bioihbjkbjnl/mcl2 huggingface dataset:
Secondary Prevention of Depression Through Group-based ACT-Therapy Preceded by an Experimental ABM-Procedure
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Depression (major depressive disorder; MDD) is a very common mental disorder. Research
      suggests that individuals with prior depressive episodes have a risk of the relapse or
      recurrence of MDD. Secondary prevention has been identified as a key goal in the long-term
      management of the disease. The current project aims to investigate whether group based
      Acceptance and Commitment Therapy (ACT) can reduce surrogate and clinical markers of relapse
      in a group highly vulnerable to depressive episodes. The group intervention will consist of
      eight sessions, and each group will consist of maximum 12 persons. The project also studies
      whether Attention Bias Modification (ABM) preceding the ACT intervention will enhance the
      effect. ABM will be administered over a fourteen days period prior to the ACT-intervention.
      Effect will be measured over a period of 12 months. The primary outcome is changes in
      depressive symptoms. ACT-specific secondary outcome measures are also included. Subjects with
      a history of major depression (n=200), currently in remission, will be recruited from
      Sørlandet Hospital (100 participants). Matched participants (100 participants) will be
      recruited at the University of Oslo. In the first phase, participants from Sørlandet hospital
      will be randomized to ABM treatment or control condition. In the second phase all
      participants from Sørlandet hospital will receive group based ACT treatment. Group based ACT
      and ABM represent interventions that are time and cost effective, and that could be made
      available to large number of individuals struggling with MDD.
    


Intervention name(s): Attention Bias Modification; Sham Attention Bias Modification; Acceptance and Commitment Therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Computer based Attention Bias Modification; Computer based Sham Attention Bias Modification; Acceptance and Commitment Therapy delivered in a group therapy setting
Other intervention name(s): ABM+; ABM-; ACT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
Condition: Pneumococcal Vaccine; Streptococcus Pneumoniae
MeSH terms: Pneumonia, Pneumococcal
Study type: Observational

Summary: 
      This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3)
      factors affecting safety in terms of the safety in infants starting to receive Prevenar at
      the age of more than 2 and less than 7 months in routine medical practice.

      This surveillance will specifically focus on the occurrence of the following:

        1. Local reactions at the injection site

        2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)
    

Detailed description: 
      This surveillance will be conducted using a continuous surveillance system, in which each
      physician enrolls patients who meet the enrollment criteria continuously until the contract
      sample size is reached.
    

Intervention name(s): 7-valent vaccine injection
Intervention type(s): Biological
Intervention description(s): For primary immunization, three doses of Prevenar 0.5 mL should be injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL should be injected subcutaneously, at least 60 days after the 3rd dose.
Other intervention name(s): Prevenar, 7vPnC
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infants starting to receive Prevenar at the age of more than 2 and less than 7 months
      
Keywords: Pneumococcal Vaccine; Prevenar; 7-valent; Special Use-result surveillance
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
Condition: Chronic Obstructive Pulmonary Disease; Lower Respiratory Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional

Summary: 
      Many "Survivors" in the World Trade Center (WTC) clinical program have a clinical syndrome
      characterized by chronic obstruction in small airways and persistence of lower respiratory
      symptoms despite therapy. This study will test the hypothesis that persistent symptoms in WTC
      "Survivors" are associated with abnormal small airways whose dysfunction is amplified during
      exercise and is associated with biologic evidence of inflammation and remodeling. The results
      from this study will have important treatment implications for our WTC population with
      potential applicability to larger populations with either inhalational lung injury and/or
      airway diseases such as asthma and chronic obstructive pulmonary disease.
    


Intervention name(s): Cardio-Pulmonary Exercise Testing (CPET)
Intervention type(s): Other
Intervention description(s): This test helps determine if the decreased tolerance to exercise or shortness of breath with activity a patient is experiencing is caused by a cardiac disease, versus a pulmonary disease.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy Controls who were not in the WTC program (n = 20)
Uncontrolled Lower Respiratory Symptoms in WTC Surivivors; ULRS study) with persistent LRS (n = 40)
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: World Trade Center; World Trade Center Survivors
Study to Assess the Safety and Effectiveness of the Penumbra System
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical evaluation is a prospective, single-arm, multi-center trial.

      The purpose of this clinical evaluation is to assess the safety and effectiveness of the
      Penumbra System in the revascularization of patients presenting with acute ischemic stroke
      secondary to intracranial, large vessel, occlusive disease.
    

Detailed description: 
      Purpose:

      The purpose of this clinical evaluation is to assess the safety and effectiveness of the
      Penumbra System in the revascularization of patients presenting with acute ischemic stroke
      secondary to intracranial, large vessel, occlusive disease. Up to 125 evaluable patients will
      be enrolled in the study.
    

Intervention name(s): Penumbra System
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Penumbra; Ischemic; Stroke; Intervention; Neurovascular; Thrombus; Embolectomy; Ischemic stroke
Conserving Breast Surgery - Comparison of Conventional With Sonography
Condition: Breast Surgery
Study type: Interventional

Summary: 
      Aim of the study is to test whether surgical removal of a tumor under sonographic control as
      compared to conventional method reduces the rate of resections and local relapse
    


Intervention name(s): Sonography assisted breast surgery; Conventional breast surgery
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Intensive Therapy for Children With Microcephaly, Hyperkinetic Movements, or Global Developmental Delay
Condition: Microcephaly; Hyperkinesis With Developmental Delay; Global Developmental Delay
MeSH terms: Microcephaly; Hyperkinesis
Study type: Interventional

Summary: 
      This trial will consist of a clinical series of up to 50 children with Global Developmental
      Delay and concomitant microcephaly or hyperkinetic movements. All children will be assessed
      for psychomotor function using standardized assessments, goal specific assessments, with the
      potential addition of neuroimaging assessment, prior to and after receiving an intensive
      burst of neuromotor therapy. The interventional effects will be explored by comparing the pre
      and post interventional assessments and neuroimaging.
    

Detailed description: 
      Up to 50 children between the ages of 6 months and 15 years will be recruited to participate
      in a burst of intensive neuromotor intervention in the form of Acquire therapy, delivered by
      the treatment team at Virginia Tech's Neuromotor Research Clinic. All children will have a
      diagnosis of Global Developmental Delay, with concomitant microcephaly or hyperkinetic
      movements. The children will be assessed for psychomotor function prior to and after the
      treatment intervention, using a series of standardized and goal specific assessments, with
      the possibility of additional neuroimaging assessments when possible. Acquire therapy is an
      intensive intervention in that it is delivered with high intensity, wherein goal directed
      behaviors are promoted at high levels of repetition and delivered at a high dose (4-6 hours a
      day) in an intensive burst of 3-4 weeks of 5 day a week treatment. Acquire therapy is an
      operant conditioning based intervention delivered in a cycle of refinement, reinforcement and
      repetition. It is play-based with activities selected to drive behavior toward goals that are
      specific to each child and selected based on each child's interests and needs. As such a
      specific protocol cannot be outlined. However, all goal directed activities are designed to
      promote awareness of and engagement with others and the environment.
    

Intervention name(s): Acquire Therapy
Intervention type(s): Behavioral
Intervention description(s): This intervention is an operant conditioning based neurorehabilitation protocol for the promotion of psychomotor function
Intervention model: Single Group Assignment
Intervention model description: As an early phase study, all enrolled children will receive the intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Global Developmental Delay; Hyperkinesis; Microcephaly; Neurorehabilitation; Intensive Interventions
A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to assess the safety and tolerability of gamma-irradiated
      varicella-zoster virus (VZV) vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C
      (Part 2) and to determine if they were immunogenic when administered to healthy individuals,
      as measured by VZV-specific antibody responses by glycoprotein enzyme-linked immunosorbent
      assay (gpELISA). The primary hypothesis was that gamma-irradiated VZV vaccine A (Part 1) and
      gamma-irradiated VZV vaccine B and C (Part 2) would elicit an acceptable VZV-specific immune
      response. The secondary hypothesis for Part 1 of the study was that heat-treated VZV vaccine
      would elicit an acceptable VZV-specific immune response.
    


Intervention name(s): Comparator: V212; Comparator: Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart; Placebo; 4-dose regimen administered ~30 days apart.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Herpes Zoster (Shingles)
IDEA-033 Three Months Dose Finding in OA Followed by IDEA-033 Three Months Extension in OA
Condition: Osteoarthritis; Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      The study objective is the eluciation of the dose-response function in efficacy (and possibly
      safety) in order to determine an optimal dose with respect to efficacy and safety. The study
      is designed with three dose levels and one placebo control.
    


Intervention name(s): IDEA-033 (and rescue medication)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: osteoarthritis; knee; IDEA-033
Rhomboid Intercostal and Sub-serratus Block
Condition: Rhomboid Intercostal Block
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The rhomboid intercostal block (RIB) can provide good analgesia effects after thoracic
      surgery . The ultrasound-guided RIB is novel analgesic techniques recently described by
      Elsharkawy et al. . Additionally, the RISS block anesthetizes the lateral cutaneous branches
      of the thoracic intercostal nerves and can be used in multiple clinical settings for chest
      wall and upper abdominal analgesia. However, the analgesic effects of the RISS block after
      breast surgery have not been analyzed through a randomized-controlled trial.
    


Intervention name(s): Patients will be received rhomboid intercostal block under ultrasound guidance.; conventional intravenous analgesia
Intervention type(s): Procedure; Drug
Intervention description(s): Following endotracheal intubation, patients allotted to the RIB group were positioned in the lateral decubitus position with the chest on the operating side lying superiorly. The ipsilateral arm was abducted from the chest to move the scapula laterally. The RIB was performed as described previously [8]. A high-frequency (6-12 MHz) linear ultrasound probe (LOGIQ e ultrasonic system, Deutschland GmbH & Co. KG, Solingen, Germany) was placed medial to the medial border of the scapula in the oblique sagittal plane. The landmarks, i.e., the trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung, were identified in the ultrasound. Under aseptic conditions, an 80-mm 21-gauge needle was inserted at the level of T6-7 in the ultrasound view. A single dose of 30 ml 0.25% bupivacaine will be injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography.; Following endotracheal intubation, patients will be received morphine sulfate (0.02 mg/kg) bolus doses were used to preserve MAP and HR within 20% of pre-induction readings
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
Safety and Efficacy Study of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV)
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to evaluate the antiviral effect of GS-5806 in healthy adults infected with a
      strain of Respiratory Syncytial Virus.
    


Intervention name(s): GS-5806; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GS-5806, powder for oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Respiratory; Syncytial; Virus; Infections; RSV
Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer
Condition: Breast Neoplasm
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of the study is to examine the safety and effectiveness of combination
      therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV
      breast cancer subjects. The study is designed to assess the safety and effectiveness of this
      combination therapy. Safety will be assessed by analyzing the types of toxicity, the severity
      of toxicity and the need for dose modification or delay due to toxicity. Effectiveness will
      be assessed by analyzing response rates, time to treatment failure, time to progression and
      overall survival. Our hypothesis is that the regimen will be more effective than standard
      historic regimens for this type and stage of cancer.
    

Detailed description: 
      Single-agent chemotherapy is rarely curative in advanced breast cancer. Combination regimens
      are the next logical step in the attempt to improve tumor response rates and prolong
      survival. Oral capecitabine is a convenient way to deliver drug a 5-fluorouracil analogue. In
      addition, vinorelbine is a newer vinca alkaloid chemotherapeutic agent with improved efficacy
      and probably improved toxicity over its predecessors in the treatment of breast cancer. We
      propose combining these two agents. As these two drugs have non-overlapping toxicities and
      differing mechanisms of action, we anticipate being able to deliver both drugs in near full
      dose.

      Secondary purposes include assessing whether there is a correlation between intra-tumoral
      enzyme levels and prognosis.
    

Intervention name(s): Vinorelbine; Capecitabine
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg/m2 IV weeks 1, 2 and 3 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.; 825 mg/m2 twice a day; days 1 - 14 of each 3 week cycle. Treatment continues until disease progression, excessive toxicity or other reason to remove patient from protocol therapy.
Intervention MeSH terms: Capecitabine; Vinorelbine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast cancer
Lateral Canthal Rhytides With Medium Depth Chemical Peel With or Without Pretreatment With Botulinum Toxin A
Condition: Wrinkles
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being done to find out if the use of botulinum toxin prior to a medium strength
      combination chemical peel (Jessner's peel followed by 35% Trichloroacetic acid peel) will
      improve the appearance of crow's feet wrinkles when compared to a chemical peel alone.
      Botulinum toxin type A is a purified substance, derived from a bacteria that block muscular
      nerve signals. Jessner's Peel, a combination of resorcinol (14g), salicylic acid (14g), and
      lactic acid (85%) in ethanol (95%), is a superficial chemical peel. These two
      products/procedures have been FDA approved to improve the appearance of facial wrinkles.
    

Detailed description: 
      Wrinkling in the skin is caused by habitual facial expressions, aging, sun damage, smoking,
      poor hydration, and various other factors. There are two major types of wrinkles-dynamic and
      static. Dynamic wrinkles, which are due to excessive muscle activity, usually of the face,
      tend to disappear when you relax your facial muscles. The most common of these dynamic
      wrinkles are frown lines, forehead wrinkles, and eye wrinkles (or crow's feet). However, if
      the excessive muscle activity is carried on for too long, these do not disappear completely
      on relaxation, and are thus called static wrinkles. Static wrinkles are formed either by
      chronic excessive muscle activity or are due to the effects of age and gravity, with a loss
      of subcutaneous fat. Examples of static wrinkles are the nasolabial folds, which are the deep
      grooves running from the sides of the nose to the corners of the mouth.
    

Intervention name(s): Botulinum Toxin; Chemical Peel Only
Intervention type(s): Drug; Procedure
Intervention description(s): The botulinum toxin will be injected into the wrinkles "crow's feet". The injections will take about 10 minutes to complete.; After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
Other intervention name(s): Botox; Jessner's peel solution; TCA peel
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Correlation of the Cervical Symptoms With Intubation Quality and Airway Assessment
Condition: Cervical Pain; Cervical Disease
MeSH terms: Uterine Cervical Diseases; Neck Pain
Study type: Interventional

Summary: 
      Cervical spine disorders can cause neck pain with or without neurological dysfunction. The
      most common cause of acute and chronic neck pain is cervical degenerative changes. Surgical
      decision of cervical pathology is made by anamnesis, neurological examination and imaging
      methods. Airway management can be difficult for patients presenting for cervical spine
      surgery. In addition, these patients may have severe cervical spine instability or spinal
      cord level myelopathy and may develop serious neurological complications associated with the
      intubation technique. Videolaringoscopes, which have become widely used with the developing
      technology, provide a better view than direct laryngoscopy in terms of cervical
      immobilization during intubation. Therefore, videolaryngoscope is preferred for cervical
      pathologies. Nowadays, the use of videolaryngoscope is recommended in patients with airway
      difficulty. Neutral position is important for intubation of patients with cervical pathology
      and it is highly recommended in the literature to evaluate these patients as difficult
      airways. All cervical patients are intubated with videolaryngoscope in investigator's clinic.
      The aim of this study was to evaluate how long the duration of cervical pathology affects
      airway anatomy and how it affects airway management during anesthesia. On the other hand,
      airway-related measurements will be performed by MRI and ultrasonography (USG), which is
      routinely evaluated in the diagnosis process, and it will be aimed to evaluate these
      measurements in terms of their effects on intubation quality. At the end of the study, all
      evaluations were analyzed and it was aimed to compare the effects of other evaluated
      parameters (such as USG and MRI measurements) on intubation difficulty level, with cervical
      pathology duration being primary.
    


Intervention name(s): Airway ultrasonography
Intervention type(s): Diagnostic Test
Intervention description(s): we will measure hyomental distance, skin-epiglottis distance, skin-hyoid distance, epiglottis-vocalcords distance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: videolaryngoscopy; quality of intubation; cervical pathology; difficult airway