bioihbjkbjnl/mcl2 huggingface dataset:
Study for Hyalobarrier to Evaluate Anti-adhesive Effect and Safety Compared to Guardix-SG After Thyroidectomy
Condition: Thyroid Disease
MeSH terms: Thyroid Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a randomized, double-blind, active controlled phase 3 trial in the patients
      with thyroid disease, who will undergo total thyroidectomy (excluding the patients with the
      patient with the past history of thyroid surgery).

      An eligible patient will be randomized and allocated to either the test group (Hyalobarrier)
      or active-comparator group (Guardix-SG). He/she will undergo marshmallow esophagography in
      detecting esophageal dysmotility at 6 weeks after study intervention and will be followed for
      12weeks.

      During the study, both the patients and the observer for the primary and secondary efficacy
      evaluation will be masked.

      Non-inferiority of the test device (Hyalobarrier) compared to the reference device
      (Guardix-SG) will be confirmed using the primary efficacy outcome,the percentage of normal
      esophageal transit.
    


Intervention name(s): Hyalobarrier; Guardix-SG
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thyroid disease; Hyalobarrier; Thyroidectomy; anti-adhesive effect
TGFB1 And LAMA1 Gene Polymorphisms in High Myopia
Condition: High Myopia; Gene Mutations
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The investigators aimed to investigate TGFB1 and LAMA1 gene polymorphisms in children with
      high myopia in order to determine the genetic basis of large myopic shifts causing severe
      visual impairment and complications.

      Seventy-four children with high myopia (≥6 diopters [D]; study group) and 77 emmetropic
      children (±0.5D; control group) were included. Genetic and polymorphism analyses were
      performed in the Medical Genetics Laboratory using DNA purified from the patients' blood
      samples.
    


Intervention name(s): TGFB1 AND LAMA1 GENE POLYMORPHISMS
Intervention type(s): Genetic
Intervention description(s): we evaluated polymorphisms in the LAMA1 (rs2089760) and TGFB1 (rs4803455) genes in children younger than 13 years of age with ≥6 D myopia in an attempt to further elucidate the genetic basis of high myopia.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Keywords: High myopia; TGFB1Gene Polymorphisms; LAMA1 Gene Polymorphisms
Role of 13C Methacetin Breath Test in Predicting Prognosis Among Patients With Acute or Acute on Chronic Liver Failure (ACLF).
Condition: Acute Liver Failure; Acute on Chronic Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure; Liver Failure, Acute
Study type: Interventional

Summary: 
      Blood will be collected after venepuncture from all patients for complete blood counts, Serum
      bilirubin (direct and indirect), aspartate aminotransferase, alanine aminotransferase,
      alkaline phosphatase, gamma glutamyl transferase, prothrombin time and INR, urea, creatinine,
      sodium, potassium, serum total protein and albumin, within 24 hours after admission and twice
      a week there after or as and when needed.

      Time line for blood tests and evaluation of clinical parameters & 13C-MBT

      For ALF patients:

      On days 0, 1, 3, and 7

      For ACLF patients:

      On days 0, 7 (week 1), 14(week 2), 28 (weeks 4)

      Blood tests would include:

      Serum bilirubin (total and direct), aspartate aminotransferase, alanine aminotransferase,
      alkaline phosphatase, gamma-glutamyltransferase, Serum proteins (total and albumin),
      prothrombin time & international normalized ratio (INR), Serum urea and creatinine, serum
      electrolytes, arterial ammonia and arterial blood gas analysis.
    


Intervention name(s): Methacetin Breath Test in ACLF and ALF patients
Intervention type(s): Device
Intervention description(s): Methacetin Breath Test will be done on Day 0,7,14,28 in Acute on Chronic Liver Failure (ACLF)and on day 0,1,3,7 in Acute Liver failure (ALF).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Exercising With a Screen or Music and Post-exercise Energy Compensation in Adolescents
Condition: Healthy
Study type: Interventional

Summary: 
      OBJECTIVE AND HYPOTHESIS:

      The objective of this study will be to examine the effects of watching a screen or listening
      to music while exercising on acute energy intake and expenditure. It is hypothesized that the
      post-exercise energy compensation will be greater in both conditions with stimuli (i.e.,
      screen and music) compared with the control condition (i.e., exercise alone).

      STUDY DESIGN:

      Randomized, 3-condition crossover study (within-subjects experimental design).

      PARTICIPANTS:

      The present study will recruit 25 male adolescents between the ages of 13 and 17 years.
      Participants will be recruited via advertisements and word of mouth (first come first served
      approach).

      OVERVIEW OF THE STUDY PROTOCOL:

      Preliminary Visit The participants will attend one baseline session and three experimental
      sessions. The preliminary visit will include measurements related to anthropometry (body
      weight, height, waist circumference) and resting metabolic rate. Participants will also
      complete questionnaires in order to better characterize them.

      Experimental Sessions Each participant will be engaged in each of the following three 30-min
      experimental conditions followed by an ad libitum lunch: (1) walking/jogging on a treadmill
      at 60% of VO2 peak while watching a screen (exercise + screen); (2) walking/jogging on a
      treadmill at 60% of VO2 peak while listening to music (exercise + music); and (3)
      walking/jogging on a treadmill at 60% of VO2 peak with no other stimulus (control condition).

      MEASUREMENTS:

      The main measures for this study include: anthropometric measurements, food intake, appetite
      sensations, energy expenditure, resting metabolic rate, and ratings of perceived exertion.

      OUTCOME MEASURES:

      The primary outcome measure will be post-exercise energy compensation. The food intake
      outcome will be assessed by using an ad libitum test meal immediately after the conditions
      and a dietary record for the remainder of the day. The energy expenditure outcome will be
      assessed by using an Actical accelerometer until bedtime. The secondary outcome measures will
      include appetite sensations and the ratings of perceived exertion (OMNI scale).
    


Intervention name(s): TV and music
Intervention type(s): Behavioral
Intervention description(s): Watching TV or listening to music while running on a treadmill
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise; Screen; Music; Energy compensation; Adolescents; Running+screen; Running+music; Running without stimulus (control condition)
Study of NDI-034858 in Participants With Moderate to Severe Plaque Psoriasis
Condition: Moderate to Severe Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, randomized, multicenter, double-blind, placebo-controlled, multiple-dose
      study designed to evaluate the efficacy, safety, and tolerability of NDI-034858 in
      participants with moderate to severe plaque psoriasis. This study will also evaluate the
      plasma concentrations of NDI-034858 and explore the immune response to NDI-034858 in
      participants with moderate to severe plaque psoriasis.
    

Detailed description: 
      Approximately 259 male and female participants, aged 18 to 70 years (inclusive) were enrolled
      in this study. Participants were randomized to receive either one of the four doses of
      NDI-034858, or placebo on Day 1. The goal was to have approximately 50 participants
      randomized per treatment group (1:1:1:1:1 ratio) on Day 1. During the treatment period,
      NDI-034858 or placebo was orally administered QD for 12 weeks. The 12 week treatment period
      was followed by a 4-week safety follow-up period.
    

Intervention name(s): NDI-034858 study drug; NDI-034858 study drug; NDI-034858 study drug; NDI-034858 study drug; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): NDI-034858 2 mg oral capsules.; NDI-034858 5 mg oral capsules.; NDI-034858 15 mg oral capsules.; NDI-034858 30 mg (2*15 mg) oral capsules.; Placebo matched to NDI-034858 oral capsules.
Other intervention name(s): NDI-034858; TAK-279; NDI-034858; TAK-279; NDI-034858; TAK-279; NDI-034858; TAK-279; Non Active Ingredient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Surgical Treatment of Early Onset Scoliosis Using a Non-invasive Growing Rod
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      It is current practice for children who have surgery for early onset scoliosis (EOS) to be
      treated with insertion of extendable implants known as growth rod systems. This allows the
      growth potential of the child to be maximised during the period of growth. However, the child
      must undergo an average of 6 further surgeries to lengthen the rods every 6 months. Sometimes
      this may continue for several years. This requires repeated general anaesthesia and places
      the patient at risk of complications as well as on-going costs to the hospital with each
      admission and theatre episode.

      Magec is a magnetic growth rod from Ellipse technologies (distributed by SurgiC). The rod is
      inserted in exactly the same way as the conventional growth rod systems. The base implants
      i.e screws and hooks remain the preferred choice of the user. The only change is that a
      different rod is used.

      There are several advantages to this device. Firstly, after the initial insertion, further
      lengthenings, unlike current systems, do not need to be carried out in theatre under a
      general anaesthetic. In contrast, they can be done in an outpatients setting with a
      non-invasive technique. The rods are lengthened using an external magnetic device. The
      lengthenings are done in a controlled manner using an age related growth guide. Thirdly, the
      change from a theatre based intervention to an outpatient procedure will have cost-savings.
      The investigators also believe that there will be psychosocial benefits to the child and
      family by the avoiding the stress associated with repeated surgery at such a young age.

      In terms of risk assessment the device does not place the child at any more risk than would
      be expected from inserting any of the existing systems. In the event of failure of the rods
      the worst outcome is a revision to conventional rods.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population will be recruited from secondary care
      
Keywords: Early; Onset; Scoliosis
A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of AZD5069 in Patients With Uncontrolled Persistent Asthma.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of
      AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS)
      and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma
    

Detailed description: 
      A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase
      II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the
      Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on
      Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists
      (LABA), in Patients with Uncontrolled Persistent Asthma
    

Intervention name(s): AZD5069; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AZD5069 oral capsules self-administered twice daily.; Placebo oral capsules self-administered twice daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Uncontrolled Asthma,; Exacerbation,; Safety
PROTECT-TIMI 30 Trial
Condition: Unstable Angina
MeSH terms: Angina, Unstable
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study was to compare the efficacy and safety of bivalirudin to
      eptifibatide (with or without unfractionated heparin or enoxaparin)given to subjects at high
      risk for heart attack and other cardiovascular complications who will undergo surgery to open
      up blocked arteries in the heart.
    

Detailed description: 
      Platelet inhibitor drugs
    

Intervention name(s): Percutaneous Coronary Intervention (PCI)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GP IIb/IIIa inhibitors; eptifibatide; Anti-thrombotic agents
An Innovative HIV Prevention Intervention Using Social Networking Technology
Condition: Sexual Risk; Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      An existing face-to-face HIV prevention intervention (The Young Men's Health Project, YMHP;
      R01DA20366) will be iteratively adapted and pilot-tested to target difficult to engage
      high-risk young men who have sex with men (YMSM) via online social networking and aims to
      reduce both high-risk sexual behavior and drug use.
    

Detailed description: 
      This pilot study entails a two-phase process. During Phase I, 15 former YMHP participants
      (intervention decliners and those who only completed one session) will participate in focus
      groups to advise us on the feasibility and pragmatic specifications of an HIV prevention
      intervention received via the IM (instant messaging) function of Facebook. Focus group
      transcripts will be examined to isolate key recommendations for modifying the intervention's
      structure and procedures. Focus groups will be reconvened for additional feedback on the
      modified intervention, followed by further adjustment. During Phase II, 40 high-risk YMSM
      (ages 18-29 and Facebook users) will be enrolled in a pilot of the modified intervention. The
      intervention will span 4 weeks and contain 8 bi-weekly 30 minute Motivational Interviewing
      (MI) chat-window sessions consisting of a sequential progression of intervention approaches
      tailored to each participant's readiness to change their drug use and high risk sexual
      behavior. Data from Phase II will include pre-post intervention behavioral risk assessments,
      as well as individual interviews with all 40 intervention participants for a qualitative
      evaluation regarding the feasibility and acceptability of the intervention's structure, and
      process. Findings from these interviews (and counselor focus group) will inform the
      fine-tuning of the intervention in preparation for a subsequent randomized control trial
      (RCT).
    

Intervention name(s): Behavioral: HIV prevention intervention
Intervention type(s): Other
Intervention description(s): Substance using HIV-negative young men who have sex with men who engage in sexual risk and use social networking (Facebook) will be recruited and enrolled in a brief intervention utilizing Motivational Interviewing over chat window to reduce their substance use and sexual risk. They will also evaluate their intervention experience at the end of their eight sessions and post-assessment.
Other intervention name(s): Reductions in sexual risk and substance use
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: sexual risk; substance use; HIV prevention; intervention acceptability and feasibility; young men who have sex with men
Comparison of Acular LS Versus Nevanac for Pain Control in Eyes Undergoing PRK
Condition: Myopia; Hyperopia
MeSH terms: Hyperopia
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the ability of two topical Nonsteroidal Anti-inflammatory drops (Acular LS &
      Nevanac) to help control pain following Photorefractive Keratectomy (PRK).
    

Detailed description: 
      Laser Vision Correction is the most commonly performed elective surgical procedure in the
      United States. Although Laser-Assisted in-situ Keratomileusis (LASIK) is the more popular
      technique, a growing number of surgeons have switched to surface ablation techniques,
      including PRK, LASEK and Epi-LASIK.1 With surface laser procedures, the corneal epithelium is
      removed by a variety of techniques (laser, manual debridement, diluted alcohol2,3,
      epi-keatome) prior to laser reshaping of the corneal stroma. Following the procedure, a
      contact lens is placed on the eye to promote epithelial regeneration. Due to the size of the
      epithelial defect, it can take between 3 to 6 days for the epithelium to regenerate. During
      this healing process, patients often complain of moderate to severe ocular pain, and delayed
      healing may result in an increased risk of infection or corneal haze4.

      Over the past decade, a variety of methods have been used to assist with reducing pain
      following surface laser procedures. Topical Nonsteroidals have been shown in a number of
      studies to help reduce the degree of pain following PRK. Topical dilute tetracaine has also
      been shown to assist with the reduction of pain following PRK. Oral pain medications, such as
      Vioxx, Celebrex, and even Prednisone have been recommended as additional treatment options
      for pain control.

      In October 2005, a new topical nonsteroidal anti-inflammatory drop, Nevanac, was approved by
      the FDA. Nevanac was approved with a a TID dosing schedule.

      Acular LS is the current market leader for topical NSAID eye drops. Acular LS is typically
      used on a QID dosing schedule.
    

Intervention name(s): ketorolac (Acular LS); Nepafenac (Nevanac)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketorolac; Nepafenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: PRK; laser vision correction; surface ablation; pain; wound healing; corneal haze
A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The COVID-19 pandemic is considered as the most crucial global health concern of the century.
      Given the complex interaction of physical and social factors on fast spreading infection,
      there have been increasing calls for comprehensive efforts using a community-based
      participatory research (CBPR) approach.

      CBPR partnership composed of representatives from community-based organisations, health and
      academia actively developed the present study. Specific aims were (1) to assess the efficacy
      and safety of Ayurvedic combination, Giloy (Tinospora Cordifolia) and Pippali (Piper longum)
      in the management of mild-to-moderate cases of COVID-19 and (2) to determine the effect in
      relieving COVID-19 symptoms and preventing the onset of severe infection.
    


Intervention name(s): Shanshamani Vati Plus
Intervention type(s): Other
Intervention description(s): Shanshamani Vati Plus was given as combination of Guduchi (Tinospora Cordifolia; 300 mg) and Pipli (Piper Longum 75 mg) twice daily.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Ayurveda; Shanshamani Vati Plus
Efficacy of Pectoral Nerve Block for Breast Reduction Surgery
Condition: Nerve Blocks; Breast Surgery; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      The purpose of the study is to evaluate the efficacy of PECS block applied to patients
      undergoing bilateral breast reduction surgery on postoperative analgesia compared to local
      infiltration anesthesia.
    

Detailed description: 
      Pectoral nerve block (PECS block) has been developed as an alternative to thoracic
      paravertebral and/or thoracic epidural blocks in recent years. It is frequently applied for
      postoperative analgesia especially in breast cancer surgery and subpectoral breast
      prosthesis.
    

Intervention name(s): PECS group; Control group
Intervention type(s): Procedure; Procedure
Intervention description(s): Pecs block performed using ultrasound guidance; Local infiltration anesthesia performed during the operation
Other intervention name(s): Regional anesthesia in breast surgery; Regional anesthesia in breast surgery
Intervention MeSH terms: Anesthetics
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study included patients with ASA I-II, 18-65 years old, with a BMI ≤ 40 kg/m2 and
        undergoing elective breast reduction operation under general anesthesia.
      
Keywords: pectoral nerve block (PECS block); breast reduction surgery; ultrasonography; postoperative pain; VAS score
GW815SF For Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the safety of medicine on COPD (Chronic Obstructive Pulmonary Disease).
      This study will last up to 56 weeks, and subjects will visit the clinic 16 times. Subjects
      will be given breathing tests, and will record their breathing symptoms daily on diary cards.
    


Intervention name(s): fluticasone propionate/salmeterol combination DISKUS
Intervention type(s): Drug
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Bronchitis; COPD; Emphysema