bioihbjkbjnl/mcl2 huggingface dataset:
Virtual Reality Hypnosis for Chronic Pain Reduction
Condition: Burns
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      We would like to determine how well hypnosis works when induced through virtual reality
      medium for patients who have suffered a major burn injury in the past two years and suffer
      from chronic pain. These patients are coming back to the outpatient burn and plastic clinic
      at Harborview Medical Center for routine follow-up. We think that patients will find
      VR-Hypnosis interesting, and it will help them relax and feel less pain.
    


Intervention name(s): Virtual Reality Hypnosis for chronic pain; Virtual Reality Distraction for Chronic Pain
Intervention type(s): Behavioral; Behavioral
Intervention description(s): At the time of their clinic visit,the subject will answer pain and anxiety questionnaires before experiencing Virtual Reality Hypnosis. After VRH, the will again answer Pain and anxiety questionnaires.; At the time of their clinic visit,the subject will answer pain and anxiety questionnaires before experiencing Virtual Reality Distraction. After VRD, the will again answer Pain and anxiety questionnaires.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Analgesic Effects of Midazolam in Human Volunteers
Condition: Analgesic Drugs; Antinociceptive Agents
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates analgesic properties of midazolam compared to placebo and fentanyl. Each
      participant will receive all three drugs (midazolam, fentanyl, placebo) on three different
      occasions (study visits) and the effect on different pain stimuli will be tested.
    


Intervention name(s): Midazolam; Fentanyl; Isotonic saline
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Dormicum
Intervention MeSH terms: Midazolam; Fentanyl
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Midazolam; Fentanyl
Evaluating the Safety of and Immune Response to an HIV Vaccine in Healthy, HIV-Uninfected Adults in Uganda
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Currently, no vaccine prevents HIV infection. This study will test the safety and immune
      responses of an HIV-1 DNA vaccine in HIV-uninfected adults in a Ugandan population.
    

Detailed description: 
      The global HIV/AIDS epidemic continues to increase at unacceptably high levels, and there is
      not yet an effective prevention method for HIV infection. This study will test the safety and
      immune responses of a preventive HIV vaccine, VRC-HIVDNA009-00-VP, which is a multiclade
      HIV-1 DNA plasmid vaccine.

      This study will seek to enroll 30 participants, randomly assigning 15 participants each to
      the study vaccine arm and the placebo vaccine arm. Three doses of the vaccine will be given
      by intramuscular (IM) injection using the Biojector 2000 needle-free injection management
      system: the first dose at Day 0 (entry), second dose at Day 28 (within 7 days before or after
      Day 28), and third dose at Day 56 (within 7 days before or after Day 56). Participants will
      attend two screening visits and visits at Days 0 (entry), 2, 14, 28, 30, 42, 56, 58, 70, 84,
      168, 252, and 336. At most visits, participants will give a medical history and undergo a
      physical exam, blood draw, and urine collection. For women, a pregnancy test will be given at
      each study injection visit. Participants also will be instructed to maintain a diary of local
      and systemic reactions for 7 days after each injection. They also will be provided with a
      ruler to measure erythema, induration, or other observable reactions and a thermometer to
      record temperature on a daily basis.
    

Intervention name(s): VRC-HIVDNA009-00-VP; Placebo vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Administered as a 4 mg/mL dose by IM injection in the deltoid muscle using the Biojector 2000 needle-free injection management system.; Administered as a 1-mL dose by IM injection in the deltoid muscle using the Biojector 2000 needle-free injection management system.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Personalised Modeling and Simulation Procedures for the Differential Diagnosis of Dynapenia: a Study on Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      The ForceLoss study aims to develop personalised modeling and simulation procedures to enable
      the differential diagnosis for the loss of muscle force, namely dynapenia. Dynapenia can be
      caused by diffuse or selective sarcopenia, lack of activation, or improper motor control.
      Each of these causes requires different interventions, but a reliable differential diagnosis
      is currently impossible. While instrumental methods can provide information on each of these
      possible causes, it is left to the experience of the single clinician to integrate such
      information into a complete diagnostic picture. But an accurate diagnosis for dynapenia is
      important in a number of pathologies, including neurological diseases, age-related frailty,
      diabetes, and orthopaedic conditions. The hypothesis is that the use of a mechanistic,
      subject-specific model of maximum isometric knee extension, informed by a number of
      instrumental information can provide a robust differential diagnosis of dynapenia.

      In this preliminary study, on healthy volunteers, the investigators will develop and optimize
      (i) the experimental protocol and (ii) the modeling and simulation framework, assessing both
      feasibility and reliability of the proposed procedures. Medical imaging, electromyography
      (EMG) and dynamometry data will be collected and combined to inform a personalised
      musculoskeletal model of each participant. Biomechanical computer simulations of a Maximal
      Voluntary Isometric Contraction (MVIC) task will then be performed. To validate the proposed
      approach, the models' estimates will be compared to in vivo dynamometry measurements and
      experimental EMG data.
    


Intervention name(s): Personalised musculoskeletal modeling
Intervention type(s): Diagnostic Test
Intervention description(s): Magnetic resonance images, electromyography and dynamometry data will be used to develop personalised musculoskeletal models
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Musculoskeletal modeling; In silico medicine; Maximal Voluntary Isometric Contraction; Electromyography; Healthy volunteers; Dynapenia; Dynamometry
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin Extended Release Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate bioequivalence of the metformin component of the
      Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet
      coadministered with canagliflozin in healthy fed and fasted participants.
    


Intervention name(s): Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]; Canagliflozin; Canagliflozin; Metformin Extended Release (XR)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive 1 XR FDC tablet containing canagliflozin 150 mg and metformin 1000 mg orally under fed (Treatment B)or fasted condition (Treatment D) in a given treatment period as per treatment sequence.; Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablets) under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.; Participants will receive canagliflozin 100 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.; Participants will receive metformin XR 500 mg tablet orally under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
Intervention MeSH terms: Metformin; Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Monitoring Lung Recruitment Maneuver in Anesthetized Morbidly Obese
Condition: Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      Morbid obese patients present changes in respiratory physiology caused by weight overload.
      Intraoperative atelectasis is a pulmonary complication that affects not only gas exchange but
      also respiratory mechanics. The present study was aimed to test the role of different
      parameters for monitoring the treatment of atelectasis by a lung recruitment maneuver.
    

Detailed description: 
      This is a prospective study perform in 30 anesthetized morbidly obese undergoing bariatric
      surgery. Lung mechanics and volumetric capnography will be non-invasively assessed during
      laparoscopy. Esophageal pressure will be measured by an esophageal balloon to measure
      transpulmonary pressure. A lung recruitment maneuver will be done. The optimum level of
      positive end-expiratory pressure (PEEP) is defined as the PEEP level when transpulmonary
      pressure remains positive during the PEEP titration trial of the recruitment maneuver. Lung
      collapse is detected when transpulmonary pressure becomes negative. The behavior of the
      studied volumetric capnography and lung mechanics parameters will be compared with the
      reference transpulmonary pressure signal.
    

Intervention name(s): Lung recruitment maneuver
Intervention type(s): Other
Intervention description(s): A Lung recruitment maneuver is aimed to resolve atelectasis during mechanical ventilation. It consists in a brief and controlled increment in airways pressure using pressure control ventilation. Positive end-expiratory pressure (PEEP) is increases every 5 centimeters of water (cmH2O), from 0 to 20 cmH2O keeping a fixed driving pressure of 20 cmH2O. A final step of 40 cmH2O of plateau pressure was maintained for 10 breaths, returning then to standard ventilatory settings.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: airways pressure; mechanical ventilation; Atelectasis
Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Laparoscopic Nephrectomy/Nephron Sparing Surgery (NSS)/Hynes-Anderson Procedures.
Condition: Erector Spinae Plane Block
Study type: Interventional

Summary: 
      62 patients age of 20 to 85, (ASA) physical status I-III undergoing laparoscopic
      nephrectomy/NSS/Hynes Anderson procedures in 1st Department of Anesthesiology in Warsaw will
      be enrolled in the study. Patients will be randomised into 2 groups - patients from the first
      group will undergo General Anaesthesia (GA) with intravenous analgesia peri-operatively,
      patients from the second group will receive GA plus the Erector Spinae Plane Block (ESP
      block) bilaterally performed under ultrasound guidance with catheter left on the side of
      surgery. Ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to
      the Th7 spinous process. Three muscles will be identified superficial to the hyperechogenic
      transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm
      18-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip gets
      in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by
      visualization of local anesthetic spreading in a linear pattern between erector spinae and
      the bony acoustic shadows of the transverse processes. . Patients in this group will be
      anesthetized with 20ml 0,25% bupivacaine + Adrenaline 1:200 000 for each side. ESP block will
      be performed at the level of Th7-8 after proper positioning he patient in the sitting
      position before GA then standard technique of catheter application will be applied. After the
      surgery the elastomeric pump will be attached to the catheter with 0,125% bupivacaine with
      Adrenaline 1:200 000. Anaesthesia will be standardised In the both groups.
    


Intervention name(s): bilateral ESP block with 0,25% Bupivacaine+ Adrenaline; ESP block continuous infusion with 0,125% Bupivacaine+Adrenaline; Morphine PCA pump
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Regional anaesthesia technique performed under ultrasound guidance before surgery; Continous infusion of Local Anaesthetic (LA) given postoperatively via the catheter.; Morphine given postoperatively.
Intervention MeSH terms: Epinephrine; Racepinephrine; Morphine; Bupivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Erector Spinae Plane block; ESP block; Laparoscopic Nephrectomy
The Efficacy of SPSIPB on Postoperative Pain in Patients Undergoing Reduction Mammoplasty Surgery: Case Series
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this study is to investigate the postoperative analgesic efficacy of SPSIPB and
      its effect on opioid consumption in patients undergoing reduction mammoplasty.
    

Detailed description: 
      Ten patients had serratus posterior superior intercostal plane block (SPSIPB) as the
      intervention. Patients had SPSIPB with 0.25% bupivacaine (total volume of 30 ml) before the
      surgery in operating room. Numerical rating scale (NRS) was used to assess postoperative pain
      on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated
      by using patient-controlled analgesia (PCA) device. Patient satisfaction was assessed by
      using quality of recovery-15 (QoR15) scale. Paracetamol was planned as resque analgesic drug
      (maximum dose: 3 gr/day).
    

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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: serratus posterior superior intercostal plane block; postoperative pain; reduction mammoplasty; regional anesthesia
Acetaminophen Versus Ibuprofen in Children With Asthma
Condition: Asthma; Wheezing
MeSH terms: Asthma; Respiratory Sounds
Study type: Interventional
Phase: Phase 3

Summary: 
      The Acetaminophen Versus Ibuprofen in Children with Asthma study will test the primary
      hypothesis that in preschool children 12-59 months of age with persistent asthma on
      standardized asthma therapy, the number of asthma exacerbations requiring systemic
      corticosteroids will be more frequent in children randomized to receive acetaminophen as
      compared to those randomized to receive ibuprofen on an as needed basis for fevers and pain.
    

Detailed description: 
      AVICA is a 48-week randomized therapeutic trial involving two parallel treatment arms:
      acetaminophen and ibuprofen. Participating children will be randomized to receive either
      acetaminophen or ibuprofen administered as needed per parental decision for fever and
      analgesia. This study will address which is the most appropriate antipyretic-analgesic
      medication in young children with asthma, and will inform both clinicians and parents seeking
      to treat children with fever and pain. Given the high frequency of administration of these
      drugs, this study will have a significant impact on pediatric healthcare regardless of
      whether a differential effect is discovered as significant uncertainty currently exists as to
      whether acetaminophen use is associated with increased asthma symptoms.
    

Intervention name(s): Acetaminophen; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): 15 mg/kg every 6 hours as needed; 9.4 mg/kg every 6 hours as needed
Other intervention name(s): tylenol; paracetamol; motrin; advil; nonsteroidal anti-inflammatory drug
Intervention MeSH terms: Acetaminophen; Ibuprofen; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Wheezing; Ibuprofen; Acetaminophen; exacerbations; pain; fever
Tamoxifen Therapy in Amyotrophic Lateral Sclerosis [ALS]
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-center, phase 2 randomized clinical trial of tamoxifen on mean percent
      predicted isometric muscle strength in patients with amyotrophic lateral sclerosis (ALS). The
      purpose is to determine whether the triphenylethylenetamoxifen, used as adjuvant therapy in
      the treatment of breast cancer, can delay the loss of isometric muscle strength in ALS
      patients.
    


Intervention name(s): Tamoxifen
Intervention type(s): Drug
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if ABI-H0731 given in combination with a standard
      of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B
      infection (cHBV)
    

Detailed description: 
      This is a Phase 2a, multi-center, double-blind, placebo-controlled study evaluating
      ABI-H0731+ ETV vs ETV alone for the treatment of viremic hepatitis B "e" antigen
      (HBeAg)-positive participants with cHBV.
    

Intervention name(s): ABI-H0731; SOC ETV; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive 300mg QD of ABI-H0731 tablets orally.; Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.; Participants will receive matching QD placebo tablets orally.
Other intervention name(s): Entecavir
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cHBV; HBV; HBeAg-positive; hepatitis B; vebicorvir; VBR
The Effect of Contrast Agent on Endothelial Function in Healthy Men
Condition: Contrast Agent; Endothelial Function; Cytokines; Apoptosis of Endothelial Progenitor Cell; Free Radical; Alpha-lipoic Acid
Study type: Interventional
Phase: Phase 4

Summary: 
      Contrast medium is essential for diagnosis of many diseases. However, recent studies showed
      that contrast agents can induce renal injury and is associated with poor long-term clinical
      outcome, especially in diabetes. To date, no data are available on the relationship between
      contrast medium and endothelial function. Endothelial dysfunction is known to precede
      atherosclerosis and is considered a risk marker for future development of cardiovascular
      disease. Therefore, we hypothesized that contrast agents may induce endothelial dysfunction
      in healthy men. In addition, we hypothesized that contrast induced endothelial dysfunction
      via free radicals. Thus, we also test alpha-lipoic acid whether or not protect endothelial
      dysfunction induced by contrast agents.
    


Intervention name(s): Contrast agent
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Contrast agent; endothelium; Free radical; Alpha lipoic acid
Trial of Lamivudine Treatment in HBeAg Negative Chronic Hepatitis B Patients (in Asia)
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim is to investigate whether Lamivudine 100mg daily is effective in the long term
      treatment of HBeAg negative chronic HBV infected patients with active liver disease in Asia
    

Detailed description: 
      Recent studies have proved lamivudine a very potent antiviral drug in suppressing viral
      replication and improving hepatic necro-inflammation with minimal adverse effects in HBeAg
      positive chronic hepatitis B patients. The efficacy of lamivudine in HBeAg positivce Asian
      patients has been weel established. However, the evidence in HBeAg negative patients is
      limited.

      In the absence of HBeAg seroconversion, guidance on the clinical management of HBeAg negative
      hepatitis B patitents treated with lamivudine and data on the efficacy of lamivudine in
      controlling pre-core HBV disease long-term is still needed. Existing data in HBeAg negative/
      HBV DNA positive HBV demonstrate clear and statisticallysignificant serological benefit of
      lamivudine over placebo during treatment. Limited sustained response was observed
      post-treatment following a one year treatment period. Whether these results can be applied to
      patients in Asia is uncertain. This study is therefore intended to further assess te efficacy
      profile over an extended treatment period in the Asian population.
    

Intervention name(s): Lamivudine/ Placebo 100mg daily
Intervention type(s): Drug
Intervention MeSH terms: Lamivudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic Hepatitis B; Lamivudine; HBeAg negative