bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1 Single Dose Study of E6011 in Japanese Healthy Adult Male Subjects (Study E6011-J081-001)
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single
      ascending dose (SAD) administration of E6011 in Japanese healthy volunteers.
    


Intervention name(s): E6011; E6011 Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single ascending dose (SAD) administration of E6011 is administered to 8 groups as a 30-minute intravenous infusion at a dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.; A SAD administration of E6011 Matching Placebo is administered to 2 participants in each of 8 groups as a 30-minute intravenous infusion at a placebo dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending E6011 Matching Placebo dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.
Intervention MeSH terms: Quetmolimab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers; immunogenicity; anti-E6011 antibody
Isolated Oligohydramnios Less Favorable Delivery and Neonatal Outcomes
Condition: Oligohydramnios, Delivered
MeSH terms: Oligohydramnios
Study type: Observational [Patient Registry]

Summary: 
      Oligohydramnios happens in 1-5% of term pregnancies. The clinical significance of isolated
      oligohydramnios been a matter of debate. We aimed in this study to investigate the impact of
      isolated oligohydramnios on the mode of delivery and risk of adverse perinatal outcome.
    

Detailed description: 
      Retrospective study conducted in Armed Forces Hospitals of Southern Region, comparing cases
      with oligohydramnios (amniotic fluid level index <5) to normal amniotic fluid cases (amniotic
      fluid level index ≥ 8). Primary outcomes are the mode of delivery and adverse perinatal
      outcomes (including mortality, NICU admission, low Apgar score and sepsis)
    

Intervention name(s): observation of delivery and neonatal outcomes
Intervention type(s): Behavioral
Intervention description(s): MONITORING THE DELIVERY MODE EITHER CESAREAN OR VAGINAL, BESIDE THE NEONATAL OUTCOME AND MORBIDITIES IN BOTH GROUPS
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Pregnant women between 32 and 41 weeks with otherwise normal pregnancy. Isolated
        oligohydramnios group are diagnosed with amniotic fluid index less than 5.
An Evaluation of Actigraphy as an Indicator of Sleep and Wake in Children
Condition: Sleep Monitoring
Study type: Observational

Summary: 
      The purpose of this study is to learn how well an instrument called an Actiwatch-2 can
      determine whether a child is asleep or awake. The Actiwatch-2 (manufactured by
      Minimitter/Respironics of Bend, Oregon) is the brand name for an actigraphy monitor; that is,
      a motion sensor that is typically worn on the wrist and looks like a wrist watch. It measures
      and records the amount of movement a person makes each minute. After being worn overnight,
      data are transferred from the Actiwatch to a computer, and a program estimates whether a
      person is awake or asleep by analyzing the recorded movement data. The enrollment target is
      80 participants. Although other actigraphy equipment has been used to monitor sleep in
      children, the Actiwatch-2 has not been validated in the pediatric population.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pediatric patients receiving sleep study as part of their standard medical care
      
Keywords: actigraphy; polysomnography; pediatrics; sleep; To validate Actigraphy against polysomnography
Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults for the 2015-2016 Season
Condition: Influenza; Healthy
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective annual release study is designed to evaluate the safety of 3 new influenza
      virus vaccine strains to be included in FluMist Quadrivalent for the 2015-2016 influenza
      season
    

Detailed description: 
      This prospective, randomized, double-blind, placebo-controlled release study will enroll
      approximately 300 healthy adults 18 to 49 years of age. Eligible participants will be
      randomly assigned in a 4:1 fashion to receive a single dose of trivalent vaccine or placebo
      by intranasal spray. Randomization will be stratified by site. This study will be conducted
      at 3 sites in the United States of America. Each participant will receive 1 dose of
      investigational product on Day 1. The duration of study participation for each participant is
      the time from study vaccination through 181 days after study vaccination.
    

Intervention name(s): Trivalent Influenza Vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): A single dose of 10^(7.0 ± 0.5) FFU per strain of trivalent influenza vaccine will be administered as intranasal spray on Day 1.; A single dose of placebo matched to trivalent influenza vaccine will be administered as intranasal spray on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Trivalent; Influenza; FluMist Quadrivalent; Vaccine; Prevention; Healthy
Upper Airway Collapse in Patients With Obstructive Sleep Apnea Syndrome by Drug Induced Sleep Endoscopy
Condition: Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

Summary: 
      This is a prospective, interventional cohort study of drug-induced sleep endoscopy (DISE).
      The goal is to evaluate the upper airway in a cohort of patients with obstructive sleep apnea
      hypopnea syndrome (OSAHS) diagnosed in a prior polysomnography.

      This study correlates the sedation level measured by entropy during DISE using propofol via a
      TCI pump with the local obstruction patterns of the upper airway according to the VOTE
      classification.

      As OSAHS is a widespread disease and the DISE procedure has become a common tool for
      diagnosis and evaluation of further treatment, a growing number of research articles deal
      with this topic. These articles are available through pubmed.
    


Intervention name(s): Drug induced sleep endoscopy
Intervention type(s): Procedure
Intervention description(s): Titration of propofol using a target controlled Infusion pump and description of the upper airway according to the VOTE classification
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy of the C8 Nerve Root Block During Interscalene Block for Anesthesia of the Posterior Aspect of the Shoulder
Condition: Brachial Plexus Block; Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      This study evaluates the effects of selective 8th cervical nerve root block during
      interscalene brachial plexus block on the relief of pain intensity upon the introduction of a
      posterior portal during arthroscopic shoulder surgery. The 5th to 7th cervical nerve roots
      will be blocked in half of participants, while the 5th to 8th cervical nerve roots will be
      blocked in the other half.
    

Detailed description: 
      By blocking only the 5th to 7th cervical nerve blocks, conventional interscalene brachial
      plexus block spares the 8th cervical and 1st thoracic dermatomes which innervate the
      posterior aspect of the shoulder. To visualize the shoulder joint space during shoulder
      arthroscopic surgery, the introduction of a posterior portal is essential. However,
      conventional interscalene brachial plexus block cannot effectively relieve the pain caused by
      its insertion due to sparing of the 8th cervical and 1st thoracic dermatomes. The addition of
      the 8th cervical nerve root block to conventional interscalene brachial plexus block
      decreases pain intensity upon the introduction of a posterior portal.
    

Intervention name(s): Conventional interscalene block; Interscalene block with C8 root block; 0.75% ropivacaine
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Under ultrasound guidance, the 5th to 7th cervical nerve roots are blocked.; Under ultrasound guidance, the 5th to 8th cervical nerve roots are blocked.; Placement of 25 to 30 ml of 0.75% ropivacaine around the cervical nerve roots
Other intervention name(s): Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 8th cervical nerve root block
Convalescent Plasma as Treatment for Acute Coronavirus Disease (COVID-19)
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      There is currently no effective treatment for COVID-19 except best supportive care. The aim
      is assess the safety, tolerability and efficacy of convalescent plasma for treatment of
      patients with varying degrees of COVID-19 illness.
    

Detailed description: 
      Convalescent plasma has been shown to be safe and effective for treatment of several
      diseases. Preliminary data indicates that it is safe and effective for treatment of COVID-19.
      However, data is limited to small studies and case series on severely ill patients. The
      proposed study assesses the safety and efficacy earlier in the course of illness, in slightly
      less severe patients with the possibility of detecting less severe adverse events and the
      potential for early treatment to hinder the development of severe disease. Plasma is
      collected from consenting donors who have recovered from SARS-CoV-2.
    

Intervention name(s): SARS-CoV-2 convalescent plasma
Intervention type(s): Biological
Intervention description(s): Treatment with convalescent plasma (180-200ml) from individuals who have recovered from SARS-CoV-2 infection
Intervention model: Single Group Assignment
Intervention model description: An open, non-randomised controlled, clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19 convalescent plasma treatment; SARS-CoV-2 infection; Safety; Effectiveness
Comparative Bioavailability Study of Two Test Products of Fixed Dose Combination Capsule of ASA (Acetylsalicylic Acid) and Pantoprazole (Each Capsule Contains ASA 100 mg and Pantoprazole 20 mg) Under Fasting Conditions
Condition: Ulcers, Duodenal and Gastric
MeSH terms: Duodenal Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, balanced, randomized, three-treatment, three-period, six-sequence, cross-over,
      single dose, comparative bioavailability pilot study under fasting conditions. The treatments
      will be administered after an overnight fasting of at least 10 hours in each period. Fasting
      will continue for four hours post-dose, and then meals will be provided at specified
      intervals. Drinking water will not be permitted one hour before dosing and until one hour
      post-dose.
    


Intervention name(s): Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one; Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two; ASA 100 mg tablet; Pantoprazole 20 mg gastro-resistant tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Formulation Test 1 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK; Formulation Test 2 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK; Aspirin® Protect 100 mg tablets (Each tablet contains ASA 100 mg) manufactured by Bayer vital GmbH, 51368 Leverkusen, Germany; Protium® 20 mg gastro-resistant tablets (Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate)) marketing authorisation holder Nycomed GmbH, Byk-Gulden-Straβe 2, D-78467, Konstanz, Germany
Other intervention name(s): Aspirin Protect; Protium
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fixed dose combination; Acetylsalicylic acid; Pantoprazole
Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy
Condition: Chemotherapeutic Agent Toxicity; Neurotoxicity; Pain; Peripheral Neuropathy; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Peripheral Nervous System Diseases; Neurotoxicity Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Electronic stimulation using a MC5-A Scrambler may help relieve pain in patients
      who develop peripheral neuropathy while undergoing chemotherapy treatments for cancer.

      PURPOSE: This phase II trial is studying how well MC5-A Scrambler therapy works in reducing
      peripheral neuropathy caused by chemotherapy.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine if MC5-A Scrambler therapy will improve the pain associated with
           chemotherapy-induced peripheral neuropathy in cancer patients by 20%.

      Secondary

        -  To evaluate the effect of MC5-A therapy on specific pain and neuropathy scales.

        -  To evaluate the effect of MC5-A therapy on overall quality of life.

        -  To evaluate the effect of MC5-A therapy on other pain drugs used.

        -  To evaluate the toxicities of MC5-A therapy.

      OUTLINE: Patients undergo gel electrode application on the skin in the most pain-free of the
      pain-affected area. Patients undergo treatment with the MC5-A Scrambler machine over 60
      minutes once daily on days 1-10. On day 1, the treatment intensity is increased every 10
      minutes to the maximum intensity individually bearable by the patient without any input of
      pain or discomfort. The patient should feel the disappearance of the pain during treatment as
      a sign that the proper nerve pathway(s) has (have) been correctly identified. Subsequent
      treatments begin at the highest intensity tolerated at the previous treatment. Patients with
      no improvement after 3 treatments discontinue treatment.

      Patients complete questionnaires about symptoms, pain, and quality of life periodically.

      After completion of study treatment, patients are followed up at 2 and 4 weeks, monthly for 3
      months, and at 6 months.
    

Intervention name(s): questionnaire administration; Sensory Neuropathy Scale instrument; Quality of Life instrument; MC5-A Scrambler device
Intervention type(s): Other; Other; Other; Device
Intervention description(s): Pain Rating Score; ECOG Common Toxicity Criteria for Sensory Neuropathy scale; Uniscale 0-100 scale global quality of life; Electrical stimulation for 60 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pain; neurotoxicity; chemotherapeutic agent toxicity; unspecified adult solid tumor, protocol specific; peripheral neuropathy
Randomized Controlled Trial of Treating Migraine With Acupuncture
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to testify whether acupuncture is effective for migraine, and
      provide evidence for the hypothesis that"Acupuncture effect is based on meridians, and
      gathering of meridian Qi is the key point."
    

Detailed description: 
      The purpose of the study is to testify whether acupuncture is effective for migraine, through
      treating migraine patients for a month, using different acupoints according to literatures of
      treating migraine with acupuncture, and try to provide clinical evidence for the hypothesis
      that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key
      point."
    

Intervention name(s): acupuncture
Intervention type(s): Other
Intervention description(s): Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Other intervention name(s): electro-acupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: migraine; acupuncture; efficacy; safety; meridian; acupoint
A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to look at the amount of the study drug, tirzepatide, that
      gets into the blood stream and how long it takes the body to get rid of it when given using
      two different devices. The study will also evaluate the safety and tolerability of
      tirzepatide and information about any side effects experienced will be collected. For each
      participant, the total duration of the study will be approximately 14 weeks, including
      screening.
    


Intervention name(s): Tirzepatide; Test; Reference
Intervention type(s): Drug; Device; Device
Intervention description(s): Administered SC; Used to administer tirzepatide SC; Used to administer tirzepatide SC
Other intervention name(s): LY3298176
Intervention MeSH terms: Tirzepatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Digital Game Use in Teaching Subcutaneous Injection Administration Skills to Nursing Students
Condition: Nursing Education
Study type: Interventional

Summary: 
      The goal of this to determine the effect of a digital game-based application on learning
      satisfaction and self-confidence in the acquisition of subcutaneous drug administration
      skills by nursing students.

      The research hypotheses it aims to answer are:

        -  Hypothesis 1: The subcutaneous injection knowledge level of the students who are
           educated with the digital game method is higher than the students who receive the
           traditional education.

        -  Hypothesis 2: The subcutaneous injection skill test scores of the students who were
           educated with the digital game method were higher than the students who received the
           traditional education.

        -  Hypothesis 3: The satisfaction and self-confidence level of the students who are
           educated with the digital game method towards subcutaneous injection is higher than the
           students who receive the traditional education.
    

Detailed description: 
      In studies on the use of digital games in nursing education; Students value instant feedback,
      visuals and experiential learning, the game developed to improve their decision-making and
      reasoning skills is extremely useful, useful and enjoyable, from nursing students to those
      with no previous operating room experience. It has been stated that when the application is
      made with a game-like simulation, the information is more permanent, they behave more
      collaboratively, and they experience less fear. The study was planned in a randomized
      controlled experimental design with pretest-posttest, experimental and control groups.
    

Intervention name(s): subcutaneous injection administration game; control group
Intervention type(s): Other; Other
Intervention description(s): The subcutaneous injection practice game was developed to examine nursing students' injection practice skills and its effect on their satisfaction with learning.; only
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: pretest-posttest, randomized controlled experimental design with experimental and control groups
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: learning satisfaction; self-confidence; digital game; nursing students