bioihbjkbjnl/mcl2 huggingface dataset:
Objective Study in Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objectives

        1. To test the feasibility, in patients with active rheumatoid arthritis, of using an
           'aggressive' treatment algorithm to bring a short term treatment objective (STO) within
           the normal or an arbitrarily defined 'desirable' range.

        2. To determine whether patients with active rheumatoid arthritis randomly allocated to a
           particular STO show a reduced rate of Magnetic resonance imaging damage progression at
           two years compared to those randomly allocated to usual care.

      Secondary Objectives

        1. To establish the relationship between achieving a given STO or combination of STOs and
           damage progression.

        2. To identify the characteristics of responders and non-responders with respect to STO
           achievement and predictors of greater and lesser degrees of damage progression.
    


Intervention name(s): LEFLUNOMIDE
Intervention type(s): Drug
Intervention MeSH terms: Leflunomide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
The Efficacy of SPSIPB on Postoperative Pain in Patients Undergoing Shoulder Surgery
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Aim is to assess the postoperative analgesic efficacy of SPSIPB and its effect on opioid
      consumption in patients undergoing shoulder surgery.
    

Detailed description: 
      There were two randomized groups: Group S (SPSIPB) (n=12), Group C (no block) (n=12). All
      patients had standard general anesthesia. Group S had serratus posterior superior intercostal
      plane block (SPSIPB) with 0.25% bupivacaine (total volume of 30 ml) before the surgery. Group
      Control had only tramadol for postoperative pain. Numerical rating scale (NRS) was used to
      assess postoperative pain on 1st, 6th, 12th, 18th and 24th hour after the surgery. Total
      tramadol consumption was calculated.
    

Intervention name(s): Serratus posterior superior intercostal plane block (SPSIPB)
Intervention type(s): Other
Intervention description(s): Serratus posterior superior intercostal plane block is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: serratus posterior superior intercostal plane block; postoperative pain; shoulder surgery; regional anesthesia
A Placebo-Controlled, Two-Part Study, Oral Dose to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of CNTX-6970 in Healthy Subjects
Condition: Chronic Pain; Nociceptive Pain
MeSH terms: Chronic Pain; Nociceptive Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, placebo-controlled, two part study with either single dose or multiple increasing
      oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTX-6970 in
      healthy subjects.
    


Intervention name(s): CNTX-6970; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral dose CNTX-6970; Oral dose placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Pain; Nociceptive Pain; Mixed Pain
Trial of rPA-102 Vaccine in Healthy Adult Volunteers
Condition: Anthrax
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and immunogenicity of rPA102 vaccine given
      intramuscularly at 0 and 4 weeks over 2 dose ranges and 4 adjuvant levels.
    


Intervention name(s): rPA102
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Anthrax; rPA102; vaccine
Efficacy of Tocilizumab in Primary Sjögren's Syndrome.
Condition: Primary Sjögren's Syndrome (pSS)
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Primary Sjögren's syndrome (pSS) is a systemic autoimmune disease characterized by
      lymphocytic infiltration leading to destruction of acinar and ductal cells and loss of
      glandular parenchyma. The main symptoms of pSS are dry eyes and dry mouth, diffuse pain, and
      fatigue. One third of patients develop systemic features, the most severe being lymphomas.

      Serum IL-6 is increased in serum, saliva, and tears of patients with pSS. IL-6 plays a
      pivotal role in B-cell activation, a hallmark of the pathogenesis of pSS, and in T-cell
      differentiation. Tocilizumab, a recombinant humanised monoclonal antibody acts as an IL-6R
      antagonist. The aim of this randomised double blind placebo controlled trial iss to evaluate
      the efficacy of tocilizumab for the treatment of pSS.
    


Intervention name(s): Tocilizumab; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparison of Perioperative Analgesia Between Intravenous Paracetamol and Fentanyl for Rigid Hysteroscopy
Condition: Analgesia; Effect of Drug
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective of study:

      To compare the efficacy of intravenous paracetamol and fentanyl for intra-operative and
      post-operative pain relief in patients undergoing diagnostic and therapeutic hysteroscopy.

      Hypothesis of study:

      There is no difference in pain control between intravenous fentanyl and paracetamol in
      patients undergoing hysteroscopy.
    

Detailed description: 
      Intraoperative pain assessment will be based on:

      Hemodynamic vital (SBP, DBP. MAP and HR) increase 20% from the baseline will be observed and
      assumed pain.

      Postoperative pain assessment will be based on:

      Mean Pain score :Visual analogue pain scale (VAS) of 0-10 cms will be used to assess the pain
      at the end of the procedure.

      Diagnostic hysteroscopy:

      Patients presenting with abnormal premenopausal or postmenopausal uterine bleeding, pain,
      infertility, intrauterine adhesions, endometrial biopsy, foreign body.

      Therapeutic hysteroscopy:

      To remove IUD, uterine polyps, fibroid, foreign body and submucosal fibroids, sterilization.
    

Intervention name(s): paracetamol, the group P; fentanyl, group-F administered as an active comparator
Intervention type(s): Drug; Drug
Intervention description(s): The paracetamol was administered 30 minutes before the start of surgery for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy; The fentanyl 2mcg/kg was administered at the time induction of anaesthesia for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy
Intervention MeSH terms: Acetaminophen; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ParacetamolGeneral anaesthesia; Fentanyl; General Anaesthesia; Hysterescopy
Two-channel Intravenous Patient-controlled Analgesia (IV-PCA) After Total Laparoscopic Hysterectomy (TLH)
Condition: Total Laparoscopic Hysterectomy; Patient-controlled Analgesia
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the dual channel intravenous patient-controlled
      analgesia (IV-PCA) with single channel elastomeric pump (only one channel of dual channel
      pump is used for blinding and the other channel is filled with same volume of saline) in
      patients undergoing total laparoscopic hysterectomy, in terms of quality of recovery,
      efficacy of postoperative pain, drug consumption, adverse event, and patient subjective
      satisfaction.
    

Detailed description: 
      The Bellomic® M silicone balloon infuser, dual continuous petite type (cebika, Uiwang-si,
      Gyeonggi-do, Republic of Korea) is a newly designed IV-PCA device that is a 2-channel
      infusion elastomeric pump with two balloon chambers.

      Conventional elastomeric IV-PCA devices were administered with a mixture of drugs in one
      chamber; when severe opioid related side effects occur, the IV-PCA administration is
      suspended by clipping, in this situation, not only the analgesic effect of opioid but also
      the effect of adjuvants could not be applied.

      On the other hand, this newly designed device can be controlled as needed by administering
      adjuvant analgesics or antiemetic agents through another adjustable chamber. It will be
      expected that facilitate the pain management and increased the patient satisfaction and
      recovery.
    

Intervention name(s): convetional PCA method unsing only 1-channel; utilizing 2-channel
Intervention type(s): Other; Other
Intervention description(s): Ch-1 (flow 2 ml/hr with bolus 2ml/30min lock-out): fentanyl 16 µg/kg, ketorolac 2 mg/kg, ondansetron 12 mg (total volume 100 ml with normal saline); Ch-2 (flow 2ml/h): 100ml normal saline only (for blinding); Ch-1 (flow 2 ml/hr with bolus 2ml/30min lock-out): fentanyl 16 µg/kg (total volume 100 ml with normal saline; Ch-2 (flow 2ml/h fixed): ketorolac 2 mg/kg, ondansetron 12 mg (total volume 100 ml with normal saline)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Sensory Integration Therapy in Autism: Mechanisms and Effectiveness
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      A common feature of ASD is over or under sensitivity to the environment and difficulty
      putting sensory information together in an orderly way, referred to here as sensory issues.
      Building on previous work, this study will test the efficacy of Sensory Integration Therapy
      (SIT), a non-invasive intervention to improve functional skills in children with ASD, in
      comparison to commonly applied ABA behavioral treatments, in the treatment of ASD symptoms. A
      total of 180 children with ASD and sensory issues in the greater New York City Metropolitan
      area will complete this study.
    

Detailed description: 
      Autism Spectrum Disorders (ASD) are among the most common neurodevelopmental disorder with
      estimated costs of treatment across the lifespan of $3.2 million. A common feature of ASD is
      over or under sensitivity to the environment and difficulty putting sensory information
      together in an orderly way, referred to here as sensory issues. Such sensory issues are now
      included in the diagnostic criteria in the DSM5 under the Restrictive and Repetitive
      Behaviors and Interests Criteria. These sensory issues have a deleterious effect on
      functional skills and limit participation in work, education, and social activities for
      individuals with ASD and their family. Building on previous work, this study seeks to extend
      understanding of Sensory Integration Therapy (SIT) as a non-invasive intervention to improve
      functional skills in children with ASD and sensory issues, and to test its efficacy in
      comparison to commonly used applied behavioral treatments. Further, the investigators will
      explore the proposed neurobiological mechanisms by which this intervention may work, and
      phenotypic moderators of outcome. This study utilizes a randomized trial to compare SIT to a
      commonly used behavioral intervention to evaluate outcomes on functional skills as a basis
      for improved independence over the lifetime. A total of 180 children with ASD and sensory
      issues in the greater New York City Metropolitan area will complete this study.
    

Intervention name(s): Sensory Integration Therapy; Applied Behavioral Analysis
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children in the SIT treatment group will receive a manualized SIT intervention that follows the principles of sensory integration.; Children in the ABA treatment group will receive intervention that follows the principles of Applied Behavioral Analysis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Acute Tart Cherry Supplement Formulation and Dose on Inflammation and Oxidative Capacity
Condition: Inflammation; Oxidative Stress
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      A comparison of acute tart cherry formations (juice vs. powdered) and doses (single vs. twice
      daily) on inflammation and oxidative capacity.
    

Detailed description: 
      Participants will be randomly allocated to a group: one tart cherry capsule daily, two tart
      cherry capsules daily, one 8oz. bottle of tart cherry juice daily, two 8oz. bottles of tart
      cherry juice taken 8 hours apart, one placebo pill, and one 8oz. bottle of placebo.
      Participants will arrive to the lab at 8 am after an overnight fast of 10 hours. They will
      provide a blood sample and then ingest their study treatment. Participants will stay in the
      lab for a further 2 hours for additional blood draws then return to the lab in 6 hours for
      another blood draw. At this time if they are in a twice daily group they will receive their
      second treatment for the day. All participants will come back to the lab 24 hours later where
      they will give a blood sample and receive their next treatment. If they are in the twice
      daily group they will be provided with their next dose and given instructions to consume it
      in 8 hours. Participants will arrive 24 hours later for a final blood draw with no
      supplementation.

      Blood samples will be measured pre-ingestion, 1 hour, 2 hours, 8 hours, 24 hours and 48 hours
      post-ingestion. Samples will be analyzed for plasma oxygen radical absorbance capacity
      (ORAC), uric acid (UA), and C-reactive protein (CRP).
    

Intervention name(s): tart cherry; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Either tart cherry juice or freeze dried powdered tart cherry in capsule was given; either cornstarch capsule or kool-aid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS +
      adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B
      patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg
      po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a
      further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po
      daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180
      micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free
      follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size
      is <100 individuals.
    


Intervention name(s): adefovir dipivoxil; peginterferon alfa-2a [Pegasys]
Intervention type(s): Drug; Drug
Intervention description(s): 10mg po daily for 96 weeks (arm 1) or 48 weeks (arm 2); 180 micrograms weekly for 48 weeks
Intervention MeSH terms: Peginterferon alfa-2a; Adefovir; Adefovir dipivoxil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose-response Study of Exendin-9,39 on Glucose Metabolism
Condition: Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple studies have examined the effect of endogenous GLP-1 secretions by using a
      competitive antagonist of GLP-1 - Exendin-9,39 - infused at rates of 300pmol/kg/min. However,
      the presence of an effect does not necessarily imply that this effect is due to the blockade
      of the endogenous GLP-1 actions at the receptor. It is possible that the supraphysiologic
      concentrations of Exendin may have effects of its own. To examine the effect of Exendin on
      glucose metabolism the investigators propose a dose-response study to determine whether the
      compound has effects in a dose-dependent fashion.
    


Intervention name(s): saline infusion; GLP-1-9,36 infusion; Exendin-9,39 at low dose; Exendin-9,39 at high dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): saline infused at 30ml/hour; infused @ 1.2pmol/kg/min; infused at 30pmol/kg/min; infused @ 300pmol/kg/min
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A 2-Part Study to Assess Potential Metabolism-Based Drug-Drug Interactions of E2006 When Coadministered With Itraconazole, Rifampin, Midazolam, or Bupropion
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a single center, open-label, drug-drug interaction study in healthy male
      and female subjects. The study will consist of 2 parts. In Part A, the effects of
      steady-state dosing of a strong CYP3A inhibitor (itraconazole) or inducer (rifampin) on the
      pharmacokinetics of E2006 and metabolites will be assessed. Approximately 30 subjects will be
      sequentially assigned to 1 of 2 treatment groups to receive itraconazole or rifampin in equal
      numbers (approximately 15 subjects per group). The itraconazole treatment group will be fully
      enrolled before enrollment is initiated for the rifampin treatment group. In Part B, the
      effects of steady-state dosing of E2006 on the pharmacokinetics of midazolam, a substrate of
      CYP3A, plus bupropion, a substrate of CYP2B6, will be assessed in approximately 24 subjects.
      The 2 study parts can be conducted in parallel.
    


Intervention name(s): rifampin 600 mg; itraconazole 200 mg; midazolam 2 mg with bupropion 75 mg; E2006
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Itraconazole; Rifampin; Midazolam; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Metabolism; Drug-Drug Interactions
Myofascial Release of the Pectoral Fascia
Condition: Healthy
Study type: Interventional

Summary: 
      Neck-shoulder pain is among the most common health care problems, especially in office
      workers and females. Forward shoulder posture (FSP) is a common postural deviation and known
      risk factor for the development of neck-shoulder pain and pathology. Common approaches for
      reducing FSP include stretching and performing manual techniques to increase the length and
      extensibility of the scapular protractors, and strengthening the scapular retractors.
      Myofascial release (MFR) is a group of manual techniques that elongate and soften restricted
      fascia, however, the effects of myofascial release to the pectorals on FSP are currently
      unknown. The objectives of this study are to determine the impact of 4-minutes of MFR on: 1)
      FSP, 2) pectoral length, 3) muscle activity of the upper, middle, and lower trapezius and
      pectoralis major, 4) scapular retractor to protractor ratio of activity, and 4) movement
      performance compared to a soft-touch control. We hypothesize that MFR will: 1) decrease FSP,
      2) increase pectoral length, 3) increase upper, middle, and lower trapezius activity and
      decrease pectorals major activity, 4) increase the scapular retractor to protractor ratio of
      activity, and 4) improve movement performance.
    


Intervention name(s): Myofascial Release; Soft-touch Control
Intervention type(s): Other; Other
Intervention description(s): Moderate pressure manual treatment to the pectoral fascia.; No pressure manual treatment to the pectoral fascia.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single blind between subjects repeated measures crossover design
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, placebo- and active-controlled, crossover study will evaluate the abuse
      liability potential of RO4917838 in recreational drug users. In a pre-study (Part 1),
      subjects will receive a single dose of either diazepam or placebo in an inpatient crossover
      design, with a wash-out period of at least 10 days between treatments. Subjects who are
      clearly able to distinguish the positive control from placebo will be enrolled in the main
      study (Part 2) and will be randomized to single oral doses of RO4917838 (3 dose levels),
      diazepam and placebo in a double-blind, double-dummy inpatient crossover design.
      Washout-periods between the 5 treatment periods in Part 2 will be at least 10 days.
    


Intervention name(s): Placebo; RO4917838; diazepam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose; Single doses (3 dose levels); Single dose
Intervention MeSH terms: Diazepam
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)