program, participants will undergo a one-on-one semi-structured interview, where
      they can describe their perceptions of the program.
    

Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): Participants will utilize low-cost, consumer available head-mounted displays to meet with peers and coaches online. The program will last 4 weeks and include 2 x 1-hour sessions per week of supervised peer-to-peer gaming. The coaches will utilize behavioral change and mindfulness techniques to promote autonomy, competence, and relatedness through a respectful, cohesive, and positive atmosphere. These strategies will be framed by the Self-Determination Theory and learned from the National Center on Health, Physical Activity, and Disability (NCHPAD) mindfulness coaching workshops. Some of the mindfulness-based strategies will include guided breathing focused exercises, body scanning, meditation, and acceptance of social anxiety and shyness
Intervention model: Single Group Assignment
Intervention model description: Single group pre-to-post design trial that will last 1-year and include 2 waves (n=6 per wave)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: virtual reality
Optic Nerve Sheath Diameter in Retrobulbar Ultrasound as a Surrogate Measure for Intracranial Pressure Before and After Non-invasive Strategies
Condition: Intracranial Hypertension; Optic Nerve Sheath Diameter
MeSH terms: Intracranial Hypertension
Study type: Observational

Summary: 
      Measurement of the diameter of the sheath of the optic nerve in patients hospitalized in
      intensive care, with increased intracranial pressure (> 20mmHg) as a substitute measure for
      diagnosis and follow-up before and after different non-invasive strategies.

      Three groups were created in which, through strategies already proven and non-invasive
      (mannitol, hypertonic solution 7.5% NaCl, reverse trendelenburg) to decrease the intracranial
      pressure, the optic nerve diameter measurement was performed and simultaneously the
      investigators monitored intracranial pressure through an intraventricular catheter
      continuously to determine if both correspond
    


Intervention name(s): optical nerve sheet diameter
Intervention type(s): Diagnostic Test
Intervention description(s): The ONSD in each eye was measured vertically and horizontally 3 mm behind the optic disc, with the two values averaged. No pressure was applied to the orbit. At each time point, measurements were taken within 5 min. The measurements were made before (T1) and after some of the strategies according to group 30 min (T2), 60 min (T3), and 90 min (T4).
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients hospitalized in the intensive care unit of the Dr. Migel Pérez Carreño hospital
        with increased intracranial pressure of traumatic or non-traumatic etiology.
Immunogenicity and Safety Trial of Adjuvanted and Non-adjuvanted Trivalent Influenza Vaccine in Tropical Africa
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will provide the Senegal Ministry of Health with data on the safety and
      immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose
      seasonal non-adjuvanted trivalent inactivated influenza vaccine (TIV) in children. This data
      will inform future policy considerations for influenza vaccine. The study is not powered to
      detect significant differences between vaccines or groups, and no hypotheses are to be
      tested; therefore, immunogenicity and safety objectives are to be analyzed descriptively.
    

Detailed description: 
      The is a phase 2b, single-center, randomized, observer-blind, parallel group,
      placebo-controlled trial of the immunogenicity and safety of adjTIV and seasonal TIV among
      healthy children aged 6 months through 71 months in the town of Niakhar, Senegal. A total of
      300 healthy children will be randomized in a 2:2:1 ratio of adjTIV to TIV to placebo. Each
      child will receive two doses of one of the three study vaccines, with each dose given 28 days
      apart. Each child will be followed closely for safety after each dose for the period from one
      month post-dose two to 3 months post-dose two. For determination of immune response to
      vaccination or background influenza infection, 3 mL of blood will be obtained at three time
      points: pre-vaccination, 28 days post-dose one (prior to receipt of dose two), and at 28 days
      post-dose two. Serum anti-influenza antibodies produced against virus strains contained in
      the vaccine will be detected using hemagglutination inhibition assay.
    

Intervention name(s): Adjuvanted seasonal trivalent inactivated influenza vaccine; Seasonal trivalent inactivated influenza vaccine; Saline (bacteriostatic 0.9% sodium chloride for injection)
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): Fluad; VaxiGrip
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza; influenza vaccine; immunogenicity; Africa; Senegal
Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.
Condition: Smokers
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine the efficacy of high nicotine-specific antibody titers in
      smoking cessation.
    


Intervention name(s): NIC002; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smokers; smoking cessation; vaccine; antibodies; anti-nicotine
The BurnAlong Pilot Study for Adolescent and Young Adult Cancer Survivors
Condition: Cancer; Cancer Metastatic; Neoplasms; Breast Cancer; Lung Cancer; Thyroid Cancer; Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Lymphoma; Leukemia; Sarcoma; Skin Cancer; Bone Cancer; Gynecologic Cancer; Pancreas Cancer; Multiple Myeloma; Colorectal Cancer; Gastrointestinal Cancer; Prostate Cancer; Glioblastoma; Brain Cancer; Head and Neck Cancer
MeSH terms: Lymphoma; Multiple Myeloma; Glioblastoma; Gastrointestinal Neoplasms; Pancreatic Neoplasms; Lymphoma, Non-Hodgkin; Brain Neoplasms; Bone Neoplasms
Study type: Interventional

Summary: 
      The purpose of this prospective, interventional, single-arm pilot study is to evaluate
      whether virtually delivered group-based physical activity is feasible for adolescent and
      young adult (AYA) cancer survivors. AYAs who were diagnosed with cancer and have completed
      cancer treatment will be recruited for this study. This study will enroll 20 participants in
      total and will last approximately 3 months.
    

Detailed description: 
      This is a single-arm, prospective, interventional pilot study.

      Adolescent and young adult (AYA) survivors of cancer ages 18-39 (n=20) will engage in three
      months of virtually group physical activity (PA) delivered via BurnAlong, a wellness platform
      and online app.

      Participants will be asked to engage in a BurnAlong workout session with a partner
      (friend/spouse/child/fellow study participant) a minimum of three times a week for 3 months.

      Participants will also meet monthly with an exercise physiologist for a customized exercise
      session. Participants are allowed to engage in additional PA and non-PA sessions on BurnAlong
      as desired.

      Participants will also be asked to engage in a private social network discussions around key
      topics of interest for AYA communities with a focus on post-traumatic growth and positive
      psychology with a minimum of 2 post engagements a week for 3 months.

      Participants will complete surveys and physical assessments at baseline and at end of study.

      Participants also participate in a 1 hr qualitative exit interview about their well-being,
      participation experiences, and experience with using the BurnAlong platform.
    

Intervention name(s): Virtual group based physical activity (BurnAlong) and Social Media Discussion Board
Intervention type(s): Behavioral
Intervention description(s): Participants will engage in two to three virtual physical activity sessions a week through the BurnAlong app for three months with a chosen partner and participate at least twice a week in the research team-mediated social media message board. Additionally, participants will be asked to participate in one live physical activity session per month with an exercise physiologist.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: virtual exercise; adolescent and young adult cancer; BurnAlong App; Well-being; cancer; physical activity
Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To evaluate if transcranial magnetic stimulation can be used as a biomarker in Amyotrophic
      Lateral sclerosis (ALS).
    

Detailed description: 
      To measure the effect on motor threshold (MT) by transcranial magnetic stimulation (TMS)
      after a single dose of perampanel at two dose levels.
    

Intervention name(s): Perampanel; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral tablet; Placebo (not drug)
Other intervention name(s): Fycompa
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a pilot study for the assessment of transcranial magnetic stimulation as a biomarker for ALS and to obtain information to guide a dose selection for future biomarker driven Phase 2 studies of Perampanel in ALS.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Running Against Prehypertension Trial (RAPT): A Pilot Trial
Condition: Prehypertension
MeSH terms: Prehypertension
Study type: Interventional

Summary: 
      This study will test strategies to help people with prehypertension adopt a running program
      to reduce their blood pressure in the long term. This study will be a 12 week intervention of
      about 40 participants randomized to running educational material, group based running
      instruction, or group based running instruction focused on form and all given the option to
      use the supplemental mHealth intervention. The purpose of this study is to collect
      feasibility, acceptability and preliminary efficacy data in preparation for a larger planned
      NIH-R01 study.
    

Detailed description: 
      The UCSF Osher Center for Integrative Medicine has increasingly been investigating lifestyle
      interventions and their upstream approach to improving health and well-being. Many such
      lifestyle interventions address health risk nonpharmacologically and present participants
      with the opportunity to change their overall trajectory of health. Exercise interventions are
      of particular interest based on evidence of numerous physical and mental health benefits. Our
      target population in the Running Against Prehypertension Trial (RAPT) was people with upper
      range prehypertension. By adopting and maintaining a running program, these individuals who
      are at a high risk of hypertension can avoid a lifetime of medication and chronic disease.
      The objective of RAPT was to collect feasibility, acceptability and preliminary efficacy data
      over a 12 week period on a running program aimed at teaching a natural running form called
      ChiRunning that used the mindful movement principles of Tai Chi. By using this natural
      running form, participants may increase satisfaction and decrease rates of injury towards
      greater adherence to the program. Participants were randomized to one of three study arms: 1)
      intervention, 8 weeks of group training in form focused ChiRunning; 2) active control, 8
      weeks of group training focused on conventional running excluding form; or 3) usual care, a
      self-directed training with educational materials.
    

Intervention name(s): Educational material control; Group running style B; Group running style A
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will be given educational materials on starting a running program using a run/walk approach.; Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.; Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Running; Blood pressure
Exploring the Experiences and Outcomes of a Summer Intensive Therapy Program- Mixed Methods Study
Condition: Children With Neurodevelopmental Disorders
MeSH terms: Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effectiveness of an interdisciplinary intensive
      therapy program for ambulatory and non-ambulatory children with neurodevelopmental disorders
      across the ICF and to explore caregiver experiences and perspectives of the program.
    

Detailed description: 
      The purpose of this study is to assess the effectiveness of an interdisciplinary intensive
      therapy program for ambulatory and non-ambulatory children with neurodevelopmental disorders
      across the ICF and to explore caregiver experiences and perspectives of the program. Research
      questions include: 1.) What are the effects of an intensive program on postural control and
      functional mobility for children with neurodevelopmental disorders? 2.) What are the effects
      of an intensive therapy program on dual tasking for children with neurodevelopmental
      disorders? 3.) What are the perceptions of caregivers of a multidisciplinary intensive
      therapy program for their children with neurodevelopmental disorders? Data will be gathered
      before and after the intensive program as part of usual care and ambulatory children will be
      further assessed in the motion analysis lab. Caregivers will complete a questionnaire about
      satisfaction with services and also a 4 question open-ended question survey about their
      experience with intensive therapy.
    

Intervention name(s): An interdisciplinary intensive therapy program
Intervention type(s): Other
Intervention description(s): Children will receive physical, occupation, and/or speech therapy 1-3 hours/day each for 4-5 days/week x 4 weeks.
Intervention model: Single Group Assignment
Intervention model description: Cohort study of children receiving intensive therapy and their caregivers
Masking: None (Open Label)
Primary purpose: Treatment
Fall Prevention Program for Older Adults
Condition: Accidental Falls
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test the effectiveness of a fall prevention program for older
      adults. Participants assigned to the intervention group will train weekly on a special
      treadmill that will simulate tripping. Patients not assigned to the tripping program will
      walk on a standard treadmill.
    

Detailed description: 
      The purpose of this study is to test the effectiveness of a fall prevention program for older
      adults. Participants assigned to the intervention group will train weekly on a special
      treadmill that will simulate tripping. Patients not assigned to the tripping program will
      walk on a standard treadmill. The training program will last for 4 weeks. Upon completion,
      participants will complete a test where a trip is simulated. Those assigned to the
      intervention group will test one additional time as well.
    

Intervention name(s): fall prevention training; Attention Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Training on a specialized treadmill that produced trip-simulating perturbations (movements.; Participants walked on a treadmill at a self-selected speed once per week for four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Effect of Glutaraldehyde on Dentin Hypersensitivity After Non-surgical Periodontal Treatment
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This randomized, placebo-controlled, triple-blind trial aims to evaluate the effect of
      glutaraldehyde associated or not with 37% phosphoric acid conditioning on dentin
      hypersensitivity reduction after non-surgical periodontal treatment, and its durability after
      15 and 30 days. desensitizing treatment. Additionally, investigate the impact of these
      treatments on health-related quality of life. The investigators selected patients who, after
      scraping and planing procedures, presented at least 2 teeth meeting the following inclusion
      criteria: presence of gingival recession without or with a periodontal pocket up to 5mm
      probing depth, which presented painful sensitivity response to tactile stimulus. and
      evaporative. Subjects were randomized into 3 groups: Placebo Group (GP) - Placebo Gel
      application followed by Placebo solution (distilled water); GPG- Placebo Gel application
      followed by application 5% aqueous glutaraldehyde solution; GSG - Application of 37%
      phosphoric acid followed by 5% aqueous glutaraldehyde solution. The sensitivity of the dental
      elements was evaluated by pain stimuli (tactile and evaporative) with the aid of a Visual
      Analog Scale (VAS). A questionnaire was applied to patients with the objective of capturing
      psychosocial experiences, prior to treatment and one month after its completion, to assess
      the impact of desensitizing treatment on health-related quality of life. Data will be
      collected and appropriate statistical tests will be applied.
    


Intervention name(s): Placebo gel; Placebo Gel + 5% Glutaraldehyde Aqueous Solution; Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%
Intervention type(s): Other; Other; Other
Intervention description(s): Placebo gel application followed by placebo solution application (distilled water); Placebo gel followed by 5% aqueous glutaraldehyde solution; 37% phosphoric acid application followed by 5% aqueous glutaraldehyde solution
Intervention MeSH terms: Glutaral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Clinical trials; Dentin Sensitivity; glutaraldehyde; Desensitizing agents