bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the Pharmacokinetic (PK) and safety of BGF MDI
      [Budesonide/glycopyrronium/formoterol (BGF) metered dose inhaler (MDI)] formulated with 2
      different propellants :Hydrofluoroolefin (HFO) and Hydrofluoroalkane (HFA) with oral
      activated charcoal in healthy subjects (male or female).
    

Detailed description: 
      This is a Phase I, randomized, double-blind, single-dose, single-center, partial-replicate, 3
      way cross-over study.

      The study will comprise:

        -  Screening period: up to 28 days prior to first dosing;

        -  Three treatment periods : Subject will be resident in the Clinical Unit from the morning
           on the day before dosing with BGF MDI (Day 1 of Treatment Period 1), until 24 hours
           following the final dose (Day 2 of Treatment Period 3 a washout period of 3 to 7 days
           between each dose;

        -  Follow-up: Within 3 to 7 days after the last administration of BGF MDI.

      Subjects will receive 3 single-dose treatments of BGF MDI [Test formulation Treatment A (BGF
      MDI HFO); Reference formulation Treatment B (BGF MDI HFA)] on Day 1 of each Treatment Period
      (1, 2, and 3) following an overnight fast of at least 8 hours. There will be a washout period
      of 3 to 7 days between each dose.

      Each subjects will be involved in the study for up to 55 days.
    

Intervention name(s): Treatment A (BGF MDI HFO with oral activated charcoal); Treatment B (BGF MDI HFA with oral activated charcoal)
Intervention type(s): Drug; Drug
Intervention description(s): Subject will receive 4 inhalations as a single dose with oral activated charcoal - test formulation; administered during 1 Treatment Period.; Subject will received 4 inhalations as a single dose with oral activated charcoal - reference formulation; administered during 2 Treatment Periods.
Other intervention name(s): Budesonide / Glycopyronium / Formoterol fumarate pressurized inhalation suspension, HFO; Budesonide / Glycopyronium / Formoterol fumarate pressurized inhalation suspension, HFA
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Corticosteroid; Long acting muscarine agonist (LAMA); Long acting beta agonist; Propellant; Bioequivalence; Lung exposure; Healthy subjects; Inhaled corticosteroid (ICS); Long-acting β2 agonist (LABA); Next generation propellant (NGP)
Ascending Dose Study of the Safety and Tolerability of REGN728 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety and tolerability (how the body reacts to the drug) of REGN728
      compared with placebo (an inactive substance that contains no medicine) in healthy subjects.
      The study drug and placebo will be administered by subcutaneous injection (under the skin) at
      the clinic visit. There will be 14 clinic visits, which will include 4 overnight stays.
      Subjects will be monitored by the study staff for side effects and the body's response to the
      study drug. Vital signs (blood pressure, temperature, breathing and heart rate) will be
      checked, blood and urine samples will be collected at some or all visits.
    


Intervention name(s): REGN728
Intervention type(s): Biological
Intervention description(s): 2 Subcutaneous Cohorts (dose 1, 2)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Advanced Platelet-rich Fibrin Combined With Open Debridement in Management of Suprabony Periodontal Defects
Condition: Periodontitis, Adult
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      in this clinical trial, patients with periodontal defects will be treated with advanced
      platelet-rich fibrin in conjunction with open debridement
    

Detailed description: 
      two groups of patients with suprabony defects, one will be treated with advanced
      platelet-rich fibrin in conjunction with open debridement and the other will be treated with
      open debridement alone. subjects will be evaluated for evidence of bone formation after 6
      months of therapy
    

Intervention name(s): advanced PRF
Intervention type(s): Biological
Intervention description(s): advanced PRF+ surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Kinesiophobia in Stroke Patients and Affecting Factors
Condition: Kinesiophobia; Stroke Patients
MeSH terms: Stroke; Kinesiophobia
Study type: Observational

Summary: 
      It was aimed to determine the presence of kinesiophobia that will affect the treatment in
      stroke patients and to investigate the relationship between these factors and kinesiophobia
      by examining factors such as postural control, depression, pain, and affected side that may
      cause kinesiophobia.
    

Detailed description: 
      Objective: This study was planned to investigate the relationship between depression,
      postural control, pain, affected side and kinesiophobia in stroke patients. Material and
      Method: Thirty patients aged between 25-70 years who had a stroke at the earliest 6 months
      and who Functional Ambulation Scale were level 2 and above according to the were included in
      the study. Patients were selected by random sampling method from the relevant population.
      Demographic data were obtained from all subjects who met the inclusion criteria. Patients
      were evaluated Kinesiophobia scores (Tampa Kinesiophobia Scale (TKÖ) and VAS-Kinesiophobia
      Assessment), depression severity (Beck Depression Inventory), postural control loss (PASS)
      and pain severity (VAS).
    

Intervention name(s): Assessment
Intervention type(s): Other
Intervention description(s): Thirty stroke patients were included in the study. After the demographic information was obtained from all patients who accepted to participate in the study by complying with the inclusion criteria; The kinesiophobia scores of the patients were evaluated, depression severity, postural control and pain severity.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        30 patients who were level 2 and above according to the Functional Ambulation
        Classification were included in the study.
      
Keywords: Kinesiophobia; stroke patients; Pain; Postural control; Depression
Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine
Condition: Prevention of Anthrax Infection
MeSH terms: Anthrax
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this phase 1 study is to evaluate the safety and immunogenicity of rPA102
      vaccine, using anthrax vaccine adsorbed (AVA) as a comparator.
    


Intervention name(s): rPA102 Vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
COMPREHENSIVE® REVERSE SHOULDER Mini BasePlate
Condition: Rotator Cuff Tear Arthropathy; Osteoporosis; Osteomalacia; Joint; Destruction, Sacroiliac
MeSH terms: Osteoporosis; Osteomalacia; Rotator Cuff Tear Arthropathy; Rotator Cuff Injuries
Study type: Observational

Summary: 
      Evaluate Survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate.
    

Detailed description: 
      The primary objective of this prospective clinical data collection is to evaluate
      survivorship for the Biomet® Comprehensive® Reverse Shoulder Mini Baseplate. Secondary
      objectives include validation of implant sizing and hardware options as well as collection of
      mid-term clinical outcomes including adverse events, scapular notching, and Constant Score.

      All shoulders on which data will be collected are legally marketed and none of the devices
      are investigational or experimental. FDA has cleared this device via Premarket Notification
      510(k) K080642. This data collection effort will document the clinical outcomes of the
      Comprehensive® Reverse shoulders. The data gathered will be collated and used to provide
      feedback to designing engineers, support marketing efforts, and answer potential questions
      from reimbursement agencies.
    

Intervention name(s): COMPREHENSIVE
Intervention type(s): Device
Intervention description(s): Comprehensive® Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Therefore, patients / cases to be included in this study shall utilize the following
        inclusion criteria:

          1. The patient must be anatomically and structurally suited to receive the implants and a
             functional deltoid muscle is necessary.

          2. Grossly deficient rotator cuff with severe arthropathy and/or

               -  Previously failed shoulder joint replacement with a grossly deficient rotator
                  cuff.

               -  Primary total shoulder replacement for the relief of pain and significant
                  disability due to gross rotator cuff deficiency, or

               -  Fracture total shoulder replacement for the relief of pain and significant
                  disability due to gross rotator cuff deficiency, or

               -  Revision total shoulder replacement for the relief of pain and significant
                  disability due to gross rotator cuff deficiency.
Erector Spinae Plane Block in Liver Transplantation Donors
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Living donor liver transplantation has become a common treatment option for patients with
      end-stage liver disease. Donor hepatectomy is associated with significant postoperative pain
      due to inverted L-shaped incision. Therefore adequate analgesia is important for recovery.

      Erector Spinae Plane Block (ESPB) is a safe anesthesia technique used to provide
      postoperative analgesia. This study aimed to compare the novel ultrasound-guided ESPB
      technique with controls in terms of postoperative opioid consumption and postoperative pain
      control on donor patients.
    


Intervention name(s): Erector Spinae Plane Block; Intravenous fentanyl patient control device
Intervention type(s): Procedure; Procedure
Intervention description(s): Intravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded.; Intravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded.
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two model for this study. The first group is erector spinae plane block group. The second one is control group.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
AdCh63 ME-TRAP and MVA ME-TRAP Malaria Vaccines Evaluation in Healthy Children in a Malaria Endemic Area
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      Infants in malaria-endemic regions of Africa are an important target for vaccination against
      malaria in view of the enormous disease burden of malaria in this population. The purpose of
      this trial is to assess the safety and immunogenicity of MVA ME-TRAP and AdCH63 ME-TRAP
      candidate vaccines in healthy children in a malaria endemic region. The regimen proposed here
      has protected non-immune volunteers in Oxford against sporozoite challenge, and so may be
      protective against naturally acquired infection in the Gambia. Administration of AdCh63
      ME-TRAP and MVA ME-TRAP to infants in this study will occur at intervals of at least two
      weeks from the administration of routine infant immunisations, given according to the Gambian
      EPI.
    


Intervention name(s): AdCh63 ME-TRAP, MVA ME-TRAP; AdCH63 ME-TRAP, MVA ME-TRAP
Intervention type(s): Biological; Biological
Intervention description(s): 1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.; 5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Immune response
5-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue Scores
Condition: Crohn Disease; Ulcerative Colitis; Fatigue; Remission
MeSH terms: Crohn Disease; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      This placebo cross-over trial aims to study the effect of the oral intake of an essential
      amino-acid 5-OH tryptophan, the precursor of serotonin, on the fatigue scores in IBD patients
      in deep clinical and biological remission.
    


Intervention name(s): 5-HTP; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): 8 weeks active substance 5-HTP (2 x 100mg per day); 8 weeks placebo (2 x 1 caps per day)
Other intervention name(s): Levotonine; placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Healthy Volunteers Study of the Effects of Olanzapine and Ziprasidone
Condition: Hyperglycemia; Hyperlipidemia
MeSH terms: Hyperglycemia; Hyperlipidemias
Study type: Interventional

Summary: 
      Primary Aim: To test the acute effects of olanzapine or ziprasidone administration, in
      comparison to placebo, on insulin sensitivity in antipsychotic-naïve healthy young men,
      measured as whole-body dextrose infusion rates (mg/kg/min), hepatic glucose production
      (glucose rate of appearance [Ra]), primarily muscle glucose utilization (glucose rate of
      disappearance [Rd]), and adipose tissue related free fatty acid production (glycerol rate of
      appearance [Ra]).

      We hypothesize that olanzapine, but not ziprasidone, will result in acute decreases in
      insulin sensitivity.

      Secondary Aim: To test the acute effects of olanzapine or ziprasidone on insulin signaling
      pathways in antipsychotic naïve healthy young men.

      We hypothesize that olanzapine, but not ziprasidone, will result in acute alterations in
      insulin signaling.
    

Detailed description: 
      See brief description
    

Intervention name(s): Olanzapine; Ziprasidone
Intervention type(s): Drug; Drug
Intervention description(s): olanzapine/Zyprexa; ziprasidone/Geodon
Other intervention name(s): Zyprexa; Geodon
Intervention MeSH terms: Olanzapine; Ziprasidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: healthy; sedentary; men; acute effects of antipsychotic; blood sugar; insulin sensitivity
Assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The is an assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy
      Subjects.
    


Intervention name(s): NKTR118 Formulation 1; NKTR118 Formulation 2; NKTR118 Formulation 3; NKTR118 Formulation 1a; NKTR118 Formulation 3a
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral dose, 25 mg; Oral dose, 25 mg; Oral dose, 25 mg; Oral dose, 25 mg; Oral dose, 25 mg
Intervention MeSH terms: Naloxegol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Pharmacokinetics; NKTR-118; fasting or fed state; cross-over study; AUC(0-t); Cmax; tmax; QTcF Interval
The Link Between Diets and Health Indicators
Condition: Healthy Diet; Microbiota
Study type: Observational [Patient Registry]

Summary: 
      The cohort study investigates the effect of different dietary intake among omnivorous, vegan,
      vegetarian and low-carb diets on health parameters and on long-term overall health. The
      participants blood parameters, dietary intake, gut microbiota composition, body mass and
      composition, resting energy expenditure, lifestyle factors and psychological factors will be
      determined and measured.
    

Detailed description: 
      Vegetarian and vegan diets have been shown to have health benefits on preventing
      cardiovascular diseases, type 2 diabetes and cancer. They are both gaining popularity in
      public. Ketogenic diet has also been very popular, especially due to its effect on weight
      loss and blood glucose parameters. To our knowledge there, are no studies that compare
      long-term effects of all three diets and omnivorous diets with regards to health parameters
      and gut microbiota composition.

      The aim of the proposed study is to investigate the link between different diets and health
      parameters, such as parameters related to longevity, inflammation, stress and gut microbiota
      composition. The study is designed to compare different diets and their relationship with the
      body as a whole.
    

Intervention name(s): Regular lifestyle in different circumstances
Intervention type(s): Behavioral
Intervention description(s): Participants' lifestyle will be followed over the years.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy individuals with stable body mass with specific eating patterns: omnivores,
        vegetarians, vegan, low carb high fat.
      
Biospecimen description: 
      Whole blood and stool samples
    
Keywords: diet; gut microbiota; longevity; inflammation; health
Tolerability of Grazax-R in Children
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is performed to assess whether the Grazax-R treatment is safe to use in children
      aged 5-12 years.
    


Intervention name(s): ALK Grass tablet
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: Allergy
To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection
Condition: Influenza Virus Infection
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the antiviral effect of TG-1000 compared with placebo in adult patients with
      acute uncomplicated influenza virus infection.
    

Detailed description: 
      This study is a multicenter, randomized, double-blind, dose-ranging study to evaluate the
      efficacy and safety of different doses of TG-1000 compared with placebo in adult patients
      with acute uncomplicated influenza virus infection.

      Approximately 200 patients will be randomly assigned to 1 of 4 treatments groups in a ratio
      of 1:1:1:1 to receive study treatment orally: "40 mg TG-1000", "80 mg TG-1000", "40mg+40mg
      TG-1000" or "placebo".
    

Intervention name(s): TG-1000
Intervention type(s): Drug
Intervention description(s): Capsules taken orally
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prophylactic Norepinephrine Infusion Combined With Colloid Coloading for Postspinal Anesthesia Hypotension
Condition: Adverse Event
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the suitable infusion dose of prophylactic
      norepinephrine infusion combined with 6% Hydroxyethyl starch (130/0.4) coload for post-spinal
      anesthesia hypotension in patients undergoing cesarean section.
    

Detailed description: 
      Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for
      cesarean section. The incidence of post-spinal anesthesia hypotension is as high as
      62.1-89.7% if prophylactic measures are not taken. Vasopressor has been highly recommended
      for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential
      substitute drug for phenylephrine, norepinephrine has gradually been used in parturients
      undergoing cesarean section. There's some evidence that prophylactic infusion of
      norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension
      in parturients undergoing cesarean section. But the ideal infusion dose of norepinephrine
      with colloid coload is still unknown. The purpose of this study is to investigate the
      suitable infusion dose of prophylactic norepinephrine infusion combined with 6% Hydroxyethyl
      starch (130/0.4) coload for post-spinal anesthesia hypotension in patients undergoing
      cesarean section.
    

Intervention name(s): Normal saline; Norepinephrine (0.025 μg/kg/min); Norepinephrine (0.05 μg/kg/min); Norepinephrine (0.075 μg/kg/min); Norepinephrine (0.1 μg/kg/min)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a maintenance dose of normal saline by IV infusion.; Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.; Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.; Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.; Simultaneous with spinal anesthesia, 500 mL 6% Hydroxyethyl starch (130/0.4) coload was given and a different maintenance dose of norepinephrine by IV infusion.
Other intervention name(s): NS; Vasopressor; Vasopressor; Vasopressor; Vasopressor
Intervention MeSH terms: Norepinephrine; Vasoconstrictor Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Norepinephrine; Hydroxyethyl starch; Postspinal anesthesia hypotension; Coload; Cesarean section