bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Azelaic Acid Foam, 15% in Papulopustular Rosacea
Condition: Papulopustular Rosacea
MeSH terms: Rosacea
Intervention: Azelaic acid foam 15%; Vehicle foam
Intervention description: Applied topically twice daily for 12 weeks; Applied topically twice daily for 12 weeks
Intervention MeSH terms: Azelaic 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: 401.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rosacea; papulopustular; azelaic acid; foam

Summary:

      This study will investigate the safety and efficacy of a new formulation of an existing
      medication for the treatment of papulopustular rosacea. The study will test the active
      ingredient plus foam against foam alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed written informed consent

          -  Diagnosis of papulopustular rosacea (IGA score of moderate or severe) with a minimum
             of 12 and maximum of 50 inflammatory lesions (papules and/or pustules) and persistent
             erythema with or without telangiectasia

          -  Free of any clinically significant disease which could interfere with the study

          -  Willingness to follow all study procedures

          -  Male or female patient at least 18 years of age

        Exclusion Criteria:

          -  Subjects known to be non-responders to azelaic acid

          -  Presence of dermatoses that might interfere with the rosacea diagnosis or the
             evaluation of treatment results

          -  Ocular rosacea, phymatous rosacea

          -  Any condition or therapy that in the opinion of the investigator may pose a risk to
             the patient of interfere with any evaluation in the study

          -  Facial laser surgery in the 6 weeks prior to the study

          -  Topical or systemic use of prescription or non-prescription medications to treat
             rosacea

          -  Use of any agent other than the investigational drugs to treat rosacea during the
             study

          -  Expected use or change in dose in the 90 days prior to the study of beta-blockers,
             vasodilators, NSAIDs, hormonal treatment or drugs causing acneiform eruptions

          -  Known hypersensitivity to any ingredients of the investigational product formulation

          -  Alcohol or drug abuse

          -  Incapability of giving fully informed consent

          -  Subject is dependent person, i.e., a relative/family member of the investigator and/or
             is a member of the investigator's staff

          -  Participation in another clinical research study within the last 4 weeks before
             randomization in this study
A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: RIST4721; Placebo
Intervention description: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets; Matching placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and
      Safety of RIST4721 in Subjects with Hidradenitis Suppurativa
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of HS for at least 1 year prior to screening

          -  HS lesions must be present in at least 2 distinct anatomic areas

          -  A total AN count (sum of abscesses and inflammatory nodules) > 6 across all anatomical
             sites at both the screening and baseline visits

          -  Willing to use contraception for the duration of the study

        Exclusion Criteria:

          -  Presence of other skin conditions which may interfere with study assessments

          -  Presence of active, chronic or latent bacterial, viral, fungal mycobacterial infection
             (including latent TB) or history of infection within 4 weeks of screening

          -  Body Mass Index (BMI) >48kg/m2

          -  Breastfeeding or pregnant
A Study to Evaluate Bleeding Patterns With Three Different Doses of DR-1031 Compared to Seasonale
Condition: Breakthrough Bleeding
MeSH terms: Metrorrhagia; Hemorrhage
Intervention: DR-1031; Seasonale®; Portia®
Intervention description: Active therapy cycle of 84 days taking combination tablets containing ascending doses of ethinyl estradiol (EE) and 150 mcg levonorgestrel (LNG), followed by a 7-day withdrawal cycle of 10 mcg EE. The total extended cycle was 91 days and participants were to complete two extended cycles. Active therapy dosage of EE varied by treatment arm.; 84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets for two consecutive 91-day cycles.; Portia® 28 consists of 21 pink active tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and seven white inert tablets. Portia was taken as a pre-study run-in medication.
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 567.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: oral contraceptives; breakthrough bleeding; spotting

Summary:

      This is a 4-arm study to evaluate and compare bleeding patterns between three different doses
      of DR-1031 oral contraceptive with Seasonale oral contraceptive. Study participants will
      receive physical and gynecological exams, including Pap smear. During the study, all
      participants will be required to complete a diary
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal

          -  Not pregnant or breastfeeding

          -  Agree to use back-up non-hormonal contraception for study period

        Exclusion Criteria:

          -  Any contraindication to the use of oral contraceptives

          -  Pregnancy within the last 3 months

          -  Smoking >10 cigarettes per day
SMART Trial: Intrapersonal and Interpersonal Stigma Reduction
Condition: Stigma, Social; Opioid Use; Opioid-use Disorder; Substance Use Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Intervention: Intrapersonal Stigma Reduction; Interpersonal Stigma Reduction
Intervention description: Brief intervention for stigma reduction; Brief intervention for support persons of intrapersonal intervention participants.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: opioid use disorder; substance use disorder; stigma

Summary:

      The goal of this project is to develop a multicomponent stigma reduction intervention to
      address intrapersonal (individual) stigma regarding Opioid Use Disorder (OUD). The
      intervention will address this cost/benefit evaluation among individuals known to face
      intersecting stigma of OUD and African American race, with treatment elements chosen
      explicitly to increase the value of treatment using salient forms of reward, and to ease
      perceived costs through explicit services in an effort to encourage the occurrence of the
      first treatment visit for OUD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Identify as African American, Black, or mixed race

          -  Identify as someone with a substance use disorder who is not currently in treatment OR
             a support person of someone enrolled

          -  Access to a telephone for follow-up assessment

          -  Reside in the Memphis, TN area

        Exclusion Criteria:

          -  Unable to understand consent procedures
Study to Allow Access to Single Agent Panobinostat for Patients Who Are on s.a. Panobinostat Treatment in a Novartis-sponsored Study and Continue to Benefit From the Treatment as Judged by the Investigator
Condition: Hematologic Neoplasms
MeSH terms: Hematologic Neoplasms
Intervention: Panobinostat
Intervention description: Panobinostat was provided as 5, 10 and 20 mg hard gelatin capsules to be taken orally. Patients started on dose from parent protocol and dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
Intervention MeSH terms: Panobinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Healthy volunteers: No
Keywords: Hematologic Neoplasms, LBH589,; Panobinostat,

Summary:

      The study allowed continued use of single agent panobinostat in patients who were on single
      agent panobinostat treatment in a Novartis-sponsored study which had met its endpoint and
      were benefiting from the treatment as judged by the investigator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patient had been enrolled in a Novartis-sponsored, Oncology OGD&GMA study receiving
             s.a. oral panobinostat and had fulfilled all their requirements in the parent study

          -  patient had been benefiting from the treatment with s.a. oral panobinostat as
             determined by the guidelines of the parent protocol and according to the
             Investigator's clinical judgment

          -  patient had demonstated compliance

          -  patient had given written informed consent.

        Exclusion Criteria:

          -  patient had been permanently discontinued from s.a. oral panobinostat study treatment
             in the parent study due to unacceptable toxicity, withdrawal of consent,
             non-compliance to study procedures or any other reason (including progression of
             disease).

          -  patient had participated in a Novartis sponsored combincation trial where panobinostat
             was dispensed in combination with another study medication and was still receiving
             combination therapy

          -  patient was pregnant or nursing at the time of entry

          -  women of child-bearing potential and male patients with sexual partners of
             child-bearing potential who were unwilling to use highly effective methods of
             contraception during dosing and for a specified duration after stopping study
             treatment
Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Intervention: Comparator: Vaniprevir; Comparator: Pegylated-Interferon (Peg-IFN); Comparator: Ribavirin; Comparator: placebo
Intervention description: Vaniprevir 300 mg b.i.d., 600 mg b.i.d., 600 mg q.d., or 800 mg q.d.; duration of treatment: 28 days; Peg-IFN 180 mcg once-weekly subcutaneous injection; duration of treatment: 48 weeks; Ribavirin 200 mg tablet b.i.d. (dose based on body weight); duration of treatment: 48 weeks; Matching placebo to vaniprevir; duration of treatment: 28 days
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered
      with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response
      (RVR) i.e., undetectable hepatitis C virus [HCV] viral ribonucleic acid [RNA] at Week 4 in
      participants with chronic HCV infection. The primary hypothesis was that the proportion of
      participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater
      than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were
      co-administered with Peg-IFN/Ribavirin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has chronic Genotype 1 Hepatitis C infection

        Exclusion Criteria:

          -  Subject has been previously treated for HCV

          -  Has Human Immunodeficiency Virus (HIV)

          -  Has Hepatitis B

          -  Has a history of clinically significant medical condition that may interfere with the
             study (e.g., stroke or chronic seizures or major neurological disorder) or is
             contraindicated for treatment with peg-IFN and Ribavirin
To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa; Acne Inversa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: INCB054707; Placebo
Intervention description: Oral; Tablet; Oral; Tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Triple
Enrollment: 209.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis
      suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week
      open-label extension period. All eligible participants will be invited to continue treatment
      for an additional 48-week Long-term extension period (also open label).
    

Eligibility criteria:

        Inclusion Criteria:

          -  HS disease duration of at least 3 months before screening.

          -  Willingness to avoid pregnancy or fathering children.

          -  Active HS in at least 2 distinct anatomical areas.

          -  Participants agree NOT to use topical antiseptics on the areas affected by HS lesions
             during the placebo-controlled 16-week treatment period

        Exclusion Criteria:

          -  Draining fistula count of > 20 at screening or baseline.

          -  Women who are pregnant (or who are considering pregnancy) or lactating.

          -  Medical history including thrombocytopenia, coagulopathy or platelet dysfunction,
             Q-wave interval abnormalities, current or history of certain infections, cancer,
             lymphoproliferative disorders and other medical conditions at the discretion of the
             investigator.

          -  History of failure to treatment of inflammatory diseases with JAK inhibitors.

          -  Have evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis.

          -  Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.

          -  Laboratory values outside of the protocol-defined ranges.
Valchlor in the Treatment of Lichen Planopilaris
Condition: Lichen Planopilaris
MeSH terms: Lichen Planus
Intervention: Mechlorethamine 0.016% Top Gel
Intervention description: Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
Intervention MeSH terms: Mechlorethamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Adults patient with active Lichen Planopilaris or Frontal Fibrosing Alopecia
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Valchor

Summary:

      The primary objective of this study is to assess the potential effectiveness of once daily
      application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
      The primary measurement of efficacy will be with the Lichen Planopilaris Activity Index
      (LPPAI) before and after 6 months of treatment. Secondary measures of efficacy will be the
      mean follicular density, Physician Global assessment (PGA) score, and the Dermatology Quality
      of Life Index (DQLI) score before and after six months of therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients 18 years or older.

          -  Biopsy proven diagnosis of Lichen Planopilaris

          -  Biopsy proven diagnosis of Fontal Fibrosing Alopecia (a clinical variant of LPP
             restricted to frontal scalp)

          -  Good general health as confirmed by medical history

          -  Patients who are willing and capable of cooperating to the extent and degree required
             by the protocol; and

          -  Patients who read and sign an approved informed consent for this study

        Exclusion Criteria:

          -  Vulnerable study population

          -  Pregnant or nursing women

          -  Women planning a pregnancy within the study period

          -  Active smokers

          -  Known history of adverse reaction to mechlorethamine

          -  Use of systemic immunosuppressive

          -  Presence of ulcerated scalp lesions
Control of Major Bleeding After Trauma Study
Condition: Trauma; Hemorrhagic Shock
MeSH terms: Shock, Hemorrhagic
Intervention: Type AB plasma; Crystalloid fluid (standard of care for resuscitation)
Intervention description: The plasma is thawed and administered to subjects in the experimental (plasma) arm.; Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 144.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: coagulopathy; hemorrhagic shock; plasma; blood product transfusion

Summary:

      Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely
      injured trauma patients are found to be coagulopathic and forty percent of the mortality
      following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy.
      It has been established that early administration of fresh frozen plasma decreases mortality
      following severe injury, replacing lost coagulation factors, improving the coagulopathy and
      restoring blood volume. This study will determine if giving plasma to severely injured trauma
      patients during ambulance transport versus after arrival to the hospital will help reduce
      hemorrhage, thus decreasing both total blood product administration and mortality.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age>=18 years

          -  Acutely injured

          -  SBP<70 mmHg or SBP 71-90 mmHg with heart rate (HR)>108 beats per minute.

        Exclusion Criteria:

          -  Visibly or verbally reported pregnant women

          -  known prisoners

          -  unsalvageable injuries (defined as asystolic or cardiopulmonary resuscitation prior to
             randomization)

          -  known objection to blood products

          -  the patient has an opt-out bracelet or, necklace or wallet card

          -  a family member present at the scene objects to the patient's enrollment in research.
Oral Enzastaurin in Participants With Relapsed Mantle Cell Lymphoma
Condition: Mantle-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: enzastaurin
Intervention description: 500 milligrams (mg), oral, daily, up to six 28-day cycles
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purposes of this study are to determine the safety of oral enzastaurin and any side
      effects that might be associated with it and whether enzastaurin can help participants with
      mantle cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mantle cell lymphoma

          -  Previous treatment for mantle cell lymphoma

          -  Previously relapsed mantle cell lymphoma with no more than 4 chemotherapy regimens.

          -  Have discontinued all previous therapies for cancer, except corticosteroids up to 25
             milligrams per day (mg/day)

          -  Adequate organ function

        Exclusion Criteria:

          -  Inability to swallow tablets

          -  Must not have significant heart problems
Treatment With Mecamylamine in Smoking and Non-smoking Alcohol Dependent Patients
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: mecamylamine; Placebo
Intervention description: mecamylamine 10mg/day; Placebo
Intervention MeSH terms: Mecamylamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: mecamylamine; treatment; alcohol dependence; smoking

Summary:

      The purpose of the study will be to evaluate the efficacy of mecamylamine in reducing alcohol
      consumption in smoking and non-smoking alcohol dependent patients.

      We hypothesize that mecamylamine will result in a greater reduction of alcohol consumption
      than placebo. We further hypothesize that mecamylamine will be effective in reducing both
      alcohol consumption and smoking in a subset of alcoholics who also smoke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  individuals with DSM-IV diagnosis of alcohol dependence

          -  smokers and non-smokers

          -  patients who do not require psychotropic medication for the management of their
             psychiatric symptoms

          -  individuals with a history of substance dependence (other than alcohol and tobacco)
             but have not met criteria for substance dependence in the past 30 days

          -  women with acceptable method of contraception

        Exclusion Criteria:

          -  pregnant women

          -  medications thought to influence drinking behavior including: acamprosate, disulfiram,
             naltrexone and ondansetron

          -  underlying medical conditions

          -  history of glaucoma, prostatic hypertrophy, urethral obstruction, cerebral
             arteriosclerosis, pyloric stenosis, or a history of hypersensitivity to mecamylamine

          -  DSM-IV diagnosis of bipolar disorder, schizophrenia, and schizophrenia-type disorders

          -  unstable medical conditions

          -  patients who require psychotropic medication for the management of an active
             psychiatric disorder

          -  patients on pharmacological treatment for alcohol and/or nicotine dependence