bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Fluoride Dose Response Using In Situ Caries Model
Condition: Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the fluoride dose response of different dentifrice
      fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate
      (MFP) and a fifth leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.
    


Intervention name(s): 0 ppm F; 250 ppm F as MFP; 1100 ppm as MFP; 2800 ppm F as MFP; 1100 ppm SnF2
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.; Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.; Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.; Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.; Each subject will be assigned to this treatment during the fifth period for this crossover study.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
The Effect of Heart Rate Variability Biofeedback Training on Health of Intrapartum Women
Condition: Mental Stress
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      In this study, the investigators examined the efficacy of heart rate variability biofeedback
      on physical and mental health problems in childbirth women.
    

Detailed description: 
      In this study, the investigators examined the efficacy of heart rate variability biofeedback
      on physical and mental health problems in childbirth women. The following validated
      self-report measures were administered before and at five days after the intervention,
      Perceived stress scale-10, Beck Anxiety Inventory, and Edinburgh Postnatal Depression Scale.
    

Intervention name(s): heart rate variability biofeedback Application (Eureka iDestressor)
Intervention type(s): Device
Intervention description(s): heart rate variability biofeedback protocol duration time is 10 min twice/day for 5days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Feasibility of Action Observation and Repetitive Task Practice on Upper Extremity Outcomes in Chronic Stroke Survivors
Condition: Stroke; Hemiparesis
MeSH terms: Stroke; Paresis
Study type: Interventional

Summary: 
      The objective of this pilot randomized controlled single blinded, parallel-group study is to
      detect change of the Action Observation (AO) and Repetitive Task Practice (RTP) combined
      practice schedule on upper limb motor impairment outcomes in chronic, moderately impaired
      stroke survivors.
    

Detailed description: 
      The current proposal aims to conduct a pilot randomized controlled single blinded,
      parallel-group study design to detect change of the Action Observation (AO) and Repetitive
      Task Practice (RTP) combined practice schedule on upper limb (UL) motor impairment outcomes
      in the chronic, moderately impaired stroke survivor. Individuals will be randomized to 1)
      experimental conditions of AO + RTP practice schedule, or 2) control condition of Placebo
      Video (PV) + RTP, and will receive an assigned regimen from a blinded intervention therapist
      for one hour, 3 times per week, for 8 weeks (total of 24 sessions), and a daily 30 minute
      HEP. A blinded assessor will complete assessments on each subject at three distinct time
      points of pretest, post intervention, and 1 month post intervention.
    

Intervention name(s): Action Observation + Repetitive Task Practice; Placebo Video + Repetitive Task Practice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Observing a video of another person performing a functional task and physically repetitively performing the same task for upper extremity hemiparesis; Observing a video of static images and physically repetitively performing functional task for upper extremity hemiparesis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A pilot randomized controlled single blinded, parallel-group study design
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; hemiparesis
Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
Condition: HIV; HIV-1; Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the non-inferiority of ritonavir-boosted GS-9137
      relative to a ritonavir-boosted Comparator Protease Inhibitor when used as part of
      combination antiretroviral regimens in subjects who have failed, or are failing, protease
      inhibitor therapy.
    


Intervention name(s): GS-9137 - A Novel HIV-1 Integrase Inhibitor
Intervention type(s): Drug
Intervention MeSH terms: HIV Integrase Inhibitors; Integrase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 2; Phase II; Randomized; Controlled; Comparator; Partially Blind; Protease Inhibitors; Integrase Inhibitors; Antiviral Agents; Antiretroviral Agents; ART; ARV; Highly Activity Antiretroviral Therapy; HAART; Treatment Experienced
Efficacy and Safety Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore whether BDB-001 Injection is effective and safe in
      the treatment of moderate to severe hidradenitis suppurativa(HS).
    


Intervention name(s): BDB-001 Injection
Intervention type(s): Drug
Intervention description(s): Multiple IV infusions of BDB-001 Injection diluted in sodium chloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Pharmacokinetics of D565 and the Drug Effect of D565 on Pharmacokinetic Characteristics of D930
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single sequence, 3-period, multiple-dose study to evaluate the
      pharmacokinetics of D565 and the drug effect of D565 on pharmacokinetic characteristics of
      D930 in healthy male volunteers.
    

Detailed description: 
      This study is a single sequence, 3-period, multiple-dose study to evaluate the
      pharmacokinetics of D565 and the drug effect of D565 on pharmacokinetic characteristics of
      D930 in healthy male volunteers.

      Subjects will receive D565 just one time on period 1 for evaluate the pharmacokinetics. And
      afterward, subjects will receive multiple dose of D930 for 9 days, and D565 with D930 for 9
      days to evaluate the drug effect on period 2 and 3.

      When period 1 finished, there are 3 days of washout period, but between period 2 and 3, there
      is no washout period.
    

Intervention name(s): D930, D565
Intervention type(s): Drug
Intervention description(s): Period 1: D565 administered 1 time for one day/ Period 2: D930 administered 3 time per day for 9 days/ Period 3: D565(1 time per day) with D930(3 time per day) administered for 9days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glaucoma
A Drug Interaction Study of GDC-0032 Co-administered With Rifampin or Itraconazole in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, two-arm, drug interaction study will investigate the effect of
      co-administration of rifampin or itraconazole on the pharmacokinetics of GDC-0032 in healthy
      volunteers. In Arm A, volunteers will receive GDC-0032 and rifampin; in Arm B, volunteers
      will receive GDC-0032 and itraconazole. The anticipated time on study treatment is
      approximately 30 days.
    


Intervention name(s): GDC-0032; Itraconazole; Rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral doses of GDC-0032; Oral doses of Itraconazole; Oral doses of Rifampin
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of RO6864018 in Male, Healthy, Asian Participants
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, single ascending dose study will assess
      the safety, pharmacokinetics, and pharmacodynamics of RO6864018 in healthy, male, Asian and
      Caucasian participants. Participants will be enrolled in cohorts and randomized 8:2 to
      receive a single oral administration of RO6864018 or placebo. Total study duration for each
      participant is up to 9 weeks.
    


Intervention name(s): RO6864018; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single oral ascending dose of RO6864018 capsules on Day 1.; A single oral dose of placebo matching RO6864018 capsules on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 Multiple Doses in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Three-part study investigating the safety and tolerability of AZD2423 multiple doses in 98
      healthy volunteers: Part 1 80 young and elderly subjects in a parallel, double blind,
      randomised study. Part 2 - 6 subjects in an open, non-randomised study. Part 3 - 12 subjects
      in a three-way cross over, open label, partially randomised study.

      Part 1 has 2 Arms, AZD2423 or Placebo, Multiple dosing during 10-14 days . Part 2 has 1 Arm
      AZD2423 Multiple dosing and Part 3 has 3 Arms AZD2423 single dosing or AZD2423 single dosing
      with food or AZD2423 single dosing, Fasting Condition
    


Intervention name(s): Part 1 - AZD2423 or Placebo; Part 2 - AZD2423; Part 3 - AZD2423
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AZD2423 Oral Solution, multiple dosing during 10-14 days or Placebo Oral Solution, multiple dosing during 10-14 days; AZD2423 Oral solution, multiple dosing; AZD2423 Oral solution, single dosing or AZD2423 Oral solution, single dosing - With Food or AZD2423 Oral solution, single dosing - Fasting Condition.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Safety; Tolerability; Healthy; Pharmacokinetics; Healthy volunteers
Validation of an Activities-of-daily-living Framework at Different Light Conditions
Condition: Presbyopia; Near Vision; Reading; Daily Activities
MeSH terms: Presbyopia
Study type: Observational

Summary: 
      Primary objective of this study is the construction and validation of an experimental
      environment for the simulation of a variety of near- and intermediate-vision activities of
      daily living (ADLs) in different combinations of light temperature and light intensity.
    

Detailed description: 
      Among the objectives of the study is to validate a framework of ADLs that require near and
      intermediate vision and better reflect visual capacity, in a special experimental environment
      of 9 different combinations of light temperature and light intensity.

      The final list consists of the following ten basic ADL tasks:

      1. Phone Book Search (PBS), 2. Supermarket receipt (SupRe), 3. Book reading (BR), 4. Cellular
      message (CM), 5. Cellular entry search (CES), 6. Reading computer screen (RCS), 7. Drops
      bottle reading (DR), 8. Subtitles reading (SubRe), 9. Open door test (ODT), and, 10.
      Screwdriver test (ST).

      The 9 light combinations are the following:

      3000 K - 25 fc, 3000 K - 50 fc, 3000 K - 75 fc 4000 K - 25 fc, 4000 K - 50 fc, 4000 K - 75 fc
      6000 K - 25 fc, 6000 K - 50 fc, 6000 K - 75 fc
    

Intervention name(s): ADL performance
Intervention type(s): Other
Intervention description(s): All validation groups address the following ten ADL tasks in 9 different combinations of light temperature (in Kelvins - K) and light intensity (in foot candles - fc) in order possible differences to be revealed among the validation groups and light combinations:
1. Phone Book Search (PBS), 2. Supermarket receipt (SupRe), 3. Book reading (BR), 4. Cellular message (CM), 5. Cellular entry search (CES), 6. Reading computer screen (RCS), 7. Drops bottle reading (DR), 8. Subtitles reading (SubRe), 9. Open door test (ODT), and, 10. Screwdriver test (ST).
The 9 light combinations are the following:
3000 K - 25 fc, 3000 K - 50 fc, 3000 K - 75 fc 4000 K - 25 fc, 4000 K - 50 fc, 4000 K - 75 fc 6000 K - 25 fc, 6000 K - 50 fc, 6000 K - 75 fc
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Normophakic participants with a clear natural lens
      
Keywords: activities of daily living; presbyopia; light temperature; light intensity
US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy
Condition: Cholecystitis
MeSH terms: Cholecystitis
Study type: Interventional

Summary: 
      A single-center randomized comparison of bedside ultrasound (US)-guided trocar technique
      versus the US-guided Seldinger technique for percutaneous cholecystostomy
    

Detailed description: 
      This is a single-center, randomized, controlled trial (RCT), comparing bedside US-guided
      trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy
      (PC). The study will randomize a total of 100 consecutive patients (50 in each group)
      undergoing PC at one large tertiary university hospital. The primary endpoints will be
      technical success and procedure-related complication rates. Secondary endpoints will be
      procedural duration, pain assessment, and clinical success after up to 3 months of follow-up.
    

Intervention name(s): Trocar percutaneous cholecystostomy; Seldinger percutaneous cholecystostomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Percutaneous cholecystostomy using the one-step Trocar technique under US guidance. An 8Fr Trocar catheter will be inserted percutaneously within the gallbladder under real-time US guidance. The procedure will be performed using an aseptic technique, local anesthesia and intravenous opioid analgesia.; Percutaneous cholecystostomy using the Seldinger technique under US guidance. Following percutaneous puncture of the gallbladder with an 18G needle under real-time US guidance, an 8Fr catheter will be inserted percutaneously over the wire within the gallbladder under real-time US guidance. The procedure will be performed using an aseptic technique, local anesthesia and intravenous opioid analgesia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Percutaneous cholecystostomy; ultrasound-guided; interventional radiology; Trocar; Seldinger
The Effect of Hydrodissection for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with
      involving compression of the median nerve in the carpal tunnel. Rather than other progressive
      disease, CTS is characterized by remission and recurrence. The hydrodissection could decrease
      the entrapment of nerve to restore blood supply. Despite the hydrodissection was pervasively
      used in clinical practice, current researches contain small participant without control group
      or randomized leading to foreseeable selection bias. The investigators design a randomized,
      double-blind, controlled trail to assess the effect after ultrasound-guided hydrodissection
      in patients with CTS.
    

Detailed description: 
      After obtaining written informed consent, patients with bilateral CTS will been randomized
      into intervention and control group. Participants in intervention group received one-dose
      ultrasound-guided hydrodissection and control side received one-dose ultrasound-guided
      injection at subcutaneous layer beyond carpal tunnel. No additional treatment after injection
      through the study period. The primary outcome is visual analog scale (VAS) and secondary
      outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area
      (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger
      pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st,
      2nd and 3rd month after the treatment.
    

Intervention name(s): Ultrasound-guided hydrodissection; Placebo ultrasound-guided injection; Ultrasound; Normal Saline
Intervention type(s): Procedure; Procedure; Device; Drug
Intervention description(s): Ultrasound-guided hydrodissection with 5cc normal saline between carpal tunnel and median nerve.; Ultrasound-guided injection with 5cc normal saline at subcutaneous layer beyond carpal tunnel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hydrodissection
Efficacy and Safety of BIIL 284 BS in Adult Patients With Active Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate efficacy and safety of 3 doses of BIIL 284 BS in active rheumatoid arthritis
      (RA) and determine the dose with most positive efficacy / safety ratio. Pharmacokinetic
      profile will be also obtained.
    


Intervention name(s): BIIL 284 BS low dose; BIIL 284 BS medium dose; BIIL 284 BS high dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese
Condition: Metabolism and Nutrition Disorders; Overweight or Obesity
MeSH terms: Obesity; Overweight; Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is investigating new medicines for weight control in people with high body weight.
      The study looks at how the study medicines work in the body. Participants will get
      semaglutide and either NNC0165-1562 or "dummy" medicine -which treatment participants get is
      decided by chance. Participants will get 2 injections per week for 5 months. A study nurse at
      the clinic will inject the medicine with a thin needle in a skin fold in the stomach. The
      study will last for about 7 months. Participants will have 27 visits to the clinic.
    


Intervention name(s): NNC0165-1562; Semaglutide; Placebo (NNC0165-1562)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive NNC0165-1562 subcutaneous (s.c., under the skin) injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.; Participants will receive semaglutide s.c. injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.; Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Three (3) cohorts are planned. In each cohort subjects will be assigned to trial product. Subjects will be randomised in a 3:1 manner within cohorts to receive either:
Semaglutide and NNC0165-1562 once weekly (9 subjects per cohort)
Semaglutide and placebo once weekly (3 subjects per cohort)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway
Condition: Difficult Airway; Ventilation
Study type: Interventional

Summary: 
      The ProSeal laryngeal mask airway (PLMA) is a new laryngeal mask device with a modified cuff
      to improve the seal and a drain tube to prevent aspiration and gastric insufflation. The
      manufacturer recommends inserting the PLMA using digital manipulation, like the Classic LMA,
      or with an introducer tool (IT), like the Intubating LMA. The mean (range) frequency of
      insertion success at the first attempt for these techniques is 84% (81-100) and 95% (90-100)
      respectively, with the main causes of insertion difficulty being impaction at the back of the
      mouth and failure of the distal cuff to reach the hypopharynx. Howarth et al described an
      insertion technique which overcomes these difficulties by using a gum elastic bougie (GEB)
      placed in the esophagus to guide the PLMA around the back of the mouth and into its correct
      position in the hypopharynx. Howarth et al reported no failed uses from 100 consecutive
      insertions. In the following study, we test the hypothesis that GEB-guided insertion is more
      frequently successful than the digital and IT techniques in patients with difficult airway.
    


Intervention name(s): ProSeal LMA
Intervention type(s): Device
Intervention description(s): GEB vs digital vs introducer tool
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment