bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3819253 (LY-CoV555) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and tolerability of LY3819253 when it is
      given by injection just under the skin to healthy participants. Blood tests will be done to
      check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it.
      Participation could last up to 16 weeks and may include up to six visits to the study center,
      with a one-week overnight stay.
    


Intervention name(s): LY3819253; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC.; Administered SC.
Other intervention name(s): LY-CoV555; Bamlanivimab
Intervention MeSH terms: Bamlanivimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032
      combination therapy in Japanese subjects.
    


Intervention name(s): BMS-790052 (Daclatasvir); BMS-650032 (Asunaprevir)
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 60mg, Once daily, 24 weeks; Capsules, Oral, 100mg, Twice daily, 24 weeks
Intervention MeSH terms: Asunaprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C Virus Infection
Preoperative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer
Condition: Rectal Neoplasms
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase II trial is to determine the efficacy and safety of the combination
      of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced
      cancers of the rectum.
    


Intervention name(s): Oxaliplatin; Capecitabine; Radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): 60mg/m² as a 2-hour intravenous infusion every week for 5-6 week; 500mg tablets and 150mg tablets. 750mg/m² bd given approximately 12 hours apart; Planned total dose of 45-50.4Gy (with cone down) in 25-28 fractions
Intervention MeSH terms: Capecitabine; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioavailability Study to Compare OPTINOSE SUMATRIPTAN With IMITREX® in Healthy Subjects
Condition: Migraine
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is:

        -  To compare the single-dose pharmacokinetics (PK) of intranasal administration of 20 mg
           OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX®
           (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in
           healthy subjects.

        -  To estimate the relative bioavailability of single-dose intranasal administration of 20
           mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX®
           (sumatriptan) Oral Tablet compared to a single-dose of 6 mg IMITREX® (sumatriptan)
           Subcutaneous Injection, in healthy subjects.
    


Intervention name(s): Sumatriptan
Intervention type(s): Drug
Intervention description(s): To compare the single-dose pharmacokinetics (PK) and relative bioavailability of intranasal administration of 20 mg OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects.
Intervention MeSH terms: Sumatriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sumatriptan; bioavailability
A Clinical Trial to Evaluate the Safety and Immunogenicity of PPV23 Vaccine Revaccinated in 60-70 Years Old
Condition: Vaccination
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: To evaluate the safety and immunogenicity of PPV23 vaccine revaccinated in 60-70
      years old in Shanghai.
    

Detailed description: 
      1. Antibody double growth rate in 28-40 days after immunization;

        2. Antibody GMC level in 28-40days after immunization;

        3. Incidence of adverse reactions in 0-30days.
    

Intervention name(s): 23-valent pneumococcal polysaccharide vaccine
Intervention type(s): Biological
Intervention description(s): The study group and the control group were vaccinated with one dose of vaccine and blood was collected after 28-40 days.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Study group is PPV23 revaccination and control group PPV23-vaccination.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: safety; immunogenicity
A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia B
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will examine the safety and efficacy of a Recombinant Coagulation Factor IX
      Albumin Fusion Protein (rIX-FP) for the control and prevention of bleeding episodes in
      subjects who have previously received factor replacement therapy for hemophilia B. The study
      consists of a screening period, a pharmacokinetic (PK) period, followed by approximately a 5
      month treatment period. Subjects will receive weekly routine prophylactic therapy and
      on-demand treatment for bleeding episodes. In addition, subjects who are not on routine
      factor replacement therapy prior to the study will receive only on-demand treatment for
      bleeding episodes.
    


Intervention name(s): Recombinant Coagulation Factor IX Albumin Fusion Protein
Intervention type(s): Biological
Intervention description(s): Study subjects will receive a single dose of 25IU/kg of rIX_FP for pharmacokinetic analysis. Subjects will then be treated for approximately 5 months. The treatment dose will be based on the subject's PK profile and the subject's bleeding phenotype.
Other intervention name(s): CSL654
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy
      compared with the monotherapy by TS-1 alone.
    

Detailed description: 
      This is a randomized, controlled, open-label, parallel, multicenter study. Patients are
      stratified according to 3 factors ; performance status (ECOG scale: 0, 1, 2), disease stage
      (unresectable gastric cancer or recurrent gastric cancer (received prior adjuvant
      chemotherapy or not)) and participating center. Patients are randomized to one of two
      treatment arms. Arm A: Patients receive oral TS-1 twice daily on days 1-28 followed by 14
      days rest. Treatment is repeated every 42 days for up to 4 courses. Arm B: Patients receive
      CDDP iv on day 8 and oral TS-1 twice daily on days 1-21 followed by 14 days rest. Treatment
      is repeated every 35 days for up to 5 courses. Patients are followed every 6 months for up to
      2 years from the day they participates in this study.
    

Intervention name(s): TS-1 and cisplatin; TS-1
Intervention type(s): Drug; Drug
Intervention description(s): TS-1(40-60 mg per body surface area) was given orally, twice daily for 3 consecutive weeks, and 60 mg/m2 cisplatin was given intravenously on day 8, followed by a 2-week rest period, within a 5-week cycle.; TS-1(40-60 mg per body surface area) was given orally, twice daily for 4 consecutive weeks, followed by a 2-week rest period, within a 6-week cycle.
Intervention MeSH terms: Cisplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stomach cancer
Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer
Condition: Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHN
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, open-label, multi-center, global, Phase III study to determine the
      efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy
      versus SoC therapy in the target patient population.
    

Detailed description: 
      This is a randomized, open-label, multi-center, global, Phase III study to determine the
      efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy
      versus SoC therapy in the target patient population.

      The main objectives of the study are to:

        -  assess the efficacy of MEDI4736 + tremelimumab combination therapy versus SoC in
           patients with squamous cell carcinoma of the head and neck (SCCHN), in terms of overall
           survival (OS), regardless of PDL-1 status

        -  assess the efficacy of MEDI4736 monotherapy versus SOC in patients with SCCHN, in terms
           of OS, regardless of PDL-1 status

      Patients will undergo a screening assessment on their tumor tissue sample to determine PD-L1
      expression per a pre-specified cut-off level. Patients with ≥25% of tumor cells with membrane
      staining will be considered PD-L1 positive while those with 0% to 24% of tumor cells with
      membrane staining will be considered PD-L1 negative. Based on the underlying PD-L1 status,
      patients will be randomized in a 1:1:1 ratio to receive treatment with MEDI4736 monotherapy,
      MEDI4736 + tremelimumab combination therapy, or SoC therapy. Patients who discontinue
      treatment in 1 treatment group may not switch to treatment in a different group.

      Stratification factors include PD-L1 status, human papillomavirus status, (in patients with
      oropharyngeal cancer only), and smoking status.

      Tumor assessments will be performed every 8 weeks until objective tumor response by Response
      Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
    

Intervention name(s): MEDI4736; MEDI4736 + Tremelimumab; Standard of Care
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MEDI4736 Monotherapy; MEDI4736 + Tremelimumab combination therapy; Standard of Care
Intervention MeSH terms: Durvalumab; Tremelimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and Neck cancer; MEDI4736; Tremelimumab
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BEA 2180 BR in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Main study: To investigate safety, tolerability, pharmacodynamics (PD) and pharmacokinetics
      (PK) of BEA 2180 BR Sub-study; To investigate whether treatment with 36 μg tiotropium bromide
      is able to protect of methacholine-induced bronchoconstriction compared to baseline
      (methacholine challenge at screening).
    


Intervention name(s): BEA 2180 BR; Placebo; Respimat® A 4; Methacholine Chloride; Spiriva
Intervention type(s): Drug; Drug; Device; Drug; Drug
Intervention description(s): methacholine challenge test
Other intervention name(s): tiotropium bromide
Intervention MeSH terms: Bromides; Tiotropium Bromide; Methacholine Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
4-Day Primary Irritation Patch Test of MIS Solution
Condition: Healthy; Irritation/Irritant; Reactions Adverse
Study type: Interventional

Summary: 
      This is a 7 day primary irritation patch test. This study investigates the irritation
      potential of Next Science MIS Wound Irrigation Solution under standardized conditions
      compared with an inert control (normal saline) and a known irritant, 20% sodium dodecyl
      sulfate (also known as sodium lauryl sulfate [SLS]) solution in deionized water [DI] water)
      on intact skin of healthy human subjects.
    

Detailed description: 
      In accordance with ISO 10993-10:2010(E), study products will be delivered via dermal patch at
      15 and 30 minutes (min) and up to 1-hour (h), 2-h, 3-h, 4-h and then, pending results, 24-h
      (evaluated up to at least 48-h) continuous exposure. Response rate will be evaluated
      immediately after application then 1 h, 2 h, 24 h, 48 h, and then 72 h post-exposure.
    

Intervention name(s): NS Solution; Normal Saline; SLS
Intervention type(s): Device; Other; Other
Intervention description(s): This will be administered via skin patch.; This will be administered via skin patch.; This will be administered via skin patch.
Other intervention name(s): Antimicrobial Solution; Negative Control; Positive Control
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects act as their own control. They each receive all three study treatment via patch application.
Masking: None (Open Label)
Primary purpose: Other
A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effect of ticagrelor versus placebo in patients
      with Type 2 Diabetes Mellitus.
    

Detailed description: 
      A multinational, randomised, double-blind, placebo-controlled phase IIIb trial to evaluate
      the effect of ticagrelor twice daily on the incidence of cardiovascular death, myocardial
      infarction or stroke in patients with type 2 diabetes mellitus
    

Intervention name(s): Ticagrelor 60 mg; Ticagrelor placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ticagrelor 60 mg bd taken orally as tablets; Ticagrelor placebo bd taken orally as tablets
Other intervention name(s): Brilinta/Brilique
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diabetes; Coronary artery disease; Outcome; Prevention; Antiplatelet
Drug Interaction - Oral Contraceptive
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to administer a combined oral contraceptive containing ethinyl
      estradiol and norgestimate with the HIV treatment of efavirenz to healthy females in order to
      assess if the concentrations of the oral contraceptives change. The safety of this treatment
      regimen will also be studied.
    


Intervention name(s): Ortho Tri-Cyclen LO; Ortho Cyclen; Ortho Cyclen + Efavirenz; Ortho Cyclen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets, oral, OTC Lo 1 tab/daily (no dosage units), once daily, 28 days.; Tablet, oral, Ortho Cyclen 1 tab/daily (no dosage units), once daily, 28 days.; Tablet, oral, OC + EFV 600 mg, once daily, 14 days.; Tablet, oral, OC 1 tab daily (no dosage units), once daily, 7 days.
Other intervention name(s): Sustiva
Intervention MeSH terms: Efavirenz; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: HIV
Study of Efficacy of Phenytoin in Therapy of Patients With Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was evaluation the efficacy of antiepileptic drug phenytoin
      (diphenine) in the treatment of bronchial asthma.
    

Detailed description: 
      Effective therapy of asthma still remains quite serious problem. According current opinion of
      leading specialists, asthma is an inflammatory disorder. But asthma also is a paroxysmal
      disorder: many specialists underline paroxysmal clinical picture of asthma. According to some
      authors, neurogenic inflammation may play important role in asthma mechanism. But migraine
      and trigeminal neuralgia are also neurogenic inflammatory paroxysmal diseases, and some
      antiepileptic drugs, like diphenine and valproates, are very effective in therapy of these
      diseases - more than in 80% of cases. If bronchial asthma also is paroxysmal inflammatory
      disease, we can suppose a possibility that some antiepileptic drugs also may show high
      efficacy in asthma therapy. Taken in consideration this hypothesis, we performed a
      double-blind, placebo-controlled 3-month trial for evaluation of phenytoin (diphenine)
      efficacy in treatment of patients with bronchial asthma.
    

Intervention name(s): Diphenine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Bronchial asthma; Phenytoin, Diphenine; Antiepileptic drugs; Efficacy
Supportive Wheelchair Back Compared to Fabric Back
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      This study tests using a wheelchair back that supports the spine in a neutral position and
      one that allows the spine and pelvis to fall into a posterior pelvic tilt.
    

Detailed description: 
      Individuals will randomly start with the supportive back vs the unsupportive back.
      Measurements of the spine and pelvis will be taken. Forward upward reach, one stroke push,
      times forward push and ramp skills will be assessed.
    

Intervention name(s): Matrix back
Intervention type(s): Device
Intervention description(s): The Matrix back will replace the individual's back and the measures will be taken.
Intervention model: Single Group Assignment
Intervention model description: comparing two different back support to access if there are postural and functional differences.
Masking: None (Open Label)
Primary purpose: Other
Cediranib (AZD2171, RECENTIN™) in Metastatic or Recurrent Renal Cell Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Cediranib is being tested to assess its effectiveness on the growth of kidney cancer tumours
      and also how well it is tolerated.
    


Intervention name(s): Cediranib; Cediranib Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 45 mg oral tablet; oral tablet
Other intervention name(s): AZD2171; RECENTIN™
Intervention MeSH terms: Cediranib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cancer; tumour; advanced cancer; Metastatic renal cell carcinoma; kidney cancer; RECENTIN
SP16 SERPIN-like Peptide Administration in Healthy Individuals
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, double-blind, placebo-controlled Phase 1 Clinical Trial of 24
      healthy individuals to test the safety, tolerability and pharmacokinetics of a single
      subcutaneous administration of Serpin Peptide 16 (SP16), a Serine Protease Inhibitor
      (Serpin)-like, small peptide agonist of the Low Density Lipoprotein Receptor-like Protein 1
      (LRPP1) hypothesized to have anti-inflammatory activity.
    

Detailed description: 
      One of the major determinants for outcome in patients with acute myocardial infarction (AMI)
      is the degree of inflammatory response. SP16 is a synthetic anti-inflammatory peptide
      developed to reproduce the anti-inflammatory activities of naturally occurring Serpins and
      has been tested as a treatment for AMI in mice. This Phase I trial will be the first to test
      the hypothesis that a single subcutaneous administration of SP16 is safe and well tolerated
      in healthy individuals, while also assessing the pharmacokinetic parameters of three
      different dosages. Participants will undergo direct clinical monitoring for up to 12 hours
      after drug administration. Additionally, participants will follow up with the same
      assessments at 24 hours, 48-72 hours and 7 days post drug administration.
    

Intervention name(s): SP16; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection of experimental anti-inflammatory drug; subcutaneous injection of sterile saline
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study is set up as 3 sequential parallel studies, each testing a different drug dosage against placebo. In each dosing cohort, three patients (2 active and 1 placebo) will be randomized to receive a single study drug infusion on separate days, at least 24 hours apart. The remaining subjects in each dosing cohort (1 placebo and 4 active) will receive study drug after at least 24 hours from the 3rd subject.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: acute myocardial infarction; inflammation
Screen to Save: A Colorectal Cancer Educational Intervention
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this research is to understand if an educational program about colorectal
      cancer helps improve people's knowledge of colorectal cancer prevention and screening and
      their intention to get screened for colorectal cancer.
    


Intervention name(s): Inflatable colon educational module
Intervention type(s): Behavioral
Intervention description(s): Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Knowledge