bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Pharmacokinetics of Oral Islatravir (MK-8591) Once Monthly in Participants at Low Risk of Human Immunodeficiency Virus 1 (HIV-1) Infection (MK-8591-016)
Condition: HIV-1 Infection
MeSH terms: Infections; Communicable Diseases
Intervention: Islatravir; Placebo
Intervention description: Islatravir 30 mg capsules taken by mouth.; Placebo capsules taken by mouth.
Intervention MeSH terms: Islatravir
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the safety, tolerability and pharmacokinetics (PK) of 6 once-monthly
      doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of
      HIV-1 infection
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is in general good health with acceptable laboratory values at screening

          -  Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before
             randomization

          -  Has low risk of HIV infection, within 12 months prior to screening visit or the
             rescreening visit (if applicable)

          -  Use contraceptives consistent with local regulations

          -  Female is not pregnant or breastfeeding, and is not a woman of childbearing potential
             (WOCBP)

          -  A WOCBP is using an acceptable contraceptive method, or is abstinent from heterosexual
             intercourse as their preferred and usual lifestyle; or has a negative pregnancy test.

        Exclusion Criteria:

          -  Has hypersensitivity or other contraindication to any of the components of the study
             interventions as determined by the investigator

          -  Has an active diagnosis of hepatitis due to any cause

          -  Has a history of malignancy ≤5 years prior to signing informed consent except for
             adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

          -  Is taking or is anticipated to require systemic immunosuppressive therapy, immune
             modulators, or any prohibited therapies from 30 days prior to Day

             1 through the duration of the study.

          -  Is currently participating in or has participated in an interventional clinical study
             with an investigational compound or device within 30 days prior to Day1 through the
             duration of the study.

          -  Has previously been randomized in a study and received islatravir (MK-8591).

          -  Female is expecting to conceive or donate eggs at any time during the study

          -  Has QTc interval (using Fridericia correction) >450 msec (for males) or >460 msec (for
             females) or deemed clinically abnormal by the investigator.
Efficacy of Fluocinonide Cream 0.1% (Vanos(R)) in Reducing Itch in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Fluocinonide cream
Intervention description: Fluocinonide cream 0.1% applied twice daily for 5 days.
Intervention MeSH terms: Fluocinonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: eczema; itch; scratching; actigraphy; adherence

Summary:

      The purpose of this study is to assess the efficacy of short-term treatment with fluocinonide
      cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female with mild to severe atopic dermatitis, 12 years of age or older, that
             agree to participate and provide written consent (parent permission and assent if
             applicable).

          -  Have an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating
             of 2 through 4 in the Investigator Global Assessment).

          -  Visual Analog Scale of Itch score at Baseline must be greater than or equal to 50 on a
             100-point scale.

          -  Percentage of overall body surface area of involvement (BSA) must be ≥2%.

          -  Women of childbearing potential will be allowed to participate in the study, and will
             be required to use at least one form of birth control.

        Exclusion Criteria:

          -  Use within four weeks from Baseline any systemic anti-inflammatory medication, which
             may influence study outcome, such as systemic corticosteroids.

          -  Application or use within two weeks of Baseline topical corticosteroid medications or
             topical anti-inflammatory medication, which may influence study outcome.

          -  Presence of a concurrent medical condition, which is determined by the investigator to
             potentially interfere with study outcomes or patient assessments.

          -  Introduction of any other prescription medication, topical or systemic, for atopic
             dermatitis while participating in the study.

          -  Use of anti-histamines while participating in the study will not be permitted unless
             the subject meets criteria for anti-histamine use on the VAS scale. Additionally, the
             subject must remain on a stable dose of anti-histamine throughout the study period. If
             a patient meets such criteria for anti-histamine use, this will be noted in the
             subject's chart.

          -  Amount of disease involvement that would require >60 gm of cream in a 1 week period.

          -  Subjects with known allergy or sensitivity to topical Vanos® cream or components.

          -  Pregnant women

          -  Women who are breastfeeding
Study to Assess Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Participants Aged ≥2 Years With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Crisaborole ointment 2%; Vehicle; Crisaborole ointment 2%; Vehicle
Intervention description: BID regimen; BID regimen; QD regimen; QD regimen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled,
      intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole
      ointment 2% in Japanese pediatric and adult participants (cohort 1: 12 years and older,
      cohort 2: 2 to under 12 years old) with mild to moderate Atopic Dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants ages; Cohort 1: 12 years and older at the time of consent.
             Cohort 2: 2 years to under 12 years old at the time of consent.

          -  Has confrimed clinical diagnosis of active AD according to Hanifin and Rajka criteria
             and has at least 6 months history prior to screening and has been clinically stable
             for more than 1 month

          -  Has at least 1% and no more than 30% BSA at baseline/Day1, excluding scalp, genitals
             and groin area

          -  Has a Investigator's static global assessment (ISGA) score of Mild (2) or Moderate (3)
             on Day 1.

        Exclusion Criteria:

          -  Has other acute or chronic medical or psychiatric condition including recent (within
             the past year) or active suicidal ideation or behavior or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the participant inappropriate for entry into
             this study.

          -  Participants had previous treatment with any topical or systemic PDE-4 inhibitor.
A Phase 2 Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Parsaclisib
Intervention description: Parsaclisib once daily for 8 weeks followed by once weekly
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diffuse large B-cell lymphoma; relapsed; refractory; non-Hodgkin lymphoma; phosphatidylinositol 3-kinase δ (PI3Kδ) inhibitor; Bruton's tyrosine kinase (BTK)

Summary:

      The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects
      with relapsed or refractory diffuse large B-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible 19 years and older in South Korea

          -  Relapsed or refractory DLBCL, which has been histologically documented, defined as
             having received at least 2 but no more than 5 prior treatment regimens and ineligible
             for high-dose chemotherapy supported by autologous stem cell transplant.

          -  Must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable
             extranodal lesion (≥1 cm in longest dimension) on computed tomography (CT) scan or
             magnetic resonance imaging (MRI).

          -  Subjects must be willing to undergo an incisional or excisional lymph node biopsy of
             accessible adenopathy or provide the most recent, available archived tumor biopsy.

          -  Eastern Cooperative Oncology Group performance status 0 to 2.

        Exclusion Criteria:

          -  Primary mediastinal (thymic) large B-cell lymphoma.

          -  Known brain or central nervous system metastases or history of uncontrolled seizures.

          -  Allogeneic stem cell transplant within the last 6 months, or active graft versus host
             disease following allogeneic transplant, or autologous stem cell transplant within the
             last 3 months.

          -  Use or expected use during the study of any prohibited medications, including potent
             cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half lives (whichever
             is longer) before the first dose of study drug.

          -  Prior treatment with the following:

               -  Group A: Prior treatment with a selective phosphatidylinositol 3-kinase (PI3K) δ
                  inhibitor (eg, idelalisib), a pan-PI3K inhibitor, or a BTK inhibitor (eg,
                  ibrutinib).

               -  Group B: Prior treatment with a selective PI3Kδ inhibitor (eg, idelalisib) or a
                  pan PI3K inhibitor.
Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
Condition: Hepatitis C; Chronic Hepatitis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Daclatasvir; Sofosbuvir
Intervention description: Specified dose on specified days for specified duration; Specified dose on specified days for specified duration
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to
      children with chronic hepatitis C infection
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Participants monoinfected with HCV genotype -1 to -6

          -  HCV RNA ≥1,000 IU/mL at Screening

          -  Participants who are HCV-treatment naïve or treatment experienced

          -  Participants in Cohort 1 must have a body weight ≥ 45kg at Day 1

        Exclusion Criteria:

          -  Mixed genotype HCV infections

          -  Evidence of an ongoing medical condition contributing to chronic liver disease other
             than HCV

          -  Evidence of cirrhosis, either compensated or decompensated

          -  Prior exposure to sofosbuvir and/or NS5A inhibitor

        Other protocol defined inclusion/exclusion criteria could apply
The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: cobitolimod; Placebo
Intervention description: Rectal administration; Solution manufactured to mimic cobitolimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colitis, Ulcerative; Gastrointestinal Diseases; Inflammatory Bowel Disease; Immunomodulator Therapy; Glucocorticoids; Anti-Inflammatory Agents; Therapeutic uses; Kappaproct; IDX0150; DIMS0150

Summary:

      The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose
      levels and frequencies compared to placebo in patients with moderate to severe left-sided
      ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years old

          -  Established diagnosis of Ulcerative Colitis (UC)

          -  Moderately to severely active left sided UC assessed by central reading

          -  Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of
             oral 5-ASA/SP use

          -  Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or
             intolerance

          -  Demonstrated an inadequate response, loss of response, or intolerance to at least one
             of the following agents:

               -  Immunomodulators

               -  Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins

        Exclusion Criteria:

          -  Suspicion of differential diagnosis

          -  Acute fulminant UC and/or signs of systemic toxicity

          -  UC limited to the rectum (disease which extend <15 cm above the anal verge)

          -  History of malignancy

          -  History or presence of any clinically significant disorder

          -  Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors,
             anti-integrins or similar immunosuppressants and immunomodulators

          -  Treatment with rectal GCS, 5-ASA/SP or tacrolimus

          -  Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs)

          -  Serious active infection

          -  Gastrointestinal infections

          -  Currently receiving parenteral nutrition or blood transfusions

          -  Females who are lactating or have a positive serum pregnancy test

          -  Women of childbearing potential not using reliable contraceptive methods

          -  Concurrent participation in another clinical study

          -  Previous exposure to cobitolimod
Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia
Condition: Post Bariatric Hypoglycemia
MeSH terms: Hypoglycemia
Intervention: Lyo avexitide; Liq avexitide
Intervention description: Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc); Liquid avexitide (Liq avexitide) administered subcutaneously (sc)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Bariatric surgery complications; Glucose Metabolism Disorders; Exendin (9-39); GLP-1

Summary:

      This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous
      exendin (9-39) in subjects with post-bariatric hypoglycemia. Development of this subcutaneous
      formulation of exendin (9-39) would represent a targeted therapeutic approach for this rare
      disease with unmet clinical need.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Post-bariatric surgery more than 6 months prior to signing the informed consent

          -  Reported history of Whipple's triad: the occurrence of hypoglycemic symptoms
             associated with a capillary blood glucose of ≤55 mg/dL, and resolution with glucose or
             carbohydrate administration.

          -  Symptomatic hypoglycemia during the baseline/screening oral glucose tolerance test
             (OGTT), as defined by the presence of plasma glucose ≤55 mg/dL with concomitant
             autonomic and/or neuroglycopenic symptoms.

        Exclusion Criteria:

          -  Patients currently using sulfonylureas or other medications that may interfere with
             glucose metabolism within 5 half-lives of drug.

          -  Participation in any clinical investigation within 4 weeks prior to dosing

          -  History of or current insulinoma

          -  Active infection or significant acute illness within 2 weeks prior to dosing

          -  Female patients who are pregnant or lactating

          -  Women of childbearing potential and not utilizing effective contraceptive methods

          -  Inadequate end organ function
Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy
Condition: Urologic Neoplasms
MeSH terms: Urologic Neoplasms
Intervention: Afatinib
Intervention MeSH terms: Afatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to assess the anti-tumour activity and safety of afatinib
      monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3
      (Erythroblastic leukaemia viral oncogene homolog of the human epidermal growth factor family
      of receptors) mutations or ERBB2 amplifications (Cohort A), and EGFR (Epidermal Growth Factor
      Receptor) amplification positive tumours (Cohort B), progressing despite previous platinum
      based chemotherapy, and thereby to improve their prognosis.

      The antitumour activity of afatinib monotherapy in these patients will be assessed by
      progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the
      trial. A key secondary endpoint will also be defined, the objective response rate (ORR).
    

Eligibility criteria:

        Inclusion criteria:

          -  Recurrent or metastatic urothelial cancer

          -  Patients must have failed prior platinum based treatment (adjuvant or 1st line)

          -  Archival tissue sample available for biomarker testing at pre-screening and tissue
             banking.

          -  Patients should complete a pre-screening biomarker analysis and should fulfill the
             following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family
             receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should
             show EGFR (Epidermal Growth Factor Receptor) amplification.

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Prior use of EGFR, ERBB2 or ERBB3 targeted treatment

          -  Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy
             or investigational agents within 4 weeks prior to the start of study treatment or
             prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first

          -  Known brain metastases or signs hereof, uncontrolled spinal cord compression or
             leptomeningeal carcinomatosis

          -  Further exclusion criteria apply
Iloperidone for Symptoms of Arousal in Post Traumatic Stress Disorder (PTSD)
Condition: Post Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Iloperidone; Placebo
Intervention description: Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.
During the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period); During 8 weeks subjects will receive oral placebo
Intervention MeSH terms: Iloperidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Post traumatic stress disorder; Treatment of post traumatic stress disorder; Symptoms of arousal in post traumatic stress disorder; Iloperidone in post traumatic stress disorder

Summary:

      A Double-Blind Placebo-Controlled Random Order Crossover Pilot Study of Iloperidone for
      Symptoms of Arousal in PTSD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PTSD diagnosis

        Exclusion Criteria:

          -  Pregnancy

          -  Traumatic Brain Injury greater than mild

          -  Primary sleep disorder

          -  Caffeinism

          -  Active substance use disorder

          -  Active suicidal risk

          -  Antipsychotic medication, antibiotics, sedatives, some antihypertensive or
             antiarrhythmic medication