bioihbjkbjnl/mcl2 huggingface dataset:
PTX-COVID19-B, an mRNA Humoral Vaccine, is Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Evaluate Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64
Condition: Covid19 Vaccine
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      The Vaccine Product, PTX-COVID19-B mRNA Humoral Vaccine, is intended for prevention of
      COVID-19 in a general population. This study is designed to evaluate the safety,
      tolerability, and immunogenicity of PTX-COVID19-B vaccine in healthy seronegative adults aged
      18 to 64.
    


Intervention name(s): PTX-COVID19-B; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Sterile solution for injection; 0.9% sodium chloride (normal saline) injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in human study of ETD001 a new drug being developed for the treatment of
      cystic fibrosis. The study is a randomised, placebo-controlled, double-blind interventional
      study to assess the safety, tolerability and pharmacokinetics of single and multiple
      ascending doses of inhaled ETD001in healthy male and female subjects.
    


Intervention name(s): ETD001 single dose; Placebo single dose; ETD001 multiple twice daily doses; Placebo multiple twice daily doses; ETD001 multiple once daily doses; Placebo multiple once daily doses
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single ascending doses of inhaled ETD001; Single doses of inhaled placebo; Ascending doses of inhaled ETD001 administered twice daily; Doses of inhaled placebo administered twice daily; Doses of inhaled ETD001 administered once daily; Doses of inhaled placebo administered once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Multiple Ascending Dose Study of ETC-1002 in Healthy Subjects
Condition: Safety Evaluation of Escalating Doses
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety,
      tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy
      subjects.
    


Intervention name(s): ETC-1002
Intervention type(s): Drug
Intervention description(s): escalating doses
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sunrise® a New Medical Device to Diagnose Sleep Apnea Syndrome
Condition: Sleep Apnea Syndrome, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

Summary: 
      Sleep Apnea Syndrome (SAS) is a serious health issue that should be managed in order to limit
      its adverse health consequences. SAS is known to induce cardiovascular diseases, diabetes and
      depression. The prevalence of SAS is still growing with social and economic repercussion.
      Today, polysomnography (PSG) is the gold standard reference method for SAS diagnosis.
      However, it is a constraining and expensive technology. In order to improve patients' life
      quality, many new technologies have been developed for the SAS diagnosis.

      The aim of this study is to evaluate the Sunrise®, a new medical integrated solution for SAS
      diagnosis, in comparison with PSG. This solution consists in a chin sensor recording
      mandibular movements and measuring the respiratory event index (ERI) through an artificial
      intelligence algorithm analysis.
    

Detailed description: 
      Sunrise® is a type IIa medical device with the CE label. It is a new home sleep technology,
      non-invasive, reliable and affordable by the patient.

      The objective of this study is to evaluate the efficiency of the device in comparison with
      PSG for sleep apnea diagnosis.

      40 subjects, suspected to be apneic, will be equipped at home by the chin sensor, the
      Sunrise® device, recording their mandibular movements while sleeping. The Sunrise® solution
      will provide the respiratory event index (REI) as well as the respiratory micro-arousals.

      Inclusion visit will be executed at the University Hospital Grenoble Alpes. However, PSG and
      Sunrise® will be set at the patient's home by IC@dom. The first night, the patient will be
      equipped by both PSG and Sunrise® and only by the Sunrise® for the two following nights.
    

Intervention name(s): Sunrise® solution; Polysomnography
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Type II medical device with the CE label. It is a chin sensor associated to an integrated and connected platform.; Gold standard method to diagnose SAS used as comparator
Other intervention name(s): PSG
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: New medical device; Mandibular movement; Respiratory event index; Polysomnography
Effects of Fructose and Exercise on Hepatic Lipid Metabolism
Condition: Metabolism
Study type: Interventional

Summary: 
      8 healthy male volunteers will be studied each on 3 occasions, ie

        -  after 4 days on a weight maintenance diet containing 5% simple sugars + low physical
           activity

        -  after 4 days on a weight maintenance diet containing 30% fructose + low physical
           activity

        -  after 4 days on a weight maintenance diet containing 30% fructose + high physical
           activity At the end of each of these 3 periods, fructose induced hepatic de novo
           lipogenesis (13C palmitate synthesis in response to ingestion of a 13C fructose load)
           and plasma VLDL-triglyceride kinetics (measured with a bolus of 2H-labeled glycerol)
           will be measured
    


Intervention name(s): weight maintenance, low sugar diet; weight maintenance, high fructose diet; weight maintenance, high fructose diet+ exercise
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fructose; VLDL-triglycerides; de novo lipogenesis; Human metabolism
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg
      twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.

      Secondary objective: To assess the safety and tolerability of ciclesonide.
    


Intervention name(s): Ciclesonide; Ciclesonide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ciclesonide MDI 40 µg BID over twelve weeks; Ciclesonide MDI 80 µg BID over twelve weeks; Placebo MDI over twelve weeks
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bronchial Asthma
A Trial Investigating the Relationship Between Pharmacodynamic and Interstitial Concentration for Insulin Detemir and Human Insulin
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is conducted in Europe. The aim of this study is to estimate the relationship
      between pharmacodynamic and interstitial pharmacokinetic steady state following intravenous
      (i.v.) administration of insulin detemir and human soluble insulin.
    


Intervention name(s): insulin detemir; human soluble insulin
Intervention type(s): Drug; Drug
Intervention description(s): Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp; Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hepatic Impairment Study
Condition: Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to find out how the subject's body processes and reacts to the study drug, and
      to find out how long it remains in the subjects system after one dose. Subjects with varying
      degrees of liver function are being asked to participate in this study. Study results from
      subjects with normal liver function will be compared with study results from subjects with
      impaired liver function.
    


Intervention name(s): Sorafenib (Nexavar, BAY43-9006); Sorafenib (Nexavar, BAY43-9006); Sorafenib (Nexavar, BAY43-9006)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Mildly Hepatic Impaired Subjects; Moderately Hepatic Impaired Subjects; Healthy Subjects
Intervention MeSH terms: Sorafenib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver disease
Impact of Acute Exercise Intensity and Pattern on Cytokine Function
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The immune system helps prevent illness, fights off infections, and repairs damaged tissues
      following an injury. However, when immune cells remain active for prolonged periods of time -
      a state known as "chronic inflammation" - they can contribute to the development and
      progression of chronic diseases like heart disease and diabetes. Exercise can reduce the risk
      of developing many of these diseases and at least part of the health benefits of exercise are
      due to the ability of exercise to reduce "chronic inflammation". The inflammation-lowering
      effects of exercise are typically captured by measuring hormone-like molecules released from
      immune cells called "cytokines" in the blood. In addition to changes in circulating cytokine
      levels, exercise may also alter how immune cells respond to these cytokines. How exercise
      intensity (i.e., how hard you are working during exercise) and pattern (i.e., exercising as a
      long continuous bout or in short intervals) impact the ability of immune cells to respond to
      cytokines is not well understood. A better understanding of how exercise intensity and
      pattern of exercise for reducing chronic inflammation may help determine the best types of
      exercises for improving health and preventing chronic diseases.
    


Intervention name(s): Moderate intensity continuous exercise; High intensity continuous exercise; High intensity interval exercise; Resting (no exercise) control
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants will perform an acute bout of continuous cycling at 70% of the power output at lactate threshold until an energy expenditure of 350 kcal is achieved. Blood samples will be obtained immediately before and immediately, 30, and 90 minutes after exercise.; Participants will perform an acute bout of continuous cycling at 10% of the difference between lactate threshold and VO2peak until an energy expenditure of 350 kcal is achieved. Blood samples will be obtained immediately before and immediately, 30, and 90 minutes after exercise.; Participants will perform an acute bout of interval cycling at at 10% of the difference between lactate threshold and VO2peak until an energy expenditure of 350 kcal is achieved. Blood samples will be obtained immediately before and immediately, 30, and 90 minutes after exercise.; Participants will remain in a rested state (i.e., no exercise) for the entire session. Blood samples will be obtained at the same time-points as the exercise sessions.
Other intervention name(s): MICE; HICE; HIIE; CTL
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Repeated measures randomized counterbalanced crossover design
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Exercise; Cytokines; Leukocytes; Interleukin-10; Interleukin-6
Multiple Dose Safety Study of NPT088 in Patients With Mild to Moderate Probable Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of multiple doses of
      NPT088 in patients with mild to moderate probable Alzheimer's Disease. The study will also
      evaluate the pharmacokinetics, immunogenicity and exploratory pharmacodynamic characteristics
      of multiple doses of NPT088.
    

Detailed description: 
      This study is a multicenter Phase 1, randomized, double-blind, placebo-controlled,
      multiple-dose, dose-escalation safety and tolerability study of NPT088 or placebo in patients
      with Probable AD with a MMSE score of 16-27. Enrolled patients will receive an intravenous
      infusion of NPT088 or placebo once a month for six months during this study. Four dose
      cohorts are planned with the first two cohorts enrolling 9 patients each (6 NPT088: 3
      placebo) and the final two cohorts enrolling 24 patients each (16 NPT088: 8 placebo) for a
      total of 66 patients (44 NPT088: 22 placebo).
    

Intervention name(s): NPT088; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IgG1 Fc-GAIM fusion protein, a recombinant fusion protein; Placebo
Other intervention name(s): IgG1; fusion protein; GAIM; anti-Abeta; anti-Tau
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: GAIM; amyloid; anti-aBeta; anti-tau
Study of Efficacy of Lamotrigine in Therapy of Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether antiepileptic drug lamotrigine is effective
      in the treatment of chronic asthma.
    

Detailed description: 
      Effective therapy of asthma still remains quite serious problem. According GINA definition,
      asthma is an inflammatory disorder. Consequently, modern pharmacotherapy of asthma provides
      wide use of anti-inflammatory drugs. But asthma also is a paroxysmal disorder: many
      specialists and even some guidelines underline paroxysmal clinical picture of asthma. Besides
      this, according to some authors, neurogenic inflammation may play important role in asthma
      mechanism. But some other neurogenic inflammatory paroxysmal disorders exist, and they are
      migraine and trigeminal neuralgia. Some antiepileptic drugs, like carbamazepine and
      valproate, are very effective in therapy of migraine and trigeminal neuralgia - more than in
      80% of cases. If bronchial asthma also is paroxysmal inflammatory disease, like migraine and
      trigeminal neuralgia, it is possible that some antiepileptic drugs also are very effective in
      asthma therapy.

      We performed double-blind placebo-controlled 3-month trial for evaluation of lamotrigine
      efficacy in therapy of poorly controlled bronchial asthma. Lamotrigine is antiepileptic drug
      of new generation, produced by Glaxo SmithCline.

      Comparison: Patients received investigational drug in addition to their usual routine
      antiasthmatic treatment, compared to patients received placebo in addition to their usual
      routine antiasthmatic treatment.
    

Intervention name(s): Lamotrigine
Intervention type(s): Drug
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bronchial asthma; Lamotrigine; Antiepileptic drug; Efficacy
Factors Associated With Chronic Respiratory Failure in Obesity
Condition: Obesity; Obesity Hypoventilation Syndrome
MeSH terms: Respiratory Insufficiency; Hypoventilation; Obesity Hypoventilation Syndrome; Obesity
Study type: Observational

Summary: 
      Some overweight individuals develop problems with their breathing such that they gradually
      breathe less and less. This leads to a lack of oxygen and a buildup of carbon dioxide in the
      blood, called ventilatory failure. As a consequence, if such a person develops a chest
      infection, they are more likely to become seriously ill and need intensive care. In addition
      they are much more likely to develop severe complications during and following operations.
      This problem can be treated with a machine at home used overnight to help breathing. It is
      interesting that ventilatory failure only happens in some overweight individuals, and the
      investigators do not understand what factors make this complication develop. There are a
      number of theories: for example the distribution of the fat, additional lung disease (such as
      asthma), the addition of obstructive sleep apnoea, a condition when there are periods of
      cessation of breathing overnight (which is more common in obese individuals), weak muscles of
      breathing (perhaps due to fatty infiltration of muscles or vitamin D deficiency), and other
      hormonal changes.

      The investigators intend to measure many potential factors in a range of overweight
      individuals, some who have ventilatory failure, and some who do not, to try and work out
      which are the important factors that cause this problem. If the investigators can identify
      such factors, then this will help predict in advance who is at risk from chest infections and
      during operations; thus allowing for earlier provision of an overnight breathing machine.
      This should reduce complications and potentially deaths in such individuals.
    

Detailed description: 
      To test the hypothesis that in obese patients with obesity-hypoventilation (OHS) there are
      specific factors related to the development of ventilatory failure, compared to obese
      subjects not in ventilatory failure
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Obese (BMI > 30kg/m2) with or without OHS (18-85yrs)

          1. Admitted for management of OHS

          2. Attending the sleep and ventilation clinic

          3. Being assessed for bariatric surgery
      
Biospecimen description: 
      Blood, fat, muscle
    
Keywords: Obesity
Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting
Condition: Hip Fractures
MeSH terms: Hip Fractures
Study type: Interventional

Summary: 
      The authors hypothesize that a pelvic kinematic disorder, demonstrated by a significant
      decrease in sacral slope, is associated with the risk of instability of total hip prosthesis,
      the sacral slope being measured by an EOS imaging system during the transition to sitting in
      unstable patients versus patients with no history of instability.
    


Intervention name(s): EOS imagery
Intervention type(s): Other
Intervention description(s): Whole body EOS imaging in seated and standing position
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Thoracic Paravertebral Blockade in Video Assisted Thoracoscopic Surgery (VATS)
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Video-assisted thoracoscopic surgeries (VATS) include severe postoperative acute pain which
      is also a predictor of chronic pain. In this study, the investigators aim to compare the
      postoperative effects of thoracic paravertebral block (TPVB) and intravenous patient
      controlled analgesia (PCA) on the prevention of chronic pain of patients undergoing VATS.
    

Detailed description: 
      Video-assisted thoracoscopic surgeries (VATS) include significant postoperative acute and
      chronic pain because of trocar site tissue damages, intercostal nerve injuries and related
      inflammatory responses. Poorly controlled pain in the early postoperative period usually
      causes chronic pain, and also affects patients' physiotherapy, mobilization and daily
      function.

      Our hypothesis in this study is 'thoracic paravertebral block (TPVB) is associated with an
      improvement in control of acute and chronic pain after VATS compared to systemic analgesia.
    

Intervention name(s): Thoracic paravertebral block (TPVB); Patient Controlled Analgesia (IV PCA)
Intervention type(s): Drug; Drug
Intervention description(s): Thoracic paravertebral block (TPVB) is being performed by injecting 5 mL of Bupivacaine 0.5% to 4 consecutive level of paravertebral spaces between T4 and T8 by using landmark technique; IV morphine patient controlled analgesia (PCA) is being used in the postoperative period for 48 hours. Basal infusion: 0.3 mg/kg/h, Bolus: 1 mg, Lock-out time: 20 min, 4-h limit: 10-12,5 mg
Other intervention name(s): Bupivacaine; Morphine
Intervention MeSH terms: Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thoracic paravertebral block; Patient controlled analgesia; Video Assisted Thoracoscopic Surgery; Postoperative acute pain; Chronic pain
ABX464 First in Man Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open label, parallel group, single ascending dose, exploratory study
      performed in a single site (Centre Cap, Montpellier, France).
    

Detailed description: 
      This study is an open label, parallel group, single ascending dose, exploratory study
      performed in a single site (Centre Cap, Montpellier, France). Six subjects per dose group
      were enrolled into 1 of 4 groups with escalating doses of ABX464 (50, 100, 150 and 200 mg).
      For each dose group, a first subject was treated, if no adverse event (AE) occurred, a second
      subject was dosed one hour later. The four last subjects were dosed the day after if no
      clinically significant AE occurred. Escalation to the following dose level was decided after
      review of PK and safety data (laboratory results, ECG, vital signs and AEs)
    

Intervention name(s): ABX464
Intervention type(s): Drug
Intervention description(s): Single Administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers