bioihbjkbjnl/mcl2 huggingface dataset:
Video Game-based Exercise for Persons With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      This study assessed the effects of interactive video game-based exercise (IVGB) on balance in
      persons with Parkinson's disease . Twenty-four patients were randomly allocated to two groups
      (12 participants per group). Group A underwent IVGB training for the first 6 weeks, with no
      exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then
      received IVGB training in the subsequent 6 weeks. Both subjective and objective measures were
      used to determine whether IVGB exercise improves balance function.
    

Detailed description: 
      The experiments were conducted as a prospective, randomized, single blinded, crossover,
      12-week trial. The group A undergoes the IVGB training in the initial 6 weeks (intervention
      phase), follows by suspended from exercise in the subsequent 6 weeks (control phase). The
      group B does not received treatment in the first 6 weeks (control phase), and then performs
      IVGB training in the following 6 weeks (intervention phase). For all participants, The
      36-Item Short-Form Health Survey (SF-36), Modified Falls Efficacy Scale (MFES), Berg Balance
      Scale (BBS), Multidirectional reach test (MDRT) and Maximum step length (MSL) test were
      assessed at weeks 0, 6, and 12 of the experiment.
    

Intervention name(s): interactive video game-based exercise; no intervention
Intervention type(s): Other; Other
Intervention description(s): Twenty-four patients were randomly allocated to two groups (12 participants per group). Group A received interactive video game-based exercise training for the first 6 weeks, with no intervention in the subsequent 6 weeks. Group B had no intervention for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.; Twenty-four patients were randomly assigned to two groups (12 participants per group). Group A received interactive video game-based exercise training for the first 6 weeks, with no intervention in the subsequent 6 weeks. Group B had no intervention for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Imaging Young Myeloma (IMAgerie JEune Myélome)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      Multicenter open-label prospective comparative study of PET-scan and MRI at the time of
      diagnosis, after 3 cycles of induction therapy (RVD) and at the completion of therapy.
    


Intervention name(s): PET scan; MRI
Intervention type(s): Procedure; Procedure
Intervention description(s): Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy; Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: MRI; PET-scan; multiple myeloma; prognosis; pharmacoeconomic analysis
Feasibility Trial of CBT for Depersonalisation in Psychosis
Condition: Psychotic Disorders; Depersonalization
MeSH terms: Psychotic Disorders; Depersonalization
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a feasibility trial designed to test the feasibility and acceptability of a brief
      form (six sessions) of Cognitive Behavioural Therapy (CBT) for
      Depersonalisation/Derealisation (DP/DR) in those individuals who also have a diagnosis of a
      psychotic disorder. Participants will be randomised to receive either six sessions of CBT
      targeting DP/DR symptoms or to a treatment as usual control condition.
    

Detailed description: 
      Depersonalisation/derealisation (DP/DR) are distressing symptoms of having a sense of
      detachment and unreality about oneself (DP) or the external world (DR). Cognitive Behavioural
      Therapy (CBT) has been found to be beneficial in treating patients with chronic DP/DR. CBT
      for DP/DR includes educating patients about these experiences so they have a better
      understanding and less fear; teaching ways of coping to help them manage the symptoms better;
      helping reduce the impact on their day to day functioning; and working together to find less
      distressing ways of interpreting these experiences. Recent research has highlighted that
      DP/DR symptoms are common in people diagnosed with psychotic disorders, and when present are
      linked with more severe psychotic symptoms. However, there has been no previous study to
      ascertain if CBT to target DP/DR in psychosis would be effective. This study therefore aims
      to establish the feasibility of a brief CBT intervention for DP/DR in people diagnosed with a
      psychotic disorder. It is hoped that the CBT will reduce the distress associated with DP/DR
      experiences, with a possibility of reducing psychotic phenomena in addition. The
      investigators will seek to recruit adults aged 18-70 with a current psychotic symptoms as
      well as meeting threshold for DP/DR disorder. Participants will be randomly assigned to
      receive six sessions of CBT or to a treatment as usual control. Outcomes will be assessed at
      baseline and follow-up interview at 10 weeks.
    

Intervention name(s): CBT for Depersonalization/Derealization; Treatment as usual
Intervention type(s): Other; Other
Intervention description(s): In addition to treatment as usual, six sessions of Cognitive Behavioural Therapy for Depersonalization/Derealisation covering psychoeducation, formulation, coping strategies.; Treatment as usual - in most cases case management/care coordination and may include medication
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized Controlled Trial
The Absorption, Metabolism and Excretion of [14C]CM082 in Human
Condition: Advanced Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, single-dose phase I study to investigate the absorption,
      metabolism and excretion of [14C] CM082 in healthy Chinese male subjects. The study will be
      conducted into two steps：Firstly, 2 subjects are enrolled in to participate in the pilot
      study to grope for the completion date of plasma, urine and feces sampling on the 3rd day
      post-dose and onwards. Then, the collection time of blood and excreta samples (urine and
      feces) from the subsequent 4-6 subjects will be adjusted according to the pilot study
    

Detailed description: 
      Subjects who had signed informed consent and meet inclusion criteria and no exclusion
      criteria are admitted to Phase I Clinical Unit two days prior to dosing (D-2). On the morning
      of Day 1 before dosing, subjects will be transferred to nuclear medical ward. And after an
      overnight fast of at least 10 h, subjects will receive a single oral dose of 200 mg (100 μCi)
      of [14C]CM082 as an oral suspension. Then, after two days of the dosing, subjects will be
      transferred back to Phase I Clinical Unit ward and confined to this unit until blood or
      excreta sampling and safety monitoring at the designated time points or intervals are
      complete
    

Intervention name(s): [14]CM082 suspension
Intervention type(s): Drug
Intervention description(s): Before administration, the solid powder for administration was placed at room temperature. 40 ml drinking water was added into the drug container to prepare the suspension for the subjects to take. After that, 200 ml drinking water was used to repeatedly rinse the drug container for many times, and the subjects continued to take the lotion. Take care not to spill the liquid out of the bottle when shaking
Intervention MeSH terms: Vorolanib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI
      1015550 in healthy male volunteers
    


Intervention name(s): Placebo; BI 1015550; BI 1015550; BI1015550; BI 1015550
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo to BI 1015550; medium dose 1 powder for oral solution; medium dose 2 powder for oral solution; low dose 2 powder for oral solution; low dose 1 powder for oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing
Condition: Peri-Implantitis
MeSH terms: Peri-Implantitis
Study type: Interventional

Summary: 
      Erythritol is a natural sugar alcohol (a four-carbon polyol) produced by the reduction of
      erythrose. It is considered safe as food additive and has many of the functional properties
      that are important for subgingival debridement. Current evidence includes no prospective
      studies comparing the outcomes of a low abrasive erythritol air-polishing as an adjunctive
      therapy to conventional titanium and ultrasonic debridement of patients in a maintenance
      program with peri-implantitis. Thus, the main purpose of this randomized, single-masked
      controlled trial (RCT) is to assess whether low abrasive erythritol air-polishing has an
      adjunct effect to conventional non-surgical treatment of peri-implantitis.
    

Detailed description: 
      This RCT will enroll subjects among patients in need for non-surgical treatment of
      peri-implantitis at a private dental clinic in Stavanger, Norway. Forty patients diagnosed
      with peri-implantitis on at least one implant will be randomly allocated by tossing a coin
      into test or control group. Patients with cement-retained and screw-retained
      supraconstructions will be included.

      Treatment of peri-implantitis will be performed by one operator (AS) at baseline, 3-, 6-, 9-
      and 12-month follow-up visits. Local anesthesia will be used when needed. In the test group,
      implants will be treated with titanium curette, ultrasonic device and a specially designed
      nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit.

      In the control group, implant with peri-implantitis will be debrided with titanium curette
      and ultrasonic device only. Test and control debridement will be performed without time
      limit. The treatment will continue until the operator is judging the implant surface to be
      free for supra- and subgingival deposits.
    

Intervention name(s): Titanium curette.; Ultrasonic; Air-polishing
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Implant debridement.; Implant debridement.; Implant debridement and polishing.
Other intervention name(s): Ultrasonic device; Air-polishing device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, single-masked controlled trial (RCT)
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peri-implantitis; Air-polishing; Erythritol
Effects of Dairy on Vitamin K-status
Condition: Vitamin K-status; Vascular Health
Study type: Interventional

Summary: 
      In this study, the beneficial effect of a nutrient enriched dairy product will be
      investigated on vitamin K-status. To achive this benefit, the study product contains extra
      vitamin K2. In addition, extra dairy minerals have been added to the study product that may
      support general health.
    

Detailed description: 
      In earlier studies, cardiovascular disease and osteoporosis were found to be associated with
      K2 intake, notably the higher menaquinones, MK-7, MK-8 and MK-9. Of these higher
      menaquinones, MK-7 was suggested to be the most effective form with respect to intestinal
      absorption, biologic half-life time, and efficacy on circulating biochemical markers. MK-7 is
      a natural product that is found in cheese, curd, and the Japanese food natto. Therefore, a
      nutrient enriched dairy product has been developed containing MK-7. The efficacy of this new
      product will be investigated on vitamin K status and on general health markers.
    

Intervention name(s): nutrient enriched product; basic dairy product
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The intervention in this study consists of the consumption of two nutrient enriched yoghurt products. The participants consume the study products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.; The intervention in this study consists of the consumption of two basic yoghurt products. The participants consume the basic yoghurt products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: vitamin K2; menaquinone-7; vascular health
Safety Study of Four Chimera Cytomegalovirus (CMV) Vaccines in Healthy Adult Males 30-50 Years of Age
Condition: Cytomegalovirus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to test the safety and tolerability of four new
      investigational Cytomegalovirus (CMV) vaccines (Towne-Toledo 1, 2, 3, 4) in healthy male
      volunteers who are CMV negative. CMV is a common virus, infecting 50-80% of adults in the
      United States by the age of twenty-one. CMV does not usually cause illness in adults or
      children. However, CMV can be a cause of deafness and mental retardation in a child if a
      mother is infected during pregnancy. It also can be a serious illness in patients with
      impaired immunity (decreased ability to fight infection).
    

Detailed description: 
      A total of thirty six participants will be enrolled. The first 12 participants will be
      randomized into four groups. Four groups will receive one of the four investigational
      vaccines. The four investigational HCMV vaccine candidates will be administered
      subcutaneously to 3 volunteers at 10 pfu (the lowest dose to be used). The safety and
      tolerability of the four investigational HCMV vaccine candidates will be monitored closely
      for a period of 12 weeks following vaccination at this dose. Investigational vaccines that
      are found to be safe and well tolerated at a dose of 10pfu will be administered to 3
      additional individuals at 102 pfu and then at 103 pfu. Safety and tolerability will be
      evaluated at each dose level by monitoring clinical signs and symptoms, laboratory parameters
      and virus detection in the blood, urine, and saliva. After the 12-week safety-monitoring
      period, participants will be followed for the remainder of one year to assess long-term
      safety and immunogenicity of the investigational vaccines.
    

Intervention name(s): cmv vaccine
Intervention type(s): Biological
Intervention description(s): dose escalation study of 4 towne-toledo chimera vaccines
Other intervention name(s): Towne vaccine; Toledo vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Vaginal Dinoprostone Administration Prior to Intrauterine Device Insertion
Condition: IUD Insertion Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing
      intrauterine system(IUs) insertion reduces IUD insertion pain and difficulty in insertion in
      adolescents and young women.
    

Detailed description: 
      Long-acting reversible contraception methods are highly effective methods for reduction of
      the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that
      provides reliable, effective and long term contraception for many women. However, the
      insertion procedure can be associated with a troublesome degree of pain that prevent some
      women from choosing its use. Different interventions have been described to decrease pain
      perception during intrauterine device insertion with no agreement on an effective one.
    

Intervention name(s): Dinoprostone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by the patient 12 hours before IUD insertion.; one tablet of placebo self-inserted by the patient 12 hours before IUD insertion.
Intervention MeSH terms: Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Treatment of Tooth Sensitivity With the Use of Biorepair Toothpaste
Condition: Dentinal Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this clinical study is to evaluate the effect of desensitizing toothpaste
      containing zinc-carbonate hydroxyapatite nanocrystals in reducing or controlling DH after 8
      weeks of treatment
    

Detailed description: 
      This clinical study design is an 8-week single center, before and after use of desensitize
      dentifrice. This study will conducted in the College of Dentistry Qassim University. 72
      patients surfing from DH, include in the study fulfill the inclusion criteria. All subjects
      20 to 70 years of age in good health, and must have 2 teeth with DH, will be included in this
      study. Screening will be performed for the selection of patients, which fulfill the inclusion
      criteria. Baseline data will be recorded and Sensitivity was assessed by air-blast
      sensitivity, using Schiff Sensitivity Scale (SSS).

      Sensitivity was assessed by air-blast sensitivity, using Schiff Sensitivity Scale (SSS)
      described as follows.

      0 = Subject does not respond to air stimulus

        1. = Subject responds to air stimulus but does not request discontinuation of stimulus

        2. = Subject responds to air stimulus and requests discontinuation or moves from stimulus

        3. = Subject responds to air stimulus, considers stimulus to be painful, and requests
           discontinuation of the stimulus
    

Intervention name(s): Single arm clinical study
Intervention type(s): Other
Intervention description(s): Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.
Intervention model: Single Group Assignment
Intervention model description: Clinical trials with a single arm: Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Biorepair sensitive toothpaste; Clinical trial; Dentinal Hypersensitivity; Schiff Sensitivity Scale; Zinc-carbonate hydroxyapatite nanocrystals
Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
Condition: Smoking
Study type: Interventional

Summary: 
      The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS
      2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by
      Japanese adult healthy smokers results in a reduction in the levels of biomarkers of exposure
      for selected harmful and potentially harmful smoke constituents (HPHCs) compared to smokers
      continuing smoking their own preferred brand of menthol conventional cigarette (mCC) and
      smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to
      provide context to the exposure reduction.
    


Intervention name(s): THS 2.2 Menthol (mTHS 2.2); Smoking Abstinence (SA); Menthol Conventional Cigarette (mCC)
Intervention type(s): Other; Other; Other
Intervention description(s): THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting; SA for 5 days in confinement prolonged by 85 days in an ambulatory setting; Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Candidate modified risk tobacco product; Conventional cigarettes; Reduced exposure; HPHCs; Ambulatory
IT-Supported Early Treatment Of Childhood Overweight
Condition: Childhood Obesity; Technology Based Obesity Intervention
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this exploratory/ developmental study is to develop and evaluate an integrated
      information system, Healthy Eating and Activity Today (HEAT), for promoting self-care in
      overweight children. HEAT is comprised of two components: 1)Telephone Linked Care-HEAT
      (TLC-HEAT), a self-care intervention delivered at home through totally automated telephone
      conversations; and 2) Primary Care-HEAT (PC-HEAT), a primary care intervention linked with
      TLC-HEAT and delivered through an electronic health record (EHR). The HEAT system will guide
      children in the early stages of overweight, i.e., children with Body Mass Index (BMI) 0-3 BMI
      points above the 95th percentile for age and gender, toward healthy weight management and
      assist the child's parent(s) and primary care provider (PCP) to support the child's efforts.
    

Detailed description: 
      For this project we will: 1) develop TLC-HEAT for use by children in the earliest stage of
      overweight and their parents; 2) integrate TLC-HEAT with an electronic health record to
      provide child- and parent-reported behavior summaries combined with evidence-based decision
      support to primary care providers (PCPs) at the point-of-care (PC-HEAT); and 3) conduct a
      pilot study of the combined HEAT system to explore the appropriateness of conducting a
      larger, randomized clinical trial in the future.
    

Intervention name(s): Telephone Linked Care-HEAT (TLC-HEAT)
Intervention type(s): Behavioral
Intervention description(s): A primary care intervention linked with Telephone Linked Care-HEAT (TLC-HEAT), and delivered through an electronic health record (EHR). The HEAT system will guide children in the early stages of overweight toward healthy weight management and assist the child's parent(s) and primary care provider (PCP) to support the child's efforts.
Primary purpose: Treatment
Keywords: Childhood Obesity; Obesity Intervention