bioihbjkbjnl/mcl2 huggingface dataset:
Benefit of Surgical Hardware Removal Following Clavicle Fracture
Condition: Clavicle Fracture
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      Little is known about the beneficial aspects of elective implant removal following plate
      osteosynthesis of displaced clavicle fractures.
    

Detailed description: 
      Elective implant removal accounts for up to 30% of all orthopaedic surgeries. While there is
      general acceptance about the need of implant removal for obvious reasons, such as infections
      or implant failure, little is known about the beneficial aspects in cases of minor reasons.
      Therefore, we initiated this study to define patients' benefit of elective implant removal
      following plate osteosynthesis of displaced clavicle fractures.

      Patients and Methods Prospective evaluation of patients was conducted before implant removal
      and 6 weeks postoperative. Subjective and objective criteria included patients' satisfaction,
      pain rating on a visual analog scale (VAS) and active range of motion (ROM) pre- and 6 weeks
      postoperative. Functional scoring included the SPADI, DASH score, the Constant Score and the
      Munich Shoulder Questionnaire (MSQ).
    

Intervention name(s): Hardware Removal
Intervention type(s): Procedure
Intervention description(s): elective removal of plate osteosynthesis at the clavicle
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients requesting implant removal
Pioglitazone Special Drug Use Surveillance "Metabolic Syndrome in Patients With Type 2 Diabetes Mellitus"
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome
Study type: Observational

Summary: 
      The purpose of this survey is to determine the onset of new cerebral and cardiovascular
      events and changes in metabolic syndrome parameters in patients with type 2 diabetes mellitus
      on long-term pioglitazone (Actos Tablets) treatment.
    

Detailed description: 
      This is a special drug use surveillance on long-term use of pioglitazone (Actos Tablets) in
      patients with type 2 diabetes mellitus, designed to determine the onset of new cerebral and
      cardiovascular events and changes in metabolic syndrome parameters, and to analyze the
      association between patient baseline characteristics, including any metabolic
      syndrome-related risk factors, and the onset of new cerebral and cardiovascular events in an
      exploratory setting.

      Participants will be patients with type 2 diabetes mellitus. The planned sample size is
      20000.

      The usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before
      or after breakfast.
    

Intervention name(s): Pioglitazone
Intervention type(s): Drug
Intervention description(s): Pioglitazone tablets
Other intervention name(s): ACTOS
Intervention MeSH terms: Pioglitazone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 2 diabetes mellitus
      
Keywords: Drug Therapy
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group-comparison Trial of Aripiprazole in the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
Condition: Bipolar I Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this trial is to evaluate the clinical efficacy and safety of
      aripiprazole in comparison to placebo in patients with Bipolar I Disorder experiencing a
      manic or mixed episode.
    


Intervention name(s): Aripiprazole; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral, 24mg/day; oral, 0mg(4tablets)/day
Other intervention name(s): OPC-14597; OPC-14597
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Motion and Comfort for Thoracolumbosacral Orthoses - Group 2
Condition: Back Injuries
MeSH terms: Back Injuries
Study type: Interventional

Summary: 
      The study will measure and compare range of motion (ROM), motion during simulated activities
      of daily living ADL), tissue interface pressure (TIP), muscle activation (EMG), and trunk
      stiffness and damping measurements (TSD) for two pairs of back braces: Postural TLSO (456),
      and TLSO (464).
    


Intervention name(s): DJO 456; Aspen 456; DJO 464; Aspen 464
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Data will be recorded while subjects wear a 456 back brace manufactured by DJO Global; Data will be recorded while subjects wear a 456 back brace manufactured by Aspen Medical Products; Data will be recorded while subjects wear a 464 back brace manufactured by DJO Global; Data will be recorded while subjects wear a 464 back brace manufactured by Aspen Medical Products
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Subjects who completed either D5180C00007 or D5180C00009 will be offered the opportunity to
      consent for the Multicentre, Double-blind, Randomized, Placebo Controlled, Parallel Group,
      Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in
      Adults and Adolescents with Severe Uncontrolled Asthma. The study consists of a treatment
      phase, followed by a follow-up phase where subjects will not receive IP. The length of the
      follow up phase is determined by which study the subject had previously completed.
    

Detailed description: 
      Subjects who have not met investigational product discontinuation criteria and have attended
      the EOT visit in either study D5180C00007 or D5180C00009 will be offered the opportunity to
      consent for the Multicentre, Double-blind, Randomized, Parallel Group, Placebo Controlled,
      Phase 3, Safety Extension Study to Evaluate the Safety and Tolerability of Tezepelumab versus
      placebo in Adults and Adolescents (12 years of age and older) with a history of asthma
      exacerbations and inadequately controlled severe asthma receiving medium or high dose inhaled
      corticosteroid (ICS) plus at least one additional asthma controller medication with or
      without oral corticosteroids

      Following treatment, subjects will enter a follow-up phase, determined by the predecessor
      study they had previously completed. Subjects will not receive IP during the follow-up phase.
      For subjects who entered the study from study D5180C00007 and did not meet IP Discontinuation
      criteria, the follow-up phase will extend from week 104 to Week 140. Subjects who entered the
      study from study D5180C00009 will have their follow-up phase extend to week 116.
    

Intervention name(s): Tezepelumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Tezepelumab subcutaneous injection; Placebo subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects previously randomized in one of the predecessor studies to tezepelumab will be assigned and remain on tezepelumab dosing in the Destination Study.
Subjects randomized to placebo arm in the predecessor studies will be re-randomized in a 1:1 ratio to either tezepelumab or placebo.
Given the randomization scheme of subjects in the predecessor studies, this will give an overall subject distribution of 3:1 (tezepelumab:placebo), assuming a similar number of subjects rollover from each arm in the predecessor studies.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma, Uncontrolled Asthma, Severe Uncontrolled Asthma
Single Session Intervention to Prevent Common Mental Disorders and Among College Students
Condition: Depression, Anxiety
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      The present study aims to determine the effect of presenting psychoeducation emphasizing
      "growth-mindset," and information on depression and anxiety symptom severity. The
      investigators hypothesize that psychoeducation emphasizing that mental health is malleable
      will increase the participant's engagement with risk factors outlined in the intervention
    

Detailed description: 
      Depression and anxiety disorders (or common mental disorders; CMDs) are increasingly common
      among college students, with rates comparable to the general population. As such, brief,
      scalable and transdiagnostic prevention efforts targeting CMDs are needed. In order to
      address this need, this study aims to evaluate the impact of a single session intervention
      (SSI) utilizing growth mindset (GM) on CMD symptom severity and investigate the mediating
      role of changes in modifiable risk factors in the relationship between intervention and CMD
      symptom reduction. The intervention will adapt existing GM interventions for college students
      to engage mechanisms in the prevention and management of common mental disorders including
      engagement in modifiable risk factors. College students will be randomly assigned to complete
      either a GM intervention or a psychoeducation control.
    

Intervention name(s): Growth Mindset and Modifiable Risk Factor Information; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 15 minute interactive article describing neuroplasticity followed by 15 minute interactive article describing modifiable risk factors for depression and anxiety; 30 minute interactive article describing symptoms of depression and anxiety, common concerns of college student
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study of Safety and Pharmacokinetics in Healthy Volunteers and Safety, Tolerability and Antiviral Activity of VM-1500 in Patients With Human Immunodeficiency Virus-1 Infection
Condition: HIV Infection
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A combined Phase Ib and IIa randomized, placebo-controlled, double-blind study of VM-1500 in
      healthy subjects and in patients with HIV-1 infection that are antiretroviral therapy naïve.
    

Detailed description: 
      The study will be split into two parts:

      Part I: A randomized, placebo-controlled, single dose, double-blind study in healthy
      volunteers with 20 mg followed by 40 mg after DSMB approval.

      Healthy group: one dose with 1 PK day 12 health volunteers (total): 6 subjects will
      randomized (4:2) to VM-1500 20 mg or placebo. After DSMB approval, 6 subjects will be
      randomized (4:2) to VM-1500 40 mg or placebo Part II: A randomized, placebo-controlled,
      multiple dose, double-blind study for 7 days in patients with HIV infection who are
      antiretroviral therapy-naïve. After positive DMSB review the dose will be escalated from 20
      mg to 40 mg once daily.

      Patient group: 2 PK days (in-house) at day 1 and day 7 16 patients (total): 8 subjects will
      be randomized (7:1) to VM-1500 20 mg or placebo once daily for 7 days. After DSMB approval, 8
      subjects will be randomized (7:1) to VM-1500 40 mg or placebo once daily for 7 days.
    

Intervention name(s): VM-1500/Placebo
Intervention type(s): Drug
Intervention description(s): VM-1500 or Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Comparative Clinical Study of Gamisoyosan on Anxiety of Generalized Anxiety Disorder According to Dosage Form
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      In this randomized, double blinded, Parallel-controlled study, the investigators planned to
      give Gamisoyosan extract, Gamisoyosan extract powder or controlled medication on Anxiety of
      generalized anxiety disorder according to dosage form.
    


Intervention name(s): Placebo; KyungBangn-Gamisoyosan-x-gwarip; KyungBangn Gamisoyosan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.; AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.; AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
Other intervention name(s): standard code for item : 200005799; standard code for item: 200005591
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Generalized anxiety disorder; Jingji-zhengchong; Gamisoyosan; anxiety
The Role of Immediate Provisional Restorations on Bone Level Implants
Condition: Jaw, Edentulous, Partially
MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially
Study type: Interventional

Summary: 
      The study is designed to evaluate the clinical and radiographic outcomes of Straumann® Bone
      Level Implant SLActive placed in healed alveolar ridge (at least 8 weeks post extraction) and
      immediately provisionalised versus the same type of implants placed in healed alveolar ridge
      but not provisionalised. In both cases the implants will be loaded at 16 weeks (final
      restorations). The outcomes will be evaluated over a 2-year period.
    

Detailed description: 
      This is a prospective, randomised, controlled, single blind, and single center study. The
      total study duration for each patient should be 24 months.

      Straumann Bone Level Ø 4.1 mm SLActive implants will be placed for single tooth replacement,
      followed by either immediate provisional prosthetic loading or no provisionalised. The final
      prosthetic loading is made at 16 weeks after implant loading. The implant length will be
      selected according to the clinical indication of the site based on previous radiographic
      evaluation.

      In total 11 visits per patient are scheduled in this study. Bone level changes, implant
      success and survival rate, soft tissue changes, aesthetic outcome and adverse events (AEs)
      will be assessed.

      The study devices are CE- (Conformité Européenne, meaning European Conformity) marked
      products.

      One center in the United Kingdom will participate.
    

Intervention name(s): Straumann® Bone Level SLActive Implant (4.1mm diameter)
Intervention type(s): Device
Intervention description(s): Straumann® Bone Level Implants will be placed in healed alveolar ridge (at least 8 weeks post extraction). Implants in Arm 1 will be immediately provisionalized. Implants in Arm 2 will not be immediately provisionalized. Implants in both Arms will be loaded at 16 weeks (final prosthetic reconstruction will be performed according to the standard procedure for single crown restoration)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Reduction of Topical Anesthetic Time for Subcutaneous Port Access Using Ultrasound
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Children ages 3-17 who are undergoing port access receive both standard care, topical
      medicine for numbing (LMX4), and the study intervention which utilizes ultrasound to speed
      the onset of LMX4 from 30 minutes to 5 minutes. The procedures will be performed on 2
      separate visits to the clinic. The child's pain with the access procedure is evaluated.
    


Intervention name(s): SonoPrep
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
Condition: Cancer; Survivorship; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      The primary purpose of this study is conduct a pilot study testing the study protocols,
      implementation program, and mixed-methods data collection.
    

Detailed description: 
      Primary Objectives:

      • To evaluate how successfully SHARE-S can be implemented into clinical care as characterized
      by rates of enrollment. Investigators hypothesize >30% of patients e-referred to SHARE-S will
      enroll.

      Secondary Objectives:

        -  To assess additional implementation outcomes that evaluate preliminary implementation
           success (i.e., further assessment of adoption, acceptability, appropriateness, further
           assessment of feasibility, and fidelity).

        -  To describe service outcome variability to inform future studies. Investigators will
           assess service outcomes relevant to Commission on Cancer requirements by reporting
           annual estimates for: (1) the estimated number of patients impacted by SHARE-S; (2) the
           cancer sites impacted by SHARE-S; and the (3) resources/processes utilized to enhance
           each of the chosen services if barriers were encountered. We will also assess safety and
           perceived patient-centeredness of care.

        -  To describe patient health outcome variability to inform future studies (i.e., social
           role, physical functioning, anxiety, depression, fatigue, sleep disturbance, pain,
           cancer-specific quality of life, health behaviors, patient autonomy, self-efficacy for
           managing cancer, engagement with the survivorship care plan document, and satisfaction
           with care).

        -  To evaluate the Implementation Program we will assess key milestones and processes for
           this pilot study of the Implementation Stage measured at the clinic level.

        -  To qualitatively assess implementation barriers and facilitators using semi-structured
           interviews that will be audio-recorded.

        -  To examine how study results vary by cancer type.
    

Intervention name(s): SHARE-S Implementation Program
Intervention type(s): Behavioral
Intervention description(s): The program consists of three components: An electronic referral among clinical teams for potential participants, patient engagement with survivorship care planning guidelines through self-management/health coaching. One coaching call before a clinic visit (60 minutes) and two coaching calls after the clinic visit (30 minutes each). Participants will also receive automated, tailored text messages (daily for three weeks before and after a clinic visit for a total of six weeks).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-Effect of KQ-791
Condition: Healthy Volunteers; Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, and the effect of food on
      KQ-791. Each participant may receive up to 3 single doses of KQ-791 (at up to 3 different
      dose levels) and 1 placebo dose over the course of the study. Up to 6 escalating dose levels
      may be studied, in two distinct groups or cohorts.
    


Intervention name(s): KQ-791; KQ-791 (after meal); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsules administered orally while fasting, in up to 3 periods; Single dose of KQ-791 in capsules, after a meal, in 1 period; Capsules, administered orally, in 1 period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
HFR Cartridge and Inflammation
Condition: Inflammatory Status; P-cresol
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      A major limitation of standard hemodialysis is that it does not clear the plasma from
      interleukin-6 (IL-6) and p-cresol, two uremic toxins responsible for the high cardiovascular
      risk in end stage renal disease (ESRD). In the present study, we evaluated whether these
      compounds are removed by HFR-Supra, a double-chamber hemodiafiltration system in which the
      ultrafiltrate (UF) returns to the patient after its regeneration through a resin cartridge.
      We selected 8 inflamed chronic hemodialysis (HD) patients, which underwent a single 240
      minutes HFR session. We studied the change in both IL-6 and p-cresol circulating levels, by
      comparing pre- and post-HFR serum concentrations. In addition, we compared Il-6 and p-cresol
      levels in the UF entering (UFin) and exiting (UFout) from the cartridge, either at the start
      or at the end of the HFR session. The proinflammatory activity of UFin and UFout was
      determined by evaluating the changes that they induced in IL-6 messenger ribonucleic acid
      (mRNA) expression and release in peripheral blood mononuclear cells (PBMC) collected from 8
      healthy volunteers and cultured in vitro for 24 hr.
    


Intervention name(s): HFR dialysis
Intervention type(s): Procedure
Intervention description(s): HFR is a dialysis technique that combines the processes of diffusion, convection and adsorption. In this double chamber hemodiafiltration system, the ultrafiltrate is reinfused after its passage (and opportune modification) through a resin cartridge.
Other intervention name(s): hmodiafiltration with on line reinfusion of ultrafiltrate
Intervention model: Single Group Assignment
Masking: None (Open Label)