bioihbjkbjnl/mcl2 huggingface dataset:
Prospective Cardiac Ultrasound Imaging Study With Demonstrator
Condition: Ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular
Study type: Interventional

Summary: 
      The Prospective Cardiac Ultrasound Imaging Study is a single center, single arm, feasibility
      study. The study aims at collecting cardiac ultrasound data from patients diagnosed with
      ventricular tachycardia, during rest and short breath hold sequences. This study is part of
      the engineering studies linked to the CardioKit-Minimum Viable Product project. The CardioKit
      prototype used in the study can monitor cyclical heart-beat motion, cyclical respiratory
      motion and non-cyclical heart position changes while the patient is lying in supine position.
    

Detailed description: 
      The research will analyse the ultrasound image data quality, especially investigating the
      ability of the prototype system to automatically and correctly interpret ultrasound images
      and artifact issues which may arise from age, body composition, mechanical valves, leads from
      implanted devices, or other implants. The study will establish if it is appropriate to
      develop a new medical device supporting automated cardiac ultrasound image interpretation
      during non-invasive cardiac procedures, i.e. ventricular tachycardia stereotactic
      radioablation. This early research protocol did collect data from 24 adult patients. The data
      were not used for diagnostic nor treatment purposes and the protocol's procedure duration was
      limited to one hour, hence the research was considered of very limited risk for the
      participants. The research will provide a Proof-of-Concept for a Medical Device to benefit
      patients with ventricular tachycardia and other cardiac pathologies in the future.
    

Intervention name(s): Cardiokit
Intervention type(s): Device
Intervention description(s): The CardioKit prototype used in the study can monitor cyclical heart-beat motion, cyclical respiratory motion and non-cyclical heart position changes while the patient is lying in supine position.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: artificial intelligence; cardiac radioablation; echocardiography; motion monitoring; ventricular arrhythmia
Study to Evaluate the Safety and Pharmacokinetics of SPI-1005
Condition: Hearing Loss; Cancer
MeSH terms: Hearing Loss
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in
      healthy adults.
    


Intervention name(s): SPI-1005; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg Ebselen oral capsules (SPI-1005), single dose; 0 mg Ebselen oral capsules (SPI-1000), single dose
Other intervention name(s): 200 mg Ebselen; 0 mg Ebselen
Intervention MeSH terms: Ebselen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ebselen
Quality Assurance of Cognitive-behavioral Therapy
Condition: Depression, Anxiety
MeSH terms: Depression
Study type: Observational

Summary: 
      The study examines associations between competence in cognitive-behavioral therapy (CBT) and
      adherence to evidence-based generic CBT in therapists and treatment outcome in patients with
      depression or an anxiety disorder in psychiatric outpatient care.
    


Intervention name(s): Cognitive-behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): Individual cognitive-behavioral therapy, including homework and behavioral change methods.
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients in psychiatric outpatient care with depression or anxiety disorder.
A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal
      21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of
      age.

      The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the
      serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days
      postvaccination for all serotypes included in V116.
    


Intervention name(s): V116; PPSV23
Intervention type(s): Biological; Biological
Intervention description(s): Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution; Pneumococcal 23-valent conjugate vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
Other intervention name(s): Pneumococcal 21-valent Conjugate Vaccine; PNEUMOVAX™23
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Higher Dose of Rekovelle in Oocyte Donors
Condition: IVF
Study type: Interventional
Phase: Phase 2

Summary: 
      Higher numbers of oocytes have not been shown to increase implantation or live newborn rates,
      but higher numbers of oocytes are likely to be beneficial in certain treatments. These
      clinical cases where a high ovarian response can be IVF cycles with genetic diagnosis,
      patients who need more than one pregnancy or, as in our case, oocyte donation. For this
      reason, and based on previous studies, investigators intend to increase the ovarian response
      by increasing the dose of follitropin. This clinical trial aims to evaluate high doses of
      Rekovelle (follitropin delta) to obtain an average of 17 oocytes in a population of oocyte
      donors, without affecting the health of the patients.
    

Detailed description: 
      IVF ovarian stimulation cycles has been shown that the individualization of the medication
      doses provides clinical results comparable to conventional ovarian stimulation regimens, but
      also it results in greater treatment safety by significantly reducing the percentage of
      patients with responses extreme ovaries, and cycle cancellations. These studies have been
      carried out with the premise that an optimal ovarian response results in obtaining 8-14
      oocytes per puncture. Although it has also been shown that larger numbers of oocytes do not
      increase clinical variables such as implantation rates or live newborn per cycle, it is
      possible that these numbers of oocytes are insufficient in specific circumstances, for
      example, patients with a desire to have more pregnancy, patients undergoing IVF cycles with
      PGT-A, or gamete donors. For these reasons, and thanks to the improvements in
      cryopreservation programs and the induction of oocyte maturation with GnRH agonists, it is
      necessary to design protocols for the individualization of doses of medication aimed at
      obtaining greater quantities of oocytes. The objective of this pilot study is the evaluation
      of higher doses of Rekovelle (follitropin delta) aimed at obtaining 17 oocytes in voluntary
      donors.
    

Intervention name(s): Follitropin Delta, Recombinant
Intervention type(s): Drug
Intervention description(s): 15 µg of follitropin delta will be administered subcutaneously daily
Intervention MeSH terms: Follicle Stimulating Hormone
Intervention model: Single Group Assignment
Intervention model description: Oocyte donors
Masking: None (Open Label)
Primary purpose: Treatment
Use of Serious Game Simulation on Newborn Resuscitation Education
Condition: Newborn; Vitality
Study type: Interventional

Summary: 
      Neonatal death is one of the important indicators showing the development level of countries.
      Many newborn deaths are preventable. Preventable neonatal deaths arise from events such as
      birth asphyxia at the time of delivery. Nursing students receive neonatal resuscitation
      training with classical training methods and graduate without the opportunity to experience
      it in a clinical setting. The aim of the study is to evaluate the effectiveness of web-based
      serious game simulation method in neonatal resuscitation training given to nursing students.
    

Detailed description: 
      The study was planned as a randomized controlled trial with a single blind, pretest-posttest
      design. This study will be conducted in the Fall Semester of the 2020-2021 Academic Year with
      nursing students studying in the 3rd grade of Akdeniz University Faculty of Nursing between
      October and December 2020. An intervention and control group (intervention group: 50, control
      group: 50) will be formed from 100 students who accepted to participate in the study.
      Participants will be randomly allocated to one of the two groups. Pre-test and post-test will
      be applied to both groups before and after the training. Neonatal resuscitation training will
      be given online to the intervention and control group. After the theoretical training,
      web-based neonatal resuscitation serious game simulation will be applied to the intervention
      group. Ethics Committee and Institutional Permission was obtained for the study. In addition,
      written consent will be obtained from the participants. Statistical analysis will be done
      using SPSS 23.0 and significance will be evaluated at p <0.05. Support will be received in
      the analysis phase of the Statistical Information Unit of Akdeniz Universit It is predicted
      that the new information obtained from the data of the research will guide the methods used
      in education and new researches.
    

Intervention name(s): Neonatal resuscitation training with classical method and serious game simulation method; Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): After the theoretical training, the participants will be given technical information on the use of web-based neonatal resuscitation serious game simulation method.
Each participant will be asked to apply this method at least three times.; Neonatal resuscitation training with classical method
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was pretest-posttest design, randomized controlled trial.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Newborn Resuscitation; Simulation; Serious game; Nursing Student
AVocAdo Extract to Improve gLycemia in Individuals With Obesity (AVAIL)
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This two-arm, double blind, randomized clinical trial will compare the effect of an avocado
      extract, compared to placebo, on cardiometabolic outcomes in adults with obesity.
    

Detailed description: 
      Sixty eligible participants will be stratified by sex and randomly assigned to placebo or
      avocado extract supplementation group for 12 weeks. Metabolic testing will be performed at
      baseline, and at the end of the intervention.
    

Intervention name(s): Avocado extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.; Participants will consume 10 grams of corn meal daily for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Obesity; Avocado extract; Cardiometabolic health
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RO7062931 in Healthy Chinese Volunteers.
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized study will evaluate the safety, tolerability and pharmacokinetics of single
      ascending subcutaneously administered doses of RO7062931 in healthy volunteers.
    


Intervention name(s): RO7062931; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RO7062931 will be administered SC in single ascending doses with starting of 0.3 mg/kg and subsequent doses of 1.0 mg/kg, 2.0 mg/kg and 3.0 mg/kg, respectively. Additional (optional) dose of 4.0 mg/kg may be administered based on safety, tolerability and PK data.; Matching placebo will be administered subcutaneously (SC).
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Outcomes of 3 Incision-size-dependent Phacoemulsification Systems
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      The purpose of this study is to compare the outcomes of cataract surgery performed with three
      incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm).
    

Detailed description: 
      It is generally the case that smaller corneal cataract surgical incisions are associated with
      more rapid wound healing, more stable corneal biomechanical properties and less surgically
      induced astigmatism (SIA). With the development of phacoemulsification and foldable
      intraocular lenses (IOL) during recent decades, the size of clear corneal incisions has been
      reduced from 3.2-mm (coaxial small incision) to 1.4-mm (bimanual micro incision). Micro
      incision cataract surgery (MICS), including bimanual and micro coaxial phacoemulsification,
      has attracted much interest recently, due to its safety and ease of learning. However, the
      superiority of coaxial micro incision cataract surgery as compared conventional coaxial
      cataract surgery is still not certain, because micro incision phacoemulsification may result
      in longer ultrasound time (UST), the use of more ultrasonic power and consequently higher
      endothelial cell loss (ECL).

      In our previous studies of the OZil Torsional phacoemulsification system (Infinity, Alcon),
      we reported that the safety and effectiveness of cataract surgery are influenced by many
      factors, including the blade used to create the incision, the phacoemulsification apparatus,
      and the IOL and mode of IOL delivery, which together constitute a surgical system, whose
      outcomes are restricted by the best performance of each component. Today, micro coaxial
      phacoemulsification is in wide use for cataract surgery, but the lower limits of incision
      size should be understood in the context of the various components of the surgical system.

      In this study, we compared the safety and efficacy of three different incision-size-dependent
      phacoemulsification systems, 1.8, 2.2 and 3.0 mm, and evaluated the relationship between
      incision size and SIA.
    

Intervention name(s): phacoemulsification
Intervention type(s): Procedure
Intervention description(s): Cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm)
Other intervention name(s): Three incision-size(1.8, 2.2 and 3.0 mm)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This prospective randomized study comprised 120 patients (120 eyes) with age-related
        cataract enrolled for surgeries between July 2010 and January 2011 at the Zhongshan
        Ophthalmic Center, Guangzhou, China.
      
Keywords: Cataract
Exercise Training in Youth With Inflammatory Bowel Disease
Condition: Pediatric Inflammatory Bowel Diseases; Pediatric Crohns Disease; Pediatric Ulcerative Colitis
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Children and adolescents with inflammatory bowel disease (IBD) suffer from many
      extra-intestinal side effects, including impaired muscle strength, low aerobic fitness, low
      bone density, and chronic inflammation. While exercise training can help remedy these issues
      in adults with IBD, no studies have examined the physiological effects of a structured
      aerobic and resistance exercise training intervention for youth with IBD.

      The aim of this pilot study is to to assess the feasibility, safety, and participant
      satisfaction of a structured 16-week training program for children with IBD. The secondary
      objectives of this study were to quantify the effects of a 16-week exercise training program
      on select physiological and behavioural outcomes in children with IBD.
    


Intervention name(s): Exercise training program
Intervention type(s): Other
Intervention description(s): 16-week, structured exercise training program including resistance and aerobic exercise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety and Pharmacokinetic Characteristics of DP-R206(Vitamin D3) in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetic characteristics of DP-R206 (150mg
      Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Vitamin D3 (24,000 IU Vitamin D3 ,
      qd) after oral administration in healthy adult volunteers.
    

Detailed description: 
      The number of patient is thirty-six. Patients were randomly assigned either a Vitamin D3
      tablet(24,000 IU Vitamin D3, qd) first, DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3
      complex tablet, qd) Second or DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex
      tablet, qd) first, Vitamin D3 tablet(24,000 IU Vitamin D3 , qd) second.
    

Intervention name(s): Vitamin D3; DP-R206
Intervention type(s): Drug; Drug
Intervention description(s): administration of Vitamin D3 24,000 IU; administration of DP-R206 (150mg ibandronate / 24,000IU Vitamin D3)
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Continuous Administration of Oral Contraceptive, Primary Dysmenorrhea
Condition: Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary hypothesis is that continuous administration of an OCP (CCOCP regimen) will
      result in more pain relief than a traditional 21/7 administration in primary dysmenorrhea
      (PD) patients.
    

Detailed description: 
      It is well established that excess prostaglandin production in primary dysmenorrhea (PD)
      leads to ischemia of the uterine muscle, which consequently causes pelvic pain. A large
      number of drugs have been studied for pain relief in dysmenorrhea patients with non-steroid
      anti-inflammatory drugs (NSAIDs) being the most effective with the overall success rate of
      more than 75%. Oral contraceptive pills (OCP) are also an established treatment for PD with
      the success rate of 70%. Lately, OCP's have been used continuously in patients with
      endometriosis and had better pain control than traditional administration of OCP.
    

Intervention name(s): CCOCP; Traditional OCP
Intervention type(s): Drug; Drug
Intervention description(s): (CCOCP) continuous treatment with Monophasic oral gestodene/ethinyl estradiol; (traditional OCP) (21 active days/7 inactive days) treatment regimen
Other intervention name(s): Oral contraceptives; Oral contraceptives
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dysmenorrhea; continuous OCP
Effects of Manualized Treatment in a Seamless System
Condition: Substance Abuse; Offenders; Criminal Thinking; HIV Risk Behaviors
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The specific aims of this project are:

        1. To conduct a randomized block experiment to test the effectiveness of different models
           of the seamless supervision/treatment system and traditional criminal justice
           supervision on reducing recidivism and drug use, and improving social adjustment among
           offenders;

        2. To understand the differential impacts based on offender risk factors (e.g., propensity
           to engage in further criminal behavior) on criminal justice outcomes and to determine
           whether differences found between seamless and traditional system participants are
           moderated by offender risk level;

        3. To understand differential treatment and social adjustment outcomes (e.g., treatment
           progress, employment status) of different types of offenders participating in various
           treatment services; and

        4. To examine levels of systems and service integration between the supervision and
           treatment systems pre- and post-intervention and to measure the impact of integration on
           outcomes over time.
    


Intervention name(s): Cognitive Behavioral Therapy; Cognitive Behavioral Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 18 sessions of CBT, twice weekly; 18 sessions with goals groups drug testing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: drug treatment; substance abuse; offenders; high risk
IOP Changes Associated With SICS and Phako
Condition: Cataract; Glaucoma
MeSH terms: Cataract
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Prospective randomized trial in patients requiring cataract surgery in which IOP, angle
      anatomy and other demographic and clinical data are compared. Subjects randomized to both
      MSICS and phakoemulsification
    

Detailed description: 
      Prospective, randomized, double masked, parallel assignment clincal trial. Five hundred eyes
      of 500 participants between 40 - 70 years with normal IOP, gonioscopically open angles and
      age related cataract. Eyes underwent phacoemulsification or MSICS following a 1:1
      randomization and allocation code. Best corrected vision (BCVA), IOP, comprehensive slit lamp
      evaluation and anterior segment optical coherence tomography (ASOCT) were performed at
      baseline and at 1, 3 and 6 months follow up.
    

Intervention name(s): cataract surgery
Intervention type(s): Procedure
Intervention description(s): Eyes (one eye per patient) randomized to either phacoemulsification and intraocular lens insertion or small incision cataract surgery and intraocular lens insertion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic