bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of CKDB-501B in Subjects With Moderate-to-severe Glabellar Lines
Condition: Glabellar Lines
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, randomized, double-blind, single-injection, active-controlled,
      parallel-design study to evaluate the safety and efficacy of CKDB-501B in Glabellar lines.
    


Intervention name(s): CKDB-501B; Botox®50U
Intervention type(s): Drug; Drug
Intervention description(s): Intramuscular injection CKDB-501B; Intramuscular injection Botox®50U
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Active-controlled
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy Study of CF101 to Treat Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test the hypothesis that CF101, which is under development to treat other
      immune-mediated inflammatory diseases, will provide clinical benefits in the treatment of
      chronic plaque psoriasis. Patients with psoriasis who qualify for the study will be treated
      every 12 hours (q12h) with CF101 capsules, or placebo capsules, for 12 weeks. The safety of
      treatment will be carefully assessed through clinical and laboratory monitoring. The effect
      of treatment on psoriasis will be evaluated through standard techniques of examination and
      measurement of the severity of skin involvement.
    

Detailed description: 
      This is a Phase 2, multicenter, randomized, double-blind, dose-ranging, placebo-controlled,
      study in adult males and females, ages 18 to 70 years, inclusive, with a diagnosis of
      moderate-to-severe chronic plaque psoriasis. At the Screening Visit, patients who provide
      written informed consent will have screening procedures performed, including a complete
      medical history, medication history, physical examination, including height, weight, blood
      pressure, pulse rate and temperature, and clinical laboratory tests.

      Eligible patients will be those who have not received systemic retinoids, corticosteroids, or
      immunosuppressants (e.g., methotrexate, cyclosporine) within 6 weeks prior to initiation of
      study; or high potency topical corticosteroids (Class I-III), keratolytics, or coal tar
      (other than on the scalp, palms, groin, and/or soles); and UV or Dead Sea therapy within 4
      weeks prior to initiation of study treatment. Eligible patients will be sequentially assigned
      to 1 of 3 dosing cohorts:

      Cohort 1: CF101 1 mg (15 patients) or Placebo (5 patients); Cohort 2: CF101 2 mg (15
      patients) or Placebo (5 patients); Cohort 3: CF101 4 mg (15 patients) or Placebo (5
      patients).

      Medication will be taken orally q12h for 12 weeks. Disease activity will be assessed using
      the Psoriasis Area and Severity Index (PASI) and the Physician Global Assessment (PGA).
      Patients will return for assessments at Weeks 2, 4, 8, 12 and 14.
    

Intervention name(s): CF101 1mg; CF101 2mg; CF101 4mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): CF101 1 mg q12 hours for 12 weeks; CF101 2 mg q12 hours for 12 weeks; CF101 4 mg q12 hours for 12 weeks; Placebo tablets q12 hours for 12 weeks
Other intervention name(s): IB-MECA; IB-MECA; IB-MECA; Inactive pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis
Recombinant Influenza Vaccine Containing Different H3 Antigens in Healthy Adults 18 to 30 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are:

        -  To describe the safety profile of the different quadrivalent recombinant influenza
           vaccine (RIV) formulations.

        -  To describe the hemagglutination inhibition (HAI) and seroneutralization (SN) antibody
           responses against hemagglutinin (HA) (H1, H3, B/Victoria, and B/Yamagata) antigens
           present in the control vaccine in all groups at all timepoints.

      The secondary objectives of the study are:

        -  To describe antigenic coverage in each group by assessing the HAI and SN antibody
           responses against a panel of H3 antigens (not present in any of the vaccine
           formulations).

        -  To describe HAI and SN antibody responses in each group against each of the H3 antigens.

        -  To compare the HAI and SN antibody responses for the groups with different H3 antigens
           to the control group.
    

Detailed description: 
      Study duration per participant is approximately 90 days.
    

Intervention name(s): Quadrivalent RIV with H3 strain 1; Quadrivalent RIV with H3 strain 2; Quadrivalent RIV with H3 strain 3; Quadrivalent RIV with H3 strain 4; Quadrivalent RIV with 2018-2019 NH H3 strain
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular; Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular; Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular; Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular; Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
Condition: Alagille Syndrome
MeSH terms: Liver Diseases; Alagille Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and
      tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus
      placebo on the biochemical markers and pruritus associated with Alagille Syndrome.
    


Intervention name(s): LUM001; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Anatomical and Structural Connectivity in Two Psychotic Phenotypes : Periodic Catatonia and Cataphasia
Condition: Schizophrenia; Catatonia
MeSH terms: Catatonia; Schizophrenia
Study type: Observational

Summary: 
      The different subtypes of Schizophrenia might have a disordered connectivity as their final
      common pathways.

      The investigators will use multimodal structural MRI to assess anatomical connectivity on the
      one side and its functional consequence on functional connectivity on the other side to
      assess two phenotypes of psychosis : periodic catatonia and cataphasia in comparison with
      control subjects.

      The coherence between structural and functional anomalies will be especially studied.
    


Intervention name(s): Quantitative multiparametric and functional MRI
Intervention type(s): Other
Intervention description(s): Structural connectivity assessed in the cortex and the white matter using multimodal quantitative parametric imaging (R1, R2, R2*, DTI, susceptibility, macromolecular proton fraction, cortical thickness, VBM).
Functional connectivity assessed using simple BOLD and combined ASL-BOLD sequences during multiple tasks including motor, language and working memory tasks.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Schizophrenia patients (subdivided in periodic catatonia and cataphasia) and normal
        controls, both having the same procedure.
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK2321138A) Manufactured Using a New Process in Adults and Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to demonstrate the acceptable safety profile and the
      immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational
      process (FLU D-QIV Investigational Process [IP]) compared to FLU D-QIV manufactured with the
      current licensed process (FLU D-QIV Licensed Process [LP]).
    

Detailed description: 
      This study will enroll 3 age cohorts:

      Adults: 18-49 years, Children: 3-17 years and 6-35 months of age.
    

Intervention name(s): Influsplit Tetra™ vaccine produced by investigational process (IP); Influsplit Tetra™ vaccine produced by licensed process (LP)
Intervention type(s): Biological; Biological
Intervention description(s): Influsplit Tetra™ vaccine using a new manufacturing process administered intramuscularly (IM) in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.; Influsplit Tetra™ vaccine using a licensed manufacturing process administered IM in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
Other intervention name(s): Fluarix Tetra™; Fluarix Quadrivalent® (GSK2321138A); Fluarix Tetra™; Fluarix Quadrivalent® (GSK2321138A)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Quadrivalent influenza vaccine; Safety; Children; Adults; Immunogenicity
Study of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects With Mild Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Study of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects with Mild
      Asthma
    

Detailed description: 
      PRS-060 is a drug candidate being developed for the treatment of asthma. The main purpose of
      this study is to investigate the safety, tolerability, and pharmacokinetics of multiple doses
      of PRS-060 administered by inhalation in subjects with mild asthma.
    

Intervention name(s): PRS-060; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study drug; Inhalant designed to mimic PRS-060
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Asthma; Anticalin; PRS-060; Pieris; IL-4 receptor alpha; IL-13; IL-4
Comparative Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of Adalimumab in Healthy Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, two-arm, parallel group, single-dose study to demonstrate
      pharmacokinetic, safety, tolerability and immunogenicity similarity of biosimilar candidate
      TUR01 to EU-sourced Humira® in healthy participants after administration of adalimumab.
    


Intervention name(s): TUR01; Adalimumab-EU
Intervention type(s): Biological; Biological
Intervention description(s): Administered as a single 40 mg, subcutaneous dose; Administered as a single 40 mg, subcutaneous dose
Other intervention name(s): Adalimumab-Turgut; Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: adalimumab; biosimilar; healthy; phase 1; pharmacokinetics; bioequivalence
Norepinephrine To Prevent Hypotension After Spinal Anesthesia For Cesarean Delivery: A Dose Finding Study
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Spinal anesthesia is the most common anesthetic technique for elective Cesarean delivery
      (CD), but the most frequent unwanted side effect is hypotension, which can cause nausea and
      vomiting, as well as effects on the fetus. Prevention and treatment of maternal hypotension
      includes intravenous fluids and vasopressors. Phenylephrine is the most common vasopressor
      used for this purpose. However, it has been shown to reduce maternal heart rate and cardiac
      output, which may be a concern in an already compromised fetus. Norepinephrine is commonly
      used in high concentrations in intensive care and recent studies have suggested that in low
      concentrations it may be a better alternative to phenylephrine in elective CD, as it does not
      reduce the maternal heart rate or cardiac output. The optimum bolus dose of norepinephrine to
      prevent hypotension after spinal anesthesia in elective CD has not been elucidated. The
      investigators propose this study to determine the dose that would be effective in 90% of
      patients (ED90).

      A previous study by Ngan Kee et al, using continuous infusion of norepinephrine to prevent
      hypotension in elective CD, suggested a potency ratio for norepinephrine to phenylephrine of
      approximately 16:1. Hence, the investigators hypothesise that the ED90 will be approximately
      6 µg, given that the current phenylephrine bolus dose at the investigators' institution is
      approximately 100 µg.
    

Detailed description: 
      The use of norepinephrine to prevent and treat hypotension during cesarean delivery (CD) is
      new and data in the literature are scarce. A recent randomised controlled trial by Ngan Kee
      et al compared continuous infusions of norepinephrine and phenylephrine to prevent
      hypotension during CD. They showed that norepinephrine was effective at maintaining blood
      pressure, with a greater cardiac output and heart rate compared to phenylephrine. However,
      the effective bolus dose of norepinephrine needed to prevent maternal hypotension was not
      determined, and since this is a relatively new arena, no dose-response studies are available
      in the literature either. Therefore, it would be logical to establish the effective bolus
      dose of norepinephrine TO PREVENT HYPOTENSION during elective CD.
    

Intervention name(s): Norepinephrine; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): 0.9% sodium chloride solution, used as a diluent.
Other intervention name(s): Norepinephrine bitartrate; sodium chloride
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: vasopressor; blood pressure; Cesarean section; spinal anesthesia
A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan
Condition: Contraception
Study type: Observational

Summary: 
      This will be a non-comparative prospective observational study of women using Femplant as a
      primary method of contraception in Pakistan.
    

Detailed description: 
      This will be a non-comparative prospective observational study of women using Femplant as a
      primary method of contraception in Pakistan. It will be conducted in close collaboration with
      the Pakistan MoH and Marie Stopes Society, Pakistan in several MoH-affiliated and Marie
      Stopes Society clinics that have experience with implants and sufficient expected flow of
      implant users per month. We will enroll a total of 600 women divided into two cohorts in this
      one-year prospective study:

        -  a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months
           after enrolment; and

        -  a surveillance cohort of 300 women who will report back to the clinic during 12 months
           after enrolment only if they have complications, medical problems, pregnancy, or want to
           remove the implant

      The main study outcomes are pregnancy, immediate and delayed complications associated with
      insertion or removal, adverse events, early discontinuation and reasons for discontinuation,
      and level of women's satisfaction with Femplant services.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        women using Femplant as a primary method of contraception in Pakistan
      
Keywords: Femplant; AE adverse event; AIDS acquired immunodeficiency syndrome; ALT (SGPT) alanine aminotransferase; ART antiretroviral therapy; AST (SGOT) aspartate aminotransferase; DCF data collection forms; DMC Data Monitoring Committee; FDA (U.S.) Food and Drug Administration; GCP Good Clinical Practice guidelines; HB sAg Hepatitis B surface antigen; ICH International Conference of Harmonisation; IND Investigational New Drug Application; IRB Institutional Review Board; IU international units; mg milligram(s); mm3 cubic millimeter(s); PCR polymerase chain reaction; SAE serious adverse event; µg microgram; ULN upper limit of the normal range; WB Western Blot
Noninvasive Peripheral Nerve Stimulation for Restless Legs Syndrome During Opioid Medication Reduction
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional

Summary: 
      Prospective open-label single-arm feasibility study assessing the tolerability of opioid
      medication reduction in conjunction with noninvasive peripheral nerve stimulation (NPNS) for
      patients taking prescription opioids to treat moderate-severe primary RLS.
    

Detailed description: 
      For RLS patients taking a stable dose of prescription opioid medications prior to study
      entry, iterative opioid dose reduction is performed in conjunction with open-label NPNS
      treatment. For each of two iterative step-downs in opioid dose (step-down #1 and step-down
      #2), a 1-2-week run-in phase to allow resolution of opioid withdrawal symptoms unrelated to
      RLS is followed by a 1-wk assessment phase to evaluate if RLS symptoms have increased. Study
      participation is terminated if there is a clinically significant increase in RLS severity
      during the assessment phase or if there are intolerable opioid withdrawal symptoms at any
      time. Participants who tolerate both step-downs have the option of an extension phase
      involving a third step-down with the same format.
    

Intervention name(s): Noninvasive Peripheral Nerve Stimulation (NPNS)
Intervention type(s): Device
Intervention description(s): NPNS device programmed to deliver active stimulation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, and Immunogenicity of VAL-181388 in Healthy Subjects
Condition: Chikungunya Virus
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study will assess the safety, tolerability, and immunogenicity of VAL-181388 in
      healthy subjects.
    


Intervention name(s): VAL-181388; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Escalating dose levels; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: VAL-181388; Chikungunya vaccine
Migraine Inducing Effect of Levcromakalim in Patients With Migraine With Aura
Condition: Headache, Migraine; Aura
MeSH terms: Migraine Disorders; Migraine with Aura; Headache
Study type: Interventional

Summary: 
      To investigate the migraine inducing effect of levcromakalim in patients with migraine with
      aura.
    


Intervention name(s): Levcromakalim; Saline
Intervention type(s): Drug; Drug
Intervention description(s): To investigate the role of levcromakalim compared with placebo in migraine with aura patients; To investigate the role of levcromakalim compared with placebo in migraine with aura patients
Intervention MeSH terms: Cromakalim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Levcromakalim
Dietary Salt Intake and Vascular Function
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to look at the effects of high- and low-salt diets on blood
      vessel function in healthy subjects.
    

Detailed description: 
      Healthy volunteers will be enrolled in a dietary sodium intervention to examine impact on
      vascular function.
    

Intervention name(s): High sodium; Low sodium
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: dietary salt; sodium; blood vessels; vascular function; endothelial function; heart disease risk; cardiovascular disease risk
Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis
Condition: Steroid and/or Prednisone Dependent Asthma; Eosinophilic Bronchitis
MeSH terms: Bronchitis; Acute Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to investigate whether addition of Omalizumab enables a
      reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis.

      This will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial
      divided into two sequential study periods.

      Period 1: After establishing the minimum dose of prednisone to maintain asthma control and
      maintain sputum eosinophils <3%, subjects will be randomized to either placebo or Omalizumab
      for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months).

      Period 2: standardised prednisone reduction at intervals of 4-weeks until there is a clinical
      and eosinophilic exacerbation or bothersome steroid withdrawal effects. If patients have an
      exacerbation, they will be treated with prednisone. This patient will continue on Omalizumab
      or placebo during the entire duration of the study but not continue the phase of steroid
      reduction.
    


Intervention name(s): Omalizumab (Xolair); Placebo
Intervention type(s): Biological; Drug
Other intervention name(s): Anti IgE; 0.9% normal saline
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Prednisone; Eosinophils; Immunoglobin E (IgE); Asthma; Bronchitis; Inflammation; Allergy