bioihbjkbjnl/mcl2 huggingface dataset:
IMCY-T1D-002: Long-term Follow-up Study of T1D Patients Previously Treated With IMCY-0098 or Placebo
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Intervention: IMCY-0098 or placebo
Intervention description: Long-term follow-up
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Long-term follow-up (LTFU), no study treatment administered.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Treatment or Placebo
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 31 Years
Healthy volunteers: No

Summary:

      This study is the follow-up of study IMCY-T1D 001 (EudraCT: 2016-003514-27, NCT03272269) in
      which patients with recent onset T1D have been treated with IMCY-0098 or placebo.

      At the end of the primary 6 month study, patients will be proposed to enter this follow-up
      study to evaluate up to 12 months (V3 - Week 48) the safety, the immune responses and the
      clinical parameters.

      The study involves a follow-up of 6 months after the end of the initial participation to the
      IMCY-T1D-001 study. Subjects will undergo visits at 24 weeks, 36 weeks and 48 weeks post
      first study product administration in study IMCY-T1D-001.

      For each patient, the study comprises a total of 3 visits occurring over a period of
      approximately 24 weeks (from study entry). The patients will undergo planned assessments and
      procedures as outlined in the table of study procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients who were treated with IMCY-0098 or placebo in the IMCY-T1D-001 clinical
             trial who are willing to participate to this long-term follow-up study.

        Exclusion criteria:

          -  Ongoing pregnancy or lactation

          -  History of or current malignancy (except excised basal cell skin cancer)

          -  Primary or secondary immune deficiency disorders

          -  Human Immunodeficiency virus (HIV) infection.

          -  Ongoing treatment with immunosuppressive agents with the exception of topical or intra
             nasal corticosteroids.

          -  Treatment with an investigational drug within the past 3 months
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection
Condition: Chronic Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Velpatasvir; Placebo
Intervention description: Tablets administered orally; Tablets administered orally
Intervention MeSH terms: Velpatasvir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hepatitis C; HCV; Genotype 1; Genotype 2; Genotype 3; Genotype 4; Genotype 5; Genotype 6; Liver Disease

Summary:

      The primary objective of the study is to evaluate the safety, tolerability, and antiviral
      activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes
      1-6.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  HCV treatment-naive adult participants (18-65 years of age) with chronic HCV infection
             and plasma HCV RNA ≥ 5 log10 IU/mL at screening

          -  Agree to use protocol defined precautions against pregnancy

        Key Exclusion Criteria:

          -  Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease,
             α1 antitrypsin deficiency, cholangitis)

          -  Evidence of cirrhosis

          -  Evidence of current drug abuse

          -  Screening laboratory results outside the protocol specified requirements

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC.; Administered SC.
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purposes of this study are to determine:

        -  The safety of tirzepatide and any side effects that might be associated with it.

        -  How much tirzepatide gets into the bloodstream and how long it takes the body to remove
           it.

        -  How tirzepatide affects the levels of blood sugar.

      This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC)
      injections just under the skin. The study will last about 16 weeks (total), including
      screening and follow-up. This study is for research purposes only and is not intended to
      treat any medical conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have T2DM controlled with diet and exercise alone or are stable on a single oral
             antidiabetic medication (metformin or dipeptidyl peptidase [DPP]-IV inhibitors)

          -  Have a body mass index of 20.0 to 35.0 kilograms per square meter, inclusive

        Exclusion Criteria:

          -  Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related
             compounds

          -  Have had more than 1 episode of severe hypoglycemia, as defined by the American
             Diabetes Association criteria, within 6 months before entry into the study or has a
             history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms

          -  Have an abnormality in the 12-lead electrocardiogram at screening that, in the opinion
             of the investigator, increases the risks associated with participating in the study

          -  Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or any GI
             disease which impacts gastric emptying or could be aggravated by GLP-1 analogs or
             DPP-IV inhibitors
A Study of Two Formulations of Ixekizumab in Healthy Participants
Condition: Healthy
Intervention: Ixekizumab
Intervention description: Administered SC.
Intervention MeSH terms: Ixekizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare two different formulations of ixekizumab. One
      formulation (Reference) is approved by the Food and Drug Administration (FDA) and one
      formulation (Test) is not approved. This study will compare how much of each formulation gets
      into the blood stream. Information about any side effects that may occur will also be
      collected. The study will last up to about four months for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are healthy male or female participants, with chronic stable medical problems, that in
             the investigator's opinion will not place the subject at increased risk by
             participating in the study

        Exclusion Criteria:

          -  Have a significant history of, or current, cardiovascular, respiratory, hepatic,
             renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of
             the investigator poses an unacceptable risk to the participant if participating in the
             study

          -  Are allergic or hypersensitive to the study medicine

          -  Had a vaccination with a live vaccine within 12 months prior to the first check-in or
             intend to get a vaccine for tuberculosis within 12 months of completing treatment on
             this study

          -  Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other
             serious infection

          -  Show evidence of active or latent tuberculosis (TB)

          -  Presence of significant neuropsychiatric disorder or a recent history of depression

          -  Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion
             of the investigator, would pose an unacceptable risk to the participant
Bioavailability of Doravirine (MK-1439) Experimental Nano Formulations in Healthy Adults (MK-1439-046)
Condition: Human Immunodeficiency Virus-1 (HIV-1)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Treatment A: Doravirine 100 mg film coated tablet; Treatment B: Doravirine 150 mg tablet (40% drug loaded granule); Treatment C: Doravirine 150 mg tablet (30% drug loaded granule); Treatment D: Doravirine 150 mg tablet (50% drug loaded granule); Treatment E: Doravirine 100 mg tablet (30% drug loaded granule)
Intervention description: Single doravirine 100 mg film coated tablet administered orally at the start of Period 2; Single doravirine NF Type 1 dose (150 mg tablet [40% drug loaded granule]) administered orally at the start of Period 1; Single doravirine NF Type 2 dose (150 mg tablet [30% drug loaded granule])administered orally at the start of Period 3; Single doravirine NF Type 3 dose (150 mg tablet [50% drug loaded granule])administered orally at the start of Period 4; Single doravirine NF Type 4 dose (100 mg tablet [30% drug loaded granule]) administered orally at the start of Period 5
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study aims to evaluate and compare the relative bioavailability of different doravirine
      (MK-1439) experimental nano formulations (NFs) with that of a doravirine film coated tablet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy participants

          -  have been a non-smoker and/or have not used nicotine or nicotine-containing products
             for at least approximately 3 months

        Exclusion Criteria:

          -  is a pregnant or a nursing female

          -  has a history of stroke, chronic seizures or major neurological disorder

          -  has a history of clinically significant endocrine, gastrointestinal, cardiovascular,
             hematological, hepatic, immunological, renal, respiratory, or genitourinary
             abnormalities or diseases

          -  has a history of neoplastic disease (including leukemia, lymphoma, malignant
             melanoma), or myeloproliferative disease
Study to Assess the Long-term Safety and Efficacy of Tirabrutinib in Adults With Relapsed/Refractory B-cell Malignancies
Condition: Relapsed/Refractory B-cell Malignancies
MeSH terms: Neoplasms
Intervention: Tirabrutinib
Intervention description: Tablets or capsules administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the long-term safety and tolerability of
      tirabrutinib in adults with relapsed/refractory B-cell malignancy who have tolerated and
      achieved stable disease or improved with tirabrutinib treatment while enrolled in a prior
      (parent study) tirabrutinib study (NCT01659255). The dosing regimen will be based on the
      prior dosing regimen from the parent study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Currently enrolled in a prior tirabrutinib study

          -  Did not discontinue treatment with tirabrutinib for any reason other than to enroll in
             this study

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at
             enrollment in this study

          -  Any Grade 3 or 4 non-hematologic toxicity that the investigator considers related to
             previous tirabrutinib use must have resolved, reverted to Grade 1, or reverted to the
             baseline of the prior study prior to Day 1 of this study

          -  Negative serum and urine pregnancy test is required for female individuals (unless
             surgically sterile or greater than 2 years post menopausal)

          -  Male and female individuals of childbearing potential who engage in heterosexual
             intercourse must agree to use protocol specified method(s) of contraception as
             described in the protocol

          -  Lactating females must agree to discontinue nursing before the study drug is
             administered

          -  Ability and agreement to attend protocol-specified visits at the study site

          -  Able to comprehend and willing to sign the informed consent form

        Key Exclusion Criteria:

          -  Known hypersensitivity to tirabrutinib, its metabolites, or formulation excipients

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Plitidepsin; Bortezomib; Dexamethasone
Intervention MeSH terms: Dexamethasone; Bortezomib
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: multiple myeloma; plitidepsin; APLIDIN

Summary:

      Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in
      Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory
      Multiple Myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years.

          -  Prior autologous transplantation (HSCT) patients are allowed.

          -  Patients must have received at least one previous treatment line of induction,
             chemotherapy, chemotherapy and transplantation or previous treatment with bortezomib
             or another proteasome drug

        Exclusion Criteria:

          -  Previous treatment with plitidepsin.

          -  Active or metastatic primary malignancy other than MM.

          -  Serious concomitant systemic disorders

          -  History of hypersensitivity reactions to bortezomib, polyoxyl 35 castor oil or
             mannitol

          -  Neuropathy

          -  Pregnant and/or lactating women

          -  HIV infection

          -  Active hepatitis B or C virus infection.

          -  Treatment with any Investigational Medicinal Product (IMP) in the 30 days before
             inclusion in the study

          -  Plasma cell leukemia at the time of study entry

          -  Contraindication for the use of steroids
Oral AGY for Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Intervention: AGY
Intervention description: AGY is a natural health product produced in egg yolks
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All participants received open label AGY, a natural health product
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Celiac disease; AGY

Summary:

      Celiac disease (CD) is an autoimmune disease of the small intestine caused by the consumption
      of gluten proteins from widely used food sources such as wheat, rye, and barley. Exposure of
      the small intestine to gluten causes an inflammatory response, leading to the destruction of
      intestine lining, often with severe symptoms including diarrhea, abdominal distention,
      fatigue, weight loss, anemia, and neurological symptoms. CD is a lifelong disease and the
      only treatment currently available is strict adherence to a life-time gluten free diet (GFD).
      However, adhering to this diet is difficult as gluten proteins are found in many food
      products. Therefore, the gluten-free diet has both lifestyle and financial implications for
      the individual and thus has been potential for impacting adversely on their quality of life.

      Various approaches are being studied to reduce the need for careful control of the diet for
      those with CD, including the use of antibodies such as IgY. IgY is produced from the egg
      yolks of super immunized laying hens. Egg yolk antibodies are natural products with minimal
      toxicity, for those without egg allergy, and offer low-cost, hygienic production of study
      product. Once the IgY antibody is put into capsule form, it is called AGY.

      Individuals with CD will be recruited only if they have a history of biopsy proven CD,
      currently follow a GFD but continue to have mild to moderate symptoms related to gluten
      exposure, and do not have an egg allergy. Blood will be tested for ATG antibody levels at
      screening. Those enrolled will have a 2 week run-in period where diet and symptoms are
      recorded, and will then receive AGY capsules to take with meals over a 4 week period.
      Outcomes will be measured by examining lab test results including antibody levels, symptoms,
      and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 or over

          -  confirmed diagnosis of Celiac disease by previous biopsy

          -  follow a gluten-free diet (GFD)

          -  have mild to moderate symptoms despite the GFD diet

        Exclusion Criteria:

          -  diabetic

          -  use of steroids in previous year

          -  current use of ASA/NSAIDs, metronidazole, or misoprostol

          -  excess alcohol intake

          -  egg allergy

          -  history of severe complications of celiac disease or chronic active GI disease

          -  pregnancy
Spironolactone Versus Prednisolone in DMD
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Spironolactone; Prednisolone
Intervention description: Spironolactone will be prescribed for 6 months, after which the family and primary care physician will determine to either remain on spironolactone or transfer to prednisolone.; Prednisolone will be prescribed for 6 months as the clinical standard of care.
Intervention MeSH terms: Prednisolone; Spironolactone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned to either to the spironolactone treatment group or to the standard clinical dose of corticosteroids.
Masking: None (Open Label)
Enrollment: 2.0
Sex: Male
Minimum age: 4 Years
Maximum age: 7 Years
Healthy volunteers: No

Summary:

      This is a randomized, open-label, pilot clinical trial of spironolactone suspension versus
      oral prednisolone for use in Duchenne muscular dystrophy. The goals are to determine the
      safety of 6 months of treatment with spironolactone treatment int he steroid-naive DMD
      population as well as to determine if either spironolactone or a standard clinical dose of
      corticosteroids results in equivalent improvement in time to complete the 100 meter timed
      test (100M).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Duchenne muscular dystrophy (DMD) patients ≥4 to ≤7 years of age

          -  Clinical features of DMD that include proximal predominant weakness and/or gait
             disturbance

          -  Presence of a truncating mutation of the DMD gene in the patient or an affected male
             relative OR a muscle biopsy that demonstrates <5% dystrophin in the patient or an
             affected male relative

          -  Normal left ventricular ejection fraction by screening echocardiogram

          -  Ability to cooperate for testing

          -  No prior treatment with glucocorticoids or vamorolone

          -  No concomitant experimental therapies

        Exclusion Criteria:

          -  Subject amenable to or currently being treated with eteplirsen, casimersen, or
             viltolarsen

          -  Hyperkalemia at screening

          -  History of or ongoing renal failure (elevated creatinine, oliguria, anuria)

          -  Hypersensitivity to spironolactone (rash, respiratory distress, arrhythmia, numbness
             or tingling of extremities)

          -  Current treatment with an ACEi

          -  Severe peptic ulcer disease or recent gastrointestinal perforations