bioihbjkbjnl/mcl2 huggingface dataset:
Neuroprotective Effects of ACTH4-10PRO8-GLY9-PRO10
Condition: Ketamine-Induced Neurotoxicity
MeSH terms: Neurotoxicity Syndromes
Study type: Interventional

Summary: 
      The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of an adrenocorticotropic
      hormone (ACTH) short fragment. That is free from hormonal effects and has neuromodulatory
      effects. We investigate the neuroprotective effects of ACTH4-10Pro8-Gly9-Pro10 can lessen
      neurotoxicity against ketamine in neonatal rats by looking at BDNF expression in the cortex
      and hippocampus tissue as well as BDNF blood levels.
    

Detailed description: 
      The compound ACTH4-10Pro8-Gly9-Pro10 is a synthetic analog molecule of a short fragment of
      adrenocorticotropic hormone (ACTH). It is free from hormonal effects and has neuromodulatory
      effects. The immune-modulating and neurotrophic activity of the drug were shown to balance
      the state of anti-inflammatory and trophic factors (IL-IO, TNF-a, TGF-Pl, BDNF, NGF) over
      proinflammatory factors (IL-Ip, IL-8, CRP, LE) to increase the anti-apoptotic defense (Bcl-2
      elevation), as well as to reduce the peroxidation process (increased SOD activity).

      ACTH4-10Pro8-Gly9-Pro10 also has neuromodulator characteristics to function as a
      neuroprotector in inhibiting the apoptotic process. Modulation by ACTH4-10Pro8-Gly9-Pro10
      will increase the levels of BDNF thereby inhibiting the process of apoptosis. Based on
      research by Gusev and Skvortsova, ischemic stroke patients who were given
      ACTH4-10Pro8-Gly9-Pro10 showed increased levels of BDNF, decreased mortality, and reduced
      length of stay. Based on the description above, the researcher was interested in analyzing
      the effect of the administration of ACTH4-10Pro8-Gly9-Pro10 on ketamine neurotoxicity in
      neonatal rats by assessing the level of BDNF.
    

Intervention name(s): ACTH4-10Pro8-Gly9-Pro10; Ketamine
Intervention type(s): Drug; Drug
Intervention description(s): ACTH4-10Pro8-Gly9-Pro10 also has neuromodulator characteristics to function as a neuroprotector in inhibiting the apoptotic process. Modulation by ACTH4-10Pro8-Gly9-Pro10 will increase the levels of BDNF thereby inhibiting the process of apoptosis; negative-positive control (ketamine 40 mg/kg BW subcutaneously)
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: ACTH4-10Pro8-Gly9-Pro10; BDNF; ketamine-induced neurotoxicity; apoptosis
Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
Condition: Moderate-to-severe Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, double blind, placebo-controlled phase IIb study to
      evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in moderate-severe AD
      subjects. The study consists of 3 periods, a up-to-4-week Screening Period, a 16-week
      randomized Treatment Period and a 8-week Safety Follow-up Period.
    

Detailed description: 
      Subjects will be required to apply moisturizers after ICF signed and continue throughout the
      study.
    

Intervention name(s): CM310; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): IL-4Rα monoclonal antibody; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic dermatitis
Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects
Condition: Healthy Volunteers; Safety; Tolerability
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled
      administration of single and multiple increasing doses, and to estimate the maximum dose that
      is tolerated in healthy people.
    


Intervention name(s): AZD9819; AZD9819; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Inhaled single doses of suspension via SPIRA nebuliser; Inhaled multiple doses of suspension via SPIRA nebuliser, once daily for 10 (maximum 14) days; Inhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B)
Other intervention name(s): Part B (multiple ascending doses); Part A and B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety; tolerability; healthy; inhalation
Efficacy Study of Telbivudine in Chronic Hepatitis B Patients
Condition: Chronic Hepatitis B; Roadmap Concept in Chronic Hepatitis B Treatment; 24-week PCR Negativity of Telbivudine; PCR Negativity at 52 and 104 Week; HBeAg Seroconversion Rate at 52 and 104 Week
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      This study is designed to support the optimal use of telbivudine by providing data to refine
      our understanding of telbivudine efficacy and resistance in real life clinical setting in
      patients with chronic hepatitis B with defined baseline characteristics and 24-week PCR
      negativity.
    

Detailed description: 
      This study will be multicenter, open-label and observational data collection of patients on
      telbivudine who meet baseline characteristics defined as the majority of patients seen in the
      clinic setting. Data collection will take place after enrollment, at Week 12, 24, 52, 76 and
      104 for efficacy assessments. In patients who discontinue observational drug earlier,
      clinical information would be kept following for assessment as well.

      Study purpose:

      This study is designed to evaluate the efficacy of telbivudine in real-life clinical settings
      with the use of the Roadmap Concept in chronic hepatitis B treatment.

      Objectives:

      Primary:

      To observe telbivudine's 2-year efficacy in real-world clinical setting of achieving HBV-DNA
      < 60 IU/ml and HBeAg seroconversion rate in patients with defined baseline characteristics
      and 24-week treatment PCR negativity as previously reported in GLOBE study's sub-analysis.

      Secondary:

        1. To observe the treatment outcomes.

        2. To validate the result of super-responder trial.

        3. To validate the Roadmap Concept.

      Population:

      The study population will consist of a representative group of 500 chronic hepatitis B
      patients with detectable HBsAg for more than 6 months who need telbivudine therapy based on
      investigators' judgment in 16 medical centers located in Taiwan.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Chronic hepatitis B patients without cirrhosis
      
Biospecimen description: 
      10 c.c whole blood
A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to demonstrate the superiority of vernakalant injection
      over amiodarone injection in the conversion of atrial fibrillation (AF) to sinus rhythm (SR)
      within 90 minutes of the start of drug administration. The secondary objective is to compare
      the safety of vernakalant to amiodarone.
    

Detailed description: 
      This is a double-blind, active-controlled, double-dummy, multi-center, randomized trial in
      subjects with symptomatic AF of 3 to 48 hours duration.

      Subjects will be randomized to receive vernakalant injection or amiodarone injection in a 1:1
      ratio.

      Safety will be assessed through the monitoring of adverse events, vital signs, continuous
      telemetry monitoring, 12-lead Holter monitoring, 12-lead ECGs, and laboratory tests.

      At 2 hours after the start of infusion, electrical cardioversion may be performed or rate
      control medication may be administered. Class I and Class III antiarrhythmics are not to be
      administered for 24 hours after the start of infusion.

      Subjects are to remain in the clinic for at least 6 hours after the start of infusion.
      Subjects will attend a follow-up visit at 7 (±2) days after treatment and will receive a
      follow-up telephone call at 30 (±3) days for assessment of serious adverse events,
      concomitant medications related to serious adverse events, and recurrence of AF.

      All roles were blinded with the exception of each site's designated unblinded personnel who
      were responsible for randomization and preparation, dispensation and accountability of the
      study medication.

      Expanded Access was not available through this protocol.
    

Intervention name(s): Vernakalant Injection; Amiodarone Injection:
Intervention type(s): Drug; Drug
Intervention description(s): 10-minute infusion of 3 mg/kg vernakalant injection followed by a 15-minute observation period, followed by an additional 10-minute infusion of 2 mg/kg of vernakalant if required (if the subject is still in AF).; 60-minute infusion of 5 mg/kg amiodarone followed by a maintenance infusion of 50 mg amiodarone over an additional 60 minutes (equivalent to approximately 15 mg/kg over 24 hrs).
Other intervention name(s): RSD1235; Kynapid; Amiodarone; Cordarone
Intervention MeSH terms: Amiodarone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atrial fibrillation; atrial fib; AF
Safety and Immunogenicity of a New Serum-free DTaP-IPVvero Combination Vaccine
Condition: Active Immunization
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is a parallel group, multi-centre, randomized, double blind, non-inferiority trial
      investigating the immunogenicity and safety of two DTaP-IPV combination vaccines:

      A)The investigational vaccine: DTaP-IPV containing IPV produced in a vero-cell line
      (DTaP-IPVvero) B)The reference vaccine: DTaP-IPV containing IPV produced in monkey kidney
      cells (DTaP-IPVmkc) The DTaP-IPV vaccines are administered to healthy infants at 2, 3½, 5,
      and 16 months of age concomitantly with Act-HIB vaccine administered as a separate injection
      in the opposite thigh.

      Three blood samples are collected at 6, 16 and 17 months of age. Sera are analyzed for
      antibodies against diphtheria, tetanus, pertussis, polio and prp.
    


Intervention name(s): DTaP-IPV vero vaccine; DTaP-IPV mkc vaccine
Intervention type(s): Biological; Biological
Intervention description(s): DTaP-IPV vero 0.5 mL solution for intramuscular injection at 2, 3½, 5 and 16 months of age; DTaP-IPV mkc 0.5 ml solution for intramuscular injection at 2, 3½, 5 and 16 months of age
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: DTaP-IPV; Clinical Trial; Safety; Immunogenicity
Comparing the Shape and Frequency of Uterine Contractions
Condition: Uterine Contractions; Delivery
Study type: Observational

Summary: 
      Dystocia is the most common indication for primary cesarean section. The most common cause of
      dystocia is uterine dysfunction. In all cephalopelvic disproportion studies, more attention
      is usually paid on fetus and pelvic rather than on the role of uterine contraction in
      delivery. So we decided to determine the relationship between dystocia and uterine
      contraction patterns.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primiparous women
      
Keywords: Uterine contraction;; Shape; Frequency;; First stage labor;; Fall; Rise ratio.
GCF Levels of IL-1Beta, MIP-1 Alfa and G-CSF in Gingivitis and Stage I-II-III-IV Periodontitis Patients
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Observational

Summary: 
      Periodontal diseases are chronic diseases that occur as a result of a violation of the
      balance between microbial dental plaque and the host response. Gingivitis is a disease
      characterized by inflammation of the gums that occurs in one or more areas without loss of
      attachments.1 in periodontitis, an inflammatory event that begins in the gum along with
      gingivitis spreads to the periodontal ligament, alveolar bone and soft tissues that support
      the tooth, causing the destruction of these structures.2 Cytokines are low molecular weight
      proteins that participate in the initial and active stages of inflammation and immunity. In
      periodontal disease pathogenesis, cytokine response has been reported to play a very critical
      role in determining disease progression.3 IL-1beta, MIP-1alfa and G-CSF are key cytokines in
      chronic inflammatory diseases and have the potential to initiate bone loss and tissue
      destruction seen in periodontal disease.4the purpose of this study; it is to determine the
      degree of inflammation and periodontal destruction by determining the levels of IL-1beta,
      MIP-1alfa, G-CSF cytokines in the gum groove fluid of periodontal healthy and diseased
      individuals.
    

Detailed description: 
      Plaque index (PI), gingival index (GI), presence of bleeding on probing (BOP), pocket depth
      (PD) and clinical attachment level (CAL) were used After clinical evaluation, individuals
      were divided into 6 groups Healthy control groups, gingivitis groups, Stage I groups, Stage
      II groups, Stage III groups and Stage IV groups GCF samples were collected after clinical
      periodontal measurement. GCF was obtained using strips of filter paper Kolmogorov-Smirnov and
      Shapiro Wilk's tests used
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        individuals who have periodontal disease will be selected
      
Biospecimen description: 
      gingival crevicular fluid
    
Keywords: periodontal disease; periodontitis; cytokines
Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR)
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      East Asian patients will be required optimal dose of newer P2Y12 inhibitors (prasugrel or
      ticagrelor) to determine the safer treatment and better outcome. Whether lower dose of these
      regimens are more adequate for clinical practice in Korea is unclear. Therefore, the
      investigators aim to evaluate efficacy and safety of half dose of new oral P2Y12 inhibitors
      in Korean patients with acute coronary syndrome (ACS) undergoing percutaneous coronary
      intervention (PCI).
    

Detailed description: 
      In recent years, newer oral P2Y12 receptor blockers (prasugrel or ticagrelor) have been
      strong recommendations for management of patients with ACS undergoing (PCI). These drugs
      provided more profound inhibitory effects than clopidogrel, which could lead to marked
      reduction in ischemic events, with relatively increase in bleeding complication, specific to
      low body weight, especially in women and East Asian patients.
    

Intervention name(s): Clopidogrel 75 mg; Prasugrel 5 mg; Ticagrelor 45 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clopidogrel 600 mg as loading dose followed by 75 mg/day as maintenance dose.; Loading / maintenance dose: prasugrel 60 mg / 10 mg/day; After 1-month treatment of conventional dose, followed half dose of 5 mg/day for chronic treatment.; Loading / maintenance dose: ticagrelor 180 mg / 90 mg/bid; After 1-month treatment of conventional dose, followed half dose of 45 mg/bid for chronic treatment.
Other intervention name(s): Plavix 75 mg; Effient 5 mg; Brilinta 45 mg
Intervention MeSH terms: Clopidogrel; Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Half dose; Newer oral P2Y12 receptor inhibitors; Acute coronary syndrome
Nausea and Pain Prophylaxis During Thyroid Surgery
Condition: Thyroid Diseases; Parathyroid Diseases
MeSH terms: Thyroid Diseases; Parathyroid Diseases
Study type: Interventional

Summary: 
      Postoperative pain and nausea may diminish a patient's wellbeing, and may also delay
      rehabilitation, as well as increase the total cost of care and treatment. Opioids are
      effective drugs for treatment of pain, but with the disadvantage of side effects such as
      somnolence and nausea. The benefits of various types of non-opioid analgesic in reducing
      patients' postoperative need for opioids have been well-documented.

      One non-opioid prophylaxis documented for various surgery is short-term treatment with
      corticosteroids. The optimal dose of corticosteroids for peroperative nausea and pain
      prophylaxis is not well-documented. In our study we will attempt to determine whether the
      aforementioned benefits of corticosteroids are valid for a group of patients undergoing
      thyroid surgery.

      Hypothesis: Single-dose treatment with dexamethasone provides a better analgesic effect
      and/or reduced use of opioids than placebo in patients undergoing elective throid surgery.
      Higher dose of dexamethasone provide better and/or longer-lasting analgesic effects without
      influencing the side effect profile.
    


Intervention name(s): dexamethasone; natriumchloride 0,9%; dexamethasone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV dexamethasone 0,15 mg/kg bodyweight. Single-dose bolus injection after start of anesthesia. Medication is opened and administrated to the patient from a coded ampoule by the physician. The medication is diluted in such a way that 1 mL is equivalent to 10 kg body weight (1,5 mg/mL).; iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.; IV dexamethasone 0,30 mg/kg body weight. Drug diluted to 3,0 mg/mL and administrated in same way as arm 2.
Other intervention name(s): Fortecortin; fortecortin
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Self-Administered Nasal Influenza Feasibility Study
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this prospective, open-label clinical trial is to evaluate the immunogenicity
      of self-administered (SA) live, attenuated influenza vaccine (LAIV) in comparison with
      healthcare worker administered (HCWA) LAIV and to evaluate the feasibility of group
      self-administration of LAIV.
    

Detailed description: 
      This Phase IV, open-label, prospective clinical trial assesses SA-LAIV, testing whether the
      immunogenicity of SA-LAIV is non-inferior to that of HCWA-LAIV, as well as evaluating the
      feasibility of utilizing group administration for SA-LAIV. Subjects will be enrolled into one
      of two major treatment arms: HCWA-LAIV (Estimated N = 550) and SA-LAIV (Estimated N = 550).
      Enrollment into each major treatment arm will be stratified by study site. Enrollment in the
      HCWA-LAIV and SA-LAIV treatment arms may occur concurrently at each site. Subjects enrolling
      in the study will be randomized to HCWA or SA, and within the SA arm to either individual
      self-administration, or group administration. Specifically, following self-administration of
      LAIV to 190 individual subjects, 180 subjects will be vaccinated in 36 groups of 5 and 180
      subjects will be vaccinated in 18 groups of 10. All vaccinations in the SA-LAIV arm will be
      given under the direction and supervision of a research staff member who is trained to
      administer LAIV vaccines. Following immunization all subjects will return for one visit at
      approximately 28 (± 7) days for follow-up.
    

Intervention name(s): FluMist
Intervention type(s): Drug
Intervention description(s): FluMist Intranasal Vaccine
Other intervention name(s): influenza virus vaccine LAIV4
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: influenza
Subcutaneous Ketamine for Postoperative Pain Relief in Rwanda
Condition: Post Operative Pain; Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A randomized double blind control trial to investigate the safety and efficacy of
      subcutaneous ketamine for control of post operative pain in low resource settings.
    

Detailed description: 
      A randomized double blind control trial. All patients undergoing upper abdominal, thoracic,
      gynecologic or orthopaedic surgeries at the Centre Hospitalier Universitaire de Kigali,
      Kigali, Rwanda will be invited to participate. Enrolled patients will receive subcutaneous
      ketamine (or placebo) administered immediately after surgery, the evening after surgery, and
      every 12 hours thereafter for a total of 5 injections at a dose of 1mg/kg. The primary
      outcome will be a reduction in mean Pain Scores using parametric statistical analysis to
      discriminate significance. Pain will be measured using an 11-point numerical rating scale.
      Secondary outcomes will be the presence of significant side effects. This trial is a
      partnership between the University of Saskatchewan and the National University of Rwanda with
      ethics approval from each institutions ethics board.
    

Intervention name(s): Ketamine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive a subcutaneous injection of ketamine (at a dose of 1mg/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.; Patients will receive a subcutaneous injection of saline (at a dose of 0.02cc/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment