bioihbjkbjnl/mcl2 huggingface dataset:
Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders
Condition: Depression; Anxiety
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      The overall aim of this study is to develop and test a psychodynamic Internet-delivered
      psychological treatment for patients with major depression and/or anxiety disorders and
      compare its efficacy to an active control group.
    


Intervention name(s): Internet-delivered Psychodynamic Treatment; Internet-delivered structured support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Ten weeks of guided self-help + therapist contact, via the Internet.; Ten weeks of therapist contact, via the Internet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fractional Micro-Needle Radiofrequency and I Botulinum Toxin A for Primary Axillary Hyperhidrosis
Condition: Primary Axillary Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      Because of the limiting data about an efficacy and safety of fractional radiofrequency for
      the treatment of hyperhidrosis, this study aim to compare clinical efficacy by Hyperhidrosis
      Disease Severity Score (HDSS) between Fractional Microneedle Radiofrequency device and
      intradermal Botulinum toxin type A injection for the treatment of primary axillary
      hyperhidrosis. The secondary objectives to determine the improvement change of iodine starch
      test, total amount of sweat production by trans-epidermal water loss (TEWL), patient's
      satisfaction and their quality of life by Dermatology Life Quality Index and side effect
      between the groups.
    


Intervention name(s): Fractional Micro-Needle Radiofrequency; Botulinum toxin type A
Intervention type(s): Device; Drug
Other intervention name(s): DeAgeEX Fractional RF; Neuronox
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fractional Micro-Needle Radiofrequency; Intradermal Botulinum Toxin A
A Study to Assess the Efficacy of Risankizumab Compared to FUMADERM® in Subjects With Moderate to Severe Plaque Psoriasis Who Are Naïve to and Candidates for Systemic Therapy
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of subcutaneous (SC)
      risankizumab and oral FUMADERM provided as study medication in participants with moderate to
      severe plaque psoriasis who are naïve to and candidates for systemic therapy.
    

Detailed description: 
      The efficacy analysis was performed in the Intent to Treat (ITT) set which included all
      participants who were randomized. The safety analysis was performed in the safety set which
      included all participants who received at least one dose of study drug. No participants were
      excluded from the efficacy analysis. Three participants in the FUMADERM® group discontinued
      after randomization prior to receiving any study drug and were thus not included in the
      safety set.
    

Intervention name(s): Fumaderm; risankizumab
Intervention type(s): Drug; Drug
Intervention description(s): Fumaderm tablet administered orally; Risankizumab administered by subcutaneous (SC) injection
Other intervention name(s): ABBV-066; BI 655066; SKYRIZI
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ABBV-0066; BI 655066; risankizumab
Nonsurgical or Surgical Treatment of ACL Injuries
Condition: Anterior Cruciate Ligament Injury
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Observational

Summary: 
      The aim of this study is to evaluate knee function, sports participation and knee reinjuries
      over 2 years in a group of patients who choose either nonsurgical or surgical treatment for
      an anterior cruciate ligament (ACL) injury
    

Detailed description: 
      This study is a part study of an overall study with the title 'Dynamic stability of the
      ACL-injured knee'. The overall study prospectively follows a cohort of newly injured patients
      with total rupture of the anterior cruciate ligament in the knee.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Athletically active anterior cruciate ligament injured patients
Corticosteroid and Lidocain Injections for Tennis Elbow
Condition: Tennis Elbow; Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      The investigators hypothesized that lidocain injection is as effective as corticosteroid
      injection in management of tennis elbow, and if so, it may replace corticosteroid injection
      in the management of tennis elbow.
    

Detailed description: 
      Lateral epicondylitis or tennis elbow is a tendinopathy of the common extensor origin of the
      lateral elbow, and is estimated to have an annual incidence of 1-3%. It is characterized by
      tenderness over the lateral epicondyle of the humerus, normal range of motion, and pain on
      resisted extension of the wrist or fingers. Symptoms can persist for between 6 months and 2
      years but usually resolve within 12 months. Although tennis elbow is often self-limited,
      around 20% of cases are refractory to conservative care. Tennis elbow is now thought to be
      non-inflammatory, and the pathologies are characterized by collagen degeneration, fibroblast
      proliferation, mucoid degeneration, and neovascularization.

      Treatment of tennis elbow includes relative rest, physical therapy (therapeutic exercise,
      massage, therapeutic ultrasound, lower power laser, etc.), analgesics, non-steroidal
      anti-inflammatory drugs, glyceryl trinitrate patches, injection therapy (corticosteroid,
      hyaluronan gel, botulinum toxin, and autologous platelet-rich plasma), shock wave therapy,
      and even surgery. Previous studies showed corticosteroid injection is effective in the short
      term, but is harmful in the long-term, and is more likely to have a recurrence. In
      consideration of a degenerative lesion in tennis elbow, corticosteroid injection may be not
      an ideal agent. Although plate-rich plasma injection showed promising results, the high cost
      limited its widespread clinical use. Since local lidocain injection is commonly used in the
      management of myofascial pain syndrome, it might be effective in the treatment of
      tendinopathy like tennis elbow. The purpose of this study is to compare the effect of
      corticosteroid injection and lidocain injection in the treatment of tennis elbow. The
      investigators hypothesized that lidocain injection is as effective as corticosteroid
      injection in management of tennis elbow, and if so, it may replace corticosteroid injection
      in the management of tennis elbow.
    

Intervention name(s): Corticosteroid; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): triamcinolone (10mg/ml) 1 ml will be injected to the lateral epicondyle of the affected elbow.; For lidocain injection, 1ml 1% lidocain will also be peppered on the same area.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lateral epicondylitis; tennis elbow; Lidocaine; corticosteroid
Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNH
Condition: Paroxysmal Nocturnal Hemoglobinuria; Marchiafava-Micheli Syndrome; Paroxysmal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Study type: Interventional
Phase: Phase 3

Summary: 
      It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety
      of Elizaria® (eculizumab, GENERIUM JSC, Russia) versus Soliris® (Alexion Pharma GmbH,
      Switzerland) in patients with paroxysmal nocturnal hemoglobinuria.
    

Detailed description: 
      After screening, patients meeting all of the inclusion / non-inclusion criteria and
      vaccinated against meningococcal infections were divided into two subgroups according to the
      eculizumab treatment status (Soliris® naïve patients / patients who had received Soliris® at
      a maintenance dose prior to the trial inclusion). Each subgroup included an even number of
      patients to maintain recruitment balance. Then, patients of each subgroup were distributed
      into one of two treatment groups by the method of stratified block randomization at a 1:1
      ratio into groups A and B, respectively. In the first group (Group A), patients received
      infusions of Elizaria (eculizumab, GENERIUM JSC), in the second one (Group B) - infusions of
      Soliris®.

      The duration of participation of each patient in the study, including the screening period,
      was about 30 weeks.
    

Intervention name(s): Elizaria®; Soliris®
Intervention type(s): Biological; Biological
Intervention description(s): Induction cycle: 600 mg (2 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes once a week for 4 weeks. Maintenance therapy: 900 mg (3 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes in Week 5, followed by 900 mg every 14 days.; Induction cycle: 600 mg (2 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes once a week for 4 weeks. Maintenance therapy: 900 mg (3 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes in Week 5, followed by 900 mg every 14 days.
Other intervention name(s): eculizumab; eculizumab
Intervention MeSH terms: Eculizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Paroxysmal Cold Hemoglobinuria; eculizumab; Complement Inactivating Agents; Hemolysis; Anemia, Hemolytic; Anemia; Hematologic Diseases; Bone Marrow Diseases; Hemoglobinuria; Proteinuria
FC Patch Comparator Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH
      P00331F to a marketed comparator.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): BAY86-5016, SH P00331F; SH P00331N
Intervention type(s): Drug; Drug
Intervention description(s): Drug amount per patch: 0.9 mg EE2 + 1.9 mg gestodene (GSD); Drug amount per patch: 0.6 mg EE2 + 6 mg NGM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: FC patch; comparator study
Using MRI Scans to Evaluate Spinal Manipulation
Condition: Lower Back Pain
MeSH terms: Low Back Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      Lumbar spinal manipulation, or chiropractic adjusting, is thought to separate the surfaces of
      the spinal joints and thereby relieve lower back pain. This study will use MRI scans to
      evaluate the spinal joints before and after spinal manipulation.
    

Detailed description: 
      Zygapophysial joints, better known as facet or "Z" joints, are located on the back
      (posterior) of the spine on each side of the vertebrae where it overlaps the neighboring
      vertebrae. Z joints provide stability and allow the spine to bend and twist. Adhesions in the
      Z joints may develop following hypomobility of vertebrae. These adhesions may be alleviated
      by separation (gapping) of the Z joints.

      Side posture adjusting (spinal manipulation) is thought by many to gap the Z joints, yet no
      measurable differences of the Z joints before and after spinal manipulation have ever been
      published. This study will evaluate gapping of the L3/L4, L4/L5, and L5/S1 Z joints by taking
      measurements directly from MRI scans of the Z joints before and during positioning for a side
      posture adjustment, and before and after side posture adjusting.

      Health volunteers will be randomly assigned to one of four groups: 1) neutral position
      followed by side posture positioning (trunk rotated to the volunteer's right); 2) neutral
      position followed by side posture spinal adjusting followed by neutral positioning; 3)
      neutral position followed by side posture spinal adjusting, followed by side posture
      positioning; and 4) neutral position followed by neutral position (control group). MRI scans
      will be taken with the volunteers in the original neutral position and in the final position
      (either second neutral position or side posture positioning).
    

Intervention name(s): Lumbar side-posture spinal adjusting
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Spinal Manipulation; Chiropractic; Zygapophysial Joints
Alcohol Effects on Driving-related Skills of Young Drivers
Condition: Psychomotor Impairment
MeSH terms: Psychomotor Disorders
Study type: Interventional

Summary: 
      Given the known driving behavior of Driving Under the Influence of Alcohol and some of its
      parallel to driving under the influence of cannabis, this supplemental study aims to validate
      the sensitivity of the primary and secondary outcome measures employed in a cannabis and
      driving study currently in progress.
    

Detailed description: 
      This study will examine the effects of an intoxicating dose of alcohol on driving-related
      skills among young drivers using driving simulator technology.

      This study is a double-blind, placebo-controlled mixed design study, including randomized
      between-subjects comparison of the effects of alcohol intoxication and both between- and
      within-subjects examination of acute and residual effects at approximately 24 and 48 hours
      following one-time alcohol administration.

      Initial contact with potential participants will be made by telephone, where study personnel
      will conduct a telephone screen for eligibility. Those telephone screened as eligible will
      attend CAMH for an eligibility assessment. Enrolled participants will complete four sessions
      on consecutive days: a practice day, an alcohol administration day, and a 24-hour and 48-hour
      post-alcohol session.
    

Intervention name(s): Alcohol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single oral administration of an alcoholic beverage mixed in a 1:3 ratio of alcohol (Vodka) to tonic water to obtain a target BAC of 0.08mg%; A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
Other intervention name(s): Smirnoff Vodka; Tonic water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Alcohol impaired driving; Driving simulation; Residual effects of alcohol; Acute psychomotor effects of alcohol; Young drivers
Development of Low Cost Devices to Increase Access to Treadmill Training
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The goals of this Model System Program are to expand upon and advance the findings and
      outcomes of previous and current Model Systems clinical research, to continue to develop and
      study the effectiveness of innovative treatment strategies for persons with spinal cord
      injury (SCI); and to evaluate the benefits of a well-designed, comprehensive, coordinated,
      interdisciplinary continuum of care that lead to improved outcomes for all persons with SCI.
      In order to achieve these goals, the following objectives of the Midwest Regional Spinal Cord
      Injury Care System (MRSCICS) model system grant proposal will be accomplished.
    

Detailed description: 
      The investigators will develop and assess the use of spring-loaded devices to assist limb
      swing and forward propulsion during body weight supported treadmill training (BWSTT) (Aim 1).
      Prototype models of both devices have been developed.

      These devices will be:

        1. simple to use in the clinical setting;

        2. will be easily adjustable to alter the assistance provided; and,

        3. will be able to quantify the amount of assistance necessary to facilitate normal
           stepping patterns.

      The investigators will also evaluate short- and long-term adaptations in locomotor
      performance following BWSTT in individuals with incomplete SCI with the use of these devices.
      This information will identify the effects of variable assistance at the limbs or trunk to
      modulate muscle activity and/or motor performance (kinematics) during stepping to maximize
      walking recovery.
    

Intervention name(s): Elastic assisted treadmill walking
Intervention type(s): Device
Intervention description(s): Rubber band pulley system that will assist therapists in advancing limbs while gait training. The device is positioned in front of a treadmill and the stretch of the elastic bands when a legs moves backwards on a treadmill is resists the movement and facilitates limb swing when walking.
Other intervention name(s): Theraband(R)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the Puff City web-based behavioral intervention of
      asthma management program in a clinical setting. This study also examines and evaluates the
      cost and efficiency of patient eligibility determination methods, patient recruitment, study
      monitoring (compliance with study regimen, participant retention and follow-up), and the
      collection of clinical endpoints.
    

Detailed description: 
      Asthma continues to be a major public health problem in the US with high economic and social
      costs. Vulnerable ethnic communities are disproportionately affected by asthma as
      demonstrated by higher morbidity and mortality for these groups. We have completed two
      school-based, randomized trials of a web-based, computer-tailored asthma management
      intervention that targets urban teens (Puff City).

      The current study, Puff City in the Clinic, will be evaluated as a clinical tool by
      initiating the web-based behavioral intervention of asthma management in a clinical setting.
      However, the current paradigm for conducting such a trial is costly with respect to patient
      recruitment, intervention delivery, and data collection and management. To address these high
      costs, the study utilizes comparative effectiveness research (CER) pragmatic approaches to
      design a randomized controlled trial for patient recruitment and determination of
      eligibility, study monitoring (compliance with study regimen, participant retention and
      follow-up), and collection of clinical endpoints.
    

Intervention name(s): Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.; Teens in the control group will receive generic, web-based asthma education.
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Web-based, computer-tailored asthma management intervention delivered in 4 sessions, plus a 6 month booster.; Web-based, generic asthma management intervention delivered in 4 sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Urban adolescents; Acute asthma; Asthma; Computer tailoring; Web-based intervention; Puff City
A Phase 4, Randomized, Double-blind, Placebo-controlled,Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma
Condition: Asthma
MeSH terms: Asthma; Dyssomnias; Parasomnias
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To assess the effect of dupilumab on sleep

      Secondary Objectives:

        -  To evaluate the effect of dupilumab on additional patient reported sleep outcomes

        -  To evaluate the effect of dupilumab on objective sleep assessment

        -  To evaluate the effect of dupilumab on asthma symptoms

        -  To evaluate the effect of dupilumab on lung function

        -  To evaluate the safety of dupilumab
    

Detailed description: 
      Study duration per participant will be approximately 16 weeks and up to 29 weeks including up
      to 5 weeks screening period, a 12-week treatment period and up to 12 weeks post-treatment
      follow-up period or until the participant switches to commercialized dupilumab (or other
      biologic product), whichever comes first.
    

Intervention name(s): SAR231893; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous; Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
Other intervention name(s): Dupixent
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interim analysis for sample size re-estimation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Chewing and Oral Processing of Solid Food
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Study type: Observational

Summary: 
      Food texture modification is commonly used as an intervention for people with dysphagia
      (swallowing impairment). However, the field currently lacks a proper understanding of how
      this intervention works. The overall goal of this project was to collect measurements of food
      bolus transit through the oropharynx (i.e., mouth and throat) during chewing, oral processing
      and swallowing.
    

Detailed description: 
      Aim: To explore chewing and oral processing behaviors across solid foods of different
      consistencies (minced and moist, soft & bite-sized, regular).

      Healthy adult participants will be asked to swallow foods representative of the "minced and
      moist", "soft and bite-sized" and "regular" consistency levels of the International Dysphagia
      Diet Standardisation Initiative.

      We will measure the number of chews taken per bolus and the overall duration of chewing to
      understand differences across consistencies.
    

Intervention name(s): Food texture modification
Intervention type(s): Other
Intervention description(s): Food prepared in three different consistencies: minced and moist, soft and bite-sized and regular, as defined by the International Dysphagia Diet Standardisation Initiative
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult volunteers with no history of swallowing difficulty