bioihbjkbjnl/mcl2 huggingface dataset:
Blood Glucose Variability and Insulin Action During Menstrual Cycle in Females With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This research study is designed to look at differences in responsiveness to the subcutaneous
      injection of a standardized dose of rapid-acting insulin analog and blood glucose variability
      during different phases of the menstrual cycle in females with type 1 diabetes (T1D).
    

Detailed description: 
      Type 1 Diabetes (T1D) is a chronic disease that leads to disability and premature death if
      not well treated. While females and males are equally affected by T1D, diabetes places
      additional burdens of care on females. Characteristically, females with T1D have worse
      glycemic control, a higher incidence of diabetic ketoacidosis, and a greater risk of
      cardiovascular complications as compared to their male peers. It has been hypothesized that
      variations in responsiveness to pre-meal bolus doses of insulin during menstrual cycling is
      an important underlying cause for increased management problems in females with T1D, but the
      hypothesis has not been adequately tested. Consequently, insulin treatment of females during
      the different cycles of menstruation remains a guessing game that often results in major
      swings in blood glucose from high to low levels. The unfavorable impact of this gap in
      knowledge extends to the efficiency and accuracy of artificial pancreas closed-loop (CL)
      system insulin delivery algorithms designed based on insulin action parameters. The proposed
      study addresses this unmet need in diabetes management for females both in open-loop (OL) and
      CL therapies.
    

Intervention name(s): Follicular Euglycemic clamp; Luteal Euglycemic clamp
Intervention type(s): Device; Device
Intervention description(s): Follicular Euglycemic clamp during follicular phase; Luteal Euglycemic clamp during luteal phase
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: diabetes; menstrual cycle; insulin
Clonidine-Remifentanil. Effect of the Combination on Acute Pain and Respiration in Healthy Volunteers
Condition: Acute Pain; Respiration; Sedation
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The hypothesis is that systemic remifentanil and Clonidine act in a synergistic manner to
      relief acute main in an experimental human pain model. Of interest is also the effect of the
      combination on respiration, sedation and cognitive behavior.
    

Detailed description: 
      To examine the possible synergistic effects og systemic remifentanil and clonidine. Its
      effects on respiration, cognitive function and sedation.
    

Intervention name(s): Remifentanil+clonidine
Intervention type(s): Drug
Intervention description(s): iv Remifentanil+ iv clonidine
Other intervention name(s): Ultiva, Catapressan
Intervention MeSH terms: Clonidine; Remifentanil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Remifentanil; clonidine; acute pain; respiration; sedation; cognitive function
Safety and Efficacy of Merlin (Ethanol and Glycolic Acid Mixture) for the Treatment of Cold Sores
Condition: Recurrent Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if Merlin, a mixture of ethanol and glycolic acid,
      is safe and effective in the treatment of cold sores.

      Subjects who meet the requirements to participate in the study will be put randomly, and
      equally, into one of two groups: 1) a group receiving Merlin to treat their cold sore; or 2)a
      group receiving a placebo of just ethanol to treat their cold sore. Neither the subject nor
      the site will know which treatment they will be getting. Once the subject has been assigned
      to a treatment group, they will be given a kit containing a bottle of the treatment and
      special swabs to apply the liquid. The subject will be told to take the kit home and wait
      until they think they are starting to get a cold sore.

      Once a subject begins to feel something or see something that they think is the start of a
      cold sore, they are to immediately call the clinic. Once the clinic confirms that the subject
      is in fact starting to get a cold sore, the subject will be told to open the kit and begin
      treatment. From the start of treatment, there will be twelve (12) treatments, with either
      Merlin or placebo, applied six (6) hours apart, up to 3 per day, over the next 96 hours (4
      days). Each treatment of Merlin or placebo is made up of three (3) applications given twenty
      (20) minutes apart, for a total of thirty-six (36) applications. FOr each application, the
      subject will use the special swab to put the Merlin or placebo solution on their cold sore.

      Subjects will need to report daily to the clinic for a minimum of 3 consecutive days, until
      either the cold sore is completely healed or 14 days from the start of treatment, whichever
      comes first. At each clinic visit the cold sore will be observed to determine at what stage
      it is at or if it has healed. The subject will also be asked how they are feeling.

      Subjects will also be told to record in a diary the time of each application of Merlin or
      placebo. They will also be asked to record how much pain, if any, related to the cold sore,
      that they are feeling.
    


Intervention name(s): ethanol/glycolic acid solution; Placebo/Ethanol
Intervention type(s): Drug; Drug
Intervention description(s): ethanol/glycolic acid solution; ethanol solution
Other intervention name(s): Merlin; Placebo
Intervention MeSH terms: Ethanol; Glycolic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: herpes labialis; cold sore
Platelet Leukocyte Aggregates in Acute Cardiac Syndrome vs Healthy Volunteers
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      This project aims to refine previous studies including the investigators work recently
      published in August 2012 Journal Thrombosis and Thrombolysis. That study showed a
      relationship between the level of platelet leukocyte aggregates in patients with acute
      coronary syndrome. The investigators intend to compare the characteristics of platelets,
      monocytes and neutrophil data of volume, scatter and conductivity obtained from routine blood
      count level with flow cytometry results defining platelet leukocyte aggregates. The
      investigators hypothesize that there will be a direct correlation between elevated
      platelet-leukocyte aggregates and biophysical data from the blood count.
    

Detailed description: 
      The goal is to investigate whether there is a simple and inexpensive method to test the level
      of platelet leukocyte aggregates through the blood count test. The parameters which are
      obtained routinely for white blood cell counts include: capacity - electrical conductivity
      (conductivity) - dispersion (scatter), and volume. Though these values are not reported
      routinely, they can be accessed for each blood count.

      The premise is that through blood counts (no need for specialized flow cytometry) and through
      the parameters mentioned a conclusion can be reached about platelet leukocyte aggregates.
      This will then aid in prognosis about the risk of an acute event for every patient with
      ischemic heart disease who comes to the emergency room.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Acute Myocardial Infact
      
Keywords: Myocardial Infarction; flow cytometry; Blood Cell Count; Platelet Activation
Effect of a Combination of Plant Extracts (BSL_EP024) on the Immune Response
Condition: Immune Response
Study type: Interventional

Summary: 
      The aim of the present trial is to study the effect of the combination of plant extracts
      (BSL_EP024) in the activation of the immune response.
    

Detailed description: 
      More than 90% of the diseases are related, directly or indirectly, with immune alterations.
      Traditionally, protection against infections and improvement of the immune response has been
      addressed by natural means through the use of plant extracts. This activity has been
      attributed to phenolic compounds.

      The aim of the present study is to evaluate the effect of the combination of plant extracts
      (BSL_EP024) on immunological response parameters.
    

Intervention name(s): Combination of Plant Extracts (BSL_EP025); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Each participant will consume 2 capsules daily at lunch for 8 weeks.; Each participant will consume 2 capsules daily at lunch for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Immune response; Plant extracts; Dietary supplement
Transcranial Direct Current Stimulation (tDCS) in the Primary Motor Cortex in Healthy Individuals
Condition: Basic Physiology; Brain Stimulation
Study type: Interventional

Summary: 
      The main aim of this study is to assess the short-term effects of active-tDCS (a-tDCS) on the
      M1 regarding sensorimotor variables such as discriminative sensation, pressure pain threshold
      and electromyographic activity compared with a sham-tDCS (s-tDCS) in healthy individuals. The
      main objective was to determine whether there were clinically relevant changes generated by
      tDCS and if they were superior to a sham intervention.
    


Intervention name(s): Sooma transcranial direct current stimulation device; Placebo Sooma transcranial direct current stimulation device
Intervention type(s): Device; Device
Intervention description(s): This group received brain training through transcranial direct current for 20 minutes.; This group received sham brain training through transcranial direct current for 20 minutes. The current is active for 15 seconds and then switches off until the intervention is finished.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Transcranial direct current stimulation
Evaluation of the Safety and Efficacy of a Single Dose of SKY0402 in Subjects Undergoing Augmentation Mammoplasty
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to demonstrate the superiority of SKY0402 over
      conventional, commercially-available bupivacaine HCl with respect to the duration of the
      analgesic effect achieved by a single local administration of the study drug.
    

Detailed description: 
      This was a Phase 2, parallel-group, active-control, randomized, double-blind study conducted
      to evaluate a single local administration of low dose or high dose of SKY0402 compared with
      75 mg of bupivacaine HCl (i.e., Marcaine® 0.5%) in women undergoing bilateral, cosmetic,
      sub-muscular, augmentation mammoplasty under general anesthesia. Each subject was to serve as
      her own control.

      A total of 40 subjects were randomized in a 1:1 ratio to receive one of the following
      regimens:

        -  Low-dose SKY0402 in one side and Marcaine 75 mg in the contralateral side.

        -  Mid-dose SKY0402 in one side and Marcaine 75 mg in the contralateral side.

      Study drug was administered locally into the breast implant pocket at the end of surgery.
      After surgery, subjects were to receive standard treatment with acetaminophen 1000 mg three
      times daily and rescue analgesia with immediate-release oxycodone, as needed, for
      breakthrough pain.

      Assessments of postoperative pain were conducted through 96 hours. Safety assessments were
      conducted including monitoring of local and systemic adverse events (AEs).
    

Intervention name(s): SKY0402 + bupivacaine HCl; Mid-dose SKY0402 + bupivacaine HCl
Intervention type(s): Drug; Drug
Intervention description(s): Low-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket; Mid-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Breast augmentation; Pain; Analgesia
Immunogenicity and Safety of ChimeriVax™ Japanese Encephalitis Vaccine in Thai Toddlers and Children
Condition: Japanese Encephalitis; Hepatitis A
MeSH terms: Hepatitis A; Encephalitis, Japanese; Hepatitis; Encephalitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Safety:

      To describe the safety profiles following vaccination.

      Immunogenicity:

      To describe the immune response after a single dose of vaccine.
    

Detailed description: 
      This is a randomized, cross-over, open, active controlled, multi-center trial in toddlers and
      children in Thailand. Stepwise enrollment of children in 2 age cohorts. Subjects will be
      followed for 5 years.
    

Intervention name(s): Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28); Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28); Japanese encephalitis vaccine (Day 0) Hepatitis A vaccine (Day 28); Hepatitis A vaccine (Day 0) Japanese encephalitis vaccine (Day 28)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): ≥4.0 Log10 Plaque forming units (PFU), Subcutaneous (SC; Day 0); 0.5 mL intramuscular (IM; Day 28); 0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28); ≥4.0 Log10 PFU SC (Day 0); 0.5 mL IM (Day 28); 0.5 mL IM (Day 0); ≥4.0 Log10 PFU SC (Day 28)
Other intervention name(s): ChimeriVax™-JE; ChimeriVax™-JE; ChimeriVax™-JE; ChimeriVax™-JE
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Japanese encephalitis (JE); Hepatitis A; Inactivated Mouse-Brain
Joint Awareness After Total Knee Replacement
Condition: Knee Osteoarthritis; Arthroplasty Complications
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational [Patient Registry]

Summary: 
      Total knee replacement (TKR) is accepted as treatment of choice for end stage gonarthrosis.
      It is performed cemented or cementless and although cemented implants were shown to decrease
      bone density more than cementless fixations there is no evidence-based difference between
      them in the literature. As far as the investigators are concerned, the effect of cementation
      on patients' joint perception has never been studied so far.
    

Detailed description: 
      In this longitudinal case-control study, joint awareness in prosthetic reconstruction was
      evaluated in 150 knees (75 cemented TKR, 75 cementless TKR) of 136 patients. They were
      operated between 2015 and 2017 in our institution with minimum 5 years of follow up. All the
      patients in each group were operated by two senior surgeons that were experienced for more
      than 10 years in arthroplasty. To reduce selection bias, logistic regression was used to
      develop propensity-matched pairs based on gender, age, body mass index (BMI), preoperative
      coronal plane deformity, preoperative range of motion (ROM) and appropriateness for TKA
      indication. Demographic and clinical data including sex, age and time since surgery were
      collected. The subjects' joint perception and the WOMAC clinical scores were recorded and
      compared. Joint awareness is assessed with Forgotten Joint Score (FJS) which has 12 questions
      and with Patient's Joint Perception questionnaire (PJP) which is a single question with 5
      possible answers, rating from the highest expected result "like a native or natural joint" to
      the worse possible case "a non-functional joint". Other than clinical scores, laboratory
      parameters, blood transfusion needs, tourniquet time, complications (septic/aseptic
      loosening, periprosthetic fracture, instability) and revision rates were also compared.
    

Intervention name(s): CEMENTLESS TOTAL KNEE REPLACEMENT
Intervention type(s): Procedure
Intervention description(s): CEMENTLESS CRUCIATE RETAINING BICOMPARTMENTAL TOTAL KNEE REPLACEMENT
Observational model: Case-Control
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Patients with primary end stage varus osteoarthritis of the knee
      
Keywords: Joint Awareness; Total Knee Replacement; Cementless; Forgotten Joint Score; Patient's Joint Perception
How Can Rehospitalisations of Patients With Schizophrenia be Avoided? A Comparison Between Different Compliance Programs
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      Participation in one of the three interventions psychoeducation by professionals,
      psychoeducation by peer-moderators, or video-education can reduce the rehospitalisation rate
      of patients with schizophrenia compared to a control group.
    


Intervention name(s): Psychoeducation by professonals; Psychoeducation by peer-moderators; Video-education; Noneducational video group (control group)
Intervention type(s): Other; Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Immunological Profile of Nickel Dermatitis
Condition: Nickel; Eczema; Nickel Sensitivity; Allergy; Inflammatory Response
MeSH terms: Dermatitis
Study type: Interventional

Summary: 
      A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously
      exposed skin area.
    

Detailed description: 
      Clinically controlled study comprising 15 people with known nickel allergy and 15 healthy
      persons as control group. At the Department of Allergy and Dermatology, Gentofte Hospital,
      test participants will be exposed to nickel sulfate in a patch test on their back, which will
      create an eczema reaction in people with nickel allergy and induce skin resident T-cells. The
      resident T-cells will enhance further exposure. The eczema is healed over 3-4 weeks, after
      which the same areas are again exposed to nickel sulfate at different concentrations in a
      patch test. Skin biopsies of the exposed areas are taken and the immune phenotype is analyzed
      trough Nanostring RNA technologies of around 600 immunerelated genes.
    

Intervention name(s): Nickel sulfate hexahydrate
Intervention type(s): Other
Intervention description(s): Patch test
Intervention MeSH terms: Nickel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Patch test; metal allergy
The Safety and Efficacy of FB2001 in Healthy Subjects and Patients With COVID-19 Infection
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an adaptive, Phase I/II study in 2 parts: Part 1 is to evaluate the Maximum Tolerable
      Dose (MTD) , tolerance, safety and pharmacokinetics of FB2001 in healthy subjects; Part 2 is
      to evaluate the safety, pharmacokinetics and efficacy of FB2001 in patients with moderate to
      severe COVID-19 disease.
    

Detailed description: 
      In Part 1 of this study, all subjects, after signing the Informed Consent Form (ICF), will be
      assessed during the screening phase. Only those subjects who successfully complete the
      screening phase and meet the study eligibility criteria will proceed to receive study
      treatment at the assigned doses and will be followed up for 14 days (for SAD) and 28 days
      (for MAD) to assess post-treatment safety.
    

Intervention name(s): FB2001; FB2001 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be administered with FB2001 by intravenous (IV) infusion; Subjects will be administered with FB2001 placebo by intravenous (IV) infusion
Other intervention name(s): DC402234; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SARS-CoV-2
Evaluation of Treatment Satisfaction and Preference for Sumavel DosePro in the Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the treatment satisfaction of subjects using Sumavel
      DosePro to treat their moderate to severe migraines.
    

Detailed description: 
      Single arm, open-label, multicenter study to evaluate the treatment satisfaction, treatment
      confidence, and subject preference for Sumavel DosePro in adult subjects diagnosed with
      migraines and currently treated with triptans. Subjects will treat up to 4 migraines over a
      60 day period and complete migraine diaries and questionnaires.
    

Intervention name(s): Sumavel DosePro; Sumatriptan
Intervention type(s): Device; Drug
Intervention description(s): Needle free delivery system containing 0.5 mL of solution of 6 mg sumatriptan, subcutaneous administration; subcutaneous injection, 6 mg, per migraine attack, no more than two administrations within a 24 hr period
Other intervention name(s): Sumavel DosePro (Sumatriptan injection)
Intervention MeSH terms: Sumatriptan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: migraine; treatment satisfaction
Non-Invasive Biomarkers in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Background Chronic airway inflammation is present in cystic fibrosis. Non-invasive
      inflammometry may be useful in disease management.

      Objective We studied 1) the ability of fractional exhaled nitric oxide and inflammatory
      markers (acidity, nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor
      necrosis factor-α, interleukin-2,-4,-5,-10) in exhaled breath condensate, to discriminate
      between cystic fibrosis and control children, and, 2) the relationship of biomarkers with
      control and severity of cystic fibrosis.

      Methods In 98 children (48 cystic fibrosis / 50 controls), condensate was collected using a
      glass condenser. Exhaled nitric oxide was measured using the NIOX®.
    


Time perspective: Other
Keywords: childhood disease; cystic fibrosis; exhaled breath condensate; exhaled nitric oxide; airway inflammation; non-invasive inflammatory markers; controls; children