bioihbjkbjnl/mcl2 huggingface dataset:
ASSET 2 Study: Long-Term Follow-up of a Randomised Control Trial
Condition: Shoulder Dislocation
MeSH terms: Shoulder Dislocation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aims to measure the long-term efficacy of arthroscopic Bankart repair for
      first-time anterior shoulder dislocation in terms of recurrent instability and functional
      outcome.
    

Detailed description: 
      Approximately half of patients who experience a dislocation of their shoulder will go on to
      experience further problems with their shoulder. Some people will suffer persisting
      instability, and notice an uncomfortable feeling of their shoulder wanting to give way. This
      can occur commonly during active movements such as playing sports or lifting heavy objects.
      Some patients experience recurrent dislocations, and find that their shoulder is so weak that
      it slips out of joint with little provocation.

      Previous research suggested that this high rate of subsequent shoulder problems can be
      greatly reduced (although not abolished completely) by surgery performed soon after the first
      dislocation. Ten years ago, there were two different methods which had been popularised:

        1. Arthroscopic Wash-Out: The first is to wash out the shoulder joint with a sterile
           solution through an arthroscope (keyhole surgery) under a general anaesthetic.

        2. Arthroscopic Repair: The second is to repair the torn tissues in the shoulder, again
           using key-hole surgery techniques under general anaesthetic.

      A previous clinical trial was undertaken in our unit (2001-2005) which randomised young
      patients aged under 35 years to one of the two possible treatments (described above). These
      procedures were not new or experimental. The same Arthroscopic Repair technique continues to
      be routinely used in NHS Lothian to treat patients who have late problems following a
      dislocated shoulder. We do not routinely perform wash-outs of the shoulder joint because this
      is only effective in treating problems that occur at an early stage.This new study intends to
      build on these findings by asking each of the patient groups to complete a short
      questionnaire which uses validated outcomes to measure their shoulder function. The aim of
      the study is to identify if there is a long-term clinical and functional benefit of early
      arthroscopic shoulder stabilisation in high-risk patients.
    

Intervention name(s): Arthroscopic Washout Only; Arthroscopic Bankart Repair
Intervention type(s): Procedure; Procedure
Intervention description(s): To wash out the shoulder joint with a sterile solution through an arthroscope (keyhole surgery) under a general anaesthetic.; To repair the torn glenoid labrum in the shoulder, using key-hole (arthroscopic) surgery techniques under general anaesthetic. The Bankart technique is well described and will be performed using suture anchors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Pregnant Women s Views About the Ethics of Prenatal Whole Genome Sequencing
Condition: Pregnant
Study type: Observational

Summary: 
      Background:

      Prenatal whole genome sequencing (PWGS) will give expecting parents large amounts of genetic
      data about their baby. This raises ethical concerns. Researchers want to find out if women
      want access to the kind of data PWGS provides. They want to know why and under what
      circumstances women would or would not want the data.

      Objective:

      To explore the views of pregnant women about possible use of PWGS. To find out whether they
      would want different categories of genetic data, and how they would use such findings.

      Eligibility:

      Women ages 18 and older who pregnant and speak English or Spanish

      Design:

      Participants will be recruited by their doctors.

      Participants will take a survey about their views of PWGQ. They may take it online or on
      paper.
    

Detailed description: 
      The impending implementation of prenatal whole genome sequencing (PWGS) raises a host of
      ethical concerns given the massive amounts of genetic information that expecting parents will
      be able to learn about their baby. This project involves a cross-sectional quantitative
      survey of pregnant women to explore whether they want access to the kinds of information
      provided by PWGS, why and under what circumstances. The survey will address questions such
      as: What sorts of information do pregnant women want to know about their baby, and why? What,
      if anything, would they do with the information? What kind of guidance would pregnant women
      like from their medical team regarding fetal genetic testing? Given the range of practical
      and ethical challenges posed by PWGS, our data will inform practitioners approaches towards
      PWGS as the technology develops and becomes more widely available. It is imperative that
      government regulators and professional societies take into account the views of people
      directly affected by any policies that are created - including patients themselves - before
      crafting rules for whether, when and how to utilize PWGS.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women.
      
Keywords: Prenatal Testing
Glycaemic Response to High REsistant STarch Bread
Condition: Blood Glucose Response
Study type: Interventional

Summary: 
      This study evaluates if the consumption of one sbeIIa/b white bread with high resistant
      starch content will result in a lower blood glucose response and increased satiety compared
      with reference white bread. All participants will be asked to consume once the sbeIIa/b white
      bread and the reference white bread during different visits.
    

Detailed description: 
      In an attempt to increase dietary fibre intake, research has focused on developing
      wheat-based food products with novel fibres and starches to complement fibre intake from
      whole grain foods. Resistant starch is starch that escapes digestion in the small intestine
      and may be fermented in the large intestine by the microbiota. Resistant starch is a type of
      dietary fibre and it is normally found in wheat-based foods made from refined flour but only
      in small amounts. White bread made from sbeIIa/b wheat, which has high levels of resistant
      starch (a type of fibre), is showing promise in modulating blood glucose response and
      increasing satiety compared with conventional white bread.

      The primary aim of this study is to determine whether consumption of sbeIIa/b white bread at
      breakfast, gives rise to a lower postprandial blood glucose response compared with
      consumption of a reference white bread in healthy individuals.

      Additional aims of the study include: determining whether consumption of sbeIIa/b white bread
      by healthy subjects, gives rise to a lower glucose concentration in interstitial fluid, as
      measured by a Continuous Glucose Monitoring system (CGM), compared with consumption of
      control white bread; and exploring satiety and energy intake changes in healthy individuals
      following consumption of sbeIIa/b white bread at breakfast, compared with consumption of
      control white bread.
    

Intervention name(s): sbeIIa/b white bread; Control white bread
Intervention type(s): Other; Other
Intervention description(s): one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast; one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind randomised crossover study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Glycaemic response; Resistant starch; Bread
Intervention for HIV-Positive Black Young Men Who Have Sex With Men (YMSM)
Condition: Acquired Immunodeficiency Syndrome
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional

Summary: 
      This study involves conducting formative research to develop a culturally appropriate
      secondary prevention intervention for HIV-positive Black young men who have sex with men
      (B-YMSM). The intervention draws upon the principles of Critical Consciousness Theory (CCT).
      The formative research includes reviewing data and findings from relevant ATN protocols
      (i.e., 070, 068, and 073) and existing health promotion interventions targeting young men of
      color (i.e., the Young Warriors program, Hermanos de Luna y Sol [HLS]) and conducting focus
      groups with up to 32 HIV- positive B-YMSM.
    

Detailed description: 
      Focus groups will be conducted at two Adolescent Medicine Trials Unit (AMTU) sites and will
      guide the selection of the intervention content areas and the development of the intervention
      manual. The intervention aims to increase participation in health promoting behaviors and
      improve self-worth and self-concept among HIV-positive B-YMSM. Specifically, the intervention
      aims to address the following health promoting behaviors: 1) increasing engagement in HIV
      treatment; 2) improving medication adherence; 3) reducing sexual risk behaviors; 4) reducing
      substance use behaviors; and 5) increasing HIV status disclosure.

      Based on reviews of ATN 070 data and existing related interventions (ATN 068, ATN 073, Young
      Warriors, HLS), draft components of the intervention curriculum for B-YMSM will be developed.
      Four focus groups will then be convened (two per AMTU) with HIV-positive B-YMSM to a) obtain
      input on the draft intervention curriculum, b) refine intervention components, and c) examine
      psychosocial factors that may mediate or moderate the intervention effect. The focus groups
      will be implemented using a "Rapid Approach" which allows for a focus on key areas of inquiry
      by asking fewer questions and focusing on targeted responses of focus group participants. All
      focus groups will be digitally recorded and transcribed. The transcripts will be reviewed and
      data analyzed using a phenomenological approach; protocol team members and members of two
      Youth Advisory Boards (YABs), which will include youth who are existing members of ATN site
      CABs as well as youth recruited from other local agencies and organizations), will work on
      the analysis of the data.
    

Intervention name(s): Focus Group
Intervention type(s): Behavioral
Intervention description(s): N/A. Protocol is the focus group
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent Medicine Trials Network for HIV/AIDS Interventions; Human Immunodeficiency Virus
Effects of Added D-fagomine on Glycaemic Responses to Sucrose
Condition: Reduction of Post-prandial Glycaemic Response
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether D-fagomine affects glycaemic responses to
      sucrose (commercial white sugar)and quantify the response
    

Detailed description: 
      This is a two treatment randomized double-blind crossover study, with each test product
      replicated twice.

      Randomization: Subjects will be randomized to a Williams Latin square design balanced for
      treatment order.

      Washout: 2 days or more (may return on day 3)

      Run-in: High carbohydrate diet guidance (>150 g/d) 1 day before treatment, recommend same
      sized dinner the previous night (no food record collection required)

      Drop-outs: Subjects who have dropped out before visit 2 will be replaced by another subject
      randomized in their place (the new subject will complete all treatments)

      Subjects will report after an overnight (12 hour) fast for baseline sample collection, and
      will consume the test product in a fasted state.
    

Intervention name(s): D-fagomine
Intervention type(s): Other
Intervention description(s): Measure the changes produced on the postprandial Glycaemic response
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Mobile Attentional Bias Modification Training in Pediatric MS
Condition: Pediatric Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study will examine the feasibility of using a mobile ABMT application as a treatment
      modality in the Pediatric Multiple Sclerosis population. Participants will be asked to
      undergo one hour-long baseline evaluation, followed by at-home ABMT application sessions.
      Subjects will complete online REDCap or MyCap surveys weekly and at the end of the study.
    


Intervention name(s): ABMT mobile application
Intervention type(s): Behavioral
Intervention description(s): After consent/assent, participants will complete 1 hour-long, in-person or remote, baseline study visit at the Multiple Sclerosis Comprehensive Care Center. During this visit, participants will complete baseline study surveys and a brief computerized attention bias assessment and be trained on the use of the ABMT mobile application. Participants will then complete at-home game play 4 days a week, for 30 days, using an iOS mobile device, approximately 10-15 minutes each day. Subjects will complete weekly online study surveys via REDCap or MyCap (Mobile REDCap Application). At the conclusion of participation, participants will complete online end of study surveys via REDCap or MyCap.
Parents of participants will complete surveys at the baseline visit, followed by online surveys at Week 2 and at the end of study. For participants who are 18 years old or older, parental participation will not be required.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of Hepatic Impairment on JNJ-42847922 in Adult Participants
Condition: Healthy; Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of
      JNJ-42847922 in adult participants with hepatic impairment when compared to healthy
      participants with normal hepatic function.
    


Intervention name(s): JNJ-42847922
Intervention type(s): Drug
Intervention description(s): Participants will receive JNJ-42847922 tablet as a single oral dose (Dose 1 or Dose 2 or Dose 3) on Day 1.
Other intervention name(s): Seltorexant
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)
Condition: Anesthesia, General
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the trial was to establish the dose-response relation of sugammadex (Org
      25969) given as a reversal agent of rocuronium or vecuronium at reappearance of T2 (the
      amplitude of the first response of second twitch to train of four (TOF) stimulation,
      expressed as percentage of control first twitch, T1) during sevoflurane anesthesia for
      Caucasian participants.
    

Detailed description: 
      For most surgical procedures a depth of neuromuscular block of 1-2 twitches after
      TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the
      anesthesiologist might decide to either give (another) maintenance dose of rocuronium or
      vecuronium when surgery continues, to await spontaneous recovery of neuromuscular block or to
      reverse the neuromuscular block. Sugammadex has been shown in previous trials to greatly
      reduce the time to full recovery when administered at reappearance of T2, both after
      rocuronium- and vecuronium induced neuromuscular blockade. The current trial P05971 was
      conducted in Europe and set up to establish the dose response relationship of sugammadex
      given during sevoflurane anesthesia at reappearance of T2 after rocuronium or vecuronium in
      Caucasian participants. In addition to recovery time, also pharmacokinetics and safety of
      sugammadex were to be evaluated.
    

Intervention name(s): Sugammadex; Placebo; Rocuronium; Vecuronium
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium.
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
At reappearance of T2 the randomized single dose of sugammadex 0.5 to 4 mg/kg IV was administered; After induction of anesthesia an intubation dose of NMBA was administered IV: either 0.9 mg/kg rocuronium (arm 1) or 0.1 mg/kg vecuronium (arm 6).
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
At reappearance of T2 the randomized single dose of Placebo IV was administered; After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered IV.
Maintenance doses of 0.1-0.2 mg/kg rocuronium IV could be administered if necessary.; After induction of anesthesia an intubation dose of 0.1 mg/kg vecuronium was administered IV. Maintenance doses of 0.02-0.03 mg/kg vecuronium IV could be administered if necessary.
Other intervention name(s): Org 25969
Intervention MeSH terms: Rocuronium; Vecuronium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Rt-PA in the Treatment of Acute Ischemic Stroke
Condition: Cerebrovascular Accident
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      To collect additional confirmatory data on alteplase(rt-PA) in the European setting and to
      demonstrate that the treatment of patients between 3 and 4.30 hours of onset of symptoms of
      acute ischemic stroke with rt-PA compared to placebo-treated patients will result in an
      improved clinical outcome without increase of fatality rate.
    


Intervention name(s): rt-PA 0.9 mg/kg verum or placebo Intravenous
Intervention type(s): Drug
Primary purpose: Treatment
Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine the validity of previously identified prognostic
      variables that may identify patients with shoulder pain that are likely to benefit from
      cervicothoracic spine manipulation.
    

Detailed description: 
      The investigators have recently identified prognostic variables in a preliminary Clinical
      Prediction Rule (CPR) that are purported to identify patients with shoulder pain who respond
      favorably to cervicothoracic spinal manipulative therapy (SMT) and daily home exercises of
      cervical and thoracic active range of motion exercises. These prognostic variables have been
      identified in a single study, and therefore it is not known if these factors will be valid in
      a different group of patients, even ones with similar characteristics as those used in the
      investigators' initial exploratory study. Further study of these identified factors is needed
      for validation in an independent sample of patients, which will improve generalizability for
      clinical practice. In this study, patients with a primary complaint of shoulder pain will be
      randomly assigned to receive cervicothoracic spine manipulation followed by therapeutic
      exercises or therapeutic exercise alone. If the variables are in fact meaningful, patients
      who exhibit 3 or more of the identified prognostic variables and receive cervicothoracic SMT
      should experience improved outcomes compared to patients who have less than 3 of these
      variables and receive the same intervention. Additionally, patients who exhibit 3 or more of
      the identified variables that receive cervicothoracic SMT should also have superior outcomes
      to patients who exhibit 3 or more of the identified variables and receive an alternate
      intervention (exercise only). Finally, the investigators will determine if the addition of
      cervicothoracic SMT to exercise improves outcomes as compared to exercise alone.
    

Intervention name(s): Manipulation + Exercise Group; Exercise Group
Intervention type(s): Procedure; Procedure
Intervention description(s): First 2 sessions
High-velocity, low-amplitude manipulations to the thoracic spine.
Low-velocity mid to end-range mobilizations to the cervical spine.
Active Range of Motion Exercises for the cervicothoracic spine
Final 6 sessions
◦ Evidence based shoulder girdle exercise program; First 2 sessions
◦ Active Range of Motion Exercises for the cervicothoracic spine
Final 6 sessions
◦ Evidence based shoulder girdle exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cervical; Clinical Prediction Rule; Exercise; Manipulation; Manual therapy; Mobilization; Physical Therapy; Prognosis; Shoulder pain; Thoracic