bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study - Effect of Omega-3 on Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single blind placebo-controlled pilot study involving Systemic Lupus Erythematosus
      and lupus nephritis patients. We propose to recruit and consent SLE patients who will be
      randomized to either receive the study drug, an over the counter fish oil supplement, or a
      placebo that contains olive oil. They will have a baseline metabolomic profile (blood test),
      nutritional assessment, fatigue severity scale, quality of life assessment, and SELENA-SLEDAI
      lupus disease activity assessments completed at the time of study medication distribution.
      Once 6 months of either the study drug or placebo is completed, then pill counts, assessments
      of experience/adherence (including side-effects, adverse effects, complaints, and
      un-blinding), and repeat nutritional assessment, fatigue severity scale, SELENA-SLEDAI, and
      metabolomic profile will be assessed. The study duration for each patient will be 6 months
      from initiation of the study drug. It is hypothesized that patients receiving the fish oil
      supplement will have improvement in their metabolomic profile. Additionally it is
      hypothesized that patients receiving the fish oil supplement will have improvement in disease
      activity, fatigue, and quality of life assessments.
    

Detailed description: 
      Supplementation with EPA and DHA could potentially reduce the inflammatory state of SLE
      patients. This study is a single blind placebo-controlled pilot for SLE patients with 25
      scheduled to receive omega-3 (EPA 2.25g/DHA 2.25g) daily and 25 scheduled to receive placebo
      (olive oil), for 6 months. Pre and post supplementation assessments will be made to determine
      if EPA and DHA levels increase, and if the levels of lipid peroxidation products, other
      cellular energy intermediates, and inflammatory markers are affected by EPA/DHA.
      Additionally, lupus disease activity, fatigue, quality of life, and diet will be assessed to
      determine if these parameters are related to the metabolome in SLE.

        -  Aim 1:

           - To determine if the metabolomic disturbances of lupus patients improve following
           supplementation with omega-3 fatty acids.

        -  Aim 2:

             -  To determine if lupus disease activity, fatigue, and quality of life improve and
                are related to the metabolomic profile changes.
    

Intervention name(s): Fish Oil; Olive Oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fish Oil (2.25gm EPA and 2.25gm DHA total); Placebo group
Other intervention name(s): Omega-3 Fatty Acids; DHA/EPA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: SLE; Fish Oil; Omega-3
Safety and Pharmacokinetic Study of BIO 300 Capsules
Condition: Acute Radiation Syndrome
MeSH terms: Syndrome; Radiation Injuries; Acute Radiation Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is designed to evaluate the safety and pharmacokinetics of BIO 300 capsules when
      administered orally to healthy male and female volunteers. BIO 300 is expected to be safe for
      use starting at 500 mg.
    

Detailed description: 
      This clinical trial will assess the safety and PK of BIO 300 capsules at doses expected to
      deliver a radioprotective or therapeutic effect in humans. Humanetics is planning to conduct
      this Phase I, single dose, dose-escalation (500, 1000, 1500, and 2000 milligrams) study of
      the safety, tolerability and pharmacokinetics of BIO 300 by recruiting approximately 24
      healthy men and women between the ages of 18 and 64 to be enrolled in cohorts of 6 subjects
      per group. The first cohort will receive one 500 mg BIO 300 capsule and pharmacokinetic blood
      sampling will be conducted over the first 4 days in an outpatient setting at a clinic skilled
      in this type of Phase I trial. Blood samples will be analyzed for BIO 300 levels, hematology,
      chemistry, lipid profiles, phosphorus, clotting factors and fibrinogen as well as pancreatic
      lipase and amylase. Urinalysis will assess kidney function as well as creatinine clearance
      and BIO 300 clearance. All subjects will be monitored for adverse events and the safety of
      BIO 300 capsules will be evaluated in this setting. After review of all safety information
      and provided no clinically significant negative findings are revealed, the second cohort will
      be treated with 1000mg BIO 300 (two 500mg capsules) using the same PK sampling program. Again
      safety concerns will be reviewed and provided no clinically significant negative findings are
      revealed, the third and fourth cohort will be treated with 1500 and 2000 mg, respectively, of
      BIO 300 using the same PK sampling program.
    

Intervention name(s): BIO 300 Capsules
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Radiation Syndrome; Hematopoietic Syndrome; Radiation Injury; BIO 300
Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of
      migraine headache in chronic migraineurs.
    


Intervention name(s): ALD403 (Eptinezumab); Placebo
Intervention type(s): Biological; Biological
Other intervention name(s): Eptinezumab-jjmr; Vyepti
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety of Ambervin® and Standard Therapy in Hospitalized Patients With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This is open-labe randomized multicenter comparative Phase III study conducted in 8 medical
      facilities. The objective of the study is to assess the efficacy, safety and tolerability of
      Ambervin for intramuscular and inhaled administration in complex therapy COVID-19 compared
      with the Standard of care (SOC) in hospitalized patients with moderate COVID-19.
    

Detailed description: 
      Upon signing the informed consent form and screening, 313 eligible patients hospitalized with
      COVID-19 were randomized at a 1:1:1 ratio to receive either Ambervin intramuscular 1mg 1
      times a day for 10 days or Ambervin inhaled 10mg 1 times a day for 10 days or SOC.
    

Intervention name(s): Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate intramuscularly; Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate inhaled; Standard of care
Intervention type(s): Drug; Drug; Drug
Intervention description(s): lyophilizate for preparation of solution for intramuscular administration 1 mg 1 time per day for 10 days; lyophilizate for preparation of solution for inhalation administration 10 mg 1 time per day for 10 days; The administration of 'StandardTherapy' drugs was done according to the regimen recommended in the 'COVID-19TreatmentGuidelines'(current version)
Other intervention name(s): Ambervin intramuscularly; Ambervin inhaled
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SARS-CoV-2; Ambervin
Drug Interaction Study of CT1812 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is Phase 1, single-center, open-label, single-sequence drug-drug interaction study to
      determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of 4 probe drugs
      (tolbutamide, midazolam, dextromethorphan and omeprazole).
    

Detailed description: 
      This is Phase 1, single-center, open-label, single-sequence drug-drug interaction study to
      determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of 4 probe drugs
      (tolbutamide, midazolam, dextromethorphan and omeprazole).

      Each subject will qualify for entry into the study within 35 days before admission to the
      clinical unit. Subjects will check into the clinical unit on Day -3 for baseline assessments.
      Each subject will receive a single dose of each of the probe drugs on Day -2 as a 'cocktail'.
      A single dose of CT1812 and each of the probe drugs will be co-administered on Day 6. On Days
      1 through 5, subjects will receive a single daily dose of CT1812.
    

Intervention name(s): CT1812; tolbutamide; dextromethorphan; Omeprazole; midazolam
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of tolbutamide; Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of dextromethorphan; Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of omeprazole; Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of midazolam
Intervention MeSH terms: Tolbutamide; Midazolam; Dextromethorphan; Omeprazole
Intervention model: Sequential Assignment
Intervention model description: This is Phase 1, single-center, open-label, single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of 4 probe drugs (tolbutamide, midazolam, dextromethorphan and omeprazole)
Masking: None (Open Label)
Primary purpose: Treatment
Study Of Angiomax In Infants Under Six Months With Thrombosis
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The goals of this study are:

        1. To assess the safety of bivalirudin in infants under six months with arterial or venous
           thrombosis;

        2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as
           measured by the activated clotting time (ACT) or activated partial thromboplastin time
           (aPTT) in Infants Under Six Months with arterial or venous thrombosis;

        3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution
           and bleeding complications compared to patients on unfractionated heparin (UH) or low
           molecular weight heparin (LMWH).
    

Detailed description: 
      The goals of this study are:

        1. To assess the safety of bivalirudin in infants under six months with arterial or venous
           thrombosis;

        2. To determine the dose of bivalirudin required to achieve adequate anticoagulation as
           measured by the activated clotting time (ACT) or activated partial thromboplastin time
           (aPTT) in Infants Under Six Months with arterial or venous thrombosis;

        3. To determine the outcome of patients on bivalirudin with respect to thrombus resolution
           and bleeding complications compared to patients on unfractionated heparin (UH) or low
           molecular weight heparin (LMWH).
    

Intervention name(s): Angiomax (bivalirudin)
Intervention type(s): Drug
Intervention MeSH terms: Bivalirudin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neonates; thrombosis; bivalirudin; direct thrombin inhibitor
Role of Anti-IgE in Severe Childhood Eczema
Condition: Atopic Eczema; Atopic Dermatitis; Child
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of anti-IgE (Omalizumab/Xolair) in children with severe eczema.
    

Detailed description: 
      To address the value of anti-IgE in children with severe eczema.
    

Intervention name(s): Xolair; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): According to manufacturer's instructions; Placebo
Other intervention name(s): Omalizumab
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Nutritional Supplementation on Pediatric Burn Patients
Condition: Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine the effect of nutrition supplementation on blood protein levels in
      pediatric burn patients.
    


Intervention name(s): Nutritional Supplement; Hospital food
Intervention type(s): Other; Other
Intervention description(s): Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.; Typical hospital food given daily at meals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
Condition: Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the safety and immunogenicity of Phase III lots of
      the CYD dengue vaccine in a pediatric population in Malaysia.

      Primary Objectives:

        -  To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD
           dengue vaccine in all participants after each injection.

        -  To describe the antibody response to each dengue virus serotype post-injection 2 and
           post-injection 3.
    

Detailed description: 
      Healthy participants aged 2 to 11 years received 3 vaccinations at pre-determined schedules
      and were followed-up for at least 6 months after the last vaccination.
    

Intervention name(s): Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus; Placebo: NaCl 0.9%
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension; 0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension
Other intervention name(s): CYD Dengue vaccine; Saline
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue fever; Dengue hemorrhagic fever; CYD dengue vaccine
Evaluation of the Safety, Tolerability and Bioavailability of Dasiglucagon Following Subcutaneous (SC) Compared to IV Administration
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the trial is to characterize the safety and tolerability of dasiglucagon 4
      mg/mL following IV administration at increasing doses in healthy volunteers. One cohort of
      subjects will receive a SC dose of dasiglucagon to characterize the bioavailability of
      dasiglucagon following SC administration compared to IV administration. Furthermore, the
      trial aims to assess the potential effect of dasiglucagon on corrected QT interval (QTc)
      prolongation via a concentrationresponse analysis.
    

Detailed description: 
      Hypoglycemia in patients with diabetes is defined as episodes of an abnormally low plasma
      glucose concentration. Hypoglycemia is a common, unpredictable, and potentially dangerous
      side effect of treatment of diabetes mellitus, especially with insulin or sulfonylureas.

      Dasiglucagon (ZP4207) is a stable peptide analog of human glucagon, available in a
      ready-to-use liquid formulation. Dasiglucagon is in development for the treatment of severe
      hypoglycemia in patients with diabetes mellitus. Dasiglucagon is a specific and full glucagon
      receptor agonist designed to mimic the effects of glucagon, having a fast absorption and
      elimination (minutes).
    

Intervention name(s): Dasiglucagon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dasiglucagon injection; Placebo for Dasiglucagon injection
Other intervention name(s): ZP4207; Placebo for Dasiglucagon
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose escalation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRS-080
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Anticalins® are engineered human proteins that are able to bind specific target molecules.
      The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin
      and is intended for treatment of anemia of chronic disease. This phase I First-in-Human study
      shall investigate safety and pharmacokinetics in healthy human volunteers.
    

Detailed description: 
      First-in-Human (FIH), randomized, dose-escalation, double-blind, placebo-controlled single
      dose in healthy volunteers.

      The single rising dose study will enroll 8 subjects per cohort (6 verum, 2 placebo), up to a
      maximum tolerated dose, defined by stopping rules. 6 dose levels are anticipated. Study drug
      will be administered as i.v. infusion on Day 1. The decision to escalate the dose by the dose
      escalation committee (DEC) will be based on an interim analysis of clinical safety and safety
      laboratory data.
    

Intervention name(s): PRS-080#022-DP; PRS-080-Placebo#001
Intervention type(s): Drug; Drug
Intervention description(s): hepcidin antagonist; Placebo treatment
Other intervention name(s): PRS-080; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Healthy Subjects
Prospective Assessment of Adolescent Drinking Trajectories With Computer-Assisted Self-administration of Ethanol (CASE)
Condition: Alcoholism
MeSH terms: Alcoholism; Underage Drinking
Study type: Observational

Summary: 
      The Computer-Assisted Self-administration of Ethanol (CASE)will be administered twice, at the
      ages 18 and 20, in a prospective study of 80 adolescents living in the Dresden area. The
      sample will be recruited for a differential family history of alcoholism (FHA) and gender,
      with inventories of alcohol use disorder (AUD) symptoms and personal recent drinking history
      (RDH) obtained prior to each CASE session.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Residents living within 15 km (9.5 miles) from downtown Dresden
Intensive Versus Conventional Treatment in Patients With Primary Amyloidosis
Condition: Primary Systemic Amyloidosis (AL)
MeSH terms: Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      AL amyloidosis is caused by a clonal plasma cell dyscrasia and characterized by progressive
      deposition of amyloid fibrils derived from monoclonal Ig light chains, leading to multisystem
      organ failure and death. The prognosis for AL amyloidosis with conventional treatment remains
      poor, Autologous stem cell transplantation (ASCT) for AL amyloidosis produces high
      hematologic and organ responses. However, treatment-related mortality remains high and
      reported series are subject to selection bias.
    

Detailed description: 
      A prospective randomized trial was conducted to compare in AL amyloidosis ASCT (melphalan 140
      or 200 mg/m2 depending on age and clinical status supported with ASCT collected with G-CSF
      alone) and the oral regimen M-Dex (melphalan 10 mg/m2 and dexamethasone 40 mg for 4 days each
      months up to 18 months). The objectives were to compare survival and hematologic and clinical
      responses.
    

Intervention name(s): Melphalan; Dexamethasone; Autologous stem cell transplantation
Intervention type(s): Drug; Drug; Procedure
Intervention MeSH terms: Dexamethasone; Melphalan
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AL amyloidosis; Autologous stem cell transplantation; Melphalan; Dexamethasone
A Study of LY3374849 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this trial is to evaluate the safety and tolerability of the study drug known as
      LY3374849, when given as an injection to healthy participants.

      The study will also investigate how quickly the body absorbs and gets rid of LY3374849 and
      how it affects the levels of blood sugar in comparison to insulin degludec, after a single
      dose is given by injection under the skin and directly into a vein.

      Participation in this study includes screening, which is required within 28 days before start
      of study and a follow up at least 28 days after receiving the last dose of study drug.

      This study has 3 parts:

        -  Participants in Part A will complete 1 study period (approximately 1 week).

        -  Participants in Part B will complete 3 study periods (approximately 3 weeks).

        -  Participants in Part C will complete 2 study periods (approximately 2 weeks).
    

Detailed description: 
      Parts B and C added per protocol amendment, approved in April 2019.
    

Intervention name(s): LY3374849 - SC; Insulin Degludec - SC; LY3374849 - IV; Insulin Degludec - IV
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered IV; Administered IV
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parts B and C are crossover design.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science