bioihbjkbjnl/mcl2 huggingface dataset:
Postdural Puncture Headache Relief With Aminophylline and SPGB
Condition: Anesthesia
MeSH terms: Post-Dural Puncture Headache; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare Sphenopalatine ganglion block (SPGB) and aminophylline
      in the efficacy and safety management of PDPH.
    

Detailed description: 
      Postdural puncture headache (PDPH) is a severe and debilitating complication after regional
      anesthesia in the obstetric population; The gold standard treatment for PDPH is epidural
      blood patch, which is an invasive and risky procedure.

      The trans-nasal sphenopalatine ganglion (SPG) block and intravenous aminophylline are
      promising options for PDPH. So the investigators designed this randomized, double-blind study
      to compare Sphenopalatine ganglion block (SPGB) and aminophylline in the efficacy and safety
      management of PDPH.
    

Intervention name(s): conservative therapy; Aminophylline; trans nasal sphenopalatine ganglion block
Intervention type(s): Other; Drug; Procedure
Intervention description(s): bed rest, fluids, abdominal binder, oral paracetamol, and caffeine; conservative therapy plus Aminophylline (250mg of Aminophylline dissolved in 100ml normal saline for intravenous infusion over 30 minutes); conservative therapy plus sphenopalatine ganglion block SPGB using hollow cotton swab and lidocaine 2%
Intervention MeSH terms: Aminophylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Water-soluble Olive Extract Supplementation
Condition: Healthy
Study type: Interventional

Summary: 
      Six weeks of supplementation of an olive extract will:

        -  Improve antioxidant status

        -  Reduce inflammation

        -  Reduce muscle damage

        -  Improve exercise performance

        -  Improve exercise recovery as compared to a placebo.
    


Intervention name(s): Olive Extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsule form ingested 1x/day for 6 weeks; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Olive; antioxidant; exercise; inflammation; recovery; Healthy men
Predictive Factors of the Difficult Intubation When Using the Videolaryngoscope
Condition: Endotracheal Intubation Using Videolaryngoscope for General Anesthesia
Study type: Observational

Summary: 
      The usefulness of videolaryngoscope has been verified by several studies, and the frequency
      of videolaryngoscopy is increasing in clinical practice. Data on the use of
      videolaryngoscopes, however, were not sufficiently accumulated when compared with data on the
      use of previously used macintosh laryngoscopes. In addition, videolaryngoscopy increases the
      success rate of endotracheal intubation compared to conventional macintosh laryngoscopy, but
      endotracheal intubation with videolaryngoscope is not successful in all cases with one
      intubation attempt. Therefore, if the difficult endotracheal intubation with the
      videolaryngoscope can be predicted in advance, it may be possible to improve the success rate
      of intubation by reducing unnecessary use of the videolaryngoscope and preparing other
      equipment. There are many studies on the preoperative examination that can predict the
      difficulty of intubation when using a macintosh laryngoscope. However, there are still
      attempts to find screening tests that predict precisely the difficult endotracheal intubation
      because the accuracy of screening tests is not high. In particular, there is a lack of
      research on factors that can predict difficult endotracheal intubation when using
      videolaryngoscope. Therefore, the investigators aimed to investigate the factors predictive
      of difficult endotracheal intubation when attempting intubation using videolaryngoscope.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are scheduled for endotracheal intubation using videolaryngoscope for general
        anesthesia
      
Keywords: Intubation; videolaryngoscope
HAL-MRE1 Subcutaneous Immunotherapy in Ragweed Allergic Patients First-in-human
Condition: Rhinitis, Allergic; Rhinoconjunctivitis, Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic; Conjunctivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this first-in-human phase I study is to assess the safety and tolerability of
      HAL-MRE1 subcutaneous immunotherapy in subjects suffering from ragweed pollen-induced
      allergic rhinitis/rhinoconjunctivitis with or without asthma.

      The study has 4 treatment groups: 1 placebo group and 3 groups treated with different doses
      of HAL-MRE1.
    

Detailed description: 
      A chemically modified, aluminum hydroxide adsorbed ragweed extract (HAL-MRE1) for
      subcutaneous administration was developed for the treatment of ragweed pollen-induced
      allergic rhinitis/rhinoconjunctivitis (ARC) with or without asthma. The aim of this
      first-in-human phase I study is to assess the safety and tolerability of HAL-MRE1
      subcutaneous immunotherapy in subjects suffering from ragweed pollen-induced ARC with or
      without asthma.

      The study will consist of 3 staggered cohorts of 15 subjects each who are randomly assigned
      to the active or placebo group in a 2:1 manner using block randomization.

      A one month gap must be maintained between the end of the ragweed pollen peak season (2018)
      and subject randomization into the study. The study has seasonal constraints; subjects with
      concomitant tree and/or grass pollen allergies must complete study treatment before any
      allergy symptoms due to tree and/or grass pollen exposure develop or start study treatment
      after the symptoms caused by the tree and/or grass pollen exposure have disappeared.
    

Intervention name(s): HAL-MRE1
Intervention type(s): Biological
Intervention description(s): HAL-MRE1 is a liquid suspension for subcutaneous administration containing aluminum hydroxide adsorbed modified allergens extracted from ragweed pollen.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subcutaneous immunotherapy; Ragweed pollen; Allergic rhinitis/rhinoconjunctivitis; Safety; Tolerability
Testing the Efficacy of an Online Social Network Intervention to Increase Social Support for Physical Activity
Condition: Cardiovascular Disease; Cancer; Obesity
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study was designed to determine whether participation in an online social network
      intervention increases perceived social support for physical activity versus a minimal
      education control group by conducting a randomized controlled trial with 140 female
      undergraduate students. The investigators hypothesize that participants in the physical
      activity centered online social network intervention group will have greater increases in
      perceived social support for physical activity compared to minimal web based physical
      activity education controls.
    


Intervention name(s): online social network enrollment plus education and self monitoring; Web education control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants are enrolled in an online social network designed to increase social support for physical activity and will self monitor physical activity and receive educational materials at a dedicated study website.; Participants will receive access to a dedicated study website where they can view educational materials related to physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of ONCOXIN® in Oral Mucositis, Appetite and Body Mass in Cancer Patients.
Condition: Mucositis Oral
MeSH terms: Mucositis; Stomatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Oral mucositis is one of the most spread side effects of anticancer therapy. It is associated
      with both chemo- and radiotherapy, decreases QoL, relative dose intensity and leads to
      nutritive deficiency. Oral mucositis causes secondary infections, increased hospital stay,
      whereas pain syndrome results in an emotional distress, anorexia and disables natural
      feeding.
    

Detailed description: 
      Primary:

      To evaluate the efficacy of ONCOXIN on oral mucositis symptoms in patients who receive
      chemotherapy and/or radiotherapy.

      Secondary:

      To evaluate the effects of ONCOXIN on nutritional status in patients who receive chemotherapy
      and/or radiotherapy.
    

Intervention name(s): Oncoxin®
Intervention type(s): Dietary Supplement
Intervention description(s): Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN 25 ml twice daily for 20 days;
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Oral Mucositis; Nutritional supplement; Chemotherapy; Radiotherapy; Ocoxin / Oncoxin
Adult Asthmatics and Acid Reflux
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of Nexium in the treatment of
      subjects with persistent asthma believed to have acid reflux as a contributory factor to
      control of their asthma.
    


Intervention name(s): Esomeprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40mg twice a day; 40mg twice a day
Other intervention name(s): Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Acid Reflux; Nexium; Esomeprazole
A Follow-up Study to Assess Resistance to ABT-072 in HCV-infected Subjects Administered ABT-072 in Prior ABT-072 Studies
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a follow-up study with no treatment and only samples being collected.
    

Detailed description: 
      The purpose of this study is to evaluate the development of specific viral mutations in
      response to treatment with ABT-072.
    

Intervention name(s): ABT-072
Intervention type(s): Drug
Intervention description(s): Blood samples are being taken from subjects previously treated with ABT-072.
Intervention model: Single Group Assignment
Masking: None (Open Label)
The Tolerability, Safety, and PK Characteristics of SIM1910-09 in Healthy Chinese Volunteers
Condition: Acute Ischemic Stroke; Cerebral Edema
MeSH terms: Ischemic Stroke; Brain Edema
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study
      to evaluate the tolerability, safety, and pharmacokinetic characteristics of SIM1910-09 for
      injection after single/multiple dosing in healthy Chinese adult volunteers.
    

Detailed description: 
      This is a double-blind, randomized, placebo-controlled, sequential-group study with
      intravenously (IV) administered SIM1910-09 in healthy human subjects to assess the safety,
      tolerability and pharmacokinetic parameters, which include of single ascending dose part and
      multiple ascending doses part. The primary objectives of this study are to assess the safety
      and tolerability of SIM1910-09 in healthy subjects. Secondary objectives are to determine the
      pharmacokinetics of SIM1910-09 and SCR-6401 (primary metabolite) after administration of
      SIM1910-09. Exploratory objectives are to learn the inhibitory effect of SIM1910-09 and
      SCR-6401 on inflammation cytokine in ex vivo blood.
    

Intervention name(s): SIM1910-09; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part A-single ascending doses， SIM1910-09 will be administered by IV bolus infusion over a 30-min. The test doses are including of : 2mg/kg, 4mg/kg, 6mg/kg, 8mg/kg, which will be tested sequentially from low dose to high dose.
Part B-multiple ascending doses, SIM1910-09 will be administered as an initial bolus dose over 30-min, plus subsequent continuous infusion over 72 hours, the test doses are including of : 4mg/kg IV bolus infusion+0.03mg/kg/h continuous infusion；4mg/kg IV bolus infusion+0.1mg/kg/h continuous infusion；4mg/kg IV bolus infusion+0.3mg/kg/h continuous infusion；4mg/kg IV bolus infusion+0.6mg/kg/h continuous infusion，which will be tested sequentially from low dose to high dose.; Part A-single ascending doses， placebo will be administered by IV bolus infusion over a 30-min. The test doses are including of : 2mg/kg, 4mg/kg, 6mg/kg, 8mg/kg, which will be tested sequentially from low dose to high dose.
Part B-multiple ascending doses, placebo will be administered as an initial bolus dose over 30-min, plus subsequent continuous infusion over 72 hours, the test doses are including of : 4mg/kg IV bolus infusion+0.03mg/kg/h continuous infusion；4mg/kg IV bolus infusion+0.1mg/kg/h continuous infusion；4mg/kg IV bolus infusion+0.3mg/kg/h continuous infusion；4mg/kg IV bolus infusion+0.6mg/kg/h continuous infusion，which will be tested sequentially from low dose to high dose.
Other intervention name(s): AER-271
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: brain edema; Acute ischemic stroke
The Impact of Problem-Based Learning (PBL) and Lecturing
Condition: Learning
Study type: Interventional

Summary: 
      The present study aimed to compare the effect of education through problem-based learning
      (PBL) or lectures on behavior, attitude and learning of nursing students.
    

Detailed description: 
      A total of 40 second-year nursing students participated: 20 students in the PBL group and 20
      students in the traditional lecture (control) group. The students underwent a one-semester
      course using the two methods of education
    

Intervention name(s): PBL
Intervention type(s): Behavioral
Primary purpose: Health Services Research
Keywords: Problem-based learning (PBL); lecture; nursing; education; none of students had any prior exposure to PBL
BeFAST or BeSTRONG: Brain Change After Fun Athletic Sports-skill Training or Brain Change After Strength TRaining Focusing ON Gait
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to compare a motor learning (ML)-based gait-related training
      intervention to a functional lower limb strength training intervention, with a concurrent
      evaluation of functional, neural and participation outcomes for children and youth with
      Cerebral Palsy (CP).

      This study is a two-group, parallel arm RCT in which twenty-two children with CP in GMFCS
      Levels I-II will be randomly allocated to a 6-week, 16 session program of: (i) ML based gait
      training or (ii) lower limb strength training. Outcome assessments occur pre/post/4-months
      post-intervention.
    


Intervention name(s): BeFAST; BeSTRONG
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The motor learning (ML)-based gait-related training program is designed to improve advanced gross motor skills and athleticism. It will involve 45-min sessions twice to three times weekly over 6 weeks for a total of 16 active sessions. A maximum of 7 weeks will be permitted. Each session will consist of 35-min of active training along with a 10-min active warm-up/cool-down that incorporates ML. Children will be given a 3- to 5-min mental motor imagery script to practice on days when they do not have active training sessions. The total number of sessions (combined training/home imagery) will be five per week.; The functional strength training program is designed to improve gait-related skills. It will involve 45-min sessions twice to three times weekly over 6 weeks for a total of 16 active sessions. A maximum of 7 weeks will be permitted. Each session will consist of 35-min of active training along with a 10-min active warm-up/cool-down. Children will be given a 3- to 5-min home program of strength exercises to practice on days when they do not have active training sessions. The total number of sessions (combined training/home program) will be five per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Two Levels of Frequency of Repositioning in the Reduction of Pressure Ulcers
Condition: Critical Illness
MeSH terms: Pressure Ulcer; Critical Illness
Study type: Interventional

Summary: 
      PENFUP FASE 2, It is a multicenter study by parallel conglomerates, planned in order to
      evaluate the efficacy between two levels of frequency of postural change in intensive care
      units for adults of hospitals in various regions of Colombia.
    

Detailed description: 
      Taking into account a design effect of 6.7, Investigators planned to include 150 participants
      from each ICU. Investigators did calculate that a total of 22 ICUs are required, in which 11
      will be assigned to the low frequency and 11 will be assigned to a high frequency group of
      postural change until obtaining a total of 1,650 patients in each arm of the study and a
      total of 3,300 participants in the study.
    

Intervention name(s): High frequency postural change; Conventional care
Intervention type(s): Other; Other
Intervention description(s): Repositioning of patients hospitalized in bed in intensive care units will be carried out with a frequency interval that we call "high-frequency" to be performed on each patient between an interval between less than or equal to every 2 hours in a full day (24 hours) (minimum goal of 8-10 in 24 hours subtracting 2 or 4 at night and not alter the circadian cycle). The position must be modified in each postural change to right lateral, supine, left lateral, or prone to supine if the position changes every 2 hrs.; Repositioning of patients hospitalized will be performed in the current way it is commonly applied to patients.
Other intervention name(s): Repositioning; Control group or usual or current care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clinical trial, randomized, pragmatic, of parallel groups (1: 1), by clusters, blinded for the collection of information, sending, and in the evaluation of outcomes.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
ProQuad Dose Selection Study (V221-011)(COMPLETED)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Study type: Interventional
Phase: Phase 2

Summary: 
      A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II
      and PUVV (Process Upgrade Varicella Vaccine) vaccines.
    


Intervention name(s): Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Comparator: M-M-R II; Comparator: PUVV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90; A single 0.5 mL subcutaneous injection at Day 0; A single 0.5 mL subcutaneous injection at Day 0
Other intervention name(s): ProQuad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Clopidogrel Bioequivalence Study in Healthy Subjects
Condition: Bioequivalence, AUC, Cmax, Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomised, three-way crossover study in healthy male and
      female subjects, performed at a single centre. The objective of the study is to assess the
      bioequivalence between one test formulation (Clopidogrel 75 mg tablet (commercial blister
      from KRKA) and two reference formulations (Clopidogrel 75 mg tablet [Plavix, sourced in US
      and Japan]).
    

Detailed description: 
      Study to evaluate the bioequivalence of orally administered European source clopidogrel
      tablets and US and Japanese source clopidogrel tablets.
    

Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention description(s): European clopidogrel tablets, 75 mg (test) versus Japanese clopidogrel tablets, 75 mg (reference); European clopidogrel tablets, 75 mg (test) versus US clopidogrel tablets, 75 mg (reference)
Other intervention name(s): Zyllt; Plavix
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Clopidogrel, Zyllt, Plavix, Phase I, Healthy Subjects, Pharmacokinetics, Bioequivalence
Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude
Condition: Healthy Volunteers With Induced Hypoxia
MeSH terms: Hypoxia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, crossover study of Trans Sodium Crocetinate (TSC)
      in healthy volunteers, age 18-40 (inclusive), exercising at altitude. The primary objective
      is to determine the effect of (TSC) on partial pressure of oxygen (PaO2) and maximal oxygen
      consumption (VO2 max); the secondary objective is to assess the effect of TSC on oxygen
      saturation (SpO2).
    


Intervention name(s): Trans Sodium Crocetinate
Intervention type(s): Drug
Intervention description(s): Single IV bolus
Intervention MeSH terms: Trans-sodium crocetinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment