bioihbjkbjnl/mcl2 huggingface dataset:
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
Condition: Covid19
MeSH terms: COVID-19
Intervention: BGB-DXP593; Placebo
Intervention description: Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm; Placebo to match BGB-DXP593 administered as specified in the treatment arm
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of BGB-DXP593 administered
      intravenously as a single dose in participants with mild to moderate COVID-19
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Laboratory-confirmed severe acute respiratory syndrome (SARS)-CoV-2 infection
             (positive reverse transcription-polymerase chain reaction [RT-PCR] test or other
             authorized antigen testing methods) in any samples following local practice ≤ 72 hours
             prior to screening.

          2. Have experienced COVID-19 symptoms for ≤ 7 days prior to treatment assignment, such as
             fever, cough, shortness of breath, sore throat, diarrhea, vomiting, and dysgeusia

          3. Agree to the collection of nasopharyngeal swabs, saliva, and venous blood

        Key Exclusion Criteria:

          1. Severe COVID-19 having oxygen saturation (SpO2) ≤ 93 % on room air at sea level or
             ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to
             fractional inspired oxygen (FiO2) < 300, respiratory rate ≥ 30/min, heart rate ≥
             125/min

          2. Requires mechanical ventilation or anticipated impending need for mechanical
             ventilation

          3. Known allergies to any of the components used in the formulation of the interventions

          4. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30
             days before dosing

          5. Have received treatment with a SARS-CoV-2 specific monoclonal antibody

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Vinflunine in the Treatment of Patients With Relapsed Extensive Small Cell Lung Cancer
Condition: Carcinoma, Small Cell; Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Small Cell
Intervention: Vinflunine
Intervention description: 320mg/m2 every 21 days as a 15-20 minute infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Extensive stage; Relapsed

Summary:

      This clinical trial involves the administration of the chemotherapeutic medication
      vinflunine. Vinflunine is not approved by the FDA and is experimental in the treatment of
      extensive small cell lung cancer. The purpose of this research trial is to study the
      effectiveness of vinflunine in patients with relapsed extensive small cell lung cancer,
      evaluate the toxicity, and evaluate how long the response to this drug lasts.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Small cell lung cancer with progression after one previous chemotherapy or
             chemotherapy/radiation therapy regimen

          -  Measurable or evaluable disease

          -  Able to perform activities of daily living with minimal assistance

          -  Adequate hematological, liver, and kidney function

          -  Must give written informed consent prior to entry

        Exclusion Criteria:

          -  CNS involvement

          -  Serious active infection or underlying medical condition

          -  Significant history of uncontrolled cardiac disease
Pemetrexed/Carboplatin Non-Small Cell Lung Cancer (NSCLC) Elderly Patients
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: pemetrexed; carboplatin
Intervention description: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles; Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
Intervention MeSH terms: Carboplatin; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      A phase II study to evaluate the efficacy and safety profile of the combination of Pemetrexed
      and Carboplatin in elderly patients with advanced non-small cell lung cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed Non Small Cell Lung Cancer Stage IIIb (not amenable to
             radiotherapy treatment) or Stage IV

          -  No previous chemotherapy for lung cancer

          -  Men and women > or = 70 years

          -  At least one uni-dimensionally measurable lesion (Response Evaluation Criteria In
             Solid Tumors [RECIST]criteria)

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1

        Exclusion Criteria:

          -  Treatment within the last 30 days with a drug that has not received regulatory
             approval

          -  Serious systemic disorders

          -  Inability to discontinue administration of aspirin or anti-inflammatory non steroid

          -  Concurrent administration of any other antitumor therapy

          -  Brain metastasis
Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy
Condition: Pancreas Cancer; Pancreas Disease; Pancreas Adenocarcinoma; Pancreas; Fistula; Surgery; Surgery--Complications; Surgery Site Fistula
MeSH terms: Pancreatic Neoplasms; Pancreatic Fistula; Pancreatic Diseases; Fistula
Intervention: Hemopatch
Intervention description: Application of hemopatch to the divided end of the pancreas during surgery.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemopatch

Summary:

      Despite improvements and advances in pancreas surgery, about 30-35% of patients who have
      pancreas surgery develop a type of complication called a pancreatic fistula. A pancreatic
      fistula occurs when fluid produced by the pancreas leaks into the abdomen after pancreas
      surgery. Patients who develop a pancreatic fistula can have poor short-term and long-term
      consequences.We are studying the effect of a medical device named HEMOPATCH on the
      development and seriousness of pancreatic fistulas. HEMOPATCH is a thin, flexible bovine
      protein-based pad that may improve tissue sealing where it is applied during surgery. Some
      small studies called case studies of between 2 and 7 patients, and two clinical trials have
      shown that HEMOPATCH is effective at stopping bleeding and reducing drain output after some
      types of surgery. However, there have been no completed clinical trials using HEMOPATCH to
      prevent or reduce pancreatic fistulas in patients having pancreas surgery, so we don't know
      if it works in this setting. Health Canada has approved the use of HEMOPATCH as a device to
      stop bleeding or seal other bodily fluids for procedures in which the control of bleeding or
      leakage of other body fluids or air by standard surgical techniques are either ineffective or
      impractical.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled to undergo distal pancreatectomy surgery that is open or laparoscopic, with
             or without splenectomy

          -  Age ≥ 18 years

          -  Able and willing to comply with study procedures and follow-up examinations contained
             within the written consent form

        Exclusion Criteria:

          -  Contraindication to placement of HEMOPATCH tissue sealant including: 1) Known
             hypersensitivity to bovine proteins; 2) Known hypersensitivity to brilliant blue [FD&C
             Blue No.1 (Blue 1)]; 3) Presence of an active infection; and 4) Known pregnancy or
             lactation (a negative urine pregnancy test must be obtained for women of child bearing
             potential during the pretreatment evaluation)

          -  Participating in another interventional trial that may result in co-intervention or
             contamination (to be determined by sponsor)
RDEA3170 and Febuxostat Combination Study in Gout Subjects
Condition: Gout
MeSH terms: Gout
Intervention: RDEA3170 15 mg; RDEA3170 10 mg; RDEA3170 2.5; RDEA3170 5 mg; Febuxostat 40 mg; Febuxostat 80 mg
Intervention MeSH terms: Febuxostat; Verinurad
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic
      (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to
      febuxostat administered alone in adult subjects with gout.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to understand the study procedures and the risks involved and is willing to
             provide written informed consent before the first study-related activity.

          -  Meets one or more criteria for the diagnosis of gout as per the American Rheumatism
             Association Criteria for the Classification of Acute Arthritis of Primary Gout.

          -  Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 45 kg/m2.

          -  Screening serum urate level ≥ 8 mg/dL.

          -  Free of any clinically significant disease or medical condition, per the
             Investigator's judgment.

        Exclusion Criteria:

          -  Unable to take colchicine for gout flare prophylaxis.

          -  History or suspicion of kidney stones.

          -  Any gastrointestinal disorder that affects motility and/or absorption.

          -  Unstable angina, New York Heart Association class III or IV heart failure, ischemic
             heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or
             subject is currently receiving anticoagulants.

          -  Screening laboratory parameters that are outside the normal limits and are considered
             clinically significant by the Investigator.

          -  Estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula
             using ideal body weight during the Screening period.

          -  Taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2
             inhibitors; chronic and stable doses are permitted if doses are stable for at least 14
             days prior to study medication dosing.

          -  Unable or unwilling to comply with the study requirements or has a situation or
             condition that, in the opinion of the Investigator, may interfere with participation
             in the study.
Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse
Condition: Dental Plaque; Dental Caries
MeSH terms: Dental Caries; Dental Plaque
Intervention: Bromelain; Powdered sugar
Intervention description: The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention.; The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Enrolled subjects undergoing orthodontic treatment with fixed appliances will be randomized to receive either the Bromelain rinse or Placebo first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment period (1 day) separated by a washout period of 1 week.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking description: Investigators were blinded during the clinical phase of the study and were unaware of the agents the subjects received. The investigators were also blinded during the visual plaque score analysis of the project and were unaware of what photograph corresponded to what phase or intervention.
Enrollment: 46.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: proteolytic enzyme; plaque removal; oral hygiene; orthodontic treatment

Summary:

      This study aims to investigate the impact of a bromelain pre-rinse adjunct on oral plaque
      removal in orthodontic subjects. The study's null hypothesis states that there is no
      statistically significant difference in visual plaque scores among orthodontic subjects with
      or without proteolytic enzyme rinse aid.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female

          -  10 to 25 years of age

          -  willing to consent to participation

          -  able to follow study instructions

          -  in active orthodontic treatment with fixed orthodontic appliances

        Exclusion Criteria:

          -  unwilling/unable to follow study instructions

          -  documented/suspected pineapple allergy

          -  proteolytic enzyme allergy

          -  food dye allergy

          -  smoker
Interferon-alpha Lozenges for Prevention of Relapse in Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: interferon-alpha lozenges; placebo lozenges
Intervention description: 500 IU lozenges of natural human interferon-alpha for oral dissolution given once or three times per day for 24 weeks; 200 mg matching placebo lozenges
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Interferon-alfa-1b
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 169.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Prevention of Relapse; HCV genotype 1b; Recurrence

Summary:

      The purpose of this study is to determine whether lozenges of interferon-alpha that are
      dissolved in the mouth can prevent relapse in patients with hepatitis C virus infection who
      had a complete virologic response after receiving a combination of injected interferon-alpha
      and oral ribavirin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HCV genotype 1b

          -  Will be completing pegylated IFN-alpha and ribavirin therapy within 4 weeks

          -  Serum HCV RNA negative within 4 weeks of study entry

        Exclusion Criteria:

          -  Child-Pugh score of B or C

          -  Decompensated liver function

          -  History of malignancy within past 5 years

          -  Other causes of liver disease besides HCV infection

          -  Uncontrolled diabetes or hypertension

          -  Unwilling to use two forms of birth control during study treatment
AMG 827 in Subjects With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: AMG 827 140; Placebo; AMG 827 280; AMG 827 210
Intervention description: 140 mg AMG 827 SC (subcutaneous); Placebo SC (subcutaneous); 280 mg AMG 827 SC (subcutaneous); 210 mg AMG 827 SC (subcutaneous)
Intervention MeSH terms: Brodalumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; IL-17; AMG 827; AMG827; Musculoskeletal Disease; Spondylarthropathy

Summary:

      The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic
      arthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has had a diagnosis of psoriatic arthritis (by the Classification of Psoriatic
             Arthritis (CASPAR) criteria) for at least 6 months

          -  Subject has ≥ 3 tender and ≥ 3 swollen joints

        Exclusion Criteria:

          -  Subject has an active infection or history of infections (systemic anti-infectives
             were used within 28 days; requiring hospitalization or intravenous anti-infectives
             within 8 weeks; recurrent or chronic)

          -  Significant concurrent medical conditions

          -  Pregnant or breast feeding

          -  Significant Laboratory abnormalities

          -  Use of sulfasalazine, hydroxychloroquine, systemically administered calcineurin
             inhibitors, azathioprine, parenteral corticosteroids including intramuscular or
             intraarticular administration, or live vaccines within 28 days

          -  Use of anti-TNF therapy within 2 months

          -  Use of an anti-interleukin (IL)12/IL-23 drug or other experimental or commercially
             available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months

          -  Prior use of rituximab

          -  Prior use of anti-IL-17 biologic therapy, including AMG 827
Dose Ranging Study of the Safety and Efficacy of Orally Administered Lyophilized Fecal Microbiota Product (PRIM-DJ2727) for the Treatment of Recurrent Clostridium Difficile Infection (CDI)
Condition: Recurrent C. Difficile Infection
MeSH terms: Infections; Communicable Diseases; Clostridium Infections; Recurrence
Intervention: Low fecal microbiota dose; Mid fecal microbiota dose; High fecal microbiota dose
Intervention description: receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days; receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment; receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      To establish optimal dosing of lyophilized Fecal microbiota transplantation (FMT) product in
      the treatment of recurrent C. difficile infection
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sexually active female subjects of child-bearing potential must agree to use an
             effective method of birth control during the treatment and follow-up period

          -  Female subjects of child-bearing potential must have a negative pregnancy test on the
             day of the procedure.

          -  Subject willing to sign an informed consent form

          -  Subject deemed likely to survive for ≥ 1 year after enrollment

          -  Able to follow study procedure and follow-ups

          -  Subjects' attending physician will provide non-transplant care for the subject

          -  Diagnosed by medical history of ≥ 3 bouts of CDI in outpatients or ≥ 2 bouts of
             recurrent CDI in an inpatient with ≥ 2 positive fecal tests for C. difficile toxin

          -  Received at least one course of adequate antibiotic therapy for CDI (≥ 10 days of
             vancomycin or metronidazole or fidaxomicin) since last bout of CDI

          -  Have a 4 degrees Celsius refrigerator at home to keep the second dose FMT for
             overnight

        Exclusion Criteria:

          -  Unable to take capsules orally

          -  Requiring systemic non-C. difficile antibiotic therapy within 14 days prior to FMT

          -  Actively taking Saccharomyces boulardii or other probiotic at the time of FMT other
             than that found in fortified foods

          -  Need for continuing use of drugs with CDI activity: oral vancomycin, oral or IV
             metronidazole, fidaxomicin, rifaximin or nitazoxanide at the time of FMT and after FMT

          -  Severe underlying disease such that the patient is not expected to survive for one or
             more years or unstable medical condition requiring daily change in treatments
A Study of LY3454738 in Adults With Chronic Spontaneous Urticaria
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: LY3454738; Placebo
Intervention description: Administered IV; Administered IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The reason for this study is to see if the study drug LY3454738 is safe and effective as
      treatment for participants with hives that are caused by chronic spontaneous urticaria (CSU)
      and that are not controlled with H1-antihistamines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must agree to use appropriate birth control throughout the study

          -  Must have a diagnosis of CSU for at least 6 months

          -  Must have CSU symptoms for at least 8 consecutive weeks despite taking anti-histamines

          -  Must agree to take an anti-histamine every day during the trial

          -  Must be willing to enter information about symptoms in an electronic diary twice a day

        Exclusion Criteria:

          -  Must not have a cause, other than CSU, for itching, hives, and/or angioedema (swelling
             beneath the skin)

          -  Must not have a current or recent active infection requiring antibiotics

          -  Must not have a history of anaphylaxis (severe, life threatening allergic reaction)

          -  Must not have asthma requiring medications other than short acting beta agonists
             (albuterol, etc.)

          -  Must not have received prior treatment with omalizumab, ligelizumab, or other
             experimental biologic for CSU