bioihbjkbjnl/mcl2 huggingface dataset:
Study of Pharmacodynamics and Safety of DGAT2i and ACCi Coadministered in Participants With Sponsor-defined Presumed Non Alcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: PF-06865571; PF-05221304; Placebo
Intervention description: Tablet; Tablet; Tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dose-ranging of combination doses
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind, Double-dummy, Placebo controlled
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The study will evaluate the effect of coadministration of a range of doses of DGAT2i with 1
      dose of ACCi, on hepatic steatosis and the ability of DGAT2i to mitigate ACCi-induced
      elevations in serum triglycerides. The study has a 2-part design with sequential conduct of
      Part 1 and Part 2 with each part conducted in distinct/separate cohorts of participants. The
      overall study design, objectives/endpoints, eligibility criteria for both parts is envisioned
      to be identical, however, data from Part 1 will be used to determine whether to conduct Part
      2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI ≥25 and ≤ 40 kg/m2

          -  concomitant medical conditions associated with NAFLD

        Exclusion Criteria:

          -  Evidence of other causes of liver disease such as Alcoholic steatohepatitis,
             (de)compensated cirrhosis, active viral hepatitis

          -  Any condition possibly affecting drug absorption

          -  Unstable liver function tests

          -  Recent cardiovascular event(s),

          -  Malignancies
Multiple-dose Regimen Study to Assess Effect of 12 Months of Secukinumab Treatment on Skin Response and Biomarkers in Psoriasis Patients
Condition: Psoriasis, Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: secukinumab; placebo
Intervention description: secukinumab; placebo comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Psoriasis, Plaque-type psoriasis; Plaque; Secukinumab; AIN457A; PASI; DLQI; IGA

Summary:

      This study is designed to evaluate the proportion of patients achieving reversal of chronic
      plaque psoriasis at week 4 and 12 following multiple doses of secukinumab administered
      subcutaneously (sc) compared to placebo. Starting from week 13, all patients will receive
      multiple doses of secukinumab up to week 52 to study long term effects of secukinumab.
      Clinical endpoints including biomarker assessments, PASI, IGA and DLQI will be compared to
      better understand, why secukinumab may be effective in psoriasis patients.
    

Eligibility criteria:

        Inclusion criteria:

          -  Chronic plaque-type psoriasis diagnosed for at least 6 months

          -  Moderate to severe psoriasis as defined by: PASI score of ≥12, IGA score of ≥3, BSA
             (body surface area) affected by plaque-type psoriasis of ≥10%

          -  Chronic plaque-type psoriasis considered inadequately controlled by: topical treatment
             and/or; phototherapy and/or previous systemic therapy

        Exclusion criteria:

          -  Forms of psoriasis other than chronic plaque-type

          -  Evidence of skin conditions at the time of the screening visit (e.g., eczema) that
             would interfere with evaluations of the effect of the investigational product on
             psoriasis

          -  History or evidence of active tuberculosis or evidence of latent tuberculosis (or
             other infections like Hepatitis-C/B), malignancy; active or known use of other
             immunosuppressive drugs (for eg: AIDs, RA, organ rejection etc.) at the screening
             visit

          -  Pregnant or nursing (lactating) women
Clinical Trial of Simvastatin to Treat Generalized Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Intervention: Simvastatin; Placebo
Intervention description: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated; Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
Intervention MeSH terms: Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: vitiligo; simvastatin

Summary:

      The investigators purpose is to initiate a phase II, randomized, placebo-controlled clinical
      trial to test simvastatin, an FDA-approved medication for hypercholesterolemia, as a new
      treatment for vitiligo. The aims of this placebo-controlled study seek to determine the
      safety and potential efficacy of simvastatin 80mg daily versus placebo in adult male patients
      with generalized vitiligo. Additionally, the investigators will collect blood to examine the
      effect of simvastatin on autoreactive CD8+ T cells in vitiligo patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male gender

          -  ages 18-64

          -  at least one vitiligo skin lesion measuring at least 2x2 cm in size

          -  willing and able to understand and sign informed consent

          -  able to complete study and comply with study procedures

        Exclusion Criteria:

          -  history of segmental vitiligo

          -  allergy to statin medications

          -  use of statin medications due to cardiac risks.

          -  use of any medications contraindicated with use of simvastatin

          -  use of topical vitiligo treatments in past 4 weeks

          -  use of laser or light-based vitiligo treatments within the past 8 weeks

          -  treatment with immunomodulating oral medications in the past 4 weeks

          -  use of statin medications in the past 8 weeks

          -  evidence of hepatic dysfunction, personal or family history of non-alcoholic steatotic
             hepatitis, or personal history of hepatitis

          -  evidence of renal dysfunction

          -  history of myopathy or rhabdomyolysis, or elevated baseline creatinine kinase

          -  recent history of alcohol or drug abuse

          -  history of diabetes

          -  untreated hypothyroidism

          -  other conditions that require the use of interfering topical or systemic therapy

          -  other current conditions that might interfere with study assessments such as, but not
             limited to, atopic dermatitis and psoriasis

          -  clinically significant abnormal findings or conditions which might, in the opinion of
             the Principal Investigator, interfere with study evaluations or pose a risk to subject
             safety during the study.
Dose-response Relationship Study of S42909 on Leg Ulcer Healing
Condition: Venous Leg Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Intervention: S42909 100 mg; S42909 200 mg; S42909 400 mg; S42909 800 mg; S42909 1200 mg; Placebo Oral Tablet
Intervention description: 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.; 50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.; 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.; 200 mg Film-coated tablets per os administration,twice a day taken at the end of the morning and at evening meals.; 200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.; Matching placebo tablets, per os administration, twice a day taken at the end of the morning and at evening meals.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Dose-response relationship study of S42909 on leg ulcer healing after oral repeated
      administration in patients with active venous leg ulcer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Caucasian (defined for this study as having 2 Caucasian parents), men or women

          -  Age ≥ 18 years old

          -  18.5 kg/m2 ≤ BMI ≤ 45.0 kg/m2 (= Weight (kg) / height² (m²))

          -  Patients with chronic venous disease documented by imaging to detect a venous disorder
             in one or both the sub- and extra-fascial venous systems. The examination performed
             within 6 months before selection can be used.

          -  Patients with at least one active venous leg ulcer localised in the gaiter area (CEAP
             C6) diagnosed or reoccurred for more than 6 weeks and less than 2 years at selection
             and 3 cm away from other ulcers. Patients with bilateral ulcerations or multiple
             ulcerations on one or both legs are eligible for selection.

          -  Size of Reference Ulcer (defined as the largest ulcer in size that is fitting the area
             selection criteria) should be ≥ 5 cm2 and ≤ 100 cm2 at the selection visit and ≥ 4.5
             cm2 and ≤ 100 cm2 at the inclusion visit (measured by transparent sheet and confirmed
             with the digital 3D imaging device).

          -  Ankle Brachial Pressure Index (ABPI) ≥ 0.8 and ≤ 1.3 measured by Doppler ultrasound.

        Exclusion Criteria:

          -  Unlikely or unwilling to be compliant to standardized compression recommendation,
             study medication and visits, previous records of poor compliance to compression
             stockings.

          -  Inadequately controlled type 1 and type 2 diabetes with an HbA1c > 8%.
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
Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 in Patients With Osteoarthritis (OA) of the Knee
Condition: Pain
MeSH terms: Osteoarthritis
Intervention: AZD1386; AZD1386; Placebo
Intervention description: oral, during 4 weeks; oral, during 4 weeks; Oral, during 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 241.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Phase II; Pain

Summary:

      The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in
      patients with osteoarthritis of the knee and at what dose. This will be done by comparing the
      effect of AZD1386 to placebo ("inactive substance") on pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with OA of the knee

          -  Male or non pregnant females 40 and 80 years old

        Exclusion Criteria:

          -  A current diagnosis of another form of arthritis, in addition to OA

          -  History, and/or presence of somatic disease, which may interfere with the objectives
Vaccine Therapy in Treating Patients With Philadelphia Chromosome-Positive Chronic Myelogenous Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: bcr-abl p210-b3a2 breakpoint-derived multipeptide vaccine; sargramostim
Intervention MeSH terms: Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: chronic myelogenous leukemia, BCR-ABL1 positive; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; relapsing chronic myelogenous leukemia

Summary:

      RATIONALE: Vaccines made from peptides may help the body build an effective immune response
      to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of
      immune cells found in bone marrow or peripheral blood. Giving booster vaccinations may make a
      stronger immune response and prevent or delay the recurrence of cancer.

      PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients
      with Philadelphia chromosome-positive chronic myelogenous leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of chronic myelogenous leukemia (CML) meeting the following criteria:

               -  Philadelphia chromosome positive disease

               -  b3a2 breakpoint mutation

          -  Prior treatment with conventional imatinib mesylate for ≥ 18 months required

               -  Complete cytogenetic response documented on ≥ 2 different examinations

                    -  Persistence of molecularly detectable residual disease (any level of bcr-abl
                       transcript)

               -  Patients continue to receive imatinib mesylate at the same dose (conventional
                  treatment) during study treatment

        PATIENT CHARACTERISTICS:

          -  WHO performance status 0-1

          -  Bilirubin ≤ 2 times upper limit of normal (ULN)

          -  AST and ALT ≤ 2.5 times ULN

          -  Creatinine ≤ 1.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No severe active infection or other serious medical illness that would preclude study
             completion

          -  No known immunodeficiency

          -  No autoimmune disorders

        PRIOR CONCURRENT THERAPY:

          -  No concurrent immunosuppression or systemic immunosuppressive medication

          -  No concurrent dose escalation of imatinib mesylate

          -  No other concurrent investigational products
Efficacy and Safety Study of ARC-4558 for Management of Pain Associated With Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies; Pain
Intervention: Placebo Gel; Clonidine Topical Gel (ARC-4558)
Intervention description: TID x 12 weeks; TID x 12 weeks
Intervention MeSH terms: Clonidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether ARC-4558 is effective in managing pain
      associated with painful diabetic neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  has Type 1 or Type 2 diabetes mellitus

          -  has a history of chronic pain attributable to a symmetrical stocking distribution
             neuropathy in the lower extremities for a duration of at least six months but less
             than or equal to five years prior to Screening

        Exclusion Criteria:

          -  has neuropathy secondary to non-diabetic causes

          -  has a significant neurological disorder or a condition that can cause symptoms that
             mimic peripheral neuropathy or might confound assessment of PDN

          -  has other chronic pain with intensity at or greater than the bilateral pain in the
             feet/toes

          -  is using an implanted medical device (eg, spinal cord stimulator, intrathecal pump, or
             peripheral nerve stimulator) for the treatment of pain

          -  is pregnant or lactating
Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
Condition: Upper Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Intervention: interferon-alpha; placebo
Intervention description: a lozenge for oral dissolution containing 150 international units of human interferon-alpha taken once daily for 16 weeks; placebo lozenges for oral dissolution taken once daily for 16 weeks
Intervention MeSH terms: Interferons; Interferon-alpha
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prophylaxis; Treatment; Symptoms; Winter Colds and Flu

Summary:

      The aim of the study is to see if lozenges containing a low dose of interferon-alpha can
      prevent and/or reduce the severity of colds and flu. Starting about 1 month before the
      expected start of the winter colds and flu season in Perth, Australia, healthy volunteers
      will allow a lozenge containing interferon, or a lozenge containing no medicine (a placebo),
      to dissolve in their mouth once a day for 16 weeks. Blood tests at the start and end of
      treatment will determine whether interferon was able to prevent infections with cold/flu
      viruses. Once a week, volunteers will complete a survey about their cold/flu symptoms,
      medications taken, days of work missed, etc. to see if interferon was able to make their
      winter colds and flu less severe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant female

          -  Females of child-bearing potential must practice a medically accepted form of birth
             control

        Exclusion Criteria:

          -  Currently exhibiting an acute upper respiratory tract infection

          -  history of chronic respiratory disease requiring regular therapy(i.e. COPD, asthma,
             bronchitis, etc.)

          -  any condition likely to increase the risk of severe or complicated influenza (i.e.
             cardiac disease, chronic renal disease, endocrine diseases, including diabetes and/or
             immunosuppressive therapy)

          -  any condition requiring regular treatment with antihistamines, analgesics or
             antipyretics

          -  known infection with HIV, hepatitis B virus or hepatitis C virus

          -  any other serious, uncontrolled disease

          -  any active infections requiring use of antibiotic or antiviral drugs

          -  non-ambulatory status

          -  suspected drug or alcohol abuse