bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia
Condition: Hypercholesteremia; Endothelial Dysfunction
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      There is an on-going discussion weather remote ischemic conditioning (RIC) is effective in
      limiting the damage of reperfusion injury in STEMI patients. The results from recent RCTs
      have been variable and most have not shown convincing positive results when analyzing hard
      endpoints. Hence, there is a great need to evaluate the impact of comorbidities on the
      effectiveness of RIC. Therefore, we have designed a study to evaluate the impact of
      hypercholesterolemia on the RIC response by evaluating ischemia-induced endothelial
      dysfunction.

      Aim: To investigate the impact of hypercholesterolemia on the RIC response in counteracting
      ischemia-induced endothelial dysfunction.
    

Detailed description: 
      Study population:

      We plan to include 12 poorly controlled/newly diagnosed subjects with familiar
      hypercholesterolemia (FH) and 12 age-matched control subjects.

      Inclusion criteria (FH subjects)

        -  Poorly treated FH, defined as LDL-C >5.5 mmol/L.

        -  Age, >18 and <65 years of age.

      Exclusion criteria

        -  Additional cardiovascular comorbidities such as diabetes mellitus, coronary artery
           disease, or kidney failure.

        -  Unwillingness to participate.

        -  Concurrently participating in another interventional trial.

      Main exposure:

      Remote ischemic conditioning, i.e. 4 cycles of 5 minutes of ischemia to the lower limb.

      Comparision group:

      Cross over design, patients preform the protocol twice, once with sham and once with RIC.
      Also a group of healthy matched controls will be recruited.

      Outcome:

      Change in FMD after 20 minutes of ischemia and 20 minutes of reperfusion with the exposure of
      either sham or RIC.

      Design:

      Randomized interventional cross-over.
    

Intervention name(s): Remote ischemic conditioning
Intervention type(s): Procedure
Intervention description(s): Brief cycles of ischemia to a limb. A blood pressure cuff was placed around the right thigh and inflated to 200 mmHg for 4 cycles of 5 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Bipolar II Depression: Lithium, SSRI, or the Combination
Condition: Bipolar Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the safety and effectiveness of a mood stabilizing medication, an
      antidepressant medication, and a combination of both medications to treat symptoms of bipolar
      type II depression.
    

Detailed description: 
      Bipolar type II depression (BD II) is a less severe type of bipolar disorder. BD II is
      characterized by one or more depressive episodes and at least one hypomanic episode. During
      hypomanic episodes, people experience especially energetic or anxious moods, and their
      thoughts are more sporadic than usual, but they do not experience the severity of mania.
      Symptoms of BD II are known to impair daily functioning as well as cause distress and even
      suicide. Antidepressant medication alone is not recommended for people with bipolar disorder
      because manic symptoms usually worsen. It is unknown whether the same recommendation should
      apply to people with BD II. Sertraline is a selective serotonin reuptake inhibitor (SSRI)
      antidepressant that increases levels of serotonin, helping the brain to maintain mental
      stability. It is often used to treat depression, panic attacks, and other disorders. Lithium
      is a mood stabilizing medication that decreases abnormal brain activity and is used to treat
      and prevent recurring episodes of mania in people with bipolar disorders. This study will
      evaluate the effectiveness of lithium alone, sertraline alone, and lithium with sertraline to
      treat symptoms of BD II.

      Participation in this double-blind study will last up to 18 weeks. Participants will be
      randomly assigned to receive either lithium, sertraline, or lithium and sertraline. Both
      medications will initially be given at a low dose and then gradually increased over 2 weeks.
      For the remainder of the study, dosages will be adjusted as necessary. Study visits will
      occur every week for the first 6 weeks and then every other week for the remaining 10 weeks.
      During all study visits, participants will complete a psychiatric assessment and
      questionnaires about their current mood and any treatment side effects. Urine and blood
      collection may occur at selected times during the study.
    

Intervention name(s): Sertraline; Lithium carbonate
Intervention type(s): Drug; Drug
Intervention description(s): Sertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day; Lithium or placebo for lithium starting at 150 mg per day; target dose of 900mg per day. Maximum dose based on clinical response and serum levels (maximum serum level of 1.2 mEq/L).
Other intervention name(s): Zoloft; Eskalith, Lithobid
Intervention MeSH terms: Lithium Carbonate; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Bipolar II Depression
Effects of Physiotherapy in Individuals With Persistent Symptoms Following Concussion
Condition: Sport-related Concussion
MeSH terms: Dizziness
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of a combined physiotherapy treatment
      (including vestibular rehabilitation and treatment for the cervical spine) in youth and young
      adults with ongoing symptoms of dizziness, neck pain and headaches following a sport-related
      concussion.
    


Intervention name(s): Control postural education, general range of motion and strengthening in addition to the standard of care; Physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Control: postural education, general range of motion and strengthening in addition to the standard of care rest followed by graded exertion. Individuals were seen once weekly for eight weeks or until time of medical clearance to return to sport.; Physiotherapy: including vestibular rehabilitation and multimodal treatment for the cervical spine, once weekly with the study physiotherapist for 8 weeks or until time of medical clearance to return to sport.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sport-related concussion; Dizziness; Neck pain; Headaches; Physiotherapy; Treatment
Phase 2 Study of TAK-850 in Comparison With Influenza Hemagglutinin (HA) Vaccine in Healthy Adult Participants
Condition: Influenza Infection
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of TAK-850
      administered subcutaneously as a single dose versus influenza HA vaccination in an
      exploratory manner.
    

Detailed description: 
      This study is a phase 2, single dose study of TAK-850 (cell-culture derived TIV) administered
      subcutaneously in healthy Japanese adults, designed as a randomized, double-blind,
      parallel-group, comparative study to evaluate the immunogenicity and safety compared to an
      egg-derived TIV.

      The drug being tested in this study is called TAK-850. TAK-850 was tested in healthy
      volunteers. This study looked at immunogenicity and safety of TAK-850 (cell-derived) compared
      to an egg-derived influenza vaccine.

      The study enrolled 400 patients. Participants were randomly assigned (by chance, like
      flipping a coin) to one of the two groups-which will remain undisclosed to the patient and
      study doctor during the study (unless there is an urgent medical need):

        -  TAK-850

        -  Influenza HA vaccine All participants received one injection. This single center trial
           was conducted in Japan. The overall time to participate in this study was 22 days.
           Participants made multiple visits to the clinic, including a final visit 21 days after
           the vaccination for a follow-up assessment.
    

Intervention name(s): TAK-850; Influenza HA vaccine
Intervention type(s): Biological; Biological
Intervention description(s): TAK-850 subcutaneous injection; Influenza HA vaccine subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine
Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines
Condition: Hepatitis B; Hepatitis; Hepatitis, Viral, Human; Hepatitis B Immunization
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis, Viral, Human; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Health workers with biological risk in their tasks, who have been vaccinated as
      non-responders to conventional vaccination against Hepatitis B. To provide Health
      workers-staff with an additional protection tool against hepatitis B infection. To evaluate
      the efficacy of the adjuvanted vaccine in healthy nonresponders to conventional hepatitis B
      vaccine.
    

Detailed description: 
      An interventional, phase 4, single group assignment, without masking (open label), preventive
      clinical trial was carried out in health workers with biological risk in their tasks, who
      have been filed as non-responders to conventional vaccination against Hepatitis B.

      Methods: 67 health workers with biological risk in their tasks, who have been filed as
      non-responders to conventional vaccination against Hepatitis B, were enrolled in the Clinical
      Trial. All participants were from 18 years up to 64 years old. The criteria defining them as
      non-responders to the conventional hepatitis B vaccine is anti HBsAb titers < 10 mUI/ml
      following the application of six doses of conventional vaccine at 20 lg doses (two complete
      guidelines). The objective of this study was to provide Health workersstaff with an
      additional protection tool against hepatitis B infection, and to evaluate the efficacy of the
      adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine.
    

Intervention name(s): Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Intervention type(s): Biological
Intervention description(s): The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule:
1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine
Intervention model: Single Group Assignment
Intervention model description: non-responders to conventional treatment of hepatitis B vaccination and consent to participate
Masking: None (Open Label)
Primary purpose: Prevention
Intense Education of Periodontal Health Maintenance
Condition: Chronical Periodontitis, Ratio of P. Gingivalis and S. Cristatus
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      Investigators hypothesize that good oral hygiene may inhibit P. gingivalis, a keystone
      periodontal pathogen, entering mature dental plaque, which leads to a higher ratio of S.
      cristatus and P. gingivalis. Investigators will educate and train periodontitis patients
      following periodontal therapy to maintain periodontal health. Initial and intense education
      of periodontal health maintenance will be provided and the ratio of S. cristatus and P.
      gingivalis in dental plaques will be compared and analyzed for correlation between patient's
      execution of periodontal health maintenance and education tools or the ratio of S. cristatus
      and P. gingivalis.
    

Detailed description: 
      The periodontal health maintenance will be evaluated by plaque index, periodontal pocket, and
      gingival inflammation status. Participants will be assigned into two groups after the second
      dentist visit based on their execution of periodontal health maintenance. Participants whose
      number of P. gingivalis is unchanged or higher compared to that found at baseline will be
      considered poor maintenance. Those not having maintained a good dental hygiene will further
      be randomly assigned to two groups. One group will be given more intense oral health
      education, while the other one will receive the same education as post therapy. The result of
      intensive education and a shift in ratio of S. cristatus and P. gingivalis will then be
      measured for both groups at the third dentist visit (9 months after initial periodontal
      treatment) and the effectiveness of the intervention will be tested at this stage.
    

Intervention name(s): Intense education
Intervention type(s): Behavioral
Intervention description(s): we will inform patients with their own data including the number of P. gingivalis and ratio of S. cristatus and P. gingivalis detected immediately after periodontal treatment and 3 month after the treatment. Explaining these data in detail, in terms that the patient can understand, are equally as important as teaching the plaque control techniques.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      Assess tolerability of different dosing formulations (adult versus pediatric).
    


Intervention name(s): Zmax
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Smoking Cessation for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: ADHD; Smoking
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate whether Osmotic-Release Methylphenidate (OROS
      MPH), relative to placebo, increases the effectiveness of standard smoking treatment (i.e.,
      nicotine patch and individual smoking cessation counseling) in obtaining prolonged abstinence
      for smokers with Attention Deficit Hyperactivity Disorder (ADHD).
    

Detailed description: 
      The primary objective of this study is to evaluate whether OROS MPH (Concerta), relative to
      placebo, increases the effectiveness of standard smoking treatment (i.e., nicotine patch and
      individual smoking cessation counseling) in obtaining prolonged abstinence for smokers with
      ADHD. The study will involve an estimated 252 participants, recruited from approximately 6
      sites.
    

Intervention name(s): Osmotic-Release Methylphenidate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): OROS-MPH dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.; OROS-MPH (placebo) dosing strategy will start with 18 mg/day for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). And, nicotine patch dosing schedule will be 21 mg/day during weeks 4-11; 14 mg/day during weeks 12-13; and 7 mg/day in week 14.
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Levodopa Concentration Profile With Stalevo 75/125 mg
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to confirm that the dose levels and dosing frequency utilising
      the new Stalevo strengths would result into more stable levodopa plasma levels. Therefore, it
      is anticipated that when lower dose of Stalevo is administered after the first higher dose of
      Stalevo, this would result in equally high levodopa maximum concentration values (Cmax) after
      each dose throughout the day compared to Cmax after the first dose.
    


Intervention name(s): Stalevo (levodopa/ carbidopa/ entacapone); Sinemet (levodopa/carbidopa)
Intervention type(s): Drug; Drug
Intervention description(s): 150mg, 125 mg, 100mg, 75mg of levodopa q.i.d. in 3.5 h interval; 150 or 100 mg levodopa q.i.d. in 3.5 hr interval
Other intervention name(s): Stalevo; Sinemet
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination; Entacapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic
Comparison Between Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System and the FreeStyle Libre Flash Glucose Monitoring System
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      1. The accuracy of the sensors (Dexcom G5 vs FreeStyle Libre Flash glucose monitoring) will
           be evaluated by simultaneous wearing of the 2 sensors during 2 weeks. During these 2
           weeks the patients will do at least four capillary blood glucose measurements to compare
           with the sensor results.

        2. Patient satisfaction will be evaluated using a questionnaire that will be completed
           after the Dexcom G5 sensor has been worn for 1 month.

        3. The data recorded by the FreeStyle Libre Flash glucose monitoring system (average
           glucose,% above target, % within target, % under target, amount of hypoglycemia) in the
           month prior to the 2 weeks of double sensor wear will be compared to the same data
           recorded by the Dexcom G5 mobile CGM system during the first month of use.
    


Intervention name(s): Dexcom G5 Mobile CGM system
Intervention type(s): Device
Intervention description(s): The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with type 1 diabetes mellitus treated with insulin injections
      
Keywords: Diabetes Mellitus; Child; Glucose sensor; Accuracy; Usability
Study to Evaluate and Compare the Bioequivalence of Two Abaloparatide-sMTS Treatments in Healthy Women.
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the bioequivalence of abaloparatide between 2 abaloparatide-sMTS
      treatments 300 μg treatments applied to the thigh for 5 minutes.
    

Detailed description: 
      This is a single site, open-label, randomized, 4-period crossover study to evaluate the
      bioequivalence of 2 abaloparatide-sMTS 300 μg treatments (Patheon sterile abaloparatide-sMTS
      and Kindeva ultra-low bioburden abaloparatide-sMTS) applied to the thigh for 5 minutes. The
      study will also evaluate the effect of small deviations in the wear-time of the Patheon
      abaloparatide-sMTS worn for 4 minutes or 7 minutes compared to the Patheon abaloparatide-sMTS
      worn for the prescribed 5 minutes.
    

Intervention name(s): abaloparatide-sMTS (Patheon); abaloparatide-sMTS (Kindeva); abaloparatide-sMTS (Patheon); abaloparatide-sMTS (Patheon)
Intervention type(s): Combination Product; Combination Product; Combination Product; Combination Product
Intervention description(s): single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes; single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes; single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes; single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes
Other intervention name(s): abaloparatide-sMTS; abaloparatide-sMTS; abaloparatide-sMTS; abaloparatide-sMTS
Intervention MeSH terms: Abaloparatide; Parathyroid Hormone-Related Protein
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: All subjects were to receive a transdermal patch containing 300 μg abaloparatide for 4,5 and 7 minutes in 4 separate periods.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: osteoporosis; transdermal delivery; microneedle patch; solid microstructured transdermal system; abaloparatide TYMLOS®; abaloparatide-SC; PK