bioihbjkbjnl/mcl2 huggingface dataset:
Phase I to Test a New Pneumococcal Vaccine
Condition: Pneumococcal Pneumonia; Pneumonia, Bacterial
MeSH terms: Pneumonia; Pneumonia, Bacterial; Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 1

Summary: 
      To obtain first-in-human data on a new candidate vaccine against Streptococcus pneumoniae in
      healthy adult and elderly volunteers.

      The study aims to assess the safety and immunogenicity of a bioconjugate investigational
      vaccine compared to the control group (Pneumovax23).
    

Detailed description: 
      The study aims to assess the safety and immunogenicity of a new bioconjugate investigational
      vaccine compared to the control group (Pneumovax23) in a randomised, staggered, 2-steps
      controlled trial.
    

Intervention name(s): Bioconjugate pneumococcal vaccine; Multivalent plain polysaccharide vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Bioconjuagte vaccine against bacterial pneumococcal infection; Multivalent plain polysaccharide vaccine against bacterial pneumococcal infection
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: pneumococcal vaccine; bioconjugate
Comparison of Kinesio Tape and Dry Needling for the Management of Rotator Cuff Tendinopathy: A Randomized Control Trial
Condition: Rotator Cuff Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      Its a single blind RCT
    

Detailed description: 
      Kinesio tape and dry needling were compared for the management of rotator cuff tendinopathy
    

Intervention name(s): kinesio tape; Dry needling
Intervention type(s): Other; Other
Intervention description(s): kinesio tape was applied over the specific muscle of rotator cuff; dry needling was applied over the affected muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind RCT
Masking: Single (Participant)
Primary purpose: Treatment
Pupillary Response to Incremental Tetanic Stimulations Under Propofol-remifentanil TCI
Condition: Pain
Study type: Interventional

Summary: 
      In patients under standardized steady-state general anesthesia, 6 tetanic stimulations of
      incremental intensities were applied to the patients. Pupillary dilation in response to these
      stimulations was recorded.
    

Detailed description: 
      The aim of the study was to investigate a possible correlation between the intensity of a
      nociceptive stimulus and the magnitude of pupillary reflex dilation in patients anesthetized
      with propofol and remifentanil target-controlled infusion.

      Anesthetic protocol: 10 minutes of steady-state general anesthesia (before extubation during
      a scheduled gynecological surgery) with remifentanil target concentration of 1 ng/ml, and
      propofol target concentration adjusted to maintain bispectral index between 45 and 55.

      Study period: 6 tetanic stimulations of incremental intensities were applied to the patients:
      10, 20, 30, 40, 50, 60 milliamps Pupillary dilation in response to these stimulations was
      recorded.

      Then, propofol and remifentanil infusions were discontinued, and patients were extubated.
    

Intervention name(s): general anesthesia for scheduled gynecological surgery; Propofol; Remifentanil, Ultiva®; tetanic stimulations; VideoAlgesiGraph
Intervention type(s): Procedure; Drug; Drug; Procedure; Device
Intervention description(s): continuous infusion, target concentration adjusted to maintain bispectral index between 45 and 55; continuous infusion, target concentration 1 ng/ml; 10-20-30-40-50-60 milliamps, 5 seconds, 100 Hertz 2 minutes between stimulations delivered via the standard neuromuscular blocking agents monitor; non invasive infrared camera placed in front of the left eye of the patients during the study period, connected to a laptop. No part of the device touches the eye.
Other intervention name(s): VideoAlgesiGraph, Synapsis (TM), Marseille, France
Intervention MeSH terms: Remifentanil; Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: general anesthesia
Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic Pain
Condition: Chronic, Non Malignant Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Two stage study looking at different titration schedules in patients with moderate to severe
      non-malignant chronic pain. Up to 80 patients at approximately 15 centers in the US to be
      enrolled. Study participation is approximately 3 months.
    


Intervention name(s): EN3270
Intervention type(s): Drug
Intervention description(s): Transdermal Therapeutic System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of Pain on Exercise-induced Hypoalgesia
Condition: Pain; Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate how acute pain induced by hypertonic saline prior
      to exercise influence the magnitude of exercise-induced hypoalgesia after 1x3 min seated
      isometric knee extension exercise in healthy women. The study is a blinded randomized
      cross-over trial The results from the study may be of great importance to the understanding
      of exercise-induced hypoalgesia, and whether the presence of pain affects the effects of
      exercise.
    

Detailed description: 
      Exercise is recommended to promote and maintain health and as treatment for more than 25
      chronic diseases and pain conditions.

      The mechanisms underlying pain relief of exercise are largely unknown but may be related to
      the modulation of central descending pain inhibitory pathways after acute exercise bouts.
      Exercise-induced hypoalgesia (EIH) is typically assessed as the temporary change in pressure
      pain thresholds (PPT) after a short acute exercise bout and EIH is seen as a proxy of
      descending pain inhibitory control. In general, EIH seems hypoalgesic (functional) in
      asymptomatic subjects. A hyperalgesic (impaired) EIH response has been reported in different
      chronic pain populations, although a functional EIH response also has been reported in
      subgroups of knee osteoarthritis patients. This implies differences in the acute response to
      exercise between healthy (pain-free) subjects and chronic pain patients, but it is still
      unknown whether the presence of pain itself affects the pain alleviating response (i.e. the
      EIH response) to acute exercise.

      It is hypothesized that acute pain will decrease the EIH response magnitude following
      hypertonic saline injection compared with the control injection. This study will increase the
      insight into the EIH mechanisms in healthy subjects in general, and how the presence of pain
      affects the body's own ability to modulate pain during exercise.
    

Intervention name(s): Pain (hypertonic saline); No pain (Isotonic saline)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A bolus injection (1 ml) of hypertonic saline (5.8%) is injected into the dominant vastus medialis muscle 20 cm proximal from the basis of patella before performance of the 1x3 min Seated Isometric Knee Extension.; A bolus injection (1 ml) of isotonic saline (0.9%) is injected into the dominant vastus medialis muscle 20 cm proximal from the basis of patella before performance of the 1x3 min Seated Isometric Knee Extension
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is a 2-arm randomized controlled cross-over trial with 1-7 days between arms
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, two-period, randomized, open-label, crossover pharmacokinetic (PK)
      study in healthy adult volunteers to evaluate dose proportionality of diazepam nasal spray
      using two dose levels
    


Intervention name(s): diazepam nasal spray
Intervention type(s): Drug
Intervention description(s): diazepam nasal spray at two dose levels (DL). One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
Other intervention name(s): PLUMIAZ™ (diazepam) Nasal Spray
Intervention MeSH terms: Diazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dose proportionality; diazepam nasal spray
TeleLifestyleCoaching for Weight Loss
Condition: Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Lifestyle changes often fail due to loss of motivation. Telemedicine and personal coaching
      have the potential to support lifestyle change and weight loss. Therefore, the aim of our
      randomized controlled trial was to examine the effect of telemedicine with and without
      coaching in comparison to a control group on weight loss in overweight participants.
    

Detailed description: 
      In an occupational health care setting overweight employees were randomized into a three arm
      12-week trial. Participants in the telemedical (TM) and telemedical coaching (TMC) group got
      a weighing machine and a step counter, with automatic transfer into a personalized online
      portal, which could be monitored from both, the participant and the study centre. The TMC
      group weekly got care calls from the study centre aiming to discuss measured data and to fix
      target agreements. The control group remained in routine care. Wilcoxon signed rank test was
      used to determine if differences (baseline vs. after 12 weeks) were significantly different
      from 0 and ANOVA test for determination of inter group differences.
    

Intervention name(s): telemedical devices (weighing machine and step counter); care calls once per week for 12 weeks
Intervention type(s): Device; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: telemedicine; coaching; lifestyle change; weight loss
Combination of Brivanib With 5-Fluorouracil/Leucovorin (5FU/LV) and 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI)
Condition: Gastro-Intestinal Cancer
MeSH terms: Intestinal Neoplasms; Gastrointestinal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine a safe and maximum tolerable dose of Brivanib when
      combined with standard dose 5FU/LV and FOLFIRI.
    


Intervention name(s): 5-FU; Leucovorin; 5-FU; Irinotecan; Brivanib; Brivanib; Brivanib
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): IV solution, IV bolus over 2-4 minutes, 400 mg/m², Every 14 days, Until disease progression/toxicity; IV solution, IV over 2 hours, 400 mg/m², Every 14 days, Until disease progression/toxicity; IV solution, IV infusion over 46 hours, 2400 mg/m², Every 14 days, Until disease progression/toxicity; IV solution, IV over 90 minutes, 180 mg/m², Every 14 days, Until disease progression/toxicity; Tablets, Oral, 400 - 800 mg, once daily, Until disease progression/toxicity; Tablets, Oral, 600 - 800 mg, once daily, Until disease progression/toxicity; Tablets, Oral, 800 mg, once daily, Until disease progression/toxicity
Other intervention name(s): Fluorouracil; Folinic acid; Fluorouracil; Camptosar; BMS-582664; BMS-582664
Intervention MeSH terms: Leucovorin; Fluorouracil; Irinotecan
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastro-Intestinal Cancer, NOS
Virtual Reality for Postoperative Pain Management
Condition: Surgery; Pain, Postoperative; Incision; Otolaryngological Disease
MeSH terms: Otorhinolaryngologic Diseases; Pain, Postoperative
Study type: Interventional

Summary: 
      This trial studies an active virtual reality (VR) experience as a means for non-pharmacologic
      postoperative pain management among patients after head and neck surgery. Investigators will
      assess differences in pain scores, analgesic use, and subjective patient experiences between
      patients participating in a VR activity and patients participating in the same activity using
      a smartphone.
    

Detailed description: 
      Management of postoperative pain after head and neck surgery is complex, and has received
      increased attention to improve patient recovery and quality of life. Narcotic analgesics are
      frequently utilized in postoperative pain management, but these have risks including nausea,
      sedation, constipation, and dependence. Multimodal analgesia can reduce narcotic use and
      improve recovery, but medical comorbidities may contraindicate the use of certain
      medications. Non-pharmacologic measures for postoperative pain control may provide novel and
      cost-effective strategies to confront this complex issue.

      Patients undergoing head and neck surgery will be randomly allocated to participate in an
      immersive experience in VR, or to participate in a similar experience on a two-dimensional
      screen using a smartphone.
    

Intervention name(s): Smartphone; Virtual Reality (Oculus Quest)
Intervention type(s): Device; Device
Intervention description(s): Patients will participate in a similar game to the VR cohort, but will use a smartphone device.; Patients will participate in a game using VR.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Virtual Reality
Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of multiple doses of
      vortioxetine, once daily (QD), in participants with major depressive disorder.
    

Detailed description: 
      The drug that was tested in this study is called vortioxetine. Vortioxetine is being tested
      to treat depression in adults who have major depressive disorder (MDD). This study looked at
      MDD relief in people who took varying doses of vortioxetine.

      The study enrolled 600 patients. Participants were randomly assigned (by chance, like
      flipping a coin) to one of the four treatment groups-which remained undisclosed to the
      patient and study doctor during the study (unless there was an urgent medical need):

        -  Vortioxetine 5 mg

        -  Vortioxetine 10 mg

        -  Vortioxetine 20 mg

        -  Placebo (dummy inactive pill) - this was a capsule that looked like the study drug but
           had no active ingredient.

      All participants were asked to take one capsule at the same time each day throughout the
      study.

      This multi-center trial was conducted in 14 countries in Europe and Asia. The overall time to
      participate in this study was up to 13 weeks. Participants made weekly visits to the clinic
      during the first 2 weeks of the 8-week treatment period and then every 2 weeks up to the end
      of the 8-week treatment period. Participants who completed the 8-week treatment period
      entered a 2-week discontinuation period to assess potential discontinuation symptoms 1 and 2
      weeks after the end of the 8-week treatment period. A safety follow-up contact (visit or
      phone call) was made 4 weeks after completion of the 8-week double-blind treatment period (2
      weeks after the end of the 2-week discontinuation period).
    

Intervention name(s): Vortioxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vortioxetine tablets; Vortioxetine placebo-matching tablets
Other intervention name(s): Lu AA21004; Brintellix®
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; Melancholia; Drug Therapy
TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults
Condition: Migraine Disorders; Migraine, Acute
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Study TRX109011/TRX109013, A Randomized, Double-blind, Double-dummy, Placebo-controlled,
      Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus
      Butalbital-containing Combination Medications (BCM) for the Acute Treatment of Migraine when
      administered during the Moderate-Severe Pain Phase of the Migraine (Studies 1 and 2 of 2)
    

Detailed description: 
      This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled,
      crossover, three-attack, outpatient study in which TREXIMET® will be compared to a
      butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and
      butalbital 50mg [Fioricet]) for the acute treatment of migraine headaches. Subjects will be
      randomized to one of 6 possible treatment sequences (TPB, TBP, BTP, BPT, PTB, PBT where T =
      TREXIMET®; P = Placebo; B = Butalbital-containing Combination Medication) . Subjects will
      treat each of the 3 migraine attacks when pain is moderate to severe. The study will include
      4 visits: (1) a Screening visit at study entry, (2) a Drug Screen visit, (3) a Randomization
      visit, and (4) a Final visit. The Final visit occurs either (A) upon withdrawal or (B) after
      treatment of 3 migraine attacks. The primary objective is to evaluate the efficacy of
      TREXIMET® versus BCM for the acute treatment of moderate/severe migraine. These two replicate
      studies were amended while ongoing to allow for the reporting of pooled data only.
    

Intervention name(s): TREXIMET®; Butalbital-containing Combination Medications (BCM); placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate [equivalent to sumatriptan 85mg] and naproxen sodium 500mg); butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) [currently marketed as Fioricet]; placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Migraine, acute; Migraine; Butalbital-containing Combination Medication (BCM); Naproxen sodium; Sumatriptan succinate; TREXIMET®
Reflexive Coughing Force in Severe Aspirators
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      To assess coughing force during reflex coughing test in those with severe dysphagia and
      severe aspiration and compare them to than those with stroke patients with no signs of
      dysphagia/aspiration.
    

Detailed description: 
      Severe aspiration with a compromised cough function can be a risk factor of aspiration
      pneumonia.

      Reflexive coughing can be tested by administration of citric acid via a nebulizer. The
      objective of this study is to measure the cough force produced via citric acid inhalation
      challenge, and determine if those with severe aspiration with severe dysphagia have more weak
      cough force during reflexive cough testing that those post-stroke patients with no signs of
      aspiration or dysphagia after stroke.

      We also aimed to measure the strenght of the respiratory measures with the use of surface
      EMG.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Stroke patients with dysphagia with aspiration
      
Keywords: stroke; deglutition disorders; cough; aspiration pneumonia; diaphragm; respiratory function
Change in C-reactive Protein (CRP) in Men and Women With Sleep Apnea After Continuous Positive Airway Pressure (CPAP)
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      C-reactive protein (CRP) is directly implicated in atherogenesis and associated
      cardiovascular morbidity in patients with obstructive sleep apnea (OSA). Effective Continuous
      Positive Airway Pressure (CPAP) treatment has been shown to gradually decrease CRP levels and
      thus consequently improve disease-related cardiovascular morbidity. However, the influence of
      gender on the CRP evolution pattern has never been assessed before. The aim of our study was
      to investigate possible gender differences in CRP evolution in OSA patients 3 and 6 months
      after the start of effective CPAP treatment.
    

Detailed description: 
      OSA is an independent risk factor for a number of cardiovascular diseases. One important
      possible mechanism underlying cardiovascular disease in patients with OSA is systemic
      inflammation. CRP, an acute phase reactant secreted by the liver, is one of the most actively
      studied biomarkers of low-grade inflammation, and numerous studies have shown that higher CRP
      levels are associated with high mortality and morbidity due to cardiovascular disease in men
      and women. In patients with OSA, the question as to whether or not CRP levels are elevated is
      still under debate. Although continuous positive airway pressure (CPAP) is effective in the
      management of OSA, conflicting data also exist regarding the effects of CPAP on CRP levels.
      However, none of the existing studies assessed the influence of gender on the CRP evolution
      pattern. Therefore, the aim of this study was to investigate possible gender differences in
      CRP evolution in patients with moderate to severe OSA, free of medical comorbidities, 3 and 6
      months after the start of effective CPAP treatment.
    

Intervention name(s): Continuous Positive Airway Pressure (CPAP)
Intervention type(s): Procedure
Intervention description(s): Continuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea (OSA) management. Subjects with OSA will be trained in the use of CPAP and will be instructed to use CPAP every night for 6 months. These subjects will then return for a post-treatment blood draw 3 and 6 months after the start of effective CPAP treatment
Other intervention name(s): positive pressure ventilation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment