bioihbjkbjnl/mcl2 huggingface dataset:
Pain Study to Assess Local Anesthetic Efficacy and Safety of CTY-5339 on Gingival Mucosal Tissue in Normal Volunteers
Condition: No Disease State or Condition
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the topical application to gingival tissue of
      the combination of benzocaine and tetracaine has a longer duration of local anesthetic
      activity than benzocaine alone.
    

Detailed description: 
      In a blinded study, either benzocaine alone or the combination of benzocaine and tetracaine
      will be sprayed onto the gingival mucosal tissue. Onset and duration of local anesthesia will
      be evaluated over a one hour period using pin prick and quantitative sensory testing of heat
      (QST-heat) stimulation. Subjects will receive both treatments in a cross-over design with
      each session separated by 4-14 days. A total of 50 subjects (normal volunteers) will be
      evaluated.
    

Intervention name(s): One spray CTY-5339-A; One spray CTY-5339-CB; One spray CTY-5339-P
Intervention type(s): Combination Product; Device; Device
Intervention description(s): Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray.; Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray.; Placebo. Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (vehicle control).
Other intervention name(s): CTY-5339-A; CTY-5339 Anesthetic Spray; benzocaine; tetracaine; tetracaine HCl; 14.0% benzocaine; 2.0% tetracaine HCl; 2.0% tetracaine; 14.0% benzocaine and 2.0% tetracaine HCl; 14.0% benzocaine and 2.0% tetracaine; benzocaine and tetracaine HCl; benzocaine and tetracaine; CTY-5339-CB; benzocaine; 14.0% benzocaine; CTY-5339-P; placebo; vehicle control
Intervention MeSH terms: Anesthetics; Tetracaine; Benzocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: local anesthesia; pain tolerance; experimental pain
Virology Follow up Study in Subjects Previously Treated With Telaprevir
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Observational

Summary: 
      Observational follow-up study to assess long-term response to telaprevir and to evaluate
      changes in Hepatitis C virus over time.
    


Intervention name(s): telaprevir
Intervention type(s): Drug
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who have previously received at least 1 dose of telaprevir-based treatment
        (telaprevir plus peginterferon alfa 2a [Peg IFN-alfa-2a] with or without ribavirin [RBV])
        in 1 of the following clinical studies: VX05-950-104, VX05 950-104EU, VX06-950-106,
        VX06-950-107, VX07-950-108, VX08-950-111, and VX-950-TiDP24-C216.
Improving Mental Health in Youth and Lowering Risk for Obesity Through a Digital Preventative Product
Condition: Mental Health Disorder; Obesity; Overweight
MeSH terms: Obesity; Overweight; Mental Disorders
Study type: Interventional

Summary: 
      The goal of this study is to test the feasibility and utilization of a redesigned mobile app
      and health coaching platform (Vira) in youth (aged 18-25 years) with elevated depressive
      symptoms who are overweight/obese and/or self-report parental history of overweight/obesity.

      Eligible participants will be randomly assigned to one of two groups: one group will use the
      Vira mobile app intervention with support from a health coach, and the other group will use
      the Vira mobile app intervention without coaching. Both groups will use the app for 12 weeks.
    

Detailed description: 
      The primary aim of this project is to examine the feasibility and utilization of a redesigned
      mobile app and health coaching platform (Vira) in a 2 x 2 (gender x condition) designed pilot
      study in a sample of 100 youth (18-25 years old) with (1) elevated depressive symptoms (PHQ-8
      score ≥10) and (2) overweight/obesity (BMI ≥ 25 and/or reporting a parental history of
      overweight/obesity). The study will examine the feasibility and utilization of the mobile app
      intervention with coaching compared to that of the mobile app intervention without coaching.

      This is an exploratory pilot study; therefore, no formal sample size calculation was
      conducted. It is anticipated that 1,000 individuals will be screened, of which 20% will be
      eligible, and that 50% of those eligible will agree to participate (final N = 100, 50 per
      arm).
    

Intervention name(s): Vira mobile app intervention; Vira mobile app intervention + coaching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Vira app is installed on the participant's phone. The app passively collects data from phone sensors (i.e., measures of physical activity, sleep patterns, mobility, and language patterns reflecting mood states and cognition) that are indicative of risk-relevant behavioral patterns and psychological states. It also so prompts users to answer a daily check in question. Mobile sensing data are processed to provide an automated assessment of the user's functioning. Users will be asked to use Vira for 12 weeks.; The Vira app can also be supported by a health coach. The health coach interacts with the user (via an instant messaging platform) and who also schedules just-in-time reminders (i.e., "nudges") to arrive in the user's phone at scheduled times to support their behavior change plan. The Vira Health Coach Platform therefore integrates mobile sensing, self-report assessment, and just-in-time nudges and notifications into the coach's workflow.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Role of Cryotherapy in Reduction of Post Operative Endodontic Pain Following Single Visit Root Canal Therapy
Condition: Effects of; Cold
Study type: Interventional

Summary: 
      AIM : To determine the efficacy of cold saline irrigation in reduction of post operative pain
      following root canal therapy.

      METHODOLOGY : Forty patients requiring root canal treatment on permanent single rooted teeth
      were included. The patients were assigned randomly into two groups of 20 patients each. The
      teeth in Group1 (n = 20) were irrigated using normal saline solution, whilst those in Group 2
      (n = 20) were irrigated with cold saline solution stored at 4 degrees centigrade. A Heft
      Parker visual analog scale was used to measure pre-operative pain and post-obturation pain at
      12, 24,48 and 72 hours after obturation. Chi square tests and Mann Whitney U tests were used
      for statistical analysis.
    


Intervention name(s): cryotherapy
Intervention type(s): Other
Intervention description(s): Role of cryotherapy in reduction of post operative pain
Other intervention name(s): Cold saline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
Condition: Bipolar I Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the long-term safety, tolerability, and
      pharmacokinetics of cariprazine in patients with bipolar I disorder.
    


Intervention name(s): Cariprazine
Intervention type(s): Drug
Intervention description(s): Cariprazine was supplied in capsules.
Other intervention name(s): RGH-188
Intervention MeSH terms: Cariprazine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mania; Acute mania; Bipolar I disorder
Wrist-used Blood Pressure Monitor Clinical Test (Cuff Range: 14cm-25cm)
Condition: Blood Pressure
Study type: Observational

Summary: 
      The purpose of this study is to monitor the blood pressure level of the patient using a wrist
      cuff ranged 14 cm-25 cm.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        resident of a community.
      
Keywords: BP
Neurobiological Aspects of the Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Evaluating neurobiological disorder associated with Attention Deficit Hyperactivity Disorder
      (ADHD) and the contribution of transcranial direct current stimulation (tDCS) in the
      adaptation of inhibitory control.
    

Detailed description: 
      1. Assess the neurobiological aspects evidenced by the amount of brain electrical activity
           observed by the amplitude of waves through graphs in patients with ADHD, using
           quantitative electroencephalography;

        2. Study the contribution of transcranial direct current stimulation compared with sham in
           the adequacy of inhibitory control in ADHD patients through neuropsychological
           test-Go/No Go;

        3. Assessing the efficacy of tDCS in neurobiological parameters evidenced by quantitative
           EEG in patients with ADHD;

        4. Perform the Reconstruction of the Functional Brain Network of each subject based on the
           quantitative EEG data through computational and mathematical modeling;

        5. Register indicators of quality of life in adults with Attention Deficit Hyperactivity
           Disorder through the Quality of Life Questionnaire for Adults with ADHD (AAQoL).
    

Intervention name(s): Transcranial Direct Current Stimulation; Sham
Intervention type(s): Device; Device
Intervention description(s): This technique consists in the use of low voltage electric current to increase or reduce neuronal excitability in the area stimulated. This is a non-invasive and safe intervention having infrequent and insignificant side effects characterized by mild local discomfort, itching, tingling and/or headache of short term.; Same character of Transcranial Direct Current Stimulation but without current
Other intervention name(s): tDCS
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder (ADHD);; Transcranial Direct Current Stimulation (tDCS);; Control Inhibitory;; Quantitative electroencephalography;; Functional Brain Network;; Go/No Go test.
Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors
Condition: Rectal Neoplasms; Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors; Rectal Neoplasms
Study type: Observational

Summary: 
      we evaluated all related clinical and pathologic data of rectal NET cases, including the
      resection margin status, NET grading, and lymphovascular invasion status. Finally, the
      present study was aimed at (1) determining the risk factors for LN and distant metastases in
      colorectal NETs (2) clarifying the clinical significance of the salvage treatment for
      colorectal neuroendocrine tumors following initial endoscopic resection with positive
      resection margin status and (3) compare different salvage treatment of this uncommon disease
      through conducting a large, multi-center cohort study.
    


Intervention name(s): salvage treatment
Intervention type(s): Procedure
Intervention description(s): salvage radical surgery or endoscopic resection
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients with rectal neuroendocrine tumors following initial endoscopic resection
      
Keywords: endoscopic resection
Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services
Condition: Depression; Anxiety
MeSH terms: Depression
Study type: Interventional

Summary: 
      The primary aim of this study is to determine the feasibility and acceptability of the
      W-GenZD mobile application among a group of adolescents and who have screened and triaged
      into low-intensity treatment within the Children's Hospital of the King's Daughters. The
      secondary aim of this study is to determine the preliminary comparative efficacy of W-GenZD
      and CBT-light teletherapy zoom groups to manage mood concerns at 4-weeks end of treatment
      relative to baseline. The third aim of this study is to investigate potential differences
      between group differences on working alliance. An exploratory aim of this study is to observe
      and describe the utilization and outcomes of the safety procedures utilized within this
      study.
    


Intervention name(s): W-GenZD Mobile Application; CBT-Light Teletherapy
Intervention type(s): Device; Behavioral
Intervention description(s): W-GenZD is a mobile application program that delivers evidence-based therapy for the symptoms of mild-moderate depression and anxiety in adolescents in brief "conversations" with a fully automated relational agent called Woebot. It is a brief, self-guided 4 week-intervention that draws from cognitive behavioral therapy (CBT), interpersonal psychotherapy for adolescents (IPT-A), and elements of dialectical behavior therapy (DBT), depending on the presenting situation, to help the adolescent develop emotion regulation skills in the context of their everyday life. In this way, the mobile application is designed to be targeted, relevant, and integrated into the lived experience of adolescents, capable of delivering the appropriate technique for the problem at hand, at the time of need.; The CBT-Light teletherapy group is a brief, 4-week intervention held once weekly for an hour, and limited to those triaged into the Children's Hospital of the King's Daughters low-intensity track and participating in this protocol. An assigned study clinician will facilitate each teletherapy group with approximately 10 adolescents in each session. Each group begins with orientation and reviewing group rules, individual check-ins with each participant (rating stress level and hopefulness), followed by a guided mindfulness moment. Sessions are designed to draw from elements of cognitive behavioral therapy (CBT) and the 4 topics include: building a coping tool box, accepting your feelings, challenging negative thoughts, and problem solving.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mental Health; Adolescence; Digital Therapeutic; Cognitive Behavioral Therapy; Chatbot; Mental Health App
Essure (Model ESS310) Placement Rate Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and successful placement rate of Essure Model ESS310 device and any
      factors that may influence the successful placement rate of this device.
    


Intervention name(s): ESS310 (BAY1454032)
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Birth control
A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Condition: Type 2 Diabetes Mellitus
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with
      type 2 diabetes mellitus who have moderate renal impairment.
    

Detailed description: 
      This is an open-label, randomized, 2-way crossover study to evaluate the PK/PD and safety of
      TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment relative
      to patients with type 2 diabetes mellitus who have normal renal function. The patients will
      receive both TA-7284-Low and TA-7284-High orally alone in either Period 1 or 2.
    

Intervention name(s): TA-7284 Low; TA-7284 High
Intervention type(s): Drug; Drug
Intervention description(s): Low; High
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TA-7284; JNJ-28431754; Canagliflozin; Renal Impairment; Sodium Glucose Co-transporter2 (SGLT2) inhibitor
Biochemical Marker to Predict the Recurrence of Atrial Fibrillation After Surgical Maze Procedure
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The role of plasma NT-proBNP, hsCRP, TIMP-1(Tissue inhibitors of MetalloProteinase-1),TGF-b,
      MMP-3(Matrix MetalloProteinase-3), and pro-MMP-1 in predicting the recurrence of AF after
      surgical Maze procedure.

      The association of expression of CTGF, TGF-b, BNP, ANP, collagen-1, and collagen-3 in LA with
      the recurrence of AF after surgical Maze procedure.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients who have valvular heart disease with atrial fibrillation and are scheduled for
        operation
      
Biospecimen description: 
      plasma mRNA
    
Keywords: Atrial fibrillation; Maze procedure
Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe
Condition: Healthy Participants
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to develop an auto-injector (AI) device for the BMS-986036
      subcutaneous formulation that can be self-administered conveniently by participants.
    


Intervention name(s): BMS-986036
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized Trial on Platelet Rich Plasma Versus Saline Dressing of Diabetic Foot Ulcers
Condition: Diabetic Foot
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional

Summary: 
      New treatments for persistent DFU have emerged, among which are the bioengineered skin
      substitutes, extracellular matrix proteins products, matrix metalloproteinases modulators,
      and growth factor therapy. Platelet rich plasma (PRP) gel has been used for stimulating wound
      healing since the last decade of the 20th century. This randomized trial was conducted to
      assess the role of PRP in gel form as a treatment for clean non-healing diabetic foot ulcer
      in comparison to regular dressing with saline as a control.
    


Intervention name(s): PRP gel; Saline dressing
Intervention type(s): Drug; Drug
Intervention description(s): The PRP gel is applied on the ulcer twice per week; Normal saline is used for dressing of the ulcer twice a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study on the Impact of the Mediterranean Diet and Intermittent Fasting
Condition: Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      This clinical trial attempts to evaluate the feasibility and acceptability of an intervention
      combining intermittent fasting and the Mediterranean diet guidelines vs an comparative
      intervention combining intermittent fasting but using the UK dietary guidelines.

      Participants will be randomised to these intervention using a parallel design. Weight change
      and blood lipids will be assessed.
    

Detailed description: 
      This study will have a randomised parallel study comparing two interventions involving
      intermittent fasting. One of the interventions will use the Mediterranean dietary guidelines
      proposed by the Mediterranean Diet Foundation, the other intervention will use the UK dietary
      guidelines (Eatwell Guide).

      In this study, the interventions will require participants to adopt these interventions for 4
      weeks. A basic website containing support information will be develop for each of these
      interventions.

      Baseline measurements will be taken at the start of the study. Blood samples will be obtained
      in a fasted state before and after 4-week study period.

      Anthropometric and body composition measurements including height and weight, waist
      circumference, bioelectrical impedance will be collected by researcher. Physical activity
      will be assessed using accelerometers.
    

Intervention name(s): Mediterranean diet guidelines plus intermittent fasting; UK Eatwell guidelines plus intermittent fasting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): For 4 weeks participants will be encouraged to adopt the Mediterranean dietary guidelines as recommended by the Mediterranean Diet Foundation in Barcelona, Spain. In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days.; For 4 weeks participants will be encouraged to adopt the UK dietary guidelines (Eatwell Guide). In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of End-tidal Carbon Dioxide (ETCO2) Measured by Transportable Capnometer (EMMATM) and the Arterial pCO2 in General Anesthesia
Condition: End Tidal Carbon Dioxide of Patients Undergoing General Anesthesia
Study type: Interventional

Summary: 
      An end-tidal CO 2 monitor (capnometer) is used most often as a noninvasive substitute for
      PaCO2 in anesthesia, anesthetic recovery and intensive care. There is now also wide-spread
      use of capnometry on-site at emergency and trauma fields. So, portable device can be used
      usefully.
    


Intervention name(s): End-tidal CO2(portable capnometer)
Intervention type(s): Device
Intervention description(s): End-tidal CO2(portable capnometer: EMMATM, Side stream capnometry module:Datex-Ohmeda S5 Anesthesia Monitor )levels were recorded at the time of arterial blood gas sampling.
Other intervention name(s): EMMA(TM )
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: end-tidal CO2; capnometer