bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension
Condition: Hypercholesterolemia; Hypertension
MeSH terms: Hypertension; Hypercholesterolemia
Intervention: ETC-1002; Placebo
Intervention description: ETC-1002 capsules taken once daily; Placebo capsules taken once daily
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: LDL; Cholesterol

Summary:

      This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo
      in participants with hypercholesterolemia and hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mean 24-hour ambulatory SBP greater than or equal to 130 mmHg

          -  or- Mean 24-hour ambulatory DBP greater than or equal to 80 mmHg

          -  Fasting LDL-C between 100 and 220 mg/dL

          -  Fasting triglycerides less than 400 mg/dL

          -  Body mass index (BMI) between 18 and 45 kg/m2

        Exclusion Criteria:

          -  Known or suspected secondary hypertension or history of malignant hypertension

          -  Taking more than two anti-hypertension medications at the first visit

          -  History or current clinically significant cardiovascular disease

          -  History or current type 1 diabetes or type 2 diabetes
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Condition: Edematous Fibrosclerotic Panniculopathy; Cellulite
MeSH terms: Cellulite; Edema
Intervention: Collagenase Clostridium Histolyticum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 259.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic
      Panniculopathy (commonly known as Cellulite).
    

Eligibility criteria:

        Inclusion Criteria for Observation Phase:

          -  Voluntarily sign and date an informed consent agreement

          -  Have participated in and completed the double-blind study EN3835-201

          -  Be willing to apply sunscreen to any treated quadrant before each exposure to sun

        Inclusion Criteria for Treatment Phase:

          -  Voluntarily sign and date an informed consent agreement

          -  Have participated in and completed the double-blind study EN3835-201

          -  Be willing to apply sunscreen to any treated quadrant before each exposure to sun

          -  Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on
             the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a
             Hexsel CSS (Cellulite Severity Scale) score no greater than 13

          -  Be judged to be in good health

          -  Have a negative urine pregnancy test at screening and be using an effective
             contraception method, be surgically sterile, or post-menopausal

        Exclusion Criteria for Observation Phase:

          -  None

        Exclusion Criteria for Treatment Phase:

          -  Has used, or intends to use during the course of the study, other treatment of EFP on
             the legs or buttocks

          -  Is presently nursing a baby or providing breast milk for a baby

          -  Intends to become pregnant during the study

          -  Currently receiving, has received within 7 days before injection of study drug, or
             plans to receive an anticoagulant or antiplatelet medication

          -  History of stroke or bleeding
A Dose-ranging Study to Evaluate Efficacy and Safety of VX-150 in Subjects With Acute Pain Following Bunionectomy
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: VX-150; Placebo
Intervention description: Capsules for oral administration.; Capsules for oral administration.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will evaluate the dose-response relationship and safety of VX-150 in treating
      acute pain following bunionectomy.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Before surgery:

          -  Body mass index (BMI) of 18.0 to 38.0 kilogram per meter square (kg/m^2)

          -  Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair,
             without collateral procedures, under regional anesthesia (Mayo and popliteal sciatic
             block) not to include base wedge procedure

        After surgery:

          -  Subject reported pain of greater than or equal to (>=) 4 on Numeric Pain Rating Scale
             (NPRS) and moderate or severe pain on the Verbal Categorical Rating Scale (VRS) within
             9 hours after removal of the popliteal sciatic block on Day 1

          -  Subject is lucid and able to follow commands

          -  All analgesic guidelines were followed during and after the bunionectomy

        Key Exclusion Criteria:

        Before surgery:

          -  History in the past 10 years of malignancy, except for squamous cell skin cancer,
             basal cell skin cancer, and Stage 0 cervical carcinoma in situ

          -  History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)

          -  History of abnormal laboratory results >=2.5*upper limit of normal (ULN)

          -  History of peripheral neuropathy

          -  A known or clinically suspected infection with human immunodeficiency virus or
             hepatitis B or C viruses

          -  Prior medical history of bunionectomy or other foot surgery on the index foot

          -  History of peptic ulcer disease, or intolerance or unwillingness to receive ibuprofen

        After surgery:

          -  Subject had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery

        Other protocol defined inclusion/exclusion criteria may apply
Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Peripheral Nervous System Diseases
Intervention: NYX-2925 50 mg; Placebo
Intervention description: NYX-2925 administered orally; Placebo administered orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to receive either placebo or NYX-2925.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Randomization algorithm, randomization allocation, allocation to study drug or placebo.
Enrollment: 228.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of NYX-2925 versus placebo in treating the neuropathic pain
      associated with diabetic peripheral neuropathy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Informed consent

          -  Subject has diabetic peripheral neuropathy of symmetrical nature in lower extremities
             for ≥4 years and reports at least moderate pain over the last week

          -  Stable diabetic and protocol allowed medication during the study

          -  Agrees to use highly effective birth control during the study

          -  Has not participated in an interventional study for at least 30 days and agrees not to
             participate in another interventional study during the study

        Exclusion Criteria:

          -  Pain due to other conditions or diseases that would complicate participation in the
             study or pain reporting

          -  Current or historical serious medical conditions

          -  Prior participation in NYX-2925 clinical trial
S0535, Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute
Intervention: arsenic trioxide; gemtuzumab ozogamicin; mercaptopurine; methotrexate; tretinoin
Intervention MeSH terms: Methotrexate; Mercaptopurine; Arsenic Trioxide; Tretinoin; Gemtuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adult acute promyelocytic leukemia (M3); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); untreated adult acute myeloid leukemia

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
      cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies,
      such as gemtuzumab, can block cancer growth in different ways. Some find cancer cells and
      help kill them or carry cancer-killing substances to them. Others interfere with the ability
      of cancer cells to grow and spread. Gemtuzumab may also stop the growth of promyelocytic
      leukemia by blocking blood flow to the cancer. Giving gemtuzumab together with combination
      chemotherapy may be more effective in treating promyelocytic leukemia.

      PURPOSE: This phase II trial is studying how well giving gemtuzumab together with combination
      chemotherapy works in treating patients with previously untreated promyelocytic leukemia.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Morphologically confirmed acute promyelocytic leukemia (APL) based on bone marrow
             examination

               -  APL-RARα-negative by RT-PCR are not eligible

          -  High-risk disease, defined as WBC > 100,000/mm^3

          -  Bone marrow specimens must be made available for cytogenetic studies

        PATIENT CHARACTERISTICS:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No prolonged QTc > 0.47 sec

          -  No other malignancy within the past 5 years, except adequately treated basal cell or
             squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
             stage I or stage II cancer from which the patients is currently in complete remission

        PRIOR CONCURRENT THERAPY:

          -  No prior systemic chemotherapy for acute leukemia

               -  At least 3 days since prior tretinoin (ATRA) allowed

          -  Prior hydroxyurea, corticosteroids, or leukapheresis to control high cell counts
             allowed
Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: HNO Donor; Placebo
Intervention description: Infusion; Infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 329.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO
      Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Actively being hospitalized for acute decompensated heart failure

          -  At least 1 administration of IV diuretic for the current episode

          -  Be randomized within 18 hours of first dose of IV diuretic for current episode for
             Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II

          -  Have shortness of breath at rest or with minimal exertion after administration of 1
             dose of IV diuretic

          -  Have history of heart failure and a left ventricular ejection fraction (LVEF) ≤ 40%

        Exclusion Criteria:

          -  Systolic blood pressure <105mm Hg or >160mm Hg or heart rate <50 or >130 bpm

          -  Have an active infection requiring IV anti-microbial treatment

          -  Be hospitalized with acute coronary syndrome, coronary revascularization or acute
             myocardial infarction during the previous 90 days prior to screening

          -  Have a history of a cerebral vascular accident (CVA or stroke) or of a transient
             ischemic attack (TIA) during the previous 90 days prior to screening

          -  Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease
             (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis)

        Other protocol defined inclusion/exclusion criteria could apply
Study of the Medication Prazosin for Alcohol Dependence
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Prazosin medication; Placebo medication
Intervention description: Form: Prazosin will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg; Form: Placebo will be taken orally, in the form of pills.
Dosing: 9 AM, 3 PM, 9 PM
Days 1-2: 0 mg, 0 mg, 1 mg
Days 3-4: 1 mg, 1 mg, 1 mg
Days 5-7: 2 mg, 2 mg, 2 mg
Day 8-10: 2 mg, 2 mg, 6 mg
Day 11-14: 4 mg, 4 mg, 6 mg
Day 15-84: 4 mg, 4 mg, 8 mg
Intervention MeSH terms: Prazosin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alcohol; Abuse; Use; Disorder; Dependence; Symptoms; Alcoholic; Alcoholism; Prazosin; Drug; Medicine; Medication; Treatment; Study; Placebo; Medical; Management; Craving; Consumption; Binge; Drinking; Drink; Heavy

Summary:

      The purpose of this study is to determine whether the drug prazosin is effective for the
      treatment of alcohol dependency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current primary DSM-IV diagnosis of alcohol dependence(AD)

          -  Heavy drinking in the last 30 days

          -  At least 18 years of age

          -  Good general medical health (see Exclusion Criteria below)

          -  Capacity to provide informed consent

          -  English fluency and literacy

        Exclusion Criteria:

          -  Psychiatric/behavioral: current post-traumatic stress disorder(PTSD); psychiatric
             disorder requiring any medication other than anti-depressants; currently taking
             disulfiram, acamprosate, or naltrexone or planning to take any of these medications
             during the 12-week medication phase of the study; current dependence on any other
             psychoactive substance other than nicotine or cannabis; a current diagnosis of opioid
             abuse, use of any opioid- containing medications or benzodiazepines during the
             previous month, or UDA positive for opioids, benzodiazepines, or sedative hypnotics.

          -  Medical: significant acute or chronic medical illness; women who are pregnant, nursing
             infant(s), or of childbearing potential and not using a contraceptive method judged by
             the study physician or PA to be effective; signs or symptoms of alcohol withdrawal at
             the time of initial consent

          -  Legal involvement that could interfere with study treatment. Individuals court ordered
             for treatment will not be eligible to participate in this study.
A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: Bermekimab; Adalimumab; Placebo
Intervention description: Bermekimab will be administered subcutaneously.; Adalimumab will be administered subcutaneously.; Placebo will be administered subcutaneously.
Intervention MeSH terms: Adalimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants
      with moderate to severe Hidradenitis Suppurativa (HS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have hidradenitis suppurativa (HS) for at least 1 year (365 days) prior to the
             baseline visit as determined by the investigator through participant interview and/or
             review of the medical history

          -  Have Hurley Stage II or Hurley Stage III HS as determined by the investigator at
             screening and baseline visits

          -  Have HS lesions present in at least 2 distinct anatomic areas (examples include but
             are not limited to left and right axilla; or left axilla and left inguinocrural fold)
             at screening and baseline visits

          -  Have a total abscess and inflammatory nodule (AN) count of greater than or equal to
             (>=) 5 at the screening and baseline visit

          -  Agree not to receive a live virus or live bacterial vaccination during the study and
             for 90 days after the last administration of study intervention

        Exclusion Criteria:

          -  Has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled
             renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,
             hematologic, rheumatologic, psychiatric, or metabolic disturbances

          -  Has unstable cardiovascular disease, defined as a recent clinical deterioration (that
             is, unstable angina, rapid atrial fibrillation) in the last 3 months or a cardiac
             hospitalization within the last 3 months

          -  Has or has had herpes zoster within the 2 months before screening

          -  Has a transplanted organ (with exception of a corneal transplant greater than [>] 3
             months before the first administration of study intervention)

          -  Has known allergies, hypersensitivity, or intolerance to bermekimab or adalimumab or
             its excipients
1% Topical Pimecrolimus Cream for the Treatment of the Rash Associated With ERBITUX
Condition: Rash
MeSH terms: Exanthema
Intervention: Pimecrolimus; Placebo
Intervention description: Pimecrolimus 1% topical cream applied twice daily for four weeks on one side of the face.; Placebo cream applied twice daily for four weeks on opposite side of the face from the Pimecrolimus side.
Intervention MeSH terms: Pimecrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cetuximab rash; Erbitux rash; Rash; Pimecrolimus; 1% Topical pimecrolimus cream

Summary:

      When cancer patients are treated with the drug cetuximab they very often develop a rash.
      Usually it appears on their face and back and other parts of the body. The rash looks like
      acne and is treated with skin creams or antibiotics most of the time. The rash can become
      very painful and cause patients to stop using cetuximab to treat their cancer, even if
      cetuximab was helping fight their cancer.

      Cetuximab is known to be a good drug to help treat cancer. This study will help us learn
      about the rash cetuximab causes so hopefully future patients can finish taking cetuximab for
      their cancer. In this study the investigators will use a cream called pimecrolimus (Elidel)
      to see if it will help prevent the rash or keep the rash from getting worse. The
      investigators also want to see how the rash affects patients and their quality of life.

      Participants will be in this study for about four weeks if their rash does not get worse.
      They will need to apply the study cream and placebo two times daily and answer quality of
      life questionnaires during this study. Participants will also be seen by a dermatologist and
      have pictures taken of their rash.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is starting treatment with cetuximab at the WVU Cancer Center

          -  Patient has advanced (unresectable or metastatic) malignancy

          -  Patient is expected to remain on cetuximab treatment for at least 2 weeks after
             enrollment on study.

          -  Patients should be 18 years or older

          -  Patients should not have a known contraindication to topical pimecrolimus therapy

          -  Patients should have given written informed consent

          -  Sexually active men and women of child bearing potential agree to use an effective
             method of contraception during study participation and for three months afterwards.

          -  Negative pregnancy test for woman of child bearing potential

        Exclusion Criteria:

          -  Known allergy to topical pimecrolimus.

          -  Patients with active or recent (within one month) infection in face

          -  Psoriasis, eczema or others skin conditions not related to cetuximab involving face

          -  Pregnant or nursing women