bioihbjkbjnl/mcl2 huggingface dataset:
Open-label, Multiple Ascending Dose Study of Ravulizumab (ALXN1210) in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Condition: Paroxysmal Nocturnal Hemoglobinuria; PNH
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Ravulizumab
Intervention description: All treatments were given as IV infusions.
Intervention MeSH terms: Ravulizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: complement inhibitor

Summary:

      The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of
      multiple intravenous (IV) doses of ravulizumab administered to complement inhibitor
      treatment-naïve participants with PNH.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥18 years of age

          2. PNH diagnosis confirmed by documented high-sensitivity flow cytometry

          3. Documented meningococcal vaccination not more than 3 years prior to dosing

          4. Female participants of childbearing potential were to use highly effective
             contraception starting at screening and continuing until at least 8 months after the
             last dose of ravulizumab.

          5. Willing and able to give written informed consent and comply with the study visit
             schedule

        Exclusion Criteria:

          1. Treatment with a complement inhibitor at any time

          2. Female participants who are planning to become pregnant, or are pregnant,
             breastfeeding or who had a positive pregnancy test at screening or Day 1

          3. Participation in an interventional clinical study within 30 days before initiation of
             dosing on Day 1, or use of any experimental therapy within 30 days prior to dosing on
             Day 1, or within 5 half-lives of the investigational product, whichever was greater

          4. History of allergy to any drug, allergen, excipients of ravulizumab or known allergy
             to Chinese hamster ovary cell proteins

          5. Inability to comply with study requirements

          6. History of any clinically significant cardiac, hepatic, immunologic, pulmonary, or
             rheumatoid disease that, in the Investigator's judgment, would preclude participation

          7. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make
             the participant unsuitable for enrollment
Safety and Efficacy of Nitrogen Mustard in Treatment of Mycosis Fungoides
Condition: Mycosis Fungoides
MeSH terms: Mycoses; Mycosis Fungoides
Intervention: mechlorethamine-MCH (nitrogen mustard)
Intervention description: All affected areas (lesions) are to be treated once daily for twelve months with mechlorethamine-MCH (nitrogen mustard) 0.02% PG or NM 0.02% AP ointment
Intervention MeSH terms: Mechlorethamine; Nitrogen Mustard Compounds
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 260.0
Sex: All
Healthy volunteers: No
Keywords: Mycosis Fungoides; Nitrogen Mustard; Cutaneous T-Cell Lymphoma; CTCL - Mycosis Fungoides

Summary:

      This study will evaluate the efficacy, tolerability and safety of the topical application of
      mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with mycosis fungoides confirmed by a skin biopsy

          -  Stage I or IIA patients must have been treated previously with prior topical therapies
             including PUVA, UVB, topical steroids, but not NM within the past 2 years, or topical
             carmustine (BCNU)

          -  Patients must be otherwise healthy with acceptable organ function.

          -  Prior to initiating study therapy, patients must not have had topical therapy within
             four weeks

          -  Lab values within normal range

          -  Willing/able to give consent

          -  Must use effective means of contraception if of childbearing potential

        Exclusion Criteria:

          -  Newly diagnosed mycosis fungoides with no prior therapy

          -  A prior history of treatment with topical NM within the past 2 years or topical
             carmustine (BCNU)

          -  Use of topical or systemic therapies for MF within four (4) weeks of entry in the
             study

          -  Patients with a diagnosis of stage IIB-IV MF

          -  Serious known concurrent medical illness or infection, which could potentially present
             a safety risk and/or prevent compliance with the requirements of the treatment program

          -  Pregnant or nursing females, or males and females of childbearing potential, not using
             an effective means of contraception

          -  Patients who have had radiation therapy within one year of study start

          -  Patients who have a history of a higher T score than T2 or a higher N score than N1

          -  Patients who do not agree to do all labs at one site
Omega-3 Fatty Acids in Adolescent Depression
Condition: Adolescent Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Omega-3 Fatty Acids; corn oil
Intervention description: 10 wk treatment period; placebo comparator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 12 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: Adolescents; Depression; Fish Oil; Omega-3 Fatty Acids; Psychiatry

Summary:

      Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of
      adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of
      omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1)
      change in the total score of the Children's Depression Rating Scale-Revised (CDRS-R) at the
      end of treatment (2) response rate on the Clinical Global Improvement scale (CGI) at the end
      of 10-week treatment.

      Hypothesis. Omega-3FA treatment in adolescents with MDD will result in a significant
      reduction of CDRS-R total scores, and a significantly higher improvement rate on the CGI at
      the end of treatment compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age: 12-19

          -  Depressed with DSM-IV diagnosis of MDD

          -  Duration of depressive episode greater than 6 weeks

        Exclusion Criteria:

          -  Current or past DSM-IV-TR bipolar, schizophrenia, psychosis, pervasive developmental
             disorder (PDD), and Tourette's disorder.

          -  Current diagnosis of eating, panic, conduct, obsessive compulsive, post traumatic
             stress, and/or substance-related disorders (other than nicotine).

          -  Adolescents who present with current suicidal ideation with intent or plan, or who may
             pose a danger to themselves.

          -  Current antidepressant treatment, or taken within 60 days prior to enrollment

          -  Neuroleptics taken within 90 days prior to enrollment
A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Belimumab
Intervention description: Belimumab 10mg/kg IV over one hour every 28 days
Intervention MeSH terms: Belimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 298.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SLE; Lupus

Summary:

      This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™
      in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.
    

Eligibility criteria:

        Primary Inclusion Criteria

        1. Have completed the LBSL02 trial and achieved a satisfactory response.

        Primary Exclusion Criteria

          1. Required more than 2 courses of corticosteroids for treatment of severe SLE flares in
             the last 5 months of LBSL02.

          2. Had an SLE flare during the last 30 days of LBSL02 and through the 1st dose in LBSL99.

          3. Used any of the following prohibited medications during their participation in LBSL02:

               -  Other investigational agents.

               -  Biologic therapeutic agents: adalimumab (Humira™), etanercept (Enbrel™),
                  infliximab (Remicade™), and rituximab (Rituxan™).

               -  Intravenous cyclophosphamide.

               -  Corticosteroids >100 mg/day prednisone equivalent for reasons other than severe
                  SLE flare.
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Pediatric
Condition: Caries,Dental; Apical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis; Dental Caries
Intervention: Kovanaze Nasal Spray; Articaine Injection
Intervention description: Intra-nasal local anesthetic; Local anesthetic
Intervention MeSH terms: Oxymetazoline; Tetracaine; Carticaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Cavities

Summary:

      The primary goal of the study is to compare the success rates of pulpal anesthesia (defined
      as ability to complete the intended dental procedure without the need for rescue anesthesia)
      between Kovanaze nasal mist and Articaine needle anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists Class I or II

          -  Preoperative heart rate of 55 to 100 beats per minute

          -  Maximum blood pressure reading of 166/100 mmHg

          -  Treatment for a pathology in the maxillary anterior tooth or premolar that requires
             administering local anesthesia

        Additional Pediatric Inclusion Criteria:

          -  Children >20 kg who require pulpotomy, restorative procedures, or stainless steel
             crowns in one maxillary tooth

        Additional Endodontic Inclusion Criteria:

          -  Adults (>18 years) who require non-surgical root canal treatment in maxillary anterior
             teeth

        Additional General Practice Inclusion Criteria:

          -  Adults who require restorations in the maxillary teeth that would need local
             anesthesia

        Exclusion Criteria:

          -  Inadequately controlled thyroid disease

          -  Five or more nosebleeds in the past month

          -  Known allergy to any study drug or para-aminobenzoic acid

          -  History of methemoglobinemia

          -  Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline),
             or non-selective beta adrenergic antagonists (i.e. propranolol);

          -  Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.
Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: PF-06700841; Vehicle (Placebo)
Intervention description: PF-06700841 topical cream; Vehicle topical cream
Intervention MeSH terms: PF-06700841
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 292.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Mild-to-Moderate Atopic Dermatitis; topical

Summary:

      This study is being conducted to provide data on efficacy, safety, tolerability and PK of
      multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of
      mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the
      dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future
      clinical development of topical PF-06700841.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Atopic Dermatitis for at least 3 months

          -  Investigator's Global Assessment (IGA) Score of 2 or 3

          -  Eczema Area Severity Index (EASI) score of 3-21

          -  Body Surface Area (BSA) of 2-20%

          -  Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

        Exclusion Criteria:

          -  Other forms of dermatological diseases (other than atopic dermatitis)

          -  Fitzpatrick skin type score greater than 5

          -  Clinically significant abnormal ECG, vital signs, and laboratory values

          -  Infection with HBV, HCV, herpes zoster or tuberculosis
A Study to Evaluate the Efficacy and Safety of CJC-1134-PC in Patients With Type 2 Diabetes Who Are Currently on Metformin Monotherapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: 1.5 mg or 2.0 mg CJC-1134-PC; Placebo
Intervention description: twice-a-week; twice-a-week
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 25 Years
Healthy volunteers: No
Keywords: GLP-1, incretin, type 2 diabetes

Summary:

      This is a multicenter, randomized, placebo-controlled, double-blind, Phase II study. The
      objective of this study is to evaluate the efficacy and safety of 12 weeks of treatment with
      CJC-1134-PC in patients who are currently on metformin monotherapy.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  BMI: 27 to 45 kg/m2

          -  Stable Type 2 diabetes mellitus for at least 3 months, as defined by the Investigator

          -  Stable life-style, i.e. diet & physical activity, as determined by the Investigator

          -  Stable metformin daily dose ≥1000 mg for at least 3 months

          -  Glycosylated hemoglobin (HbA1c) at screening ≥ 7.1% and ≤ 11%
Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo; Brodalumab
Intervention description: Placebo administered subcutaneously; Brodalumab administered subcutaneously
Intervention MeSH terms: Brodalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 421.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Inadequately controlled asthma, brodalumab, AMG 827

Summary:

      The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective
      compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite
      scores.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of asthma, and presently has reversibility over pre-bronchodilator forced
             expiratory volume in 1 second (FEV1) of ≥ 20% at screening

          -  Percent of predicted FEV1 ≥ 40% and ≤ 80% at screening

          -  Inhaled corticosteroid (ICS) ≥ 200 and ≤ 1000/μg/day fluticasone powder or equivalent

          -  Ongoing asthma symptoms with asthma control questionnaire (ACQ) composite score at
             screening and baseline ≥ 1.5 points

        Exclusion Criteria:

          -  History of chronic obstructive pulmonary disease (COPD) or other chronic pulmonary
             condition other than asthma

          -  History of allergic bronchopulmonary aspergillosis

          -  Respiratory infection within 4 weeks of screening or 1 week of baseline visit

          -  Subject has known history of Crohn's disease

          -  Subject has any other significant concurrent medical condition of laboratory
             abnormalities, as defined in the study protocol

          -  Subject has previously used any anti-interleukin-17 (IL17) biologic therapy

          -  Subject is pregnant or breastfeeding, or planning to become pregnant while enrolled in
             the study

          -  Female subject is unwilling to use highly effective methods of birth control unless 2
             years post-menopausal or surgically sterile

          -  Subject has severe depression measured by Personal Health Questionnaire Depression
             Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide
             Severity Rating Scale (e-CSSRS)

          -  Subject has a history or evidence of psychiatric disorder or substance abuse
             considered by the Investigator to pose a risk to subject safety
Study Evaluating the Effects of Toradol and Lyrica for Pain Control After Donor Nephrectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Ketorolac; Pregabalin; Placebo oral capsule; Saline
Intervention description: Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively.; Pregabalin was administered orally: 75 mg 30 minutes prior to operation.; Placebo oral capsule was administered orally 30 minutes prior to operation.; Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.
Intervention MeSH terms: Ketorolac; Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: live kidney donor; donor nephrectomy

Summary:

      The investigators will assess how the use of toradol and pregabalin affects return to bowel
      function and see if there is a difference in length of hospital stay. Narcotic use can affect
      bowel function so the investigators hypothesize that use of Toradol will decrease delayed
      bowel function and aid in a patients discharge and reduction of hospital stay.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients anticipating donating a kidney in a live kidney donor transplant.

        Exclusion Criteria:

          -  Patients not receiving a donor nephrectomy

          -  Pregnant, lactating, or nursing mothers

          -  Medical allergies or history that would otherwise be contraindicated for of a
             non-steroidal anti-inflammatory drug.
Reducing the Incidence of Nevirapine Resistance Mutations in Pregnant HIV Infected Women Who Receive Anti-HIV Drugs Prior to and After Giving Birth
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Didanosine, enteric-coated; Lopinavir/ritonavir; Nevirapine; Zidovudine
Intervention description: once daily; twice daily; single-dose at the onset of labor; twice daily
Intervention MeSH terms: Ritonavir; Lopinavir; Zidovudine; Nevirapine; Didanosine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 175.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV Seronegativity; Treatment Naive; Pregnancy; Perinatal Transmission; Vertical Transmission; Mother-To-Child Transmission; MTCT

Summary:

      The purpose of this study is to determine which of 3 different anti-HIV drug regimens given
      to HIV infected pregnant women during and after their pregnancies is most effective in
      reducing the incidence of nevirapine (NVP) resistance mutations. Blood levels of NVP and
      lopinavir/ritonavir (LPV/r) will also be studied.

      Study hypothesis: NVP resistance following single-dose NVP can be prevented with the
      concomitant administration of additional antiretroviral therapy (ART).
    

Eligibility criteria:

        Inclusion Criteria for Mothers:

          -  HIV infected

          -  Pregnant with a viable fetus

          -  Between 28 and 38 weeks of pregnancy

          -  CD4 count greater than 250 cells/mm3 within 30 days prior to study entry

          -  Able to receive oral ART during labor

          -  Willing to use acceptable forms of contraception while on study treatment

          -  Able to provide written informed consent

        Exclusion Criteria for Mothers:

          -  Known allergy or hypersensitivity to ddI, LPV, NVP, ritonavir (RTV), or ZDV

          -  Any ART other than ZDV during a previous pregnancy or the current pregnancy

          -  Certain medications

          -  Planning to receive additional ART during the first 8 weeks postpartum

          -  Planning to breastfeed

          -  Unlikely to comply with postpartum study requirements, in the opinion of the
             investigator

          -  Certain abnormal laboratory values within 30 days prior to study entry
Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Lubiprostone; Placebo
Intervention description: 8 mcg administered orally twice daily (BID); Matching placebo, 0 mcg administered orally twice daily (BID)
Intervention MeSH terms: Lubiprostone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Care provider and outcomes assessor were also blinded
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject meets the diagnosis of IBS-M or IBS-U as confirmed using the adapted ROME III
             Diagnostic Questionnaire for Adult Functional GI Disorders.

          -  Subject Screening diary entries must show an average worst abdominal pain in the past
             24 hours score of at least 4 on a 11-point scale.

          -  Subject must be on a stable dose of selective serotonin re-uptake inhibitors (SSRIs),
             serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO)
             inhibitors if taking antidepressants.

        Exclusion Criteria:

          -  Subject has current diagnosis of IBS with diarrhea (IBS-D) or IBS with constipation
             (IBS-C), according to Rome III Criteria.

          -  Any gastrointestinal (GI) condition, other than IBS-related, affecting GI motility or
             defecation.

          -  Medical/surgical condition that might interfere with the absorption, distribution,
             metabolism, or excretion of the study medication.