bioihbjkbjnl/mcl2 huggingface dataset:
FDA Cigarette Warning Labels: Eye Tracking Study
Condition: Smoking, Cigarette
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effect of cigarette pictorial warning label
      content (lesser-known vs well-known risks) on visual engagement, recall, and knowledge of
      tobacco use harms.
    

Detailed description: 
      This laboratory-based study will aim to enroll 120 current cigarette users to complete a
      1-day cross-sectional, randomized, parallel design protocol.

      The participants will be randomized to one of two conditions, pictorial warning labels (PWLs)
      with well-known or lesser-known tobacco harms. After completing a baseline questionnaire, the
      participants will view 4 warning labels from the assigned group and complete a follow-up
      questionnaire. Eye-tracking will provide data on visual processing of the warning labels and
      the effect of these labels on knowledge, attitudes, and beliefs about smoking will be
      supplemented by self-report.
    

Intervention name(s): Pictorial Warning Labels
Intervention type(s): Other
Intervention description(s): Participants will be randomized to one of two conditions and will view 4 pictorial warning labels from the assigned group for an eye-tracking task.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a 2 x 2 factorial design experimental study using objective measures and self-report survey. We will recruit 120 daily smokers (60 young adults and 60 adults) to participate in a single-session laboratory-based study. The participants will be assigned to either the lesser-known or well-known PWL group. After completing a baseline questionnaire, the participants will view 4 warning labels in a randomized order from their assigned group followed by a follow-up questionnaire. Primary outcomes will be eye-tracking measures, label recall and recognition, and knowledge of tobacco harms.
Masking: Single (Participant)
Primary purpose: Other
Keywords: Pictorial warning labels; Cigarette smoking; Eye-tracking
Mindfulness Based Interventions in Pediatric Nurses
Condition: Behavior, Health
Study type: Interventional

Summary: 
      The aim of the study was to evaluate the effect of the Mindfulness Stress Reduction
      Intervention on increasing the psychological resilience of pediatric nurses.

      Design: This is a single-center, single-blind, randomized controlled trial

      Method:

      In the study, the group in which the Mindfulness-Based Stress Reduction Initiative was
      applied was taken as the experimental (n: 15), the unstructured group (n: 14) in which the
      stressful life experiences were shared as the control group. Due to the limited number of the
      research population (N:56), 29 nurses who agreed to participate in the study and met the
      inclusion criteria were included in the study without using the sampling method. This
      research was conducted with pediatric nurses working in the inpatient units of a children's
      hospital affiliated to a university in Izmir. Stress reduction training based on mindfulness,
      including meditation and breathing techniques, was given to the experimental group for 5
      weeks. No intervention was applied to the control group.

      The primary outcomes of the study were measured using the Perceived Stress Scale, the
      Self-Compassion Scale, the Interpersonal Reactivity Index, and Psychological Resilience Scale
      for Adults.

      This study is important because it is the first randomized controlled study on the effect of
      Mindfulness Based Stress Reduction (MBSR) on resilience in nurses in our country.

      In addition, the results will contribute to preventing nurses from leaving the profession in
      the early period, providing more flexibility and therefore safe patient care to the nursing
      workforce, especially in today's health system where there is a heavy nursing shortage.
    


Intervention name(s): Mindfulness Based Interventions in Pediatric Nurses
Intervention type(s): Other
Intervention description(s): This intervention are structured mindfulness program including meditation and breathing techniques .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pediatric Nurse; Psychological Resilience; Mindfulness
Pharmacokinetics of Faldaprevir of Soft Capsule
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the trial is to assess the bioavailability of Faldaprevir soft capsule with single
      oral dose and multiple oral doses in Chinese subjects
    


Intervention name(s): faldaprevir(high dose); Faldaprevir(low dose)
Intervention type(s): Drug; Drug
Intervention description(s): faldaprevir(high dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to high dose treatment in random order; faldaprevir(low dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to low dose treatment in random order
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cold Induced Activation of Brown Adipose Tissue in Winter Swimmers
Condition: Adipose Tissue; Brown Adipose Tissue; Brown Fat; Uncoupling Protein 1; Adipokines; Proteomics; Infra-red Thermography; BAT; Winter Swimmers; Type2 Diabetes; Proteins
Study type: Interventional

Summary: 
      This study investigates cold-induced brown fat activation in winter swimmers and not-winter
      swimmers by skin temperature measures assessed with infra red thermography imaging and skin
      temperatures. Winter swimmers and not-winter swimmers will participate in an acute cooling
      intervention and thermoneutral intervention for comparison of energy expenditure and skin
      temperatures at the supraclavicular area.
    

Detailed description: 
      The field of human brown adipose tissue (BAT) research is focused on activation of BAT as a
      means of manipulating energy expenditure and potentially anti-obesity and anti-diabetic
      properties of the tissue. This is well established in rodent studies and explained as due to
      the specific brown fat uncoupling protein 1 (UCP1). Despite increasing evidence that
      indicates a metabolic regulatory role of BAT in humans, BAT activation/recruitment is not
      fully understood.

      Cold induced brown fat activity will be measured by skin temperature measures by means of
      infra-red thermography imaging and skin temperature.

      15 healthy male winter swimmers and 8 healthy male non-winter swimmers (controls) will be
      included in the study.
    

Intervention name(s): Cooling
Intervention type(s): Procedure
Intervention description(s): Individualized cooling protocol
Other intervention name(s): Cold activation; Cold stimulation; Cold activation of BAT
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
A Study of t:Slim X2 With Control-IQ Technology
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to learn whether an investigational automated insulin delivery
      system ("study system") for children with type 1 diabetes can safely improve blood glucose
      (sometimes called blood sugar) control. The system uses continuous glucose monitoring (CGM),
      an insulin pump, and a software algorithm to automatically give insulin and control blood
      glucose. This is called a "closed-loop control" system.
    

Detailed description: 
      After consent is signed, eligibility will be assessed. Eligible participants not currently
      using an insulin pump and Dexcom CGM with minimum data requirements will initiate a run-in
      phase of 2-4 weeks that will be customized based on whether the participant is already a pump
      or CGM user. Participants who skip or successfully complete the run-in will be randomly
      assigned 3:1 to the use of closed-loop control (CLC group) using t:slim X2 with Control-IQ
      Technology vs. Control Group for 16 weeks. The Control Group will be offered to transition to
      use CLC and the experimental arm will extend their use of CLC for 12 weeks.
    

Intervention name(s): t:slim X2 with Control-IQ Technology & Dexcom G6 CGM; Control Group
Intervention type(s): Device; Device
Intervention description(s): Eligible participants will be use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology & Dexcom G6 CGM; Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Other intervention name(s): Experimental; Sensor-Augmented Pump (SAP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Artificial Pancreas (AP); Control-IQ System; Insulin Pump; Closed Loop Control (CLC); Continuous Glucose Monitor (CGM); Multiple Daily Injections (MDI); Sensor Augmented Pump (SAP)
A Study to Investigate the Influence of Hepatic Impairment on MK-8189 Treatment (MK-8189-012)
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics (PK) of MK-8189 in participants
      with moderate hepatic impairment (based on the Child-Pugh classification) to healthy
      participants. This is Part 1 of the study; following review of the safety and PK data from
      Part 1, a decision will be made as to whether Part 2 of the study will be initiated. If done,
      Part 2 of the study will compare the PK of MK-8189 in participants with mild hepatic
      impairment to healthy participants.
    


Intervention name(s): MK-8189
Intervention type(s): Drug
Intervention description(s): Administered at a dose of 4 mg via oral tablet
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Closed-loop System Using Transcranial Direct Current Stimulation (tDCS) for Epilepsy
Condition: Epilepsy; Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional

Summary: 
      In this pilot study, the researchers investigated the feasibility of a closed-loop
      electroencephalography (EEG) / transcranial direct current stimulation (tDCS) system for
      treatment of epilepsy. They looked to see the feasibility of triggering tDCS stimulation
      within 10 seconds of a detected EEG partial-onset seizure, and also a proof-of-principle
      determination of whether tDCS applied during this vulnerable period may be feasible to
      prevent the oncoming seizure.

      This study required 5 visits over the course of approximately 8 weeks. Each visit was
      separated by at least 2 weeks. Two of the visits had 24-hour EEG monitoring sessions. During
      these two sessions, the EEG and tDCS were hooked into a closed loop system, such that when
      seizure activity wasdetected, the tDCS was triggered to deliver stimulation. Subjects
      received active stimulation or sham stimulation sessions during the first 24-hour visit, and
      the opposite during the second. The subjects were randomized and counterbalanced.

      We have also added a healthy subjects cohort to assess the feasibility of the closed loop
      system. In order to test the proof-of-concept of this system, the experiment will focus on
      detecting and acting upon alpha- and beta-band changes traced in the EEG activity that is
      being recorded, and provide tDCS stimulation based upon those changes. We will enroll 6
      subjects who will have 2 visits each. During these two visits subjects will be randomized to
      active or sham stimulation sessions and receive the opposite during their second visit.
    


Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): For both active and sham tDCS, the device will be hooked up to the closed loop system, using electrodes of 35cm^2. During active tDCS, the subject will receive 2mA for 5 min. During sham tDCS, the current will only be active for 30 seconds (current ramping up and then down) to simulate the sensations of active tDCS.
The subject will undergo either active or sham stimulation for their first 24-hour EEG monitoring visit, and the opposite intervention on the second 24-hour EEG monitoring visit.
Other intervention name(s): low intensity 1x1 direct current stimulator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: transcranial direct current stimulation; electroencephalography
Genecept Assay™ vs. Treatment-as-Usual to Evaluate Efficacy of Assay-Guided Treatment in Adults With MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      In this randomized clinical trial, subjects will be assigned to either an assay-guided
      treatment condition (AGT) or a treatment-as-usual condition (TAU). All subjects will provide
      a DNA sample at the Screening Visit for the Genecept Assay ™. In the AGT condition, assay
      results will be provided to the treating investigator, who will use the results to guide
      antidepressant pharmacotherapy. In the TAU condition, the investigator will treat the
      subjects without the knowledge of the pharmacogenetic testing results. Assay results for all
      subjects will be provided to the investigator once all Week 8 visit procedures have been
      completed. Raters of the primary endpoint assessment and subjects will remain blinded to
      treatment assignment.
    

Detailed description: 
      This study compares efficacy and safety outcomes in Major Depressive Disorder (MDD) adult
      patients randomized to assay-guided treatment (AGT) or treatment-as-usual (TAU). The
      treatment duration will be 8-weeks. Subjects will be assessed at visits at Week 2, 4, 6 and
      8. Approximately 300 subjects will be randomized 1:1 to the two treatment group (AGT and
      TAU). This is a multi-center trial, with approximately 25 sites in the US. Randomization will
      be by IWRS. The treating investigator will be unblinded to treatment assignment
      (necessarily). Other site staff, sponsor staff (including site monitors) and all others will
      be blinded to treatment assignment for the duration of the subject's participation in the
      study. The (blinded) rater for the primary endpoint, the SIGH-D-17 Hamilton Depression Scale,
      will have no other contact with the subject such as collection of screening data, follow-up
      assessments, documentation of adverse events, etc. Blinded raters will not discuss subjects
      with other study staff.

      After recruitment for main study is completed, an additional 70 subjects , age 65 years and
      older will be randomized to the Exploratory Elderly MDD Study. This follow-on sub-study will
      apply all procedures of the main study to this elderly population subset.
    

Intervention name(s): Assay-guided treatment (AGT); Treatment-as-usual (TAU)
Intervention type(s): Genetic; Other
Intervention description(s): The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.; Subjects are treated-as-usual without the aid of the assay.
Other intervention name(s): Genecept Assay™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Genotyping; Genecept Assay™
Assessment of the INVOcell Culture Device When Used for up to Five-Day Incubation
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The INVOcell Culture Device received de novo request for 3-day intravaginal incubation. The
      device is held in place with the intravaginal cavity by a Retention Device. The clinical
      study will assess the ability of a modified Retention Device to hold INVOcell in place during
      5-day vaginal incubation as well as comfort and vaginal irritation as secondary endpoints.
    

Detailed description: 
      This is a single center, open label non-comparative prospective trial to evaluate the
      retention of the INVOcell IVC with the Retention Device over the vaginal incubation period of
      up to 5 days.

      The purpose of this study is to assess the retention of the INVOcell IVC device with the
      Retention Device over the vaginal incubation period of up to 5 days.

      Primary Endpoint

      • Retention of the INVOcell IVC device with the Retention Device over the vaginal incubation
      period of up to 5 days.

      Secondary Endpoint

        -  Comfort of the INVOcell IVC and Retention Device

        -  Vaginal tissue reactions during the vaginal incubation

        -  Optical clarity and the ability to visualize the embryos after the incubation
    

Intervention name(s): INVOcell
Intervention type(s): Device
Intervention description(s): Female participants undergoing in vitro fertilization (IVF) and or/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproductive will be asked to participate
Other intervention name(s): Intravaginal Culture; IVC; Vaginal incubation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of the Dapivirine Vaginal Ring in Lactating Women
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 PK Study of the Dapivirine Vaginal Ring in Lactating Women.
    

Detailed description: 
      PK Study of the Dapivirine Vaginal Ring in Lactating Women.
    

Intervention name(s): Dapivirine
Intervention type(s): Drug
Intervention description(s): Participants will receive a silicone elastomer vaginal matrix ring containing 25 mg of dapivirine to wear for approximately 14 continuous days. Participants age 18 and over, at least 6 weeks postpartum, able to produce and express breast milk for 14 consecutive days.
Other intervention name(s): Dapivirine vaginal ring
Intervention MeSH terms: Dapivirine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevention; Lactating Women; Healthy
Spatz Adjustable Balloon for Obesity (SABO)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the Spatz3 Adjustable balloon, a
      non-surgical device, is effective in the treatment of obesity.
    

Detailed description: 
      Device Name: Spatz3 Adjustable Balloon System® (Spatz3) Clinical Phase: Pivotal Trial Design:
      Multicenter open-label randomized controlled trial Trial Participants: Adults, ages 22-65,
      with a BMI ≥ 30 and < 40 who have failed to achieve and maintain weight-loss with a weight
      control program Control group: Supervised diet and exercise Planned sample size: 282 subjects
      randomized 2:1 to device/control study treatment duration: 32 weeks Primary endpoint: Percent
      change in total body weight (%TBL) at 32 weeks
    

Intervention name(s): Spatz3 Adjustable Balloon
Intervention type(s): Device
Intervention description(s): An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight loss
Trial Comparing Part-time Versus Full-time Patching for Severe Amblyopia
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      The goals of this study are:

        -  To determine whether the visual acuity improvement obtained with part-time (6 hours)
           patching is equivalent to the visual acuity improvement obtained with full-time patching
           (all or all but one waking hour) for severe amblyopia.

        -  To develop more precise estimates than currently available for the visual acuity
           improvement that occurs during treatment of amblyopia with patching.

        -  To identify factors that may be associated with successful treatment of amblyopia with
           patching.
    

Detailed description: 
      Amblyopia is the most common cause of monocular visual impairment in both children and young
      and middle-aged adults. Patching has been the mainstay of amblyopia therapy. It is generally
      held that the response to treatment is best when it is instituted at an early age,
      particularly by age two or three, and is poor when attempted after eight years of age.

      For severe amblyopia, it is generally accepted that occlusion with patching is the standard
      of care. Other modalities of treatment, such as atropine penalization and optical
      penalization, are widely considered insufficient as initial treatments for severe amblyopia.
      However, controversy exists with regard to how many hours per day of patching should be
      prescribed. Advocates of full-time patching purport that such a regimen is needed to restore
      visual acuity more rapidly and more effectively. Advocates of part-time patching believe it
      to be better tolerated by the child and family, therefore producing less stress on the
      parent-child relationship and producing better results through better compliance. Part-time
      patching may also promote the development of binocularity in patients who have
      "straight-eyes", reduce the chance of a straight-eyed patient developing manifest strabismus
      or losing stereopsis, and reduce the incidence of reverse- or occlusion-amblyopia.

      The study is a randomized trial comparing daily patching regimes for children with severe
      amblyopia. It will consist of about 160 children. Patients in the severe (20/100 to 20/400)
      group will patch part-time (6 hours) or full-time (all or all but one waking hour) of each
      day for the 4 month study period. There are at least two follow up visits during the 4-month
      period. Visual acuity is the major study outcome. It is assessed at the 4-month exam.
    

Intervention name(s): Eye patch
Intervention type(s): Device
Intervention description(s): adhesive eye patch used to cover the sound eye
Other intervention name(s): Coverlet; Opticlude
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment