bioihbjkbjnl/mcl2 huggingface dataset:
Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification
Condition: Refractive Errors
MeSH terms: Cataract; Refractive Errors; Capsule Opacification
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Multifocal IOLs that maintain distance focus and improve near vision have been developed to
      reduce spectacle dependence.Multifocal IOLs improve patient performance of near-vision tasks,
      such as reading crafts, hobbies, and social activities to a greater extent than do monofocal
      IOLs. However, halos and reduced contrast sensitivity have been associated with multifocal
      IOLs and are common reasons for patient's dissatisfaction.Trifocal technology has been
      developed to create intermediate focus to overcome these difficulties. Continuous reports of
      the visual outcomes of the FineVision trifocal IOLs are encouraging.
    

Detailed description: 
      Monofocal IOLs, which provide effective distance vision, currently account for the majority
      of IOLs implantations. Patients who have undergone cataract surgery with implantation of
      monofocal IOL may require spectacles to perform near-distance (e.g., reading) or
      intermediate-distance (e.g., using a computer) tasks depending on their visual
      demandsMultifocal IOLs that maintain distance focus and improve near vision have been
      developed to reduce spectacle dependence.Multifocal IOLs improve patient performance of
      near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent
      than do monofocal IOLs. However, halos and reduced contrast sensitivity have been associated
      with multifocal IOLs and are common reasons for patient's dissatisfaction.Trifocal technology
      has been developed to create intermediate focus to overcome these difficulties. Continuous
      reports of the visual outcomes of the FineVision trifocal IOLs are encouraging.
    

Intervention name(s): Trifocal diffractive intraocular lens
Intervention type(s): Device
Intervention description(s): Trifocal IOL having foldable single-piece fully diffractive pupil dependent aspheric IOL. Which have been made of hydrophilic acrylic with an ultraviolet (UV) and blue light inhibitor. It has an optic diameter of 6.15 mm and an overall diameter of 10.75 mm; it has +3.5D additional power for near vision and +1.75 D additional power for intermediate vision, consisting of 26 diffractive steps.
Other intervention name(s): (FineVision IOL)
Intervention model: Single Group Assignment
Intervention model description: This is a prospective, non-comparative, non-randomized study including 36 eyes had implantation of trifocal diffractive IOL
Masking: None (Open Label)
Primary purpose: Treatment
Reducing Adolescent Pregnancy
Condition: Pregnancy in Adolescence; Counseling; Contraception Behavior
Study type: Interventional

Summary: 
      This multi-site study is employing a brief contraception counseling intervention in the
      Emergency Department (ED) to shed light on factors that affect decision making as well as
      barriers and facilitators to conception initiation in the Emergency Department (ED) setting.
      The overarching goal of the study is to reduce unintended pregnancy among females ages 15 to
      18 who present to the Emergency Department (ED).
    

Detailed description: 
      This study is a prospective cohort study involving females who present to one of two
      emergency departments (ED) between the ages of 16 and 18, who are at risk of unintended
      pregnancy.

      Our primary objective is to assess intention to initiate contraception ("high"=very/somewhat
      likely vs "low"=unsure/not likely/definitely not on Likert scale survey) among females aged
      15 to 18 years who receive emergency department-based contraceptive counseling.

      Our secondary objectives are as follows:

        1. Among the same population, assess completion of a referral for any contraceptive care,
           defined as attendance at a referral site within 4 weeks after the index ED visit.

        2. Assess the proportion who ultimately initiate contraception through electronic medical
           record documentation (i.e., visit note, procedure note, medication review) and
           participant report (follow-up calls).

        3. Use qualitative interview methodology to explore attitudes, barriers, and facilitators
           that affect decisions to A) express intention to initiate contraception, B) complete a
           referral for contraceptive care, and C) ultimately initiate contraception among this
           unique group of high-risk adolescents.
    

Intervention name(s): Contraception Counseling
Intervention type(s): Behavioral
Intervention description(s): Each participant will receive a 10 minute confidential contraception counseling session with an APP in the Emergency Department
Intervention model: Single Group Assignment
Intervention model description: Contraception counseling will occur for all adolescent participants and APPs will be enrolled to conduct counseling. The number of participants enrolled includes the final number of participants including adolescent and APPs.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception counseling; Adolescent pregnancy; Contraception initiation
iQuit Mindfully: Text Messaging for Smoking Cessation
Condition: Cigarette Smoking
Study type: Interventional

Summary: 
      The purpose of this study is to investigate text messaging as a way to enhance
      mindfulness-based treatment for smoking cessation.
    

Detailed description: 
      This study is a pilot investigation of mindfulness-based smoking cessation treatment
      incorporating between-session text messaging ("iQuit Mindfully"). Participants will be
      randomly assigned to one of two groups: Mindfulness-based Addiction Treatment (MBAT) or iQuit
      Mindfully (MBAT with the addition of between-session text messages).

      All participants will receive in-person group treatment based on the 8-week MBAT protocol in
      addition to nicotine patch therapy and self-help materials. Participants assigned to iQuit
      Mindfully will receive additional support via text messaging. Assessments will occur at
      baseline, at each of the weekly in-person visits, at end of treatment, and at 1-month
      follow-up. Feasibility, smoking abstinence, mindfulness practice, and indicators of tobacco
      dependence and psychological well-being will be assessed.
    

Intervention name(s): Mindfulness-based Addiction Treatment; iQuit Mindfully; Self-Help guide; Nicotine Patch
Intervention type(s): Behavioral; Behavioral; Behavioral; Drug
Intervention description(s): Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).; iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.; Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).; Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
Other intervention name(s): Mindfulness-based text messaging for smoking cessation; Generic Nicotine Patch
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy
Condition: Hallux Valgus
MeSH terms: Hallux Valgus; Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR
      50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours
      (SPID48) to measure analgesic effect in Korean patients with acute pain following
      bunionectomy.
    

Detailed description: 
      This is a randomized (study drug assigned by chance like flipping a coin), double-blind
      (neither physician nor patient knows the name of the assigned drug), placebo-controlled,
      parallel-group, multicenter study to evaluate the efficacy and safety of tapentadol
      immediate-release (IR) 50 mg and 75 mg in patients who are undergoing bunionectomy (a
      surgical procedure to remove a bunion). This study was designed to be a similar study to the
      pivotal global study of PAI-3003/KF32 in order to bridge the results from the global studies
      and to show similarity in effect of tapentadol between Korean and Caucasian population which
      will allow extrapolation of the foreign clinical data of tapentadol into Korea. The study
      will be divided into screening period, surgical period, qualification period, and a
      double-blind treatment period. The study length, including the screening period, will be up
      to a maximum duration of 32 days. Eligible patients will be randomly assigned to 1 of 3
      treatment groups (tapentadol IR 50 mg, tapentadol IR 75 mg or placebo) in a 1:1:1 ratio.
      Efficacy and safety assessments will be performed during the study.
    

Intervention name(s): Tapentadol IR 50 mg; Tapentadol IR 75 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Type= exact number, unit= mg, number= 50, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours.; Type= exact number, unit= mg, number= 75, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours.; Form= tablet, route= oral use. Placebo tablets will be administered as a single oral dose every 4 to 6 hours, for a period of 72 hours.
Intervention MeSH terms: Tapentadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Hallux Valgus; Bunionectomy; Bunion; Acute pain; Tapentadol; Tapentadol IR
Placental Cord Drainage After Vaginal Delivery
Condition: Blood Loss
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      Placental Cord Drainage after Vaginal Delivery A randomized clinical trial
    


Intervention name(s): Cord drainage; Cord clamping
Intervention type(s): Other; Other
Intervention description(s): Cord drainage; Cord clamping
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Tampon Design Validation Study
Condition: Menstruation
Study type: Interventional

Summary: 
      This prospective multi-center, open-label, randomized, cross-over study is designed to
      validate the user needs of a tampon design. The hypothesis is that user needs are met.
    


Intervention name(s): Tampon BR; Tampon CR; Tampon BS; Tampon CS
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Modified Regular Absorbency Tampons; Reference Regular Absorbency Tampons; Modified Super Absorbency Tampons; Reference Super Absorbency Tampons
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Objective Evaluation of Patients With Palmar Hyperhidrosis Submitted to Two Levels of Sympathectomy: T3 and T4.
Condition: Hyperhidrosis; Quality of Life
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      Compare the results obtained with video-assisted sympathectomy performed in two distinct
      levels ganglionic (third versus fourth thoracic ganglion) for the treatment of palmar
      hyperhidrosis, through a blind randomized clinical trial using an objective method to measure
      the sweat before and after the operation.
    

Detailed description: 
      Currently, the treatment of choice for treating palmar hyperhidrosis (PH) is video-assisted
      thoracic sympathectomy (VATS) . This minimally invasive technique has been well standardized
      and provides adequate results with low morbidity.

      The main side effect of VATS is compensatory hyperhidrosis (CH). This is present in most
      cases and is considered the greatest cause of dissatisfaction. To reduce the risk of CH,
      various studies have been conducted to compare different levels of ganglion resection. These
      studies have been based on subjective quantification of sweating (assessment of sweating
      reported by patients) and on the application of quality-of-life questionnaires.

      Recently, tests for the objective evaluation of sweating have been developed to quantify
      sweating among patients with various diseases, including PH. So far, there have not been any
      studies comparing the long-term results of thoracic sympathectomy on the third ganglion (G3)
      versus the fourth ganglion (G4)with objective evaluation to quantify sweating.

      The present study was prospective, randomized and blinded, with the objective of comparing
      the results from VATS at two different resection levels: G3 versus G4. All the patients were
      followed over a one-year period, and their palmar sweating was quantified using a portable
      device (VapoMeter) to measure transepidermal water loss (TEWL). In addition, CH was evaluated
      by applying a specific quality-of-life questionnaire.
    

Intervention name(s): Video-assisted sympathectomy
Intervention type(s): Procedure
Intervention description(s): All participants were randomized into two groups of 20 patients (G3 and G4) and underwent video-assisted sympathectomy, being followed for 12 months. During this period, the subjects completed a questionnaire about quality of life and carried out the measurements of sweat by VapoMeter.
Other intervention name(s): Thoracic sympathectomy; Endoscopic thoracic sympathectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hyperhidrosis; Thoracic sympathectomy; Objective measurement of sweat
Optimized Glycemic Control in Heart Failure Patients With DM2:"Effect on Left Ventricular Function and Skeletal Muscle"
Condition: Type 2 Diabetes; Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators wish to investigate wether a more strict diabetic control improves cardiac
      function, muscle strength, exercise capacity and decreases symptoms.

      The investigators hypothesis is that improving the glycemic control in suboptimized diabetics
      with heart failure will improve cardiac performance, muscle strength, exercise capacity and
      decrease symptoms.
    


Intervention name(s): all antidiabetic drugs will be appliable
Intervention type(s): Other
Intervention description(s): We expect all participants to be set on insulin during the intervention, however all types of insulin and other antidiabetics can be used goal: Hba1c lower than 7,5%
Intervention MeSH terms: Hypoglycemic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
No Antimicrobial Prophylaxis for Laparoscopic Distal Gastrectomy
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the feasibility and safety of no use of antimicrobial
      prophylaxis during laparoscopic distal gastrectomy for gastric carcinoma.
    

Detailed description: 
      This is a phase II clinical trial investigating the postoperative surgical site infection
      (SSI) rates after no antimicrobial prophylaxis use during laparoscopic distal gastrectomy.
      Target ranges of SSI rates after laparoscopic distal gastrectomy were determined based on the
      previous reports and our data. If SSI rates are within the target range, the investigators
      will proceed to a randomized controlled trial investigating the efficacy of no antimicrobial
      use for laparoscopic gastrectomy.
    

Intervention name(s): No Antimicrobial prophylaxis
Intervention type(s): Other
Intervention description(s): Antimicrobial prophylaxis are not administered during an operation
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stomach neoplasms; Surgical site infection; Laparoscopic gastrectomy; Antimicrobial prophylaxis
Evaluate the Pharmacokinetics of CC-220 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared With Healthy Subjects
Condition: Hepatic Impairment; Healthy Volunteers
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, open-label study to assess the PK of a single 1-mg oral dose of CC-220
      in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy
      control subjects with normal hepatic function.

      Degree of hepatic impairment will be determined during the Screening period by the subject's
      score according to Child-Pugh Classification Criteria
    

Detailed description: 
      Subjects will be enrolled in Groups 1 through 5 as follows:

        -  Group 1: Approximately 8 male or female subjects with mild hepatic impairment (with a
           Child Pugh score of ≥ 5 to ≤ 6) will be enrolled in Group 1.

        -  Group 2: Approximately 8 male or female subjects with moderate hepatic impairment (with
           a Child Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group 2.

        -  Group 3: Approximately 8 male or female subjects with severe hepatic impairment (with a
           Child Pugh score of ≥ 10 to ≤ 13) will be enrolled in Group 3.

        -  Group 4: Approximately 8 healthy male or female subjects with normal hepatic function
           will be enrolled in Group 4. Subjects in Group 4 will be matched to subjects in Group 2
           with respect to sex, age (± 10 years), and weight (± 13.6 kg [30 pounds]).

        -  Group 5: Approximately 8 healthy male or female subjects with normal hepatic function
           will be enrolled in Group 5. Subjects in Group 5 will be matched to subjects in Group 3
           with respect to sex, age (± 10 years), and weight (± 13.6 kg [30 pounds]).

      Subjects with mild, moderate, and severe hepatic impairment and subjects with normal hepatic
      function may start the study in parallel.
    

Intervention name(s): CC-220
Intervention type(s): Drug
Intervention description(s): CC-220
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic impairment; Healthy Subjects; CC-220; Pharmacokinetics
Bioequivalence Study of Lamotrigine Extended-Release Tablets 50 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study of Lamotrigine Extended Release tablets 50 mg of Dr.
      Reddy's Laboratories Limited, India comparing with that of LAMICTAL XR(containing
      Lamotrigine) Extended Release tablets 50mg of GlaxoSmithKline Research Triangle Park, NC in
      healthy, adult, human subjects under fasting conditions.
    

Intervention name(s): Lamotrigine
Intervention type(s): Drug
Intervention description(s): Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
Other intervention name(s): LAMICTAL XR
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Lamotrigine Extended Release; crossover
The Impact of Vocational Rehabilitation on Mentally III Veterans
Condition: Posttraumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      To study the impact of Individual Placement and Support (IPS) supported employment (SE)
      compared to treatment-as-usual vocational rehabilitation program (VRP) for veterans with
      posttraumatic stress disorder (PTSD).
    

Detailed description: 
      Objectives: to study the impact of Individual Placement and Support (IPS) supported
      employment (SE) compared to treatment-as-usual vocational rehabilitation program (VRP) for
      veterans with posttraumatic stress disorder (PTSD).

      Research Design: This prospective randomized study evaluates the impact of IPS-SE compared to
      VRP on occupational, sobriety, psychiatric, and quality of life outcomes and health care
      costs for veterans with chronic PTSD who enter the Tuscaloosa VA Medical Center's (TVAMC)
      vocational rehabilitation program.

      Methodology: Occupational functioning is determined primarily by whether the veteran can
      obtain and maintain competitive employment, and, secondarily, by time worked and wages earned
      for those employed. Veterans who meet inclusion criteria will be randomized to either IPS-SE
      or VRP. Outcomes will be assessed over a fixed 12-month observation period (beginning at
      randomization and computed for the entire 12-month observation period) as percent subjects
      employed at least one week (employed rate), and monthly employment rates (maintained employed
      rate). In addition, PTSD symptoms and other health-related quality of life measures will be
      evaluated. This strategy uses all available data during the 1-year period.
    

Intervention name(s): Vocational Rehabilitation Program (VRP); Individual Placement and Support (IPS)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Vocational Rehabilitation Program (VRP) is a treatment-as-usual method using traditional train-place approaches, such as prevocational work skills training , compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist; Individual Placement and Support (IPS) is an evidence--based model of supported employment that emphasizes rapid job search within client preferences, community job development, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of the IPS specialist within the treatment team.
Other intervention name(s): Transition work program (TWP); Supported emplooyment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Posttraumatic Stress Disorder; Veterans; Vocational Rehabilitation; Supported Employment; Individual Placement and Support